# Respiratory Protection; Proposed Rule

> Briefs, arguments, decisions, and more.

URL: https://www.frixlaw.com/law-library/documents/fr%3A94-27197

## Record

- **Collection:** Federal Register
- **Document type:** Uncategorized Document
- **Published:** November 15, 1994

## Text

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.

-----------------------------------------------------------------------

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

[Text truncated at 120,000 characters. The full text is on the page linked above.]

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-27197. Public record. Not legal advice.