[Federal Register Volume 59, Number 219 (Tuesday, November 15, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27197]
[[Page Unknown]]
[Federal Register: November 15, 1994]
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Part II
Department of Labor
_______________________________________________________________________
Occupational Safety and Health Administration
29 CFR Part 1910 et al.
Respiratory Protection; Proposed Rule
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DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910, 1915, and 1926
[Docket No. H049]
RIN 1218-0099
Respiratory Protection
AGENCY: Occupational Safety and Health Administration (OSHA), Labor.
ACTION: Notice of proposed rulemaking (NPRM) and public hearings.
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SUMMARY: OSHA is proposing to modify its existing standards on
respiratory protection (29 CFR 1910.134, 29 CFR 1915.152 and 29 CFR
1926.103). The current respirator standard was adopted from a voluntary
consensus standard in 1971. Since that time, changes in methodology,
technology, and approach related to respiratory protection have
occurred, which OSHA's standard does not include. The purpose of this
rulemaking is to update the current standard to reflect these changes
so that employers will provide effective protection for employees who
wear respirators.
The proposed standard includes requirements for a written
respiratory protection program; procedures for selecting respirators;
requirements for medical evaluation; procedures for fit testing;
requirements for using respirators; procedures for maintaining
respirators; training; criteria for evaluating program effectiveness.
Public hearings are being scheduled to provide interested parties the
opportunity to orally present information and data related to the
issues raised by this proposed rule.
DATES: Written comments on the proposed standard must be postmarked on
or before February 13, 1995. Notices of intention to appear at the
informal public hearings on the proposed standard must be postmarked by
January 27, 1995. Parties who request more than 10 minutes for their
presentations at the informal public hearing and parties who will
submit documentary evidence at the hearing must submit the full test of
their testimony and all documentary evidence postmarked no later than
February 13, 1995. The hearing will take place in Washington, D.C. and
is scheduled to being on March 7, 1995 and continue until Friday, March
24, 1995.
ADDRESSES: Written comments should be submitted in quadruplicate or 1
original (hardcopy) and 1 disk (5\1/4\ or 3\1/2\) in WordPerfect 5.0,
5.1, 6.0 or ASCII to: The Docket Office, Docket H-049, U.S. Department
of Labor, Occupational Safety and Health Administration, Room N2625,
200 Constitution Avenue, N.W. Washington, D.C. 20210; (202) 219-7894.
(Any information not contained on disk, e.g., studies, articles, etc.,
must be submitted in quadruplicate.)
Notices of intention to appear at the informal rulemaking hearing,
testimony, and documentary evidence are to be submitted in
quadruplicate to: Mr. Tom Hall, OSHA Division of Consumer Affairs,
Occupational Safety and Health Administration, 200 Constitution Avenue,
N.W., Room N3649, Washington, D.C. 20210; (202) 219-8615. Written
comments received, notices of intention to appear, and all other
material related to the development of this proposed standard will be
available for inspection and copying in the public record in the Docket
Office, Room N2439, at the above address.
The hearing will be held in the auditorium of the U.S. Department
of Labor, 200 Constitution Avenue, NW., Washington, DC.
FOR FURTHER INFORMATION CONTACT: Proposal: Ms. Anne Cyr, Office of
Information and Consumer Affairs, Occupational Safety and Health
Administration, 200 Constitution Avenue, N.W., Room N3647, Washington,
D.C. 20210; (202) 219-8151.
Hearings: Mr. Tom Hall, Division of Consumer Affairs, Occupational
Safety and Health Administration, 200 Constitution Avenue, N.W., Room
N3649, Washington, D.C. 20210; (202) 219-8615.
SUPPLEMENTARY INFORMATION:
I. Clearance of Information Collection Requirements
5 CFR Part 1320 sets forth procedures for agencies to follow in
obtaining OMB clearance for information collection requirements under
the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. The
proposed revised respirator standard requires employers to allow OSHA
access to records. In accordance with the provisions of the Paperwork
Reduction Act and the regulations issued pursuant thereto, OSHA
certifies that it has submitted the information collection requirements
for this proposed rule on respiratory protection to OMB for review
under Section 3504(h) of that Act. OMB has approved (OMB number 1218-
0099) in concept the submitted information collection activities
contained in the proposed revision pending public consideration and
comment.
Public reporting burden for this collection of information is
estimated to be five minutes per response. Send comments regarding this
burden estimate or any other aspect of this collection of information,
to the Office of Information Management, Department of Labor, Room N-
1301, 200 Constitution Avenue, NW., Washington, DC 20210; and to the
Office of Information and Regulatory Affairs, Office of Management and
Budget, Paperwork Reduction Project (1218-AA05), Washington, DC 20503.
II. Introduction
A. Format of the Preamble
The preamble accompanying this notice of proposed rulemaking is
divided into fifteen parts, numbered I through XV. The following is a
table of contents:
I. Clearance of Information Collection Requirements
II. Introduction
A. Format of the Preamble
B. History of the Development of Respiratory Protection
C. Respirator Use
D. Types of Respiratory Hazards
E. Limitations of Respiratory Use
III. Legal Authority
IV. Background
A. Regulatory History
B. Need for the Standard
C. Recognition of the Need for a Standard by Other Groups
V. Certification/Approval Procedures
VI. Summary of the Preliminary Regulatory Impact Analysis and
Regulatory Flexibility Analysis and Environmental Impact Assessment
VII. Summary and Explanation of the Proposed Standard
A. Scope and Application
B. Definitions
C. Respiratory Protection Program
D. Selection of Respirators
E. Medical Evaluation
F. Fit Testing Procedures
G. Use of Respirators
H. Maintenance and Care of Respirators
I. Supplied Air Quality and Use
J. Identification of Filters, Cartridges, and Canisters
K. Training
L. Respiratory Protection Program Evaluation
M. Recordkeeping and Access to Records
N. Substance Specific Standards
O. Maritime Standards
P. Construction Advisory Committee
VIII. References
IX. Public Participation--Notice of Hearings
X. Federalism
XI. State Plan Standards
XII. List of Subjects
XIII. Authority and Signature
XIV. Proposed Standard and Appendices
XV. Proposed Substance Specific Standards Revisions
B. History of the Development of Respiratory Protection
The concept of using respiratory protective devices to reduce or
eliminate hazardous exposures to airborne contaminants first came from
Pliny (c. A.D. 23-79) who discussed the use of loose fitting animal
bladders in Roman mines to protect workers from the inhalation of red
oxide of lead (1,2). Later, in the 1700's, the ancestors of modern
atmosphere-supplying devices, such as the self-contained breathing
apparatus or hose mask, were developed. Although the devices themselves
have become more sophisticated in design and materials, respirators'
performance is still based on one of two basic principles; purifying
the air by removing contaminants before they reach the breathing zone
of the worker, or providing clean air from an uncontaminated source.
In 1814, a particulate-removing filter encased in a rigid container
was developed--the predecessor of modern filters for air-purifying
respirators. In 1854, it was recognized that activated charcoal could
be used as a filtering medium for vapors. World War I and the use of
chemical warfare also resulted in improvement in the design of
respirators. Overall, there have been few major developments in the
basic design of respirators over the years except for the resin-
impregnated dust filter in 1930. This development has made available
efficient, inexpensive filters that have good dust-loading
characteristics and low breathing resistance. Another more recent
development is the ultrahigh efficiency filter made from paper that
contains very fine glass fibers. These extremely efficient filters are
used for very small airborne particles and produce little breathing
resistance.
C. Respirator Use
The purpose of a respirator is to prevent the inhalation of harmful
airborne substances. Functionally, a respirator is designed as an
enclosure which covers the nose and mouth or the entire face or head.
Respirators are of two general ``fit'' types: Tight fitting (i.e.,
quarter masks, which cover the mouth and nose, and where the lower
sealing surface rests between the chin and the mouth; the half mask,
which fits over the nose and under the chin; and the full facepiece,
which covers from the hairline to below the chin), and loose fitting
(i.e., hoods, helmets, blouses, or full suits which cover the head
completely). There are two major classes of respirators: Air-purifying
respirators (devices which remove contaminants from the air), and
atmosphere-supplying respirators (those which provide clean breathing
air from an uncontaminated source).
Air-purifying respirators are grouped into three general types:
Particulate removing, vapor and gas removing, and combination. Elements
which remove particulates are called filters, while vapor and gas
removing elements are called either chemical cartridges or canisters.
Filters and canisters/cartridges are the functional portion of air-
purifying respirators, and they can generally be removed and replaced
once their effective life has expired. The exception would be
disposable respirators, those which cannot be cleaned and disinfected
or resupplied with an unused filter after use. Combination elements
that protect for both particulates and vapors and gases are also
available.
Particulate-removing respirators are designed to reduce inhaled
concentrations of nuisance dusts, fumes, mists, toxic dusts, radon
daughters, asbestos containing dusts or fibers, or any combination of
these substances, by filtering some of the contaminants from the
inhaled air before they enter the breathing zone of the worker. They
may have single use or replaceable filters. These respirators may be
non-powered or powered air-purifying (using a blower to pull
contaminated air through a filter; the resulting cleaned air is blown
on the face).
Vapor and gas removing respirators are designed with sorbent
elements (canisters or cartridges) that adsorb and/or absorb the vapors
or gases from the contaminated air before they enter the breathing zone
of the worker. Combination cartridges and canisters are available to
protect against both particulates and vapors and gases.
Atmosphere-supplying respirators are respirators which provide air
from a source independent of the surrounding atmosphere instead of
removing contaminants from the atmosphere. These respirators are
classified by the method by which air is supplied and the way in which
the air supply is regulated. Basically, these methods are: Self-
contained breathing apparatus (air or oxygen is carried in a tank on
the worker's back, similar to SCUBA gear); supplied air respirators
(compressed air from a stationary source is supplied through a high
pressure hose connected to the respirator); and combination self-
contained and supplied air respirators.
D. Types of Respiratory Hazards
Respiratory hazards may result from either an oxygen deficient
atmosphere or from breathing air contaminated with toxic particles,
vapors, gases, fumes or mists. The proper selection and use of a
respirator depends upon an initial determination of the concentration
of the hazard or hazards present in the workplace.
Contaminants are classified as particulate contaminants, which
include mechanical dispersoids, condensation dispersoids, dusts,
sprays, fumes, mists, fogs, smokes, and smogs; and vapors or gases
which include acids, alkalines, organics, organometallics, hydrides,
and inert materials.
The particulates may be dusts such as clays, limestone, gypsum, or
aluminum oxides; inert pulmonary reaction producing substances such as
silicates; minimal pulmonary fibrosis producing substances such as iron
oxide or tin oxide; extensive pulmonary fibrosis producing substances
such as free silica or asbestos; chemical irritants such as acids or
alkalies; systemic poisons such as pesticides, hydrogen cyanide or
lead; allergy producing substances such as cotton, isocyanates,
epichlorohydrin, fur fibers, or vegetable fibers; and febrile-reaction
producing agents such as bagasse, or copper and zinc oxide; and
biological materials.
The gaseous air contaminants include irritants such as nitrogen
dioxide, phosgene, and arsenic trichloride; asphyxiants such as carbon
monoxide, and hydrogen cyanide; anesthetics such as nitrous oxide,
hydrocarbons, and ethyl and isopropyl ether; and systemic poisons such
as carbon tetrachloride.
E. Limitations of Respirator Use
Not all workers can wear respirators. Individuals with impaired
lung function, due to asthma or emphysema for example, may be
physically unable to wear a respirator. Individuals who cannot get a
good facepiece fit, including those individuals whose beards or
sideburns interfere with the facepiece seal, will be unable to wear
tight fitting respirators. Determination of adequate fit is required
for a respirator to be effective.
In addition to the problems with usage already discussed,
respirators may also present communication problems, vision problems,
fatigue and reduced work efficiency. Nonetheless, it is sometimes
necessary to use respiratory protection as the means of control.
In principle, respirators frequently may be capable of providing
adequate protection. However, problems associated with selection, fit,
and use often render them ineffective in actual application, preventing
the assurance of consistent and reliable protection; regardless of the
theoretical capabilities of the respirator. Occupational safety and
health experts have spent considerable effort over the years developing
fit testing procedures and methods of measuring respirator protection
so that these adverse variables can be better controlled, thereby
improving protection for those employees required to wear them.
The comments which resulted from the Advance Notice of Proposed
Rulemaking (ANPR) that was published by OSHA on May 14, 1982 (47 FR
20803) suggest that one method for controlling some of the problems
associated with respirator selection, fit, and use is to describe
clearly the steps to be followed in administering a program to protect
employees required to wear respirators. The modifications in this
proposal are also intended to upgrade the provisions in Sec. 1910.134
to reflect the current state of the art in respiratory methodology and
technology.
III. Legal Authority
Authority for issuance of this proposed revised standard is found
primarily in sections 6(b), 8(c), and 8(g)(2) of the Occupational
Safety and Health Act of 1970 (the Act), 29 U.S.C. 655(b), and
657(g)(2).
Section 6(b) authorizes the Secretary to ``by rule promulgate,
modify, or revoke any occupational safety and health standard.'' This
notice is the first mandatory step in the procedure prescribed for
promulgating such new or modified standards.
The Congress specifically mandated that:
The Secretary, in promulgating standards dealing with toxic
materials, or harmful physical agents under this subsection, shall
set the standard which most adequately assure, to the extent
feasible, on the basis of the best available evidence, that no
employee will suffer material impairment of health or functional
capacity even if such employee has regular exposure to the hazard
dealt with by such standard for the period of his working life.
Development of standards under this subsection shall be based upon
research, demonstrations, experiments, and such other information as
may be appropriate. In addition to the attainment, of highest degree
of health and safety protection for the employee, other
considerations shall be the latest available scientific data in the
field, the feasibility of standards, and experience gained under
this section and other health and safety laws. (Section 6(b)(5).
The revisions which OSHA proposes would update current standards
concerning respiratory protection mainly by incorporating technological
advances and by expanding certain respirator program elements such as
fit testing and by clarifying other provisions.
These revisions are intended to ensure that employees who use
respirators to protect them from workplace atmospheric contamination,
will be protected to the technical limitations of the devices they
wear. Protection from exposure to workplace airborne contaminants is
one of the major goals of the Act and a major mission for the Agency,
since the risk to employees of chronic and acute disease because of
exposure to toxic substances is substantial and well documented (see
e.g., preamble to 29 CFR Part 1910, Air Contaminants, Proposed Rule, at
53 FR 20960 et seq.)
Similarly, these regulations need to be updated to assure that
employees are protected to the extent that currently available
technology permits. Therefore OSHA finds that revisions to these
regulations governing respiratory protection are clearly necessary and
appropriate to protect employees against the risk of material
impairment of health or functional capacity and are issued pursuant to
the authority of section 6(b)(5) of the Act).
Authority to issue this standard is also found in section 8(c) of
the Act. In general, this section empowers the Secretary to require
employers to make, keep, and preserve records regarding activities
related to the Act. In particular, section 8(c) gives the Secretary
authority to require employers to ``maintain accurate records of
employee exposures to potentially toxic materials or harmful physical
agents which are required to be monitored or measured under section
6.'' Provisions of OSHA standards which require the preparation and
monitoring of exposure records, such as contained in a written
respirator program, are also issued pursuant to section 8(c) of the
Act.
The Secretary's authority to issue this proposed standard is
further supported by the general rulemaking authority granted in
section 8(g)(2) of the Act. This section empowers the Secretary ``to
prescribe such rules and regulations as he may deem necessary to carry
out [his] responsibilities under the Act''--in this case as part of or
ancillary to, a section 6(b) standard. The Secretary's responsibilities
under the Act are defined largely by its enumerated purposes, which
include:
Encouraging employers and employees in their efforts to reduce the
number of occupational safety and health hazards at their places of
employment, and to stimulate employers and employees to institute new
and to perfect existing programs for providing safe and healthful
working conditions (29 U.S.C. 651(b)(1));
Authorizing the Secretary of Labor to set mandatory occupational
safety and health standards applicable to business affecting interstate
commerce, and by creating an Occupational Safety and Health Review
Commission for carrying out adjudicatory functions under the Act; (29
U.S.C. 651(b)(3));
Building upon advances already made through employee and employer
initiative for providing safe and health working conditions (29 U.S.C.
651(b)(5));
By providing for the development and promulgation of occupational
safety and health standards; providing for appropriate reporting
procedures with respect to occupational safety and health which
procedures will help achieve the objectives of this Act and accurately
describe the nature of the occupational safety and health problem;
exploring ways to discover latent diseases, establishing causal
connections between diseases and work in environmental conditions * * *
(29 U.S.C. 651(b)(6));
Encouraging joint labor-management efforts to reduce injuries and
diseases arising out of employment (29 U.S.C. 651(b)(13));
And developing innovative methods, techniques, and approaches for
dealing with occupational safety and health problems (29 U.S.C.
651(b)(5)).
Because this proposed revised standard is reasonably related to
these statutory goals, the Secretary finds that this standard is
necessary to carry out his responsibilities under the Act.
In addition, section 4(b)(2) of the Act provides for OSHA standards
to apply to construction and other work places where the Secretary
determines these standards to be more effective than existing standards
which otherwise apply to those workplaces. So we are applying them to
construction and maritime.
The Supreme Court's benzene decision (Industrial Union Department,
AFL-CIO v. American Petroleum Institute. 448 U.S. 601) requires OSHA,
in general, to make a ``significant risk determination'' before issuing
health and safety standards. It is clear that exposure to hazardous air
contaminants in the workplace poses significant risks to workers. Where
engineering controls cannot be used to reduce exposures below hazardous
levels, respirators properly selected, fitted and worn can contribute
substantially to a reduction in the level of air contaminants reaching
the employee's breathing zone. Under the current respiratory protection
standard, which lacks adequate requirements for fit testing, selection,
medical evaluation, use, maintenance, and respiratory protection
program provisions, employees wearing respirators are receiving less
protection than the respirators can potentially give, and in some cases
may suffer exposure to hazards as a result of improper respirator use.
The significant risk to employees therefore has not been adequately
reduced by the existing respirator standard.
The enforcement experience of OSHA and various state health
agencies demonstrate the wide-spread nature of defects in respirator
programs while the unamended respirator standard has been in effect.
From fiscal 1977 to 1982, 58% of inspected worksites where respirators
were used to protect against excessive levels of air contamination had
deficiencies in at least one respirator area, including respirator fit
condition, unapproved or unsuitable respirators, and lack of continuous
wear (Ex. 33-5). Inadequate supervision of respirator use was cited as
a major cause of improper and ineffective usage by the North Carolina
Department of Labor, Kentucky's Department of Labor and Virginia's
Bureau of Occupational Health (Docket H-160, Ex. 2-69, 2-103, 2-129).
These state plan states have respirator standards that are the same as
OSHA's unamended standard.
OSHA cannot precisely quantify the risk to employees whose
employers rely on inadequate respiratory protection programs to protect
them against excessive levels of atmospheric contamination. However,
the widespread levels of improper use of respirators put at significant
risk employees who, at least some of the time, are overexposed to air
contaminants. Based on OSHA's experience that one half of workplaces
using respirators use them incorrectly under the current standard, even
a small improvement in respirator use should work a significant
reduction in the risk of developing adverse health effects because of
preventable misuse of respirators. OSHA believes that a greater benefit
will result from the imposition of these revised requirements for the
following reason.
Each controllable variable of respirator performance, i.e., initial
fit, appropriateness of selection, and consistency of use is addressed
by these revisions. The proposed requirement for a program
administrator, for example, addresses the concerns of many commenters
that proper supervision is the core of an adequate respirator program
and effective respirator performance. Required fit testing protocols
are proposed to assure that the respirator does not leak around the
face, is comfortable and that the employee is taught how to properly
tension straps for optimum fit and comfort. Thus the proposed revised
standard with its provisions for quantitative and qualitative fit
testing, improved and clarified respirator selection, use, and
maintenance, will increase the effectiveness of respirators worn in the
workplace and significantly reduce the risks to employees to a greater
degree than the present standard.
OSHA has quantified the risk and reduction of risk as part of the
regulatory analysis and regulatory flexibility analysis, Section VI of
the preamble. That analysis clearly shows that workers wearing
respirators under the requirements of the current standard are exposed
to a significant risk of chronic and acute health effects because of
the inadequacies of the present standard. OSHA seeks comment on the
issue of significant risk and how the proposed respirator standard
revisions will affect that risk, along with any comment on the
regulatory analysis performed by OSHA and all other issues related to
significant risk.
IV. Background
A. Regulatory History
Congress created the Occupational Safety and Health Administration
(OSHA) in 1970, and gave it the responsibility for promulgating
standards to protect the health and safety of American workers. As
directed by Congress in the Occupational Safety and Health Act, OSHA
adopted existing Federal or national consensus standards, developed by
various organizations such as the American Conference of Governmental
Industrial Hygienists (ACGIH) and the American National Standard
Institute (ANSI). The ANSI standard Z88.2-1969, ``Practices for
Respiratory Protection'' (3), is the origin of the first six sections
of OSHA's 29 CFR 1910.134, ``Respiratory Protection'' (4). The seventh
section is a direct, complete inclusion of ANSI Standard K13.1-1969,
``Identification of Gas Mask Canisters.'' Until the adoption of these
standards by OSHA, most guidance on respiratory protective device use
in hazardous environments was advisory rather than mandatory.
The construction industry standard for respiratory protection, 29
CFR 1926.103, was promulgated in April 1971. On February 9, 1979, 29
CFR 1910.134 was formally recognized as also being applicable to the
construction industry (44 FR 8577) (4). OSHA is required under the OSH
Act to seek the advice of an existing advisory committee when
promulgating a rule which will affect an industry represented by the
committee. In view of the application of the respirator protection
standard to the construction industry, OSHA distributed copies of the
draft of this proposed revised standard on September 20, 1985 to the
Construction Advisory Committee for review and discussion at their next
meeting in February 1986 so that the Construction Advisory Committee
could prepare its official response. The response that was received
from the committee was considered in revising the draft proposal as
discussed later in this preamble.
The maritime standards were originally promulgated in the 1960's
under a different codification in the CFR by agencies which preceded
OSHA. The present code designations and their promulgation dates are,
as follows: 29 CFR 1915.82, February 20, 1960 (25 FR 1543); 29 CFR
1916.82, January 22, 1963 (28 FR 547); 29 CFR 1917.82, March 27, 1964
(29 FR 4052); and 29 CFR 1918.102, February 20, 1960 (25 FR 1565) (4).
The current 29 CFR 1910.134 requires that the employer establish
and implement a comprehensive respiratory protection program. The
program is to contain written procedures and provide for proper
cleaning, disinfection, storage, inspection and maintenance of the
respirators. General provisions are set forth on fitting and training.
Requirements are included for quality of breathing air and practices to
ensure that it is not contaminated. Provisions for emergencies and for
communication and rescue in atmospheres immediately dangerous to life
or health are specified. A color code for gas mask cansisters is
detailed and other provisions are included.
The current standard requires the employer to instruct and train
employees ``in the proper use of respirators and their limitations.''
The additional provisions of the proposal amplify the current
requirements by specifying, for example, that the training program
include instruction in procedures for inspection, donning and removal,
checking the fit, and sufficient practice to enable the employee to
become thoroughly familiar and confident with the use of the
respirator. OSHA believes, based on its experience promulgating and
enforcing respirator provisions in other health standards and
Sec. 1910.134, that such hands-on training can materially improve the
effectiveness of respirator use.
Recent OSHA health standards have imposed respirator related
requirements not found in 29 CFR 1910.134 (See section 1910.1018(h),
arsenic; section 1910.1025(f), lead; section 1910.1029(g), coke oven
emissions; and section 1910.1043(f), cotton dust). These requirements
include the following provisions.
* Quantitative fit tests have been required semiannually, (arsenic,
1910.1018(h)(3)(ii); lead, 1910.1025(f)(3)(ii).
* Employees have been given the option of using powered air-
purifying respirators (PAPR) upon request (arsenic,
1910.1018(h)(5)(iii); lead, 1910.1025(f)(2)(ii); coke oven emissions,
1910.1029(g)(2)(ii); cotton dust, 1910.1043(f)(2)(iv)).
* Employees have been permitted to change the filter elements of a
respirator whenever an increase in breathing resistance is detected,
(arsenic, 1910.1018(h)(4)(ii); lead, 1910.1025(f)(4)(ii); coke oven
emissions, 1910.1029(g)(4)(ii); cotton dust, 1910.1043(f)(4)(ii)).
* Employees have been permitted to wash their faces and respirator
facepieces to prevent skin irritation associated with using
respirators, (arsenic, 1910.1018(h)(4)(iii); lead 1910.1025(f)(4)(iii);
coke oven emissions, 1910.1029(g)(4)(iii); cotton dust
1910.1043(f)(4)(iii).
* Employers have been required to provide respirators that exhibit
minimum facepiece leakage, (arsenic, 1910.1018(h)(3)(i); lead,
1910.1025(f)(3)(i); coke oven emissions, 1910.1029(g)(4)(i); cotton
dust 1910.1043(f)(4)(i)).
* Referral of an employee to a physician trained in pulmonary
medicine has been required for an employee who exhibits difficulty
breathing either at fit testing or during routine respirator use
(arsenic, 1910.1018(h)(3)(iv); lead, 1910.1025(f)(3)(iii)).
The current respirator standard (1910.134(b)(11)) states that
respirators that are ``approved or accepted shall be used when
available.'' OSHA has chosen to recognize only those respirators
approved by the National Institute for Occupational Safety and Health
(NIOSH), and the Mine Safety and Health Administration (MSHA). The
NIOSH and MSHA respirator performance requirements are given in Title
30, Code of Federal Regulations, Part 11. A revision of that standard
is now being considered by NIOSH and MSHA.
Because of differences with the respirator requirements in other
OSHA standards, changes in respirator methodology and technology, and
the revision of referenced documents or related codes, OSHA published
an Advance Notice of Proposed Rulemaking (ANPR) on May 14, 1982 (47 FR
20803). This notice sought information on the effectiveness of the
current provisions, the need for revision, and the substance of what
these revisions might be. Responses were received from 81 interested
parties, and generally supported revising OSHA's respiratory protection
provisions and provided suggestions for approaches the Agency might
take (Ex. 15).
On September 17, 1985 OSHA announced the availability of a
preliminary draft of the proposed respiratory protection standard
revision for public comment (the preproposal draft standard press
release). This preproposal draft standard reflected the public comments
received from the May 1982 ANPR and OSHA's own analysis of changes
needed in the standard to take into account the current state-of-the-
art for respiratory protection. Responses were received from 56
interested parties (Ex. 36) and their comments have been reviewed in
preparing this proposal.
B. Need for the Standard
This rulemaking addresses an existing standard, rather than
addressing a new subject area, and seeks to correct the inadequacies of
that existing standard. Since the OSHA standards on respiratory
protection were adopted, research on the proper use of such equipment
has resulted in new technology which improves protection for the
wearers. The current standards do not reflect what is now accepted
practice for implementation of comprehensive respiratory protection
programs to protect employees. This is particularly true in the areas
of fit testing and assignment of protection factors to respirators.
The wearing of respiratory protective devices to reduce exposure to
airborne contaminants is widespread in industry. It has been estimated
that 2.6 million workers wear respirators, either occasionally or
routinely, in non-emergency work situations. In addition, over 59,000
facilities maintain respirators for emergency use (5, Ex. 34). Although
in most situations it is preferred industrial hygiene practice to use
engineering controls to reduce contaminant emissions at their source,
there are operations where this type of control is not technologically
or economically feasible or is otherwise inappropriate. There are many
variables which affect the degree of protection afforded by these
respiratory protective devices.
Indeed, the misuse of respirators can actually be hazardous to
employee safety and health. Selection of the wrong equipment, one of
the most frequent errors made in respiratory protection, will result in
the employee being unknowingly vulnerable to the hazard and thus
inhaling concentrations of the contaminant that may be harmful. This
may result in a broad range of health effects caused by airborne
contaminants, including silicosis, asbestosis, permanent lung damage
and cancer. In the report by Rosenthal and Paull (Ex. 33-5) it is shown
that, on the basis of OSHA's citation records, there is a high degree
of correlation between inadequate respirator programs and overexposures
to respirator wearers exposed to regulated substances. Respirators
which are not maintained, inspected, and cleaned, can actually increase
exposure, as well as cause dermatitis or skin irritation and place a
greater strain on the respiratory system. Because the wearing of the
respirator gives the employee a sense of security and presumed
protection which may be false, an improper respirator program presents
a high degree of hazard for the employee.
The devices themselves can only provide the protection they are
designed for if they are properly selected for the task; if they are
fitted to the wearer and are consistently donned and worn properly; and
if they are maintained and cared for so they continue to provide the
protection required for the work situation. These variables can only be
controlled if a comprehensive respiratory protection program is
developed and implemented in each workplace where respirators are used
to protect employees from inhalation of airborne contaminants. OSHA has
reviewed the present rulemaking record and the record of citations for
respirator standard violations. On the basis of that review it is clear
that to be effective such a program must use an integrated, systematic
approach that will result in consistent and appropriate choices of
respiratory equipment to be used; involvement of employees to ensure
that they understand why respirators are being worn, and how they
contribute to their effective use; and monitoring of the equipment and
its use to ensure that respirator effectiveness is optimized.
There are many examples of how respirators may not provide the
protection they were designed to provide in the absence of an effective
respirator program with adequate employee training. When the hazardous
substance is a dust, mist or fume there are often conditions under
which it is possible for the inside of the respirator to become
contaminated with the hazardous substance. For example, the employee
may have an itch on the cheek and scratch it with a dirty finger thus
destroying the integrity of the respirator fit.
An employee may leave the respirator area, remove the respirator,
and rest it on his or her chest. The inside of the respirator could
then pick up the contaminant from the air or work clothes and later
when the respirator is donned the employee will inhale the contaminant
from within the respirator. If a respirator is not cleaned properly or
if it is stored in a locker or on a ledge covered with the contaminant,
the employee will again breathe in the contaminant from within the
respirator.
An employee engaged in manual labor may dislodge the respirator
with a tool or even a normal motion unless the respirator has been
appropriately fit tested and the employee knows that a readjustment is
necessary. An employee may be engaged in work which requires good
vision or extensive communication. Without conscious thought the
employee may push the respirator into a position that improves vision
or make talking easier but which would result in a poor facepiece seal.
As discussed later in this preamble, several studies of the
performance of respirators worn in the workplace have been submitted to
the regulatory docket to show that in actual use, respirators can be
effective. These studies of workplace protection factors (WPFs) are
necessarily performed in workplaces which have good respiratory
protection programs. Consequently though the studies on WPFs may
provide a reasonable criterion for setting maximum protection factors,
it is not the case that those levels of protection are always achieved
even if employers have an adequate respirator program. In the case of a
poor respirator program it should be apparent that these levels would
seldom be achieved.
The complexity of the necessary program, and the extensive
commitment of ongoing resources to maintain that program, are often not
sufficiently considered when determining control measures to be used.
As stated in one commonly used industrial hygiene text (6):
There will always be a temptation to resort to respirators as a
cheap substitute for a ventilation system. If this is done it is
clear that management has not carefully considered the alternatives
since reliance on and effective use of respirators is definitely not
cheap.
As discussed above, OSHA's current standard in 29 CFR 1910.134 was
largely adopted from, and references, the ANSI Z88.2-1969 standard on
respiratory protection. ANSI issued a revised version of that standard
in 1980 (ANSI Z88.2-1980) (Ex. 10). ANSI's intent in issuing this
revision was to ensure that the standard did ``reflect the current
state of the art.'' ANSI accomplished this by expanding and adding to
the standard provisions which address technological developments in
respiratory protection since the 1969 standard was published.
Techniques in fit testing and the use of protection factors are two
areas which have been elaborated upon in the 1980 standard to help
ensure more effective protection for respirator wearers.
This change highlights the need for revising the OSHA standard,
particularly since Sec. 1910.134(c) specifies that respirators are to
be selected according to the 1969 ANSI standard and provides no
additional guidance for employers. Moreover, it is necessary to change
OSHA's standard to ensure that it too reflects current respiratory
protection methodology in order to provide appropriate protection for
employees.
The 1980 ANSI standard was a logical extension of the 1969 ANSI
standard (and thus OSHA's) in many respects. It established
requirements for a respiratory protection program so that respirator
selection, fit, and use were standardized, thus controlling some of the
variables which make respirators ineffective. The program was to
include written standard operating procedures; assessment of the
fitness of potential respirator wearers; selection of respirators;
training; fit testing; maintenance; and program evaluation.
One regulatory alternative in this regard would have been to adopt
the ANSI Z88.2-1980 standard, or to at least base the rulemaking
largely on the latest ANSI standard as was done with the original OSHA
standard. ANSI, however, was developing a major revision of its 1980
standard, recently finalized as ANSI Z88.2-1992. OSHA has given this
latest ANSI standard detailed consideration in preparing this proposal.
An OSHA standard based entirely on the 1980 ANSI standard would have
been obsolete as soon as published. OSHA has therefore made the
decision to pursue a rulemaking based on existing data and the record
generated thus far by responses to the ANPR and the prepublication
draft. The proposed standard has included provisions of the 1980 and
1992 ANSI standards where justified by the record. The reasons for
provisions which differ from those in the ANSI standards are given in
this preamble in the discussion of the content of the proposed
standard. OSHA has chosen not to adopt the ANSI standard per se, but
many of the provisions, as well as the general approach, are consistent
with ANSI.
In the ANPR, OSHA asked if the ANSI Z88.2-1980 standard should be
adopted. For the most part, respondents did not advocate that the
Agency simply adopt the ANSI standard (Ex. 15-13, 15-30, 15-34, 15-40,
15-45, 15-56, 15-73, 15-80). However, a number of respondents did
advocate that it be used as guidelines or a reference for the OSHA
standard or that modifications to it might make it appropriate for
adoption (Ex. 15-19, 15-31, 15-37, 15-43, 15-51, 15-67).
In the ANPR, OSHA requested comments on the need to revise
Sec. 1910.134, and 1980 ANSI standard notwithstanding. Only five
respondents indicated that the standard should not be revised (Ex. 15-
10, 15-35, 15-56, 15-75 (A and B), 15-77). The overwhelming majority of
respondents, representing a wide range of organizations, stated that
Sec. 1910.134 needs to be revised to reflect current technology and to
help ensure appropriate protection of employees (Ex. 15-11, 15-18, 15-
20, 15-26, 15-30, 15-42, 15-50, 15-54, 15-62, 15-74, 15-76, 15-80).
For example, industry respondents such as the Chemical
Manufacturers Association (CMA) expressed the view that (Ex. 15-22):
The requirements of 1910.134 were adequate at the time they were
adopted, but have been outdated by advances in respirator
technology. The standard should be updated to reflect current
conditions and to permit sufficient flexibility for companies to
respond to continuing technological improvements. Present standards
tend to suppress innovation and have a potential for harm by
retarding the adoption of technological advances.
The Los Alamos National Laboratory (LANL), an institution which has
conducted considerable research on respiratory protection, also
supported the need to revise OSHA's current standard, and commented
upon the appropriate approach to take (Ex. 15-79):
Currently standards should be revised to reflect changes in
respiratory protection capabilities, techniques, and equipment which
have been developed over the past 10 years. ANSI Z88.2 (1980)
provides the best basis for developing a new standard. In addition,
the ``Guide to Industrial Respiratory Protection'' (published as Los
Alamos report LA-6671-M, and Health, Education, and Welfare (HEW)
Publication, National Institute for Occupational Safety and Health
(NIOSH 76-189) provides detailed information relative to the
requirements for an adequate respirator program. It is not
recommended that direct adoption of sections, of either of these
documents, be the approach used by OSHA. Both documents are several
years old, and the ANSI document constitutes a compromise between
various interests involved in developing and adopting a consensus
standard. Development of a revised standard will require a major
effort by OSHA to identify, update, and expand those sections of
ANSI Z88.2 (1980) which should be made part of the new OSHA
standard.
Labor representatives also supported revising the standard, as
represented by this statement of the United Steelworkers of America
(Ex. 15-28):
At the present time the respiratory protection standard is not
effective in providing workers with any great degree of protection
due to the inadequacies of the standard, lack of requirements for
employers to follow so that all respiratory protection programs are
uniform and equally protective, and ineffective enforcement due to
the vagueness of the requirements.
Manufacturers of respiratory protective devices are also among
those who support revising OSHA's current respiratory protection
standards. For example, the Minnesota Mining and Manufacturing Company
stated (Ex. 15-30):
When 1910.134 was promulgated nearly a decade ago it reflected
the state-of-the-art for a good respiratory protection program. The
state-of-the-art for respiratory protection, however, has rapidly
advanced since that time and although many of the elements included
in the original standard retain their relevance and importance,
other elements have been developed and more efficient means for
achieving the goals of an effective respiratory protection program
have been introduced * * *
There are two issues in particular which have evolved
technologically since the current OSHA standards were adopted:
Assignment of protection factors or maximum use concentrations for
particular models or types of respirators; and the development of fit
testing procedures.
With respect to assigned protection factors, OSHA has decided not
to establish its own set of numbers but instead to defer to NIOSH in
setting assigned protection factors for the various respirator classes.
NIOSH will be developing assigned protection factors as part of its
revised respirator certification standard, 42 CFR Part 84. Since NIOSH
may not publish 42 CFR Part 84 before this OSHA respirator standard
revision is finalized, OSHA will in the interim enforce the assigned
protection factors listed in the NIOSH Respirator Decision Logic (RDL).
The concept of protection factors and the decision to defer to NIOSH
are discussed in more detail in a later section of this preamble.
Fit testing, the other area in which considerable advances have
been made since the promulgation of OSHA's current standard, also
varies among the substance-specific standards. The cotton dust standard
(29 CFR 1910.1043) requires that the respirator used exhibit minimum
facepiece leakage and be fitted properly. The coke oven emissions
standard (29 CFR 1910.1029) requires annual quantitative fit testing,
but has no protocol for fit testing. The lead standard (29 CFR
1910.1025) requires either qualitative or quantitative fit testing
every six months and contains specific qualitative fit test protocols
to be followed. Although the current respiratory protection standard
refers to the necessity for proper fit, there are no procedures to
follow or specific indications of how fit factors are to be taken into
account in the assignment of respirators.
There are two types of fit testing that can be used for tight
fitting facepiece respirators that rely on a facepiece-to-face seal to
perform adequately. Qualitative fit testing involves the introduction
of a test agent into the breathing zone of the respirator wearer which
can be detected by its irritant properties, taste, or smell. If the
wearer detects the characteristic effect of the test agent used, it
indicates that the respirator is leaking and does not fit properly, and
thus a different respirator is needed to protect that employee.
Quantitative fit testing involves the generation of a known
concentration of a test agent outside the facepiece, and a measurement
of the concentration within the facepiece of the respirator. The ratio
of these concentrations yields a number which indicates the protective
capability of the device. This approach does not involve the subjective
response of the wearer as does the qualitative fit test.
OSHA began including requirements for the use of quantitative fit
testing in substance-specific standards starting in 1976 with the coke
oven emissions standard. However, no procedures were provided. In the
lead standard, OSHA conducted a separate rulemaking proceeding to
address the appropriateness of QLFT. It was determined at that time
that qualitative fit testing can be appropriate, but only under certain
conditions. It was found, for example, that such fit testing can
provide a reasonable degree of reliability only when specified
protocols are followed. Thus the lead standard was revised to permit
qualitative fit testing as well as quantitative fit testing to protect
employees in atmospheres no greater than ten times the permissible
exposure limit for lead, when exposed employees are wearing half mask
negative pressure air-purifying respirators.
The overall problems with respect to QLFT protocols that came to
the surface in the lead standard revisions, plus the fact that there
was no specified QNFT protocol, made it apparent that these subjects
needed to be addressed in the overall respiratory protection standard.
Proper fit is so essential to maximizing functioning of respirators
that OSHA must include in its requirements the latest findings of
respirator research on means to assess and assure such fit.
In assessing the need to revise Sec. 1910.134, OSHA reviewed the
Agency's enforcement statistics related to this standard for a period
of about ten years, from 1972 to 1982 (9). This standard is one of the
most frequently cited health standards, which indicates both a lack of
understanding as to what is required for compliance, and a lack of
awareness as to the importance of establishing and implementing a
comprehensive respiratory protection program. During the period
reviewed, there were 22,662 violations of the standard recorded, of
which 8,406 were serious violations (37%). Some 3,648 of the violations
were for not establishing a program (1,752 of these were serious
because overexposure to hazardous substances were involved). Other
commonly cited provisions include development of standard operating
procedures; training and fit testing; cleaning and disinfection of
equipment; storage of equipment; and use of approved respirators.
Compliance should be enhanced by the provisions of the proposed
standard. In those areas which are frequently cited, the new proposal
provides additional guidance for employers to help ensure that they are
aware of what is required to comply, and thus protect their employees
adequately. OSHA expects that these revisions will improve the level of
protection provided by the current standard: nothing in these revisions
is intended to decrease protection provided under the current standard.
To summarize OSHA's position, the Agency has determined that
promulgating a revised respiratory protection standard is necessary to
ensure that employees wearing respirators in the workplace are doing so
under conditions which adequately protect their health. This
determination by OSHA is supported by the public in responses to the
ANPR published by the Agency. It is also necessitated by changes in
respiratory protection methodology and subsequent revisions to the
consensus standards upon which the current standard is based, thus
making the current standard outdated. The determination of the need for
the standard is also supported by OSHA's experiences in promulgating
substance-specific standards with respiratory protection provisions in
them, and in the Agency's enforcement experiences with the current
standard.
Based on an evaluation of these considerations, OSHA has prepared
this proposed standard and is hereby initiating the public rulemaking
process.
C. Recognition of the Need for a Standard by Other Groups
The need for standardization in this area, particularly for
consistent guidance and controlled practices, can also be demonstrated
by the number and extent of voluntary standards that have been adopted,
as well as by the existence of standards at all levels of government.
As has already been discussed, the primary voluntary consensus
standard in this area was that developed by the American National
Standards Institute as ANSI Z88.2-1980, entitled ``Practices for
Respiratory Protection'' (Ex. 10). This standard was an updated version
of the 1969 ANSI standard which was used as the primary basis of OSHA's
current standard, Sec. 1910.134. Following are some of the 1980 ANSI
standard changes:
Oxygen deficiency is more thoroughly discussed.
Quantitative fit testing is now included and described.
Qualitative fit testing is more fully described.
The concept of protection factors is introduced and
protection factors are assigned.
ANSI has also developed a new standard on physical qualifications
for respirator use (ANSI Z88.6-1984) (Ex. 38-10).
The OSHA standard, based on the outdated 1969 ANSI standard, does
not address these topics. The ANSI revisions reinforce OSHA's decision
to revise its standard to address the same and other issues.
Other countries also recognized the need for standards governing
the use of respirators. Of particular note is the consensus standard
recently developed by the Canadian Standards Association (Z94.4-M1982,
Selection, Care and Use of Respirators) (10). This document is a
comprehensive treatment of the subject and, similar to OSHA's proposed
standard, its emphasis is on the establishment and implementation of a
comprehensive respiratory protection program. As stated in the preface
to that standard:
The primary aim of this Standard is to give detailed instruction
in the selection of the proper respirator and its use and
maintenance. The emphasis is on the implementation of a respiratory
protection program developed in a logical progression of steps
beginning with:
(a) A very clear definition of the hazards that will be
encountered and the degree of protection required;
(b) The selection and fitting of the respirator;
(c) The required training in the correct use and care of the
respirator; and
(d) The implementation of a maintenance program that will ensure
that a high level of respiratory protection is maintained.
The Canadian consensus standard deals with several areas in more
detail than OSHA's current standard, and some of the language used has
been incorporated into this proposed standard, particularly in the
areas of training and program evaluation.
Documents developed by U.S. military organizations also indicate
the need for comprehensive respiratory protection programs. A military
standard entitled ``Respiratory Protection Program'' (TB MED 223/AFOSH
STD 161-1/DLAM 1000.2) has been developed for the use of the Air Force,
Army, and the Defense Logistics Agency (15). This document is similar
to OSHA's current standard (Sec. 1910.134), but includes sections which
expand upon the requirements of that standard and provide additional
guidance in critical areas. The military standard provides considerable
direction on the selection of respirators, including the protection
factor concept, that is not included in OSHA's current standard. It
also provides additional information on fit testing and training.
OSHA's proposed standard similarly recognizes the deficiencies of
Sec. 1910.134, and provides additional guidance to employers in these
same areas as well as others.
It can be seen from this brief discussion that there is widespread
agreement among safety and health professionals that adequate
respiratory protection cannot be provided in the absence of specific
procedures. The range of equipment choices available, the diversity of
hazards against which they are to protect, the differences in work
situations, and other variables increase the complexity of the decision
making process in terms of selecting the appropriate respirators, and
ensuring they fit, are worn properly, and are maintained as necessary.
OSHA proposes to revise its current standard to ensure that appropriate
procedures are implemented by employers, and thus increase the
probability that protection to the extent technologically feasible for
respirators will be provided for employees.
V. Certification/Approval Procedures
Section 1910.134 requires that only those respirators approved
jointly by NIOSH and MSHA be used by the employer when they exist. The
current respirator testing and approval regulation, 30 CFR 11, which
authorized the Bureau of Mines (BM) and NIOSH to jointly approve
respiratory protection devices was promulgated on March 25, 1972 at 37
FR 6244. On November 5, 1974 the Mine Enforcement Safety Administration
(MESA) joined NIOSH in jointly approving respirators. Following the
transfer of MESA to the Department of Labor, where it became the Mine
Safety and Health Administration (MSHA), authority was transferred on
March 24, 1978 to MSHA for joint approval with NIOSH of respirators.
Most of the BM respiratory testing methods, while developed in the
1950's or earlier, were changed in the 1970's to reflect changes in
testing technology.
NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was
held in July 1980 to address the certification program. On August 27,
1987, NIOSH published a notice of proposed rulemaking (52 FR 32402)
which would allow NIOSH to certify respirators under the new 42 CFR
Part 84 regulations, replacing the current joint NIOSH/MSHA 30 CFR 11
certification regulations. The proposed NIOSH certification regulations
contained new and revised requirements for testing and certification of
respirators, and included a set of minimum assigned protection factors
for various classes of respirators. Public hearings on the first draft
NIOSH proposal were held in January, 1988. On the basis of the comments
received, NIOSH is preparing a revised proposal for further public
comment.
Numerous commenters to the ANPR addressed the issue of NIOSH
respirator certification (Ex. 15-11, 15-27A, 15-58, 15-14, 15-43, 15-
50) and most agreed that the certification program should be improved.
Some suggested that OSHA assume the function of certification of
respirators. OSHA believes it is advisable not to undertake operation
of the certification program currently operated by NIOSH and MSHA. OSHA
has neither the expertise nor equipment to perform respirator
performance testing. OSHA intends that information generated in this
proceeding will be made available to NIOSH to use in its revision of
its respirator certification standards, and that NIOSH will make its
rulemaking record available to OSHA. OSHA believes that, for the
present, the best course is to continue to require NIOSH respirator
certification as it has in the past.
VI. Summary of the Preliminary Regulatory Impact Analysis and
Regulatory Flexibility Analysis and Environmental Impact Assessment
Introduction
Executive Order 12866 requires that a regulatory impact assessment
be conducted for any rule having an annual effect on the economy of
$100 million or more, or adversely affecting in a material way the
economy, sector of the economy, productivity, competition, jobs, or
state, local or tribal governments. In addition, the Regulatory
Flexibility Act of 1980 (Pub. L. 96-353, 94 Stat. 1164 (5 U.S.C. 601 et
seq.)) requires the Occupational Safety and Health Administration
(OSHA) to determine whether a proposed regulation will have a
significant economic impact on a substantial number of small entities,
and the National Environmental Policy (NEPA) of 1969 (42 U.S.C. 4321,
et seq.) requires the agency to assess the environmental consequences
of regulatory actions.
In order to properly assess potential impacts, in 1988 OSHA
prepared a Preliminary Regulatory Impact and Regulatory Flexibility
Analysis (PRIA) for the proposed revisions to the respiratory
protection standard. This analysis includes a profile of the affected
industries, the estimated number of workers who wear respirators, and
the nonregulatory alternatives, technological feasibility, costs,
benefits, and an overall economic impact of the proposed standard. The
PRIA is available in the OSHA Docket Office. OSHA believes the basic
data and conclusions are still correct. Inflation has increased costs
but has generally increased profits and sales in reasonably similar
proportions. This assessment is largely based upon the conclusions of
the PRIA; cost numbers have been adjusted for inflation.
Data Sources
The primary sources of information used for this impact analysis
are a report by Centaur Associates, Inc. entitled, ``Preliminary
Regulatory Impact Analysis of Alternative Respiratory Protection
Standards'' and a report by Centaur Associates, Inc. entitled,
``Compliance Cost Analysis: Current and Proposed Respiratory Protection
Standards'', available in the docket. Most of the information contained
in this report was collected from an in-depth sample survey of the
current work practices in 2,300 manufacturing plants in which
respirators are used. The results from the manufacturing sector were
extrapolated to nonmanufacturing plants and construction firms.
A third source of data are the comments received by OSHA in
response to the Advanced Notice of Proposed Rulemaking (ANPR). OSHA
welcomes additional comments and all information supplied will be
carefully reviewed and evaluated for incorporation into the Regulatory
Impact Analysis (RIA) that will accompany the final rule.
Industries and Employees Affected
The data currently available to OSHA indicate that the proposed
standard would affect approximately 3.6 million employees of whom 1.6
million are employed in the manufacturing sector, 1.5 million are
employed in the nonmanufacturing sector, and 0.5 million are employed
in the construction sector. Of the 3.0 million employees who wear
respirators for routine or occasional work, 1.1 million use respirators
routinely and 1.9 million use respirators occasionally. About 600,000
employees wear respirators for both routine and emergency use. Of these
600,000 employees, approximately 150,000 wear respirators only for
emergencies. Respirators are used routinely or occasionally in about
606,200 establishments of which 123,200 are manufacturing plants,
360,100 are nonmanufacturing plants, and 122,900 are construction
sites. Respirators are also used only for emergencies in another 51,800
establishments, of which 15,200 are manufacturing plants, 27,300 are
nonmanufacturing plants, and 9,300 are construction sites. Each general
industry and construction sector would be affected by this proposed
standard because respirators are used in many different work activities
in each of these sectors.
Nonregulatory Environment
In general, worker compensation systems designed to compensate
employees for occupationally related illnesses have not had a
significant impact upon the incidence of long-term chronic occupational
illnesses. One reason is that it is extremely difficult to determine
the cause of illness at the time the disease is diagnosed. The long
latency period between the exposure and the onset of disease, and the
mobility of employees among occupations and firms combine to make it
difficult to establish a direct causal relationship between an
occupational exposure and the resultant illness. The absence of a
readily observable cause and effect relationship provides a
disincentive for some firms to establish appropriate safety and health
measures. In addition, the lack of information regarding health risks,
inadequate training, or a misunderstanding of the function of a
respirator may lead to employee exposure to harmful levels of hazardous
substances. Thus, the nonregulatory environment does not guarantee
employee safety because the economic incentives are absent, employees
are improperly trained in respirator use, and employees do not have
sufficient information on the resultant benefits of respirator use.
Technological Feasibility
The proposed respirator standard does not require the use of large-
scale capital equipment. All of the provisions involve equipment,
evaluations, and work practices that are widely used. Thus, on the
basis of the information currently available, the proposed standard has
been found to be technologically feasible. Additional information that
is submitted will be carefully evaluated by OSHA before issuing the
final rule.
Summary of Cost
OSHA derived its cost estimates by first examining the cost of
coming into compliance with both the existing and proposed standards,
using current work practices as its baseline. This estimate does not
include the cost of purchasing the respirators; it includes only the
cost of all the other activities required by the existing and proposed
respiratory protection programs. The requirement to wear respirators
comes from other standards or specific conditions--not from this
standard. Consequently, respirator purchase has been costed in other
standards which require their use. This standard requires improvements
in the respirator program when other standards require their use and
this analysis costs these additional program requirements.
OSHA estimates that the total annualized incremental cost of the
proposed revisions to the respirator standard are $106.8 million. As
shown in Table A, approximately half of this cost ($55.6) is estimated
to fall on the nonmanufacturing sector, with the remainder in
manufacturing ($38.2) and construction ($13.1). The largest incremental
cost is attributable to enhanced requirements for qualitative fit
testing ($58.5 million). Other enhanced requirements include provisions
dealing with disposable respirator practices ($16.7 million),
respirator facepiece selection ($15.2 million), employee training
($14.4 million) and respirator use in IDLH atmospheres ($10.4 million).
In reviewing the original standard, some provisions were considered
to impose costs on employers without providing safety, and have been
modified. Cost savings would be derived from modified requirements
regarding air quality in atmosphere-supplying respirators ($8 million)
and eyeglass mounts ($0.4 million). These estimates are conservative,
as they do not factor in savings to employers already in compliance
with existing provisions.
While the proposed standard clarifies a number of existing
requirements, several of them were judged in the PRIA not to actually
impose a new burden on employers. However, the respirator survey found
significant noncompliance with several provisions of the existing
standard, and by extension, the proposed standard. Costs relating to
compliance with these provisions is discussed in depth in the PRIA.
Table A.--Annualized Costs of Proposed Revisions to Respirator Standard (Millions $1992)\1\
----------------------------------------------------------------------------------------------------------------
Sector
Provision -----------------------------------------------------------
Manufacturing Nonmanufacturing Construction Total
----------------------------------------------------------------------------------------------------------------
Medical............................................. $0.0 $0.0 $0.0 $0.0
Qualitative Fit Testing (with protocols)............ 17.3 33.0 8.1 58.5
Employee Training................................... 5.7 6.6 2.1 14.4
Program Administrator Training...................... 0.0 0.0 0.0 0.0
Written Procedures.................................. 0.0 0.0 0.0 0.0
Program Administration and Respirator Maintenance... 0.0 0.0 0.0 0.0
Storage............................................. 0.0 0.0 0.0 0.0
Eyeglass Mounts..................................... -0.2 -0.1 -0.0 -0.4
Poor Warning Properties............................. 0.0 0.0 0.0 0.0
Respirator Use in IDLH\2\ Atmospheres............... 6.6 3.2 0.7 10.4
Air Quality in Atmosphere-Supplying Respirators..... -4.2 -3.1 -0.7 -8.0
Disposable Respirator Practices..................... 9.4 5.6 1.7 16.7
Respirator Facepiece Selection...................... 3.6 10.4 1.2 15.2
-----------------------------------------------------------
Total......................................... 38.2 55.6 13.1 106.8
----------------------------------------------------------------------------------------------------------------
\1\Represents incremental burden over existing standard; numbers may not add precisely due to rounding.
A\2\Immediately dangerous to life and health.
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.
Benefits
The proper use of a respirator when augmented by an appropriate
respiratory protection program can prevent fatalities and illnesses
from both acute and chronic exposures to hazardous substances. Based on
data found in the OSHA Integrated Management Information System (IMIS),
OSHA determined that there is an annual average of 66,500 illnesses
that are due to acute exposures to airborne hazardous substances. OSHA
estimated that compliance with the existing standard could have
prevented about 20 percent of these incidents, and that the proposed
revisions to the existing standard could prevent an additional 5 to 10
percent. Thus, full compliance with proposed revisions to the existing
standard could prevent between 3,325 and 6,650 illnesses due to acute
exposures annually.
In addition, using an Office of Technology Assessment estimate that
5 percent of all cancers are occupationally related, OSHA estimated
that there are annually between 9,085 and 15,660 new cancer cases,
between 6,850 and 11,000 cancer deaths, due to chronic exposures to
occupational airborne carcinogens. In addition, airborne exposure to
hazardous substances such as silica are estimated to account for
another 4,200 chronic illnesses annually. OSHA anticipates that full
compliance with the existing standard would prevent about 10 percent of
these cases, and that proposed revisions to the existing standard would
prevent an additional 2.5 to 5 percent. Thus, after a period of time,
between 227 and 783 new cancer cases, between 171 and 550 cancer
fatalities, and between 105 and 210 chronic illnesses could be
prevented each year by full compliance with the proposed revisions to
the respirator standard.
OSHA requests public comment on these benefits estimates in general
and the methodology used in making them. The agency requests comment on
how much an effective respiratory protection program, as proposed,
would reduce the level of occupational illness currently found. In
addition, information and data are requested on current respirator use
patterns as related to exposure (i.e. percentage of respirator users
with potential exposures at levels up to 10 times the PEL; 50 times the
PEL, etc.) and any anticipated impact this proposed standard would have
on respirator use.
Economic Impact and Feasibility
In assessing the economic feasibility of the respirator standard,
the Agency examined the costs of compliance of the standard, in
relation to sales and profits in affected industries. This analysis was
based on data in the 1986 Centaur report for manufacturing, and on
industry profile information from OSHA's 1989 PPE survey and 1992 Dun
and Bradstreet financial data.
OSHA assessed the potential economic impacts and has preliminarily
determined that the standard is economically feasible for each of the
major industry groups that will be affected. OSHA conducted its
analysis at the two-digit SIC level. This has been OSHA's procedure for
doing regulatory impact analyses for other proposed standards. OSHA
preliminarily concludes that this is reflective of the actual impact on
the average firm within each subsector. It does not appear that the
affected groups will experience significant adverse economic impact as
a result of the standard. However, if any interested person has
information to show that the analysis at the two-digit level is not
representative of the potential economic impact of the proposal, OSHA
requests the following information: reasons why the preliminary
regulatory impact analysis is not reflective of the actual anticipated
costs in any particular sector; specific information as to why the
analysis at the two-digit level fails to adequately represent the
economic impact; and specific information to help OSHA to better
predict the impact on the sector in question. Such information should
be included in the comments on the proposal.
As indicated in Table B, OSHA estimates that for all affected
industries, incremental costs of compliance would amount to less than
0.1 percent of sales, meaning that less than a 0.1 percent increase in
prices would be necessary to cover these costs. At this level,
businesses should have no trouble passing these costs onto consumers,
as it is unlikely consumers would notice the difference, in the face of
other market fluctuations. Even if this were somehow not possible, in
the worst case, any reduction in profits would be less than 1% in any
industry. For these reasons, the Agency anticipates the standard should
be economically feasible in all industries.
The Agency invites comment by any industries that anticipate
problems with economic feasibility in complying with these revisions to
the respirator standard.
Table B.--Cost of Revisions to Respirator Standard as a Percentage of Sales and Profits
----------------------------------------------------------------------------------------------------------------
Pre-tax Costs/ Costs/
SIC Industry Costs per Sales per profits per sales profits
establishment establishment establishment (percent) (percent)
----------------------------------------------------------------------------------------------------------------
07............. Agricultural Services...... $73 $316,434 29,249 0.023 0.25
08............. Forestry................... 116 613,039 73,941 .019 .16
13............. Oil & Gas Extraction....... 117 14,732,157 1,406,260 .001 .01
15,16,17....... Construction............... 107 895,587 42,998 .012 .25
22............. Textile Mill Products...... 2,409 8,344,061 467,815 .029 .52
24............. Lumber & Wood Products..... 151 3,152,807 186,290 .005 .08
25............. Furniture & Fixtures....... 325 1,710,553 94,173 .019 .34
26............. Paper & Allied Products.... 721 3,359,030 196,804 .021 .37
28............. Chemicals & Allied Products 627 22,228,880 1,234,883 .003 .05
29............. Petroleum Refining......... 173 2,235,435 169,352 .008 .10
30............. Rubber & Misc. Plastic 253 29,274,209 2,759,402 .001 .01
Products.
32............. Stone, Clay, Glass & 171 144,936,193 7,246,699 .000 .00
Concrete.
33............. Primary Metal Industries... 1,120 7,173,641 452,870 .016 .25
34............. Fabricated Metal Products.. 167 6,805,024 436,597 .002 .04
35............. Machinery (Except 264 4,377,647 263,117 .006 .10
Electrical).
36............. Electrical & Electronic 121 17,509,789 919,731 .001 .01
Equipment.
37............. Transportation Equipment... 653 4,557,703 269,325 .014 .24
38............. Measuring & Controlling 74 7,397,676 508,126 .001 .01
Instruments.
39............. Misc. Manufacturing 142 10,705,268 605,548 .001 .02
Industries.
41............. Passenger Transportation... 146 1,350,813 63,449 .011 .23
42............. Motor Freight.............. 81 1,268,289 56,371 .006 .14
48............. Communications............. 151 16,162,621 2,816,217 .001 .01
49............. Utilities.................. 792 16,459,198 1,712,408 .005 .05
50............. Durable Wholesale Trade.... 297 2,497,626 126,143 .012 .24
51............. Nondurable Wholesale Trade. 115 5,059,902 212,107 .002 .05
52............. Hardware, Garden, Mobile 225 994,229 45,694 .023 .49
Home Retail.
55............. Auto Dealers & Service 61 1,957,405 59,316 .003 .10
Stations.
75............. Automotive Services........ 83 394,881 28,719 .021 .29
76............. Misc. Repair............... 110 188,739 18,493 .058 .59
----------------------------------------------------------------------------------------------------------------
Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.
Regulatory Flexibility Analysis
Pursuant to the Regulatory Flexibility Act of 1980, the Assistant
Secretary preliminarily determined that the proposed standard would not
be a significant burden upon a substantial number of small entities.
There may, however, be a higher cost per respirator-wearing-employee
for some small entities. In particular, larger plants that have in-
house testing facilities and in-house medical facilities would be able
to provide the necessary services at lower unit costs than could
smaller companies. OSHA is soliciting information on this issue, and
any comments received will be carefully reviewed and evaluated for
incorporation into the RIA of the final rule.
Environmental Impact Assessment--Finding of No Significant Impact
The proposed rule and its alternatives have been reviewed in
accordance with the requirements of the National Environmental Policy
Act (NEPA) of 1969 (42 U.S.C. 4321, et seq.), the regulations of the
Council on Environmental Quality (CEQ) (40 CFR Part 1500), and the
Department of Labor's (DOL's) NEPA Procedures (29 CFR Part 11). As a
result of this review, the Assistant Secretary for OSHA determined that
the proposed rule will have no significant environmental impact.
The focus of the proposed standard is on reducing risks to
employees who must wear respiratory protection in order to reduce their
exposures to hazardous airborne substances when effective engineering
controls are not feasible, while they are being installed, or during
emergencies. The proposed provisions include written respiratory
protection programs and evaluation, medical evaluation, fit-testing
procedures, guidance on the maintenance, care, and use of respirators,
and training. The implementation of the respirator program would remove
hazardous airborne particulates and contaminants from the breathing
zone of the worker and not from the general ambient atmosphere in the
work environment. In general, the procedures and applications of the
proposed provisions do not impact on air, water or soil quality, plant
or animal life, the use of land, or other aspects of the environment
and therefore are not anticipated to have any significant effect on the
environment.
VII. Summary and Explanation of the Proposed Standard
In developing the proposed standard, OSHA received and analyzed all
of the regulations, documents, and comments described above, as well as
other information the Agency has obtained during the developmental
process. This information can be found in the public record, Docket H-
049. The material collected and reviewed generally supports OSHA's
finding that in order to ensure adequate respiratory protection,
employers requiring employees to wear respirators must develop and
maintain an appropriate respiratory protection program.
Setting clear protective requirements for selecting, fitting,
using, and maintaining respiratory protective devices will help
employers to provide the appropriate protection for their employees,
and thus reduce their exposure to hazardous chemicals.
This proposal is intended to replace OSHA's current respiratory
protection standard for general industry, 29 CFR 1910.134, and the
respiratory protection provisions in the OSHA construction standards,
29 CFR 1926, and maritime standards, 29 CFR 1915-1918. Although a
performance standard orientation has been adopted, enforcement
experience with the current standard has shown that the existing
requirements do not provide sufficient specific information for
employers to comply, particularly in the areas of respirator selection,
medical surveillance, and fit testing. Therefore, this proposal is
designed to provide employers with a clear description of the
appropriate steps to follow to establish an effective respiratory
protection program.
OSHA recognizes that there may be differing opinions regarding the
particular provisions that should be included in such a comprehensive
respiratory protection standard. The Agency is hereby soliciting
information on alternative requirements to address the problems of
inadequate or improper respiratory protection. The final standard
adopted will incorporate whatever means are best for ensuring an
effective respiratory protection program and which are supported by the
public rulemaking record. The proposed standard continues the public
rulemaking process by presenting the Agency's assessment of the best
method to accomplish the development and maintenance of a respiratory
protection program given our current state of knowledge.
The following summary and explanation is designed to clarify the
intent of the proposed provisions, as well as to identify issues OSHA
is aware of and would like to receive comments on. Comments are also
invited on other relevant issues which are not specifically raised in
this discussion. All such comments should clearly identify the
provision of the standard to which they apply, as well as the position
taken on that provision. It is most helpful, and makes the record more
accessible, when comments are organized in the same order that the
standard is written and are indexed to the particular provisions of the
standard to which they refer. It should also be noted that on technical
issues, substantiation should be presented as well as opinion on the
appropriateness of a particular requirement. Such substantiation may
take the form of anecdotal evidence of experience, scientific data,
etc. Submission of substantive commments helps OSHA build a thorough
record upon which to base the final standard. A complete record on all
the issues will help ensure that the final standard is appropriately
drawn to address the issue of respiratory protection.
(A) Scope and Application
The existing OSHA respirator standard contains a methods of
compliance provision (Sec. 1910.134(a)(1)) which establishes a
hierarchy of control techniques to be used for protecting employees
from exposure to airborne contaminants, with engineering controls to be
implemented first and respirators allowed only when engineering
controls are not feasible or while they are being instituted.
This provision of the standard is not a subject of this rulemaking;
only issues relevant to the content of a respirator use program are to
be addressed at this time. OSHA is reviewing Sec. 1910.134(a)(1) and
similar hierarchy of controls provisions contained in Sec. 1910.1000 in
a separate rulemaking.
In the prepublication draft, OSHA asked whether to make the
requirements for a respirator program apply whenever the employer
either required or permitted the use of respirators. The requirement
that the program be implemented whenever employees were permitted to
wear respirators on their own was criticized by commenters (Ex. 36-11,
36-13, 36-38, 36-44, 36-47, 36-48, 36-51A) who felt that this provision
was inappropriate and would serve to discourage permission to use
respirators voluntarily and thus, in some situations, could lessen
workplace protection. Upon consideration of these comments, OSHA is now
proposing to retain the wording in paragraph (a)(2) of the current
standard which requires that respirators be provided when such
equipment is necessary to protect the health of the employee.
Paragraph (a)(2) actually addresses two issues--(1) when
respirators are required to be used and (2) that of the need to
implement a full respiratory protection program. Regarding when
respirators are required to be used, OSHA interprets paragraph (a)(2)
as clearly requiring their use in the absence of engineering controls
whenever employee exposures would exceed an OSHA permissible exposure
limit (PEL) or warrant a 5(a)(1) citation under the OSH Act. Under
these conditions, the proposal would require respirators to be provided
by the employer and a respiratory protection program that meets the
full requirements of the respirator standard to be implemented. This
interpretation continues OSHA's existing compliance policy covering the
required use of respirators.
A respiratory protection program complying with the full provisions
of this proposal would be required whenever an employer requires any
employee to wear a respirator, regardless of the exposure level and
whether the substance is regulated. The use of a respirator in itself
could constitute a hazard and improper use of a respirator can also
increase the exposure hazards and in some cases can make the exposures
more dangerous than if the respirator had not been used in the first
place.
However, OSHA requests comments on whether the respirator program,
when required by the employer in the absence of a regulatory
requirement of another standard, could be modified for certain
respirator types, uses, or conditions, to still provide the needed
protection. Comments with supporting data are requested on what
specific provisions of the proposal could be reduced or eliminated in
this case based on respirator type or environmental or workplace
conditions, and under what specific circumstances the required
provisions could be changed.
If a respirator is used by an employee but its use is not required
by OSHA standards or statute, or by the employer, which is known as a
voluntary respirator use situation, then the requirements of the
proposed standard, although recommended, are not proposed to be
mandatory.
OSHA is also seeking comment on the appropriateness of the scope of
the respirator standard, and on whether the scope of the standard
should go beyond required respirator use to include voluntary
respirator use situations as well.
OSHA requests comments on whether there are certain low risk
respirator use situations which could justify the reduction or
elimination of certain provisions in the mandatory respirator program
in order to provide additional compliance flexibility. How such lower
risk situations could be defined, and which provisions could be
modified or eliminated should be listed along with a discussion of how
changing the provisions would effect potential risks of respirator use.
The proposal contains a threshold of five hours of respirator wear
in any work week before a medical evaluation must be obtained. Is a
five hour threshold appropriate, or should it be larger, and if so,
what specific situations would serve to justify a larger time
threshold? Should there be any time limit, or should any respirator use
trigger medical provisions?
(B) Definitions
The proposed standard includes a number of definitions which are
unique, and which should be consulted to properly understand the
standard. The current respiratory protection standard has no
definitions, which may have contributed to misunderstandings in knowing
how to comply.
A number of the definitions deal with specific types of respiratory
protective devices, or with components of those devices. For example,
``air-purifying respirator'', ``disposable respirator'', ``filter'',
and ``positive pressure respirator'' are all defined in this paragraph.
Most of these definitions are based on generally recognized sources,
such as the current ANSI standard, or documents from the National
Institute for Occupational Safety and Health. Others have been
developed by OSHA for purposes of this standard. With the few
exceptions discussed in the following paragraphs, the definitions are
straight forward and self-explanatory. OSHA invites comment on the
appropriateness of these definitions and invites the submission of
alternatives. Some of the definitions require explanation as follows.
A definition for ``hazardous exposure level'' has been developed
and included for the following purpose. In order to select a respirator
which provides the proper degree of protection, it is necessary to know
both the anticipated ambient airborne exposure level and the exposure
that is acceptable in the breathing zone. One can then determine the
extent to which the respirator must reduce the ambient exposure level.
Thus in the respirator selection scheme, an exposure limit must be used
to establish a goal to determine the degree of protection needed for
employees exposed in a given work situation. Although this standard
does not set specific exposure limits, a concept of exposure must be
included in the selection criteria to be consistent with current
practice.
Since OSHA has permissible exposure limits established for about
600 substances, and there are thousands of hazardous substances to
which employees are exposed, other sources of hazard information must
be used for substances not regulated by OSHA. This does not mean that
OSHA is in effect establishing permissible exposure limits for these
other substances. It just means that where employers decide to use
respirators to control exposure, a target exposure level must be
established to determine the appropriate respirator to use. Therefore,
OSHA has defined the term ``hazardous exposure level'' for purposes of
selecting respirators, as follows.
Where OSHA does have a PEL, it must be used. If there is no PEL for
the substance, the employer must use the American Conference of
Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)
for the chemical if one exists.
If there is no PEL or TLV for the chemical, the employer must
determine the ``hazardous exposure level'' based on available
scientific information including the MSDS. In some situations, the
suppliers of the chemicals may make recommendations for appropriate
exposure levels based on their own experience. In any event, the
employer must establish a protective goal, based on available
information, in order to choose the appropriate respirator, and must be
able to substantiate how that goal was chosen.
It should be noted that the OSHA PEL, ACGIH TLV, and other
available exposure limits are required to be reported on the material
safety data sheet generated by chemical manufacturers and importers
under the requirements of OSHA's Hazard Communication Standard (29 CFR
1910.1200). This information should assist downstream employers in
choosing respirators to protect their employees.
As stated in the scope paragraph, the standard is to apply when
employees are required to wear respirators to reduce their exposures to
airborne concentrations of ``hazardous chemicals'' in the workplace.
For purposes of this standard, ``hazardous chemical'' is defined as a
substance which meets the definition of ``health hazard'' under OSHA's
Hazard Communication Standard (29 CFR 1910.1200). This approach helps
to ensure that definitions of hazard are consistent in current OSHA
standards; provides a broad scope of coverage for this standard; and
incorporates a data base for employers in the form of material safety
data sheets generated under the requirements of the Hazard
Communication Standard.
The Hazard Communication Standard defines ``health hazard'' as a
substance for which there is statistically significant evidence based
on at least one study conducted in accordance with established
scientific principles, showing that acute or chronic health effects may
occur in exposed employees. The term ``health hazard'' includes
substances which are carcinogens, toxic or highly toxic agents,
reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins,
nephrotoxins, neurotoxins, agents which act on the hematopoietic
system, and agents which damage the lungs, skin, eyes or mucous
membranes.
OSHA notes that the definition of ``hazardous chemical'' is used
here merely to target the broad range of substances which may entail
respirator use. However the requirements of this proposed standard only
apply when a regulated substance is being used or when an employer
requires the use of a respirator for any reason. One term which is
frequently used in regard to atmospheres which require respiratory
protection is ``immediately dangerous to life or health'' or ``IDLH.''
Such atmospheres require the most protective types of respirators for
workers. Although the term is used frequently, there has been no one
accepted definition of it. In the preproposal draft of the respirator
standard, OSHA defined an IDLH atmosphere as one ``where the
concentration of oxygen or hazardous chemical(s) would cause a person
without respiratory protection to be fatally injured or would cause
irreversible or incapacitating effects on that person's health.'' In
addition, the definition stated that in establishing the IDLH for a
workplace situation, the employer was to consider ``the maximum
concentration of the hazardous chemical at which one could escape
within ten minutes without any escape-impairing or immediate or delayed
irreversible health effects'' and ``the minimum concentration of the
hazardous chemical at which severe eye or respiratory irritation or
other reactions would inhibit escape without injury.'' This definition
was derived from the IDLH definition in the Joint NIOSH/OSHA Respirator
Decision Logic. An escape time of 30 minutes was considered in the
Decision Logic as the maximum permissible exposure time for escape from
an IDLH atmosphere. There has always been disagreement whether the
maximum escape time should be reduced to 10 minutes as OSHA recommended
in the preproposal draft, or whether some other time limit such as 15
or 30 minutes should be used. Since there is no clear evidence as to
what the time limit should be and just how such a limit would be used
in determining an IDLH atmosphere, OSHA is proposing a less specific,
but clearly protective, IDLH definition that does not refer to a
maximum escape time limit, as described below.
NIOSH revised its IDLH definition in the August 27, 1987 (52 FR
32413) proposed revision of the respiratory protective devices
certification procedures to read:
``Immediately Dangerous to Life or Health'' (IDLH): Respiratory
exposures which:
(1) Pose an immediate threat of loss of life or of irreversible or
delayed effects on health or;
(2) Eye exposures which would prevent escape from such an
atmosphere.
The OSHA Hazardous Waste Operations and Emergency Response
Standard, 29 CFR 1910.120, contains an IDLH definition that reads as
follows:
``IDLH'' or ``Immediately dangerous to life or health'' means an
atmospheric concentration of any toxic, corrosive, or asphyxiant
substance that poses an immediate threat to life or would cause
irreversible or delayed adverse health effects or would interfere with
an individual's ability to escape from a dangerous atmosphere.
The hazardous waste IDLH definition addresses all the issues
covered in the NIOSH IDLH definition and more clearly addresses
asphyxiant atmospheres. OSHA has therefore chosen to adopt the
hazardous waste operations IDLH definition for this respiratory
protection proposal which, in addition to being most appropriate, will
also assure consistency between the various OSHA standards that address
IDLH atmospheres. Comment is requested on this definition of
immediately dangerous to life or health, and on its appropriateness for
respiratory protection standards.
Since the warning properties of a gas or vapor are to be considered
in the selection of an air-purifying respirator, OSHA has included a
definition of what constitutes ``adequate warning properties.'' The
``adequate warning properties'' referred to in regard to respiratory
protection are ``the detectable characteristics of a hazardous
chemical, including odor, taste, and/or irritation effects which are
detectable and persistent at concentrations at or below a hazardous
exposure level and exposure at these low levels does not cause
olfactory fatigue.'' This definition combines the definitions for
warning properties and adequate warning properties from the preproposal
draft.
The definitions of ``oxygen deficient atmosphere'' and ``oxygen
deficient IDLH atmosphere'' have also been changed from the definitions
in the preproposal draft. An oxygen deficient atmosphere is now defined
as ``an atmosphere with an oxygen content of less than 19.5% by volume
at altitudes of 8000 feet or below.'' This definition retains the
traditional 19.5% oxygen level as the point below which an oxygen
deficient atmosphere exists. It is also consistent with the minimum
oxygen content of Grade D breathing air. Above 8000 feet, an oxygen
deficient atmosphere, one with an oxygen level below 19.5%, would also
be considered an oxygen deficient IDLH atmosphere (see below) and the
proposal treats it as such. Thus the definition for ``oxygen
deficient'' does not address altitudes above 8000 feet. This change in
definition will allow the use of air-purifying respirators in normal
atmospheric air for altitudes up to 14,000 feet.
The oxygen deficient IDLH atmosphere definition has been changed to
``an atmosphere with an oxygen content below 16% by volume at altitudes
of 3000 feet or below, or below the oxygen levels specified in Table I
for altitudes up to 8000 feet, or below 19.5% for altitudes above 8000
feet up to 14,000 feet.'' An oxygen content of 16% at 3000 feet of
altitude corresponds to an oxygen partial pressure of 100 millimeters
of mercury in the freshly inspired air in the upper portion of the
lungs which is saturated with water vapor. This oxygen partial pressure
is level which the ANSI Z88.2-1980 respirator standard defines as
``oxygen deficiency, immediately dangerous to life or health''.
However, rather than using the calculation formula from ANSI, this
proposal provides an equivalent table of the oxygen percentages for
oxygen deficient atmospheres and oxygen deficient IDLH atmospheres at
various altitudes for simplicity of use. The table provides a side-by-
side presentation of the oxygen deficient atmosphere and oxygen
deficient IDLH atmosphere levels to avoid any confusion between the
two, and removes the necessity of calculating the values from a
formula.
At altitudes above 8000 feet up to 14,000 feet an oxygen deficient
IDLH atmosphere would exist when the oxygen content in the workplace
atmosphere falls below 19.5%. The respirator selection provision of the
proposal require that an atmosphere-supplying respirator with auxiliary
escape provision or an SCBA be used in such situations. These
respirators supply the wearer with Grade D breathing air. Since the
allowable oxygen content in Grade D breathing air can range from 19.5%
to 23% oxygen, OSHA has chosen the 19.5% lowest allowable oxygen level
for Grade D air as the level below which an oxygen deficient IDLH
atmosphere would occur for altitudes above 8000 feet.
OSHA requests comments and specific data on the effects of reduced
oxygen content in workplace atmospheres and on the appropriateness of
the ``oxygen deficient'' atmosphere and ``oxygen deficient IDLH''
atmosphere definitions contained in the proposal. Alternatives to the
OSHA proposed definitions should include the physiologic basis for any
changes proposed for the oxygen levels used to determine these oxygen
deficient atmospheres.
(C) Respiratory Protection Program
Once an employer has decided to use respiratory protection, a
written respiratory protection program must be developed and
implemented. This requirement is essentially the same as that in the
existing respirator standard, 29 CFR 1910.134(b)(1), which requires
that written standard operating procedures governing the selection and
use of respirators be established. The purpose of this requirement is
to ensure that employers establish a standardized procedure for
selecting, using, and maintaining respirators for each workplace where
respirators will be used.
The ANSI Z88.2-1980 standard for respiratory protection states that
written standard operating procedures covering a complete respirator
program shall be established and implemented (Ex. 10). This performance
oriented requirement recognizes the need for a systematic respiratory
protection program to provide for consistency in protection. The ANSI
standard does not contain detailed instructions on the content of
standard operating procedures, but it does describe elements of a
minimally acceptable respirator program.
The current OSHA respirator standard requires written standard
operating procedures covering selection, use, cleaning, maintenance,
inspections, emergency use, training of supervisors and respirator
wearers, and recordkeeping. As part of the preliminary regulatory
impact analysis for this proposal, data were collected on current
respirator practices and procedures in over 2300 manufacturing plants
in 15 SIC codes. This sample was extrapolated to produce estimates of
respirator-related practices for about 123,200 manufacturing plants
with routine and occasional respirator use. Only 25.5% of these plants
are estimated to have had written standard operating procedures, and
only 7.9% had procedures that addressed all seven areas specified. Over
80% of the large plants (1000 or more employees) had written
procedures, while in small plants (less than 50 employees) only about
22% had written procedures. The survey showed that the intent of the
existing respirator standard as well as the areas to be addressed in
standard operating procedures were not clear to employers.
In a review of violations of the OSHA respirator standard from 1977
to 1982, 13% of the citations were for lack of standard operating
procedures (Ex. 33-5). This percentage of citations actually
underrepresents the total number of cases where problems were found
since it is OSHA policy not to issue citations when no overexposures
were documented.
A review of the comments received in response to the ANPR showed
wide general support for the requirement for written standard operating
procedures. Only one comment by Western Electric Co. for AT&T (Ex. 15-
51) recommended that the written program requirement be dropped. The
commenter stated that while many users of respirators require written
procedures for an effective protection program, OSHA should not be
concerned about written procedures, but only about the overall
effectiveness of the respirator program. There were several submissions
that supported the existing written standard operating procedure
requirement (Ex. 15-37, 15-42, 15-50, 15-56, 15-77) and recommended
that OSHA make no significant changes. However, OSHA's compliance
experience shows that there is a need to clarify the intent of the
requirement and make it clear to employers what OSHA expects in a
written respiratory protection program.
Several ANPR commenters felt OSHA should not include detailed
specifications in the requirement for written standard operating
procedures (Ex. 15-13, 15-22, 15-30, 15-55, 15-73, 15-75). Some felt
the requirement should be written in performance language, with the
specific contents of the procedures to be left to the employer (Ex. 15-
26, 15-41, 15-44, 15-52, 15-70, 15-76). The ANSI Z88.2-1980
specifications were considered adequate and were recommended by still
others (Ex. 15-14, 15-31, 15-33, 15-35, 15-46, 15-58). Certain
commenters presented lists of recommended elements to be covered where
appropriate in the procedures (Ex. 15-18, 15-19, 15-22, 15-34, 15-53,
15-81). These recommended areas for coverage in the written standard
operating procedures varied slightly among the commenters, but the
major areas of respirator inspection, cleaning, maintenance, selection,
training, use, fit testing, recordkeeping and program evaluation were
common to most of the lists. Others recommended OSHA use the program
specification in the Los Alamos National Laboratory (LANL) respirator
training program or in the NIOSH guide to respiratory protection (Ex.
15-27A, 15-81). The AIHA (Ex. 15-81) also stated that the standard
operating procedures should be more specific in defining employer/
employee responsibilities and the types of respirators required for
specific jobs.
Written standard operating procedures are essential to an effective
respiratory protection program. Developing and writing down standard
operating procedures requires employers to think through just how all
of the requirements of the respiratory protection standard will be met
in their workplace. The current respirator standard requires that
employers develop written standard operating procedures that include
all information and guidance necessary for respirator selection, use,
and care, along with written procedures covering safe use of
respirators in dangerous atmospheres that might be encountered in
normal operations or emergencies. The proposal in section (c) contains
additional descriptions of the elements to be included in the written
standard operating procedures to provide additional guidance for
employers. The requirement is performance oriented since the proposal
does not contain detailed specifications for the required written
standard operating procedures. The list of elements to be covered is
similar to those contained in the ANSI Z88.2-1980 standard, and
includes many of the recommended elements presented by commenters to
the preproposal draft (Ex. 15-18, 15-19, 15-22, 15-34, 15-53, 15-81).
The specific contents of the procedures are left to the employer who
can tailor them to match the many varied situations that can occur.
Many of the elements will be common to all respiratory protection
programs, such as respirator selection, care, use, training, and
program evaluation. Some elements such as air quality with supplied air
respirators are required only when those types of respirators are used.
The elements of the standard operating procedures are part of the
mandatory provisions of the proposal. Listing the requirements in a
non-mandatory appendix, as was suggested, would perpetuate a recognized
problem area. The current standard fails to clearly identify the areas
to be covered in the written standard operating procedures, and as a
result only a quarter of the written procedures that were surveyed
addressed all the needed elements (Ex. 33-5). Placing the elements in a
non-mandatory appendix would encourage the continuance of current
practice in writing standard operating procedures. The problem is not
only poorly written procedures, but failure to address some of the
necessary elements at all. Only by making the required elements
mandatory and enforceable can an improvement in written standard
operating procedures and thus an overall program be assured.
Employers are required by the proposal to designate a person
qualified by training and/or experience in the proper selection, use,
and maintenance of respirators to be responsible for implementing the
respirator protection program, and for conducting the periodic
evaluations of its effectiveness. This requirement is similar to that
in the ANSI standard (Ex. 10) which requires that responsibility and
authority for the respirator program be assigned to a single qualified
person with sufficient knowledge of respirator protection to properly
supervise the program. The OSHA standard is performance oriented since
it allows the employer to choose the person best qualified for the
assignment.
The training requirements of the respirator program supervisors was
the subject of a question in the ANPR. Several ANPR commenters said
that specifying the type of training required would be beyond the scope
of the standard (Ex. 15-13, 15-35, 15-75, 15-75A, 15-75c). Others
recommended OSHA adopt the performance language of the ANSI standard
(Ex. 15-26, 15-31, 15-38). Still others recommended that the supervisor
be under the direction of an industrial hygienist or safety
professional (Ex. 15-55, 15-70, 15-76). Some wanted the level of
training required to be commensurate with the complexity of the program
and the degree of risk. (Ex. 15-18, 15-37, 15-46, 15-47, 15-59). Most,
however, recommended that OSHA require the supervisor to have knowledge
of respirators equivalent to that obtained from taking the NIOSH
occupational respiratory protection course. (Ex. 15-30, 15-33, 15-41,
15-42, 15-52, 15-53, 15-54, 15-58, 15-62, 15-71, 15-73).
Specifying in detail the type and extent of training required for
program supervisors has not been done in this proposal. The level of
training that would be appropriate for a workplace with limited
respirator use would be quite different from that required at another
workplace with extensive respirator use that includes IDLH atmospheres,
highly toxic chemicals, or other complex respirator use operations.
Therefore, OSHA has adopted a performance language provision for
program supervisor training that is similar to the ANSI standard
requirement. The level of training for the respirator program
supervisor must be adequate to deal with the complexity of the
respirator program. OSHA has not established any one training program,
such as the NIOSH respirator course, as the level of training program
supervisors must achieve. The NIOSH course covers many different
respirator types and uses, and may provide too much information on
certain types of respirators such as SCBAs for program supervisors who
run simple programs, yet not provide enough information for respirator
program supervisors with a highly complex respirator program. The
program supervisor can also use the assistance of industrial
hygienists, safety professionals, or other respirator experts to help
run the respirator program. Therefore, the training requirements for
respirator program supervisors have been written in performance
language, to allow the training requirements to fit the needs of the
respirator program.
A number of commenters on the preproposal draft addressed the issue
of program administration. Only the American Textile Manufacturer's
Institute (Ex. 36-18) felt the requirement that a person be designated
to administer the respiratory protection program should be deleted.
Other commenters supported the requirement (Ex. 36-14, 36-31, 36-36,
36-40, 36-44, 36-47). The training requirements for the program
administrator was also the subject of comments. The Nuclear Regulatory
Commission (Ex. 36-31) recommended that both training and 6 to 12
months field experience in using respirators should be required.
Lawrence Durio (Ex. 36-36) recommended that the person responsible for
the respirator protection program be a certified industrial hygienist
or complete a NIOSH sponsored course in respiratory protection designed
specifically for the training of respiratory protection program
managers. Richard Boggs of ORC (Ex. 36-47) recommended that the
qualifications of the administrator reflect the complexity of the
respirator program. California/OSHA (Ex. 36-44) recommended that all
program administers at least have demonstrable knowledge of the
requirements of 1910.134 and where respirators may be used for entry
into IDLH atmospheres, the program administrator must attend the NIOSH
respirator course or equivalent. Donald Rapp of the Dow Chemical
Company (Ex. 36-40) recommended that OSHA allow a committee as well as
an individual to be the responsible party, since a committee is more
likely to be responsible for the program than an individual in larger
companies. ORC (Ex. 36-47) also recommended that OSHA allow
responsibility to be vested in an individual or in a committee/
department designated as the central authority.
To assure that the integrity of the respiratory protection program
is maintained through the continuous oversight of one responsible
individual, the proposal requires that a qualified person be designated
as responsible for the management and administration of the program.
That individual can work with a committee or assign responsibility for
portions of the program to other personnel, but the overall
responsibility for the operation of the program remains with the
designated person. This approach promotes coordination of all facets of
the program. The training requirement for the program administrator has
been left performance oriented. With the varying complexity of
respirator programs, specifying a uniform training requirement would be
very difficult. The level of training required varies with the
complexity of the respirator program. OSHA invites further comments on
whether specific minimum training requirements for program
administrators should be set, and on what the training should be.
Employers are required to keep the written respiratory protection
program current. The preproposal draft required that the written
respiratory protection program be maintained ``in a current fashion.''
The Motor Vehicle Manufacturer's Association (Ex. 36-37) recommended
that the phrase ``in a current fashion'' be deleted since requiring
that the employer maintain the written program implies that it be
maintained in a current fashion. In order to clarify the intent of the
provision the phrase ``in a current fashion'' has been removed and the
wording has been revised to require that the employer maintain a
written respiratory protection program that reflects current workplace
conditions and respirator use. As the workplace situation or respirator
use changes, the program is to be revised. Also the program must be
made available, upon request, to employees, designated representatives
and to OSHA.
(D) Selection of Respirators
1. Introduction
The existing OSHA respiratory standard does not contain specific
guidance for the selection of respirators. Instead, the standard
requires that the selection of respirators be made according to the
guidance of the American National Standard, Practices for Respirator
Protection Z88.2-1969. The 1969 ANSI standard recommended appropriate
respirators for use with various categories of contaminants, but did
not attempt to set individual protection levels for each type of
respirator. Although the ANSI standard was revised in 1980, the current
ANSI committee (Ex. 36-55) considered the 1980 standard to be obsolete
and was in the process of developing another revision with provisions
that differ substantially from the 1980 version. A consensus on a
revised 1992 ANSI standard was not reached by ANSI during the time of
the original OSHA rulemaking comment periods. Therefore there were no
substantive comments received by OSHA on the provisions of the revised
1992 ANSI respiratory protection standard. However, as discussed later,
OSHA has reviewed the new ANSI standard and has given it thorough
consideration in the preparation of the final OSHA proposed standard.
The joint NIOSH/OSHA respiratory decision logic, originally
published in 1975, was an early attempt to develop a logic for
respirator selection that could easily be followed and would enable an
individual to pick the appropriate respirator consistently. OSHA
believes that changes in respirator technology and new data on
respirator fit and protection levels have rendered this early decision
logic, as well as the 1980 ANSI standard obsolete, and rules for
selection are essential to avoid the risk of using respirators which
are incapable of providing the necessary protection. The current OSHA
standard lacks such rules, and an analysis of enforcement experience
(Ex. 33-5) shows that as a result, the selection of inappropriate or
unapproved respirators and failure to provide suitable respiratory
protection accounted for 26% of the violations of the respirator
standard cited during fiscal years 1977 to 1982.
The proposal requires employers to provide respiratory protection
at no cost to employees. This is consistent with the provisions of the
current respiratory protection standard, as well as with the OSH Act,
to ensure that employers provide whatever controls are necessary to
protect employees from hazards generated by the work operation.
Where elastomeric facepieces are to be used, the employer shall
provide a selection of respirators from an assortment of at least three
sizes for each type of facepiece from at least two manufacturers.
Comments were received stating that the cost of maintaining three
different sizes of two manufacturer's respirators would appear
excessive if only one or two employees require a respirator (Ex. 36-
32). Others indicated that the assortment should be required for the
initial fit (Ex. 36-28, 36-36) but not for the annual retest since each
fit test respirator must be cleaned before its next use. OSHA is
maintaining in this proposal the requirement for an assortment of
respirators for both the initial and annual fit tests. OSHA believes
that nothing in the course of respirator use is more important than
achieving the best possible fitting respirator and that this is only
possible where an adequate selection is available. Availability of
different sizes and types of respirators during retesting is especially
critical where the employee's physical conditions may have changed as
the result of a modest weight change or changed facial configuration
due to surgery or dental work, which may affect respirator fit.
2. Workplace Conditions
The first step in selecting respirators for a particular workplace
is to consider available information concerning workplace conditions
and characteristics of the hazardous chemical. The proposal lists
eleven such categories of information.
(i) Nature of the hazard. The nature of the hazard, whether it is
in the form of a gas, dust, organic vapor, fume, mist, oxygen
deficiency, or any combination of hazards needs to be taken into
account.
(ii) Physical and chemical properties of the air contaminant. The
physical and chemical properties that affect respirator selection such
as particle size for dusts, vapor pressure, breakthrough times, and the
ability of the filter material to remove, adsorb, or absorb the
contaminant.
(iii) The adverse health effects of the respiratory hazard. In
selecting a respirator any adverse physiological effects that may occur
from exposure to the hazard, including effects that may occur due to
respirator leaks or failure need to be considered.
(iv) The relevant permissible exposure limit or recommended
exposure limit. The OSHA permissible exposure limit, or in its absence,
any American Conference of Governmental Industrial Hygienists
recommended Threshold Limit Value (TLV), NIOSH recommended exposure
limit, or other exposure limit set by the employer must be considered
in selecting the appropriate respirator.
(v) The results of workplace sampling of airborne concentrations of
contaminants. Sampling and analysis of the workplace air determines
what degree of exposure is occurring, and thus what degree of
protection is required. Where such sampling and analysis have been
done, the results are to be used as a point of comparison for the
hazardous exposure level i.e. to determine how much the concentration
must be lowered by the respirator to reduce employee exposure to a safe
level.
(vi) Nature of the work operation or process. The type of job
operation, the equipment or tools that will be used, and any motion or
travel the job requires can influence the type of respirator selected.
For example, in the case where respirators are used to protect
employees who are spray painting or working at an open surface tank,
the type of operation can affect the type of respirator selected,
particularly if supplied air respirators, which require a connection to
a clean air source, are used.
(vii) Time period respirator is worn. The employer must also
consider the period of time during which the respirator will be used by
employees during a work shift. Breakthrough times for different
chemicals can vary greatly, and are dependent on the concentrations
found in the workplace. A respirator that provides adequate protection
for one chemical may be inadequate for another chemical with a
different breakthrough time. In addition, employees wearing respirators
for longer periods of time may need different types of respirators for
more comfortable wear.
(viii) Work activities and stress. The work activities of employees
while wearing respirators are also a factor. Heavy work that is
physically draining may affect an employee's capability of wearing
certain types of respirators.
Temperature and humidity conditions in the workplace may also
affect the stress level associated with wearing a respirator as well as
the effectiveness of respirator filters and cartridges. These types of
factors must be assessed in selecting the appropriate equipment for a
particular work situation.
(ix) Fit testing. The proposal includes requirements for fit
testing. The results of these tests are to be used in the selection
process. Some employees may be unable to achieve an adequate fit with
certain respirator models or a particular type of respirator--such as
half mask air-purifying respirators--so an alternative respirator model
with an adequate fit or other type of respirator that provides adequate
protection must be used. Fit test results must be used to determine
when this is the case and what alternative respirator should be
selected.
(x) Warning properties. The warning properties of a hazardous gas
or vapor must also be considered when selecting a respirator. When
using an air purifying respirator the odor, taste, or irritation
effects of the substance present should have a threshold concentration
low enough so that the substance can be detected before health effects
can occur. Also, the detection threshold should be low enough that
olfactory fatigue with subsequent loss of the warning properties of the
chemical cannot occur. This subject is discussed in more detail under
section 5 below.
(xi) Physical characteristics, functional capabilities, and
limitations of respirators. The last category of information to be
considered when selecting respiratory protection is the physical
characteristics, functional capabilities, and limitations of the
respiratory protection equipment itself. For example, airline
respirators should not be used by mobile employees around moving
machinery unless entanglement of airlines in equipment is easily
avoided.
Once the employer has determined what respirator types are
appropriate for the workplace, respirators must be selected from among
those approved and certified according to 42 CFR Part 84 by the
National Institute for Occupational Safety and Health (NIOSH) when such
respirators exist.
3. Use of NIOSH/MSHA Certified Respirators
a. Alternatives. Alternatives to requiring that NIOSH/MSHA
certified respirators be used are limited. Several ANPR commenters
stated that OSHA should allow the use of non-approved respirators for
which scientifically valid test data are available (Ex. 15-11, 15-38,
15-45, 15-53, 15-54, 15-55, 15-56, 15-58, 15-81), where the respirators
were tested by independent laboratories (Ex. 15-10, 15-53) or where the
manufacturer has sound test data (Ex. 15-10, 15-19, 15-53, 15-62, 15-
73). Others insisted that OSHA should not accept respirator
certification from any source other than NIOSH/MSHA (Ex. 15-14, 15-34,
15-46, 15-48, 15-70, 15-75A, 15-77). OSHA regards all such suggestions
as having serious flaws.
Independent certification laboratories for respirators do not yet
exist. An extensive commitment of money and resources would be required
by any private organization establishing such a testing system. Some
believe that if OSHA allows certification of respirators by independent
laboratories, this will encourage the development of such systems.
However, it would be very difficult to write a provision allowing
independent certification systems when none now exist. Developing the
respirator test protocols such independent laboratories would use would
involve a considerable level of effort and would duplicate the revision
efforts already underway by NIOSH to revise the respirator
certification standards. Moreover it would be necessary to establish a
program to certify the testing laboratories as well. The Agency does
not presently have the means to accomplish such assessments, and in
fact, does not have the personnel or resources to become certifiers of
respirators.
OSHA is therefore proposing to maintain the requirement that NIOSH
approved respirators be used when such respirators exist. For OSHA
compliance purposes, a respirator certification program is necessary in
order to assure that respirators used in industry are capable of
providing the needed protection. OSHA recognizes that there are
problems with the existing NIOSH/MSHA certification program. Several of
the comments OSHA received were related to problems with NIOSH/MSHA
respirator certification, including the issue of modifications to
respirators, interchanging of respirator parts and the use of
respirators for which NIOSH has not yet granted approval. Since these
problem areas are being addressed by NIOSH during its revision of the
respirator certification program under the new 42 CFR 84, it is
inappropriate for OSHA to try to correct problems with the present
NIOSH/MSHA regulations in the revised OSHA respirator standard.
b. Approval for modified respirators. Several commenters suggested
that OSHA should not automatically reject the use of approved
respirators that have modifications (Ex. 15-10, 15-19, 15-22, 15-26,
15-31, 15-40, 15-41, 15-45, 15-46, 15-52, 15-54, 15-55, 15-56, 15-62,
15-75c). Modifications could include interchange of parts, canisters,
air hoses, etc. These modifications would have to be evaluated, whether
through testing to demonstrate comparable protection and reliability
(Ex. 15-10, 15-22, 15-31, 15-38, 15-46, 15-50, 15-52, 15-53, 15-54, 15-
55, 15-62, 15-73, 15-75c, 15-81), by requiring that modifications be
done under the auspices of NIOSH (Ex. 15-18, 15-33, 15-38, 15-76), or
by allowing minor modifications if approved by a certified industrial
hygienist (Ex. 15-73). OSHA believes that NIOSH is the appropriate
Agency to consider this issue and that such consideration should be
part of the certification process.
OSHA also believes that the proposed 42 CFR Part 84 is the proper
forum in which to resolve any problems with respirator modifications.
Therefore, this proposal does not change OSHA's general policy of
rejecting modifications to approved respirators.
OSHA invites comment on the question of whether to require NIOSH
approval for the respirators selected, and on alternatives to this
requirement, including practical considerations of compliance and
enforcement.
c. Use of non-approved respirators. Several commenters on the
preproposal draft recommended that OSHA establish procedures for
permitting the use of non-approved respirators. (Ex. 36-22, 36-28, 36-
29, 36-30, 36-36, 36-41, 36-44, 36-45, 36-47, 36-51A, 36-52, 36-53). As
was pointed out, there are types of respiratory protection, such as
supplied air suits for which no NIOSH/MSHA approval schedule currently
exists (Ex. 36-28, 36-29, 36-36, 36-52, 36-53). California OSHA (Ex.
36-44) recommended that OSHA add wording that would give OSHA the
ability to approve respirators that do not have a NIOSH/MSHA approval
schedule. The Industrial Safety Equipment Association (Ex. 36-45)
stated that OSHA should allow the use of non-approved respirators if
data are available to show that they operate satisfactorily. The AIHA
(Ex. 36-41) also recommended that if an employer can demonstrate
effective, safe utilization of a device, then its use should be
permitted. The American Petroleum Institute (Ex. 36-51A) requested that
OSHA permit the use of non-approved respirators when OSHA accepts these
devices based on a case-by-case evaluation of evidence provided by the
employer or manufacturer. They also stated that this method had worked
well in the past for acrylonitrile, mercury, fluorides and vinyl
chloride.
While it is true that OSHA has in the past approved the use of
certain unapproved respirators, this approval has generally been as the
result of a thorough review of the respirators capabilities as part of
a substance specific standard. OSHA does not have the personnel or
facilities to perform respirator testing, and has no present plans to
set itself up as a respirator approval agency. Therefore, this proposed
respirator standard does not contain language which would formalize a
procedure for approving respirators. OSHA invites comment on whether
and how such an approval procedure should be added to the standard.
4. Assigned Protection Factors
The proposal requires that respirators be selected in accordance
with the respirator selection tables in the NIOSH proposed revision of
the tests and requirements for certification of respiratory protective
devices (42 CFR Part 84). The protection factor concept has developed
over the years since OSHA adopted its current standards. It is a
recognition of the fact that different types of equipment provide
different degrees of protection, and equipment limitations must be
considered in selecting respirators.
Three commenters in response to the preproposal draft recommended
that OSHA allow the use of other selection guidelines in addition to
those in the preproposal draft Appendix A. Motorola (Ex. 36-22) stated
that there was great controversy over the assigned protection factors,
and in order to maintain a performance standard approach OSHA should
allow the use of not only the respirator selection tables but the ANSI
Z 88.2 selection tables, or other guidelines published and peer
reviewed by other consensus groups or professional associations.
Homestake Mining (Ex. 36-30) had a similar recommendation, maintaining
that it would allow the employer to use the latest and best information
for respirator selection. They also recommended that a provision be
added to require that employers demonstrate and support their rationale
for using values other than those in the respirator selection tables.
The AIHA (Ex. 36-41) also recommended a similar approach to respirator
selection guidelines.
OSHA believes that the foregoing suggestions are inadequate.
Although the new 1992 ANSI recommendations have now been published, it
is not sufficient for OSHA to reference the ANSI recommended protection
factors because ANSI has provided no discussion of the basis for its
recommendations. Moreover, some of the provisions of the ANSI standard
appear to contradict specific information which OSHA considers
reliable. In particular, the ANSI recommended protection factors
disagree substantially with recommendations by NIOSH. Only if ANSI were
to supply detailed discussion as to how its protection factors were
derived--including reference to and complete description of specific
studies used to derive those APFs--would OSHA be able to evaluate the
merits of the latest ANSI recommendations. Moreover, allowing employers
to select respirators on the basis of different guidelines, with
different APF values, can only bring confusion as to how to comply with
the standard.
OSHA considered establishing assigned protection factor tables
based on existing studies in which performance factors were measured
both in laboratories and in workplaces. The quality of available data,
however, was seen to vary substantially from one type of respirator to
another depending on how much emphasis had been placed on a particular
type of respirator by the organization doing the testing. Moreover, the
results of studies which had been done for a particular purpose may not
necessarily be able to be extrapolated legitimately for use in drawing
other conclusions.
As an example of the widely varying results and quality of
available data, the following is a brief review of studies pertaining
to negative pressure air-purifying respirators. Similar weaknesses in
available data exist for other types of respirators as well.
Negative Pressure Air-Purifying Respirators
Lenhart and Campbell of NIOSH (Ex. 27-2) did workplace performance
testing in 1984 in a primary lead smelter for half mask negative
pressure air-purifying respirators. The resulting report stated that
98% of the workplace protection factors (WPFs) would be at or above 10,
90% above 30, and 75% above 100. It concluded that ``an assigned
protection factor of 10 is appropriate for the half mask negative
pressure air-purifying respirators evaluated in this study'' (Ex. 27-2,
p. 181). Each individual who participated in the study had first
achieved a quantitative fit factor of at least 250 with the half mask
respirator in the fit test booth. For this reason the authors
emphasized that the study's results may overestimate the WPFs that
would be achieved by a general worker population that had not achieved
quantitative fit test results of at least 250.
Skaggs and Loibl of the Los Alamos National Laboratory (Ex. 38-3)
examined the performance of half mask and full facepiece respirators
under simulated work conditions in a controlled environmental chamber.
Three different temperatures (0 deg.c, 20 deg.c, 32 deg.c) and two
humidities (15% and 85%) were examined. Half mask and full facepiece
respirators were worn by test subjects performing work type exercises
such as shoveling oiled gravel, walking up and down stairs, pounding
nails, moving cinder blocks, and pounding with a sledge hammer. During
the prefit respirator fit testing for the half mask, fit factors
ranging from a low of 32 to as high as 20,000 were measured. Fit
factors measured during the simulated work exercises ranged from 16 to
20,000. However, only one of the 49 test subjects who obtained fit
factors during the prefit testing of 100 or greater with the half mask
failed to achieve fit factors of at least 50 during the simulated work
exercises. For the full facepiece respirator the prefit fit factors
ranged from 110 to 20,000 and the simulated work fit factors ranged
between 21 and 20,000. For the 54 test subjects who achieved fit
factors of 500 or greater with the full facepiece respirator during
prefit testing, only one filed to achieve a fit factor of 100 or
greater during the simulated work fit tests.
In the case of full facepiece respirators tested with QNFT, studies
performed by the Los Alamos National Laboratory (LANL) in 1972 (Ex. 24-
2) resulted in a recommendation that full facepiece respirators be
allowed a protection factor of 50. The recommendation was based on QNFT
performed in a test booth on wearers who had been pre-screened in each
case with a qualitative test using irritant smoke. Most of the
respirators tested achieved fit factors into the thousands but one
respirator only achieved fit factors of less than 100. On the bases of
that one respirator the decision was made by LANL to restrict their
recommendation to 50. However, Edward Hyatt, the author of the study,
in his subsequent response to the ANPR, (Ex. 15-27), and in a later
comment on a variance application in 1984 (Ex. 24-11), recommended that
negative full facepiece respirators be assigned a protection factor of
100 provided a fit factor of 1000 could be obtained in the test booth.
It was understood (although not stated in his response) that his reason
for revising his recommendation was that the one respirator which
performed so poorly in the original tests had been taken off the
market.
In November, 1983 researchers from the Lawrence Livermore National
Laboratory published a paper (Ex. 24-9) on reproducibility of fit using
QNFT. One element of the research described in the paper was the
measurement of fits of two brands of full facepiece respirators as well
as fits of half mask respirators of the same two manufacturers. There
are two important aspects of the measurements. First, the poorest
fitting of the full facepiece respirators was more than five times
better than the best fitting half masks respirators. Second; the lowest
fit factor of the full facepiece models was 1,063. Nevertheless, the
range of respirators was very limited.
In October 1984, DuPont submitted to the OSHA asbestos standard
docket an unpublished study of workplace protection factors (WPF) for
disposable half mask respirators, and half mask air-purifying
respirators using either dust/fume/mist filters or high efficiency
filters (Ex. 38-7). The study concluded that all the respirators tested
could reliably provide protection factors of 10, except that one of the
disposable respirators tested could only provide a protection factor of
5. The lower protection provided by the last disposable respirator was
attributed to penetration of asbestos fibers through the filter media.
OSHA considers this study to be inadequate in establishing protection
factors for several reasons. First, asbestos is not typical, in
geometry or migration properties, of the broad range of dusts and mists
that are encountered in workplaces. To assign a general protection
factor based on the almost unique properties of asbestos would be
highly inappropriate. In addition, this particular study was conducted
under special conditions in which the respirators were used in a wet
environment whose effect on fit is difficult to evaluate and whose
effect on penetration would be different for asbestos than for most
other contaminants. In addition the study did not follow NIOSH
analytical guidelines for sampling and counting asbestos fibers. For
example, NIOSH recommends that reliable analysis requires that at least
10 fibers be counted for 100 fields. However, in the DuPont study, 89%
of the analyzable tests (71 out of 80) and filters with in-mask fiber
counts for less than 10 per 100 fields.
The 3M Corporation also submitted an unpublished protection factor
study for disposable respirators used in the presence of asbestos
fibers at the Shiloh Brake Corporation (Ex. 40). Once again, asbestos
fibers, for the reasons given above, are not sufficiently
representative of dusts and mist in most workplaces for use in
establishing general protection factors.
Another unpublished study cited in the record was performed by the
Chemical Manufacturers Association (CMA) at a cadmium pigment
production facility (Ex. 38-22). The entire submission, however,
consisted of four paragraphs of description accompanied by two computer
graphs showing results. There is no discussion of how the tests were
conducted or any description which would enable one to evaluate the
validity of the study or to duplicate the testing. OSHA considers this
submission to be inadequate for meaningful review.
In yet another unpublished study, the 3M Corporation has submitted
results of measurements of protection factors of disposable dust/mist
respirators in the presence of aluminum, titanium, and silicon
particulates (Ex. 41A) The study, which was conducted in October, 1986,
failed to include basic information on concentrations and particle size
distributions. In July, 1988 3M returned to the same site to measure
particle size distribution and in August, 1989 submitted the results to
the record (Ex. 41B). OSHA believes that, to be valid, all supporting
measurements of a study must be made at the time the primary
measurement is made. It is virtually impossible to assure that all
relevant ambient conditions will be identical almost two years later to
what they were at the time of the original test. Moreover, the data
submitted by the 3M Corporation in August, 1989 had serious anomalies
which were unaccounted for in the accompanying discussion. For example,
the mass distribution in the stages of various impactors could be
accounted for only by circumstances which would be very unusual. Some
impactors had few or no particles of any size. Others had only very
large particles and very small particles. In the latter case, the
report referred to the possibility of a bimodal distribution, but
supplied no physical reasons based on actual workplace conditions to
account for such a distribution.
In general, unpublished studies such as those cited above are
difficult to evaluate since significant details are often absent in the
discussions and there has been no peer review of the assumptions,
methods, and plausibility of results.
By contrast, a published workplace protection factor study by NIOSH
(Ex. 38-2) of the performance of disposable dust mist respirators
provides results showing lower protection factors which cannot be
ignored. The study determined the effectiveness of a disposable dust/
mist respirator against overexposure to nuisance particulate dust (Ex.
38-2). A total of 25 paired samples were taken, each consisting of a
measurement inside the probed respirator and one at the lapel. Seven
workers and two NIOSH industrial hygienists were sampled. Quantitative
facepiece fit testing was performed to check for gross leakage. NIOSH
calculated that ``95% of workplace protection factors would be expected
to be at or above 3, 87% at or above 5, 70% above 10, and only 7% would
be expected to be above 100.'' Nevertheless, despite the fact that the
data seemed to predict a protection factor of 3 at the 95% confidence
level, NIOSH concluded that an ``assigned protection factor of 5 for
disposable half mask respirators is not discredited by the results of
this study.'' However, it involved only seven subjects and thus the
range of facial sizes and structures involved were limited.
The foregoing studies pertaining to negative pressure air-purifying
respirators demonstrate the wide variability in applicability of such
studies in the determination of assigned protection factors. Therefore,
OSHA decided that these available studies as well as those in other
respirator categories are inadequate for a well founded assignment of
protection factors.
In view of this apparent inadequacy, OSHA has determined that in
order to establish assigned protection factors, there must be a program
to conduct experimental evaluations of respirator performance.
Therefore, OSHA and NIOSH have agreed that the assignment of protection
factors should be made by NIOSH. It is OSHA's intention in this
rulemaking that protection factors shall be assigned by NIOSH in its
ongoing rulemaking for its certification program. (The first phase of
this rulemaking was published in the Federal Register as a proposed
rule at 59 FR 26850 on Tuesday, May 24, 1994 as 42 CFR Part 84.) When
NIOSH completes its rulemaking process of assigned protection factors,
OSHA will issue a technical amendment to this respiratory protection
standard referring to the NIOSH final regulation. OSHA does not intend
to have notice and comment on its technical amendment because NIOSH
will have notice and comment in its rulemaking. In the period before
NIOSH has completed promulgating 42 CFR Part 84, OSHA will, in the
interim, require that respirators be selected in accordance with the
protection factors assigned by NIOSH in the current NIOSH Respirator
Decision Logic (Ex. 38-20).
The NIOSH protection factor values are not intended to replace
protection factor values which, in individual substance specific OSHA
standards, are more stringent. Thus, the OSHA provision which defers to
the NIOSH protection factor tables is not to be interpreted, for
example, as overriding the OSHA asbestos standard which does not permit
the use of disposable respirators at all. Nor does this provision
preclude OSHA's prerogative to assign more conservative protection
factors under circumstances demonstrated in the records of future
substance specific rulemakings.
Finally, it is OSHA's understanding that respirators certified
under 30 CFR Part 11, depending on the type, will continue to be NIOSH
certified for a period of time after the effective date of 42 CFR Part
84. This ``sunset'' provision will continue to allow existing
certifications while respirators that meet the new requirements of 42
CFR Part 84 are developed and certified. Following the sunset period
for each type of respirator, only those certifications granted under 42
CFR Part 84 will be valid. During the sunset period, OSHA will require
that protection be assigned as prescribed in 42 CFR Part 84 for
respirators previously certified under 30 CFR Part 11. The new NIOSH
regulation will also provide assigned protection factor values for
respirators certified under the new requirements.
5. Warning Properties
The question of whether OSHA should permit the use of air-purifying
respirators where substances have inadequate warning properties has
been of serious concern for several years. Some commenters to the ANPR
felt that air-purifying respirators should only be used for chemicals
that have adequate warning properties (Ex. 15-33, 15-34, 15-46, 15-48,
15-70). Others felt that respirator use should not be restricted based
on poor warning properties, but that OSHA should identify a control
mechanism that would allow their use (Ex. 15-18, 15-19, 15-22, 15-26,
15-50, 15-54, 15-55, 15-58, 15-62, 15-66, 15-73). Several commenters
felt it should not be necessary for a chemical always to present
distinct warning properties (Ex. 15-27A, 15-31, 15-38, 15-41, 15-44,
15-45, 15-47). For example, reliance on an industrial hygienist's
professional judgment, along with an evaluation as described in the
OSHA Industrial Hygiene Field Operations Manual (now called the
Industrial Hygiene Technical Manual), was recommended by the American
Iron and Steel Institute (Ex. 15-37). Others stated that if the
contaminant concentration was monitored and the absorption capabilities
of the respirator cartridge for that chemical are known, the service
life of the cartridge can be safely calculated (Ex. 15-17, 15-53). The
use of a monitoring device that would give sound and visual signals was
recommended as an alternative to requiring that air-purifying
respirators be used only for chemicals with adequate warning properties
(Ex. 15-10).
OSHA currently does not allow air-purifying respirators to be used
when a gas or vapor has inadequate warning properties, except in the
case of a few designated chemicals for which specific standards were
promulgated, such as vinyl chloride, ethylene oxide and acrylonitrile.
The departures from the prohibition on using air-purifying respirators
for substances with poor warning properties were established in each
case as part of an overall rulemaking for each chemical, which included
a careful examination of industry exposure levels and respirator use
factors.
Allowing such use would require an examination of the toxicity of
the chemical, its odor threshold, the health consequences of particular
exposure levels, breakthrough time for the chemical for the type of
respirator that will be used, how long the respirator will be used
during the workshift, and the concentrations of the chemical that are
found in the workplace. Calculating the service life of a particular
respirator cartridge or canister for a chemical with poor warning
properties would be possible using these facts and an appropriate
safety factor. This service life calculation may be difficult where
workplace exposure levels vary greatly throughout the day and from day
to day. Using continuous monitoring devices with alarms, as was
suggested by some of the commenters, is another possibility. Continuous
monitoring is complicated, expensive, and would require a case-by-case
review of each plant situation to determine the ability of the
monitoring system. Therefore, this proposal has not considered the use
of continuous monitoring devices when determining where respirators can
be used.
Motorola (Ex. 36-22) recommended that OSHA allow the use of air-
purifying respirators for chemicals with poor warning properties if the
respirator had a reliable end of service life indicator or an air-
purifying cartridge and/or filter change schedule had been implemented,
and the use of supplied air respirators would hamper an operation or
increase risk. If the employer could not demonstrate the acceptability
of the respirator according to these conditions, supplied air
respirators would be required. Homestake Mining (Ex. 36-30) also
recommended the same conditions along with the requirement for
biological monitoring to demonstrate respirator effectiveness, where
applicable. DuPont (Ex. 36-38) also recommended that air-purifying
respirators be allowed for chemicals with poor warning properties when
supplied air respirators cannot be used, with the conditions that a
reliable end of service life indicator and appropriate cartridge change
schedule be used. The AIHA (Ex. 36-44), Richard Boggs of ORC (Ex. 36-
47), and Thomas Nelson of the ANSI Z 88.2 respirator committee (Ex. 36-
55) described similar conditions for the use of air-purifying
respirators for chemicals with poor warning properties. Mr. Nelson also
wanted to limit their use to concentrations of the contaminant less
than 10 times the PEL or TLV.
The ANSI Z 88.2-1992 respiratory protection standard in section
7.2.2.2 (m) would allow the use of an air purifying respirator for a
gas or vapor with poor warning properties only when (1) the air
purifying respirator has a reliable end of service life indicator that
will warn the user prior to contaminant breakthrough, or (2) a
cartridge change schedule is implemented based on cartridge service
data including desorption studies (unless cartridges are changed
daily), expected concentration, pattern of use, and duration of
exposure have been established, and the chemical does not have a
ceiling limit.
OSHA agrees that there are circumstances under which it may be safe
or necessary to use air-purifying respirators despite the absence of
adequate warning properties. In doing so, however, two factors must be
considered: breakthrough of the cartridge and face seal leakage.
Cartridge breakthrough can be addressed by use of end-of-service-life
indicators that are approved by NIOSH or by implementation of a filter
change schedule based on documented service life data, exposure levels
and exposure durations. Face seal leakage is not addressed directly
except by requiring fit testing. Therefore, OSHA is proposing that the
use of air-purifying respirators in the absence of adequate warning
properties be restricted to situations where the odor, taste, or
irritation threshold is not more than three times the hazardous
exposure level. Since the least effective respirator with a chemical
cartridge in the proposed NIOSH 42 CFR Part 84 respirator selection
tables has an Assigned Protection Factor of 10, then if the level at
which the warning property exists is within three times the hazardous
exposure level, OSHA believes that a sufficient margin of safety will
be provided, since even a partial breakthrough is unlikely to reduce
the protection factor from 10 down to three under the foregoing
restrictions on use.
6. Oxygen Deficient and Oxygen Deficient IDLH Atmospheres
This proposal requires that only atmosphere-supplying respirators
be used in oxygen deficient atmospheres. In oxygen deficient IDLH
atmospheres either a full facepiece pressure demand SCBA or a
combination full facepiece pressure demand supplied air respirator with
auxiliary self-contained air supply must be used. A critical issue is
the definition of what constitutes oxygen deficient and oxygen
deficient IDLH atmospheres.
Table I of paragraph (d) presents in tabular form the oxygen
percentages below which the terms oxygen deficient and oxygen deficient
IDLH atmosphere apply--as a function of altitude above sea level.
By referring to the information in this table, an employer can
readily pick out the appropriate type of respirator required at various
altitudes and oxygen levels. OSHA chose to use an equivalent table of
oxygen levels for simplicity, rather than incorporating a calculation
formula as ANSI did in its Z88.2-1980 standard, like the table in the
ANSI Z88.2-1992 standard on the combined effects of altitude and
reduced percentage of oxygen.
Numerous comments were submitted in response to both the
preproposal draft and the ANPR on the definition of oxygen deficient
and oxygen deficient IDLH atmospheres (Ex. 15-14, 15-19, 15-26, 15-27A,
15-31, 15-33, 15-35, 15-37, 15-38, 15-46, 15-52, 15-53, 15-55, 15-58,
15-62, 15-70, 36-13, 36-17, 36-18, 36-22, 36-26, 36-27, 36-29, 36-30,
36-31, 36-32, 36-34, 36-38, 36-39, 36-40, 36-41, 36-44, 36-47, 36-52,
36-53, 36-54, 36-55). All suggestions were based on the concept of a
minimum value for oxygen partial pressure in the upper portion of the
lungs. Most commenters agreed with the ANSI Z88.2-1980 partial pressure
value of 100 mm Hg below which an oxygen deficient IDLH atmosphere
exists. There was, however, disagreement as to the oxygen partial
pressure at which an oxygen deficient atmosphere is considered to
exist.
Oxygen Deficient Atmospheres
The Los Alamos National Laboratory (LANL) recommended the use of an
oxygen partial pressure of 125 mm Hg, which corresponds to a 16.5%
oxygen level at sea level, as the point below which an oxygen deficient
atmosphere exists for altitudes up to 7,000 feet (Ex. 36-52). Above
7,000 feet LANL recommended that any reduction in ambient air oxygen
content (20.95%) be considered oxygen deficient. California OSHA (Ex.
36-44) recommended oxygen levels below 19.5% for altitudes from 0 to
5,000 feet, 20.5% for altitudes between 5,001 and 9,000 feet, and
20.95% for altitudes above 9000 feet be considered as oxygen
deficiencies.
The ANSI Z88.2-1992 standard radically lowered the recommendation
for oxygen-deficiency non-IDLH atmospheres to one with an oxygen
partial pressure ranging between 95 mm Hg pp O2 (12.5% oxygen at
sea level atmospheric pressure) to 122 mm Hg (16% oxygen at sea level).
Under these conditions a supplied air respirator is required. Where
oxygen levels are 95 mm Hg or less, an oxygen-deficiency IDLH
atmosphere would exist, and would require the use of a positive
pressure SCBA or a combination supplied air respirator with SCBA.
However, where oxygen levels are above 16% supplied air respiratory
protection would not have to be used for protection against oxygen
deficiency.
For confined spaces, the ANSI Z88.2-1992 standard would consider
any reduction in oxygen level below 20.9% an IDLH atmosphere unless the
source of the oxygen reduction is understood and controlled. However,
it would permit entry into a confined space that contains between 16%
and 20.9% oxygen (at sea level) without any respiratory protection if
extraordinary precautions are taken to assure that the worker would not
encounter any poorly ventilated areas. OSHA considers any location with
an oxygen level that is reduced below 19.5% to be an oxygen deficient
atmosphere requiring the use of at least a supplied air respirator as a
minimum.
An incident recently occurred that illustrates the problem with the
ANSI oxygen deficiency definition. Two well cleaners died in the
confined space of a shallow well. They had no fans to ventilate the
well, and only crude homemade equipment for lowering someone into the
well. After being lowered into the well, the first cleaner complained
of lightheadedness. His partner was lowered into the well to attempt a
rescue. The crude retrieval equipment broke under the weight of the two
cleaners. Both were overcome by the low oxygen levels and died of
asphyxiation and drowning. The oxygen level in the well was 17%, as
measured by the firefighters who removed the bodies. By reducing the
oxygen deficient IDLH level to 16% and permitting entry without
respiratory protection at oxygen levels between 16% and 19.5%, the ANSI
standard would permit such dangerous practices. The need for
extraordinary precautions, as ANSI recommends, will not be recognized
by many who choose only to see that the oxygen deficiency levels have
been reduced.
NIOSH approves air-purifying respirators for use only in
atmospheres containing 19.5% oxygen. Moreover, Grade D breathing air is
and has been considered the acceptable standard for such air and Grade
D breathing air contains, by definition, a minimum of 19.5% oxygen.
Since OSHA requires that NIOSH approved respirators be used, and that
grade D breathing air be used for supplied air respirators, OSHA is
proposing the 19.5% oxygen level as the point below which an oxygen
deficient atmosphere exists. Oxygen partial pressure decreases as
altitude increases. At 8,000 feet a 19.5% oxygen level still
corresponds to an oxygen partial pressure above 100 mm Hg, the level
where an oxygen deficient IDLH atmosphere would begin. Therefore, for
altitudes up to 8,000 feet any decrease in oxygen level below 19.5% is
considered an oxygen deficient atmosphere and the use of atmosphere-
supplying respirators would be required. For altitudes above 8,000
feet, an oxygen level below 19.5% would constitute an oxygen deficient
IDLH atmosphere. Column 2 of Table I presents the percent oxygen levels
below which an oxygen deficient atmosphere exists for altitudes from
sea level to 8,000 feet. Comments are requested on the values in the
table.
Oxygen Deficient IDLH Atmospheres
Many commenters felt that the ANSI Z88.2-1980 definition of an
oxygen deficiency-IDLH atmosphere was satisfactory (Ex. 15-14, 15-19,
15-26, 15-27A, 15-31, 15-33, 15-35, 15-37, 15-38, 15-46, 15-52, 15-53,
15-55, 15-58, 15-62, 15-70, 15-71). ANSI in its 1980 standard (Ex. 10)
defines an oxygen deficiency-IDLH atmosphere as one which causes an
oxygen partial pressure of 100 millimeters of mercury (mm Hg) column or
less in the freshly inspired air in the upper portion of the lungs
which is saturated with water vapor. This corresponds to an oxygen
content of from 14% at sea level to 20.95% at 14,000 feet. The oxygen
content is adjusted using a formula to account for the effects of
changing altitude. AMAX (Ex. 15-55) felt the ANSI oxygen deficiency
requirements (and thus the Los Alamos position as well) were overly
restrictive since they would require people working at altitudes above
10,000 feet to wear supplied air respirators, and their employees have
successfully used air-purifying respirators at these high altitudes for
many years.
The Los Alamos National Laboratory (Ex. 36-52), and California OSHA
(Ex. 36-44), agreed that the 100 mm Hg oxygen partial pressure level
was the appropriate criterion for defining an oxygen deficient IDLH
atmosphere, but only for altitudes from sea level to 10,000 feet. For
altitudes from 10,000 feet to 14,000 feet they recommended that OSHA
use 20.95% oxygen as the level below which an oxygen deficient IDLH
atmosphere exists since people who are physiologically acclimated can
live and work above 10,000 feet without adverse effects and the
standard should account for this reality. The current ANSI Z88.2
Respirator Committee (Ex. 36-55) has concluded that for altitudes below
14,000 feet, work should be permitted without protection for oxygen
deficiency when the oxygen content of ambient air (20.95%) is not
reduced.
The foregoing comments are all in agreement that, up to 8,000 feet
the oxygen concentration equivalent of an oxygen partial pressure of
100 mm of Hg in the upper portion of the lungs is appropriate for a
threshold IDLH level. This is equivalent at sea level to an oxygen
concentration of 14%. However, NIOSH has pointed out (Ex. 25-4) that in
the presence of an oxygen concentration of less than 16% at sea level
one can experience impaired attention, thinking and coordination. At
14% or below, NIOSH states the possibility of faulty judgment, poor
muscular coordination, rapid fatigue that could cause permanent heart
damage, and intermittent respiration. In an IDLH or escape situation
all of the described effects could place a worker in serious jeopardy.
Therefore, OSHA believes that an oxygen concentration of 16% or below
at sea level should require the extra precautions that go with IDLH
atmospheres. The AMAX comment that its employees have suffered no
consequences of not having used supplied air respirators at greater
than 10,000 feet is believed by OSHA to signify that they have not
worked in atmospheres with less than 19.5% oxygen.
The ANSI Z 88.2-1992 standard defines an oxygen deficiency IDLH
atmosphere to be one with an oxygen partial pressure of 95 mm Hg or
less (12.5% oxygen at sea level). The oxygen deficiency may be caused
by either a reduction in the normal 20.9% oxygen content, by reduced
total atmospheric pressure to 450 mm Hg (8.6 psi), equivalent to 14,000
feet elevation, or any combination of reduced percentage of oxygen and
reduced pressure. The ANSI rationale as stated in Appendix A.5 for
these low levels is that the 12.5% oxygen content corresponds to an
oxygen partial pressure of 48 mm Hg in the alveoli of the lungs, with
the alveolar blood 83% saturated with oxygen. At higher alveolar oxygen
partial pressures (60 to 100 mm Hg), as the ANSI appendix points out,
only slight changes in hemoglobin oxygen saturation are seen. Much
larger changes occur in the blood oxygen levels as the alveoli oxygen
levels fall from 60 down to 30 mm Hg. By choosing such a low oxygen
partial pressure for the start of an oxygen deficient IDLH atmosphere,
ANSI has effectively removed any safety margin from its standard. An
acclimatized individual may be able to effectively operate at the
equivalent of 14,000 foot altitude. However, individuals normally used
to the 20.9% oxygen present in the outside air or supplied by their
respirator are not acclimatized. They could be seriously and rapidly
debilitated by the quick drop in oxygen partial pressure such a 12.5%
oxygen deficiency IDLH level represents if their respirator should
fail. The safety margins in the ANSI Z 88.2-1992 oxygen deficiency IDLH
and non IDLH definitions have been reduced to their bare minimums. OSHA
has chosen to reject these less protective ANSI oxygen deficiency
definitions in favor of the more forgiving levels it is proposing to
adopt.
OSHA is proposing a value of 16% oxygen by volume as the level
below which an oxygen deficient IDLH atmosphere exists for altitudes
from sea level to 3,000 feet. For altitudes from 3,001 feet up to 8,000
feet, percent oxygen levels have been calculated that correspond to a
value of 100 mm Hg oxygen partial pressure. At altitudes above 8,000
feet and up to 14,000 feet, OSHA is proposing that an oxygen level
below 19.5% would be considered an oxygen deficient IDLH atmosphere.
This agrees with the ANSI Z 88.2-1980 oxygen deficiency-IDLH level of
100 mm Hg, which corresponds to the point where the oxygen content of
the alveolar blood is 90% saturated with oxygen and below which
symptoms of hypoxia occur. Although OSHA is accepting the claim that
work can be performed by acclimated persons at altitudes above 10,000
feet when the ambient air oxygen percentage is not reduced, comments
and data are requested that will support or contradict this conclusion.
To avoid possible confusion, OSHA has not used a formula for
calculating the oxygen deficient IDLH levels as ANSI did, but instead
presents in Column 3 of Table I in paragraph (d) a list of the percent
oxygen levels for altitudes from sea level to 14,000 feet.
Table I.--Oxygen Percentages Constituting Oxygen Deficient and Oxygen
Deficient IDLH Atmospheres
------------------------------------------------------------------------
Column 3
Column 2 percent
percent oxygen
oxygen below
below which an
Column 1 altitude above sea level (in feet) which an oxygen
oxygen deficient
deficient IDLH
atmosphere atmosphere
exists exists
------------------------------------------------------------------------
0 to 3000....................................... 19.5 16.0
3001 to 4000.................................... 19.5 16.4
4001 to 5000.................................... 19.5 17.1
5001 to 6000.................................... 19.5 17.8
6001 to 7000.................................... 19.5 18.5
7001 to 8000.................................... 19.5 19.3
Above 8000 to 14,000............................ (\1\) 19.5
------------------------------------------------------------------------
\1\For altitudes above 8000 feet, an oxygen deficient IDLH atmosphere
exists when the oxygen level falls below 19.5%
(E) Medical Evaluation. Most who responded to the ANPR, although
divided in their responses to many of the questions on medical
surveillance, were in general agreement that the provision in the
present standard is inadequate and that there should be initial and
follow up evaluations of some sort. In particular, there was a
consensus that it is not safe to wait for specific complaints or
problems to arise before conducting such evaluations (Ex. 15-10, 15-26,
15-27A, 15-31, 15-45, 15-46, 15-48, 15-49, 15-53, 15-54, 15-55, 15-63,
15-70, 15-75, 15-76).
Experience in industry shows that most healthy workers do not have
problems wearing a respirator when it is properly chosen and fitted (1,
2, 6). The most commonly found problems are claustrophobia--which may
be an intolerance of feeling enclosed or may give rise to a subjective
feeling of breathing difficulty. Other common problems are chronic
rhinitis, catarrh, and nasal allergies where it is necessary to remove
the respirator frequently to deal with nasal discharge. Some
individuals with chronic sinusitis may have breathing difficulties
wearing a respirator.
Most other difficulties relate to the cardiorespiratory system. The
wearing of a negative pressure respirator does increase the resistance
to inspiration. The problem is reduced with powered air-purifying
respirators and with positive pressure atmosphere-supplying
respirators. Exhalation resistance with modern negative pressure
respirators does not significantly increase expiratory effort. The
types of cardiorespiratory problems which may increase the individual's
breathing problems when wearing a respirator are chronic obstruction,
respiratory disease, emphysema, asthma in some cases, and moderate to
severe pneumoconiosis.
Cardiac or cardiorespiratory diseases that may affect respirator
wear include coronary thrombosis, any type of congestive heart disease
or decompensations cor pulmonale, other ischemic heart disease and some
cases of hypertension.
The amount of difficulty will clearly depend on the degree of
cardiorespiratory inadequacy and also on the amount of physical effort
required by the work. Some people who may have difficulty wearing a
negative pressure respirator should be able to manage well with a
positive pressure type respirator.
The decision about the fitness of the individual to wear a
respirator is clearly a judgment that can only be made by the physician
taking into account the state of the individual's health as well as the
physical requirements of the job.
The preproposal draft would have required that employers refer
employees for medical evaluations if they would be routinely wearing a
respirator for more than one hour per work shift, or five hours per
week. This provision would eliminate medical surveillance for employees
who wear respirators only infrequently, while ensuring that those who
must rely on respirators for longer periods of time would be
appropriately evaluated.
The preproposal draft provision exempting occasional respirator
users from the medical evaluation requirements was the subject of many
comments. Some commenters felt there could be problems with
interpreting the exemption (Ex. 36-32), or that the exemption would be
difficult to enforce with employers claiming exemptions for employees,
and the employees claiming they should have the evaluation (Ex. 36-8).
Dow Chemical (Ex. 36-40) stated that the exemption would be a tough
administration problem. AMAX Inc. (Ex. 36-27) stated that the exemption
limits were excessive and burdensome to industry. The Ethyl Corporation
(Ex. 36-11) felt the exemption limits were too rigid and stated that a
more appropriate time limit might be 10 to 13 hours per week or 25% to
33% of working hours. The Amoco Corporation (Ex. 36-35) supported the
flexibility that the occasional users exemption showed and the American
Textile Manufacturer's Institute (Ex. 36-18) felt medical evaluations
should be provided for all individuals who wear respirators for more
than ``pass through'' activities. Dow Chemical (Ex. 36-40) recommended
that any employee required to wear respiratory protection for any
reason be provided a medical evaluation, which may or may not include a
medical examination.
The Mine Safety and Health Administration (MSHA) (Ex. 36-34) felt
the exemption did not focus on the individuals at risk such as those
wearing an SCBA in confined spaces for repairs. The AIHA (Ex. 36-41)
and DuPont (Ex. 36-38) also pointed to the problem of SCBA wearers who
perform heavy work for short periods of time without having been
medically evaluated. California OSHA (Ex. 36-44) recommended that the
occasional use exemption not apply to SCBA wearers. The Lawrence
Livermore National Laboratory (Ex. 36-26) felt that the occasional use
exemption would eliminate physical evaluations for emergency response
activities and other short use, high risk jobs.
OSHA is removing the draft requirement that a medical evaluation be
made available to any worker using a respirator more than one hour per
work shift. This provision would have required an evaluation if the
respirator were to be worn for one stretch of 61 minutes even if that
were the only time it was worn. OSHA believes that such a requirement
is unreasonable and that repeated use of the respirator will be covered
by the five hour per week provision. Therefore, the proposal now
requires that a written opinion be obtained from a physician that each
employee who needs to wear a respirator for five hours or more during
any work week is fit to wear one. However, in view of questions that
have been raised, OSHA invites comments on the duration of respirator
use that should constitute a threshold for the medical evaluation
requirement. OSHA recognizes that problems may occur with
interpretation or enforcement of the occasional use exemption and
solicits comments on projected problems. OSHA emphasizes that the
occasional use exemption is intended to apply only to short time
respirator wearers, not those who wear respirators on a routine basis.
Medical Evaluation Procedures
Although OSHA believes that a medical evaluation is important,
there appears to be considerable difference of opinion as to what
circumstances should trigger a physical examination, what the physical
examination should consist of, who is to administer such an
examination, and what the specific criteria should be for passing or
failing the examination with respect to fitness for wearing a
respirator. Because there is no definitive information either in the
record or, as far as OSHA can tell, in the open literature as to how to
resolve these issues OSHA is raising for comment three alternative
versions of the medical evaluation provision. The first, which is
represented by proposed regulatory text, would require that the
employer obtain a doctor's written opinion on the employee's ability to
wear a respirator. The nature of the medical evaluation performed would
be left up to the physician to determine. The second alternative would
require the performing of a medical evaluation consisting of a medical
history and medical examination, from which a physician's opinion on
respirator use would be written. The third alternative would require
that a health questionnaire be administered to all respirator wearers,
with a medical evaluation being performed on those whose answers to any
of the questions on the questionnaire show the need for such an
evaluation, or who wear an SCBA for emergency or rescue operations.
After reviewing the questionnaires and any medical evaluation
performed, a physician's written opinion on respirator use would then
be prepared.
OSHA is seeking comment on each of the three alternatives and on
the specific elements that make up the required procedures of each
alternative. The comments that will be received to this proposal, along
with OSHA's review of other medical evaluation information, will be
used to develop a single medical evaluation procedure for the final
standard. Therefore, commenters should detail why they prefer one of
the three alternatives in this proposal above the others, and
specifically address which required elements should be contained in the
medical evaluation procedures. A more detailed discussion of each of
the three alternatives follows.
Alternative 1--Written Physician's Opinion
The first alternative of the medical evaluation procedures is part
of the proposed standard as paragraph (e). It would require that, for
every employee who wears a respirator more than five hours during any
work week, a written opinion be obtained from a licensed physician as
to the fitness of the employee to wear a respirator based on the type
of respirator used, the workplace conditions and the employee's
physical condition. Information regarding respirator type and workplace
conditions would be required to be supplied to the physician by the
employer. The decisions as to whether a physical examination is
necessary, and if so its content, is left to the judgment of the
physician. OSHA is proposing suggested elements of a physical
examination in an appendix to guide the physician should he or she
choose to perform such an examination. In addition, this proposal
requires that an annual review, which in the physician's judgment may
not entail an examination, be conducted by a physician.
Possible regulatory language for the other two alternatives of the
medical evaluation section are presented as follows. Although they are
not included in the text of the standard, OSHA will consider all three
alternatives in its deliberations leading to a final standard.
Alternative 2--Medical History and Examination
The second alternative for a medical evaluation provision is a
requirement for a mandatory medical history and medical examination.
The preproposal draft standard contained this alternative, but OSHA has
modified it in response to comments received. As in alternative 1,
guidance for the elements of the evaluation would be supplied by
nonmandatory Appendix C.
These recommended elements are basically the same as were specified
as mandatory in the prepublication draft and are similar to those
recommended by ANSI in its standard on physical qualifications for
personnel using respirators, ANSI Z88.6-1984 (Ex. 38-10).
The preproposal draft would have required that a medical history be
taken and a medical examination be conducted for each respirator user
with exemptions for nonroutine users. Also included were mandatory
elements to be reviewed during the performance of the medical history
and medical examination. Several commenters recommended that OSHA adopt
a more performance oriented approach for the medical evaluation
provisions while listing in a nonmandatory appendix what the physician
should consider during the examination (Ex. 36-18, 36-22, 36-38, 36-40,
36-41, 36-50, 36-55).
Comment is requested on the individual elements that make up the
medical history and medical examination recommended provisions listed
in Appendix C. OSHA also requests comment on whether it should set
specific medical trigger levels for elements of the medical
examination, and if so, what these trigger levels should be.
A mandatory requirement for pulmonary function testing was opposed
by commenters on the grounds that it is not clear that pulmonary
function testing would provide information that would not already be
apparent to the physician from performing a normal physical exam. It
was also pointed out that there are no specific pulmonary function test
values that are considered to be clearly suitable thresholds for
ability to wear a respirator (Ex. 36-3, 36-22, 36-30, 36-32, 36-34, 36-
47, 36-55). The discussion in Appendix C on pulmonary function testing
states that spirometry including FEV1 and FVC, while not required
should be performed. The recommendation for screening spirometry
contains a set of values for FVC and FEV1 which have been adopted
from the ANSI Z88.6 recommended standard. These values, a FVC of less
than 80 percent or a FEV1 of less than 70 percent, represent
levels at which restrictions on respirator use should be considered.
A study of clinical pulmonary function and industrial respirator
wear by Raven, Moss, Page, Garmon, and Skaggs (Ex. 38-8) recommended
that a standard clinical pulmonary function test, the 15 second maximum
voluntary ventilation (MVV.25), may be the test of choice for
determining worker capability to wear a respirator. A ``conservative''
score on this test, along with other clinical data from the medical
evaluation would form the basis for screening respirator wearers. OSHA
requests information and comment on the use of the (MVV.25) as a
screening test for respirator use, and whether it should be added to
the nonmandatory recommendation for FEV1 and FVC testing.
Appendix C also contains recommendations for elements to be covered
in the medical history. The provision in the preproposal draft stating
that psychological problems or symptoms be noted in the medical history
has been removed. Rebecca Eklund of Freeport McMoran Inc. (Ex. 36-28)
pointed out that the psychological conditions requirement was too
inclusive since there are many psychological conditions which in no way
affect the wearing of a respirator. Because the medical examination
covers psychological conditions relevant to wearing respirators, such
as claustrophobia or severe anxiety, the recommendation that
psychological problems be noted in the medical history is redundant and
therefore has been dropped.
Comments were also received on the preproposal draft requirement
that tolerance to tachycardia (i.e. excessively rapid heartbeat) be
noted. OSHA notes that the recommendation that tolerance to tachycardia
due to inhaling heated air be noted is part of the ANSI Z88.6 physical
qualifications for respirator wearers, and for that reason was included
in the preproposal draft. Closed circuit SCBA units, also known as
rebreathers, supply air to the wearer at elevated temperatures of
120 deg. F or greater. A possible physiologic response to breathing
heated air is tachycardia. Commenters stated that tachycardia produced
by heated air was called difficult to validate (Ex. 36-8), was not
necessary to note since few respirators produce heated air (Ex. 36-29),
difficult to assess and attribute to heated air (Ex. 36-32), not
generally accepted by the medical profession as a problem (Ex. 36-37),
challenged any problem with breathing heated air (Ex. 36-47), and
questioned the necessity to impose the restriction since only
rebreather respirators produce heated air (Ex. 36-52).
OSHA agrees with the commenters that few closed circuit SCBAs are
in use, and that checking every respirator user for tolerance to
tachycardia is not necessary. Therefore, the recommendation for noting
tolerance to tachycardia due to inhaling heated air has been removed.
OSHA requests any information on problems that have occurred with
tachycardia for wearers of closed circuit SCBAs, and comment on whether
this recommendation should be included (either as a mandatory
requirement or in Appendix C only) for those who will be using closed
circuit SCBAs.
The suggested elements of the medical examination itself, where one
is performed, have also been modified and placed in Appendix C. The
recommendation for the physician to assess facial conditions that may
interfere with respirator fit has been dropped. As Alan Hack of the Los
Alamos National Laboratory stated, most physicians will not be familiar
enough with respirator facepieces to be able to make such an evaluation
(Ex. 36-29). Also, any decision on respirator facepiece fit would more
properly be made when selecting the best fitting respirators during fit
testing.
The need for assessing hearing ability was also questioned by
commenters on the preproposal draft. Several commenters recommended the
elimination of the hearing assessment provision since it is irrelevant
to the wearing of a respirator (Ex. 36-8, 36-13, 36-27, 36-29, 36-47,
36-52). California OSHA (Ex. 36-44) stated that hearing ability should
not be a consideration except perhaps where a worker wears a continuous
flow airline respirator with hood or helmet that covers the head. The
ability to hear is certainly important during IDLH entry, but this is a
concern regardless of respirator use. The American Association of
Occupational Health Nurses (Ex. 36-8) and Alan Hack (Ex. 36-29) pointed
out that nonaudible alarms such as visual or vibration alarms could be
used along with the buddy system for such situations. Monsanto (Ex. 36-
32) questioned what level would constitute an acceptable hearing
ability. ORC (Ex. 36-47) and California OSHA (Ex. 36-44) also
questioned whether OSHA was requiring audiometric testing.
Having considered the foregoing comments, OSHA believes that the
second alternative should retain a recommendation for performing a
hearing assessment nonmandatory Appendix C. There are situations where
the wearing of a respirator, particularly one with a full helmet or
hood, can significantly reduce hearing and the ability to respond to
emergency alarms or warning devices. However, OSHA recognizes that the
problem of hearing ability in the workplace is peripheral to the
ability to wear a respirator. Therefore, OSHA seeks further comment on
the necessity of assessing hearing ability when wearing respirators and
on the appropriateness of this recommendation to the respirator
standard. The assessment of hearing ability to assure communication and
response to instructions and alarms does not require, in the standard,
audiometric testing. For most respirator wearers a simple oral
assessment of hearing ability would be sufficient.
With respect to the question of perforated tympanic membranes,
Shell Oil (Ex. 36-50) submitted a report by Dr. Thomas Milby which
reviewed the issue of potential employee exposure to hydrogen sulfide
via the route of damaged tympanic membranes. The report stated that
there was no valid information in the scientific literature supporting
that perforated eardrums would produce an increased risk of
contamination for workers. Calculations were performed for the Shell
report which showed, in a worst case analysis, ambient air
concentrations of H2S would have to reach some 158 ppm before the
worst case loss of an ear drum would permit exposure at the PEL of 10
ppm. Shell also included a study by Richard Ronk and Mary Kay White of
NIOSH (Ex. 38-11) which concluded that workers with perforated eardrums
should not be excluded from working in hydrogen sulfide atmospheres.
They stated that in no reasonable case can the presence of a tympanic
membrane defect significantly affect respiratory protection. California
OSHA (Ex. 36-44) cited the NIOSH study as showing that tympanic
membrane perforation was not a problem. Other commenters also
recommended that this provision be dropped since it is not specifically
a respirator related problem (Ex. 36-3, 36-18, 36-35, 36-47, 36-52).
In light of the scientific review of tympanic membrane perforation
submitted by Shell Oil, and the report by NIOSH which also reports no
significant exposure from perforated eardrums, the recommendation for
checking for perforated tympanic membranes has not been included in
this proposal. OSHA requests any information and data regarding
problems with respirator use associated with tympanic membrane defects,
and any evidence for the need for checking for perforated eardrums for
respirator wearers.
The American Association of Occupational Health Nurses (Ex. 36-8),
commenting on the preproposal draft provision requiring assessment of
the endocrine system, pointed out that such problems should have been
noted as a previously diagnosed disease during the medical history.
They also stated that assessing the endocrine system for all respirator
wearers would be costly and time consuming. If a history of diabetes or
other endocrine disease was detected, than evaluations could be done on
a case by case basis. Other commenters said that physicians would be
reluctant to accept liability for signing off on such an assessment and
that the evaluations should be restricted to the employee's pulmonary
function and cardiovascular system (Ex. 36-10) and should eliminate the
endocrine test as not relevant to the wearing of respirators (Ex. 36-
13). Alan Hack (Ex. 36-29) and the Los Alamos National Laboratory (Ex.
36-52) stated that ``Workers so afflicted [with endocrine conditions
which result in sudden loss of consciousness] will be restricted from
many employment tasks that do not require use of respirators. Such
restrictions should not be applied specifically to respirator
wearers.'' Dow Chemical (Ex. 36-40) stated that the physical
manifestations of endocrine system disease would be found during the
neurologic examination.
OSHA believes that endocrine conditions such as diabetes should be
considered by the physician when determining whether a respirator can
be worn. Previously diagnosed endocrine conditions should be picked up
during the taking of the medical history. However, undiagnosed
endocrine system problems can still exist. The respirator use
evaluation may be the only physical examination the employee has had
for some time, and a diabetic condition could have developed. The
extent of the assessment suggested, from looking for signs of disease
during the physical exam to more extensive testing of those with signs
of disease, is at the discretion of the physician. Any general work
limitations or restrictions that apply to other work activities of an
individual due to endocrine disorders should also be considered when
determining whether a respirator can be used. OSHA does not recommend
any specific tests for endocrine conditions, leaving the determination
to the physician's judgment. Because the potential for sudden loss of
consciousness or response capability is something that should be
considered when determining an individual's ability to wear a
respirator, the proposal includes the endocrine system assessment
recommendation, as derived from the ANSI Z88.6 standard, in Appendix C.
OSHA requests further comment on the need for assessing the endocrine
system, and on determining which endocrine system conditions would
preclude the use of respirators.
The preproposal draft also contained a requirement that an exercise
stress test be performed for employees who use SCBA's or rebreather
type respirators. The American Association of Occupational Health
Nurses (Ex. 36-8) stated that exercise stress testing would be
expensive and difficult to obtain for fire departments and small
companies. Brown and Root (Ex. 36-10) maintained that an exercise
stress test would be costly (approximately $240) and, if not
standardized, would mean very little in determining whether an SCBA or
rebreather respirator can be worn. Other commenters stated that OSHA
should not require a routine cardiovascular stress test, but require
one only if requested by the physician (Ex. 36-35, 36-40, 36-47). They
also opposed the use of electrocardiograms on a routine basis, claiming
that false positives require expensive follow-up testing. Also the
nature of the tests required for exercise stress was not specified by
OSHA, and an example of an exercise stress test was requested. SOCMA
(Ex. 36-48) commented that exercise stress tests cost between $250 and
$300, and urged OSHA to consider other testing that would yield similar
data in a more cost effective manner, using a performance approach. The
Motor Vehicle Manufacturer's Association (Ex. 36-37) recommended the
provision be deleted and a simple pulse rate count be substituted.
The exercise stress testing provision was derived from the maximum
exercise stress test recommended by the ANSI Z88.6 physical
qualification standard. The ANSI standard stated that individuals with
apparent ischemic disease or who cannot perform well on a treadmill due
to respiratory, musculoskeletal, or other physical problems should not
use SCBAs or be assigned to emergency response teams. OSHA recognizes
that exercise stress tests can be expensive, and that criteria for
evaluating specific conditions that would disqualify workers have not
yet been developed. Moreover, the requirement in the preproposal draft
for stress testing would have applied only to a small group of
respirator wearers, and even then it would be difficult to determine
whether such a test was really appropriate. OSHA concedes that such
problems would appear to render inappropriate a mandatory requirement
for stress testing. Therefore, determining whether an employees' health
condition precludes the wearing of an SCBA or assignment to an
emergency response team has been left to the physician. However,
Appendix C recommends exercise stress testing for workers who were an
SCBA or rebreather respirator device under strenuous work conditions or
in emergencies.
OSHA is seeking further comment on the appropriateness of the
exercise stress test, the most cost effective method of performing such
testing and alternative methods of determining an individuals physical
ability to wear SCBAs and rebreather respirators.
OSHA is seeking general comment on which recommendations should be
retained as part of Appendix C, and whether certain provisions such as
pulmonary function testing and exercise stress testing should be kept
in the nonmandatory appendix or made mandatory provisions of the
standard. Additional comment is also sought on whether OSHA should add
to the nonmandatory appendix a section which further describes health
conditions that should be considered during the medical evaluation. The
proposal lists specific areas to be investigated but does not attempt
to develop a list of medical conditions and diseases that may preclude
the use of respirators. OSHA requests comment on whether such
information would be of use for evaluating the ability to wear
respirators and which medical conditions and diseases should be on such
a list.
The proposal contains an exemption from the required initial
medical evaluation when adequate medical records show that an employee
has successfully taken a medical examination, or received a written
opinion from a physician within the past year, on the basis of which
the employee was determined to be fit to use the same type of
respirator under similar use conditions. This exemption will help avoid
the expense of duplicate medical examinations for transient workers who
have already passed an initial medical evaluation for respirator use on
one job and later moved on to work for another employer.
The preproposal draft contained a provision requiring review of the
employee's medical status when an employee experienced difficulty in
breathing while using a negative pressure or demand respirator. Alan
Hack (Ex. 36-29) and Los Alamos (Ex. 36-52) recommended that a review
occur when an individual experiences difficulty with any respirator,
not limited to negative pressure devices. Homestake Mining (Ex. 36-30)
also recommended a review following breathing difficulty with any
respirator. OSHA agrees that breathing difficulty while wearing any
type of respirator requires a medical status review, and the language
of this alternative has been changed accordingly.
The final departure from the ANSI Z88.6 physical qualification
recommendations is the requirement in this alternative that the
employee's medical status be reviewed annually or at any time the
employee experiences difficult breathing while being fitted for or
using a respirator. Although the latter requirement is implied by ANSI,
the annual review is not. By such an annual review, OSHA is not
necessarily requiring a physical examination. The objective of this
provision is to provide a mechanism which necessitates routine review
of any difficulty an employee may be experiencing. Other then being
performed by or under the supervision of a physician, the specific
nature of this annual review is left to the physician to determine.
OSHA invites comments as to the appropriateness of this provision.
AMAX Inc. (Ex. 36-27) citing experience with the OSHA lead
standard, stated that an annual review of medical status was not
required and review should be required only when requested by the
employee. Air Products and Chemicals Inc. agreed. (Ex. 36-13). OSHA
requests comment on this approach.
In the preproposal draft, OSHA included guidelines for medical
examinations suggesting that they be given every five years for
employees under forty, every two years for those from forty to fifty
years of age, and every year for those above fifty. ANSI in its Z88.6-
1984 standard recommended examinations every 5 years for those below
age 35, every 2 years up to age 45, and annually thereafter. The NIOSH
Respirator Decision Logic suggests examinations every 5 years for those
under 35 years of age, every 2 years for those from 35 to 45, and every
1 to 2 years for those above 45, under most working conditions
requiring respirators. Under strenuous work conditions with an SCBA,
NIOSH suggested exams every 3 years for those under 35, every 18 months
for those from 35 to 45, and annually for those above 45 (Ex. 38-20).
OSHA requests comment on whether an annual review of medical status
is needed, or whether a sliding scale of examination dates, such as
recommended by NIOSH or ANSI, could be substituted for the annual
medical review.
Commenters questioned the preproposal draft requirement that the
medical evaluation be performed by a licensed physician. Many
commenters pointed out that there were portions of the medical
evaluation that could be performed by other health professionals such
as occupational health nurses and physicians assistants, or nurse
practitioners, certified audiometric technicians, and pulmonary
function testing technicians (Ex. 36-8, 36-10, 36-13, 36-18, 36-21, 36-
22, 36-30, 36-32, 36-35, 36-37, 36-40, 36-41, 36-51A, 36-53, 36-55).
OSHA has revised the language for this alternative to permit other
health professionals to perform whatever medical evaluation procedures
the physician chooses to delegate to them. OSHA requests comments on
this issue and on the extent of the role that should be given to these
health professionals.
In requiring a medical evaluation, OSHA has proposed in this
alternative that an examination be given to respirator wearers
regardless of the type of respirator used or the conditions under which
it will be used. Commenters have suggested that not all types of
respirators place the same physical demands upon wearers, and that the
medical evaluation criteria could be reduced for certain low resistance
respirators. John Barr of Air Products and Chemicals (Ex. 36-13) stated
that positive pressure respirators place no significant burdens on
wearers, and that disposable dust masks have no discernable effect upon
respiration. He suggested that OSHA exempt such respirators from the
need for a qualifying medical exam.
OSHA requests comments on whether the medical evaluation provisions
should be less extensive for less burdensome respirators, such as
positive pressure respirators or single use dust masks, and if so, what
provisions could be reduced or eliminated. More generally, comment is
sought on whether the medical evaluation provisions should be modified
to accommodate particular respirator work conditions, and if so, what
those modifications should be.
OSHA requests information and data on the breathing resistance
levels of respirators for wearers, and whether a medical determination
could be made to select a breathing resistance level which poses no
problem for respirator wearers.
OSHA's suggested regulatory language for the second alternative
medical evaluation procedure reads as follows:
(e) Medical evaluation.
(1) The employer shall provide a medical evaluation for each
employee required to wear a respirator for more than five hours during
any work week. The medical evaluation shall be performed by a licensed
physician or by a health professional operating under the physicians
supervision and shall include completion of a medical history and
performance of a medical examination. In advance of the medical
evaluation the employer shall provide the examining professional with
information concerning:
(i) The type of respiratory protection to be used;
(ii) The substances the employee will be exposed to;
(iii) Description of the work effort required;
(iv) Duration and frequency of usage;
(v) The type of work performed, including any special
responsibilities that affect the safety of others such as fire fighting
or rescue work;
(vi) Any special environmental conditions (such as heat or confined
space entry); and
(vii) Additional requirements for protective clothing and
equipment.
(2) Upon completion of the examination, the employer shall obtain
from the examining physician a written opinion which states whether the
employee is fit to wear a respirator and recommends any limitations on
respirator use. A copy of this written opinion shall be provided to the
examined employee.
(3) In the case of new employees, employers may accept an already
existing medical examination or written opinion from a physician
provided it was conducted within a year of the date of employment,
covered the same type of respirator under similar use conditions, and
meets the requirements of (e)(1).
(4) The employer shall have the employee's medical status reviewed
by, or under the supervision of, a licensed physician annually and at
any time the employee experiences unusual difficulty breathing while
being fitted for or while using a respirator. The employer shall have
the responsible licensed physician provide a written opinion resulting
from the review as required under (e)(2).
Alternative 3--Questionnaire
A third alternative for medical evaluation would require that a
medical questionnaire be used to survey respirator users and to
identify those who require physical examinations on the basis of their
medical history (Ex. 15-8, 15-22, 15-34, 15-41, 15-42, 15-44, 15-45,
15-47, 15-68, 15-62). The specific nature of this questionnaire and its
accompanying procedures was not always clearly presented by the
commenters, but the health evaluation provisions in the Organization
Resources Counselors, Inc. (ORC) recommended respiratory protection
program (Ex. 36-47) was suggested as a model medical evaluation
procedure (Ex. 36-3, 36-22, 36-35, 36-38, 36-40, 36-41, 36-47, 36-50,
36-51A).
The program recommended by ORC requires that a screening
questionnaire be administered by a health professional or trained
person for each respirator wearer, prior to fit testing. Anyone who
gives a ``yes'' answer to a question on the questionnaire, or who wears
an SCBA for emergency or rescue operations would receive a medical
evaluation, performed by or under the direction of a physician. The
procedures to be used for the medical evaluation would be left to the
judgment of the health professional performing the evaluation. The
employer and employee would be notified of any restrictions on
respirator wear that are identified by the health evaluation. The ORC
recommended program included a nonmandatory appendix containing sample
questionnaires and suggestions for medical examinations of individuals
who answered yes to the screening questions.
Other commenters who stated that automatic medical exams for all
respirator wearers were not necessary (Ex. 36-3, 36-13, 36-21, 36-22,
36-30, 36-35, 36-38, 36-40, 36-41, 36-47, 36-50, 36-51A) also supported
a medical questionnaire to screen the respirator user population so
that only those whose medical condition warrants a medical exam would
get one. The commenters stated that the questionnaire could be
administered quickly, and the unnecessary expense of medical exams for
healthy respirator users would be avoided.
OSHA has suggested in this alternative that the question of who
should administer the medical questionnaire and determine which
respirator users should be referred for a medical exam be resolved by
adopting the recommended procedure in the ORC respiratory protection
program. Either a health professional or a person trained in
administering the questionnaire by a physician would have this
responsibility. This would place this critical part of the medical
evaluation under a trained individual acting under the direction of the
physician who has the ultimate responsibility for approving respirator
use. OSHA requests comments on the administration of the medical
questionnaire and on the appropriate individuals for performing this
requirement.
Employees who are assigned to emergency or rescue operations with
SCBA respirators would still be required under alternative 3 to have a
medical examination. These individuals are placed in highly stressful
environments while wearing a heavy SCBA, which places an added burden
on their physical condition. A questionnaire would not serve adequately
as a screening procedure for these respirator wearers, and therefore
OSHA would follow the ORC recommendation for alternative 3 and require
that a medical exam be performed. The extent of that examination would
be left up to the physician to determine. OSHA asks for comments on the
need for performing a medical exam for these SCBA wearers, and on
appropriate medical procedures to be used to evaluate their ability to
perform adequately during emergency or rescue operations.
As examples of medical questionnaires, OSHA has included in
Appendix C the ANSI Z88.6 medical questionnaire for respirator use, as
well as the three sample questionnaires from the ORC Recommended
Respiratory Protection Program. OSHA has placed these questionnaires in
this nonmandatory appendix in order to seek comment on the
appropriateness of using such questionnaires and on which provisions in
these samples are appropriate for determining an individual's ability
to wear a respirator. OSHA also requests any alternative questionnaires
that are used in industry.
The proposed regulatory language that has been developed for this
third alternative of the medical evaluation procedures reads as
follows:
(e) Medical evaluation
(1) The employer shall provide a medical evaluation before
respirator use starts for each employee required to wear a respirator.
(i) The medical evaluation shall consist of the completion of a
screening medical questionnaire for all respirator users.
(ii) A medical examination shall be administered to any employee
whose answers to any of the questions on the questionnaire show the
need for such an examination.
(iii) A medical examination shall be administered to any employee
who is assigned to emergency or rescue operations while wearing an
SCBA.
(iv) The questionnaire shall be administered by a health
professional or a person trained in its administration by a licensed
physician.
(v) Any medical examination administered shall be performed by a
licensed physician or health professional under the direction of the
physician. If a medical examination is given, the employer shall obtain
from the examining physician a written opinion which states whether the
employee has any detected medical condition which would place the
employee's health at increased risk or material impairment for
respirator use and any recommended limitations upon the use of
respirators.
(vi) A copy of this written opinion shall be provided to the
examined employee. In advance of the medical examination the employer
shall provide the examining professional with information concerning:
(A) The type of respiratory protection to be used;
(B) The substances the employee will be exposed to;
(C) Description of the work effort required;
(D) Duration and frequency of usage;
(E) The type of work performed, including any special
responsibilities that affect the safety of others such as fire fighting
or rescue work;
(F) Any special environmental conditions (such as heat or confined
space entry); and
(G) Additional requirements for protective clothing and equipment.
(2) In the case of new employees, employers may accept an already
existing medical examination or written opinion from a physician
provided it was conducted within a year of the date of employment,
covered the same type of respirator under similar use conditions, and
meets the requirements of (e)(1).
(3) The employer shall have the employee's medical status reviewed
by, or under the supervision of, a licensed physician annually and at
any time the employee experiences unusual difficulty breathing while
being fitted for or while using a respirator. The employer shall have
the responsible licensed physician provide a written opinion resulting
from the review as required under (e)(1).
Other Issues
Medical Removal Protection
In some substance specific standards (e.g. cotton dust 29 CFR
1910.1043 and asbestos 29 CFR 1910.1001) OSHA has required economic
protection for employees who, for medical reasons, cannot wear required
respirators. California OSHA (Ex. 36-44) and the United Steel Workers
of America (Ex. 36-46) recommended that OSHA request any data on the
instances and types of cases where employees have been determined not
to be able to wear a respirator and what happened to these workers
under current respirator programs. Determining the prevalence of such
rejections and the fates of those who were rejected could be useful in
determining the need of employers to supply alternative respirators or
the need for OSHA to require that employers provide alternative jobs
for those who cannot wear a particular type of respirator. Therefore,
OSHA requests the submission of any data or information regarding
instances and details of cases where workers were found to be unable to
wear respirators and how this determination affected the worker's job
responsibilities. OSHA would also like to receive any available
information on the frequency with which such situations occur, or
alternatively on how many such cases are known to have happened.
Since the inability to wear a respirator, or failing to pass a
medical evaluation, could result in employees losing their jobs, some
commenters recommended that OSHA should add provisions to help
employees in these situations. Medical removal protection, the
requirement that employers provide employees who are unable to wear
respirators with alternative assignments at the same seniority and pay,
was recommended by several commenters (Ex. 36-14, 36-26, 36-44, 36-46).
Giving employees who fail to pass the initial medical evaluation the
right to a second opinion, similar to the provision for physician
review in the lead standard (29 CFR 1910.1025(j)(3)) was suggested by
other commenters (Ex. 36-44, 36-46). Adding a requirement that the
employer provide an alternate type of respirator such as a PAPR or
supplied air respirator in cases where an employee cannot use a
negative pressure air-purifying respirator due to medical restrictions
was recommended by California OSHA (Ex. 36-44). Although such
provisions were included in recent OSHA standards such as cotton dust
(29 CFR 1910.1043(f)(2)(iii), (f)(2)(iv), (h)(5)(i)(c)) and asbestos
(29 CFR 1910.1001(g)(2)(ii)) OSHA does not feel that sufficient
information has been submitted upon which such provisions could be
included in this proposal for general application to all workplaces.
Therefore, additional information and data are requested which address
these issues.
(F) Fit Testing Procedures
Although it has long been recognized that respirators must fit
properly in order to provide protection, it has only been within the
last few years that systematic approaches for assessing and assuring
fit have been developed. As a result of continuing research, a number
of fit testing protocols have been developed and tested (Ex. 2, 8). In
addition, because of the variability of face size characteristics among
individuals, different sizes of facepieces are now available, in
contrast to the recent past when a ``one size fits all'' approach was
generally taken.
In general there are two categories of fit testing--qualitative and
quantitative. Qualitative fit testing involves the introduction of a
gas, vapor, or aerosol challenge agent into an area around the
respirator wearer. A determination is then made as to whether the
respirator wearer can detect the presence of the challenge agent
through subjective means such as odor, taste, or nasal irritation. If
the presence is detected, the respirator fit is considered to be
inadequate.
In a quantitative respirator fit test the respirator is worn in a
stable test atmosphere containing a suitable challenge agent. The
adequacy of the fit is determined by measuring the actual levels of the
challenge agent, both outside and inside the facepiece of the
respirator.
The current standard sets out no specific protocols for fit testing
although it does require training which provides an opportunity to have
the respirator ``fitted properly''. It also requires employees to be
trained to check the fit each time the respirator is put on without
specifying how the check is to be performed or even what type of check
is acceptable. Experience and research over the past ten years have
demonstrated that this is insufficient, as set forth in the following
discussion.
Even when fit testing is performed, it may be inadequate. In the
past, some manufacturers included their own qualitative fit testing
protocols as part of the manufacturers instructions to the user.
Numerous commenters complained that NIOSH or OSHA should check the
manufacturers instructions for adequacy and consistency (Ex. 15-14, 15-
16, 15-36, 15-41, 15-46, 15-47, 15-48, 15-50, 15-52, 15-75A, 15-79),
since employers often use or attempt to use such instructions to fit
respirators to their employees faces. Since fit testing is often done
by the employer, commenters also suggested that the simplicity of the
protocol be stressed.
Commenters to the ANPR suggested that a standardized protocol be
developed which is oriented toward the hazard or level of exposure when
determining the qualitative efficacy of a respirator (Ex. 15-10, 15-48,
15-64). In addition, it was suggested that the type of odor or irritant
used should also be standardized (Ex. 15-54, 15-58, 15-70, 15-71, 15-
76). Correlation of the testing done qualitatively and quantitatively
would also aid in assuring that respirators being worn are effective
(Ex. 15-17B, 34-8). The proposed standard attempts to standardize the
protocol and also simplify the procedures.
OSHA has recognized the need for fit testing in the development of
recent substance specific rulemakings. Quantitative fit tests were
required in such standards as acrylonitrile (29 CFR 1910.1045) and lead
(29 CFR 1910.1025). However, specific protocols were not provided in
any of these substance specific standards. Later, questions arose
regarding the feasibility of the requirement for quantitative fit
testing in the lead standard (29 CFR 1910.1025). As a result OSHA
conducted a specific rulemaking for the fit testing provisions of the
lead standard. It was consequently determined that qualitative fit
testing could be used with half mask negative pressure respirators,
provided that one of three specified protocols was followed, and
provided that lead concentrations do not exceed ten times the
permissible exposure limit (47 FR 51110).
These specified qualitative fit testing (QLFT) protocols use
isoamyl acetate, irritant smoke, or saccharin as the test agents. OSHA
believes, based on the record of the lead supplemental rulemaking (47
FR 51110), that the three QLFT protocols accepted for use in the lead
standard are generally appropriate for use with negative pressure half
mask respirators and has therefore incorporated them.
This proposal would require that fit testing be performed where
air-purifying respirators as well as tight fitting atmosphere-supplying
respirators are used. Either qualitative fit testing or quantitative
fit testing may be conducted for quarter facepiece, half mask, or full
facepiece respirators. The proposal details the procedures for
qualitative and quantitative fit tests in Appendix A. Commenters (Ex.
36-38) on the preproposal draft stated that the protocol exercise
regimens and other elements common to both qualitative and quantitative
fit testing were not consistent. Therefore the common elements of the
protocols in Appendix A have been standardized in this proposal in
order to provide consistency.
It is recognized that one purpose of revising the existing
respiratory protection standard is to allow for changes in respiratory
protection technology. Numerous comments were made suggesting that
limiting the qualitative and quantitative tests to certain specified
methods would freeze technology at the present state and would not
allow for future changes nor provide any incentive to develop new test
methods or test agents (Ex. 36-22, 36-32, 36-35, 36-51, 36-53). OSHA
agrees and would like to develop more performance oriented criteria by
which new or modified fit test procedures can be evaluated. Such
criteria must guarantee a high level of certainty that the fit test
will in fact select the best fitting respirator and give maximum
assurance of reliable fit. Performance oriented criteria that will
enable reliable new fit tests to be developed and implemented do not,
to OSHA's knowledge, exist at the present time. OSHA seeks comment so
that it can build a provision into the standard that encourages and
permits improvements in fit test technology. Such comment should
include specifications for validation procedures and for what
organizations can be designated as credible validation performers.
In the absence of performance oriented criteria for determining the
reliability of fit tests, OSHA is proposing to allow the use of
qualitative or quantitative fit tests other than the methods specified
in Appendix A provided they are validated to provide equivalent or
better reliability.
When a qualitative fit test is properly administered for a half
mask, quarter mask, or full facepiece negative pressure air-purifying
respirator in accordance with the protocols in Appendix A, OSHA
proposes to allow the respirator to be used in concentrations up to a
maximum of ten times the established permissible exposure limit.
Quantitative fit testing (QNFT), a more recent development,
measures the efficacy of a respirator by actually measuring and
comparing the contaminant level inside and outside a respirator
facepiece. As with qualitative fit testing, commenters stated that
manufacturers' QNFT protocols differ greatly (Ex. 15-22, 15-26, 15-30,
15-44). Many objected that different test agents were used (Ex. 15-44,
15-55, 15-58, 15-79). Some manufacturers protocols only test the
respirator once instead of using the average of several tests. OSHA in
reviewing these comments agreed that the QNFT procedure should be
standardized and for this reason includes a protocol in the proposed
standard.
Either qualitative or quantitative fit testing may be used for
quarter facepiece, half mask, or full facepiece respirators. However,
OSHA has only limited data on the applicability of the qualitative fit
test protocols for either quarter facepiece or full facepiece
respirators. Therefore, although this proposal does allow the use of
quarter facepiece and full facepiece respirators which pass the QLFT in
atmospheres up to ten times the established exposure limit, OSHA
invites interested parties to submit data which demonstrate how well
the QLFT protocols can detect poor fits for full facepiece and quarter
facepiece respirators.
If the employer chooses to use quantitative fit testing, a full
facepiece respirator may be used up to a maximum of its assigned
protection factor of 50 as shown in Table I of paragraph (d), provided
that the fit factor obtained during quantitative fit testing is at
least 500.
The proposal requires fit testing of tight fitting atmosphere-
supplying and powered air-purifying respirators. It is recognized that
demand type atmosphere-supplying respirators have negative air pressure
inside the facepiece compared to the air pressure outside the
respirator upon inhalation. The efficacy of these respirators therefore
relies to a large degree on the integrity of the facepiece to face fit.
Therefore it is clearly appropriate to require fit testing of demand or
negative pressure tight fitting atmosphere-supplying respirators.
Comments were also received regarding positive pressure tight fitting
atmosphere-supplying respirators (Ex. 36-26, 36-45, 36-44). Such
comments suggested that it is appropriate to require the fit testing of
positive pressure devices since it has been determined that positive
pressure respirators do not always maintain positive pressure. Further,
the possible adverse effects of the negative pressure spikes can be
minimized by providing positive pressure respirator users with good
fitting facepieces. Therefore, it has been suggested that quantitative
fit testing should be required for positive pressure equipment (Ex. 36-
26). Accordingly, OSHA is proposing that tight fitting atmosphere-
supplying respirators utilizing quarter facepiece, half mask, and full
facepiece masks be fit tested either by a qualitative or quantitative
fit test. The proposal specifies that only the mask needs to be tested,
not the entire respirator unit. Since the testing of entire atmosphere-
supplying respirator units may require even more specialized QNFT
equipment, and since the fit of the facepiece itself is the basic
consideration, only the mask is required to be tested. It is recognized
that most respirator facepieces (i.e brand, model, size) are available
in air-purifying models as well as atmosphere-supplying units.
The fit test is to be performed on the same brand, size, and model
of an air-purifying respirator. Once a fit is achieved with a
particular mask, a NIOSH approved atmosphere-supplying respirator which
utilizes the same type of mask as used in the test (i.e., brand, size,
model) is to be selected for use by the employee. The respirator may
then be used with an assignment protection factor as noted in Table II.
OSHA is proposing that fit testing be performed before an employee
first starts wearing a respirator in the work environment and at least
annually thereafter. Semiannual respirator fit testing is required
currently in certain OSHA substance specific standards such as lead,
inorganic arsenic, acrylonitrile, and asbestos. In the preproposal
draft respirator standard, OSHA proposed that fit testing be performed
annually. Testing respirator fit on an annual basis was considered more
appropriate for a general respirator use standard rather than the
semiannual fit testing required in some substance specific OSHA
standards. Commenters on the preproposal draft standard agreed with the
annual testing requirement (Ex. 36-8, 36-11, 36-26, 36-30, 36-31, 36-
44, 36-45, 36-47). Others disagreed. Michael Stewart of the Boeing
Company (Ex. 36-24) commented that fit testing should not be required
at a fixed, arbitrary frequency since changes which affect a proper
respirator seal occur at random. He proposed that OSHA require fit
testing whenever an employee experiences difficulty in obtaining an
adequate face seal during a routinely performed positive/negative fit
check. However, a study of the negative pressure fit check has shown
(Ex. 24-21) that this fit check would pass respirator wearers with
inadequate fits, particularly those that require protection factors
above 10. Therefore, the use of positive/negative facepiece fit checks
to determine when a fit test should be given would be an inadequate
substitute for annual fit testing. The Monsanto Company (Ex. 36-32),
Amoco Corporation (Ex. 36-35) and the Dow Chemical Company (Ex. 36-40)
stated that annual fit testing was not necessary and it was their
experience that fit testing every second year was adequate. It is
OSHA's belief, however, that fit testing not only determines respirator
fit, but also provides an opportunity to check on comfort and problems
with respirator wear, and reinforces respirator training by having
wearers review the proper methods of donning and wearing the
respirator. Moreover, a two year interval between fit tests has not
been shown to provide adequate assurance that necessary respirator fit
factors will be maintained in the workplace. OSHA encourages these
companies and others to provide any supporting data or specific
experiences they have that would support an alternative to annual fit
testing. OSHA invites comments from all interested parties on the
annual fit testing requirement and on alternative fit testing
frequencies. OSHA also requests any experience from fit testing
programs on how frequently the annual fit test results in the changing
of the previously assigned respirator for a new model or size.
The point was raised that either contractors or corporate staff
members often have sole responsibility to conduct quantitative fit
testing at local facilities and that a problem is created when new
hires enter the work force after the annual fit test has been completed
at the facility (Ex. 36-11). OSHA is proposing that where assigned
protection factors higher than ten are necessary, requiring
quantitative fit testing, an employer may utilize a qualitative fit
test to select respirators for new employees provided that a
quantitative fit test is administered within thirty days. This is
allowed only when the employer is relying on an outside party to
conduct quantitative fit testing. OSHA is also asking for comments on
whether this provision should be broadened to cover other situations,
such as when the QNFT equipment is out of service for repairs, where
the thirty day exemption would prove useful.
It is generally recognized that facial configuration, and
ultimately respirator fit, can be affected by factors such as weight
gain or loss, and can change with time. Comments were submitted
requesting that specific criteria be provided on the conditions which
would require a retest, such as a set amount of weight change (Ex. 36-
13, 36-28). To clarify the issue the current proposal states that
retesting is required as necessary, such as when visual observations
are noted regarding an employee's condition which could affect
respirator fit. Further it is stated that such conditions may be facial
scarring, cosmetic surgery, or an obvious change in body weight. OSHA
believes that it is not possible to provide specific quantifiable
criteria for the extent of such changes and that it is unavoidable that
the employer will need to exercise judgment in deciding when a non-
scheduled fit test is necessary.
Once fitted the employee shall be given the opportunity to wear the
respirator for two weeks. If the respirator becomes unacceptably
uncomfortable the employee must be given an opportunity to select a
different respirator facepiece and be retested. Employers relying on
contractors to conduct fit testing may wish to have the employee
successfully fitted in two different respirators. This would prevent
having the contractor return to the facility to retest an employee
whose respirator became uncomfortable.
Appendix A
Appendix A applies to both qualitative and quantitative fit testing
of quarter facepiece, half mask, and full facepiece respirators. The
appendix identifies three established qualitative fit test protocols
and one quantitative fit test protocol utilizing one of two test
agents.
A protocol for the TSI Portacount fit testing method has not been
included as an established quantitative fit test protocol at this time.
The use of the Portacount is currently acceptable under a compliance
interpretation which treats its use as a de minimis violation of the
substance specific standards which require the use of an aerosol
generation system for quantitative fit testing. As part of this
rulemaking a protocol for the Portacount will be reviewed and, if
appropriate, the existing substance specific standards fit test
provisions will be revised to permit its use. OSHA invites the
submission of other fit test protocols for public comment and OSHA
approval before inclusion as established fit test methods.
In addition Appendix A contains two sets of ``minimum criteria for
a valid fit test''. One set of criteria applies to qualitative fit
tests which utilize a ``non-established'' test agent or method. The
second set applies to quantitative fit tests which use a ``non-
established'' test agent or test method. The purpose of including these
criteria is to allow and encourage the development of new qualitative
and quantitative fit test methods and/or media. This is in response to
numerous comments stating that any new standard should be flexible
enough to allow new methods, test agents, and respirator test
technology to be developed (Ex. 36-22, 36-32, 36-35, 36-51A, 36-53).
OSHA requests comments as to the appropriateness and adequacy of the
proposed Minimum Criteria.
New test methods and/or agents may be accepted by OSHA after their
use is proposed in a Notice of Proposed Rulemaking, and comments are
requested, according to a notice and comment rulemaking procedure
pursuant to the Administrative Procedure Act, 5 U.S.C. 553. OSHA
believes that this procedure, authorized by the OSH Act in the last
sentence of section 6(b)(7) will allow relevant public comment to be
submitted for OSHA's evaluation without the need for public hearings.
Since the protocols which will be adopted in this standard will have
been subjected to rulemaking, additional protocols too, should be
examined in a public proceeding. However, requiring full 6(b)
rulemaking, with public hearings, would in OSHA's view, unduly delay
decision making on the validity of new fit testing protocols and would
be unnecessary. OSHA believes that this procedure strikes an
appropriate balance between the need to accommodate technological
advances in fit testing, and the need to obtain input from affected
employers and employees.
Both the qualitative and quantitative validation criteria for new
fit test methods require that the fit test data submitted for approval
demonstrate statistically that the fit test method would be as
protective. These requirements set a strict performance criteria for
new test methods. While these criteria have generally been used in the
past in evaluating test data it is not clear that these performance
levels are the most appropriate ones to be used for evaluating new fit
tests. Some of the existing qualitative fit test methods that are
generally accepted do not meet these performance levels. The irritant
smoke (Ex. 24-12) and saccharin (Ex. 24-20) QLFT protocols identified
92 percent of users with poor fits at the 95% confidence level. The
isoamyl acetate QLFT protocol identified 93% of the poor respirator
fits (Ex. 24-19). As an alternative, it has been suggested that OSHA
allow the use of new fit test methods that are proven to meet or exceed
the performance levels of the currently accepted methods. OSHA requests
comments, data, and information on the appropriate performance levels
that should be required for new fit test methods, and on whether the
95% of users/95% confidence level requirements contained in the
validation criteria for new fit test methods should be retained or
revised.
The question of whether OSHA should propose standard test aerosol
particle sizes to be used in validating new qualitative fit test
methods has been raised. For validation testing of respirators equipped
with high efficiency particulate air (HEPA) filters a polydisperse test
aerosol with a mass median aerodynamic diameter of 0.6 micrometers with
a geometric standard deviation of less than 2 was considered by OSHA.
For testing respirators equipped with non-HEPA filters a polydisperse
test aerosol with a mass median aerodynamic diameter of 2.0 micrometers
and a geometric standard deviation of less than 2 was suggested. These
are the particle size ranges for silica dust that NIOSH uses for HEPA
and dust/mist filter certification. Whether these particular aerosol
sizes are the most appropriate ones to be specified for use in
validating new qualitative fit test methods is uncertain. In the
proposal OSHA has not established a standard test aerosol particle
size. With respect to qualitative fit testing, OSHA invites comments
and questions as to the size of aerosols acceptable for use in
qualitative fit test protocols, whether OSHA should establish standard
test aerosol sizes for validation testing, and if so, what the
appropriate sizes should be.
It should be remembered that, regarding the minimum criteria for
validation of a new fit test procedure, the test subjects of interest,
and the only ones that enter into the statistical analysis, are those
who have poor respirator fits. The statistics must be based on the
ability of the new test procedure to detect an already established
poorly fitting respirator. It must be kept in mind that the validation
of a fit test measures the performance of the fit test and not of the
respirator. The objective of the validation testing is to assure that
the new test procedure provides results which are at least as reliable
as those of the existing protocols.
The validation of new fit testing procedures has to be a carefully
controlled measurement procedure using test instrumentation with an
accuracy that exceeds that found in standard quantitative fit testing.
The validation testing that has been done on the existing fit test
procedures were performed using laboratory grade instrumentation. As a
matter of caution, it is recommended that those performing validation
testing for new fit test procedures submit to OSHA the test parameters
of the instrumentation that will be used in advance, before extensive
testing is done. OSHA invites comments to specify more precisely the
performance parameters that should be established for valid comparison
measurements. The section in this proposal that describes minimum
criteria for validation of new QNFT protocols requires that
instrumentation achieve sufficient accuracy and precision, but does not
specify values for these parameters. Therefore, OSHA requests comments
on appropriate values for accuracy and precision of validation
instrumentation including sampling systems, detectors and processors.
OSHA is aware that the ANSI Z88 respirator committee is working on
minimum criteria for fit test instrumentation. If during the rulemaking
process ANSI finalizes its recommendations, OSHA will give them serious
consideration with respect to the minimum criteria.
New Fit Testing Technology
The minimum criteria for fit testing also contains a section that
deals with minimum criteria for new technology. It contains provisions
which are general in nature, since without knowing what the new fit
testing technology will be it is not possible to develop specific
criteria. Fit testing methods using new technology will have to be
approved by OSHA on a case by case basis, taking into account the
specific nature of the new technology. OSHA requests comments on how
new technology for fit testing should be evaluated, and what ground
rules for minimum criteria OSHA should establish concerning its use.
OSHA is aware that there are other fit testing methods under
development that do not rely on particle counting, such as the
controlled negative pressure fit test or fit tests that use a gas as
the fit test agent. Other novel fit test methods using different
technologies may be developed in the future. OSHA intends to allow for
the possible acceptance of these novel fit test methods. However, there
has to be a way to guarantee that any new fit test method is at least
as effective as the existing particulate methods in screening out poor
respirator fits. The proposed criteria in Appendix A for new fit test
methods related to particle counting fit test methods, and may not be
appropriate for other technologies. OSHA, therefore, would like
suggestions on what criteria would be appropriate for accepting or
rejecting fit test methods based on non-conventional principles.
Fit Test Exercises
Complaints were also registered on the issue that the fit test
protocols specified in the prepublication draft proposal were not
consistent in that the exercise regimens, length of test exercises and
type of exercises were not consistent among the qualitative fit test
methods and that there were corresponding differences between the
qualitative and quantitative fit test protocols (Ex. 36-38). For
example, the isoamyl acetate method consisted of seven exercises; the
saccharin protocol, five exercises; the irritant fume protocol, six
exercises; and the quantitative fit test protocol, eight exercises.
Therefore the initial section of Appendix A contains uniform
requirements applicable to both qualitative and quantitative fit tests.
Except for minor modifications, the uniform requirements are the same
as those identified in the OSHA lead standard (29 CFR 1910.1025) as a
result of the rulemaking on its fit testing provisions. Only those
areas where substantive changes were made and where comment has been
received are addressed below.
In the course of the fit test the test subject is to seat the
respirator by moving the head from side-to-side and up and down, slowly
while taking a few deep slow breaths. This represents a change from the
selection protocol in the lead standard, since the lead standard
protocol requires the head to be moved ``rapidly'' from side to side
and up and down. The Los Alamos National Laboratory commented that
there is uncertainty regarding the ability of rapid head movement to
seat a respirator, and also indicated that it may actually make the fit
worse (Ex. 36-52). Therefore OSHA has revised the proposal regarding
this aspect by removing the word ``rapidly''.
The employer is to maintain a record of the fit test administered
to an employee. The fit test record is to include the date and type of
test, test agent, employee information, and type of respirator. When
QNFT is administered a record of the test recording (i.e. strip chart,
computer integration, etc.) is to be maintained. The fit test records
are to be maintained until the next fit test is administered. A record
is necessary to enable OSHA to determine compliance by verifying that
an employee has been fit tested before first starting respirator use
and at least annually thereafter; that the tested employee passed the
qualitative fit test, or achieved a sufficiently high fit factor to
pass the quantitative fit test for the assigned protection factor
required; that the quantitative fit test was correctly performed and
the fit factor calculated properly; and that the respirator model and
size as determined during fit testing are the same as being used by
that employee in the workplace.
Initially OSHA proposed that a fit test card be furnished to the
employee. The card was to contain information regarding the size and
type of respirator fitted and the date of the test. Comment was made
(Ex. 36-39) that the requirement for a fit test card created an
additional recordkeeping burden. Therefore the requirement has been
deleted in the current proposal.
An alternative to the required fit test recordkeeping would be to
allow the employer to sign a certification that fit testing has been
performed and not require that any fit test records be maintained. This
certification would state that fit testing had been performed and
provide the date of the certification, the employee identifier of the
person certified, and the signature or initials of the responsible
individual making the certification. Since a certification is not
considered a record for recordkeeping purposes, and the fit test
records generated during the fit test would not have to be maintained,
the recordkeeping burden of the proposed standard would be reduced.
However, the replacement of the requirement for retaining the fit test
records by a certification requirement would have an impact on the
performance of an inspection. Inspectors would have to rely on
secondary sources such as interviews of employees and fit test
operators to confirm compliance with the specific fit test requirements
of the standard. OSHA requests comments on the burden associated with
maintaining fit test records and on the feasibility of fit test
certification as an alternative to the recordkeeping currently required
in the proposal.
The test subject is to perform eight exercises. Seven of the
exercises are to be performed for one minute while the grimace exercise
is to be performed for 15 seconds. The test exercises are: normal
breathing, deep breathing, turning head side to side, moving head up
and down, talking out loud, grimace, 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.
Comment was received stating that requiring the test subject to
bend at the waist would in effect eliminate the use of the waist length
hood or shower curtain type fit test hood (Ex. 36-27, 36-52).
Therefore, this proposal allows jogging to be performed in lieu of
bending at the waist when the size of the fit test enclosure will not
allow the test subject to bend at the waist.
Objections were also raised over requiring the test subject to
read, particularly the rainbow passage (Ex. 36-8, 36-27, 36-28, 36-32,
36-36, 36-39, 36-49). Statements were made that some employees cannot
read well. Therefore, the proposal now requires that the employee
either talk out loud or read from a prepared text.
One comment stated that OSHA has made numerous changes to accepted
protocols without verifying the effect of the changes on test
performance (Ex. 36-38). It states further that the isoamyl acetate
(IAA) and saccharin procedures originally presented in the lead
standard would take only 3 minutes, but that the proposal changed this
to 10 minutes without verifying that the concentration in the test
chamber could be maintained for the duration of the test.
OSHA does not regard the foregoing as valid. The QLFT test
validated and adopted in the lead standard as a result of rulemaking
has 6 exercises (IAA). Five of the exercises are to be performed for
one minute and the ``talking'' exercise is to be performed for
``several'' minutes. Thus the total test time would be 7 to 8 minutes.
In this proposal OSHA is requiring eight exercises of which seven are
to be performed for one minute and one exercise for 15 seconds, for a
total time of 7 minutes and 15 seconds. Thus the total time required in
this proposed standard is essentially the same length as the IAA QLFT
protocol in the 29 CFR 1910.1025 lead standard. Any differences in
required time are clearly minimal. Since the length of the two tests
are the same, OSHA has concluded that the IAA concentration at the end
of the proposed protocol would be the same as if it were performed
under the QLFT IAA protocol contained in the lead standard.
Qualitative Fit Test Protocols
Isoamyl acetate protocol
With the exception of the test exercises described above, the IAA
test protocol included in the proposal is the same as the IAA protocol
adopted under the lead standard (29 CFR 1910.1025). Comment was
received stating that the odor threshold screening test can be
performed in the same room in which the fit test is conducted, provided
that ventilation is adequate (Ex. 26-18), or when only a few people at
a time are tested (Ex. 36-8), and that two rooms on separate
ventilation systems may not be available and are unnecessary. However,
in none of these comments was the specific issue of olfactory fatigue
addressed.
In the proposal OSHA is requiring the odor threshold screening test
and fit test to be conducted in separate rooms and that the rooms not
be connected to the same recirculating ventilation system. In the
rulemaking in the lead standard on qualitative fit testing OSHA, in
response to the recognition of one of the shortcomings of the IAA test
(i.e., olfactory fatigue), deemed it appropriate that separate rooms
and ventilation systems be required for the IAA fit testing and odor
threshold screening test (47 FR 51114). Since nothing in the foregoing
comments responded to the olfactory fatigue concern, OSHA is
maintaining the requirement for separate rooms and ventilation systems.
Saccharin Solution Aerosol Protocol
The saccharin solution aerosol protocol in the proposal is
essentially identical to that contained in the lead standard (29 CFR
1910.1025 Appendix D II). Comments were received suggesting that OSHA
not allow the use of saccharin as a test agent since it is a suspect
carcinogen (Ex. 36-28, 36-36) and that it is listed in the National
Toxicology Program's Third Annual Report on Carcinogens (Ex. 36-34).
However, the saccharin fit test protocol is the only QLFT protocol that
has been validated for use with disposable dust/mist respirators.
Eliminating the saccharin protocol would result in prohibiting the use
of disposable dust/mist respirators, since they could not be fit
tested. Although OSHA acknowledges that saccharin is a suspect
carcinogen, it is highly unlikely that an annual exposure of 10
minutes, during most of which time a respirator is worn, could
constitute any measurable risk. OSHA considers such an exposure to be
de minimis. Therefore, for the present time OSHA will allow the use of
saccharin as a test agent for respirators in the absence of an
acceptable alternative for testing disposable dust respirators. In this
respect saccharin differs from DEHP, a test agent used in QNFT, for
which acceptable substitutes exist. OSHA in this proposal is
encouraging the development of new test agents and test methods as a
replacement for the use of saccharin by including provisions which
would allow such new protocols and test agents to be used.
Irritant Fume Protocol
Comment was received on the irritant fume protocol stating
correctly that the irritant fume and IAA protocols had inadvertently
been combined in the prepublication draft and that the cartridges
required for the respirator are incorrect, i.e., high efficiency
organic vapor-acid gas, (Ex. 26-18, 36-28, 36-45, 36-52). The
prepublication draft of this proposal inadvertently contained the above
referenced requirements which were contained in the amendment to the
lead standard. The lead standard was corrected at a later date (3-3-
83). The correction required only high efficiency filters and deleted
all references to the use of IAA in the irritant fume protocol. These
corrections are accordingly reflected in the current proposal.
Objections were raised over requiring the use of a low flow air
pump set to deliver 200 milliliters per minute. Statements were made
that an aspirator bulb should be acceptable unless justification is
provided for requiring a low flow air pump (Ex. 36-27, 36-28). OSHA is
maintaining in the proposal the provision requiring the use of the low
flow air pump. The purpose of the pump is twofold: to provide the
challenge agent at a constant and stable rate; and to prevent a large
amount of irritant from being released at one time. Use of an aspirator
bulb will not provide delivery of the test agent at a stable, constant
rate. Further, the use of an aspirator bulb can easily result in a
large amount of irritant smoke being inadvertently released at one
time.
Quantitative Fit Test (QNFT)
Under the QNFT provisions the employer is to assign to one party
such as a staff member or contractor the duty of implementing the QNFT
program. The person assigned is to be knowledgeable about the
instrumentation, calibration, use and administration of the tests.
Further the employer is responsible for ensuring that the QNFT
equipment is kept and maintained in such a way that it will operate at
its original specifications, including maintaining the aerosol size and
concentration in the test environment. OSHA is requesting comment on
appropriate means/methods which should be used to ensure that the QNFT
unit is producing aerosol with the particle size distribution and
concentration for which the unit was originally designed.
The quantitative fit test is to be conducted according to
procedures which are widely recognized and accepted in the industrial
hygiene community. It is performed in a test environment containing a
challenge agent such as a hood, portable booth, or chamber. Measurement
of the challenge agent concentration is made inside the respirator and
inside the ambient test chamber environment by appropriate detection
methods such as forward light scattering photometry or flame
photometry. During the test the respirators are to be fitted with high
efficiency filters, or otherwise fitted with filters that offer 99.97%
efficiency against 0.3 micron aerosols according to the NIOSH
definition of high efficiency as stated in 30 CFR Part 11 or 42 CFR
Part 84. Therefore virtually any measurable leakage will be the result
of leaks between the respirator sealing surface and the respirator
wearers face. If challenge agents other than particulates are used, the
sorbent/filters must offer a similar degree of collection efficiency
against the challenge agent.
Challenge Agents
In the ANPR OSHA requested comment on what test agents are suitable
for QNFT. The ANPR also raised the question of whether it should be
allowable to use substances identified as suspected carcinogens and if
allowable, what basis should be used to determine that the probable
dose is acceptable or unacceptable. Although it is generally recognized
that QNFT fit testing equipment using test agents such as di-2-
ethylhexyl phthalate (DEHP, commonly referred to as DOP), corn oil, and
sodium chloride are commercially available at the present time, OSHA
was and is interested in exploring all possible test agents for use in
QNFT. On the issue of suitable test agents for QNFT, OSHA received a
variety of comments. Some commenters suggested that the agency accept
any agent demonstrated to be effective (Ex. 15-30), relatively
nontoxic, easily detectable, and relatively stable (Ex. 15-13). Others
provided lists of agents such as sodium chloride, di-2-ethylhexyl
phthalate, di-2-ethylhexyl sebacate (DEHS), corn oil, mineral oil, and
1% ethylene in air (Ex. 15-15). Another list submitted consisted of
sodium chloride, di-2-ethylhexyl phthalate, di-2-ethylhexyl sebacate,
corn oil and mineral oil (Ex. 15-58). Others provided one or two test
agents: sodium chloride and corn oil (Ex. 15-55); DOP and corn oil (Ex.
15-37); corn oil and vanilla extract (Ex. 15-10); sodium chloride (Ex.
15-44); or corn oil (Ex. 15-26, 15-47, 15-50). In response to the
question of appropriate test agents it was suggested that ``The
essential characteristics for an acceptable solid or liquid aerosol
agent for QNFT are described in ANSI Z88.2-1980 and/or the LANL basic
protocol''. The Dow Chemical Company stated that there are many
suitable test agents for QNFT (Ex. 15-19). It said that within Dow,
Freon 12 was used extensively and that to be suitable the agent should
be readily detectable at low concentrations. Dow later stated
replacement of their units would be expensive and unnecessary, should
Freon 12 be excluded as a test agent under this proposal (Ex. 36-40).
The second question of whether it should be allowable to use test
agents identified as carcinogens was prompted by animal studies
concerning DEHP which were positive for carcinogenicity. Several
commenters declared that suspect carcinogens in general should not be
allowed to be used (Ex. 15-34, 15-44, 15-48, 15-50, 15-55, 15-58, 15-
70). The St. Joe Lead Company (Ex. 15-44) stated: ``In general, they
should not be used. The problem is not so much that one could determine
the doses well below any dose of concern, but rather that the concept
of a health related test utilizing a known carcinogen would tend to
undermine the positive psychological value of concern of the employer
for the worker's health.'' Comment was received stating that there is
insufficient toxicological evidence to eliminate materials such as DEHS
or PEG as test agents and that gases should not be precluded (Ex. 36-
52). Any test agent should be allowed as long as the employer can
assure that employees are not exposed to hazardous concentrations.
Other comments ranged from declaring that substances known to be
human carcinogens should not be used as fit test agents (Ex. 15-22, 15-
26) to stating that suspect carcinogens may be used depending on
potency, concentration, exposure and other safety factors (Ex. 15-22).
In the information submitted by NIOSH (Ex. 16) which was incorporated
into a later document entitled ``Alternatives to Di-2-Ethylhexyl
Phthalate (DOP) Respirator Quantitative Fit Testing'' (Ex. 24-10), it
was stated that di-2-ethylhexyl phthalate (DEHP) or DOP was recently
found to be carcinogenic in two rodent species by the National
Toxicology Program. NIOSH reviewed the evidence for carcinogenic
potential and overall toxicity of DEHP as it is used in quantitative
fit testing, and concluded that DEHP should be replaced. The
carcinogenic risk was estimated to be minimal for the respirator wearer
under normal conditions. However, NIOSH pointed out that two critical
exposure factors must be considered in QNFT; (1) Exposures to the DEHP
aerosol can vary for the respirator wearer being tested if QNFT is
improperly conducted; (2) Field practitioners administering QNFT,
especially those using portable testing equipment, where aerosol
ventilation is difficult to control can be subjected to routine and
varying exposures. NIOSH tested several agents as possible substitutes
for DEHP in existing QNFT equipment which was originally made for DEHP
aerosol. Test results revealed that refined corn oil, di-2-ethylhexyl
sebacate (DEHS), and dimethecone all exhibited polydisperse aerosol
particle characteristics essentially equivalent to those generated with
DEHP. Further tests showed that both refined corn oil and DEHS aerosols
were highly suited for conducting QNFT. Finally, reports describing the
toxicity and health effects of each agent were reviewed. The review
revealed that extensive tests conducted on refined corn oil show that
its toxicity is very low and that it has not demonstrated carcinogenic
potential during its use as a control agent in carcinogenic bioassays.
NIOSH concluded that a refined corn oil aerosol is the best option to
replace DEHP in quantitative fit testing.
Monsanto (Ex. 15-26) made reference to the NIOSH work which
prompted Monsanto to switch from DEHP to corn oil as the prescribed
challenge agent. After considering the data, OSHA has concluded that
corn oil or sodium chloride aerosol systems are most appropriate for
quantitative fit testing and the proposal so specifies in the QNFT
protocol. OSHA cites the positive carcinogenic findings of DEHP in two
rodent species by NTP (Ex. 24-10) as sufficient evidence to preclude
its use in QNFT when suitable substitutes are commercially available.
Corn oil has exhibited essentially equivalent polydisperse aerosol
particle characteristics to that of DEHP, and it can be used in
existing systems designed for DEHP with only slightly more maintenance
required (Ex. 24-10). Comment was received stating that corn oil does
require more maintenance and urged OSHA and NIOSH to expedite the
search for other suitable test agents (Ex. 36-39).
Other test agents have been suggested such as DEHS, ethylene,
vanilla extract, freon-12, and mineral oil. OSHA does not intend to
exclude these test agents. However, there are insufficient data on
their suitability. For example, questions have been raised on the
suitability of DEHS since its metabolic fate may be similar to that of
DEHP. Mineral oil was suggested as a suitable test agent but has been
observed to remain in the lung for prolonged periods (Ex. 24-10).
OSHA invites comments on the suitability of other test agents such
as mineral oil, freon-12, ethylene, and di-2-ethylhexyl sebacate
(DEHS). OSHA will consider evidence on the suitability and reliability
of other test agents and the detection systems associated with other
test agents. Information on the toxicity of the agent, sensitivity and
limits of detection of the system, and other pertinent data will also
be useful.
Test Chamber
The proposal requires that the test chamber be large enough to
permit the person being tested to freely perform the QNFT exercise
regimen without disturbing the challenge agent concentration, and that
the chamber effectively contains the challenge agent in uniform
concentration. Uniform stable challenge agent concentration is
important since the ambient challenge concentration is measured from a
single point, i.e. normally a sample hose suspended from the ceiling of
the test chamber/hood and connected to the aerosol detection system.
Therefore, the proposal requires that a stable ambient challenge agent
concentration be achieved prior to the commencement of the test
exercise regimen. As long as the concentration is uniform throughout
the chamber, the concentration at the respirator will be substantially
the same as the concentration at the location where the ambient chamber
concentration is measured. Since the results of the QNFT will be
determined by calculating the concentration of the challenge agent in
the respirator in relation to the average ambient chamber
concentration, a large change in the test chamber challenge
concentration during the course of the test would result in unreliable
results.
Fit Factor Estimation
The challenge agent detection system must be coupled to a strip
chart record, integrator, or computer which creates a record of the
test in order to enable the calculation of the fit factor following the
test. The time interval between an event such as side to side head
movement and its being recorded should be minimal. This is consistent
with the systems used by Los Alamos National Laboratory as well as
commercially available systems. In the ANPR, OSHA requested comments on
two related questions: (1) Should QNFT demonstrate the variation of
contaminant concentration inside the respirator during the breathing
cycle, and (2) to be an adequate test, should QNFT evaluate respirator
performance for each test exercise performed by the test subject? Some
responses indicated that the QNFT should be able to demonstrate the
variation of contaminant concentration inside the respirator during the
breathing cycle (Ex. 15-19, 15-46, 15-48, 15-50, 15-54, 15-58). It was
stated by one commenter that ``a chart recorder should be considered as
mandatory since this would be an extremely difficult process to follow
by using only a dial indicator'', (Ex. 15-50). It was suggested that
the peak penetration averaging method contained in ANSI Z88.2 1980 is
the most acceptable method for determining respirator fit and in order
to achieve this, the QNFT must be capable of demonstrating the peaks of
penetration associated with the breathing cycle (Ex. 15-58).
Others disagreed (Ex. 15-15, 15-26, 15-27, 15-31, 15-55). In
particular, National Draeger Inc. (Ex. 15-15) pointed out a currently
available quantitative fit test system utilizes a 1% ethylene-in-air
test gas. By measuring the ethylene concentration inside the respirator
with a detector tube, a fit factor for the respirator is calculated.
This system for quantitative fit testing does not provide an
instantaneous breath-by-breath measurement that has to be averaged, but
measures the maximum ethylene penetration into the respirator, which
National Draeger felt was appropriate.
In response to the question raised on whether the QNFT should
evaluate respirator performance for each test exercise, some commenters
indicated that each a determination of efficiency is not necessary (Ex.
15-31, 15-48, 15-50, 15-62, 15-73). It was stated on one submission
that there is no need to determine the respirator efficiency for each
test exercise performed since in actual practice the protection
achieved in the workplace is not accurately predicted by QNFT (Ex. 15-
73). Other comments suggested that the respirator efficiency for each
test exercise should be determined. In the data submitted by the Office
of the Assistant Secretary of Defense (Ex. 15-54) it was suggested that
``QNFT should be able to distinguish the respirator efficiency for each
test exercise. The exercise should identify which movement(s) allow for
facepiece leakage and at what level the leakage occurs.'' The
Industrial Safety Equipment Association suggested that ``not having the
ability to distinguish respirator efficiency for each set of exercises
could result in an overstated assigned protection factor'' (Ex. 15-58).
The American National Standard Practices for Respiratory Protection
(ANSI Z88.2-1980) recommends that the instrument used to measure the
penetration of the test agent into the respirator be connected to a
fast-response recorder which records the penetration values
continuously (Ex. 10). Quantitative fit test methods developed by the
Los Alamos National Laboratory use a detection and recording system
which detects the test agent penetration into the respirator facepiece
during the breathing cycle (Ex. 2, 27-12, 24-18). Notations are made on
the record at the beginning and end of each test exercise and the
penetration for each exercise is determined. Comment was received
following the prepublication version of the proposed standard which
also stated that the standard should allow the use of other instruments
such as computers or integrators which would allow integration of the
aerosol penetration inside the respirator (Ex. 36-34, 36-45, 36-52).
Having considered the comments and suggestions OSHA is proposing
that either a strip chart recorder be used to provide a graphic display
of the fit test or that an integrator or computer be used which
provides a determination of the aerosol penetration into the respirator
for each test exercise performed. The detection system shall be capable
of detecting the challenge agent during the breathing cycle, i.e.,
inspiration and expiration. This will permit the determination of the
penetration of the test agent during the breathing cycle.
Comments were requested on the methods used to calculate the
aerosol penetration into the respirator. Suggestions were made to
allow: the use of integrator (Ex. 36-29, 36-45, 36-52); the maximum
peak penetration method (Ex. 36-28, 36-36) and the average peak
penetration method (Ex. 36-28, 36-36). Upon examination of these
various methods OSHA has decided to allow any of the three methods to
be used provided that a determination of the test agent penetration is
made for each test exercise.
OSHA is proposing that the fit factor derived from QNFT be
calculated by dividing the average challenge agent concentration inside
the chamber, (i.e. the ambient concentration) by the average challenge
agent concentration inside the respirator. The average ambient
concentration is derived from the measurement of the challenge agent
concentration in the test environment (outside the respirator) at the
beginning and end of the test. The average challenge agent
concentration inside the respirator is determined from the aerosol
penetration for each test exercise by using one of the three approved
methods to calculate the aerosol penetration.
The test aerosol penetration measured for the grimace exercise is
not to be used in calculating the average challenge agent concentration
inside the respirator. 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 broken during the grimace
exercise. With a properly fitting respirator the test instrumentation
will record a rise in challenge agent concentration inside the mask
during the grimace exercise and a drop in challenge agent concentration
when the respirator reseats itself. If the respirator fails to reseat
itself following the grimace exercise, the subsequent bending over and
normal breathing exercises will show excessive leakage of challenge
agent into the mask and result in failing the fit test. Since even a
properly fitting respirator may show increased challenge agent
penetration during the grimace exercise, the penetration measured
during the grimace exercise is not used in calculating the fit factor.
OSHA invites comments on the proposed method based upon experience
with the calculation of fit factors obtained from QNFT.
As stated previously OSHA is proposing that there be a clear
association between the event taking place in the test environment and
its being recorded. This is critical for the proper calculation of
aerosol penetration for a specific test exercise and ultimately
determining the fit factor. It is the short duration leaks that can
occur during and as a result of a particular fit test exercise that
indicate poor respirator fit. These penetration peaks are used to
determine the fit factor. An inability to resolve these penetration
peaks could result in the fit factor being overstated, since by
averaging all the test exercise penetration levels the high penetration
levels that occurred with one test exercise would be obscured. Also the
grimace exercise is designed to cause a leak in the facepiece fit to
determine if the respirator will reseal. An inability to clearly
associate the event in the test environment with its recording would
invalidate this test exercise and make correct calculating of the fit
factor impossible.
Several factors can affect the time interval between an event and
its being recorded, such as sample hose diameter, sampling rate, and
length of sampling hose. Response time will increase with an increase
in length of sampling line and/or increase in diameter of sampling
line. Therefore the length of the sampling lines and their inside
diameter should be as small as possible. Inside diameters of \1/8\ inch
or less have been commonly used (Ex. 2). Sampling rates generally vary
from 1 to 2 liters per minute (Ex. 24-7, 6), depending on the detection
system used. The tubing used for sampling the test chamber challenge
agent concentration and the tubing used for testing the challenge agent
concentration inside the respirator must be of the same length and
inside diameter. This will result in an equivalent aerosol loss in the
sampling lines due to aerosol deposition in each sample line.
In order to minimize potential contamination of the atmosphere in
the room where tests are being conducted, and to minimize exposure of
the QNFT test operator to the challenge agent, as well as to prevent
interference with the detection system from room air contaminated with
the challenge agent, the proposed protocol requires that any air
exhausted from the test booth/chamber 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 be kept below 50 percent (Ex. 25-3 p. 40).
This is consistent with manufacturer's instructions for sodium chloride
units.
It is imperative that the respirator used in QNFT be in proper
working order. A respirator which may fit an individual better than
others could be rejected if there is leakage due to problems resulting
from improper maintenance such as sticking exhalation valves, leakage
around the probe port, leakage around hose connections, or missing
gaskets. Therefore the proposal requires that all respirators used in
QNFT be inspected for defects and cleanliness. Such inspection must
include checking the condition of the facepiece body for cracking and
holes or tears in the rubber, checking the inhalation and exhalation
valve assemblies for cracks and/or tears in valve material, checking
for foreign material between the valve and valve seats, proper
installation of the valve body in the facepiece, and warped or wrinkled
valves. Respirators with such conditions cannot be used for fit
testing. This is consistent with practices as published by the Los
Alamos National Laboratory (Ex. 25-3 p. 37, 25-4 p. 34).
An additional requirement is that either a positive or negative
pressure fit check be conducted to ensure that the respirator facepiece
is properly adjusted prior to starting QNFT testing. The test protocol
in the preproposal draft also required that a screening QLFT be
conducted after the respirator was worn for a brief time. Comments were
received stating that a mandatory screening QLFT is unnecessary (Ex.
36-52). The purpose of the screening QLFT was to minimize the QNFT test
time by quickly identifying poorly fitting respirators (with gross
leakage) prior to the commencement of the QNFT. The screening QLFT
suggested was an abbreviated IAA or irritant fume QLFT. The test agent
was briefly introduced into the air near the facepiece seal area. If
the agent was detected then a different respirator was tried. This
screening QLFT requirement would reduce QNFT test time for employers,
since poorly fitting respirators that would normally fail a QNFT would
fail the screening QLFT first. However, a mandatory screening QLFT
complicates the testing procedure, and poorly fitting respirators would
be detected during the fit checks before starting the QNFT, or by
exceeding the maximum peak leakage rate allowed during QNFT. Screening
QLFT is recommended to reduce expensive testing time, but does not need
to be mandatory, and therefore this requirement has been dropped.
Prior to the commencement of the QNFT a stable challenge test agent
concentration must be achieved. The concentration of some test
environments such as small booths or waist type hoods may be diluted
significantly when the test subject enters the booth. Normally the
ambient challenge agent concentration will stabilize within 2 to 5
minutes. ANSI Z88.2-1980 addressed this issue by requiring that the
design of the chamber and equipment used to generate the test
atmosphere should ensure that the concentration inside the chamber does
not vary more than 5% during a test (Ex. 10). OSHA is proposing that
the test system be checked to verify that a stable chamber
concentration (10%) has been achieved prior to the QNFT and
at the end of the test. It has been OSHA's experience that a
10% variation in test agent concentration stability has
little appreciable effect. OSHA requests comments on any problems with
test agent concentration stability and on the appropriate percent
variation that should be allowed.
OSHA is further proposing that in order to successfully complete a
QNFT the test subject must complete three separate tests with the same
respirator. Respirator research has demonstrated that variation occur
in the fit factors achieved with repeated fit tests on the same
individual with the same respirator. No wearer can expect to duplicate
the exact same fit with a particular respirator as the respirator is
removed and donned repeatedly. If only one fit test is performed, there
is no guarantee that the level of fit measured during that one test
will be achieved with repeated wearings. Therefore, OSHA is requiring
that three tests be performed, with the lowest fit factor obtained
being used to determine whether the minimum required fit factor is
exceeded. Using the lowest of the three values, OSHA feels, is the most
protective approach to make sure that the respirator will not be used
in an atmosphere which might require a higher fit factor than that
respirator can consistently give. OSHA requests comments on the three
quantitative fit test requirement and any data on alternative ways of
measuring continued protection levels for individual respirator
wearers.
OSHA had initially proposed that the results of the three tests
must be within 10% of each other. However, response to that aspect
indicated that obtaining three results within 10% were not feasible and
the suggestion was made that OSHA should reevaluate that requirement
(Ex. 36-22, 36-29, 36-38, 36-39, 36-41, 36-45). Comment was also
received stating that three tests were unnecessary (Ex. 36-34).
OSHA in the current proposal has deleted the requirement for test
results to be within a 10% range since consistently obtaining tests
with a 10% range may not be feasible. However, the requirement for
performing three fit tests is being maintained.
The results of all three tests must be above the minimum fit factor
needed for that class of tight fitting air-purifying respirator. The
required fit factors are established by applying a safety factor of 10
to the NIOSH APFs. For example, quarter and half mask air-purifying
respirators with a NIOSH APF of 10 would need to achieve at least a fit
factor of 100; and full facepiece air-purifying respirators with a
NIOSH APF of 50 would require a minimum fit factor of 500. Finally the
lowest of the three values must be used as representing the fit test
results.
OSHA has proposed a safety factor of 10 because of variability in
the fit testing procedures themselves, and to account for other
variables such as changes in facepiece fit when the respirator is worn
in the workplace as opposed to during fit testing. A safety factor of
10 accounts for these variations, and is current practice.
Adjustments in the respirator are not to be made during the QNFT.
Any facepiece fit adjustments must be made before starting the exercise
regimen. This is consistent with existing practices (Ex. 25-3 p. 38)
and is intended to prevent manipulation of the respirator in order to
achieve high 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 of 50 for half masks and 100 for full
facepiece respirators and indicate an unacceptably poor respirator fit.
Once the test is terminated the respirator may be refitted or adjusted
and the subject retested. If any of the subsequent three required QNFT
tests that are performed after the respirator has been refitted or
adjusted are terminated because of excessive penetration, then the
respirator is considered to have an unacceptable fit and a different
respirator must be selected and tested.
(G) Use of Respirators
Once the respirator has been properly selected and fitted, its
protection efficiency must be maintained by proper use. The employer is
required to ensure that respirators are used properly in the workplace,
and to include specific procedures for doing so in the written plan for
compliance. This requirement is written in performance language, with
the specific content of the written procedures left for the employer to
establish.
One area of particular concern involves atmospheres where oxygen
deficiency or the concentrations of a hazardous chemical are unknown
and/or potentially immediately dangerous to the life of health (IDLH)
of employees. Care must be exercised in these situations since failure
of the respirator to provide the appropriate protection may result in
serious injury or death. Therefore, the employer is required to
establish specific written procedures for the use of respirators in
IDLH atmospheres including four specific use limitations.
The first provision requires that employees wear only positive
pressure SCBAs or combination supplied air respirators with auxiliary
air supply in IDLH atmospheres. Negative-pressure air-purifying
respirators are subject to face seal leakage, and depend on a filtering
or adsorption mechanism for protection. The positive pressure supplied
air respirators allowed in IDLH atmospheres supply air from an
uncontaminated source, have less of a problem with face seal leakage
and have no filter penetration problems. Two types of such positive
pressure respirators are listed in the respirator selection tables in
paragraphs (d) of the proposed standard for use in IDLH atmospheres;
the positive pressure SCBA and a positive pressure supplied respirator
with auxiliary self-contained air supply. They are the only respirators
to be used in IDLH work conditions to ensure that the employee has the
greatest degree of protection possible.
The second IDLH provision requires a ``buddy'' system where
employees are required to work in IDLH atmospheres. There must be at
least one additional person present, in communications with the
worker(s) in the IDLH area but located where he or she will be outside
the IDLH atmosphere and thus would be able to provide or call for
emergency assistance if necessary. The third provision specifies that
retrieval equipment must be supplied or equivalent provisions for
rescue be made for those entering the IDLH atmosphere. The fourth
provision states that a positive pressure self-contained breathing
apparatus must be provided for the person(s) responsible for emergency
assistance. These provisions are essentially the same as those that are
in OSHA's current standards.
A more general issue involves tight fitting facepiece respirators
which rely on a good facepiece to face seal in order to achieve
effective protection. Therefore, the employer could not allow employees
to wear such respirators with conditions which prevent such a seal.
Facial hair such as a growth of beard or sideburns, absence of
dentures, or a skull cap that projects under the facepiece seal are
examples of such conditions. Many ANPR commenters stated that OSHA
should prohibit facial hair that interferes with the facepiece seal
(Ex. 15-11, 15-18, 15-26, 15-27A, 15-30, 15-33, 15-35, 15-36, 15-41,
15-52, 15-58, 15-62, 15-73, 15-77). Others stated that beards should be
allowed with respirators that do not rely on adequate face seals for
protection such as supplied air hoods, helmets, or suits. (Ex. 15-14,
15-31, 15-34, 15-46, 15-47, 15-48, 15-54, 15-55, 15-79, 15-81).
Research performed with half mask and full facepiece respirators on the
effects of facial hair on facepiece seal show that fit cannot be
assured if hair is present. (Ex. 3, 13, 15-50, 23-2, 23-3).
Two ANPR commenters recommended that OSHA allow beards when the
results of a fit test indicate that a satisfactory seal has been
obtained (Ex. 15-38, 15-42). A report of a study by Fergin (23-1) on
carbon setters with beards which tested the protection factors of
several types of disposable respirators stated that acceptable
performance was achieved and that there was no significant difference
in respirator performance for employees with or without beards under
pot room conditions. Fergin stated that ``. . . where acceptable
protection factors can be demonstrated for subjects with facial hair,
the no-beard rule should be waived from a regulatory viewpoint for such
proven cases.'' However, the ability to obtain a fit factor for a
bearded respirator wearer does not mean that the worker can reliably be
expected to achieve that same protection level each time the respirator
is used. Beards grow and change daily, even hourly. Each time a
respirator is donned there is fit variability. Such variability in face
seal is greatly increased for bearded workers. This large variability
in fit means that a reliable seal cannot reasonably be expected. OSHA
believes that the evidence supports the contention that a reliable seal
cannot be achieved where facial hair interferes with the seal of tight
fitting respirators.
In commenting on the preproposal draft the Association of Western
Pulp and Paper Workers (Ex. 36-2) opposed the facial hair policy
proposed by OSHA and recommended that OSHA prohibit blanket no beard
policies of employers. The International Chemical Workers Union (Ex.
36-14) recommended that the standard specify respiratory types that
could be used with facial hair. Amoco Corporation (Ex. 36-35) requested
that more definitive language be added to allow employers clearer
guidelines to enforce facial hair policies. Allied Corporation (Ex. 36-
49) also wanted a stronger statement prohibiting facial hair. The
Nuclear Regulatory Commission (Ex. 36-31) and the Industrial Safety
Equipment Association (Ex. 36-45) agreed with OSHA's proposed
prohibition on beards when wearing tight fitting facepiece respirators.
The Organization Resources Counselors (Ex. 36-47) and 3M (Ex. 36-54)
stated that the prohibition on facial hair that interferes with the
facepiece seal should also include positive pressure respirators that
depend upon a tight facepiece to face seal.
The draft provision prohibiting conditions such as beards that
interfere with the seal of tight fitting respirators has been modified
after consideration of these comments. Additional wording has been
added to clarify that the provision covers not only negative pressure
respirators that require a tight seal but pressure demand and positive
pressure respirators as well. The provision covers only tight fitting
respirators and is not meant to be a blanket prohibition on beards with
respirators. There are other types of respiratory equipment such as
hoods, helmets and suits which can be worn by employees with beards
since they do not rely upon a tight facepiece fit. Also the wording in
the examples has been changed to read ``facial hair that interferes
with the facepiece seal'' rather than a growth of beard or sideburns
since it is interference with the facepiece seal that OSHA prohibits,
not the presence of facial hair. OSHA invites comments on this issue
and the wording of the proposed provision of the standard, and whether
OSHA should require that employers provide respirators which do not
rely upon a tight facepiece fit in such circumstances.
Corrective glasses or goggles must also be worn in such a way that
they do not interfere with the seal of the facepiece to the face.
Although the employer is free to choose any option to comply with this,
OSHA suggests that full facepiece respirators be worn where either
corrective glasses or eye protection are required since corrective
lenses can be mounted into the full facepiece respirators. In addition,
the full facepiece may be more comfortable, and less cumbersome, than
wearing a half mask and chemical goggles which seal to the face as
well.
OSHA's current respirator standard does not allow contact lenses to
be worn with respiratory protection. In reviewing this requirement, the
main justification has been that with full facepiece respirators, if a
contaminant got into the employee's eye, the involuntary response would
be to remove the mask to attend to the eye, thus removing the
respiratory protection. A second possible problem with contact lenses
is that the dry air inside a positive pressure SCBA facepiece could dry
out the contact lenses. It has also been suggested that contaminants
that get into the facepiece can become lodged under the contact lens,
be held against the eye, and enter into the bloodstream. While these
possible problem areas have been proposed for contact lenses, OSHA has
not found evidence of such problems occurring in the workplace. With
the improvements that have occurred with contact lens technology,
particularly in soft contact lenses, people who are able to wear
contact lenses comfortably in everyday life should be able to wear
contact lenses with a respirator.
OSHA funded a survey on the use of contact lenses by fire fighters
which was conducted by the Lawrence National Livermore Laboratory (Ex.
38-9). Of the 403 fire fighters who regularly wore contact lenses with
SCBA, only 6 responded that contact lens created a problem such as a
contact lens being out of place or a particle under the lens causing
the respirator facepiece to be removed in an environment where the
facepiece would normally be worn. The wearing of conventional
eyeglasses inside the respirator facepiece, as is required by the
current OSHA standard, had a proportionately higher number of problems.
The study concluded that the prohibition on wearing contact lenses with
a full facepiece respirator should be withdrawn.
The Oil, Chemical and Atomic Workers Union (Ex. 36-23) supported
removing the prohibition on the use of contact lenses with respirators.
Alan Hack of the Los Alamos National Laboratory (Ex. 36-29) cited the
Lawrence Livermore contact lens study and the lack of adverse
experience with contacts as reasons for permitting their use. The
Nuclear Regulatory Commission (Ex. 36-31) agreed that the contact lens
prohibition needed to be examined and hoped the Lawrence Livermore
survey on contact lenses would not contradict their use with
respirators. MSHA (Ex. 36-34) stated that contact lenses should not be
used with respirators until further data has been developed to indicate
their safety with the movement of chemicals through the lens, since
many of the new contact lenses allow passage of air and water through
the lens. Earle Shoub (Ex. 36-17) stated that if OSHA is determined to
permit the use of contact lenses under a full facepiece respirator,
this permission should not extend to IDLH atmospheres.
OSHA believes the Lawrence Livermore contact lens study of fire
fighters supports removing the prohibition on the use of contact lenses
with respirators. No evidence shows that wearing contact lenses with
respirators increases safety hazards. Therefore, OSHA is proposing to
remove the prohibition in the current standard on the use of contact
lenses with respirators. OSHA requests any comments or information as
to the appropriateness of using contact lenses with respirators, and
any problems that have occurred with the use of contact lenses in the
workplace.
In dealing with skin irritation and contamination, the proposal
would require the employer to permit employees to leave the respirator
use area as a necessary to wash their faces and respirator facepieces.
The preproposal draft provision permitted employees to leave the work
area is necessary to wash their faces and respirators. Several
commenters asked that the phrase ``work area'' be changed to
``respirator area'' (Ex. 36-22, 36-30, 36-40, 36-41), since employees
can wash their faces and respirators at appropriate cleaning sites
located outside the respirator use area without necessarily having to
leave the work area. The Motor Vehicle Manufacturers Association (Ex.
36-37) recommended changing the wording of the provision from ``as
necessary'' to ``if necessary'' since excessive washing of the skin may
aggravate an irritated skin by removing protective oils. Richard Boggs
of ORC (Ex. 36-47) recommended that this requirement be dropped since
it was a labor relations issue and not all conditions of respirator use
result in situations where such a requirement would make sense. OSHA
agrees with the commenters that employees do not necessarily need to
leave the work area to clean their faces and respirators, and the
wording of the provision has been changed from work area to respirator
use area. OSHA believes that potential health problems of skin
irritation and contamination associated with wearing a respirator
cannot properly be relegated to a labor relations issue as ORC suggests
and OSHA has retained this provision in the proposal.
Another new provision involves the filter elements of air-purifying
respirators. Employers are to allow employees to change such elements
whenever employees detect a change in breathing resistance or chemical
breakthrough. Since breathing rates differ, and workplace contamination
levels may vary, it is difficult to predict the service life of a
particular filtering element. Subjectively detected breathing
resistance indicates that the load on the particulate filter may be
approaching capacity and that the filter must be changed to ensure
continuing protection. This decision was supported by several
commenters in response to ANPR question 29 on service life (Ex. 15-18,
15-19, 15-38, 15-47, 15-48, 15-52, 15-54, 15-75B).
Comments on the preproposal draft also recommended that odor or
chemical vapor breakthrough was a reason for changing an organic vapor
cartridge or canister (Ex. 36-29, 36-30, 36-32, 36-41, 36-52, 36-55).
The wording of the proposal has been changed to add chemical vapor
breakthrough as a cause for changing filters. Wording has also been
added to permit employees to leave the respirator use area to change
filters since this should be done only in clean air.
The proposal also includes a provision that requires respirators be
repaired or discarded and replaced immediately when they are no longer
in their original working condition. Examples of these changes in
condition would be that the strap has broken, the respirator has lost
its shape, or the face seal can no longer be maintained. Since
respirators must be in good working condition to function, it is
imperative that they not be used if they have been impaired in any way.
The respirator manufacturers can supply replacement parts for damaged
portions of their elastomeric respirators. Disposable respirators
cannot be repaired and must be discarded when damaged.
Many commenters to the ANPR stated that disposable respirators
should be allowed to be used until they no longer can provide the
protection for which they were designed (Ex. 15-13, 15-14, 15-19, 15-
22, 15-30, 15-34, 15-36, 15-37, 15-41, 15-44, 15-46, 15-48, 15-53, 15-
58, 15-75A, 15-75B, 15-81). How the useful service life would be
determined, whether by professional judgment or by having the
manufacturers of the respirators make a determination, was unclear.
Such a specific service life determination is difficult to make.
Support for a one day or one shift limit for the use of disposable
respirators was presented by several ANPR commenters (Ex. 15-8, 15-18,
15-26, 15-33, 15-50, 15-54, 15-55, 15-70, 15-75). Disposable
respirators are designed to be used and discarded. Their durability
with repeated use is not great, and most of them are not designed to be
easily cleaned or sanitized.
The proposal requires that disposable respirators which cannot be
cleaned and sanitized be discarded at the end of the task or work shift
whichever comes first. There are some disposable respirators which can
be cleaned and sanitized after use, but they cannot be resupplied with
an unused filter, and therefore the proposal would require disposal
after their useful service life limit has been reached.
The employer is also to ensure that employees, upon donning the
respirator, perform a facepiece seal check prior to entering the work
area when wearing a respirator. The negative-pressure sealing check and
the positive-pressure sealing check included in Appendix B, or the
respirator manufacturer's recommended procedures shall be used for all
respirators on which such checks are possible. The use of such seal
checks are a way of helping to ensure that attention is paid to
obtaining an adequate facepiece seal each time a respirator is used.
An additional requirement being proposed by OSHA is that each self-
contained breathing apparatus used in IDLH atmospheres, or for
emergency entry or fire fighting, be certified for a minimum service
life of thirty minutes. Certified SCBA devices are available with
shorter service lives, but given the types of situations encountered in
IDLH or emergency situations, OSHA maintains that a minimum of thirty
minutes would be required to ensure protection in these conditions. The
thirty minute service life requirement does not apply to combination
supplied air respirators with auxiliary air supply since the air for
normal work operations is supplied by an air line. No service life
requirement has been set for the auxiliary air supply bottle, but the
auxiliary air supply must be sufficient to permit escape from the IDLH
atmosphere should the air line fail. Emergency escape SCBAs also do not
have to meet the thirty minute service life requirement, since their
intended use is only for escape.
The preproposal draft contained provisions to allow the use of
``buddy breathing'' devices and the interchange of air cylinders
between SCBAs, as is permitted under the OSHA fire brigades standard
(29 CFR 1910.156(F)). Comments on the preproposal draft by NIOSH (Ex.
36-42) recommended that OSHA not allow the interchange of respirator
air cylinders since differences in air cylinder backpack construction
could result in the cylinder falling off while in an IDLH atmosphere.
Cylinders come in several different sizes, with varying air capacities
and operating pressures, and can be constructed of different materials.
As NIOSH points out, this can present problems with respirator
operation when some types of cylinders are interchanged. NIOSH also
considered initiating an approval program for SCBAs with emergency
escape breathing support systems (buddy breathers) but found from their
survey of interested parties that a safe and practical emergency escape
breathing support system could not be certified at this time. Current
buddy breathing systems have problems with equipment reliability and
with maintaining adequate airflow in the positive pressure mode. The
Industrial Safety Equipment Association (Ex. 36-45) also disagreed with
the air cylinder interchange and buddy breather provisions and stated
that extending their use to general industry applications would present
problems since rescue and specialized training are not as prevalent in
general industry as in fire fighting, and recommended that the practice
not be allowed. Dow Chemical (Ex. 36-40) recommended that the air
cylinder interchange and buddy breather provisions be deleted or put in
a nonmandatory appendix. ORC (Ex. 36-47) also recommended a
nonmandatory appendix. MSHA (Ex. 36-34) stated that the use of buddy
breathers or the interchanging of air cylinders voids the NIOSH/MSHA
approvals and asked whether OSHA was going to certify these changes as
safe for the wearer. Earle Shoub (Ex. 36-17) also pointed out that the
use of these modified respirators voids their NIOSH/MSHA approval, and
suggested OSHA include a specific exemption from the NIOSH/MSHA
approval requirement when they are used.
Since there are problems in assuring the proper operation of
respirators modified to include buddy breathing devices, and there are
problems with interchanging air cylinders of different construction,
pressure, and size between different SCBAs, OSHA has decided to delete
the provisions dealing with buddy breathing devices and air cylinder
interchange from the proposal. The problems with their use given by the
preproposal draft commenters and the lack of a demonstrated need for
their use in general industry work situations has lead OSHA to remove
these provisions from the proposal. Their use is still allowed for fire
brigades under the fire brigades standard. OSHA seeks comment on this
decision and on the performance of such devices in industry.
Commenters were equally divided on the issue of requiring low flow
alarms or indicators for PAPRs. The AIHA (Ex. 15-81) thought the issue
was related more to equipment certification rather than use, and
suggested that NIOSH consider the advisability of low flow indicators
as permissible modifications. Some felt OSHA should encourage the
development of low flow indicators since it is the positive pressure
generated by the normal PAPR airflow rates that give PAPRs their high
protection factors (Ex. 15-14, 15-22, 15-34, 15-46, 15-48, 15-50, 15-
51, 15-54, 15-55, 15-62, 15-76, 15-77, 15-79). Since low airflow could
be detected by the wearer, some commenters felt airflow indicators were
unnecessary (Ex. 15-16, 15-19, 15-27A, 15-44, 15-53, 15-58, 15-66, 15-
70, 15-73, 15-81).
OSHA has decided not to require the use of low flow alarms or
indicators for PAPRs. The protection levels that PAPRs achieve are in
part dependent upon maintaining an adequate airflow through the
respirator. OSHA encourages the use of airflow indicators with PAPRs,
but since they are not currently available on existing PAPRs it has
been decided not to require them at this time.
When PAPRs should be used was also the subject of comments. Some
commenters felt that OSHA should not dictate the circumstances where
PAPRs should be used (Ex. 15-30, 15-53, 15-58, 15-73). Most commenters
felt PAPRs should be used where the employer or safety and health
professionals determine their use is appropriate (Ex. 15-13, 15-14, 15-
19, 15-22, 15-51, 15-62, 15-70, 15-76). Others felt PAPRs should be
used when a high level of protection must be assured (Ex. 15-27A, 15-
46, 15-79). PAPR use was also recommended where a significant
physiological burden would be imposed by a negative pressure respirator
(Ex. 15-38, 15-44, 15-46).
OSHA has also decided not to dictate the circumstances where PAPRs
may be used. The employer or safety and health professional in charge
of the respirator program is in the best position to determine where
and when PAPR use is most appropriate. The PAPR's ability to provide
increased protection, easier breathing, and greater worker acceptance
should be taken into account during respirator selection. However, the
responsibility for respirator selection has been placed on the
respirator program administrator, and OSHA relies on the administrator
to assure that the appropriate respirator is chosen. However, OSHA asks
for comments on whether employees should be able to choose PAPRs rather
than negative pressure respirators because of their reduced breathing
resistance. OSHA has permitted this in several standards such as the
coke oven emissions (29 CFR 1910.1029) and cotton dust (29 CFR
1910.1043). However, OSHA's experience is that few employees make the
request.
(H) Maintenance and Care of Respirators
In order to ensure continuing protection from respiratory
protective devices, it is necessary to establish and implement proper
maintenance and care procedures. 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.
OSHA believes that the provisions on maintenance and care that
exist in the current standard are effective and adequate. Therefore
this proposal has mainly readopted the current OSHA provisions, the
primary exception being the provisions which deal with cleaning and
disinfecting respirators after they are worn. The present standard,
while requiring cleaning and disinfecting, does not specify when to do
it or provide guidelines for how it should be done. Consequently many
employers have not been following these provisions, with the consequent
result that the cleaning and disinfecting provision is one of the most
frequently cited for violation by OSHA compliance officers. Respirators
which are not cleaned and disinfected--particularly those used by more
than one employee--can cause skin irritation and dermatitis. Where the
toxin to be protected against is a dust, mist or fume, build up of it
on the respirator seal or within the respirator will reduce the
protection factor given by the respirator because the toxin is in the
breathing zone. In addition, the build-up of contamination on the
respirator can contribute to the deterioration of the materials, and
thus deterioration of the protection. Full facepieces must be cleaned
to ensure that employees can see through the facepieces.
The proposal requires that routinely used respirators which are
reserved for the exclusive use of a particular employee be cleaned and
disinfected at least after each day's use. If a respirator is routinely
used by more than one employee, it must be cleaned and disinfected
after each use. Respirators maintained for emergency use must also be
cleaned and disinfected after each use. Recommended procedures for
cleaning and disinfection are included in Appendix B of the proposed
standard.
In comments on the preproposal draft, Thomas Nelson of the ANSI
Z88.2 respirator committee suggested that the cleaning instructions of
the respirator manufacturer be allowed, since they may be different
than these in Appendix B, or cover contaminants which cannot be cleaned
using the methods in Appendix B such as radioactive materials. The Dow
Chemical Company (Ex. 36-40) recommended that the reference to Appendix
B be deleted and a statement to follow the manufacturer's recommended
procedures be added. OSHA agrees and has added wording permitting the
use of manufacturer's cleaning instructions.
Comments on the proposed draft also addressed the issue of the
frequency of cleaning and disinfecting of respirators. The American
Textile Manufacturers Institute (Ex. 36-18) felt that respirators
should be cleaned after each day's use and disinfected periodically as
needed. The Motor Vehicle Manufacturer's Association (Ex. 36-37) stated
that cleaning and disinfecting of respirators should be required
periodically. DuPont (Ex. 36-38) felt that the provisions of the
respirator program suggested by Organization Resources Counselors (ORC)
(Ex. 36-47 Attachment 1) that requires cleaning frequently enough to
avoid hazardous exposures to residues was sufficient. Richard Boggs of
ORC (Ex. 36-47) urged adopting the language in the ORC program since it
would allow the individual organization to tailor its cleaning and
sanitizing programs to the needs of the operation.
OSHA believes that allowing periodic cleaning and disinfecting
without specifying the time period or requiring only that respirators
be cleaned frequently enough to avoid hazardous exposures to residues
are vague concepts which are not defined, which may be difficult to
enforce and would perpetuate the poor cleaning practices which have
already been shown to be a compliance problem (Ex. 33-5). Therefore,
the proposal continues to require that routinely used respirators be
cleaned and disinfected after each day's use and that respirators used
by more than one employee be cleaned and disinfected after each use.
The proposal does not state who should do the cleaning and
disinfecting, only that it be done. The United Steel Workers of America
(Ex. 36-46) recommended that OSHA require that the employer do the
cleaning and repairing of respirators. They stated that when the
employer requires that employees turn in their respirators at the end
of each shift to a central cleaning facility for inspection, cleaning,
and repairs by trained personnel and with the respirators returned to
the employees the next day, a better cleaning program results. OSHA
agrees that such a centralized cleaning and repair operation can ensure
that properly cleaned and disinfected respirators are available for
use, but it is not the only way to do so. For example, in plants where
respirator use is infrequent or where the numbers of respirators in use
are small, central facilities may be inappropriate. The employer is
allowed to choose the cleaning, disinfecting and repair program that
best fits the requirements of the standard and the particular
circumstances of the job. If the employer chooses to require that
employees do the cleaning of respirators, then the employer must
provide the cleaning and disinfecting equipment, supplies, facilities,
and time for the job to be done. The proposal requires that the
employer ensure that the cleaning is done properly, and that only
properly cleaned and disinfected respirators are used.
Storage of respirators must be done properly to ensure that the
equipment is protected and not subject to environmental conditions that
may cause deterioration. The proposed provisions for storage are
essentially the same as the current standard. The employer must protect
the stored equipment from damage, dust, sunlight, extreme temperatures,
excessive moisture, or damaging chemicals. The respirator manufacturer
will often provide additional information on proper storage procedures
which should be observed by the employer. Storage conditions are listed
in performance language. For example, temperature ranges are not
specified. It appears that the degree of severity of a condition would
be related to the tolerance of the particular equipment in question and
would thus vary from model to model. OSHA invites comment on whether
this approach is appropriate, or whether the conditions of storage
should be specified in more detail.
Respirators intended for emergency use shall be kept accessible to
the work area. Where weathering, contamination or deterioration of the
respirator could occur compartments shall be used to protect the
respirator and must be clearly marked to indicate that they contain
emergency respirators. This represents a change in wording of the
proposed standard in response to comments on the preproposal draft (Ex.
36-45, 36-47, 36-55). Since many emergency respirators are stored in
environmentally controlled areas, according to the ANSI Z88.2
respirator committee (Ex. 36-55), compartments would be unnecessary.
The new wording of the proposed standard requires the use of
compartments only where weathering, contamination or deterioration
could occur.
Respirators that are used routinely in the work area are to be
stored in a plastic bag or otherwise protected from contamination or
damage. The prohibition on the use of lockers or tool boxes has been
removed in response to comments in the preproposal draft (Ex. 36-47,
36-49). The requirement that respirators be stored in such a way as to
prevent damage should avoid problems of damage from improper storage in
lockers provided the employer takes appropriate precautions.
When respirators are packed or stored, the facepiece and exhalation
valve must be stored in a manner that will prevent deformation. This is
to prevent impairment of the elastomer due to stretching or reshaping
of the facepiece or exhalation valve because of positioning of the
equipment.
In order to assure the continued reliability of respirator
equipment it must be inspected on a regular basis. The frequency of
inspection is related to the frequency of use. Respirators that are
used routinely are to be inspected before each use, and during cleaning
after each use. Those that are maintained in the facility for emergency
use must be inspected at least monthly, and checked for proper function
before and after each use. However, respirators used for emergency
escape must be inspected before being carried into the workplace.
The proposal has changed the requirement that employers make a
record of inspection dates and findings for emergency use respirators.
Employers only need certify that the required inspections have been
made. The employer must perform the respirator inspection as required
by paragraph (h)(3) to determine that the respirator is functioning
properly and is fully charged. Then the inspection is certified by
having the inspector fill in a tag or label kept with the respirator or
attached to the respirator storage compartment that contains the date
of the inspection, the name or signature of the inspector, and the
serial number or other means of identifying the respirator that was
inspected. The inspection certification need only be maintained until
it is replaced by the certification of the next inspection. This
replaces the requirement in the present standard that the inspection
record be kept as long as the respirator is in the workplace. Since the
inspection tag or label serves to indicate that the respirator has been
inspected within the time limit set for inspections there is no need to
maintain the first certification once a new inspection is performed and
certified.
Self-contained breathing apparatus are also to be inspected
monthly. Air and oxygen cylinders must be maintained in a fully charged
state and recharged when pressure falls to 90% of the manufacturer's
recommended pressure level, and the employer must determine that the
regulator and warning devices function properly.
The standard specifies what constitutes a minimal respirator
inspection: Respirator function, the tightness of connections and the
condition of the facepiece, headstraps, valves, connecting tube, and
filters, canisters or cartridges must be checked. In addition, the
rubber and elastomer parts must be evaluated for pliability and signs
of deterioration. It should be noted that stretching and manipulating
rubber or elastomer parts with a massaging action will help keep them
pliable and flexible and prevent them from taking a set during storage.
The proposed standard also includes provisions related to the
repair of respirators. Repairs or adjustments are to be made only by
persons appropriately trained to perform them, using parts designed for
that respirator. The employer is to ensure that the manufacturer's
recommendations regarding the type and extent of repairs that can be
performed are followed. In any case, reducing or admission valves or
regulators must be returned to the manufacturer or given to an
appropriately trained technician for adjustment or repair. These
provisions are consistent with the requirements of the current
standard.
OSHA invites comments on the provisions related to the maintenance
and care of respirators, including suggestions for other items which
should be considered for inclusion in or deletion from this section
based on the experience of those currently implementing respiratory
protection programs.
(I) Supplied Air Quality and Use
Where atmosphere-supplying respirators are being used to protect
employees it is essential to ensure that the air being breathed is of
sufficiently high quality. The current standard and this proposed
revision reference a number of standard sources which establish
parameters for breathing air quality.
For oxygen, the employer is to ensure that it meets the requirement
of the latest edition of the United State Pharmacopoeia for medical or
breathing oxygen. This represents no change from the current standard.
In the ANPR, comments were requested on whether acceptable
respirator breathing air should continue to meet the specifications for
Grade D breathing air as described in Compressed Gas Association
Commodity Specification G 7.1-1966 or whether an alternate
specification such as Grade E should be used. OSHA received comments
stating that Grade D air is adequate and should continue to be used
(Ex. 15-10, 15-18, 15-31, 15-52, 15-73, 15-75). The Los Alamos National
Laboratory (Ex. 36-52) recommended that Grade E air be used, since most
air that passes Grade D will also pass Grade E. However, LANL gave no
specific reasons for doing so. Therefore OSHA does not believe that the
need for a higher grade has been shown.
In the proposal, breathing air is to meet the requirements for the
grade D air classification in the ANSI/Compressed Gas Association
Commodity Specification G-7.1-1989. This is the revised and current
version of the G-7.1 1966 Compressed Gas Association Commodity
Specification. This means that the oxygen content (v/v) must contain
the amount of oxygen normally present in atmospheric air of 19.5 to
23.5 percent oxygen for synthesized air; hydrocarbon (condensed) of 5
milligram per cubic meter of air or less; carbon monoxide of 10 ppm or
less, and carbon dioxide of 1,000 ppm or less. OSHA invites comments on
the appropriateness of maintaining Grade D as the required quality of
air.
The proposal prohibits the use of compressed oxygen in atmosphere-
supplying respirators or in open circuit self-contained breathing
apparatus that have previously used compressed air. This is to prevent
fire or explosion resulting from the high pressure oxygen coming in
contact with oil or grease (Ex. 10). The proposed standard also
specifies that oxygen not be used with supplied air respirators. These
requirements are also in the current standard.
Both the current standard and the proposal allow air for
respirators to be provided from cylinders or compressors. Cylinders are
required to be tested and maintained as prescribed in the Shipping
Container Specification Regulations of the Department of Transportation
(49 CFR Part 178).
Compressors are to be constructed and situated so contaminated air
cannot enter the air supply system. In addition, the compressors are to
be equipped with suitable in-line air-purifying sorbent beds and
filters to clean the air and assure breathing air quality. The
requirement that air compressors have a receiver of sufficient capacity
to permit escape from a hazardous atmosphere in the event of compressor
failure has been dropped. As was pointed out in several comments on the
preproposal draft, a receiver is necessary only when the wearer cannot
safely stop work and leave the area without injury (Ex. 36-29, 36-32,
36-45, 36-47, 36-52, 36-54, 36-55). Since this proposal requires that
respirators used in IDLH situation be either an SCBA or combination
supplied air respirator with escape air supply, the need for a receiver
for air compressors has been eliminated. Also the requirement for
alarms to indicate compressor failure and overheating have been
eliminated. In the event of compressor failure with a wearer using a
combination supplied air respirator with escape air supply, the loss of
air supply would be readily apparent, and the wearer can switch to the
auxiliary escape air supply and leave the area.
In the ANPR, OSHA also requested comments and input on the
following questions: (1) How frequently should carbon monoxide
concentrations be measured from an air compressor not equipped with a
carbon monoxide alarm, and (2) Is there any reason not to require a
carbon monoxide alarm on all oil lubricated compressors that provide
breathing air? Responses to the issue of the frequency of carbon
monoxide measurements ranged from quarterly (Ex. 15-42) to twice a
month provided the air intake for the compressor is located away from
contamination (Ex. 15-52), to continuously (Ex. 15-14, 15-31, 15-34,
15-50, 15-65, 15-73). John L. Henshaw of Monsanto Company stated ``One
specified frequency would not be applicable under all conditions of
breathing air compressor use.'' (Ex. 15-26).
In response to the ANPR question regarding carbon monoxide alarms
on oil lubricated compressors, numerous comments were received stating
that there was no reason not to require such an alarm (Ex. 15-10, 15-
18, 15-26, 15-31, 15-46, 15-59, 15-70, 15-81). One commenter, Evan
Campbell of Diamond Shamrock stated, ``We recommend the installation of
continuous carbon monoxide monitors with an alarm on oil lubricated air
compressors operated by internal combustion engines, electric motors or
auxiliary power takeoff . . .'' (Ex. 15-65). In the comments of the
National Constructors Association it was indicated that screw type
compressors or oil free compressors do not need a carbon monoxide alarm
provided the air intake is not near a potential carbon monoxide source
(Ex. 15-34).
There was general recognition in the comments that contamination of
the intake air on a compressor used to supply breathing air is of
primary concern. Several comments cited the study published in the
American Industrial Hygiene Association Journal by T.M. Distler of the
Lawrence Livermore Laboratory (Ex. 32-1) entitled ``Formation of Carbon
Monoxide in Air Compressors'' (Ex. 15-13, 15-22, 15-26, 15-30, 15-41,
15-81). The findings of this study revealed that low pressure
compressors are unlikely to reach temperatures where carbon monoxide
would be produced from the lubricant; synthetic lubricants do not
significantly lessen carbon monoxide production; exhaust gases from
combustion engines are the major threat to the quality of the
compressed air; high temperature shut-offs or alarms do not
significantly protect against carbon monoxide contamination of
compressed air.
The preproposal draft contained provisions that required oil
lubricated compressors to have carbon monoxide monitors and high
temperature alarms. Freuhauf Corporation (Ex. 36-1) requested that
compressors equipped with a high temperature shutdown device not be
required to have carbon monoxide monitor since the compressor would be
shut down before breakdown of the oil could occur. The Lawrence
Livermore National Laboratory (Ex. 36-26), citing its study of
compressors authored by Distler (Ex. 32-1), found no need for carbon
monoxide monitors and alarms for oil lubricated compressors. However,
they recommend that carbon monoxide monitoring and alarms be required
for breathing air compressors powered by internal combustion engines,
due to the potential for reentrainment of exhaust gases. Alan Hack (Ex.
36-29) stated that carbon monoxide alarms appear to be unreliable,
there was little evidence of carbon monoxide production with oil
lubricated compressors, and that OSHA should not require them. ASARCO
(Ex. 36-39) recommended that OSHA allow the use of carbon monoxide
absorption filters with visible color change indicators in place of
carbon monoxide monitors. Richard Boggs of ORC (Ex. 36-47) recommended
deleting section (i)(4)(v) requiring carbon monoxide monitors, citing
the report on compressors performed by Distler. The Los Alamos National
Laboratory (Ex. 36-52) stated that carbon monoxide alarms currently in
use were unreliable, and that there was little evidence of carbon
monoxide production with oil lubricated compressors. Lynnette Hendricks
of the 3M Corporation (Ex. 36-54) stated that the requirement for
carbon monoxide alarms added negligibly to the effort to provide
quality breathing air, and that 3M was aware of no instances where oil
lubricated compressor failures resulted in carbon monoxide exposure to
workers. Thomas Nelson of the ANSI Z88.2 respirator committee (Ex. 36-
55) recommended that the need for carbon monoxide alarms be dropped
when the air intake is located away from sources of carbon monoxide
contamination. He also recommended dropping the high temperature alarm
requirement. The State of Wyoming OSHA (Ex. 36-9) recommended that
continuous carbon monoxide monitors with alarms be required for oil
lubricated compressors operated by internal combustion engines or
electric motor auxiliary power takeoffs. The International Chemical
Workers Union (Ex. 36-14) stated that continuous carbon monoxide
monitors and alarms for oil lubricated compressors were the only
effective methods to monitor carbon monoxide concentrations.
OSHA knows of one such incident which involved carbon monoxide
production by an oil lubricated compressor. An MSHA Accident
Investigation Report issued in January 1985 (Ex. 38-12) reported that a
diesel engine powered two stage rotary air compressor that utilized oil
for cooling had overheated during a sandblasting operation at a
limestone quarry. This resulted in the near fatal carbon monoxide
poisoning of the sandblaster who was wearing a continuous flow abrasive
blasting hood which received its air from the compressor. The air
compressor had a thermo bypass valve that should have normally directed
the oil through a cooling radiator once the oil had reached a
temperature of 185 deg. F. The thermo bypass valve failed, allowing the
cooling oil temperature to rise above its flashpoint of 420 deg. F. The
oil ignited in the oil separator and the fire spread to the combined
oil receiver/air receiver, producing carbon monoxide. The compressor
was equipped with a high temperature shutoff switch set for 235 deg. F,
but it had been disconnected for at least 30 days prior to the
incident. The compressor was not equipped with a carbon monoxide filter
or alarm. The air line to the respirator had an inline filter to remove
oil, water, and particulates from the compressed air as it left the air
receiver, but it allowed the carbon monoxide to pass through to the
respirator wearer. The sandblaster collapsed from carbon monoxide
poisoning. The sandblaster's assistant shut down the compressor,
removed the victim's abrasive blasting hood, and called for emergency
assistance. Neither of the employees performing the sandblasting
operation had received any training in proper respirator use.
This extremely rare incident raises serious questions about carbon
monoxide filters and alarms as well as high temperature shutoff
devices, and whether their use should be required for oil lubricated
compressors. A properly functioning high temperature shutoff switch
should have shut down the overheated compressor, but it is unclear
whether this would have occurred before the carbon monoxide laden air
went out to the respirator wearer. This compressor had no carbon
monoxide filter with alarm to warn the respirator wearer. However,
given that the high temperature alarm was previously disconnected, it
is unclear whether that alarm would have been disabled as well. OSHA
requests any further information regarding other incidents involving
carbon monoxide production by oil lubricated compressors, and any
comments on the necessity for carbon monoxide filters and alarms as
well as high temperature alarms for air compressors.
This proposal does not contain a requirement that carbon monoxide
alarms or high temperature shutoff devices be used with oil lubricated
compressors. As the Distler air compressor study (Ex. 32-1) points out,
air compressors are unlikely to reach temperatures where carbon
monoxide production would occur. Exhaust gases from internal combustion
engines and the intake of contaminated air are the major threats to air
quality, and these threats occur with all compressors, not just oil
lubricated ones. The proposal requires that the air intake for
compressors be placed to avoid the entry of contaminated air. One way
to ensure that contaminated air does not enter the air supply would be
for OSHA to require carbon monoxide filters with continuous monitoring
alarms for all breathing air compressors. OSHA requests comments on
whether it should adopt this requirement for all compressors. OSHA
requests any information about problems with air compressor air
quality, filters and alarms, and invites comments on how best to ensure
breathing air quality for respirators.
OSHA is aware that in recent years devices known as ambient air
movers have been developed to provide air to supplied air respirators.
These units are small compressors which are not oil lubricated and have
no air receiver. Such compressors may have a use in non-IDLH
atmospheres. The use of ambient air movers has been allowed under an
OSHA compliance directive even though such devices do not have an air
receiver as required by the current standard. The proposal drops the
requirement for an air receiver for compressors. An ambient air mover
is just another type of air compressor, and it is treated like any
other compressor under the proposal.
Requirements in this proposal regarding the moisture content of
compressed air for air cylinders and a provision requiring that air
line couplings be incompatible with outlets for other gas systems are
consistent with current accepted practice and with OSHA's current
standard, having simply been updated to reflect the latest versions of
the references. The proposal establishes a limitation of the moisture
content of air in compressed air cylinders of no greater than 27
milliliters per cubic meter of air. This is to prevent freezing of the
valves. The air coupling provision is also included to prevent
inadvertent servicing of airline respirators with non-respirable gases
or vapors. To accomplish this, breathing air couplings are to be made
incompatible with outlets from non-respirable plant air or other gas
systems.
In addition, employers must use breathing gas containers marked in
accordance with the American National Standard Method of Marking
Portable Compressed Gas Containers to Identify the Material Contained,
Z48.1-1954 (R-1971); Federal Specification BB-A 1034a, June 21, 1968,
Air, Compressed for Breathing Purposes; or Interim Federal
Specification GG-13-00675b, September 23, 1976, Breathing Apparatus,
Self-Contained.
(J) Identification of Filter, Cartridges, and Canisters
The current standard requires that the employer mark gas mask
canisters with properly worded labels and color coding to ensure proper
identification. However, as many commenters on the preproposal draft
pointed out (Ex. 36-18, 36-19, 36-27, 36-30, 36-32, 36-34, 36-40, 36-
45, 36-47, 36-49, 36-54, 36-55), the marking of filters, cartridges and
canisters is the responsibility of the respirator manufacturer under
the NIOSH 30 CFR 11 and 42 CFR 84 respirator certification standards.
Therefore, this proposal has eliminated the requirements and tables
relating to the marking of canisters from the standard. Two
requirements have been added to replace the marking requirements.
First, the employer must ensure that all filters, cartridges and
canisters used are properly labeled and color coded. Since the
manufacturer already does this, the employer need only check that the
label is there. Second, the label may not be removed, obscured or
defaced while in service since that would defeat its purpose.
(K) Training
The most thorough respiratory protection program will not be
effective if employees do not wear respirators, or if wearing them, do
not do so appropriately. The only way to ensure that employees are
aware of the purpose of wearing respirators, and how they are to be
worn, is to train them. The record shows widespread agreement that
employee training is an important part of the respiratory protection
program and is essential for correct respirator use (Ex. 15-13, 15-18,
15-19, 15-22, 15-30, 15-33, 15-41, 15-45, 15-50, 15-53, 15-54, 15-67,
15-79).
The current standard does not contain a separate section for
training. The minimal requirements it imposes are included within other
sections of the standard.
This proposal retains and clarifies the present provisions in a
separate section for training and provides more comprehensive guidance
than does the present standard.
In response to ANPR commenters who urged OSHA to mandate a program
that is performance oriented and can be presented informally, (Ex. 15-
13, 15-18, 15-22, 15-30, 15-41, 15-47, 15-62, 15-73, 15-75), this
proposal is performance oriented in that it specfies categories of
information to cover during training. It neither specifies how the
training is to be performed nor the format of the employers training
program. The employer can use whatever training method is effective for
the particular worksite as long as it contains the topics discussed
below. Employers can utilize prepared materials such as audio-visuals
and slide presentations or they can use approaches ranging from formal
classroom instruction to informal discussions during safety meetings
(Ex. 15-53), or a combination of methods.
The first category of information to be included in the training
program is the nature, extent and effects of respiratory hazards to
which the employee may be exposed. This includes identification of the
hazardous chemicals involved, what exposure levels there would be if no
respiratory protection were being used, and what the potential health
effects of such exposure would be if the respirator is not worn or not
worn properly. This type of information will be available on the
material safety data sheet for the hazardous chemical that the chemical
manufacturer will be required to produce under the Hazard Communication
Standard (29 CFR 1910.1200). These training requirements on health
hazards of hazardous chemicals are also required under the Hazard
Communication standard (29 CFR 1910.1200) and could easily be combined
into the same training program. Many commenters agreed that this
subject is an essential element of training (Ex. 61-3, 61-8, 15-10, 15-
14, 15-18, 15-19, 15-27A, 15-41, 15-46, 15-53, 15-62, 15-73). None
disagreed.
Once employees are trained regarding the nature of the hazards,
employers are to provide an explanation of the operation, limitations,
and capabilities of the respirators selected for the employees to wear.
This would include, for example, an explanation of how the respirator
provides protection by either filtering the air, absorbing the vapor,
or providing clean air from an uncontaminated source. Where
appropriate, it also should include limitations on the equipment such
as prohibitions against using an air-purifying respirator in the event
of an emergency with IDLH atmospheres and an explanation of why they
should not be used in such situations. In other words the employee
should be able to understand the operation of the respirator thoroughly
as a result of this training, and thus know why it was selected for the
task at hand. Most commenters supported covering this topic in the
training program. (Ex. 61-3, 15-14, 15-18, 15-27A, 15-41, 15-46, 15-53,
15-62, 15-73). There was no disagreement.
Once the employee understands the nature of the hazards, and the
particular equipment selected to protect against those hazards, the
employer is to provide specific instruction regarding the type and
frequency of respirator inspections. Although the employer is required
to ensure that such inspections are performed, employees using the
equipment may frequently be responsible for inspecting the respirators
assigned to them. Therefore, it is necessary that they have this
process explained and demonstrated to them so they are capable of
recognizing any problems that may threaten the continued protective
capability of the respirator. The training must include the steps
employees are to follow if they discover any problems during
inspection, i.e. who this should be reported to and where they can
obtain replacement equipment if necessary.
The training must also include the procedures for donning or
removing the respirator, checking the fit and seals, and actually
wearing the respirator. It is very important to ensure that the
everyday respirator fit is as close as possible to the fit obtained
during fit testing, and therefore employees must be able to duplicate
that fit through proper donning and removal. The fit testing procedure
can help in training employees, particularly if quantitative fit
testing is used since it can demonstrate numerically to employees the
dramatic differences in measured fit when the respirator is not
adjusted properly (Ex. 15-44). The proposal requires employers to
include sufficient practice so that employees can perform these tasks
effectively. The proposal also includes positive and negative pressure
facepiece seal checks in non-mandatory Appendix B. If other tests are
equally effective in testing the face seal, they may be used. Employees
must be trained regarding the appropriate tests to be used for the
respirators they are wearing. The inclusion of these topics in training
was unanimously supported in the record (Ex. 61-3, 61-8, 15-10, 15-14,
15-22, 15-27A, 15-41, 15-46, 15-50, 15-62, 15-73).
The employer is also to explain the procedures for maintenance and
storage of respirators. This provision may vary by establishment since
in some cases the employees are responsible for doing some of the
maintenance and for storing the respirators while not in use, but in
other facilities specific people are assigned to carry out these
activities. In any event, employees should be aware of the proper
procedures to follow. The significance of this point was raised by a
large number of commenters (Ex. 61-3, 61-8, 15-10, 15-14, 15-27A, 15-
41, 15-46, 15-50, 15-62).
Respirators do malfunction on occasion, or emergency situations
occur which require different respirators for the exposure levels
involved. The training program must include a discussion of these
possibilities, and the procedures the employer has established to deal
with them. Most ANPR commenters concurred that comprehensive training
is necessary where respirators are to be used in situations immediately
dangerous to life or health, including oxygen deficient atmospheres,
such as in fire fighting, rescue operations and confined area entry
(Ex. 15-18, 15-19, 15-26, 15-31, 15-33, 15-37, 15-41, 15-47, 15-48, 15-
50, 15-54, 15-55, 15-56, 15-59, 15-70).
Several commenters requested that OSHA adopt the applicable
training requirements of the American National Standard Institute
(ANSI) Z88.2-1980 Practices for Respiratory Protection which discussed
the basic training requirements of an acceptable respirator program
(Ex. 15-13, 15-14, 15-26, 15-27A, 15-31, 15-44, 15-46, 15-50, 15-54,
15-55, 15-58, 15-70, 15-76, 15-81). The new training requirements are
similar to the ANSI requirements for training except that the proposal
does not require a discussion on the role of engineering controls.
Although some commenters felt that the provisions covering training
in the present standard are adequate (Ex. 15-37, 15-56, 15-75A), in
view of the importance of training in motivating employees to wear
respirators correctly and effectively, the additional information
required by this proposal is deemed by OSHA to be critical for an
effective respirator program. With the exception of the American Iron
and Steel Institute (Ex. 15-37), A.E. Staley Manufacturing Company (Ex.
15-56), and the Sperry Corporation (Ex. 15-75A), the record supports
further guidance for training than is currently contained in 1910.134
(Ex. 15-13, 15-14, 15-26, 15-27A, 15-31, 15-44, 15-46, 15-50, 15-54,
15-55, 15-58, 15-70, 15-76, 15-81).
In addition to specific training requirements regarding the proper
use of respirators, the employer must inform employees of the existence
and contents of the respirator standard (29 CFR 1910.134). They must
also be told of the existence and contents of the written respiratory
protection program required by the respirator standard, where it is
kept in the facility, and how the employee can arrange to examine it if
desired.
The majority of commenters agreed that annual training is necessary
to assure an effective continuing program (Ex. 15-10, 15-18, 15-19, 15-
20, 15-37, 15-44, 15-47, 15-48, 15-50, 15-54, 15-55, 15-71). The Sperry
Corporation, however, recommended that employees be retrained every 6
months, but did not provide a rationale for their contention. In
response to the preproposal draft, California OSHA (Ex. 36-44)
recommended that a more comprehensive initial training and more
frequent refresher training be required for employees assigned to use
SCBA in potentially IDLH atmospheres; emergency response users of SCBA
would receive refresher instruction in the operation inspection, and
wearing of the SCBA at least every three months for the first two years
following initial training, and thereafter every six months. Frank
Wilcher of the International Safety Equipment Association (Ex. 36-45)
also recommended that employees who use SCBAs be trained semiannually
because of the higher degree of complexity of these units and the
possibility of greater hazards associated with their use.
The Washington State Department of Labor and Industries (Ex. 36-20)
recommended that training should be performed at least annually and be
adjusted to the complexities of the respirator program and the level of
respirator use. William O'Keefe of the American Petroleum Institute
(Ex. 15-41) asserted that training should be repeated periodically, but
at least every 2 years and more frequently as workplace conditions may
warrant. Richard Boggs of ORC (Ex. 36-47) in response to the
preproposal draft recommended that a 2 year cycle of retraining and
refresher instruction after the initial respirator use training was
reasonable. He recommended that any decision for more frequent training
should be made by the employer. Annual retraining was called needlessly
expensive. Amoco Corporation (Ex. 36-35) recommended that the
retraining frequency for routinely used respirators be a minimum of two
years, but emergency use respirators would require annual retraining.
The American Textile Manufacturers Institute (Ex. 36-18) recommended
retraining every two years for employees requiring an APF of 10 or
less. Both the ANSI Z88.2-1980 and Z88.2-1993 respiratory protection
standards call for annual retraining.
OSHA concurs with the majority of comments contending that annual
training is sufficiently frequent to ensure employee cooperation and
active participation in the program. Training every two years instead
of annually for routinely worn respirators has been rejected, since the
purpose of the training is not only to instruct wearers in proper
techniques but also to encourage their cooperation and participation in
the respirator program. Switching to training every two years would
tend to diminish attention to proper respirator use. OSHA compliance
experience has demonstrated that inadequate respirator training is a
common problem (Ex. 33-5) and is often associated with respirator
program deficiencies that potentially lead to employee exposures.
Therefore, the proposal contains the requirement for annual training
for respirator wearers. Training required by this proposal is to be
given to the employee before he or she is required to wear a respirator
in the workplace. Employees must receive training at least annually so
they will be reminded regularly of the effects of the respiratory
hazards to which they may be exposed and how they can prevent such
exposure by proper wearing of respirators. OSHA requests comments on
the frequency of training, particularly the need for increased training
and more frequent refresher training for employees using SCBAs or
emergency use respirators.
(L) Respiratory Program Evaluation
It is inherent in respirator use that problems with protection,
irritation, breathing resistance, comfort, etc. will arise. While it is
not possible to eliminate all problems with wearing a respirator, the
employer must try to eliminate as many problems as possible to improve
protection and encourage wearer acceptance of respirators. Eliminating
problems is accomplished most effectively when the program is evaluated
carefully and revised as necessary. Although the current standard does
require that the employer perform periodic checks of the effectiveness
of the respiratory protection program, little guidance is provided
regarding how this evaluation is to be done. The proposal includes a
paragraph dealing with this requirement and provides more information
regarding what should be assessed by the employer.
The person responsible for administration of the respiratory
protection program is to review the program at least annually and is to
conduct frequent random inspections of the workplace to ensure that the
provisions of the program are being properly implemented. The annual
review is to include an assessment of each element of the program that
is required to be included under paragraph (c)(1).
In addition to this review of the program itself, the employer is
to consult employees wearing respirators to ascertain whether they
perceive any problems with the equipment. Factors to be included in
this assessment are comfort; resistance to breathing; fatigue;
interference with vision; interference with communication; restriction
of movement; interference with job performance; and the employee's
confidence in the respirators effectiveness. The employer should
attempt to correct any such problem that is brought forward. Comments
are requested on these requirements. Companies which have instituted
similar assessments are encouraged to submit their views.
(M) Recordkeeping and Access to Records
The final paragraph of the proposal deals with recordkeeping
related to the respiratory protection program. The employer is to
record, maintain and provide access to any records of medical
evaluations performed under paragraph (e) of the proposal. This record
consists of the employee's name, a description of the employee's
duties, the physician's written opinion and recommendations on the
employee's ability to use a respirator, any results of medical
examinations or tests performed, and a copy of the information provided
to the physician. Once generated to comply with this standard, the
records are to be kept, and access is to be provided to them under the
provisions of 29 CFR 1910.20, OSHA's rule on Access to Employee
Exposure and Medical Records.
The present standard does not contain a separate section for
recordkeeping. It simply requires employers to indicate on the
respirator to whom it was assigned and the date it was issued. It also
requires recording of inspection dates and findings for respirators
used for emergency use.
The importance of recordkeeping as a means of verifying compliance
with the respiratory protection program requirements was stated
frequently in the record (Ex 15-18, 15-22, 15-33, 15-41, 15-47, 15-82).
Commenters urged OSHA to require only those records necessary to
demonstrate an effective program (Ex 15-19, 15-21, 15-41, 15-47, 15-
71). However, there was considerable disagreement over what
recordkeeping items to require. Because OSHA recognizes that
recordkeeping may be administratively burdensome and time consuming,
the Agency has only required employers to maintain records that are
necessary for determining compliance with the requirements of the
proposal.
The written respiratory protection program itself needs to be kept
current as long as respirators are in use in the workplace. However,
there is no specific retention period as long as the latest version of
the program is available in the workplace.
Employee fit testing records are required as part of Appendix A,
section (1)(L). This record consists of the employee's name, the type,
brand, and size of the respirator fitted; date of the fit test; and the
strip chart recording or other record of the test results where
quantitative fit testing was performed. The fit test record must be
maintained until the next fit test is administered. The reason for
requiring that fit test records be maintained is to provide a record of
the results of fit testing in order to determine whether annual fit
testing has been done and if the individual tested passed the QNFT with
a fit factor that was adequate for the type of respirator being used.
The preproposal draft did not contain a requirement that fit test
records be maintained, but several commenters had serious doubts that
OSHA would be able to determine if an individual had been properly
fitted and was wearing the appropriate respirator by visual observation
alone (Ex 36-6, 36-17, 36-34, 36-46). OSHA agrees that fit testing
records must be maintained to ensure that all respirator wearers have
received a fit test, that the appropriate respirator chosen by fit
testing is being worn, and that retesting is performed annually. Fit
testing records can also serve other uses in the respiratory protection
program. The Ethyl Corporation (Ex 36-11) uses the strip chart
recording of the fit test as a training tool when it is reviewed with
the fit test subject.
(N) Substance Specific Standards
This proposed standard will affect OSHA's substance specific health
standards. All such standards now incorporate provisions of the
existing Sec. 1910.134 as part of their requirements. Moreover, some
respirator related provisions in the substance specific standards
differ from their counterpart provisions in this proposal, mostly in
respirator selection and the events which trigger medical examinations
for respirator users.
OSHA is proposing to revise all references to Sec. 1910.134 in the
existing substance specific standards to conform to the proposed
revised standard. Thus, for standards such as lead, coke oven
emissions, asbestos, and others which now require that ``the employer
shall institute a respiratory protection program in accordance with 29
CFR 1910.134 (b), (d), (e), and (f)'', the text will read ``the
employer shall institute a respiratory protection program in accordance
with 29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and
(l).'' The revised provisions cover program elements, selection
criteria for respirators, fit testing, use of respirators, maintenance
and care, air quality, training, and program evaluation. Each of these
subject areas was addressed in previously incorporated paragraphs (b),
(d), (e), and (f) of the existing standard. For the `` carcinogen''
standards (Sec. 1910.1003-1016), which now require that in certain
instances employees use certain kinds of respirators ``in accordance
with 1910.134'', the regulatory text will remain unchanged. However,
the employer will have to comply with the amended provisions of the
revised Sec. 1910.134 rather than the earlier provisions.
OSHA is including the proposed revised paragraph (e) covering
medical surveillance only in the carcinogen standards in 1910.1003-
1910.1016. Each of the other substance specific standards now includes
in its medical surveillance requirements a provision that the employee
be evaluated concerning any potential limitations on respirator use.
OSHA believes that the medical surveillance programs established under
these substance specific standards are therefore sufficient to protect
employees who are not medically able to wear respirators. Because each
medical surveillance requirement in the substance specific standards
was designed as a comprehensive program to evaluate employees for
conditions and risks unrelated to respirator usage as well, OSHA
believes any revision changing the required frequency or content of
medical examinations would unnecessarily disturb ongoing medical
surveillance programs. Comments on this approach are solicited from the
public, especially those who have information concerning the
sufficiency of medical evaluations for respirator use under substance
specific standards.
OSHA has adopted various approaches to deal with respirator
provisions in those substance specific standards which differ from this
proposal. Based on the information and data in the respiratory
protection docket, OSHA believes in order to maintain an effective
respirator program regardless of the contaminant or workplace
conditions, there should be a minimum program level. Thus, for
provisions in substance specific standards which are more protective
than the counterpart revised provisions of this standard, OSHA does not
propose any changes. For example, the respirator selection tables of
some standards provide for more restricted use of respirators than
would the respirator selection criteria in this proposal. The least
protective respirator allowed by the ethylene oxide standard is a full
facepiece respirator with an ethylene oxide canister regardless of
protection factor required, whereas respirator selection according to
this proposal would allow a half mask or quarter facepiece cartridge/
canister respirator up to the NIOSH assigned protection factor of 10.
OSHA believes that the more protective provisions of respirator
selection adopted for specific substances after rulemaking proceedings
conducted pursuant to Section 6(b) of the Act reflect the content of
each rulemaking record, the toxicity and circumstances of use of each
substance and therefore should be retained.
In keeping with this principle of not going below the minimum
program, in those cases where existing respirator selection options in
the substance specific standards are less protective than would be
permitted by the proposed NIOSH respirator selection tables, OSHA
proposes to revise such permitted respirator selections to conform to
paragraph (d). For example, the lead standard (1910.1025 (f)(2)) now
allows any powered air-purifying respirator with high efficiency
filters to be used in concentrations up to 1000 times the PEL, and the
coke oven emissions standard allows the use of PAPRs in any
concentration, whereas under this proposal respirator selection would
allow powered air-purifying respirators to be used only in atmospheres
of 25 and 50 times the PEL for respirators certified under 42 CFR Part
84, depending on type. In the case of new or modified respirator types
as well as existing respirator types, OSHA continues to require that
they be NIOSH certified for the contaminant involved as a prerequisite
to their permitted use.
OSHA is also revising the respirator related provisions in the
following OSHA safety standards, Sec. 1910.94 (Ventilation),
Sec. 1910.111 (Anhydrous Ammonia), Sec. 1910.252 (Welding), and
Sec. 1910.262 (Pulp, Paper, and Paperboard Mills) to make them conform
to the revised requirements for respirator certification, selection,
and use contained in this proposal.
In addition to making existing substance specific standards conform
to the revised provisions of the respiratory protection standard in
general, OSHA is also requesting comments on specific respirator-
related issues of three specific standards.
OSHA is intending to reinstate the provision in the lead standard
that requires the use of high efficiency filters for all air purifying
respirators used with lead. In 1979, OSHA had stayed that provision to
allow further administrative reconsideration (44 FR 5446). The recent
asbestos standard record that has been generated supports requiring the
use of high efficiency filters with whatever respiratory protection
equipment is used to protect against highly toxic substances. When OSHA
announced the stay on the requirement for high efficiency filters in
the lead standard, it was stated that NIOSH would be asked for further
interpretation of the record. Partially in response to this request,
NIOSH performed a study on the effectiveness of various filters in the
presence of lead aerosols. The results of this study (Ex. 38-6) show a
substantial difference in penetration between high efficiency filters
and others. OSHA therefore believes there is a clear increase in
protectiveness as a result of the use of high efficiency filters in a
lead aerosol atmosphere. Moreover, OSHA believes the use of high
efficiency filters does not impose an undue burden on employers in
relation to the use of less efficient filters, and that requiring the
use of high efficiency filters in the presence of lead--a highly toxic
substance--is both appropriate and reasonable. As a result of these
considerations, OSHA intends to lift the stay on enforcement of the
requirement that high efficiency filters (type III filters as defined
under 42 CFR Part 84) be used.
As a second issue, the OSHA asbestos standard requires the use of
high efficiency filters with air-purifying respirators and does not
allow the use of disposable respirators with asbestos. Reasons for not
permitting the use of such respirators were that it was determined in
the asbestos standard record that high efficiency filters are necessary
to provide the necessary protection against penetration; and that
disposable respirators for the most part also were not shown to provide
adequate fit and were not by virtue of design amenable to the
performance of a fit check. However, it has come to OSHA's attention
that there are disposable respirators with elastomeric facepieces and
high efficiency filters which are said to provide fits as good as
provided by half mask elastomeric respirators which have replaceable
high efficiency filters. Such disposable respirators can be
quantitatively fit tested, and are designed so that fit check
procedures can be performed. OSHA is asking for comments on whether
such respirators should be allowed to be used under the asbestos
standard.
The third issue concerns the OSHA standard for inorganic arsenic.
At the time this standard was promulgated in May 1978, disposable
respirators with high efficiency filters were not available. Therefore,
disposable respirators were not addressed in the respirator selection
tables of the standard. Now that there are such respirators, OSHA needs
to determine whether they can provide adequate assurance of fit so as
to be suitable for inorganic arsenic which is known to be carcinogenic.
OSHA is proposing that disposable respirators not be permitted under
the inorganic arsenic standard for the same reasons as stated for the
asbestos standard. OSHA is seeking comment on whether disposable
respirators with and without elastomeric facepieces should or should
not be allowed to be used under the inorganic arsenic standard in view
of facepiece sealability or any other considerations.
O. Maritime Standards: Parts 1915, 1917, 1918
In this document OSHA is proposing to update the respiratory
provisions in Shipyards, Sec. 1915.152. OSHA requests comments on the
proposal and whether any changes in the proposed language is
appropriate for shipyards based on relevant unique circumstances.
Currently, the respiratory provision for Marine Terminals is a cross
reference to Sec. 1910.134. See Secs. 1917.92 and 1917 (a)(2)(viii).
The current respiratory provision for Longshoring is at Sec. 1918.102
and is many years out of date. OSHA proposed on June 2, 1994 at 59 FR
28594, 28622-3, 28690 to replace it with a cross reference to
Sec. 1910.134. See proposed Sec. 1918.1(a)(12).
OSHA requests comments on whether the proposed respirator standards
are appropriately incorporated into the Marine Terminal and Longshoring
Parts by cross reference or directly. OSHA requests comments on costs
and feasibility issues for these sectors. OSHA also requests comments
on whether provisions different from the general industry standard are
appropriate based on unique circumstances in these sectors.
P. Construction Advisory Committee
The revised respirator standard that results from this rulemaking
will replace the existing respiratory protection standards in the
construction industry (29 CFR 1926.103) and in maritime operations (29
CFR 1915.152). Since this revision affects the construction industry,
the September 1985 preproposal draft standard was presented to the
Construction Advisory Committee for Occupational Safety and Health
(CACOSH) for their comments. The CACOSH comments, combined with the
other comments received, were considered in preparing a revision of the
September 1985 draft proposal.
As part of the Notice of Proposed Rulemaking (NPRM) approval
process, the revised NPRM was presented at the March 1987 CACOSH
meeting and the Committee's comments were presented to OSHA at the
August 1987 meeting (Ex. 39). The following discussion summarizes the
issues raised in these comments and presents OSHA's response to them.
The proposal would replace the existing construction industry
standard for respiratory protection, 29 CFR 1926.103, with the
provisions of the revised 29 CFR 1910.134 respirator standard. The
Construction Advisory Committee recommended that there should be a
separate respirator standard for construction. Whether there were
particular changes that should be made to the provisions of the
standard to reflect respirator usage in the construction industry was
not clearly addressed by the Committee since the comments they
presented were equally applicable to general industry respirator use.
OSHA believes that there is no need for a separate rulemaking for the
construction industry since no differences in content would appear to
be appropriate. Consequently this recommendation was not incorporated.
However, OSHA is establishing these respiratory provisions explicitly
in the construction standards as 29 CFR 1926.103.
Paragraph (a)--Scope and Application
The Construction Advisory Committee recommended that the scope and
application section, paragraph (a)(1) of the standard, require that all
feasible engineering controls be used by employers and that the
employer demonstrate that engineering controls are not feasible before
respirators are used. The proposed change would eliminate the
requirement that appropriate respirators be used while engineering
controls are being installed. Since the only effect of this proposed
language change would be to eliminate the required use of respirators
during the installation of engineering controls, it has not been
adopted.
The Committee proposed that paragraph (a)(2) be modified to require
that employers provide respirators at one half the PEL or TLV, and that
employees be required to wear them before the PEL is exceeded. To
accompany this revision the Committee proposed a new definition
establishing an ``action level'' at one half the PEL for all regulated
substances. OSHA does not believe it to be within the scope of this
proposed standard for respirator use to trigger action levels and is
therefore not incorporating this CACOSH recommendation.
Paragraph (b)--Definitions
The Committee suggested that the definition of an atmosphere-
supplying respirator be revised to include reference to ``Grade D
breathing air''. This definition was intended by OSHA to describe a
particular technical device, the atmosphere-supplying respirator. The
requirement for Grade D breathing air is contained in paragraph
(i)(1)(i) of the proposed standard and is not relevant to the
definition of the type of respirator. Therefore, the definition of
atmosphere-supplying respirator has not been changed.
CACOSH suggested that OSHA add a definition for ``Grade D breathing
air'' to the proposal. While this term is already described in
paragraph (i), Supplied Air Quality and Use, a definition for Grade D
breathing air has been added in the definition section of the proposal.
A definition for ``competent person'' was proposed to be added as
follows: ```Competent Person' means one who is capable of identifying
existing respiratory hazards in the workplace and who has the authority
to take prompt corrective measures to eliminate them, as specified in
29 CFR 1926.32 (f). The duties of the competent person include at least
the following: reviewing the respiratory protection program, ensuring
that the employer conducts the training, fit testing, tests and
maintains the records for respirators and ensuring that engineering
controls in use are in proper operating condition and are functioning
properly.'' This proposed definition would establish duties and
authority for the competent person, who would perform the function of
the respiratory program administrator required in paragraph (c)(2) of
the proposal. However, the definition contains duties and
responsibilities that go beyond the requirements set for a program
administrator. These duties, such as ensuring that engineering controls
are in proper operating condition and are functioning properly, are the
responsibility of whomever the employer chooses to designate. Although
the competent person definition has not been included in this proposal,
OSHA is asking for comments on the need for this definition or for
alternative definitions to accomplish the same purpose.
In the proposal's definition of hazardous exposure level, the ACGIH
TLVs are used to determine the hazardous exposure level in the absence
of a PEL. The Construction Advisory Committee recommended that the
NIOSH Recommended Exposure Limit (REL) should also be used along with
the TLV, and that whichever was lowest to be used in determining the
hazardous exposure level. OSHA agrees that the NIOSH Recommended
Exposure Limits are an appropriate source for exposure limits in the
absence of a PEL. However, it is not clear that the lowest value from
either the TLV or REL for a particular substance should be used. OSHA
has received no comment on the appropriateness of the NIOSH RELs in the
docket, and is requesting comment on how OSHA should require the use of
the RELs by employers in establishing hazardous exposure levels for
respirator use. Language has been added to the hazardous exposure level
definition to require the use of the RELs, but only in the absence of a
PEL or TLV, since these values are widely recognized as appropriate for
such uses. OSHA requests comments on this addition and on the use of
RELs in relation to TLVs.
The proposal states in paragraph (d)(6) that air-purifying
respirators may not be used for a hazardous chemical with poor or
inadequate warning properties. The proposed standard defines adequate
warning properties as detectable odor, taste, or irritation effects
which are detectable and persistent at or below the hazardous exposure
level. CACOSH recommended inclusion of a definition of ``inadequate
warning properties'' as those associated with an odor or taste
threshold equal to or greater than one-half of the substance's PEL or
TLV. The CACOSH definition reduces the cutoff level for warning
properties to one-half the PEL or TLV. This would reduce the number of
chemicals with adequate warning properties with which air-purifying
respirators can be used. OSHA requests comments and information on the
appropriateness of using a cutoff level of one-half the PEL or TLV as
the point where inadequate warning properties start, and on the effects
such a level would have on air-purifying respirator use.
The definition of ``maximum use concentration'' (MUC) in the
proposal limits the use of gas and vapor air-purifying elements to a
maximum level which cannot exceed the NIOSH limits on the respirator
approval label. CACOSH suggested that OSHA add a sentence to the
definition to limit the MUC to a maximum of 1000 ppm. NIOSH in Table 5
of their Respirator Decision Logic (Ex. 38-20) presents recommended MUC
levels for gas and vapor air-purifying elements. The 1000 ppm MUC is
used only for organic vapor cartridges. Different MUCs are given, based
on whether the element is a cartridge, chin canister, or front-or-back-
mounted canister. The MUC is limited by the NIOSH Decision Logic to the
maximum listed in the table or the IDLH level of the specific organic
vapor, whichever is lower. OSHA requests comments on whether it should
adopt the NIOSH limitations on MUC for use in the revised OSHA
respirator standard.
CACOSH also suggested that OSHA add a definition for ``odor
threshold'' as the concentration at which 100 percent of a human test
group would detect the odor of a substance. However, odor thresholds
vary greatly among individuals, a few of whom may be virtually
insensitive to a large number of chemicals. A requirement that 100
percent of a human test group be able to identify the chemical could
result in the elimination of most chemicals as having no odor
threshold. OSHA has therefore not adopted this definition. However,
OSHA is requesting comment on the appropriate levels that should be
used in determining odor thresholds, the test methods used, and the
appropriateness of requiring that odor threshold testing be performed
for individuals who must wear air-purifying respirators.
The Construction Advisory Committee also recommended replacing the
proposal's definition of ``respirator'' with the following:
```Respirator' means any device worn by an individual and intended to
reduce an exposure to airborne contaminants or supply the wearer with
Grade D breathing air in a contaminated or oxygen deficient
atmosphere.'' OSHA believes that performance characteristics of
respirators should be stated where appropriate in the standard. Some
respirators are adequate while others are not. However, an inadequate
respirator is still a respirator. Therefore OSHA has not adopted this
CACOSH change in the definition of respirator.
The Committee also proposed revising the language in the definition
of service life in the proposal with the following: ```Service Life'
means the period of time it takes for a specified substance to break
through a chemical or organic vapor cartridge or canister.'' Service
life, as the definition in the proposal states, is a function not only
of the type of substance but also of the specific concentration of that
substance. Removing the specific concentration of the substance from
the definition, as the CACOSH revised definition does, obscures the
meaning of the definition, and therefore it has not been adopted. The
NIOSH Respirator Decision Logic (Ex. 38-20) uses a broader definition
that covers all air-purifying respirators as well as SCBA. It reads as
follows: ``SERVICE LIFE: The length of time required for an air-
purifying element to reach a specific effluent concentration. Service
life is determined by the type of substance being removed, the
concentration of the substance, the ambient temperature, the specific
elements being tested (cartridge or canister), the flow rate
resistance, and the selected breakthrough value. The service life for a
self-contained breathing apparatus (SCBA) is the period of time, as
determined by the NIOSH certification tests, in which adequate
breathing gas is supplied.'' OSHA requests comments on whether it
should adopt the broader NIOSH definition of service life, replacing
the definition in this proposal.
Paragraph (c)--Respirator Program
Paragraph (c)(1) of the proposal contains a requirement that the
employer establish and implement a written respirator program that
covers certain elements, as applicable. The Construction Advisory
Committee recommended that OSHA change the word ``cover'' to
``include'' and remove the phrase ``as applicable.'' The phrase as
applicable was included in the requirements to cover situations where
not all the elements listed in the paragraph would be appropriate for
some particular written respiratory program. For instance, if only air-
purifying respirators are to be used, it would not be applicable to
include in the written program the elements covering supplied air
quality, the maintenance and cleaning of supplied air respirators, or
fit testing of SCBAs. Therefore, OSHA has not changed the wording in
the proposal.
The Committee raised the issue of monitoring exposure levels in
construction. They recommended that OSHA add a new element to the
existing elements of the written respirator program in paragraph (c)(1)
that would read as follows: ``(i) Procedures for monitoring the work
environment and selecting respirators based on monitoring results for
use in the workplace.'' Discussion by the Committee brought out that
construction work situations are not stable, and that monitoring
results for a particular individual operation would likely not be
returned in time by a laboratory before that task was completed.
Previous monitoring results can be used, along with past experience
with similar work operations, to estimate exposure levels. The
Committee then recommended that OSHA add to the standard a requirement
that ``If monitoring is not done, the most protective respirator shall
be used.'' In most cases this would mean using supplied air respirators
or SCBAs in the absence of monitoring. The proposal does not now
require monitoring, but it does require that where monitoring results
exist, the employer evaluate them in selecting the proper respirator.
OSHA requests comments and suggestions on whether monitoring should be
made mandatory for making respirator selections, and what monitoring
procedures should be used. OSHA also requests comments on the
recommendation by CACOSH that the most protective respirator must be
used in the absence of monitoring.
One of the elements in the written respirator program, paragraph
(c)(1)(vi), states that the program shall include procedures to ensure
proper air quality for atmosphere-supplying respirators. CACOSH
proposed adding the words ``quantity and flow'' to this element on air
quality procedures. OSHA agrees that adding these words will provide
more direction for employers on what the procedures should cover, and
has revised the wording of this element accordingly.
In paragraph (c)(2) CACOSH recommended that OSHA substitute the
term ``competent person'' for the language ``person qualified by
appropriate training and/or experience.'' This has been discussed
previously in the CACOSH recommendation for a definition of ``competent
person.'' The language in the proposal has not been changed, but will
be reviewed in light of any comments received on the ``competent
person'' definition.
The written respiratory protection program, in paragraph (c)(3), is
required to reflect current workplace conditions and respirator use.
The Committee wanted to add the term ``training'', to require that the
program reflect current workplace conditions, training and respirator
use. This suggestion has not been adopted since OSHA believes that
training should reflect current workplace conditions and the written
respirator program, and not the reverse. It was recommended by the
Committee that OSHA add to paragraph (c) a paragraph that would allow
employees and designated representatives access to exposure and medical
records maintained by the employer. OSHA has not adopted this
suggestion, since this requirement is already included in 29 CFR
1910.20, the medical and exposure records access standard, which is
referenced in this proposed standard.
In paragraph (c)(5), the employer is required to make the written
program available to affected employees, designated representatives,
and OSHA. The Committee requested that employers be required to send a
copy of the program to the OSHA Special Assistant for Construction.
This suggestion has not been adopted, since no procedures exist in the
Special Assistant's Office that would utilize these written programs if
they were sent in. However, language has been added that would require
the sending of a copy of the program to the Assistant Secretary upon
request. This should meet any possible need that may arise for copies
of the written program without creating an unreasonable burden.
The Committee further recommended that the respirator program
should be maintained and made available to employees at the job site,
and that the medical and monitoring results pertaining to respirator
use be available at the work site as well. How the latter would be
performed, given the highly mobile nature of construction activities,
was not clear. OSHA requests comments on this recommendation and any
suggestions on how to provide the above information at the job site in
a reasonable manner without placing an inappropriate burden on
employers.
Paragraph (d)--Selection of Respirators
In its review of paragraph (d) of the proposal on selection of
respirators, the Committee requested a new provision that would require
monitoring for contaminants when air-purifying respirators are used to
be sure that the maximum use concentration for the respirator type
would not be exceeded. This provision is related to the requirement for
monitoring that was previously discussed, and on which comments are
requested.
In paragraph (d)(3) of the respirator selection section of the
proposal, the employer is required to evaluate certain information when
selecting respirators. The information to be evaluated is listed in
paragraphs (d)(3) (i) to (xi). The Committee recommended that the word
``obtain'' be added to paragraph (d)(3), to require that employers
``obtain and evaluate the following information for each work
situation''. By requiring that employers both obtain and evaluate the
information, the intent of the provision would be clarified. OSHA has
adopted this changed language to better clarify the provision for
employers.
The proposal in paragraph (d)(4) requires that respirators approved
by NIOSH be selected when they exist. The Committee wanted to remove
the phrase ``when they exist'' since they felt that one should use the
most protective respirator available, an SCBA or supplied air
respirator, in cases where no approved air-purifying respirator exists.
As stated in the proposal, OSHA has the option of allowing the use of
non-approved respirators for certain types of exposures. The option of
allowing the use of non-approved respirators has been of value in the
past. An example is the ethylene oxide standard, 29 CFR 1910.1047,
where the use of certain air-purifying respirators is permitted, while
the use of these respirators would not have been approved by NIOSH.
OSHA wants to continue to have this option with any future standard.
Therefore, this recommendation has not been adopted.
In paragraph (d)(6) the proposal states that air-purifying
respirators shall not be used for hazardous chemicals with poor or
inadequate warning properties. However, in paragraphs (d)(6) (i) and
(ii) their use with such substances is allowed when permitted under an
OSHA substance specific standard or when certain conditions for use are
met. As discussed previously in this section the Committee wanted to
include poor odor threshold as a reason for prohibiting use, and to
remove paragraph (d)(6)(ii) which allows their use under limited
circumstances. OSHA has asked for comments on this issue.
In oxygen deficient atmospheres, the proposal in paragraph (d)(8)
allows the use of air-purifying respirators in an atmosphere with an
oxygen content of 19.5 percent or greater at altitudes of 14,000 feet
or below. The Committee wanted to remove this provision, thus requiring
the use of supplied air respirators for many work sites at altitudes
where the use of air-purifying respirators has caused no problems.
There was nothing presented at the meeting to support this request. The
record on the issue has been discussed previously in this preamble, and
OSHA is inviting further comment on this issue and on the use of air-
purifying respirators at high altitudes on construction worksites.
Paragraph (e)--Medical Evaluations
In the medical section of the proposed standard, the Committee
recommended that a mandatory medical examination be required in
accordance with ANSI Z88.2 and that the standard include a list of
diseases and conditions which should be considered by the physician in
determining an individual's ability to wear a respirator. As discussed
in the section of this preamble on medical surveillance, OSHA is
inviting comment on three specific alternatives for medical
surveillance requirements.
The medical evaluation section of the proposal in paragraph (e)(1)
states that the medical provisions apply for each employee required to
wear a respirator for more than five hours in any work week. The
Committee wanted to eliminate the five hour per work week exemption.
Their concern was that there would be many times on a construction
project where employees would use respiratory protection for periods
much shorter than five hours, and a situation would develop where
respirators could be used without requiring a respirator physical. This
issue has been discussed in the medical evaluation section of the
preamble, and comments have been requested on the five-hour-in-any-
work-week provision. OSHA will consider the Committee's comment, along
with any other comments received, in resolving this issue.
In paragraph (e)(1) of the medical evaluation provision that the
Committee reviewed, the employer is required to obtain a physician's
written opinion which states whether the employee has any detected
medical condition which would place the employee's health at increased
risk of material impairment from respirator use and any recommended
limitations upon the use of respirators. The Committee suggested that
OSHA revise the language in this provision to read: ``For each employee
required to wear a respirator the employer shall obtain from a licensed
physician a written opinion based upon any detected medical condition,
which states whether the employee can wear the respirator and perform
the work or whether there are limitations to type of respirator worn or
work performed.'' The Committee was concerned that the original
language could be interpreted as permitting the employer to know what
the medical conditions were that limit respirator use. They wanted to
limit the language so that the employer would only receive from the
physician an opinion on whether the employee can perform the required
work while wearing a respirator or whether there is some restriction on
the respirator type that can be used. The current proposal now requests
comments on three alternatives for medical surveillance requirements,
one of which is the provision reviewed by CACOSH. OSHA requests
comments on all three alternatives and, in particular, on the need for
restricting the medical opinion to only the individual's ability to
wear a respirator.
Employers are required in the proposal to provide the physician
performing a medical evaluation with certain information concerning the
types of respirators to be used and conditions under which they will be
used by employees. The Committee recommended that OSHA add a provision
requiring that the employer inform the physician of the contaminants
the employee will be exposed to. OSHA agrees with this comment, and has
added such a provision to paragraph (e)(1).
In paragraph (e)(2) the employer is allowed to accept a new
employee's previous medical examination or written physician's opinion
on respirator use, provided it was conducted within a year of the date
of employment. The Committee recommended that OSHA also require that
these previously performed exams or written opinions meet the same
conditions required of medical evaluations provided by the employer
under paragraph (e)(1). This suggestion has been accepted, and
appropriate language has been added to paragraph (e)(2) to require that
the previously performed exams or opinions meet the requirements of
paragraph (e)(1) for medical evaluations.
It was recommended that OSHA add a new provision to paragraph (e)
to require that the employer provide a powered air-purifying respirator
or atmosphere-supplying respirator to any employee found medically
unable to wear a negative pressure respirator but otherwise able to
perform the task to be done. There is no applicable record in the
docket upon which to base a decision. OSHA therefore, is requesting
comments or information on this issue.
Paragraph (f)--Fit Testing
With respect to fit testing procedures, the Committee recommended
that paragraph (f)(1) be rewritten to state that respirators shall fit
the employee so no exposure above the TLV or ceiling level shall occur.
OSHA has added a new provision to require that the respirator used
shall reduce employee exposures in the breathing zone to below the
hazardous exposure limit. This change answers the Committee comment and
preserves the language of the original proposal.
In paragraph (f)(2) the Committee suggested revising the language
to clarify that a fit test is required whenever a different make or
size respirator is used if the facial characteristics of the employee
change. Facial changes are already addressed in paragraph (f)(7).
Passing a fit test with one particular make and size respirator does
not mean that a different respirator can be used without further fit
testing. Therefore, reference to different makes and sizes has been
added to paragraph (f)(2) to cover variations in respirator make and
size.
The Committee also wanted to limit fit testing to only tight
fitting negative pressure respirators. For the reasons previously
discussed in the fit testing section of the preamble, OSHA does not
feel this is sufficient. Therefore, the proposal continues to require
fit testing of both tight fitting air-purifying as well as tight
fitting atmosphere-supplying respirators.
In paragraph (f)(9) the employer is allowed to use a qualitative
fit test for selecting respirators for employees who require fit
factors greater than 10 in situations where outside contractors who do
the quantitative fit testing are not available. A thirty day time limit
is placed on this exemption from the requirement for quantitative fit
testing. The Committee felt this exemption is not safe and should not
be allowed. An employee who is hired between the normal visits of the
quantitative fit test contractor therefore could not be assigned to any
work area requiring fit factors greater than 10 until a quantitative
fit test was passed. OSHA requests comments on this issue and on the
Construction Advisory Committee suggestion to delete paragraph (f)(9)
from the standard.
Paragraph (g)--Respirator Use
In paragraph (g)(3) of the respirator use section of the proposal,
the employer is required to refuse the use of respirators that rely on
a tight facepiece fit when facial conditions such as a beard or
scarring would prevent such fits. The Committee wanted this provision
to cover loose fitting respirators as well as tight fitting ones.
However, conditions such as a beard or facial scarring would have no
effect on the performance of loose fitting hoods or helmets, and OSHA
therefore does not regard it as appropriate to make this change.
Employees who wear corrective glasses are required in paragraph
(g)(4) to wear them in a manner that does not interfere with the
facepiece seal of the respirator. The Committee suggested an additional
requirement that, where the employee must wear corrective lenses and
the respirator requires that these be of special design, the employer
shall provide the lenses at no cost to the employee. The question of
who pays for respirator corrective lenses has not previously been
addressed, and OSHA has no information in the docket on this issue.
Therefore, OSHA requests comments and information on the responsibility
for paying for specially designed corrective lenses for respirators.
The cleaning, sanitizing, and discarding of disposable respirators
is addressed in paragraph (g)(9) of the proposal. The Committee
recommended that OSHA delete this provision since it refers to
disposable respirators. In an earlier discussion of assigned protection
factors, the Committee recommended that OSHA only permit the use of
respirators that achieve a minimum assigned protection factor of ten.
Since disposable respirators, in the Committee's opinion, could only
achieve an assigned protection factor of five, their use should not be
permitted. The Committee therefore recommended that paragraph (g)(9),
which refers to disposable respirators, be deleted since it refers to a
class of respirators which could not be used. However, after further
discussion the recommendation for a minimum assigned protection factor
of ten was withdrawn. Since it was this withdrawn provision that
supported the Committee's recommendation to deleting any reference to
disposable respirators, and disposable respirators as a class are still
covered by the proposal, the provision covering their cleaning,
sanitizing and disposal has not been deleted.
Paragraph (h)--Maintenance and Care of Respirators
In the Maintenance and Care of Respirators section of the proposal,
paragraph (h)(1) requires that respirators be cleaned and disinfected
by following certain procedures. The Committee wanted to add the phrase
``on paid time'' in order to require that the cleaning not be required
to be performed by employees on their own time. OSHA believes that this
is not a respiratory protection issue but a labor relations issue that
should be addressed by labor/management negotiation. Therefore, the
suggested wording has not been added.
Paragraph (k)--Training
The training section of the proposal requires that employers
provide a training program for employees who are required to wear
respirators. The Committee wanted to add language to paragraph (k)(1)
to require employers to provide, conduct and document the effectiveness
of the training program. The proposal already contains the requirement
that employers provide a training program, which has always been
interpreted by OSHA as requiring that the training be conducted.
Documenting the effectiveness would mean that some sort of testing of
employee capabilities to properly use respirators after training would
have to be performed. OSHA currently evaluates training programs by
other means such as by seeing how respirators are being used by
employees on the job and by interviewing respirator users. OSHA does
not regard the suggested additional requirements proposed by the
Committee as necessary for enforcement of the standard and has
therefore not included them.
Paragraph (m)--Recordkeeping
The recordkeeping section of the proposal requires that employers
maintain the medical evaluation record in accordance with 29 CFR
1910.20, the records access standard. The Committee wanted to add the
phrase, ``and make available'', to this provision. Although already
implied by the reference to the records access standard, the suggested
language has been added to paragraph (m)(1)(iii) to require that
employers maintain and make available this record in accordance with 29
CFR 1910.20.
The Committee further wanted to add a provision that all records
required by this standard be retained for a period of 30 years. The
records retention provisions of the records access standard already
address this issue, and duplicating those requirements is felt by OSHA
to be unnecessary.
Appendix B--Recommended Practices
Appendix B of the proposal contains recommended practices for
performing positive and negative pressure faceseal checks. Respirator
wearers are required by paragraph (g)(10) to perform a faceseal check
before entering the work area by following either the recommended
faceseal check methods or by following the respirator manufacturer's
recommended method. The Construction Advisory Committee wanted OSHA to
add a new fit check method covering the use of isoamyl acetate or
irritant smoke in an abbreviated fit check procedure. OSHA request
comments on the use of isoamyl acetate or irritant smoke fit check
procedures for daily faceseal tests and on appropriate procedures for
performing such fit check testing using these test agents.
VIII. References
1. Pritchard, John A., A Guide to Industrial Respiratory Protection,
HEW Publication No. (NIOSH) 76-189, June 1976.
2. Teresinski, Michael F. and Paul N. Cheremisino, Industrial
Respiratory Protection, Ann Arbor Science Publishers; Ann Arbor,
Michigan, 1983.
3. American National Standards Institute, Practices for Respiratory
Protection, ANSI Z88.2-1969.
4. Occupational Safety and Health Administration, General Industry
Standards, 29 CFR Part 1910, Construction Standards, 29 CFR Part
1926; and Maritime Standards, 29 CFR Parts 1915 through 1918.
5. Centaur Associates, Inc. Preliminary Regulatory Impact Analysis
of Alternative Respiratory Protection Standards, 1984.
6. Schulte, Harry F. ``Personal Protection Devices'' in The
Industrial Environment--Its Evaluation and Control, U.S. Government
Printing Office, Washington, D.C. 20402.
7. American National Standard Institute, Practices for Respiratory
Protection, ANSI Z88.2-1980.
8. NIOSH/OSHA Respirator Decision Logic, in A Guide to Industrial
Respiratory Protection, HEW Publication No. (NIOSH) 76-189, June
1976.
9. Occupational Safety and Health Administration, Management
Information System Print-Out, 1983.
10. Canadian Standards Association, Selection, Care, and Use of
Respirators, Z94.4-M1982, Ontario, Canada, 1982.
11. Luxon, Stuart G. ``Harmonization of Respirator Standards in
Europe'', American Industrial Hygiene Association Journal, April
1973, pp. 143-149.
12. Ryan C. et. al. ``Critical Review of International Standards for
Respiratory Protective Equipment--I. Respiratory Protective
Equipment for Particulate-Laden Atmospheres, American Industrial
Hygiene Association Journal, 44 (10): 756-761 (1983).
13. Breysse, P.N., et. al. ``Critical Review of International
Standards for Respiratory Protective Equipment--II. Gas and Vapor
Removal Efficiency and Fit Testing:, American Industrial Hygiene
Association Journal, 44 (10): 762-767 (1983).
14. White, N. et. al. ``Critical Review of International Standards
for Respiratory Protective Equipment III. Practical Performance
Tests'', American Industrial Hygiene Association Journal, 44 (10):
768-773 (1983).
15. Department of the Army, the Air Force, and the Defense Logistics
Agency. Respiratory Protection Program, TB MED 223/AFOSH STD 161-1/
OCAM 1000.2, Washington, DC, April 1977.
IX. Public Participation--Notice of Hearing
Interested persons are invited to submit written data, views, and
arguments on all issues with respect to this proposed standard. These
comments must be postmarked on or before February 13, 1995. Comments
are to submitted in quadruplicate or 1 original (hardcopy) and 1 disk
(5\1/4\ or 3\1/2\) on WordPerfect 5.0, 5.1, 6.0 or ASCII. Note: any
information not contained on disk, e.g., studies, articles, etc., must
be submitted in quadruplicate to the Docket Office, Docket No. H-049,
Room N2625, U.S. Department of Labor, 200 Constitution Avenue NW.,
Washington, DC 20210.
Writtent submissions must clearly identify the provisions of the
proposal which are addressed and the position taken with respect to
each issue.
All written comments, data, views, and arguments that are received
within the specific comment period will be made a part of the record
and will be available for public inspection and copying at the above
Docket Office address.
Notice of Intention to Appear at the Informal Hearing
Pursuant to section 6(b)(3) of the Act, an opportunity to submit
oral testimony concerning the issues raised by the proposed standard
including economic and environmental impacts, will be provided at an
informal public hearing to be held in Washington, DC from March 7 to
March 24, 1995. If OSHA receives sufficient requests to participate in
the hearing, the hearing period may be extended or shortened if there
are few requests.
The hearing will commence at 9:30 a.m. on March 7, 1995, in the
Auditorium, Frances Perkins Building, U.S. Department of Labor, 3rd
Street and Constitution Avenue N.W., Washington, DC 20210.
All persons desiring to participate at the hearing must file in
quadruplicate a notice of intention to appear, postmarked on or before
January 27, 1995. The notice of intention to appear, which will be
available for inspection and copying at the OSHA Technical Data Center
Docket Office (Room N2625), telephone (202) 219-7894, must contain the
following information:
1. The name, address, and telephone number of each person to
appear;
2. The capacity in which the person will appear;
3. The approximate amount of time required for the presentation;
4. The issues that will be addressed;
5. A brief statement of the position that will be taken with
respect to each issue; and
6. Whether the party intends to submit documentary evidence and, if
so, a brief summary of it.
The notice of intention to appear shall be mailed to Mr. Thomas
Hall, OSHA Division of Consumer Affairs, Docket H-049, Room N3649, U.S.
Department of Labor, 200 Constitution Avenue N.W., Washington, DC
20210; telephone (202) 219-8617.
A notice of intention to appear also may be transmitted by
facsimile to (202) 219-5986, by the same date, provided the original
and 3 copies are sent to the same address and postmarked no more than 3
days later.
Filing of Testimony and Evidence Before the Hearing
Any party requesting more than ten (10) minutes for a presentation
at the hearing, or who will submit documentary evidence, must provide
in quadruplicate the complete text of the testimony, including any
documentary evidence to be presented at the hearing. One copy shall not
be stapled or bound and be suitable for copying. These materials must
be provided to Mr. Thomas Hall, OSHA Division of Consumer Affairs at
the address above and be postmarked no later than February 13, 1995.
Each such submission will be reviewed in light of the amount of
time requested in the notice of intention to appear. In those instances
where the information contained in the submission does not justify the
amount of time requested, a more appropriate amount of time will be
allocated and the participant will be notified of that fact prior to
the informal public hearing.
Any party who has not substantially complied with this requirement
may be limited to a ten-minute presentation, and may be requested to
return for questioning at a later time.
Any party who has not filed a notice of intention to appear may be
allowed to testify for no more than 10 minutes as time permits, at the
discretion of the Administrative Law Judge, but will not be allowed to
question witnesses.
Notice of intention to appear, testimony and evidence will be
available for inspection and copying at the Docket Office at the
address above.
Conduct and Nature of Hearing
The hearing will commence at 9:30 a.m. on the first day.
At that time, any procedural matters relating to the proceeding
will be resolved.
The nature of an informal rulemaking hearing is established in the
legislative history of section 6 of the OSH Act and is reflected by
OSHA's rules of procedure for hearings (29 CFR 1911.15(a)). Although
the presiding officer is an Administrative Law Judge and limited
questioning by persons who have filed notices of intention to appear is
allowed on crucial issues, the proceeding is informal and legislative
in type. The Agency's intent, in essence, is to provide interested
persons with an opportunity to make effective oral presentations which
can proceed expeditiously in the absence of procedural restraints which
impede or protract the rulemaking process.
Additionally, since the hearing is primarily for information
gathering and clarification, it is an informal administrative
proceeding rather than an adjudicative one. The technical rules of
evidence, for example do not apply. The regulations that govern
hearings and the pre-hearing guidelines to be issued for this hearing
will ensure fairness and due process and also facilitate the
development of a clear, accurate and complete record. Those rules and
guidelines will be interpreted in a manner that furthers that
development. Thus, questions of relevance, procedure and participation
generally will be decided so as to favor development of the record.
The hearing will be conducted in accordance with 29 CFR Part 1911.
It should be noted that Sec. 1911.4 specifies the Assistant Secretary
may upon reasonable notice issue alternative procedures to expedite
proceedings or for other good cause.
The hearing will be presided over by an Administrative Law Judge
who makes no decision or recommendation on the merits of OSHA's
proposal. The responsibility of the Administrative Law Judge is to
ensure that the hearing proceeds at a reasonable pace and in an orderly
manner. The Administrative Law Judge, therefore, will have all the
powers necessary and appropriate to conduct a full and fair informal
hearing as provided in 29 CFR Part 1911 including the powers:
1. To regulate the course of the proceedings;
2. To dispose of procedural requests, objections and comparable
matters;
3. To confine the presentations to the matters pertinent to the
issues raised;
4. To regulate the conduct of those present at the hearing by
appropriate means;
5. In the Judge's discretion, to question and permit the
questioning of any witnesses and to limit the time for questioning; and
6. In the Judge's discretion, to keep the record open for a
reasonable, stated time (known as the post-hearing comment period) to
receive written information and additional data, views and arguments
from any person who has participated in the oral proceedings.
OSHA recognizes that there may be interested persons or
organizations who, through their knowledge of the subject matter or
their experience in the field, would wish to endorse or support the
whole proposal or certain provisions of the proposal. OSHA welcomes
such supportive comments, including any pertinent data and cost
information which may be available, in order that the record of this
rulemaking will present a balanced picture of the public response on
the issues involved.
X. Federalism
This Notice of Proposed Rulemaking has been reviewed in accordance
with Executive Order 12612 (52 FR 41685, October 30, 1987), regarding
Federalism. This Order requires that agencies, to the extent possible,
refrain from limiting state policy options, consult with states prior
to taking any actions which would restrict state policy options, and
take such actions only when there is clear constitutional authority and
the presence of a problem of national scope. The Order provides for
preemption of state law only if there is a clear Congressional intent
for the Agency to do so. Any such preemption is to be limited to the
extent possible.
Section 18 of the Occupational Safety and Health Act (OSH Act)
expresses Congress' clear intent to preempt state laws relating to
issues on which Federal OSHA has promulgated occupational safety and
health standards. Under the OSH Act, a state can avoid preemption only
if it submits, and obtains Federal approval of, a plan for the
development of such standards and their enforcement. Occupational
safety and health standards developed by such Plan-States must, among
other things, be at least as effective in providing safe and healthful
employment and places of employment as the Federal standards. Where
such standards are applicable to products distributed or used in
interstate commerce, they may not unduly burden commerce and must be
justified by compelling local conditions (see OSH Act, Section 18 C).
The proposed Federal standards on respiratory protection addresses
hazards which are not unique to any one state or region of the country.
Nonetheless, states with occupational safety and health plans approved
under Section 18 of the OSH Act will be able to develop their own state
standards to deal with any special problems which might be encountered
in a particular state. Moreover, because this standard is written in
general, performance-oriented terms, there is considerable flexibility
for state plans to require, and for affected employers to use, methods
of compliance which are appropriate to the working conditions covered
by the standard.
In brief, this Notice of Proposed Rulemaking addresses a clear
national problem related to occupational safety and health in general
industry. Those states which have elected to participate under Section
18 of the OSH Act are not preempted by this standard, and will be able
to address any special conditions within the framework of the Federal
Act while ensuring that the state standards are at least as effective
as that standard.
XI. State Plan Standards
The 25 states and territories with their own OSHA-approved
occupational safety and health plans must adopt a comparable standard
within six months of the publication dates of a final standard. These
25 states are: Alaska, Arizona, California, Connecticut, New York (for
state and local government employees only), Hawaii, Indiana, Iowa,
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North
Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Until such
time as a state standard is promulgated, Federal OSHA will provide
interim enforcement assistance, as appropriate, in these states.
XII. List of Subjects in 29 CFR Parts 1910, 1915, and 1926
Health, Occupational safety and health, Reporting and recordkeeping
requirements.
XIII. Authority and Signature
This document was prepared under the direction of Joseph A. Dear,
Assistant Secretary of Labor for Occupational Safety and Health, U.S.
Department of Labor, 200 Constitution Avenue, NW., Washington, DC
20210.
Accordingly, pursuant to sections 4, 6(b), 8(c), and (8)g of the
Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657),
Sec. 107, Contract Work Hours and Safety Standards Act (Construction
Safety Act), (40 U.S.C. 333); Sec. 41, Longshoremen's and Harbor
Worker's Compensation Act (33 U.S.C. 941); 29 CFR Part 1911 and
Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059),
9-83 (48 FR 35736), or 1-90 (55 FR 9033) as applicable, 29 CFR Part
1910 is proposed to be amended as set forth below. In addition,
pursuant to section 4(b)(2) of the Act, OSHA has determined that this
amended standard would be more effective than the corresponding
standards now in Parts 1915 and 1926 of Title 29, Code of Federal
Regulations. Therefore, these corresponding standards would be
superseded by these changes.
Signed at Washington, DC, this 28th day of October, 1994.
Joseph A. Dear,
Assistant Secretary of Labor for Occupational Safety and Health.
XIV. Proposed Standard and Appendices
It is hereby proposed to amend Parts 1910, 1915, and 1926 of Title
29 of the Code of Federal Regulations as follows:
PARTS 1910, 1915, 1926--[AMENDED]
1. The authority citation for Subpart I of 29 CFR part 1910 is
revised to read as follows:
Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-
71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55
FR 9033), as applicable. Section 1910.134 also issued under 29 CFR
Part 1911.
PART 1915--[AMENDED]
2. The authority citation for 29 CFR part 1915 is revised to read
as follows:
Authority: Sec. 41, Longshore and Harbor Workers' Compensation
Act (33 U.S.C. 941); secs. 4, 6, 8, Occupational Safety and Health
Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order
Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or
1-90 (55 FR 9033), as applicable. Section 1915.99 also issued under
5 U.S.C. 553. Section 1915.152 also issued under 29 CFR Part 1911.
PART 1926--[AMENDED]
3. The authority citation for Subpart E of 29 CFR part 1926 is
revised to read as follows:
Authority: Sec. 107, Contract Work Hours and Safety Standards
Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, 8,
Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655,
657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41
FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as applicable.
Section 1916.103 also issued under 29 CFR Part 1911.
Secs. 1910.134, 1915.152 and 1926.103 [Amended]
4. Parts 1910, subpart I; 1915, subpart I; and 1926, subpart E of
Title 29 of the Code of Federal Regulations are amended by adding
identical sections are Secs. 1910.134, 1915.152 and 1926.103 to read as
follows:
Sec. ****.*** Respiratory protection.
(a) Scope and application. (1) In the control of those occupational
diseases caused by breathing air contaminated with harmful dusts, fogs,
fumes, mists, gases, smokes, sprays, or vapors, the primary objective
shall be to prevent atmospheric contamination. This shall be
accomplished as far as feasible by accepted engineering control
measures (for example, enclosure or confinement of the operation,
general and local ventilation, and substitution of less toxic
materials). When effective engineering controls are not feasible, or
while they are being instituted, appropriate respirators shall be used
pursuant to this section.
(2) Respirators shall be provided by the employer when such
equipment is necessary to protect the health of the employee. The
employer shall provide the respirators which are applicable and
suitable for the purpose intended. The employer shall be responsible
for the establishment and maintenance of a respiratory protective
program which shall include the requirements outlined in paragraph (c)
of this section.
(b) Definitions. Adequate warning properties means the detectable
characteristics of a hazardous chemical including odor, taste, and/or
irritation effects which are detectable and persistent at
concentrations at or below the hazardous exposure level, and exposure
at these low levels does not cause olfactory fatigue.
Air-purifying respirators means a respirator which is designed to
remove air contaminants (i.e. dust, fumes, mists, gases, vapors, or
aerosols) from the ambient air or air surrounding the respirator.
Assigned protection factor means the number assigned by NIOSH to
indicate the capability of a respirator to afford a certain degree of
protection in terms of fit and filter/cartridge penetration.
Assistant Secretary means the Assistant Secretary of Labor for
Occupational Safety and Health, U.S. Department of Labor, or designee.
Atmosphere-supplying respirator means a respirator which supplies
the wearer with air or oxygen from a source independent of the
immediate ambient atmosphere. This includes air-supplied respirators
and self-contained breathing apparatus (SCBA) units.
Canister or cartridge means the element of a gas and vapor or
particulate air-purifying respirator which contains the sorbent, filter
and/or catalyst which removes specific contaminants from air drawn
through it.
Closed circuit respirator means a SCBA in which the air is
rebreathed after exhaled carbon dioxide has been removed and the oxygen
content restored by a compressed or liquid oxygen source or an oxygen
generating solid.
Demand means a mode of operation for atmosphere-supplying
respirators in which air flows into the respirator only when inhalation
creates a lower pressure within the facepiece than the ambient
atmospheric pressure.
Director means the Director of the National Institute for
Occupational Safety and Health, U.S. Department of Health and Human
Services, or designee.
Disposable respirator means a respiratory protective device which
cannot be resupplied with an unused filter or cartridge and which is to
be discarded in its entirety after its useful service life has been
reached.
Filter means a media component used in respirators to remove solid
and/or liquid particles from the inspired air.
Fit factor means an estimate of the ratio of the average
concentration of a challenge agent in a test chamber to the average
concentration inside the respirator as worn with a high-efficiency
filter.
Hazardous chemical means a substance which meets the definitions
for ``health hazard'' under the Hazard Communication Standard (29 CFR
1910.1200(c)).
Hazardous exposure level means:
(1) The permissible exposure limit (PEL) for the hazardous chemical
in 29 CFR Part 1910, Subpart Z, of the General Industry Standards of
the Occupational Safety and Health Administration (OSHA); or,
(2) If there is no PEL for the hazardous chemical, the Threshold
Limit Values (TLV) recommended by the American Conference of
Governmental Industrial Hygienists (ACGIH) in the latest edition of
Threshold Limit Values for Chemical Substances and Physical Agents in
the Work Environment: or,
(3) If there is no PEL or TLV for the hazardous chemical, the NIOSH
Recommended Exposure Limit (REL); or,
(4) If there is no PEL, TLV, or REL for the hazardous chemical, an
exposure level based on available scientific information including
material safety data sheets.
Immediately dangerous to life or health or IDLH means an
atmospheric concentration of any toxic, corrosive or asphyxiant
substance that poses an immediate threat to life or would cause
irreversible or delayed adverse health effects or would interfere with
an individual's ability to escape from a dangerous atmosphere.
Maximum use concentration (MUC) means the maximum concentration of
an air contaminant in which a particular respirator can be used, based
on the respirator's assigned protection factor. The MUC cannot exceed
the use limitations specified on the NIOSH approval label for the
cartridge, canister, or filter. The MUC can be determined by
multiplying the assigned protection factor for the respirator by the
permissible exposure limit for the air contaminant for which the
respirator will be used.
Negative pressure respirator means a respirator in which the air
pressure inside the facepiece is positive during exhalation in relation
to the outside air pressure and negative during inhalation in relation
to the outside air pressure.
Oxygen deficient atmosphere means an atmosphere with an oxygen
content of less than 19.5% by volume at altitudes of 8000 feet or
below. (For altitudes above 8000 feet, see the oxygen deficient IDLH
atmosphere definition.)
Oxygen deficient IDLH atmosphere means an atmosphere with an oxygen
content below 16% by volume at altitudes of 3000 feet or below, or
below the oxygen levels specified in Table III for altitudes up to 8000
feet, or below 19.5% for altitudes above 8000 up to 14,000 feet.
Positive pressure respirator means an atmosphere-supplying
respirator which is designed so that air pressure inside the facepiece
is positive in relation to the outside air pressure during inhalation
and exhalation.
Powered air-purifying respirator means an air-purifying respirator
which uses a blower to deliver air through the air-purifying element to
the wearer's breathing zone.
Pressure demand means a mode of operation for atmosphere-supplying
respirators in which the air pressure inside the respirator is
substantially maintained at a specific positive pressure differential
with respect to the ambient air pressure. To maintain this pressure
differential additional air is admitted on demand to the facepiece when
the wearer inhales.
Qualitative fit test (QLFT) means an assessment of the adequacy of
respirator fit by determining whether or not an individual wearing the
respirator can detect the odor, taste, or irritation of a contaminant
introduced into the vicinity of the wearer's head.
Quantitative fit test (QNFT) means an assessment of the adequacy of
respirator fit by numerically measuring concentrations of a challenge
agent inside and outside the facepiece. The ratio of the two
measurements is an index of leakage of the seal between the respirator
facepiece and the wearer's face.
Rebreather respirator. See closed circuit respirator.
Respirator means any device worn by an individual and intended to
provide the wearer with respiratory protection against inhalation of
airborne contaminants or oxygen deficient air.
Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the source of air or oxygen is contained
within the respirator independent of any other source.
Service life of a chemical or organic vapor cartridge or canister
means the period of time it takes for a specified concentration of a
specific substance to break through the cartridge or canister. This
concentration is determined by the manufacturer for each type of
cartridge or canister for particular substances.
Supplied air respirator means a respirator which receives breathing
air through an air line or hose from a portable or stationary source of
compressed air.
(c) Respiratory protection program--(1) The employer in accordance
with this section shall establish and implement a written respiratory
protection program which shall ensure that the respirators are properly
selected, fitted, used, and maintained as necessary to protect the
health of employees. The program shall cover the following elements as
applicable:
(i) Procedures for selecting respirators for use in the workplace;
(ii) Medical evaluations of employees required to wear respirators;
(iii) Use of respirators;
(iv) Fit testing procedures for air-purifying respirators and tight
fitting positive pressure respirators;
(v) Procedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, or otherwise maintaining respirators;
(vi) Procedures to ensure proper air quality, quantity and flow for
atmosphere-supplying respirator;
(vii) Training of employees in the respiratory and health hazards
of the hazardous chemicals to which they are potentially exposed as
required under the Hazard Communication standard (29 CFR 1910.1200);
(viii) Training of employees to ensure the proper use and
maintenance of the respirators; and,
(iv) Procedures for periodically evaluating the effectiveness of
the program.
(2) The employer shall designate a person qualified by appropriate
training and/or experience to be responsible for the management and
administration of the respiratory protection program and for conducting
the required periodic evaluations of its effectiveness.
(3) The written respiratory protection program shall reflect
current workplace conditions and respirator use.
(4) Employers shall, upon request, make the written respiratory
protection program available to affected employees, their designated
representatives, the Assistant Secretary, and the Director. A copy of
the program shall be submitted to the Assistant Secretary and/or the
Director, if requested.
(d) Selection of respirators--(1) The employer shall provide
respirators and respiratory equipment at no cost to employees.
(2) Where elastomeric facepiece respirators are to be used, the
employer shall provide a selection of respirators from an assortment of
at least three sizes for each type of facepiece and from at least two
different manufacturers.
(3) In addition, the employer shall obtain and evaluate the
following information for each work situation:
(i) The nature of the hazard;
(ii) The physical and chemical properties of the air contaminant;
(iii) The adverse health effects of the respiratory hazard;
(iv) The relevant hazardous exposure level;
(v) The results of workplace sampling of airborne concentrations of
contaminants;
(vi) The nature of the work operation or process;
(vii) The period of time respiratory protection will be worn by
employees during the work shift;
(viii) The work activities of the employees and the potential
stress of these work conditions on employees wearing the respirators;
(ix) Fit test results;
(x) Warning properties of the hazardous chemical; and,
(xi) The physical characteristics, functional capabilities, and
limitations of the various types of respirators.
(4) The employer shall select appropriate respirators from among
those approved and certified by the National Institute for Occupational
Safety and Health (NIOSH).
(5) The employer shall make types of respirators available for
selection and shall assure that employees use respirators in accordance
with the assigned protection factor tables in the NIOSH Respirator
Decision Logic published in May 1987. This is available from the NIOSH
Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108,
4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket
Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, NW.,
Washington, DC 20210.
(6) [Reserved]
(7) The employer shall not allow use of any respirator where the
maximum use concentration for an air contaminant exceeds the
limitations specified on the NIOSH approval label for the cartridge,
canister or filter for such respirators.
(8) Air-purifying respirators shall not be used for a hazardous
chemical with poor or inadequate warning properties unless either:
(i) Their use is permitted under the provisions of a substance
specific OSHA standard, or
(ii) The odor or irritation threshold is not in excess of three
times the hazardous exposure level and there is no associated ceiling
limit.
(9) In addition, in order to use an air-purifying respirator for
hazardous chemicals with poor or inadequate warning properties, at
least one of the following conditions must be met:
(i) The respirator has an end of service life indicator approved by
NIOSH for use with the specific chemical, or
(ii) A change schedule has been implemented to assure that air-
purifying cartridges, canisters and/or filters are replaced before 80%
of their useful service life has expired, based upon documented service
life data, airborne concentration of the chemical, and duration of
exposure.
(10) Where an oxygen deficient atmosphere or an oxygen deficient
IDLH atmosphere exists, appropriate respirators shall be selected as
follows:
(i) Either an air-purifying respirator or atmosphere supplying
respirator may be used where an atmosphere has a measured oxygen
content of 19.5% by volume or greater at altitudes of 14,000 feet or
below.
(ii) An atmosphere-supplying respirator shall be used for oxygen
deficient atmospheres with a measured oxygen content level above that
level defined as oxygen deficient IDLH but which is less than 19.5% by
volume at altitudes of 8000 feet or below.
(iii) For oxygen deficient IDLH atmospheres with a measured oxygen
content below 16% by volume at altitudes up to 3000 feet, or below the
oxygen levels specified in Table III at altitudes up to 8000 feet, or
below 19.5% at altitudes above 8000 feet up to 14,000 feet, or in
atmospheres where the concentration of the hazardous chemical is
unknown or in other IDLH atmospheres, either a full facepiece pressure
demand SCBA or a combination full facepiece pressure demand supplied
air respirator with auxiliary self-contained air supply shall be used.
Table I.--Oxygen Percentages Constituting Oxygen Deficient and Oxygen
Deficient IDLH Atmospheres
------------------------------------------------------------------------
Column 3
Column 2 percent
percent oxygen
oxygen below which
Column 1 altitude above sea level (in feet) below which an oxygen
an oxygen deficient
deficient IDLH
atmosphere atmosphere
exists exits
------------------------------------------------------------------------
0 to 3000..................................... 19.5 16.0
3001 to 4000.................................. 19.5 16.4
4001 to 5000.................................. 19.5 17.1
5001 to 6000.................................. 19.5 17.8
6001 to 7000.................................. 19.5 18.5
7001 to 8000.................................. 19.5 19.3
Above 8000 to 14,000.......................... (\1\) 19.5
------------------------------------------------------------------------
\1\For altitudes above 8000 feet, an oxygen deficient IDLH atmosphere
exists when the oxygen level falls below 19.5%.
(e) Medical evaluation--(1) For each employee required to wear a
respirator for more than five hours during any work week, the employer
shall obtain from a licensed physician a written opinion which states
whether the employee has any detected medical condition which would
place the employee's health at increased risk of material impairment
from respirator use and any recommended limitations upon the use of
respirators. In requesting the written medical opinion, the employer
shall provide the licensed physician with information concerning:
(i) The type of respiratory protection to be used;
(ii) The substances the employee will be exposed to;
(iii) Description of the work effort required;
(iv) Duration and frequency of usage;
(v) The type of work performed, including any special
responsibilities that affect the safety of others such as fire fighting
or rescue work;
(vi) Any special environmental conditions (such as heat or confined
space entry); and,
(vii) Additional requirements for protective clothing and
equipment.
(2) In the case of new employees, employers may accept an already
existing medical examination or written opinion from a physician
provided it was conducted within a year of the date of employment,
covered the same type of respirator under similar use conditions, and
meets the requirements of paragraph (e)(1).
(3) The employer shall have the employee's medical status reviewed
by, or under the supervision of, a licensed physician annually and at
any time the employee experiences unusual difficulty breathing while
being fitted for or while using a respirator. The employer shall have
the responsible licensed physician provide a written opinion resulting
from the review as required under paragraph (e)(1).
(f) Fit testing--(1) The employer shall ensure that the respirator
selected fits the employee well enough to reduce employee exposures
inside the mask to below the hazardous exposure level.
(2) The employer shall ensure that an employee is fit tested prior
to initial use of the respirator, whenever a different make or size
respirator is used, and annually thereafter.
(3) The employer shall fit test employees required to wear tight
fitting air-purifying respirators and tight fitting atmosphere-
supplying respirators. The fit test shall be administered using either
an established qualitative or quantitative fit test procedure contained
in section II of Appendix A or an alternative procedure which has been
developed and approved which meets the Minimum Criteria as defined in
section I of Appendix A.
(4) In order to use an alternative fit test procedure which meets
the Minimum Criteria as defined in section I of Appendix A, the
employer shall obtain advance approval from the Assistant Secretary.
Once such a procedure is published by OSHA as an approved procedure in
the Federal Register, any employer may use it without further approval.
(5) The employer shall present relevant data as required by
Appendix A to demonstrate that any new method used provides results
comparable to or better than one or more of the established methods
contained in Appendix A for the type of test, i.e. qualitative or
quantitative. The employer shall be permitted to use any method for
which such data have already been submitted to and approved by the
Assistant Secretary.
(6) Fit testing protocols.
(i) The employer shall use either qualitative or quantitative fit
testing for tight fitting air-purifying respirators with quarter and
half mask facepieces.
(A) Qualitative fit testing shall be performed in accordance with
the established protocols specified in section II of Appendix A or new
protocols that meet the minimum criteria contained in section I of
Appendix A. If the respirator passes the qualitative test the employees
may wear it in atmospheres no greater than ten times the hazardous
exposure level.
(B) Quantitative fit testing shall be performed in accordance with
an established protocol specified in section II of Appendix A or a
protocol that meets the minimum criteria contained in section I of
Appendix A. The test subject shall not be permitted to wear a half mask
or quarter facepiece respirator unless a minimum fit factor of one
hundred (100) is obtained in the test chamber. The respirator may not
be worn in concentrations greater than ten (10) times the hazardous
exposure level regardless of the measured fit factor in the chamber.
(ii) The employer shall use either qualitative or quantitative fit
testing for tight fitting air-purifying respirators with full
facepieces.
(A) Qualitative fit testing shall be performed in accordance with
the established protocols specified in section II of Appendix A or new
protocols that meet the minimum criteria contained in section I of
Appendix A. If the respirator passes the qualitative fit test the
employees may wear it in atmospheres no greater than ten (10) times the
hazardous exposure level.
(B) Quantitative fit testing shall be performed in accordance with
the established protocol specified in section II of Appendix A or a new
protocol that meets the minimum criteria contained in section I of
Appendix A. The test subject shall not be permitted to wear a full
facepiece respirator unless a minimum fit factor of five hundred (500)
is obtained in the test chamber. The full facepiece respirator may not
be worn in concentrations greater than fifty (50) times the hazardous
exposure level regardless of the measured fit factor in the chamber.
(iii) Fit testing of tight fitting atmosphere-supplying respirators
and tight fitting powered air-purifying respirators.
(A) Tight fitting atmosphere-supplying respirators and tight
fitting powered air-purifying respirators, i.e. half mask, quarter
facepiece, and full facepiece, shall be fit tested using either
qualitative or quantitative fit testing pursuant to paragraphs
(f)(6)(i) (A) and (B).
(B) During the test only the facepiece shall be tested without any
air-supplying equipment or attachments. This may be accomplished by
testing a particular respirator facepiece make, model and size (which
is available for use on atmosphere-supplying air units as well as on
air-purifying respirators) which is equipped with appropriate air-
purifying elements.
(1) Qualitative fit testing shall be performed in accordance with
the established protocols specified in section II of Appendix A or a
new protocol that meets the minimum criteria contained in section I of
Appendix A. If the respirator wearer passes the fit test then the same
respirator facepiece (i.e. make and model and size), which is available
on a NIOSH approved atmosphere-supplying respirator shall be used by
the employee. The respirator shall be used with an assigned protection
factor as provided in paragraphs (d) (5) and (6) of this section.
(2) Quantitative fit testing shall be performed in accordance with
the protocol specified in Appendix A or a protocol that meets the
minimum criteria contained in Appendix A. A NIOSH approved atmosphere-
supplying respirator with the same respirator facepiece (make, model,
size) with which the employee passed the quantitative fit test shall be
used. The respirator shall be used with an assigned protection factor
as provided in paragraphs (d) (5) and (6) of this section.
(7) The employee shall be refitted as necessary, such as when
visual observations are noted regarding an employee's condition which
could affect respirator fit. Conditions to look for include facial
scarring, cosmetic surgery, or an obvious change in body weight.
(8) The employee, once successfully fitted, shall be given the
opportunity to wear the respirator for a period of two weeks. If the
respirator becomes unacceptably uncomfortable at any time, the employee
shall be given the opportunity to select a different respirator
facepiece and be retested.
(9) Where an employer relies on an outside contractor/party to
conduct quantitative fit testing and the contractor is not readily
available, and where assigned protection factors greater than 10 are
necessary, the employer may administer a qualitative fit test to enable
the selection of a respirator provided that a quantitative fit is
administered in accordance with Appendix A within thirty (30) days.
(g) Use of respirators--(1) The employer shall develop and
implement written standard operating procedures for the use of
respirators which anticipate possible emergency as well as routine use
of respirators based on the conditions in the workplace in which they
are to be used.
(2) The employer shall develop and implement specific procedures
for the use of respirators in atmospheres where oxygen deficiency or
the concentrations of a hazardous chemical are unknown and/or
potentially immediately dangerous to the life or health (IDLH) of the
employees. These procedures shall include the following provisions:
(i) The employees shall wear positive pressure self-contained
breathing apparatus (SCBA) or combination full facepiece pressure
demand supplied air respirator with auxiliary self-contained air
supply.
(ii) When an employee(s) wears a respirator in IDLH, unknown or
potentially IDLH atmospheres where the employee(s) could be overcome if
the respiratory protection fails, the employer shall ensure that at
least one additional person located outside the IDLH atmosphere is in
communication with the employee(s) in the IDLH atmosphere, and able to
provide effective emergency assistance; and,
(iii) Where employees enter IDLH atmospheres, the employer shall
ensure that they are equipped with retrieval equipment for lifting or
removing them from the hazardous area, or shall ensure that equivalent
provisions for rescue have been made.
(iv) The emergency assistance personnel present shall be equipped
with a positive pressure self-contained breathing apparatus.
(3) The employer shall not permit negative pressure, pressure
demand or positive pressure respirators which depend for effective
performance on a tight facepiece-to-face seal to be worn by employees
with conditions that prevent such fits. Examples of these conditions
include facial hair that interferes with the facepiece seal, absence of
normally worn dentures, facial scars or headgear that projects under
the facepiece seal.
(4) If an employee wears corrective glasses or goggles, the
employer shall ensure that they are worn in such a manner that they do
not interfere with the seal of the facepiece to the face of the wearer.
(5) The employer shall permit employees to leave the respirator use
area to wash their faces and respirator facepieces as necessary to
prevent skin irritation associated with respirator use.
(6) The employer shall permit employees to leave the respirator use
area to change the filter elements or replace air-purifying respirators
whenever they detect the warning properties of the contaminant.
(7) The employer shall permit employees to leave the respirator use
area to change the filter elements of air-purifying respirators
whenever they detect a change in breathing resistance or chemical vapor
breakthrough.
(8) The employer shall ensure that respirators are immediately
repaired, or discarded and replaced when they are no longer in proper
original working condition.
(9) The employer shall ensure that disposable respirators which
cannot be cleaned and sanitized are discarded at the end of the task or
the work shift, whichever comes first. A disposable respirator which
can be cleaned and sanitized shall be disposed of after its useful
service life has been reached.
(10) The employer shall ensure that employees upon donning the
respirator perform a facepiece seal check prior to entering the work
area for all respirators on which such a check is possible to be
performed. The recommended procedures in Appendix B or the respirator
manufacturer's recommended procedures shall be used.
(11) The employer shall ensure that each self-contained breathing
apparatus used in IDLH atmospheres, or for emergency entry or fire
fighting, is certified for a minimum service life of thirty minutes.
This requirement does not apply to combination supplied air respirators
with auxiliary air supply or to emergency escape SCBAs.
(h) Maintenance and care of respirators--(1) Cleaning and
disinfecting. The employer shall ensure that respirators are cleaned
and disinfected using the cleaning procedures recommended by the
respirator manufacturer or cleaning procedures recommended in Appendix
B at the following intervals.
(i) Routinely used respirators issued for the exclusive use of an
employee shall be cleaned and disinfected after each day's use;
(ii) Routinely used respirators issued to more than one employee
shall be cleaned and disinfected after each use; and,
(iii) Respirators maintained for emergency use shall be cleaned and
disinfected after each use.
(2) Storage. The employer shall store respirators as follows:
(i) All respirators shall be stored in a manner that protects them
from damage, dust, sunlight, extreme temperatures, excessive moisture,
or damaging chemicals;
(ii) Emergency respirators shall be kept accessible to the work
area. In locations where weathering, contamination, or deterioration of
the respirator could occur, respirators shall be stored in compartments
built to protect them. Such compartments shall be clearly marked as
containing emergency respirators and shall be used in accordance with
any applicable manufacturer instructions;
(iii) Non-emergency respirators shall be stored in plastic bags or
otherwise protected from contamination or damage; and,
(iv) Respirators shall be packed or stored to prevent deformation
of the facepiece or exhalation valve.
(3) Inspection. (i) The employer shall ensure that respirators are
inspected as follows:
(A) All respirators used in non-emergency circumstances shall be
inspected before each use and during cleaning after each use;
(B) All respirators maintained for emergency situations shall be
inspected at least monthly, and checked for proper function before and
after each use. Emergency escape respirators shall be inspected before
being carried into the workplace; and,
(C) Self-contained breathing apparatus shall be inspected monthly.
Air and oxygen cylinders shall be maintained in a fully charged state
and recharged when the pressure falls to 90% of the manufacturer's
recommended pressure level. The employer shall determine that the
regulator and warning devices function properly.
(ii) The employer shall ensure that the respirator inspections
include the following:
(A) A check of respirator function, tightness of connections and
the condition of the facepiece, headstraps, valves, connecting tube,
and cartridges, canisters or filters; and,
(B) A check of rubber or elastomer parts for pliability and signs
of deterioration.
(iii) The employer shall certify in writing the inspection of
respirators maintained for emergency use. Certification shall include
the date the inspection was performed, the name (or signature) of the
person that made the inspection, and a serial number or other means of
identifying the inspected respirator. This certification may be in the
form of a tag or label attached to the storage compartment for the
respirator, or kept with the respirator, and shall be maintained until
replaced by the certification of the next inspection.
(4) Repairs. The employer shall ensure that respirators which fail
to pass inspection are removed from service and repaired or adjusted in
accordance with the following:
(i) Repairs or adjustments to respirators are to be made only by
persons appropriately trained to perform such operations, using parts
designed for the respirator;
(ii) No repairs shall be performed that are outside the
manufacturer's recommendations concerning the type and extent of
repairs that can be performed; and
(iii) Reducing or admission valves or regulators shall be returned
to the manufacturer or given to an appropriately trained technician for
adjustment or repair.
(i) Supplied air quality and use--(1) The employer shall ensure
that compressed air, compressed oxygen, liquid air, and liquid oxygen
used for respiration is of high purity, and in accordance with the
following specifications: Compressed and liquid oxygen shall meet the
requirements of the latest edition of the United States Pharmacopoeia
for medical or breathing oxygen; and compressed breathing air shall at
least meet the requirements of the specification for Grade D breathing
air as described in ANSI/Compressed Gas Association Commodity
Specification G-7.1-1989 (oxygen content (v/v) of 19.5-23.5%
(atmospheric air); hydrocarbon (condensed) of 5 milligrams per cubic
meter of air or less; carbon monoxide of 10 ppm or less, and carbon
dioxide of 1,000 ppm or less).
(2) Compressed oxygen shall not be used in atmosphere-supplying
respirators or in open circuit self-contained breathing apparatus that
have previously used compressed air.
(3) Oxygen shall not be used with supplied air respirators.
(4) Breathing air to respirators shall be provided from cylinders
or air compressors:
(i) Cylinders shall be tested and maintained as prescribed in the
Shipping Container Specification Regulations of the Department of
Transportation (49 CFR part 178);
(ii) Compressors shall be constructed and situated so as to avoid
entry of contaminated air into the air-supply system and shall be
equipped with suitable in-line air-purifying sorbent beds and filters
to further assure breathing air quality, and to minimize moisture
content so that the dew point at line pressure is 10 deg.C below the
ambient temperature; and
(iii) The moisture content in compressed air cylinders shall not
exceed 27 milliliters per cubic meter.
(5) The employer shall ensure that breathing air couplings are
incompatible with outlets for non-respirable plant air or other gas
systems to prevent inadvertent servicing of air line respirators with
non-respirable gases or oxygen.
(6) The employer shall use breathing gas containers marked in
accordance with the American National Standard Method of Marking
Portable Compressed Gas Containers to Identify the Material Contained,
Z48.1-1954 (R 1971); Federal Specification BB-A-1034a, June 21, 1968,
Air, Compressed for Breathing Purposes; or Interim Federal
Specification GG-13-00676b, September 23, 1976, Breathing Apparatus,
Self-Contained.
(j) Identification of filters, cartridges, and canisters--(1) The
employer shall ensure that all filters, cartridges and canisters used
in the workplace are properly labeled and color coded with the NIOSH
approval label before they are placed in service.
(2) The employer shall ensure that the existing NIOSH approval
label on a filter, cartridge, or canister is not removed, obscured or
defaced while they are in service in the workplace.
(k) Training--(1) The employer shall provide a training program for
employees required by the employer to wear respirators which includes
the following:
(i) Nature, extent, and effects of respiratory hazards to which the
employee may be exposed as required under the Hazard Communication
standard (29 CFR 1910.1200);
(ii) Explanation of the operation, limitations, and capabilities of
the selected respirator(s);
(iii) Instruction in procedures for inspection, donning and
removal, checking the fit and seals, and in the wearing of the
respirator, including sufficient practice to enable the employee to
become thoroughly familiar with, confident, and effective in performing
these tasks;
(iv) Explanation of the procedures for maintenance and storage of
the respirator;
(v) Instruction on how to deal with emergency situations involving
the use of respirators or with respirator malfunctions; and
(vi) The contents of this section (29 CFR 1910.134), and of the
written respiratory protection program, its location and availability.
(2) The employer shall provide the training prior to requiring the
employee to wear a respirator in the workplace, and annually
thereafter.
(l) Respiratory protection program evaluation--(1) The employer
shall review the respiratory protection program at least annually, and
shall conduct frequent random inspections of the workplace to ensure
that the provisions of the program are being properly implemented for
all affected employees. The review of the program shall include an
assessment of each element required under paragraph (c)(1) of this
section.
(2) The employer shall periodically consult employees wearing
respirators to assess wearer acceptance and attempt to correct any
problems that are revealed during this assessment. Factors to be
included in the assessment are whether the respirators being used are:
(i) Preventing the occurrence of illness;
(ii) Properly fitted;
(iii) Properly selected for the hazards encountered;
(iv) Being worn when necessary; and
(v) Being maintained properly.
(m) Recordkeeping and access to records----(1) Medical evaluation.
(i) The employer shall establish and maintain an accurate record for
each employee subject to medical evaluation required by paragraph (e)
of this section, in accordance with 29 CFR 1910.20, Access to Employee
Exposure and Medical Records.
(ii) This record shall include:
(A) The name, social security number and description of the duties
of the employee;
(B) The employer's copy of the physician's written opinion on the
initial, periodic and special examinations, including results of
medical examination and all tests, opinions and recommendations;
(C) A copy of the information provided to the physician as required
by paragraph (e)(1) of this section.
(iii) The employer shall maintain and make available this record in
accordance with 29 CFR 1910.20.
(2) Availability. (i) The employer shall assure that all records
required to be maintained by this section shall be available or
submitted upon request to the Assistant Secretary and the Director for
examination and copying.
(ii) Employee medical records required by this paragraph shall be
provided upon request for examination and copying to the subject
employee, to anyone having the specific written consent of the subject
employee, and to the Assistant Secretary and the Director in accordance
with 29 CFR 1910.20.
(3) Transfer of records. (i) The employer shall comply with the
requirements involving transfer of records set forth in 29 CFR 1910.20.
(ii) If the employer ceases to do business and there is no
successor employer to receive and retain the records for the prescribed
period, the employer shall notify the Director at least 90 days prior
to disposal, and transmit them to the Director if requested by the
Director within that period.
(n) Effective date. The standard in this section is effective [90
days after date of publication of the final rule in the Federal
Register]
(o) Appendixes. The protocols in Appendix A on fit testing
procedures are mandatory. The recommended practices in Appendix B and
the medical evaluation procedures in Appendix C are nonmandatory.
Appendix A: Fit Testing Procedures (Mandatory)
I. New Fit Test Protocols
1. In order for a new fit test method to be used by an employer
a description of the fit test method and validation testing data
must be submitted to OSHA for evaluation.
2. OSHA will evaluate the method and data and if the method is
found to conform to the validation criteria OSHA has established,
OSHA will publish a proposed revision of 29 CFR 1910.134 under the
section 6(b)(7) limited rulemaking provision of the Occupational
Safety and Health Act of 1970 for public comment. OSHA will invite
comments and make a final decision on the protocol after
consideration of comments received on the proposal.
3. OSHA will publish a revised 29 CFR 1910.134 incorporating the
new fit test method into Appendix A.
A. Minimum Criteria for a Valid Qualitative Fit Test
1. This section applies in addition to section II.A. of Appendix
A where a test method and/or test agent not identified in section
II.B. of Appendix A is to be used for testing the fit of a
respirator. Fit tests which meet the criteria of this section may be
used to verify the fit of respirators for use up to the assigned
protection factors specified in the respirator selection table in
paragraph (d) of this section.
2. Test Agents. (a) The test agent shall be relatively non,
toxic. The concentrations generated during the test shall not exceed
an OSHA permissible exposure limit, the ACGIH threshold limit value,
or any known recommended exposure limit when there is no OSHA PEL or
ACGIH TLV, and not create a health or physical hazard for the test
subject or operator.
(b) It shall be demonstrated that the test agent used will
penetrate deficiencies in the respirator facepiece to face sealing
area.
(c) It shall be demonstrated that the test agent can elicit a
subjective response in the test subject without fatiguing the
response mechanism (i.e., smell, taste, or other relevant sensation)
of the test subject.
(d) A reference concentration shall be established for the test
agent. It shall be demonstrated that the test subject can detect by
subjective means the test agent at the reference concentration prior
to commencement of the test.
(e) A stable test agent concentration shall be established for
purposes of challenging the fit of the respirator.
(f) Where a test enclosure is used, the concentration of test
agent inside the test enclosure shall exceed the product of the
reference concentration of the test agent, the assigned protection
factor of the respirator being tested, and a safety factor of 10.
For example, if the reference concentration is 1 ppm, and the
respirator being tested is a half mask with an assigned protection
factor of 10, then the minimum test agent concentration would be 100
ppm.
(g) Where gases/vapors are used as test agents to test air-
purifying respirators, an appropriate cartridge/canister shall be
utilized which affords a high degree of collection efficiency for
the test agent.
(h) Precautions shall be taken to avoid allowing the test agent
from the fit test area to contaminate the area where the test
subjects are tested to determine their response to the threshold
screening concentrations. Contamination of the area where the
threshold screening test is administered by the test agent from the
fit test area will render any tests unacceptable.
B. Validation Criteria for Qualitative Fit Tests
1. In order to establish a QLFT method/agent as being acceptable
for an APF of 10, it shall be demonstrated that at the 95%
confidence level 95% of the facepieces with a fit factor less than
100 as determined by an established QNFT method will be identified.
2. Means of establishing the 95% confidence level shall include
the following procedures:
(a) The respirators used in the validation procedure shall be
equipped so as to permit valid QNFT testing as specified in Appendix
A of this section.
(b) The hoses on the test respirators shall be clamped shut and
the new QLFT test administered. Immediately following the new QLFT
method a QNFT shall be administered using the protocol established
in section II.C. of Appendix A except that a strip chart recording
of the test shall be made. The numbers of respirators, test subject
size population, exercises sizes of respirators, and numbers of
tests shall be sufficient to enable a determination to be made as to
whether or not the 95% confidence level is attained in identifying
whether 95% of facepieces with less than a fit factor or 100 will be
identified by the new QLFT method.
C. Minimum Criteria for a Valid Particle Counting Quantitative Fit
Test
1. This section applies in addition to sections II.A. and
II.C.4.(j) of Appendix A where a test method and/or test agent not
identified in section II.C. of Appendix A is to be used for testing
the fit of a respirator. Fit tests which meet the criteria of this
section may be used to verify the fit of respirators for use up to
the assigned protection factors in paragraph (d) of this section.
2. Aerosol/Gas Generation.
(a) The aerosol/gas generator shall produce a stable test agent
concentration (10%) throughout the test environment. The
test agent concentration shall not vary as a function of time more
than 10 percent.
(b) The concentration of the aerosol/gas shall not exceed an
OSHA permissible exposure limit, the ACGIH threshold limit value, or
any known recommended exposure limit when there is no OSHA PEL or
ACGIH TLV, and not create a health or physical hazard for the test
subject or operator.
(c) Aerosols used to test respirators with high efficiency
particulate air (HEPA) filters shall be polydisperse with a mass
median aerodynamic diameter of 0.6 micrometers and a geometric
standard deviation of 2. The test agent shall not be appreciably
absorbed or retained in the lungs upon inhalation.
(d) A test agent detection system shall be able to reliably
monitor the agent concentration in the test environment and inside
the respirator during the breathing cycle.
(e) If it is desired to use a test agent aerosol larger than 0.6
micrometers in diameter to test respirators with other than high
efficiency filters, it shall be demonstrated that the particle size
is capable of penetrating deficiencies in the respirator facepiece
to face sealing area, will be reliably detected by the measurement
instruments, and that a significant portion will not be retained by
the lungs upon inhalation.
D. Validation Criteria for Quantitative Fit Test Protocols
1. In determining the acceptability of a new method, its
accuracy across the full range of measurement must be at least as
great as the QNFT protocol established in section II.C. of Appendix
A.
2. Means of establishing the accuracy across the full range of
measurements shall include the following procedures:
(a) The respirators used in the validation procedure shall be
probed and equipped with hoses as established in the QNFT procedures
in Appendix A of this section.
(b) Validation of a proposed new QNFT shall be accomplished
using instrumentation with sufficient accuracy and precision.
Accuracy and precision of the validation instrumentation shall be
considered by the Assistant Secretary in determining whether to
approve a proposed new protocol.
(c) The numbers of respirators, test subject size population,
exercises sizes of respirators, and numbers of tests shall be
sufficient to enable a determination to be made as to whether or not
the 95% confidence level is attained with respect to agreement
between the two methods.
E. Minimum Criteria for New Technology
1. Test methods/equipment shall not alter the design, balance,
integrity, manner of respirator fitting, nor distort the respirator
in a manner which would result in the test respirator having
different characteristics than under normal use.
2. Equipment measuring: respirator efficiency; test agent
penetration; protection factors; or fit factors must be capable of
reliably detecting and measuring the test agent, protection factor
or fit factor with a high degree of accuracy. The limitations of
detection and test sensitivity must be known.
3. Test respirators must be donned and adjusted in the same
manner in which it will be used in the workplace.
4. It must be demonstrated that the new technology used will
produce reliable and reproducible results.
5. There shall be a sufficient safety factor applied to account
for variations in the use of the respirator and reproducibility of
test results.
6. Where test agents, aerosol or gases/vapors are used in a test
environment the following shall apply:
(a) The test agent concentration must be maintained below an
established PEL, ACGIH TLV, or recommended exposure level and not
create a health hazard or physical hazard for the test subject or
associated personnel.
(b) For particulate test agents:
--The particle size must be uniform, the concentration stable.
--Particles must be able to penetrate deficiencies in the respirator
to face seal, but not be retained by the airways of respiratory
tract,
(c) Filters, cartridges used on the test respirator must be
capable of removing 99.97% of the test agent (i.e. large particles
collected on dust filters, small particles collected on high
efficiency filters).
(d) Detection system for test agents must be capable of
detecting the concentration of test agent inside the respirator
during the entire breathing cycle.
F. Validation for New Technological Methods of Determining
Respirator Fit
1. In determining the acceptability of a new method, its
accuracy across the full range of measurement must be at least as
great as that of the QNFT protocol established in section II.C. of
Appendix A.
2. Means of establishing the accuracy across the full range of
measurements shall include the following:
(a) For particle counting methods, the respirators used in the
validation procedure shall be probed and equipped with hoses as
established in the QNFT procedures in Appendix A of this section.
(b) For any method, the new test method shall be administered
first. Immediately following the new method, a QNFT shall be
administered using the protocol established in section II of
Appendix A except that a strip chart recording of the test shall be
made. The numbers of respirators, test subject size population,
exercises sizes of respirators, and numbers of tests shall be
sufficient to enable a determination to be made as to whether or not
the 95% confidence level is attained with respect to agreement
between the two methods.
II. Current Fit Test Protocols
A. The employer shall include the following provisions in the
fit test procedures. These provisions apply to both QLFT and QNFT.
1. The test subject shall be allowed to pick the most
comfortable respirator from a selection including respirators of
various sizes from different manufacturers.
2. Prior to the selection process, the test subject shall be
shown how to put on a respirator, how it should be positioned on the
face, how to get strap tension and how to determine a comfortable
fit. A mirror shall be available to assist the subject in evaluating
the fit and positioning the respirator. This instruction may not
constitute the subject's formal training on respirator use, as it is
only a review.
3. The test subject shall be informed that he/she is being asked
to select the respirator which provides the most comfortable fit.
Each respirator represents a different size and shape, and if fitted
and used properly, will provide adequate protection.
4. The test subject shall be instructed to hold each facepiece
up to the face and eliminate those which obviously do not give a
comfortable fit.
5. The more comfortable facepieces are noted; the most
comfortable mask is donned and worn at least five minutes to assess
comfort. Assistance in assessing comfort can be given by discussing
the points in item II A.6. of this appendix. If the test subject is
not familiar with using a particular respirator, the test subject
shall be directed to don the mask several times and to adjust the
straps each time to become adept at setting proper tension on the
straps.
6. Assessment of comfort shall include reviewing the following
points with the test subject and allowing the test subject adequate
time to determine the comfort of the respirator:
(a) Position of the mask on the nose
(b) Room for eye protection
(c) Room to talk
(d) Position of mask on face and cheeks
7. The following criteria shall be used to help determine the
adequacy of the respirator fit:
(a) Chin properly placed;
(b) Adequate strap tension, not overly tightened;
(c) Fit across nose bridge;
(d) Respirator of proper size to span distance from nose to
chin;
(e) Tendency of respirator to slip;
(f) Self-observation in mirror to evaluate fit and respirator
position.
8. The test subject shall conduct the negative and positive
pressure fit checks as described in Appendix B or ANSI Z88.2-1980.
Before conducting the negative or positive pressure test, the
subject shall be told to seat the mask on the face by moving the
head from side-to-side and up and down slowly while taking in a few
slow deep breaths. Another facepiece shall be selected and retested
if the test subject fails the fit check tests.
9. The test shall not be conducted if there is any hair growth
between the skin and the facepiece sealing surface, such as stubble
beard growth, beard, or long sideburns which cross the respirator
sealing surface. Any type of apparel which interferes with a
satisfactory fit shall be altered or removed.
10. If a test subject exhibits difficulty in breathing during
the tests, she or he shall be referred to a physician to determine
whether the test subject can wear a respirator while performing her
or his duties.
11. If at any time within the first two weeks of use the
respirator becomes uncomfortable, the test subject shall be given
the opportunity to select a different facepiece and to be retested.
12. The employer shall maintain a record of the fit test
administered to an employee. The record shall contain at least the
following information:
(a) Name of employee;
(b) Type of respirator;
(c) Brand, size of respirator;
(d) Date of test;
(e) Where QNFT is used: the fit factor, strip chart recording or
other recording of the results of the test. The record shall be
maintained until the next fit test is administered.
13. Exercise regimen. Prior to the commencement of the fit test,
the test subject shall be given a description of the fit test and
the test subject's responsibilities during the test procedure. The
description of the process shall include a description of the test
exercises that the subject will be performing. The respirator to be
tested shall be worn for at least 5 minutes before the start of the
fit test.
14. Test Exercises. The test subject shall perform exercises, in
the test environment, in the manner described below;
(a) Normal breathing. In a normal standing position, without
talking, the subject shall breathe normally.
(b) Deep breathing. In a normal standing position, the subject
shall breathe slowly and deeply, taking caution so as to not
hyperventilate.
(c) Turning head side to side. Standing in place, the subject
shall slowly turn his/her head from side to side between the extreme
positions on each side. The head shall be held at each extreme
momentarily so the subject can inhale at each side.
(d) Moving head up and down. Standing in place, the subject
shall slowly move his/her head up and down. The subject shall be
instructed to inhale in the up position (i.e., when looking toward
the ceiling).
(e) Talking. The subject shall talk out loud slowly and loud
enough so as to be heard clearly by the test conductor. The subject
can read from a prepared text such as the Rainbow Passage, count
backward from 100, or recite a memorized poem or song.
(f) Grimace. The test subject shall grimace by smiling or
frowning.
(g) Bending over. The test subject shall bend at the waist as if
he/she were to touch his/her toes. Jogging in place shall be
substituted for this exercise in those test environments such as
shroud type QNFT units which prohibit bending at the waist.
(h) Normal breathing. Same as exercise 1.
Each test exercise shall be performed for one minute except for
the grimace exercise which shall be performed for 15 seconds.
The test subject shall be questioned by the test conductor
regarding the comfort of the respirator upon completion of the
protocol. If it has become uncomfortable, another model of
respirator shall be tried.
B. Qualitative Fit Test (QLFT) Protocols.
1. General
(a) The employer shall assign specific individuals who shall
assume full responsibility for implementing the respirator
qualitative fit test program.
(b) The employer shall ensure that persons administering QLFT
are able to prepare test solutions, calibrate equipment and perform
tests properly, recognize invalid tests, and assure that test
equipment is in proper working order.
(c) The employer shall assure that QLFT equipment is kept clean
and well maintained so as to operate at the parameters for which it
was designed.
2. Isoamyl Acetate Protocol
(a) Odor threshold screening.
The odor threshold screening test, performed without wearing a
respirator, is intended to determine if the individual tested can
detect the odor of isoamyl acetate.
(1) Three 1 liter glass jars with metal lids are required.
(2) Odor free water (e.g. distilled or spring water) at
approximately 25 degrees C shall be used for the solutions.
(3) The isoamyl acetate (IAA) (also known as isopentyl acetate)
stock solution is prepared by adding 1 cc of pure IAA to 800 cc of
odor free water in a 1 liter jar and shaking for 30 seconds. A new
solution shall be prepared at least weekly.
(4) The screening test shall be conducted in a room separate
from the room used for actual fit testing. The two rooms shall be
well ventilated but shall not be connected to the same recirculating
ventilation system.
(5) The odor test solution is prepared in a second jar by
placing 0.4 cc of the stock solution into 500 cc of odor free water
using a clean dropper or pipette. The solution shall be shaken for
30 seconds and allowed to stand for two to three minutes so that the
IAA concentration above the liquid may reach equilibrium. This
solution shall be used for only one day.
(6) A test blank shall be prepared in a third jar by adding 500
cc of odor free water.
(7) The odor test and test blank jars shall be labeled 1 and 2
for jar identification. Labels shall be placed on the lids so they
can be periodically peeled, dried off and switched to maintain the
integrity of the test.
(8) The following instruction shall be typed on a card and
placed on the table in front of the two test jars (i.e., 1 and 2):
``The purpose of this test is to determine if you can smell banana
oil at a low concentration. The two bottles in front of you contain
water. One of these bottles also contains a small amount of banana
oil. Be sure the covers are on tight, then shake each bottle for two
seconds. Unscrew the lid of each bottle, one at a time, and sniff at
the mouth of the bottle. Indicate to the test conductor which bottle
contains banana oil.''
(9) The mixtures used in the IAA odor detection test shall be
prepared in an area separate from where the test is performed, in
order to prevent olfactory fatigue in the subject.
(10) If the test subject is unable to correctly identify the jar
containing the odor test solution, the IAA qualitative fit test
shall not be performed.
(11) If the test subject correctly identifies the jar containing
the odor test solution, the test subject may proceed to respirator
selection and fit testing.
(b) Isoamyl acetate fit test.
(1) The fit test chamber shall be similar to a clear 55-gallon
drum liner suspended inverted over a 2-foot diameter frame so that
the top of the chamber is about 6 inches above the test subject's
head. The inside top center of the chamber shall have a small hook
attached.
(2) Each respirator used for the fitting and fit testing shall
be equipped with organic vapor cartridges or offer protection
against organic vapors. The cartridges or masks shall be changed at
least weekly.
(3) After selecting, donning, and properly adjusting a
respirator, the test subject shall wear it to the fit testing room.
This room shall be separate from the room used for odor threshold
screening and respirator selection, and shall be well ventilated, as
by an exhaust fan or lab hood, to prevent general room
contamination.
(4) A copy of the test exercises and any prepared text from
which the subject is to read shall be taped to the inside of the
test chamber.
(5) Upon entering the test chamber, the test subject shall be
given a 6-inch by 5-inch piece of paper towel, or other porous,
absorbent, single-ply material, folded in half and wetted with 0.75
cc of pure IAA. The test subject shall hang the wet towel on the
hook at the top of the chamber.
(6) Allow two minutes for the IAA test concentration to
stabilize before starting the fit test exercises. This would be an
appropriate time to talk with the test subject; to explain the fit
test, the importance of his/her cooperation, and the purpose for the
head exercises; or to demonstrate some of the exercises.
(7) If at any time during the test, the subject detects the
banana like odor of IAA, the test has failed. The subject shall
quickly exit from the test chamber and leave the test area to avoid
olfactory fatigue.
(8) If the test has failed, the subject shall return to the
selection room and remove the respirator, repeat the odor
sensitivity test, select and put on another respirator, return to
the test chamber and again begin the procedure described in B.2.(b)
(1) through (7) of this appendix. The process continues until a
respirator that fits well has been found. Should the odor
sensitivity test be failed, the subject shall wait about 5 minutes
before retesting. Odor sensitivity will usually have returned by
this time.
(9) When a respirator is found that passes the test, its
efficiency shall be demonstrated for the subject by having the
subject break the face seal and take a breath before exiting the
chamber.
(10) When the test subject leaves the chamber, the subject shall
remove the saturated towel and return it to the person conducting
the test. To keep the test area from becoming contaminated, the used
towels shall be kept in a self sealing bag so there is no
significant IAA concentration build-up in the test chamber during
subsequent tests.
3. Saccharin Solution Aerosol Protocol
The saccharin solution aerosol QLFT protocol is the only
currently available, validated test protocol for use with
particulate disposable dust respirators not equipped with high-
efficiency filters. The entire screening and testing procedure shall
be explained to the test subject prior to the conduct of the
screening test.
(a) Taste threshold screening.
The saccharin taste threshold screening, performed without
wearing a respirator, is intended to determine whether the
individual being tested can detect the taste of saccharin.
(1) During threshold screening as well as during fit testing,
subjects shall wear an enclosure about the head and shoulders that
is approximately 12 inches in diameter by 14 inches tall with at
least the front portion clear and that allows free movements of the
head when a respirator is worn. An enclosure substantially similar
to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is
adequate.
(2) The test enclosure shall have a \3/4\-inch hole in front of
the test subject's nose and mouth area to accommodate the nebulizer
nozzle.
(3) The test subject shall don the test enclosure. Throughout
the threshold screening test, the test subject shall breathe through
his/her wide open mouth with tongue extended.
(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer
the test conductor shall spray the Threshold check solution into the
enclosure. This Nebulizer shall be clearly marked to distinguish it
from the fit test solution nebulizer.
(5) The threshold check solution consists of 0.83 grams of
sodium saccharin USP in 1 cc of warm water. It can be prepared by
putting 1 cc of the fit test solution (see (b)(5) below) in 100 cc
of distilled water.
(6) To produce the aerosol, the nebulizer bulb is firmly
squeezed so that it collapses completely, then released and allowed
to fully expand.
(7) Ten squeezes are repeated rapidly and then the test subject
is asked whether the saccharin can be tasted.
(8) If the first response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted.
(9) If the second response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted.
(10) The test conductor will take note of the number of squeezes
required to solicit a taste response.
(11) If the saccharin is not tasted after 30 squeezes (step 10),
the test subject may not perform the saccharin fit test.
(12) If a taste response is elicited, the test subject shall be
asked to take note of the taste for reference in the fit test.
(13) Correct use of the nebulizer means that approximately 1 cc
of liquid is used at a time in the nebulizer body.
(14) The nebulizer shall be thoroughly rinsed in water, shaken
dry, and refilled at least each morning and afternoon or at least
every four hours.
(b) Saccharin solution aerosol fit test procedure.
(1) The test subject may not eat, drink (except plain water), or
chew gum for 15 minutes before the test.
(2) The fit test uses the same enclosure described in (a) above.
(3) The test subject shall don the enclosure while wearing the
respirator selected in section B.3.(a) of this appendix. The
respirator shall be properly adjusted and equipped with a
particulate filter(s).
(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer
is used to spray the fit test solution into the enclosure. This
nebulizer shall be clearly marked to distinguish it from the
screening test solution nebulizer.
(5) The fit test solution is prepared by adding 83 grams of
sodium saccharin to 100 cc of warm water.
(6) As before, the test subject shall breathe through the wide
open mouth with tongue extended.
(7) The nebulizer is inserted into the hole in the front of the
enclosure and the fit test solution is sprayed into the enclosure
using the same number of squeezes required to elicit a taste
response in the screening test.
(8) After generating the aerosol the test subject shall be
instructed to perform the exercises in section VII. A. 14 of this
appendix.
(9) Every 30 seconds the aerosol concentration shall be
replenished using one half the number of squeezes as initially.
(10) The test subject shall indicate to the test conductor if at
any time during the fit test the taste of saccharin is detected.
(11) If the taste of saccharin is detected, the fit is deemed
unsatisfactory and a different respirator shall be tried.
4. Irritant Fume Protocol
(a) The respirator to be tested shall be equipped with high-
efficiency particulate air (HEPA) filters.
(b) The test subject shall be allowed to smell a weak
concentration of the irritant smoke before the respirator is donned
to become familiar with its characteristic odor.
(c) Break both ends of a ventilation smoke tube containing
stannic oxychloride, such as the MSA part No. 5645, or equivalent.
Attach one end of the smoke tube to a low flow air pump set to
deliver 200 milliliters per minute.
(d) Advise the test subject that the smoke can be irritating to
the eyes and instruct the subject to keep his/her eyes closed while
the test is performed.
(e) The test conductor shall direct the stream of irritant smoke
from the smoke tube towards the face seal area of the test subject.
He/She shall begin at least 12 inches from the facepiece and
gradually move to within one inch, moving around the whole perimeter
of the mask.
(f) The exercises identified in section VII. A. 14 above shall
be performed by the test subject while the respirator seal is being
challenged by the smoke.
(g) Each test subject passing the smoke test without evidence of
a response shall be given a sensitivity check of the smoke from the
same tube once the respirator has been removed to determine whether
he/she reacts to the smoke. Failure to evoke a response shall void
the fit test.
(h) The fit test shall be performed in a location with exhaust
ventilation sufficient to prevent general contamination of the
testing area by the test agent.
C. Quantitative Fit Test (QNFT) Protocol.
1. General
(a) The employer shall assign specific individuals who shall
assume full responsibility for implementing the respirator
quantitative fit test program.
(b) The employer shall ensure that persons administering QNFT
are able to calibrate equipment and perform tests properly,
recognize invalid tests, calculate fit factors properly and assure
that test equipment is in proper working order.
(c) The employer shall assure that QNFT equipment is kept clean
and well maintained so as to operate at the parameters for which it
was designed.
2. Definitions
(a) Quantitative fit test. The test is performed in a test
chamber. The normal air-purifying element of the respirator is
replaced by a high-efficiency particulate air (HEPA) filter in the
case of particulate QNFT aerosols or a sorbent offering contaminant
penetration protection equivalent to high-efficiency filters where
the QNFT test agent is a gas or vapor.
(b) Challenge agent means the aerosol, gas or vapor introduced
into a test chamber so that its concentration inside and outside the
respirator may be measured.
(c) Test subject means the person wearing the respirator for
quantitative fit testing.
(d) Normal standing position means standing erect and straight
with arms down along the sides and looking straight ahead.
(e) Maximum peak penetration method means the method of
determining test agent penetration in the respirator as determined
by strip chart recordings of the test. The highest peak penetration
for a given exercise is taken to be representative of average
penetration into the respirator for that exercise.
(f) Average peak penetration method means the method of
determining test agent penetration into the respirator utilizing a
strip chart recorder, integrator, or computer. The agent penetration
is determined by an average of the peak heights on the graph or by
computer integration for each exercise except the grimace exercise.
Integrators or computers which calculate the actual test agent
penetration into the respirator for each exercise will also be
considered to meet the requirements of the average peak penetration
method.
3. Apparatus
(a) Instrumentation. Aerosol generation, dilution, and
measurement systems using corn oil or sodium chloride as test
aerosols shall be used for quantitative fit testing except as
provided for by Section I of this Appendix.
(b) Test chamber. The test chamber shall be large enough to
permit all test subjects to perform freely all required exercises
without disturbing the challenge agent concentration or the
measurement apparatus. The test chamber shall be equipped and
constructed so that the challenge agent is effectively isolated from
the ambient air, yet uniform in concentration throughout the
chamber.
(c) When testing air-purifying respirators, the normal filter or
cartridge element shall be replaced with a high-efficiency
particulate filter supplied by the same manufacturer.
(d) The sampling instrument shall be selected so that a strip
chart record may be made of the test showing the rise and fall of
the challenge agent concentration with each inspiration and
expiration at fit factors of at least 2,000. Integrators or
computers which integrate the amount of test agent penetration
leakage into the respirator for each exercise may be used provided a
record of the readings is made.
(e) The combination of substitute air-purifying elements,
challenge agent and challenge agent concentration in the test
chamber shall be such that the test subject is not exposed in excess
of an established exposure limit for the challenge agent at any time
during the testing process.
(f) The sampling port on the test specimen respirator shall be
placed and constructed so that no leakage occurs around the port
(e.g. where the respirator is probed), a free air flow is allowed
into the sampling line at all times and so that there is no
interference with the fit or performance of the respirator.
(g) The test chamber and test set up shall permit the person
administering the test to observe the test subject inside the
chamber during the test.
(h) The equipment generating the challenge atmosphere shall
maintain the concentration of challenge agent inside the test
chamber constant to within a 10 percent variation for the duration
of the test.
(i) The time lag (interval between an event and the recording of
the event on the strip chart or computer or integrator) shall be
kept to a minimum. There shall be a clear association between the
occurrence of an event inside the test chamber and its being
recorded.
(j) The sampling line tubing for the test chamber atmosphere and
for the respirator sampling port shall be of equal diameter and of
the same material. The length of the two lines shall be equal.
(k) The exhaust flow from the test chamber shall pass through a
high-efficiency filter before release.
(l) When sodium chloride aerosol is used, the relative humidity
inside the test chamber shall not exceed 50 percent.
(m) The limitations of instrument detection shall be taken into
account when determining the fit factor.
(n) Test respirators shall be maintained in proper working order
and inspected for deficiencies such as cracks, missing valves and
gaskets, etc.
4. Procedural Requirements
(a) When performing the initial positive or negative pressure
test the sampling line shall be crimped closed in order to avoid air
pressure leakage during either of these tests.
(b) An abbreviated screening isoamyl acetate test or irritant
fume test may be utilized in order to quickly identify poor fitting
respirators which passed the positive and/or negative pressure test
and thus reduce the amount of QNFT time. When performing a screening
isoamyl acetate test, combination high-efficiency organic vapor
cartridges/canisters shall be used.
(c) A reasonably stable challenge agent concentration shall be
measured in the test chamber prior to testing. For canopy or shower
curtain type of test units the determination of the challenge agent
stability may be established after the test subject has entered the
test environment.
(d) Immediately after the subject enters the test chamber, the
challenge agent concentration inside the respirator shall be
measured to ensure that the peak penetration does not exceed 5
percent for a half mask or 1 percent for a full facepiece
respirator.
(e) A stable challenge concentration shall be obtained prior to
the actual start of testing.
(f) Respirator restraining straps shall not be overtightened for
testing. The straps shall be adjusted by the wearer without
assistance from other persons to give a reasonable comfortable fit
typical of normal use.
(g) The test shall be terminated whenever any single peak
penetration exceeds 5 percent for half masks and 1 percent for full
facepiece respirators. The test subject shall be refitted and
retested. If two of the three required tests are terminated, the fit
shall be deemed inadequate.
(h) In order to successfully complete a QNFT, three successful
fit tests are required. The results of each of the three independent
fit tests must exceed the minimum fit factor needed for the class of
respirator (e.g. quarter facepiece respirator, half mask respirator,
full facepiece respirator) as specified in paragraph (f) of this
section.
(i) Calculation of fit factors.
(1) The fit factor shall be determined for the quantitative fit
test by taking the ratio of the average chamber concentration to the
concentration measured inside the respirator for each test exercise
except the grimace exercise.
(2) The average test chamber concentration is the arithmetic
average of the test chamber concentration at the beginning and of
the end of the test.
(3) The concentration of the challenge agent inside the
respirator shall be determined by one of the following methods:
(i) Average peak concentration
(ii) Maximum peak concentration
(iii) Integration by calculation of the area under the
individual peak for each exercise except the grimace exercise. This
includes computerized integration.
(j) Interpretation of test results. The fit factor established
by the quantitative fit testing shall be the lowest of the three fit
factor values calculated from the three required fit tests.
(k) The test subject shall not be permitted to wear a half mask
or quarter facepiece respirator unless a minimum fit factor of 100
is obtained, or a full facepiece respirator unless a minimum fit
factor of 500 is obtained.
(l) Filters used for quantitative fit testing shall be replaced
at least weekly or whenever increased breathing resistance is
encountered, or when the test agent has altered the integrity of the
filter media. Organic vapor cartridges/canisters shall be replaced
daily (when used) or sooner if there is any indication of
breakthrough by a test agent.
Appendix B: Recommended Practices (Nonmandatory)
I. Facepiece Seal Checks
A. Positive Pressure Check
Close off the exhalation valve and exhale gently into the
facepiece. The face fit is considered satisfactory if a slight
positive pressure can be built up inside the facepiece without any
evidence of outward leakage of air at the seal. For most respirators
this method of leak testing requires the wearer to first remove the
exhalation valve cover before closing off the exhalation valve and
then carefully replacing it after the test.
B. Negative Pressure Check
Close off the inlet opening of the canister or cartridge(s) by
covering with the palm of the hand(s) or by replacing the filter
seal(s), inhale gently so that the facepiece collapses slightly, and
hold the breath for ten seconds. If the facepiece remains in its
slightly collapsed condition and no inward leakage of air is
detected, the tightness of the respirator is considered
satisfactory.
II. Recommended Procedures for Cleaning Respirators
A. Remove filters, cartridges, or canisters. Disassemble
facepieces by removing speaking diaphragms, demand and pressure-
demand valve assemblies, hoses, or any components recommended by the
manufacturer. Discard or repair any defective parts.
B. Wash components in 50 deg.C water with a mild detergent or
with a cleaner recommended by the manufacturer. A stiff bristle (not
wire) brush may be used to facilitate the removal of dirt.
C. Rinse components thoroughly in clean, warm (50 deg.C
maximum), preferably running water. Drain.
D. When the cleaner used does not contain a disinfecting agent,
respirator components should be immersed for two minutes in one of
the following:
1. Hypochlorite solution (50 ppm of chlorine) made by adding
approximately one milliliter of laundry bleach to one liter of water
at 50 deg.C; or,
2. Aqueous solution of iodine (50 ppm iodine) made by adding
approximately 0.8 milliliters of tincture of iodine (6-8 grams
ammonium and/or potassium iodine / 100 cc of 45% alcohol) to one
liter of water at 50 deg.C; or,
3. Other commercially available cleansers of equivalent
disinfectant quality when used as directed, unless their use is
recommended against by the respirator manufacturer.
E. Rinse components thoroughly in clean, warm (50 deg.C
maximum), preferably running water. Drain. The importance of
thorough rinsing cannot be overemphasized. Detergents or
disinfectants that dry on facepieces may result in dermatitis. In
addition, some disinfectants may cause deterioration of rubber or
corrosion of metal parts if not completely removed.
F. Components should be hand-dried with a clean lint-free cloth
or air-dried.
G. Reassemble facepiece, replacing filters, cartridges, and
canisters where necessary.
H. Test the respirator to ensure that all components work
properly.
Appendix C: Medical Evaluation Procedures (Nonmandatory)
This appendix contains recommended elements that should be taken
into account during the performance of the required medical
evaluation for respirator use. These elements should be evaluated in
taking the medical history and performing the medical examination.
However, the specific nature of the medical evaluation and the
extent of testing performed is left for the responsible physician to
determine. This recommended list of elements to be covered is not
meant to limit the physician to the testing procedures recommended,
since the examining physician is free to perform additional tests if
necessary to determine an individual's ability to wear a respirator.
This appendix is informational and is not intended, by itself, to
create any additional obligations not otherwise imposed or to
detract from any existing obligations.
(A) The medical history should include:
(1) Previously diagnosed diseases, particularly stressing known
cardiovascular or respiratory diseases;
(2) Problems associated with breathing during normal work
activities;
(3) Past problems with respirator use;
(4) Past and current usage of medication;
(5) Any known physical conditions which may interfere with
respirator use;
(6) Previous occupations; and,
(7) Use of medications whose side effects might impact upon
cardiopulmonary fitness.
(B) The medical examination should assess:
(1) Hearing ability (should be sufficient to assure
communication and response to instructions and alarm systems);
(2) Pulmonary function testing including spirometry for
FEV1 and FVC* (presence and degree of restrictive or
obstructive disease or perfusion disorders);
---------------------------------------------------------------------------
*In interpreting spirometry, if the FVC is less than 80 percent
or the FEV1 is less than 70 percent, restriction from
respirator use should be considered.
---------------------------------------------------------------------------
(3) Cardiovascular system (evidence of symptomatic coronary
artery disease, significant arrhythmias; occurrence of frequent
premature ventricular contractions (PVC's) with elevated pulse rates
or uncontrolled hypertension symptoms;
(4) Endocrine system (conditions which may result in sudden loss
of consciousness or response capability);
(5) Neurological system (inability to perform coordinated
movements and conditions affecting response and consciousness);
(6) Psychological condition (claustrophobia; severe anxiety);
(7) Miscellaneous conditions specific to the work situation
(skin conditions where occlusive materials may result in symptoms or
aggravation of a pre-existing dermatitis); and,
(8) Exercise stress (for those employees who use a self-
contained breathing apparatus or rebreather type respirator under
strenuous work conditions or in emergencies, particularly in fire
and rescue operations).
XV. Proposed Substance Specific Standards Revisions
PART 1910--[AMENDED]
Subpart Z--[Amended]
5. The authority citation for Subpart Z of Part 1910 continues to
read as follows:
Authority: Secs. 4, 6, and 8, Occupational Safety and Health
Act, 29 U.S.C. 653, 655, 657; Secretary of Labor's Orders Nos. 12-71
(36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR
9033), as applicable, and 29 CFR Part 1911.
All of subpart Z issued under section 6(b) of the Occupational
Safety and Health Act, 29 U.S.C. 655(b), except those substances
listed in the Final Rule Limits column of Table Z-1-A, which have
identical limits listed in the Transitional Limits columns of Table
Z-1-A, Table Z-2 or Table Z-3. The latter were issued under section
6(a) (29 U.S.C. 655(a)).
Section 1910.1000, the Transitional Limits columns of Table Z-1-
A, Table Z-2 and Z-3 also issued under 5 U.S.C. 553. Section
1910.1000, Tables Z-1-A, Z-2 and Z-3 not issued under 29 CFR part
1911 except for the arsenic, benzene, cotton dust and formaldehyde
listings.
Section 1910.1001 also issued under Sec. 107 of Contract Work
Hours and Safety Standards Act, 40 U.S.C. 333.
Section 1910.1002 not issued under 29 U.S.C. 655 or 29 CFR Part
1911; also issued under 5 U.S.C. 553.
Section 1910.1003 through 1910.1018 also issued under 29 U.S.C.
653.
Section 1910.1025 also issued under 29 U.S.C. 653 and 5 U.S.C.
553.
Section 1910.1028 also issued under 29 U.S.C. 653.
Section 1910.1043 also issued under 5 U.S.C. 551 et seq.
Section 1910.1045 and 1910.1047 also issued under 29 U.S.C. 653.
Section 1910.1048 also issued under 29 U.S.C. 653.
Section 1910.1051 also issued under 29 U.S.C. 653.
Section 1910.1200, 1910.1499 and 1910.1500 also issued under 5
U.S.C. 553.
6. Section 1910.1001 is amended by revising paragraphs (g)(3)(i)
and (g)(4)(ii) and by removing and reserving Appendix C as follows:
Sec. 1910.1001 Asbestos.
* * * * *
(g) ***
(3) Respirator program.
(i) When respiratory protection is required, the employer shall
institute a respirator program in accordance with Sec. 1910.134 (b),
(c), (d), (f), (g), (h), (i), (j), (k), and (l).
* * * * *
(4) ***
(ii) For each employee wearing negative pressure respirators or
tight fitting positive pressure respirators, employers shall perform
either quantitative or qualitative face fit tests at the time of
initial fitting and at least every six months thereafter. The
qualitative fit tests may be used only for testing the fit of half mask
respirators where they are permitted to be worn, and shall be conducted
in accordance with Appendix A of Sec. 1910.134. The tests shall be used
to select facepieces that provide the required protection as prescribed
in Table I of this section.
* * * * *
7. Sections 1910.1003, 1910.1004, and 1910.1006 through 1910.1016
are amended by adding a new paragraph (d)(1) to each section to read as
follows:
Sec. 1910.1003 4-Nitrobiphenyl.
Sec. 1910.1004 alpha-Naphthylamine.
Sec. 1910.1006 Methyl chloromethyl ether.
Sec. 1910.1007 3,3'-Dichlorobenzidine (and its salts).
Sec. 1910.1008 bis-Chloromethyl ether.
Sec. 1910.1009 beta-Naphthylamine.
Sec. 1910.1010 Benzidine.
Sec. 1910.1011 4-Aminodiphenyl.
Sec. 1910.1012 Ethyleneimine.
Sec. 1910.1013 beta-Propiolactone.
Sec. 1910.1014 2-Acetylaminofluorene.
Sec. 1910.1015 4-Dimethylaminoazobenzene.
Sec. 1910.1016 N-Nitrosodimethylamine.
* * * * *
(d)(1) Respirator program. When respiratory protection is used
pursuant to this section, employers shall institute a respiratory
protection program in accordance with Sec. 1910.134 (b), (c), (d), (f),
(g), (h), (i), (j), (k), and (l).
* * * * *
8. Section 1910.1017 is amended by revising paragraphs (g)(3) and
(g)(4) to read as follows:
Sec. 1910.1017 Vinyl chloride.
* * * * *
(g) ***
(3) A respiratory protection program meeting the requirements of
Sec. 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l)
shall be estabished and maintained.
(4) The employer shall make types of respirators available for
selection and shall assure that employees use respirators in accordance
with the assigned protection factor tables in the NIOSH Respirator
Decision Logic published in May 1987. This is available from the NIOSH
Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108,
4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket
Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W.,
Washington, D.C. 20210. The table that follows shows the NIOSH RDL
values.
------------------------------------------------------------------------
Atmospheric
concentration of vinyl Required respirator
chloride
------------------------------------------------------------------------
Not in excess of 10 ppm (A) Combination type C supplied air respirator,
(10x PEL). demand type, with half facepiece, and
auxiliary self-contained air supply; or
(B) Type C supplied air respirator, demand
type, with half facepiece; or
(C) Any chemical cartridge respirator with an
organic vapor cartridge which provides a
service life of at least 1 hour for
concentrations of vinyl chloride up to 10 ppm.
Not in excess of 25 ppm (A) A powered air-purifying respirator with
(25x PEL). hood, helmet, full or half facepiece, and a
canister which provides a service life of at
least 4 hours for concentrations of vinyl
chloride up to 25 ppm, or
(B) Gas mask, front or back mounted canister
which provides a service life of at least 4
hours for concentrations of vinyl chloride up
to 25 ppm; or
(C) Type C supplied air respirator, continuous
flow type, with hood or helmet.
Not in excess of 50 ppm (A) Combination type C supplied air respirator,
(50x PEL). demand type, with full facepiece, and
auxiliary self-contained air supply; or
(B) Open-circuit self-contained breathing
apparatus with full facepiece, in demand mode;
or
(C) Type C supplied air respirator, demand
type, with full facepiece; or
(D) Type C supplied air respirator, continuous
flow type, with half or full facepiece.
Not in excess of 1000 (A) Type C supplied air respirator, pressure
ppm (1000x PEL). demand type, with half facepiece.
Not in excess of 2000 (A) Type C supplied air respirator, pressure
ppm (2000x PEL). demand type, with full facepiece.
Not in excess of 10,000 (A) Combination type C supplied air respirator,
ppm (10,000x PEL). pressure demand type, with full facepiece and
auxiliary self-contained air supply; or
(B) Open-circuit, self-contained breathing
apparatus, pressure demand type, with full
facepiece.
------------------------------------------------------------------------
* * * * *
9. Section 1910.1018 is amended by revising paragraphs (h)(2)(i),
Table I and Table II, (h)(2)(iii), (h)(3)(ii), (h)(3)(iii), and
(h)(4)(i) as follows:
Sec. 1910.1018 Inorganic arsenic.
* * * * * *
(h) * * *
(2) Respirator selection. (i) Where respirators are required under
this section the employer shall select, provide at no cost to the
employee and assure the use of the appropriate respirator or
combination of respirators in accordance with the assigned protection
factor tables in the NIOSH Respirator Decision Logic published in May
1987. This is available from the NIOSH Publication Dissemination
Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway,
Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-
20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210.
Table I of this section for inorganic arsenic compounds without
significant vapor pressure, or Table II of this section for inorganic
arsenic compounds which have significant vapor pressure show the NIOSH
RDL assigned protection factor values.
(ii) * * *
Table I.--Respiratory Protection for Inorganic Arsenic Particulate
Except for Those With Significant Vapor Pressure
------------------------------------------------------------------------
Concentration of
inorganic arsenic (as Required respirator
AS) or condition of use
------------------------------------------------------------------------
Not greater than 100 (A) Half mask air-purifying respirator,
g/m\3\ (10x equipped with high efficiency filters; or\1\
PEL). \2\
(B) Any half mask supplied air respirator.
Not greater than 250 (A) Powered air-purifying respirator, loose
g/m\3\ (25x fitting hood or helmet, equipped with high
PEL). efficiency filters; or
(B) Hood or helmet supplied air respirator,
operated in continuous flow mode.
Not greater than 500 (A) Full facepiece air-purifying respirator
g/m\3\ (50x equipped with high efficiency filters; or
PEL).
(B) Powered air-purifying respirator with tight
fitting half or full facepiece, equipped with
high efficiency filters; or
(C) Full facepiece supplied air respirator,
operated in demand mode; or
(D) Self-contained breathing apparatus,
operated in demand mode.
Not greater than 10,000 (A) Half facepiece supplied air respirator,
g/m\3\ (1000x operated in pressure demand mode.
PEL).
Not greater than 20,000 (A) Full facepiece supplied air respirator,
g/m\3\ (2000x operated in pressure demand mode.
PEL).
Not greater than (A) Combination full facepiece pressure demand
100,000 g/ supplied air respirator with auxiliary self-
m\3\ (10,000x PEL). contained air supply; or
(B) Full facepiece self-contained breathing
apparatus, operated in pressure demand mode.
------------------------------------------------------------------------
\1\High efficiency filter--99.97% efficiency against 0.3 micrometer
monodisperse diethylhexyl phthalate (DOP) particles.
\2\This category does not include disposable respirators, use of which
is not permitted under this standard.
Table II.--Respiratory Protection for Inorganic Arsenicals (Such as
Arsenic Trichloride\2\ and Arsenic Phosphide) With Significant Vapor
Pressure
------------------------------------------------------------------------
Concentration of
inorganic arsenic (as Required respirator
AS) or condition of use
------------------------------------------------------------------------
Not greater than 100 (A) Half mask23 air-purifying respirator
g/m3 (10x equipped with high efficiency filter1 and acid
PEL). gas cartridge.
(B) Any half mask23 supplied air respirator.
Not greater than 250 (A) Powered air-purifying respirator, with
g/m3 (25x loose fitting hood or helmet, equipped with
PEL). high efficiency filters and acid gas
cartridge; or
(B) Hood or helmet supplied air respirator,
operated in continuous flow mode.
Not greater than 500 (A) Full facepiece front or back mounted gas
g/m3 (50x mask equipped with high efficiency filters and
PEL). acid gas canister; or
(B) Powered air-purifying respirator with tight
fitting half or full facepiece,\2\ equipped
with high efficiency filters and acid gas
canister; or
(C) Full facepiece supplied air respirator,
operated in demand mode; or
(D) Full facepiece self contained breathing
apparatus, operated in demand mode.
Not greater than 10,000 (A) Half facepiece supplied air respirator,
g/m3 (1000x operated in pressure demand mode.
PEL).
Not greater than 20,000 (A) Full facepiece supplied air respirator,
g/m3 (2000x operated in pressure demand mode.
PEL).
Not greater than (A) Combination full facepiece pressure demand
100,000 g/m3 supplied air respirator with auxiliary self-
(10,000x PEL). contained air supply; or
(B) Full facepiece self contained breathing
apparatus, operated in pressure demand mode.
------------------------------------------------------------------------
\1\High efficiency filter--99.97% efficiency against 0.3 micrometer
monodisperse diethyl-hexyl phthalate (DOP) particles.
\2\Half mask respirators shall not be used for protection against
arsenic trichloride, as it is rapidly absorbed through the skin.
\3\This category does not include disposable respirators, use of which
is not permitted under this standard.
(iii) The employer shall select respirators from among those
approved by NIOSH.
(3) * * *
(ii) The employer shall perform qualitative fit tests at the time
of initial fitting and at least semiannually thereafter for each
employee wearing respirators, where quantitative fit tests are not
required. The protocols for qualitative fit testing set out in Appendix
A to Sec. 1910.134 shall be followed in administering qualitative fit
tests pursuant to this section.
(iii) Employers with more than 20 employees wearing respirators
shall perform a quantitative face fit test at the time of initial
fitting and at least semiannually thereafter for each employee wearing
negative pressure respirators. The test shall be used to select
facepieces that provide the required protection as prescribed in Table
I or II. The protocols for quantitative fit testing set out in Appendix
A to Sec. 1910.134 shall be followed in administering quantitative fit
tests pursuant to this section.
* * * * *
(4) Respirator program. (i) The employer shall institute a
respiratory protection program in accordance with Sec. 1910.134 (b),
(c), (d), (f), (g), (h), (i), (j), (k), and (l).
* * * * *
10. Section 1910.1025 is amended by revising paragraphs (f)(2)(i)
and Table II, (f)(2)(iii), (f)(3)(ii) and (f)(4)(i) and the fourth
paragraph of section IV of Appendix B and removing Appendix D as
follows:
Sec. 1910.1025 Lead.
* * * * *
(f) * * *
(2) Respirator selection. (i) Where respirators are required under
this section the employer shall make types of respirators available for
selection and shall assure that employees use respirators in accordance
with the assigned protection factor tables in the NIOSH Respirator
Decision Logic published in May 1987. This is available from the NIOSH
Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108,
4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket
Office, Exhibit No. 38-20, room N2439, 200 Constitution Avenue, N.W.,
Washington, D.C. 20210. Table II of this section shows the NIOSH RDL
values.
* * * * *
Table II.--Respiratory Protection for Lead Aerosols
----------------------------------------------------------------------------------------------------------------
Airborne concentration of lead or
condition of use Required respiratory\1\
----------------------------------------------------------------------------------------------------------------
Not in excess of 0.5 mg/m\3\ (10x (A) Half mask air-purifying respirator equipped with high efficiency
PEL). filters\2\\3\, or
(B) Half mask supplied air respirator operated in demand (negative
pressure) mode.
Not in excess of 1.25 mg/m\3\ (25x (A) Powered air-purifying respirator with loose fitting hood or helmet,
PEL). equipped with high efficiency filters;\3\ or
(B) Hood or helmet supplied air respirator, operated in continuous flow
mode.
Not in excess of 2.5 mg/m\3\ (50x (A) Full facepiece air-purifying respirator equipped with high efficiency
PEL). filters;\3\ or
(B) Powered air-purifying respirator with tight fitting half mask or full
facepiece equipped with high efficiency filters;\3\ or
(C) Half mask or full facepiece supplied air respirator, operated in demand
mode; or
(D) Full facepiece self-contained breathing apparatus, operated in demand
mode.
Not in excess of 50 mg/m\3\ (1000x (A) Half mask supplied air respirator, operated in pressure demand mode.\2\
PEL).
Not in excess of 100 mg/m\3\ (2000x (A) Full facepiece supplied air respirator, operated in pressure demand
PEL). mode.
Note in excess of 500 mg/m\3\ (A) Combination full facepiece pressure demand supplied air respirator with
(10,000x PEL). auxiliary self-contained air supply; or
(B) Full facepiece self-contained breathing apparatus, operated in pressure
demand mode.
----------------------------------------------------------------------------------------------------------------
\1\Respirators specified for high concentrations can be used at lower concentrations of lead.
\2\Full facepiece is required if the lead aerosols cause eye or skin irritation at the use concentrations.
\3\A high efficiency particulate filter means 99.97 percent efficiency against 0.3 micron size particles.
* * * * *
(iii) The employer shall select respirators from among those
approved for protection against lead dust, fume, and mist by NIOSH.
(3)* * *
(ii) Employers shall perform either quantitative or qualitative
face fit tests at the time of initial fitting and at least every six
months thereafter for each employee wearing negative pressure
respirators. The qualitative fit tests may be used only for testing the
fit of half mask respirators where they are permitted to be worn.
Quantitative and qualitative fit tests shall be conducted in accordance
with Appendix A of Sec. 1910.134. The tests shall be used to select
facepieces that provide the required protection as prescribed in Table
II of this section.
* * * * *
(4)* * *
(i) The employer shall institute a respiratory protection program
in accordance with 29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i),
(j), (k), and (l).
* * * * *
Appendix B to Section 1910.1025--Employee Standard Summary
* * * * *
IV. Respiratory Protection--Paragraph (F)
* * * * *
Your employer must assure that your respirator facepiece fits
properly. Proper fit of a respirator is critical. Obtaining a proper
fit on each employee may require your employer to make available two or
three different mask types. In order to assure that your respirator
fits properly and that facepiece leakage is minimized, your employer
must give you either a qualitative or quantitative fit test in
accordance with Appendix A of 29 CFR 1910.134.
* * * * *
11. Section 1910.1029 is amended by revising paragraphs (g)(2)(i)
and Table I, (g)(2)(iii) and (g)(3) to read as follows:
Sec. 1910.1029 Coke oven emissions.
* * * * *
(g)* * *
(2) Selection. (i) Where respirators are required under this
section, the employer shall make types of respirators available for
selection and shall assure that employees use respirators in accordance
with the assigned protection factor tables in the NIOSH Respirator
Decision Logic published in May 1987. This is available from the NIOSH
Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108,
4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket
Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, NW.,
Washington, DC 20210. Table I of this section shows the NIOSH RDL
values.
Table I.--Respiratory Protection for Coke Oven Emissions
----------------------------------------------------------------------------------------------------------------
Airborne concentration of coke oven
emissions Required respirator
----------------------------------------------------------------------------------------------------------------
(a) not in excess of 1500 g/m\3\ (10x PEL). respirator;
or
(2) Any particulate filter respirator or combination chemical cartridge and
particulate filter respirator for coke oven emissions; or
(3) Half mask supplied air respirator, operated in demand mode; or
(4) Any respirator listed in paragraph (g)(2)(i)(b) through (f) of this
section.
(b) not in excess of 3750 g/m\3\ (25x PEL). equipped with high efficiency filters; or
(2) Hood or helmet supplied air respirator, operated in continuous flow
mode.
(c) not in excess of 7500 g/m\3\ (50x PEL). particulate filters or combination chemical cartridge and high efficiency
particulate filter for coke oven emissions; or
(2) Powered air-purifying respirator with tight fitting half mask or full
facepiece equipped with high efficiency particulate filters or combination
chemical cartridge and high efficiency particulate filter for coke oven
emissions; or
(3) Full facepiece supplied air respirator, operated in demand mode; or
(4) Full facepiece supplied air respirator, operated in continuous flow
mode.
(5) Self-contained breathing apparatus with full facepiece, operated in
demand mode.
(d) not in excess of 150 mg/m\3\ (1) Half mask supplied air respirator, operated in pressure demand mode.
(1000x PEL).
(e) not in excess of 300 mg/m\3\ (1) Full facepiece supplied air respirator, operated in pressure demand
(2000x PEL). mode.
(f) not in excess of 1500 mg/m\3\ (1) Combination full facepiece pressure demand supplied air respirator with
(10,000x PEL). auxiliary self-contained air supply; or
(2) Full facepiece self-contained breathing apparatus, operated in pressure
demand mode.
----------------------------------------------------------------------------------------------------------------
* * * * *
(ii) * * *
(iii) The employer shall select respirators from among those
approved for protection against coke oven emissions by NIOSH.
(3) Respirator program. The employer shall institute a respiratory
protection program in accordance with Sec. 1910.134 (b), (c), (d), (f),
(g), (h), (i), (j), (k), and (l).
* * * * *
12. Section 1910.1043 is amended by revising paragraphs (f)(2)(i),
deleting Table I, revising (f)(2)(ii), (f)(2)(iii) and (f)(3), and
adding a new Appendix F to read as follows:
* * * * *
Sec. 1910.1043 Cotton dust.
* * * * *
(f) * * *
(2) Respirator selection. (i) Where respirators are required under
this section, the employer shall make types of respirators available
for selection and shall assure that employees use respirators in
accordance with the assigned protection factor tables in the NIOSH
Respirator Decision Logic published in May 1987. This is available from
the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication
No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the
OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution
Avenue, N.W., Washington, D.C. 20210. Table 1 of Appendix F of this
section shows the NIOSH RDL values.
(ii) The employer shall select respirators from those tested and
certified for protection against dust by NIOSH.
(iii) Whenever negative pressure air-purifying respirators are
required by this section, the employer shall, upon the request of the
employee, provide the appropriate powered air-purifying respirator with
a high efficiency particulate filter selected pursuant to Table 1 of
this section in lieu of the negative pressure air-purifying respirator
specified in Table 1 of this section.
* * * * *
(3) Respirator program. The employer shall institute a respiratory
protection program in accordance with Sec. 1910.134 (b), (c), (d), (f),
(g), (h), (i), (j), (k), and (l).
* * * * *
Appendix F--Respirator Selection
Table I.--Respiratory Protection for Cotton Dust
----------------------------------------------------------------------------------------------------------------
Airborne concentration of cotton
dust Required respirator
----------------------------------------------------------------------------------------------------------------
Not greater than:
(a) 5 times the PEL............ Single use or quarter mask respirator.
(b) 10 times the PEL........... Half mask or full facepiece air-purifying respirator equipped with any type
of particulate filter.
Half mask supplied-air respirator operated in a demand (negative pressure)
mode.
(c) 25 times the PEL........... Hood or helmet powered air-purifying respirator equipped with any type
particulate filter.
Supplied-air respirator equipped with a hood or helmet and operated in a
continuous flow mode.
(d) 50 times the PEL........... Full facepiece air-purifying respirator equipped with a high efficiency
filter.
Powered air-purifying respirator equipped with a tight-fitting facepiece
and a high efficiency filter.
Full facepiece supplied-air respirator operated in a demand mode.
Supplied-air respirator with tight-fitting facepiece operated in a
continuous flow mode.
Full facepiece self-contained respirator operated in a demand mode.
(e) 1,000 times the PEL........ Half mask supplied-air respirator operated in a pressure demand or other
positive pressure mode.
(f) 2,000 times the PEL........ Full facepiece supplied-air respirator operated in a pressure demand or
other positive pressure mode.
(g) 10,000 times the PEL....... Full facepiece self-contained respirator operated in a pressure demand or
other positive pressure mode.
Full facepiece supplied-air respirator operated in a pressure demand or
other positive pressure mode in combination with an auxiliary self-
contained breathing apparatus operated in a pressure demand or other
positive pressure mode.
----------------------------------------------------------------------------------------------------------------
13. Section 1910.1044 is amended by revising paragraphs (h)(2)(i),
(h)(2)(ii) and Table 1, and (h)(3)(i) to read as follows:
Sec. 1910.1044 1,2-dibromo-3-chloropropane.
* * * * *
(h) * * *
(2) Respirator selection (i) Where respirators are required under
this section, the employer shall select, provide at no cost to the
employee, and assure that the employee uses the appropriate respirator
in accordance with the assigned protection factor tables in the NIOSH
Respirator Decision Logic published in May 1987. This is available from
the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication
No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the
OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution
Avenue, N.W., Washington, D.C. 20210. Table 1 shows the NIOSH RDL
values.
(ii) The employer shall select respirators from among those
approved by NIOSH.
Table 1.--Respiratory Protection for DBCP
----------------------------------------------------------------------------------------------------------------
Airborne concentration of DBCP or
condition of use Respirator type
----------------------------------------------------------------------------------------------------------------
(a) Less than or equal to 10 ppb (1) Half mask supplied-air respirator operated in demand mode; or
(10x PEL). (2) Half mask self-contained breathing apparatus operated in demand mode.
(b) Less than or equal to 25 ppb (1) Hood or helmet supplied-air respirator operated in continuous flow
(25x PEL). mode.
(c) Less than or equal to 50 ppb (1) Full facepiece supplied-air respirator operated in demand mode; or
(50x PEL).
(2) Full facepiece self-contained breathing apparatus operated in demand
mode; or
(3) Half mask or full facepiece supplied air-respirator operated in
continuous flow mode.
(d) Less than or equal to 1000 ppb (1) Half mask supplied air-respirator operated in pressure demand or other
(1000x PEL). positive pressure mode.
(e) Less than or equal to 2000 ppb (1) Full facepiece supplied air-respirator operated in pressure demand or
(2000x PEL). other positive pressure mode.
(f) Less than or equal to 10,000 (1) Combination full facepiece pressure demand supplied air-respirator with
ppb (10,000x PEL). auxiliary self-contained air supply.
(2) Full facepiece self-contained breathing apparatus operated in pressure
demand or other positive pressure mode.
(g) Firefighting................... (1) Full facepiece self-contained breathing apparatus operated in pressure
demand or other positive pressure mode.
----------------------------------------------------------------------------------------------------------------
* * * * *
(3) Respirator program. (i) The employer shall institute a
respiratory protection program in accordance with Sec. 1910.134 (b),
(c), (d), (f), (g), (h), (i), (j), (k), and (l).
* * * * *
14. Section 1910.1045 is amended by revising paragraphs (h)(2)(i)
and Table 1, (h)(2)(ii), (h)(3)(i) and (h)(3)(iii) to read as follows:
Sec. 1910.1045 Acrylonitrile.
* * * * *
(h) * * *
(2) Respirator selection. (i) Where respiratory protection is
required under this section, the employer shall select, provide at no
cost to the employee, and assure that the employee uses the appropriate
respirator in accordance with the assigned protection factor tables in
the NIOSH Respirator Decision Logic published in May 1987. This is
available from the NIOSH Publication Dissemination Office, DHHS (NIOSH)
Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226
or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200
Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 shows the
NIOSH RDL values.
Table I.--Respiratory Protection for Acrylonitrile (AN)
----------------------------------------------------------------------------------------------------------------
Concentration of AN or condition of
use Respirator type
----------------------------------------------------------------------------------------------------------------
(a) Less than or equal to 20 ppm (1) Chemical cartridge respirator with organic vapor cartridge(s) and half
(10x PEL). mask facepiece; or
(2) Supplied air respirator with half mask facepiece.
(b) Less than or equal to 50 ppm (1) Hood or helmet powered air purifying respirator with organic vapor
(25x PEL). cartridge(s); or
(2) Hood or helmet supplied air respirator operated in continuous flow
mode.
(c) Less than or equal to 100 ppm (1) Full facepiece respirator with (A) organic vapor cartridges, (B)
or maximum use concentration (MUC) organic vapor gas mask chin style, or (C) organic vapor gas mask canister,
of cartridges or canisters, front or back mounted; or
whichever is lower (50x PEL). (2) Half mask or full facepiece powered air purifying respirator with
organic vapor cartridge/canisters; or
(3) Supplied air respirator with full facepiece operated in demand mode; or
(4) Self-contained breathing apparatus with full facepiece operated in
demand mode; or
(5) Half mask or full facepiece supplied air respirator operated in
continuous flow mode.
(d) Less than or equal to 2000 ppm (1) Half mask supplied air respirator operated in pressure demand or other
(1000x PEL). positive pressure mode.
(e) Less than or equal to 4000 ppm (1) Full facepiece supplied air respirator operated in pressure demand or
(2000x PEL). other positive pressure mode.
(f) Less than or equal to 20,000 (1) Combination full facepiece supplied air respirator with auxiliary self-
ppm (10,000x PEL). contained breathing apparatus operated in pressure demand or other
positive pressure mode; or
(2) Self-contained breathing apparatus with full facepiece operated in
pressure demand or other positive pressure mode.
(g) Firefighting................... (1) Self-contained breathing apparatus with full facepiece operated in
pressure demand or other positive pressure mode.
(h) Escape......................... (1) Any organic vapor respirator; or
(2) Any self-contained breathing apparatus.
----------------------------------------------------------------------------------------------------------------
(ii) The employer shall select respirators from among those
approved for use with organic vapors by NIOSH.
(3) Respirator program. (i) The employer shall institute a
respiratory protection program in accordance with Sec. 1910.134 (b),
(c), (d), (f), (g), (h), (i), (j), (k), and (l).
* * * * *
(iii) Testing. Fit testing of respirators shall be performed to
assure that the respirator selected provides the protection required by
Table 1. Fit testing shall be performed pursuant to the protocols set
out in Appendix A to Sec. 1910.134.
(A) Qualitative fit. The employer shall perform qualitative fit
tests at the time of initial fitting and at least semiannually
thereafter for each employee wearing respirators.
(B) Quantitative fit. Each employer with more than 10 employees
wearing negative pressure respirators shall perform quantitative fit
testing at the time of initial fitting and at least semiannually
thereafter for each such employee.
* * * * *
15. Section 1910.1047 is amended by revising paragraphs (g)(2)((i),
(g)(2)(ii) and (g)(3) and redesignating Table 1 of paragraph (h)(2)
introductory text as Table 1 of paragraph (g)(2)(i) and revising Table
1 to read as follows:
Sec. 1910.1047 Ethylene oxide.
* * * * *
(g) * * *
(2) Respirator selection. (i) Where respiratory protection is
required under this section, the employer shall select, provide at no
cost to the employee, and assure that the employee uses the appropriate
respirator in accordance with the assigned protection factor tables in
the NIOSH Respirator Decision Logic published in May 1987. This is
available from the NIOSH Publication Dissemination Office, DHHS (NIOSH)
Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226
or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200
Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 shows the
NIOSH RDL values.
Table I.--Minimum Requirements for Respiratory Protection for Airborne EtO
----------------------------------------------------------------------------------------------------------------
Condition of use or concentration
of airborne EtO (ppm) Minimum required respirator
----------------------------------------------------------------------------------------------------------------
Equal to or less than 25 ppm (25x (a) Hood or helmet supplied air respirator operated in continuous flow
PEL). mode.
(b) Hood or helmet powered air purifying respirator with EtO approved
cartridge/canisters.
Equal to or less than 50 ppm (50x (a) Full facepiece air purifying respirator with EtO approved canister,
PEL). front or back mounted; or
(b) Full facepiece powered air purifying respirator with EtO approved
cartridge/canisters; or
(c) Full facepiece supplied air respirator operated in demand mode; or
(d) Full facepiece self contained breathing apparatus operated in demand
mode; or
Equal to or less than 2000 ppm (a) Full facepiece supplied air respirator operated in pressure demand
(2000x PEL). mode.
Equal to or less than 10,000 ppm (a) Combination full facepiece pressure demand supplied air respirator with
(10,000x PEL). auxiliary self-contained air supply; or
(b) Full facepiece self-contained breathing apparatus operated in pressure
demand mode.
Firefighting....................... (a) Pressure demand self-contained breathing apparatus equipped with full
facepiece.
Escape............................. (a) Any respirator described above.
----------------------------------------------------------------------------------------------------------------
Note--Respirators approved for use in higher concentrations are permitted to be used in lower concentrations.
(ii) The employer shall select respirators from among those
approved for protection against EtO by NIOSH.
(3) Respirator program. Where respiratory protection is required by
this section, the employer shall institute a respirator program in
accordance with 29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i), (j),
(k), and (l).
* * * * *
16. The authority citation for Subpart D of Part 1926 continues to
read as follows:
Authority: Secs. 4, 5, 6, 8, Occupational Safety and Health Act
of 1970, 29 U.S.C. 653, 655, 657; Sec. 107, Contract Work Hours and
Safety Standards Act (Construction Safety Act), 40 U.S.C. 333; and
Secretary of Labor's Orders 12-17 (36 FR 8754, 8-76 (41 FR 25059),
or 9-83 (48 FR 35736), as applicable. Sections 1926.55(c) and
1926.1101 also issued under 29 CFR Part 1911.
17. Section 1926.1101 is amended by revising paragraphs (h)(3)(i)
and (h)(4)(ii) and removing and reserving Appendix C as follows:
Sec. 1926.1101 Asbestos.
* * * * *
(h) * * *
(3) * * * (i) Where respiratory protection is used the employer
shall institute a respirator program in accordance with Sec. 1910.134
(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).
* * * * *
(4) * * * (i) * * *
(ii) For each employee wearing negative pressure respirators or
tight fitting positive pressure respirators, employers shall perform
either quantitative or qualitative face fit tests at the time of
initial fitting and at least every six months thereafter. The
qualitative fit tests may be used only for testing the fit of half mask
respirators where they are permitted to be worn, and shall be conducted
in accordance with Appendix A of Sec. 1910.134. The tests shall be used
to select facepieces that provide the required protection as prescribed
in Table I of this section.
* * * * *
18. Section 1926.103 is revised to read as follows:
Sec. 1926.103 Respiratory protection.
Respiratory protection for construction employment is covered by 29
CFR 1910.134.
19. The authority citation for Part 1915 continues to read as
follows:
Authority: Sec. 41, Longshoremen's and Harbor Worker's
Compensation Act (33 U.S.C. 941), secs. 4, 6, and 8, Occupational
Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary
of Labor's Order No. 12-72 (36 FR 8754), 8-76 (41 FR 25059), or 9-83
(48 FR 35736) as applicable; and 29 CFR Part 1911.
20. 29 CFR Part 1915 is amended by revising Subpart I to read as
follows:
Subpart I--Personal Protective Equipment
Sec. 1915.152 Respiratory protection.
Respiratory protection for shipyard employment is covered by 29 CFR
1910.134.
21. The authority citation for Subpart G of Part 1910 continues to
read as follows:
Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71
(36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as
applicable.
Sections 1910.94 and 1910.99 also issued under 29 CFR Part 1911.
22. Section 1910.94 is amended by revising paragraphs (a)(5)(i),
(a)(5)(iv), (a)(6), (c)(6)(iii)(a), and (d)(9)(vi) to read as follows:
Sec. 1910.94 Ventilation.
* * * * *
(a) * * *
(5) Personal protective equipment. (i) Only respiratory protective
equipment approved by the National Institute for Occupational Safety
and Health (NIOSH) shall be used for protection of personnel against
dusts produced during abrasive-blasting operations.
* * * * *
(iv) A respiratory protection program as defined and described in
Sec. 1910.134 shall be established wherever it is necessary to use
respiratory protective equipment.
* * * * *
(6) Air supply and air compressors. The air for abrasive-blasting
respirators shall be free of harmful quantities of dusts, mists, or
noxious gases, and shall meet the requirements for supplied air quality
and use contained in Sec. 1910.134(i).
* * * * *
(c) * * *
(6) * * *
(iii)
(a) When an operator must position himself in a booth downstream of
the object being sprayed, an air supplied respirator or other type of
respirator approved by the National Institute for Occupational Safety
and Health (NIOSH) for the material being sprayed shall be used by the
operator.
* * * * *
(d) * * *
(9) * * *
(vi) When, during emergencies as described in paragraph (d)(11)(v)
of this section, workers must be in areas where concentrations of air
contaminants are greater than the limit set by paragraph (d)(2)(iii) of
this section or oxygen concentrations are less than 19.5 percent, they
shall be required to wear respirators adequate to reduce their exposure
to a level below these limits, or to provide adequate oxygen. Such
respirators shall also be provided in marked, quickly accessible
storage compartments built for the purpose, when there exists the
possibility of accidental release of hazardous concentrations of air
contaminants. Respirators shall be approved by the National Institute
for Occupational Safety and Health (NIOSH) and shall be selected by a
competent industrial hygienist or other technically qualified source.
Respirators shall be used in accordance with Sec. 1910.134, and persons
who may require them shall be trained in their use.
* * * * *
23. The authority citation for Subpart H of Part 1910 continues to
read as follows:
Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71
(36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as
applicable.
Sections 1910.106, 1910.107, 1910.108 and 1910.109 also issued
under 29 CFR Part 1911.
24. Section 1910.111 is amended by revising paragraphs (a)(2)(x)
and (b)(10)(ii) to read as follows:
Sec. 1910.111 Storage and handling of anhydrous ammonia
(a) * * *
(2) * * *
(x) Gas mask--Gas masks approved by the National Institute for
Occupational Safety and Health (NIOSH) for anhydrous ammonia.
* * * * *
(b) * * *
(10) * * *
(ii) All stationary storage installations shall have at least two
suitable gas masks in readily accessible locations. Full face masks
with ammonia canisters as approved by the National Institute for
Occupational Safety and Health (NIOSH) are suitable for emergency
action for most leaks, particularly those that occur outdoors. For
protection in concentrated ammonia atmospheres self-contained breathing
air apparatus is required.
* * * * *
25. The authority citation for Subpart Q of Part 1910 continues to
read as follows:
Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71
(36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as
applicable.
Section 1910.252 also issued under 29 CFR Part 1911.
26. Section 1910.252 is amended by revising paragraphs (c)(4)(ii),
(c)(4)(iii), (c)(7)(iii), (c)(9)(i), and (c)(10) to read as follows:
Sec. 1910.252 General requirements.
* * * * *
(c) * * *
(4) * * *
(ii) Airline respirators. In such circumstances where it is
impossible to provide such ventilation, airline respirators or hose
masks approved by the National Institute for Occupational Safety and
Health (NIOSH) for this purpose shall be used.
(iii) Self-contained units. In areas immediately hazardous to life,
a full facepiece pressure demand self-contained breathing apparatus or
combination full facepiece pressure demand supplied air respirator with
auxiliary self-contained air supply approved by NIOSH shall be used.
* * * * *
(7) * * *
(iii) Local ventilation. In confined spaces or indoors, welding or
cutting involving metals containing lead, other than as an impurity, or
involving metals coated with lead-bearing materials, including paint
shall be done using local exhaust ventilation or airline respirators.
Outdoors such operations shall be done using respiratory protective
equipment approved by the National Institute for Occupational Safety
and Health (NIOSH) for such purposes. In all cases, workers in the
immediate vicinity of the cutting operation shall be protected by local
exhaust ventilation or airline respirators.
* * * * *
(9)* * *
(i) General. Welding or cutting indoors or in confined spaces
involving cadmium-bearing or cadmium-coated base metals shall be done
using local exhaust ventilation or airline respirators unless
atmospheric tests under the most adverse conditions have established
that the workers' exposure is within the acceptable concentrations
defined by Sec. 1910.1000. Outdoors such operations shall be done using
respiratory protective equipment such as fume respirators approved by
the National Institute for Occupational Safety and Health (NIOSH) for
such purposes.
* * * * *
(10) Mercury. Welding or cutting indoors or in a confined space
involving metals coated with mercury-bearing materials including paint,
shall be done using local exhaust ventilation or airline respirators
unless atmospheric tests under the most adverse conditions have
established that the workers' exposure is within the acceptable
concentrations defined by Sec. 1910.1000. Outdoors such operations
shall be done using respiratory protective equipment approved by the
National Institute for Occupational Safety and Health (NIOSH) for such
purposes.
* * * * *
27. The authority citation for Subpart R of Part 1910 continues to
read as follows:
Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of
1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71
(36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as
applicable.
Sections 1910.261, 1910.262, 1910.265, 1910.267, 1910.268,
1910.269, 1910.274 and 1910.275 also issued under 29 CFR Part 1911.
28. Section 1910.261 is amended by revising paragraphs (b)(2),
(g)(10), (h)(2)(iii) and (h)(2)(iv) to read as follows:
Sec. 1910.261 Pulp, paper, and paperboard mills.
* * * * *
(b) * * *
(2) Personal protective clothing and equipment. Foot protection,
shin-guards, hard hats, noise attenuation devices, or other personal
protective clothing and equipment shall be worn when the extent of the
hazard is such as to warrant their use. Such equipment shall be worn
whenever specifically required by other paragraphs of this section. All
equipment shall be maintained in accordance with applicable American
National Standards. Respirators, goggles, and protective masks, rubber
gloves, rubber boots, and other such equipment shall be cleaned and
disinfected before being used by another employee. Eye, head, and ear
protection, where specified, shall conform to American National
Standards Z24.22-1957, Z87.1-1968, and Z89.1-1969. Respiratory
protection shall conform to the requirements of Sec. 1910.134.
* * * * *
(g) * * *
(10) Gas masks (digester building). Gas masks shall be available.
These masks shall furnish adequate protection against sulfurous acid
and chlorine gases, and shall be inspected and tested at frequent
intervals, not to exceed 1 month, in accordance with American National
Standard Z87.1-1968, and Sec. 1910.134.
* * * * *
(h) * * *
(2) * * *
(iii) Gas masks shall be provided for emergency use, in accordance
with Sec. 1910.134.
(iv) For emergency and rescue work, a self-contained breathing
apparatus or supplied air respirator in accordance with the
requirements of Sec. 1910.134 shall be provided.
* * * * *
[FR Doc. 94-27197 Filed 11-14-94; 8:45 am]
BILLING CODE 4510-26-M
