Respiratory Protection; Proposed Rule

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. H049]

RIN 1218-0099

Respiratory Protection

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice of proposed rulemaking (NPRM) and public hearings.

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SUMMARY: OSHA is proposing to modify its existing standards on

respiratory protection (29 CFR 1910.134, 29 CFR 1915.152 and 29 CFR

1926.103). The current respirator standard was adopted from a voluntary

consensus standard in 1971. Since that time, changes in methodology,

technology, and approach related to respiratory protection have

occurred, which OSHA's standard does not include. The purpose of this

rulemaking is to update the current standard to reflect these changes

so that employers will provide effective protection for employees who

wear respirators.

The proposed standard includes requirements for a written

respiratory protection program; procedures for selecting respirators;

requirements for medical evaluation; procedures for fit testing;

requirements for using respirators; procedures for maintaining

respirators; training; criteria for evaluating program effectiveness.

Public hearings are being scheduled to provide interested parties the

opportunity to orally present information and data related to the

issues raised by this proposed rule.

DATES: Written comments on the proposed standard must be postmarked on

or before February 13, 1995. Notices of intention to appear at the

informal public hearings on the proposed standard must be postmarked by

January 27, 1995. Parties who request more than 10 minutes for their

presentations at the informal public hearing and parties who will

submit documentary evidence at the hearing must submit the full test of

their testimony and all documentary evidence postmarked no later than

February 13, 1995. The hearing will take place in Washington, D.C. and

is scheduled to being on March 7, 1995 and continue until Friday, March

24, 1995.

ADDRESSES: Written comments should be submitted in quadruplicate or 1

original (hardcopy) and 1 disk (5\1/4\ or 3\1/2\) in WordPerfect 5.0,

5.1, 6.0 or ASCII to: The Docket Office, Docket H-049, U.S. Department

of Labor, Occupational Safety and Health Administration, Room N2625,

200 Constitution Avenue, N.W. Washington, D.C. 20210; (202) 219-7894.

(Any information not contained on disk, e.g., studies, articles, etc.,

must be submitted in quadruplicate.)

Notices of intention to appear at the informal rulemaking hearing,

testimony, and documentary evidence are to be submitted in

quadruplicate to: Mr. Tom Hall, OSHA Division of Consumer Affairs,

Occupational Safety and Health Administration, 200 Constitution Avenue,

N.W., Room N3649, Washington, D.C. 20210; (202) 219-8615. Written

comments received, notices of intention to appear, and all other

material related to the development of this proposed standard will be

available for inspection and copying in the public record in the Docket

Office, Room N2439, at the above address.

The hearing will be held in the auditorium of the U.S. Department

of Labor, 200 Constitution Avenue, NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Proposal: Ms. Anne Cyr, Office of

Information and Consumer Affairs, Occupational Safety and Health

Administration, 200 Constitution Avenue, N.W., Room N3647, Washington,

D.C. 20210; (202) 219-8151.

Hearings: Mr. Tom Hall, Division of Consumer Affairs, Occupational

Safety and Health Administration, 200 Constitution Avenue, N.W., Room

N3649, Washington, D.C. 20210; (202) 219-8615.

SUPPLEMENTARY INFORMATION:

I. Clearance of Information Collection Requirements

5 CFR Part 1320 sets forth procedures for agencies to follow in

obtaining OMB clearance for information collection requirements under

the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. The

proposed revised respirator standard requires employers to allow OSHA

access to records. In accordance with the provisions of the Paperwork

Reduction Act and the regulations issued pursuant thereto, OSHA

certifies that it has submitted the information collection requirements

for this proposed rule on respiratory protection to OMB for review

under Section 3504(h) of that Act. OMB has approved (OMB number 1218-

0099) in concept the submitted information collection activities

contained in the proposed revision pending public consideration and

comment.

Public reporting burden for this collection of information is

estimated to be five minutes per response. Send comments regarding this

burden estimate or any other aspect of this collection of information,

to the Office of Information Management, Department of Labor, Room N-

1301, 200 Constitution Avenue, NW., Washington, DC 20210; and to the

Office of Information and Regulatory Affairs, Office of Management and

Budget, Paperwork Reduction Project (1218-AA05), Washington, DC 20503.

II. Introduction

A. Format of the Preamble

The preamble accompanying this notice of proposed rulemaking is

divided into fifteen parts, numbered I through XV. The following is a

table of contents:

I. Clearance of Information Collection Requirements

II. Introduction

A. Format of the Preamble

B. History of the Development of Respiratory Protection

C. Respirator Use

D. Types of Respiratory Hazards

E. Limitations of Respiratory Use

III. Legal Authority

IV. Background

A. Regulatory History

B. Need for the Standard

C. Recognition of the Need for a Standard by Other Groups

V. Certification/Approval Procedures

VI. Summary of the Preliminary Regulatory Impact Analysis and

Regulatory Flexibility Analysis and Environmental Impact Assessment

VII. Summary and Explanation of the Proposed Standard

A. Scope and Application

B. Definitions

C. Respiratory Protection Program

D. Selection of Respirators

E. Medical Evaluation

F. Fit Testing Procedures

G. Use of Respirators

H. Maintenance and Care of Respirators

I. Supplied Air Quality and Use

J. Identification of Filters, Cartridges, and Canisters

K. Training

L. Respiratory Protection Program Evaluation

M. Recordkeeping and Access to Records

N. Substance Specific Standards

O. Maritime Standards

P. Construction Advisory Committee

VIII. References

IX. Public Participation--Notice of Hearings

X. Federalism

XI. State Plan Standards

XII. List of Subjects

XIII. Authority and Signature

XIV. Proposed Standard and Appendices

XV. Proposed Substance Specific Standards Revisions

B. History of the Development of Respiratory Protection

The concept of using respiratory protective devices to reduce or

eliminate hazardous exposures to airborne contaminants first came from

Pliny (c. A.D. 23-79) who discussed the use of loose fitting animal

bladders in Roman mines to protect workers from the inhalation of red

oxide of lead (1,2). Later, in the 1700's, the ancestors of modern

atmosphere-supplying devices, such as the self-contained breathing

apparatus or hose mask, were developed. Although the devices themselves

have become more sophisticated in design and materials, respirators'

performance is still based on one of two basic principles; purifying

the air by removing contaminants before they reach the breathing zone

of the worker, or providing clean air from an uncontaminated source.

In 1814, a particulate-removing filter encased in a rigid container

was developed--the predecessor of modern filters for air-purifying

respirators. In 1854, it was recognized that activated charcoal could

be used as a filtering medium for vapors. World War I and the use of

chemical warfare also resulted in improvement in the design of

respirators. Overall, there have been few major developments in the

basic design of respirators over the years except for the resin-

impregnated dust filter in 1930. This development has made available

efficient, inexpensive filters that have good dust-loading

characteristics and low breathing resistance. Another more recent

development is the ultrahigh efficiency filter made from paper that

contains very fine glass fibers. These extremely efficient filters are

used for very small airborne particles and produce little breathing

resistance.

C. Respirator Use

The purpose of a respirator is to prevent the inhalation of harmful

airborne substances. Functionally, a respirator is designed as an

enclosure which covers the nose and mouth or the entire face or head.

Respirators are of two general ``fit'' types: Tight fitting (i.e.,

quarter masks, which cover the mouth and nose, and where the lower

sealing surface rests between the chin and the mouth; the half mask,

which fits over the nose and under the chin; and the full facepiece,

which covers from the hairline to below the chin), and loose fitting

(i.e., hoods, helmets, blouses, or full suits which cover the head

completely). There are two major classes of respirators: Air-purifying

respirators (devices which remove contaminants from the air), and

atmosphere-supplying respirators (those which provide clean breathing

air from an uncontaminated source).

Air-purifying respirators are grouped into three general types:

Particulate removing, vapor and gas removing, and combination. Elements

which remove particulates are called filters, while vapor and gas

removing elements are called either chemical cartridges or canisters.

Filters and canisters/cartridges are the functional portion of air-

purifying respirators, and they can generally be removed and replaced

once their effective life has expired. The exception would be

disposable respirators, those which cannot be cleaned and disinfected

or resupplied with an unused filter after use. Combination elements

that protect for both particulates and vapors and gases are also

available.

Particulate-removing respirators are designed to reduce inhaled

concentrations of nuisance dusts, fumes, mists, toxic dusts, radon

daughters, asbestos containing dusts or fibers, or any combination of

these substances, by filtering some of the contaminants from the

inhaled air before they enter the breathing zone of the worker. They

may have single use or replaceable filters. These respirators may be

non-powered or powered air-purifying (using a blower to pull

contaminated air through a filter; the resulting cleaned air is blown

on the face).

Vapor and gas removing respirators are designed with sorbent

elements (canisters or cartridges) that adsorb and/or absorb the vapors

or gases from the contaminated air before they enter the breathing zone

of the worker. Combination cartridges and canisters are available to

protect against both particulates and vapors and gases.

Atmosphere-supplying respirators are respirators which provide air

from a source independent of the surrounding atmosphere instead of

removing contaminants from the atmosphere. These respirators are

classified by the method by which air is supplied and the way in which

the air supply is regulated. Basically, these methods are: Self-

contained breathing apparatus (air or oxygen is carried in a tank on

the worker's back, similar to SCUBA gear); supplied air respirators

(compressed air from a stationary source is supplied through a high

pressure hose connected to the respirator); and combination self-

contained and supplied air respirators.

D. Types of Respiratory Hazards

Respiratory hazards may result from either an oxygen deficient

atmosphere or from breathing air contaminated with toxic particles,

vapors, gases, fumes or mists. The proper selection and use of a

respirator depends upon an initial determination of the concentration

of the hazard or hazards present in the workplace.

Contaminants are classified as particulate contaminants, which

include mechanical dispersoids, condensation dispersoids, dusts,

sprays, fumes, mists, fogs, smokes, and smogs; and vapors or gases

which include acids, alkalines, organics, organometallics, hydrides,

and inert materials.

The particulates may be dusts such as clays, limestone, gypsum, or

aluminum oxides; inert pulmonary reaction producing substances such as

silicates; minimal pulmonary fibrosis producing substances such as iron

oxide or tin oxide; extensive pulmonary fibrosis producing substances

such as free silica or asbestos; chemical irritants such as acids or

alkalies; systemic poisons such as pesticides, hydrogen cyanide or

lead; allergy producing substances such as cotton, isocyanates,

epichlorohydrin, fur fibers, or vegetable fibers; and febrile-reaction

producing agents such as bagasse, or copper and zinc oxide; and

biological materials.

The gaseous air contaminants include irritants such as nitrogen

dioxide, phosgene, and arsenic trichloride; asphyxiants such as carbon

monoxide, and hydrogen cyanide; anesthetics such as nitrous oxide,

hydrocarbons, and ethyl and isopropyl ether; and systemic poisons such

as carbon tetrachloride.

E. Limitations of Respirator Use

Not all workers can wear respirators. Individuals with impaired

lung function, due to asthma or emphysema for example, may be

physically unable to wear a respirator. Individuals who cannot get a

good facepiece fit, including those individuals whose beards or

sideburns interfere with the facepiece seal, will be unable to wear

tight fitting respirators. Determination of adequate fit is required

for a respirator to be effective.

In addition to the problems with usage already discussed,

respirators may also present communication problems, vision problems,

fatigue and reduced work efficiency. Nonetheless, it is sometimes

necessary to use respiratory protection as the means of control.

In principle, respirators frequently may be capable of providing

adequate protection. However, problems associated with selection, fit,

and use often render them ineffective in actual application, preventing

the assurance of consistent and reliable protection; regardless of the

theoretical capabilities of the respirator. Occupational safety and

health experts have spent considerable effort over the years developing

fit testing procedures and methods of measuring respirator protection

so that these adverse variables can be better controlled, thereby

improving protection for those employees required to wear them.

The comments which resulted from the Advance Notice of Proposed

Rulemaking (ANPR) that was published by OSHA on May 14, 1982 (47 FR

20803) suggest that one method for controlling some of the problems

associated with respirator selection, fit, and use is to describe

clearly the steps to be followed in administering a program to protect

employees required to wear respirators. The modifications in this

proposal are also intended to upgrade the provisions in Sec. 1910.134

to reflect the current state of the art in respiratory methodology and

technology.

III. Legal Authority

Authority for issuance of this proposed revised standard is found

primarily in sections 6(b), 8(c), and 8(g)(2) of the Occupational

Safety and Health Act of 1970 (the Act), 29 U.S.C. 655(b), and

657(g)(2).

Section 6(b) authorizes the Secretary to ``by rule promulgate,

modify, or revoke any occupational safety and health standard.'' This

notice is the first mandatory step in the procedure prescribed for

promulgating such new or modified standards.

The Congress specifically mandated that:

The Secretary, in promulgating standards dealing with toxic

materials, or harmful physical agents under this subsection, shall

set the standard which most adequately assure, to the extent

feasible, on the basis of the best available evidence, that no

employee will suffer material impairment of health or functional

capacity even if such employee has regular exposure to the hazard

dealt with by such standard for the period of his working life.

Development of standards under this subsection shall be based upon

research, demonstrations, experiments, and such other information as

may be appropriate. In addition to the attainment, of highest degree

of health and safety protection for the employee, other

considerations shall be the latest available scientific data in the

field, the feasibility of standards, and experience gained under

this section and other health and safety laws. (Section 6(b)(5).

The revisions which OSHA proposes would update current standards

concerning respiratory protection mainly by incorporating technological

advances and by expanding certain respirator program elements such as

fit testing and by clarifying other provisions.

These revisions are intended to ensure that employees who use

respirators to protect them from workplace atmospheric contamination,

will be protected to the technical limitations of the devices they

wear. Protection from exposure to workplace airborne contaminants is

one of the major goals of the Act and a major mission for the Agency,

since the risk to employees of chronic and acute disease because of

exposure to toxic substances is substantial and well documented (see

e.g., preamble to 29 CFR Part 1910, Air Contaminants, Proposed Rule, at

53 FR 20960 et seq.)

Similarly, these regulations need to be updated to assure that

employees are protected to the extent that currently available

technology permits. Therefore OSHA finds that revisions to these

regulations governing respiratory protection are clearly necessary and

appropriate to protect employees against the risk of material

impairment of health or functional capacity and are issued pursuant to

the authority of section 6(b)(5) of the Act).

Authority to issue this standard is also found in section 8(c) of

the Act. In general, this section empowers the Secretary to require

employers to make, keep, and preserve records regarding activities

related to the Act. In particular, section 8(c) gives the Secretary

authority to require employers to ``maintain accurate records of

employee exposures to potentially toxic materials or harmful physical

agents which are required to be monitored or measured under section

6.'' Provisions of OSHA standards which require the preparation and

monitoring of exposure records, such as contained in a written

respirator program, are also issued pursuant to section 8(c) of the

Act.

The Secretary's authority to issue this proposed standard is

further supported by the general rulemaking authority granted in

section 8(g)(2) of the Act. This section empowers the Secretary ``to

prescribe such rules and regulations as he may deem necessary to carry

out [his] responsibilities under the Act''--in this case as part of or

ancillary to, a section 6(b) standard. The Secretary's responsibilities

under the Act are defined largely by its enumerated purposes, which

include:

Encouraging employers and employees in their efforts to reduce the

number of occupational safety and health hazards at their places of

employment, and to stimulate employers and employees to institute new

and to perfect existing programs for providing safe and healthful

working conditions (29 U.S.C. 651(b)(1));

Authorizing the Secretary of Labor to set mandatory occupational

safety and health standards applicable to business affecting interstate

commerce, and by creating an Occupational Safety and Health Review

Commission for carrying out adjudicatory functions under the Act; (29

U.S.C. 651(b)(3));

Building upon advances already made through employee and employer

initiative for providing safe and health working conditions (29 U.S.C.

651(b)(5));

By providing for the development and promulgation of occupational

safety and health standards; providing for appropriate reporting

procedures with respect to occupational safety and health which

procedures will help achieve the objectives of this Act and accurately

describe the nature of the occupational safety and health problem;

exploring ways to discover latent diseases, establishing causal

connections between diseases and work in environmental conditions * * *

(29 U.S.C. 651(b)(6));

Encouraging joint labor-management efforts to reduce injuries and

diseases arising out of employment (29 U.S.C. 651(b)(13));

And developing innovative methods, techniques, and approaches for

dealing with occupational safety and health problems (29 U.S.C.

651(b)(5)).

Because this proposed revised standard is reasonably related to

these statutory goals, the Secretary finds that this standard is

necessary to carry out his responsibilities under the Act.

In addition, section 4(b)(2) of the Act provides for OSHA standards

to apply to construction and other work places where the Secretary

determines these standards to be more effective than existing standards

which otherwise apply to those workplaces. So we are applying them to

construction and maritime.

The Supreme Court's benzene decision (Industrial Union Department,

AFL-CIO v. American Petroleum Institute. 448 U.S. 601) requires OSHA,

in general, to make a ``significant risk determination'' before issuing

health and safety standards. It is clear that exposure to hazardous air

contaminants in the workplace poses significant risks to workers. Where

engineering controls cannot be used to reduce exposures below hazardous

levels, respirators properly selected, fitted and worn can contribute

substantially to a reduction in the level of air contaminants reaching

the employee's breathing zone. Under the current respiratory protection

standard, which lacks adequate requirements for fit testing, selection,

medical evaluation, use, maintenance, and respiratory protection

program provisions, employees wearing respirators are receiving less

protection than the respirators can potentially give, and in some cases

may suffer exposure to hazards as a result of improper respirator use.

The significant risk to employees therefore has not been adequately

reduced by the existing respirator standard.

The enforcement experience of OSHA and various state health

agencies demonstrate the wide-spread nature of defects in respirator

programs while the unamended respirator standard has been in effect.

From fiscal 1977 to 1982, 58% of inspected worksites where respirators

were used to protect against excessive levels of air contamination had

deficiencies in at least one respirator area, including respirator fit

condition, unapproved or unsuitable respirators, and lack of continuous

wear (Ex. 33-5). Inadequate supervision of respirator use was cited as

a major cause of improper and ineffective usage by the North Carolina

Department of Labor, Kentucky's Department of Labor and Virginia's

Bureau of Occupational Health (Docket H-160, Ex. 2-69, 2-103, 2-129).

These state plan states have respirator standards that are the same as

OSHA's unamended standard.

OSHA cannot precisely quantify the risk to employees whose

employers rely on inadequate respiratory protection programs to protect

them against excessive levels of atmospheric contamination. However,

the widespread levels of improper use of respirators put at significant

risk employees who, at least some of the time, are overexposed to air

contaminants. Based on OSHA's experience that one half of workplaces

using respirators use them incorrectly under the current standard, even

a small improvement in respirator use should work a significant

reduction in the risk of developing adverse health effects because of

preventable misuse of respirators. OSHA believes that a greater benefit

will result from the imposition of these revised requirements for the

following reason.

Each controllable variable of respirator performance, i.e., initial

fit, appropriateness of selection, and consistency of use is addressed

by these revisions. The proposed requirement for a program

administrator, for example, addresses the concerns of many commenters

that proper supervision is the core of an adequate respirator program

and effective respirator performance. Required fit testing protocols

are proposed to assure that the respirator does not leak around the

face, is comfortable and that the employee is taught how to properly

tension straps for optimum fit and comfort. Thus the proposed revised

standard with its provisions for quantitative and qualitative fit

testing, improved and clarified respirator selection, use, and

maintenance, will increase the effectiveness of respirators worn in the

workplace and significantly reduce the risks to employees to a greater

degree than the present standard.

OSHA has quantified the risk and reduction of risk as part of the

regulatory analysis and regulatory flexibility analysis, Section VI of

the preamble. That analysis clearly shows that workers wearing

respirators under the requirements of the current standard are exposed

to a significant risk of chronic and acute health effects because of

the inadequacies of the present standard. OSHA seeks comment on the

issue of significant risk and how the proposed respirator standard

revisions will affect that risk, along with any comment on the

regulatory analysis performed by OSHA and all other issues related to

significant risk.

IV. Background

A. Regulatory History

Congress created the Occupational Safety and Health Administration

(OSHA) in 1970, and gave it the responsibility for promulgating

standards to protect the health and safety of American workers. As

directed by Congress in the Occupational Safety and Health Act, OSHA

adopted existing Federal or national consensus standards, developed by

various organizations such as the American Conference of Governmental

Industrial Hygienists (ACGIH) and the American National Standard

Institute (ANSI). The ANSI standard Z88.2-1969, ``Practices for

Respiratory Protection'' (3), is the origin of the first six sections

of OSHA's 29 CFR 1910.134, ``Respiratory Protection'' (4). The seventh

section is a direct, complete inclusion of ANSI Standard K13.1-1969,

``Identification of Gas Mask Canisters.'' Until the adoption of these

standards by OSHA, most guidance on respiratory protective device use

in hazardous environments was advisory rather than mandatory.

The construction industry standard for respiratory protection, 29

CFR 1926.103, was promulgated in April 1971. On February 9, 1979, 29

CFR 1910.134 was formally recognized as also being applicable to the

construction industry (44 FR 8577) (4). OSHA is required under the OSH

Act to seek the advice of an existing advisory committee when

promulgating a rule which will affect an industry represented by the

committee. In view of the application of the respirator protection

standard to the construction industry, OSHA distributed copies of the

draft of this proposed revised standard on September 20, 1985 to the

Construction Advisory Committee for review and discussion at their next

meeting in February 1986 so that the Construction Advisory Committee

could prepare its official response. The response that was received

from the committee was considered in revising the draft proposal as

discussed later in this preamble.

The maritime standards were originally promulgated in the 1960's

under a different codification in the CFR by agencies which preceded

OSHA. The present code designations and their promulgation dates are,

as follows: 29 CFR 1915.82, February 20, 1960 (25 FR 1543); 29 CFR

1916.82, January 22, 1963 (28 FR 547); 29 CFR 1917.82, March 27, 1964

(29 FR 4052); and 29 CFR 1918.102, February 20, 1960 (25 FR 1565) (4).

The current 29 CFR 1910.134 requires that the employer establish

and implement a comprehensive respiratory protection program. The

program is to contain written procedures and provide for proper

cleaning, disinfection, storage, inspection and maintenance of the

respirators. General provisions are set forth on fitting and training.

Requirements are included for quality of breathing air and practices to

ensure that it is not contaminated. Provisions for emergencies and for

communication and rescue in atmospheres immediately dangerous to life

or health are specified. A color code for gas mask cansisters is

detailed and other provisions are included.

The current standard requires the employer to instruct and train

employees ``in the proper use of respirators and their limitations.''

The additional provisions of the proposal amplify the current

requirements by specifying, for example, that the training program

include instruction in procedures for inspection, donning and removal,

checking the fit, and sufficient practice to enable the employee to

become thoroughly familiar and confident with the use of the

respirator. OSHA believes, based on its experience promulgating and

enforcing respirator provisions in other health standards and

Sec. 1910.134, that such hands-on training can materially improve the

effectiveness of respirator use.

Recent OSHA health standards have imposed respirator related

requirements not found in 29 CFR 1910.134 (See section 1910.1018(h),

arsenic; section 1910.1025(f), lead; section 1910.1029(g), coke oven

emissions; and section 1910.1043(f), cotton dust). These requirements

include the following provisions.

* Quantitative fit tests have been required semiannually, (arsenic,

1910.1018(h)(3)(ii); lead, 1910.1025(f)(3)(ii).

* Employees have been given the option of using powered air-

purifying respirators (PAPR) upon request (arsenic,

1910.1018(h)(5)(iii); lead, 1910.1025(f)(2)(ii); coke oven emissions,

1910.1029(g)(2)(ii); cotton dust, 1910.1043(f)(2)(iv)).

* Employees have been permitted to change the filter elements of a

respirator whenever an increase in breathing resistance is detected,

(arsenic, 1910.1018(h)(4)(ii); lead, 1910.1025(f)(4)(ii); coke oven

emissions, 1910.1029(g)(4)(ii); cotton dust, 1910.1043(f)(4)(ii)).

* Employees have been permitted to wash their faces and respirator

facepieces to prevent skin irritation associated with using

respirators, (arsenic, 1910.1018(h)(4)(iii); lead 1910.1025(f)(4)(iii);

coke oven emissions, 1910.1029(g)(4)(iii); cotton dust

1910.1043(f)(4)(iii).

* Employers have been required to provide respirators that exhibit

minimum facepiece leakage, (arsenic, 1910.1018(h)(3)(i); lead,

1910.1025(f)(3)(i); coke oven emissions, 1910.1029(g)(4)(i); cotton

dust 1910.1043(f)(4)(i)).

* Referral of an employee to a physician trained in pulmonary

medicine has been required for an employee who exhibits difficulty

breathing either at fit testing or during routine respirator use

(arsenic, 1910.1018(h)(3)(iv); lead, 1910.1025(f)(3)(iii)).

The current respirator standard (1910.134(b)(11)) states that

respirators that are ``approved or accepted shall be used when

available.'' OSHA has chosen to recognize only those respirators

approved by the National Institute for Occupational Safety and Health

(NIOSH), and the Mine Safety and Health Administration (MSHA). The

NIOSH and MSHA respirator performance requirements are given in Title

30, Code of Federal Regulations, Part 11. A revision of that standard

is now being considered by NIOSH and MSHA.

Because of differences with the respirator requirements in other

OSHA standards, changes in respirator methodology and technology, and

the revision of referenced documents or related codes, OSHA published

an Advance Notice of Proposed Rulemaking (ANPR) on May 14, 1982 (47 FR

20803). This notice sought information on the effectiveness of the

current provisions, the need for revision, and the substance of what

these revisions might be. Responses were received from 81 interested

parties, and generally supported revising OSHA's respiratory protection

provisions and provided suggestions for approaches the Agency might

take (Ex. 15).

On September 17, 1985 OSHA announced the availability of a

preliminary draft of the proposed respiratory protection standard

revision for public comment (the preproposal draft standard press

release). This preproposal draft standard reflected the public comments

received from the May 1982 ANPR and OSHA's own analysis of changes

needed in the standard to take into account the current state-of-the-

art for respiratory protection. Responses were received from 56

interested parties (Ex. 36) and their comments have been reviewed in

preparing this proposal.

B. Need for the Standard

This rulemaking addresses an existing standard, rather than

addressing a new subject area, and seeks to correct the inadequacies of

that existing standard. Since the OSHA standards on respiratory

protection were adopted, research on the proper use of such equipment

has resulted in new technology which improves protection for the

wearers. The current standards do not reflect what is now accepted

practice for implementation of comprehensive respiratory protection

programs to protect employees. This is particularly true in the areas

of fit testing and assignment of protection factors to respirators.

The wearing of respiratory protective devices to reduce exposure to

airborne contaminants is widespread in industry. It has been estimated

that 2.6 million workers wear respirators, either occasionally or

routinely, in non-emergency work situations. In addition, over 59,000

facilities maintain respirators for emergency use (5, Ex. 34). Although

in most situations it is preferred industrial hygiene practice to use

engineering controls to reduce contaminant emissions at their source,

there are operations where this type of control is not technologically

or economically feasible or is otherwise inappropriate. There are many

variables which affect the degree of protection afforded by these

respiratory protective devices.

Indeed, the misuse of respirators can actually be hazardous to

employee safety and health. Selection of the wrong equipment, one of

the most frequent errors made in respiratory protection, will result in

the employee being unknowingly vulnerable to the hazard and thus

inhaling concentrations of the contaminant that may be harmful. This

may result in a broad range of health effects caused by airborne

contaminants, including silicosis, asbestosis, permanent lung damage

and cancer. In the report by Rosenthal and Paull (Ex. 33-5) it is shown

that, on the basis of OSHA's citation records, there is a high degree

of correlation between inadequate respirator programs and overexposures

to respirator wearers exposed to regulated substances. Respirators

which are not maintained, inspected, and cleaned, can actually increase

exposure, as well as cause dermatitis or skin irritation and place a

greater strain on the respiratory system. Because the wearing of the

respirator gives the employee a sense of security and presumed

protection which may be false, an improper respirator program presents

a high degree of hazard for the employee.

The devices themselves can only provide the protection they are

designed for if they are properly selected for the task; if they are

fitted to the wearer and are consistently donned and worn properly; and

if they are maintained and cared for so they continue to provide the

protection required for the work situation. These variables can only be

controlled if a comprehensive respiratory protection program is

developed and implemented in each workplace where respirators are used

to protect employees from inhalation of airborne contaminants. OSHA has

reviewed the present rulemaking record and the record of citations for

respirator standard violations. On the basis of that review it is clear

that to be effective such a program must use an integrated, systematic

approach that will result in consistent and appropriate choices of

respiratory equipment to be used; involvement of employees to ensure

that they understand why respirators are being worn, and how they

contribute to their effective use; and monitoring of the equipment and

its use to ensure that respirator effectiveness is optimized.

There are many examples of how respirators may not provide the

protection they were designed to provide in the absence of an effective

respirator program with adequate employee training. When the hazardous

substance is a dust, mist or fume there are often conditions under

which it is possible for the inside of the respirator to become

contaminated with the hazardous substance. For example, the employee

may have an itch on the cheek and scratch it with a dirty finger thus

destroying the integrity of the respirator fit.

An employee may leave the respirator area, remove the respirator,

and rest it on his or her chest. The inside of the respirator could

then pick up the contaminant from the air or work clothes and later

when the respirator is donned the employee will inhale the contaminant

from within the respirator. If a respirator is not cleaned properly or

if it is stored in a locker or on a ledge covered with the contaminant,

the employee will again breathe in the contaminant from within the

respirator.

An employee engaged in manual labor may dislodge the respirator

with a tool or even a normal motion unless the respirator has been

appropriately fit tested and the employee knows that a readjustment is

necessary. An employee may be engaged in work which requires good

vision or extensive communication. Without conscious thought the

employee may push the respirator into a position that improves vision

or make talking easier but which would result in a poor facepiece seal.

As discussed later in this preamble, several studies of the

performance of respirators worn in the workplace have been submitted to

the regulatory docket to show that in actual use, respirators can be

effective. These studies of workplace protection factors (WPFs) are

necessarily performed in workplaces which have good respiratory

protection programs. Consequently though the studies on WPFs may

provide a reasonable criterion for setting maximum protection factors,

it is not the case that those levels of protection are always achieved

even if employers have an adequate respirator program. In the case of a

poor respirator program it should be apparent that these levels would

seldom be achieved.

The complexity of the necessary program, and the extensive

commitment of ongoing resources to maintain that program, are often not

sufficiently considered when determining control measures to be used.

As stated in one commonly used industrial hygiene text (6):

There will always be a temptation to resort to respirators as a

cheap substitute for a ventilation system. If this is done it is

clear that management has not carefully considered the alternatives

since reliance on and effective use of respirators is definitely not

cheap.

As discussed above, OSHA's current standard in 29 CFR 1910.134 was

largely adopted from, and references, the ANSI Z88.2-1969 standard on

respiratory protection. ANSI issued a revised version of that standard

in 1980 (ANSI Z88.2-1980) (Ex. 10). ANSI's intent in issuing this

revision was to ensure that the standard did ``reflect the current

state of the art.'' ANSI accomplished this by expanding and adding to

the standard provisions which address technological developments in

respiratory protection since the 1969 standard was published.

Techniques in fit testing and the use of protection factors are two

areas which have been elaborated upon in the 1980 standard to help

ensure more effective protection for respirator wearers.

This change highlights the need for revising the OSHA standard,

particularly since Sec. 1910.134(c) specifies that respirators are to

be selected according to the 1969 ANSI standard and provides no

additional guidance for employers. Moreover, it is necessary to change

OSHA's standard to ensure that it too reflects current respiratory

protection methodology in order to provide appropriate protection for

employees.

The 1980 ANSI standard was a logical extension of the 1969 ANSI

standard (and thus OSHA's) in many respects. It established

requirements for a respiratory protection program so that respirator

selection, fit, and use were standardized, thus controlling some of the

variables which make respirators ineffective. The program was to

include written standard operating procedures; assessment of the

fitness of potential respirator wearers; selection of respirators;

training; fit testing; maintenance; and program evaluation.

One regulatory alternative in this regard would have been to adopt

the ANSI Z88.2-1980 standard, or to at least base the rulemaking

largely on the latest ANSI standard as was done with the original OSHA

standard. ANSI, however, was developing a major revision of its 1980

standard, recently finalized as ANSI Z88.2-1992. OSHA has given this

latest ANSI standard detailed consideration in preparing this proposal.

An OSHA standard based entirely on the 1980 ANSI standard would have

been obsolete as soon as published. OSHA has therefore made the

decision to pursue a rulemaking based on existing data and the record

generated thus far by responses to the ANPR and the prepublication

draft. The proposed standard has included provisions of the 1980 and

1992 ANSI standards where justified by the record. The reasons for

provisions which differ from those in the ANSI standards are given in

this preamble in the discussion of the content of the proposed

standard. OSHA has chosen not to adopt the ANSI standard per se, but

many of the provisions, as well as the general approach, are consistent

with ANSI.

In the ANPR, OSHA asked if the ANSI Z88.2-1980 standard should be

adopted. For the most part, respondents did not advocate that the

Agency simply adopt the ANSI standard (Ex. 15-13, 15-30, 15-34, 15-40,

15-45, 15-56, 15-73, 15-80). However, a number of respondents did

advocate that it be used as guidelines or a reference for the OSHA

standard or that modifications to it might make it appropriate for

adoption (Ex. 15-19, 15-31, 15-37, 15-43, 15-51, 15-67).

In the ANPR, OSHA requested comments on the need to revise

Sec. 1910.134, and 1980 ANSI standard notwithstanding. Only five

respondents indicated that the standard should not be revised (Ex. 15-

10, 15-35, 15-56, 15-75 (A and B), 15-77). The overwhelming majority of

respondents, representing a wide range of organizations, stated that

Sec. 1910.134 needs to be revised to reflect current technology and to

help ensure appropriate protection of employees (Ex. 15-11, 15-18, 15-

20, 15-26, 15-30, 15-42, 15-50, 15-54, 15-62, 15-74, 15-76, 15-80).

For example, industry respondents such as the Chemical

Manufacturers Association (CMA) expressed the view that (Ex. 15-22):

The requirements of 1910.134 were adequate at the time they were

adopted, but have been outdated by advances in respirator

technology. The standard should be updated to reflect current

conditions and to permit sufficient flexibility for companies to

respond to continuing technological improvements. Present standards

tend to suppress innovation and have a potential for harm by

retarding the adoption of technological advances.

The Los Alamos National Laboratory (LANL), an institution which has

conducted considerable research on respiratory protection, also

supported the need to revise OSHA's current standard, and commented

upon the appropriate approach to take (Ex. 15-79):

Currently standards should be revised to reflect changes in

respiratory protection capabilities, techniques, and equipment which

have been developed over the past 10 years. ANSI Z88.2 (1980)

provides the best basis for developing a new standard. In addition,

the ``Guide to Industrial Respiratory Protection'' (published as Los

Alamos report LA-6671-M, and Health, Education, and Welfare (HEW)

Publication, National Institute for Occupational Safety and Health

(NIOSH 76-189) provides detailed information relative to the

requirements for an adequate respirator program. It is not

recommended that direct adoption of sections, of either of these

documents, be the approach used by OSHA. Both documents are several

years old, and the ANSI document constitutes a compromise between

various interests involved in developing and adopting a consensus

standard. Development of a revised standard will require a major

effort by OSHA to identify, update, and expand those sections of

ANSI Z88.2 (1980) which should be made part of the new OSHA

standard.

Labor representatives also supported revising the standard, as

represented by this statement of the United Steelworkers of America

(Ex. 15-28):

At the present time the respiratory protection standard is not

effective in providing workers with any great degree of protection

due to the inadequacies of the standard, lack of requirements for

employers to follow so that all respiratory protection programs are

uniform and equally protective, and ineffective enforcement due to

the vagueness of the requirements.

Manufacturers of respiratory protective devices are also among

those who support revising OSHA's current respiratory protection

standards. For example, the Minnesota Mining and Manufacturing Company

stated (Ex. 15-30):

When 1910.134 was promulgated nearly a decade ago it reflected

the state-of-the-art for a good respiratory protection program. The

state-of-the-art for respiratory protection, however, has rapidly

advanced since that time and although many of the elements included

in the original standard retain their relevance and importance,

other elements have been developed and more efficient means for

achieving the goals of an effective respiratory protection program

have been introduced * * *

There are two issues in particular which have evolved

technologically since the current OSHA standards were adopted:

Assignment of protection factors or maximum use concentrations for

particular models or types of respirators; and the development of fit

testing procedures.

With respect to assigned protection factors, OSHA has decided not

to establish its own set of numbers but instead to defer to NIOSH in

setting assigned protection factors for the various respirator classes.

NIOSH will be developing assigned protection factors as part of its

revised respirator certification standard, 42 CFR Part 84. Since NIOSH

may not publish 42 CFR Part 84 before this OSHA respirator standard

revision is finalized, OSHA will in the interim enforce the assigned

protection factors listed in the NIOSH Respirator Decision Logic (RDL).

The concept of protection factors and the decision to defer to NIOSH

are discussed in more detail in a later section of this preamble.

Fit testing, the other area in which considerable advances have

been made since the promulgation of OSHA's current standard, also

varies among the substance-specific standards. The cotton dust standard

(29 CFR 1910.1043) requires that the respirator used exhibit minimum

facepiece leakage and be fitted properly. The coke oven emissions

standard (29 CFR 1910.1029) requires annual quantitative fit testing,

but has no protocol for fit testing. The lead standard (29 CFR

1910.1025) requires either qualitative or quantitative fit testing

every six months and contains specific qualitative fit test protocols

to be followed. Although the current respiratory protection standard

refers to the necessity for proper fit, there are no procedures to

follow or specific indications of how fit factors are to be taken into

account in the assignment of respirators.

There are two types of fit testing that can be used for tight

fitting facepiece respirators that rely on a facepiece-to-face seal to

perform adequately. Qualitative fit testing involves the introduction

of a test agent into the breathing zone of the respirator wearer which

can be detected by its irritant properties, taste, or smell. If the

wearer detects the characteristic effect of the test agent used, it

indicates that the respirator is leaking and does not fit properly, and

thus a different respirator is needed to protect that employee.

Quantitative fit testing involves the generation of a known

concentration of a test agent outside the facepiece, and a measurement

of the concentration within the facepiece of the respirator. The ratio

of these concentrations yields a number which indicates the protective

capability of the device. This approach does not involve the subjective

response of the wearer as does the qualitative fit test.

OSHA began including requirements for the use of quantitative fit

testing in substance-specific standards starting in 1976 with the coke

oven emissions standard. However, no procedures were provided. In the

lead standard, OSHA conducted a separate rulemaking proceeding to

address the appropriateness of QLFT. It was determined at that time

that qualitative fit testing can be appropriate, but only under certain

conditions. It was found, for example, that such fit testing can

provide a reasonable degree of reliability only when specified

protocols are followed. Thus the lead standard was revised to permit

qualitative fit testing as well as quantitative fit testing to protect

employees in atmospheres no greater than ten times the permissible

exposure limit for lead, when exposed employees are wearing half mask

negative pressure air-purifying respirators.

The overall problems with respect to QLFT protocols that came to

the surface in the lead standard revisions, plus the fact that there

was no specified QNFT protocol, made it apparent that these subjects

needed to be addressed in the overall respiratory protection standard.

Proper fit is so essential to maximizing functioning of respirators

that OSHA must include in its requirements the latest findings of

respirator research on means to assess and assure such fit.

In assessing the need to revise Sec. 1910.134, OSHA reviewed the

Agency's enforcement statistics related to this standard for a period

of about ten years, from 1972 to 1982 (9). This standard is one of the

most frequently cited health standards, which indicates both a lack of

understanding as to what is required for compliance, and a lack of

awareness as to the importance of establishing and implementing a

comprehensive respiratory protection program. During the period

reviewed, there were 22,662 violations of the standard recorded, of

which 8,406 were serious violations (37%). Some 3,648 of the violations

were for not establishing a program (1,752 of these were serious

because overexposure to hazardous substances were involved). Other

commonly cited provisions include development of standard operating

procedures; training and fit testing; cleaning and disinfection of

equipment; storage of equipment; and use of approved respirators.

Compliance should be enhanced by the provisions of the proposed

standard. In those areas which are frequently cited, the new proposal

provides additional guidance for employers to help ensure that they are

aware of what is required to comply, and thus protect their employees

adequately. OSHA expects that these revisions will improve the level of

protection provided by the current standard: nothing in these revisions

is intended to decrease protection provided under the current standard.

To summarize OSHA's position, the Agency has determined that

promulgating a revised respiratory protection standard is necessary to

ensure that employees wearing respirators in the workplace are doing so

under conditions which adequately protect their health. This

determination by OSHA is supported by the public in responses to the

ANPR published by the Agency. It is also necessitated by changes in

respiratory protection methodology and subsequent revisions to the

consensus standards upon which the current standard is based, thus

making the current standard outdated. The determination of the need for

the standard is also supported by OSHA's experiences in promulgating

substance-specific standards with respiratory protection provisions in

them, and in the Agency's enforcement experiences with the current

standard.

Based on an evaluation of these considerations, OSHA has prepared

this proposed standard and is hereby initiating the public rulemaking

process.

C. Recognition of the Need for a Standard by Other Groups

The need for standardization in this area, particularly for

consistent guidance and controlled practices, can also be demonstrated

by the number and extent of voluntary standards that have been adopted,

as well as by the existence of standards at all levels of government.

As has already been discussed, the primary voluntary consensus

standard in this area was that developed by the American National

Standards Institute as ANSI Z88.2-1980, entitled ``Practices for

Respiratory Protection'' (Ex. 10). This standard was an updated version

of the 1969 ANSI standard which was used as the primary basis of OSHA's

current standard, Sec. 1910.134. Following are some of the 1980 ANSI

standard changes:

Oxygen deficiency is more thoroughly discussed.

Quantitative fit testing is now included and described.

Qualitative fit testing is more fully described.

The concept of protection factors is introduced and

protection factors are assigned.

ANSI has also developed a new standard on physical qualifications

for respirator use (ANSI Z88.6-1984) (Ex. 38-10).

The OSHA standard, based on the outdated 1969 ANSI standard, does

not address these topics. The ANSI revisions reinforce OSHA's decision

to revise its standard to address the same and other issues.

Other countries also recognized the need for standards governing

the use of respirators. Of particular note is the consensus standard

recently developed by the Canadian Standards Association (Z94.4-M1982,

Selection, Care and Use of Respirators) (10). This document is a

comprehensive treatment of the subject and, similar to OSHA's proposed

standard, its emphasis is on the establishment and implementation of a

comprehensive respiratory protection program. As stated in the preface

to that standard:

The primary aim of this Standard is to give detailed instruction

in the selection of the proper respirator and its use and

maintenance. The emphasis is on the implementation of a respiratory

protection program developed in a logical progression of steps

beginning with:

(a) A very clear definition of the hazards that will be

encountered and the degree of protection required;

(b) The selection and fitting of the respirator;

(c) The required training in the correct use and care of the

respirator; and

(d) The implementation of a maintenance program that will ensure

that a high level of respiratory protection is maintained.

The Canadian consensus standard deals with several areas in more

detail than OSHA's current standard, and some of the language used has

been incorporated into this proposed standard, particularly in the

areas of training and program evaluation.

Documents developed by U.S. military organizations also indicate

the need for comprehensive respiratory protection programs. A military

standard entitled ``Respiratory Protection Program'' (TB MED 223/AFOSH

STD 161-1/DLAM 1000.2) has been developed for the use of the Air Force,

Army, and the Defense Logistics Agency (15). This document is similar

to OSHA's current standard (Sec. 1910.134), but includes sections which

expand upon the requirements of that standard and provide additional

guidance in critical areas. The military standard provides considerable

direction on the selection of respirators, including the protection

factor concept, that is not included in OSHA's current standard. It

also provides additional information on fit testing and training.

OSHA's proposed standard similarly recognizes the deficiencies of

Sec. 1910.134, and provides additional guidance to employers in these

same areas as well as others.

It can be seen from this brief discussion that there is widespread

agreement among safety and health professionals that adequate

respiratory protection cannot be provided in the absence of specific

procedures. The range of equipment choices available, the diversity of

hazards against which they are to protect, the differences in work

situations, and other variables increase the complexity of the decision

making process in terms of selecting the appropriate respirators, and

ensuring they fit, are worn properly, and are maintained as necessary.

OSHA proposes to revise its current standard to ensure that appropriate

procedures are implemented by employers, and thus increase the

probability that protection to the extent technologically feasible for

respirators will be provided for employees.

V. Certification/Approval Procedures

Section 1910.134 requires that only those respirators approved

jointly by NIOSH and MSHA be used by the employer when they exist. The

current respirator testing and approval regulation, 30 CFR 11, which

authorized the Bureau of Mines (BM) and NIOSH to jointly approve

respiratory protection devices was promulgated on March 25, 1972 at 37

FR 6244. On November 5, 1974 the Mine Enforcement Safety Administration

(MESA) joined NIOSH in jointly approving respirators. Following the

transfer of MESA to the Department of Labor, where it became the Mine

Safety and Health Administration (MSHA), authority was transferred on

March 24, 1978 to MSHA for joint approval with NIOSH of respirators.

Most of the BM respiratory testing methods, while developed in the

1950's or earlier, were changed in the 1970's to reflect changes in

testing technology.

NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was

held in July 1980 to address the certification program. On August 27,

1987, NIOSH published a notice of proposed rulemaking (52 FR 32402)

which would allow NIOSH to certify respirators under the new 42 CFR

Part 84 regulations, replacing the current joint NIOSH/MSHA 30 CFR 11

certification regulations. The proposed NIOSH certification regulations

contained new and revised requirements for testing and certification of

respirators, and included a set of minimum assigned protection factors

for various classes of respirators. Public hearings on the first draft

NIOSH proposal were held in January, 1988. On the basis of the comments

received, NIOSH is preparing a revised proposal for further public

comment.

Numerous commenters to the ANPR addressed the issue of NIOSH

respirator certification (Ex. 15-11, 15-27A, 15-58, 15-14, 15-43, 15-

50) and most agreed that the certification program should be improved.

Some suggested that OSHA assume the function of certification of

respirators. OSHA believes it is advisable not to undertake operation

of the certification program currently operated by NIOSH and MSHA. OSHA

has neither the expertise nor equipment to perform respirator

performance testing. OSHA intends that information generated in this

proceeding will be made available to NIOSH to use in its revision of

its respirator certification standards, and that NIOSH will make its

rulemaking record available to OSHA. OSHA believes that, for the

present, the best course is to continue to require NIOSH respirator

certification as it has in the past.

VI. Summary of the Preliminary Regulatory Impact Analysis and

Regulatory Flexibility Analysis and Environmental Impact Assessment

Introduction

Executive Order 12866 requires that a regulatory impact assessment

be conducted for any rule having an annual effect on the economy of

$100 million or more, or adversely affecting in a material way the

economy, sector of the economy, productivity, competition, jobs, or

state, local or tribal governments. In addition, the Regulatory

Flexibility Act of 1980 (Pub. L. 96-353, 94 Stat. 1164 (5 U.S.C. 601 et

seq.)) requires the Occupational Safety and Health Administration

(OSHA) to determine whether a proposed regulation will have a

significant economic impact on a substantial number of small entities,

and the National Environmental Policy (NEPA) of 1969 (42 U.S.C. 4321,

et seq.) requires the agency to assess the environmental consequences

of regulatory actions.

In order to properly assess potential impacts, in 1988 OSHA

prepared a Preliminary Regulatory Impact and Regulatory Flexibility

Analysis (PRIA) for the proposed revisions to the respiratory

protection standard. This analysis includes a profile of the affected

industries, the estimated number of workers who wear respirators, and

the nonregulatory alternatives, technological feasibility, costs,

benefits, and an overall economic impact of the proposed standard. The

PRIA is available in the OSHA Docket Office. OSHA believes the basic

data and conclusions are still correct. Inflation has increased costs

but has generally increased profits and sales in reasonably similar

proportions. This assessment is largely based upon the conclusions of

the PRIA; cost numbers have been adjusted for inflation.

Data Sources

The primary sources of information used for this impact analysis

are a report by Centaur Associates, Inc. entitled, ``Preliminary

Regulatory Impact Analysis of Alternative Respiratory Protection

Standards'' and a report by Centaur Associates, Inc. entitled,

``Compliance Cost Analysis: Current and Proposed Respiratory Protection

Standards'', available in the docket. Most of the information contained

in this report was collected from an in-depth sample survey of the

current work practices in 2,300 manufacturing plants in which

respirators are used. The results from the manufacturing sector were

extrapolated to nonmanufacturing plants and construction firms.

A third source of data are the comments received by OSHA in

response to the Advanced Notice of Proposed Rulemaking (ANPR). OSHA

welcomes additional comments and all information supplied will be

carefully reviewed and evaluated for incorporation into the Regulatory

Impact Analysis (RIA) that will accompany the final rule.

Industries and Employees Affected

The data currently available to OSHA indicate that the proposed

standard would affect approximately 3.6 million employees of whom 1.6

million are employed in the manufacturing sector, 1.5 million are

employed in the nonmanufacturing sector, and 0.5 million are employed

in the construction sector. Of the 3.0 million employees who wear

respirators for routine or occasional work, 1.1 million use respirators

routinely and 1.9 million use respirators occasionally. About 600,000

employees wear respirators for both routine and emergency use. Of these

600,000 employees, approximately 150,000 wear respirators only for

emergencies. Respirators are used routinely or occasionally in about

606,200 establishments of which 123,200 are manufacturing plants,

360,100 are nonmanufacturing plants, and 122,900 are construction

sites. Respirators are also used only for emergencies in another 51,800

establishments, of which 15,200 are manufacturing plants, 27,300 are

nonmanufacturing plants, and 9,300 are construction sites. Each general

industry and construction sector would be affected by this proposed

standard because respirators are used in many different work activities

in each of these sectors.

Nonregulatory Environment

In general, worker compensation systems designed to compensate

employees for occupationally related illnesses have not had a

significant impact upon the incidence of long-term chronic occupational

illnesses. One reason is that it is extremely difficult to determine

the cause of illness at the time the disease is diagnosed. The long

latency period between the exposure and the onset of disease, and the

mobility of employees among occupations and firms combine to make it

difficult to establish a direct causal relationship between an

occupational exposure and the resultant illness. The absence of a

readily observable cause and effect relationship provides a

disincentive for some firms to establish appropriate safety and health

measures. In addition, the lack of information regarding health risks,

inadequate training, or a misunderstanding of the function of a

respirator may lead to employee exposure to harmful levels of hazardous

substances. Thus, the nonregulatory environment does not guarantee

employee safety because the economic incentives are absent, employees

are improperly trained in respirator use, and employees do not have

sufficient information on the resultant benefits of respirator use.

Technological Feasibility

The proposed respirator standard does not require the use of large-

scale capital equipment. All of the provisions involve equipment,

evaluations, and work practices that are widely used. Thus, on the

basis of the information currently available, the proposed standard has

been found to be technologically feasible. Additional information that

is submitted will be carefully evaluated by OSHA before issuing the

final rule.

Summary of Cost

OSHA derived its cost estimates by first examining the cost of

coming into compliance with both the existing and proposed standards,

using current work practices as its baseline. This estimate does not

include the cost of purchasing the respirators; it includes only the

cost of all the other activities required by the existing and proposed

respiratory protection programs. The requirement to wear respirators

comes from other standards or specific conditions--not from this

standard. Consequently, respirator purchase has been costed in other

standards which require their use. This standard requires improvements

in the respirator program when other standards require their use and

this analysis costs these additional program requirements.

OSHA estimates that the total annualized incremental cost of the

proposed revisions to the respirator standard are $106.8 million. As

shown in Table A, approximately half of this cost ($55.6) is estimated

to fall on the nonmanufacturing sector, with the remainder in

manufacturing ($38.2) and construction ($13.1). The largest incremental

cost is attributable to enhanced requirements for qualitative fit

testing ($58.5 million). Other enhanced requirements include provisions

dealing with disposable respirator practices ($16.7 million),

respirator facepiece selection ($15.2 million), employee training

($14.4 million) and respirator use in IDLH atmospheres ($10.4 million).

In reviewing the original standard, some provisions were considered

to impose costs on employers without providing safety, and have been

modified. Cost savings would be derived from modified requirements

regarding air quality in atmosphere-supplying respirators ($8 million)

and eyeglass mounts ($0.4 million). These estimates are conservative,

as they do not factor in savings to employers already in compliance

with existing provisions.

While the proposed standard clarifies a number of existing

requirements, several of them were judged in the PRIA not to actually

impose a new burden on employers. However, the respirator survey found

significant noncompliance with several provisions of the existing

standard, and by extension, the proposed standard. Costs relating to

compliance with these provisions is discussed in depth in the PRIA.

Table A.--Annualized Costs of Proposed Revisions to Respirator Standard (Millions $1992)\1\

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

Sector

Provision -----------------------------------------------------------

Manufacturing Nonmanufacturing Construction Total

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

Medical............................................. $0.0 $0.0 $0.0 $0.0

Qualitative Fit Testing (with protocols)............ 17.3 33.0 8.1 58.5

Employee Training................................... 5.7 6.6 2.1 14.4

Program Administrator Training...................... 0.0 0.0 0.0 0.0

Written Procedures.................................. 0.0 0.0 0.0 0.0

Program Administration and Respirator Maintenance... 0.0 0.0 0.0 0.0

Storage............................................. 0.0 0.0 0.0 0.0

Eyeglass Mounts..................................... -0.2 -0.1 -0.0 -0.4

Poor Warning Properties............................. 0.0 0.0 0.0 0.0

Respirator Use in IDLH\2\ Atmospheres............... 6.6 3.2 0.7 10.4

Air Quality in Atmosphere-Supplying Respirators..... -4.2 -3.1 -0.7 -8.0

Disposable Respirator Practices..................... 9.4 5.6 1.7 16.7

Respirator Facepiece Selection...................... 3.6 10.4 1.2 15.2

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

Total......................................... 38.2 55.6 13.1 106.8

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

\1\Represents incremental burden over existing standard; numbers may not add precisely due to rounding.

A\2\Immediately dangerous to life and health.

Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.

Benefits

The proper use of a respirator when augmented by an appropriate

respiratory protection program can prevent fatalities and illnesses

from both acute and chronic exposures to hazardous substances. Based on

data found in the OSHA Integrated Management Information System (IMIS),

OSHA determined that there is an annual average of 66,500 illnesses

that are due to acute exposures to airborne hazardous substances. OSHA

estimated that compliance with the existing standard could have

prevented about 20 percent of these incidents, and that the proposed

revisions to the existing standard could prevent an additional 5 to 10

percent. Thus, full compliance with proposed revisions to the existing

standard could prevent between 3,325 and 6,650 illnesses due to acute

exposures annually.

In addition, using an Office of Technology Assessment estimate that

5 percent of all cancers are occupationally related, OSHA estimated

that there are annually between 9,085 and 15,660 new cancer cases,

between 6,850 and 11,000 cancer deaths, due to chronic exposures to

occupational airborne carcinogens. In addition, airborne exposure to

hazardous substances such as silica are estimated to account for

another 4,200 chronic illnesses annually. OSHA anticipates that full

compliance with the existing standard would prevent about 10 percent of

these cases, and that proposed revisions to the existing standard would

prevent an additional 2.5 to 5 percent. Thus, after a period of time,

between 227 and 783 new cancer cases, between 171 and 550 cancer

fatalities, and between 105 and 210 chronic illnesses could be

prevented each year by full compliance with the proposed revisions to

the respirator standard.

OSHA requests public comment on these benefits estimates in general

and the methodology used in making them. The agency requests comment on

how much an effective respiratory protection program, as proposed,

would reduce the level of occupational illness currently found. In

addition, information and data are requested on current respirator use

patterns as related to exposure (i.e. percentage of respirator users

with potential exposures at levels up to 10 times the PEL; 50 times the

PEL, etc.) and any anticipated impact this proposed standard would have

on respirator use.

Economic Impact and Feasibility

In assessing the economic feasibility of the respirator standard,

the Agency examined the costs of compliance of the standard, in

relation to sales and profits in affected industries. This analysis was

based on data in the 1986 Centaur report for manufacturing, and on

industry profile information from OSHA's 1989 PPE survey and 1992 Dun

and Bradstreet financial data.

OSHA assessed the potential economic impacts and has preliminarily

determined that the standard is economically feasible for each of the

major industry groups that will be affected. OSHA conducted its

analysis at the two-digit SIC level. This has been OSHA's procedure for

doing regulatory impact analyses for other proposed standards. OSHA

preliminarily concludes that this is reflective of the actual impact on

the average firm within each subsector. It does not appear that the

affected groups will experience significant adverse economic impact as

a result of the standard. However, if any interested person has

information to show that the analysis at the two-digit level is not

representative of the potential economic impact of the proposal, OSHA

requests the following information: reasons why the preliminary

regulatory impact analysis is not reflective of the actual anticipated

costs in any particular sector; specific information as to why the

analysis at the two-digit level fails to adequately represent the

economic impact; and specific information to help OSHA to better

predict the impact on the sector in question. Such information should

be included in the comments on the proposal.

As indicated in Table B, OSHA estimates that for all affected

industries, incremental costs of compliance would amount to less than

0.1 percent of sales, meaning that less than a 0.1 percent increase in

prices would be necessary to cover these costs. At this level,

businesses should have no trouble passing these costs onto consumers,

as it is unlikely consumers would notice the difference, in the face of

other market fluctuations. Even if this were somehow not possible, in

the worst case, any reduction in profits would be less than 1% in any

industry. For these reasons, the Agency anticipates the standard should

be economically feasible in all industries.

The Agency invites comment by any industries that anticipate

problems with economic feasibility in complying with these revisions to

the respirator standard.

Table B.--Cost of Revisions to Respirator Standard as a Percentage of Sales and Profits

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

Pre-tax Costs/ Costs/

SIC Industry Costs per Sales per profits per sales profits

establishment establishment establishment (percent) (percent)

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

07............. Agricultural Services...... $73 $316,434 29,249 0.023 0.25

08............. Forestry................... 116 613,039 73,941 .019 .16

13............. Oil & Gas Extraction....... 117 14,732,157 1,406,260 .001 .01

15,16,17....... Construction............... 107 895,587 42,998 .012 .25

22............. Textile Mill Products...... 2,409 8,344,061 467,815 .029 .52

24............. Lumber & Wood Products..... 151 3,152,807 186,290 .005 .08

25............. Furniture & Fixtures....... 325 1,710,553 94,173 .019 .34

26............. Paper & Allied Products.... 721 3,359,030 196,804 .021 .37

28............. Chemicals & Allied Products 627 22,228,880 1,234,883 .003 .05

29............. Petroleum Refining......... 173 2,235,435 169,352 .008 .10

30............. Rubber & Misc. Plastic 253 29,274,209 2,759,402 .001 .01

Products.

32............. Stone, Clay, Glass & 171 144,936,193 7,246,699 .000 .00

Concrete.

33............. Primary Metal Industries... 1,120 7,173,641 452,870 .016 .25

34............. Fabricated Metal Products.. 167 6,805,024 436,597 .002 .04

35............. Machinery (Except 264 4,377,647 263,117 .006 .10

Electrical).

36............. Electrical & Electronic 121 17,509,789 919,731 .001 .01

Equipment.

37............. Transportation Equipment... 653 4,557,703 269,325 .014 .24

38............. Measuring & Controlling 74 7,397,676 508,126 .001 .01

Instruments.

39............. Misc. Manufacturing 142 10,705,268 605,548 .001 .02

Industries.

41............. Passenger Transportation... 146 1,350,813 63,449 .011 .23

42............. Motor Freight.............. 81 1,268,289 56,371 .006 .14

48............. Communications............. 151 16,162,621 2,816,217 .001 .01

49............. Utilities.................. 792 16,459,198 1,712,408 .005 .05

50............. Durable Wholesale Trade.... 297 2,497,626 126,143 .012 .24

51............. Nondurable Wholesale Trade. 115 5,059,902 212,107 .002 .05

52............. Hardware, Garden, Mobile 225 994,229 45,694 .023 .49

Home Retail.

55............. Auto Dealers & Service 61 1,957,405 59,316 .003 .10

Stations.

75............. Automotive Services........ 83 394,881 28,719 .021 .29

76............. Misc. Repair............... 110 188,739 18,493 .058 .59

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

Source: U.S. Department of Labor, OSHA, Office of Regulatory Analysis.

Regulatory Flexibility Analysis

Pursuant to the Regulatory Flexibility Act of 1980, the Assistant

Secretary preliminarily determined that the proposed standard would not

be a significant burden upon a substantial number of small entities.

There may, however, be a higher cost per respirator-wearing-employee

for some small entities. In particular, larger plants that have in-

house testing facilities and in-house medical facilities would be able

to provide the necessary services at lower unit costs than could

smaller companies. OSHA is soliciting information on this issue, and

any comments received will be carefully reviewed and evaluated for

incorporation into the RIA of the final rule.

Environmental Impact Assessment--Finding of No Significant Impact

The proposed rule and its alternatives have been reviewed in

accordance with the requirements of the National Environmental Policy

Act (NEPA) of 1969 (42 U.S.C. 4321, et seq.), the regulations of the

Council on Environmental Quality (CEQ) (40 CFR Part 1500), and the

Department of Labor's (DOL's) NEPA Procedures (29 CFR Part 11). As a

result of this review, the Assistant Secretary for OSHA determined that

the proposed rule will have no significant environmental impact.

The focus of the proposed standard is on reducing risks to

employees who must wear respiratory protection in order to reduce their

exposures to hazardous airborne substances when effective engineering

controls are not feasible, while they are being installed, or during

emergencies. The proposed provisions include written respiratory

protection programs and evaluation, medical evaluation, fit-testing

procedures, guidance on the maintenance, care, and use of respirators,

and training. The implementation of the respirator program would remove

hazardous airborne particulates and contaminants from the breathing

zone of the worker and not from the general ambient atmosphere in the

work environment. In general, the procedures and applications of the

proposed provisions do not impact on air, water or soil quality, plant

or animal life, the use of land, or other aspects of the environment

and therefore are not anticipated to have any significant effect on the

environment.

VII. Summary and Explanation of the Proposed Standard

In developing the proposed standard, OSHA received and analyzed all

of the regulations, documents, and comments described above, as well as

other information the Agency has obtained during the developmental

process. This information can be found in the public record, Docket H-

049. The material collected and reviewed generally supports OSHA's

finding that in order to ensure adequate respiratory protection,

employers requiring employees to wear respirators must develop and

maintain an appropriate respiratory protection program.

Setting clear protective requirements for selecting, fitting,

using, and maintaining respiratory protective devices will help

employers to provide the appropriate protection for their employees,

and thus reduce their exposure to hazardous chemicals.

This proposal is intended to replace OSHA's current respiratory

protection standard for general industry, 29 CFR 1910.134, and the

respiratory protection provisions in the OSHA construction standards,

29 CFR 1926, and maritime standards, 29 CFR 1915-1918. Although a

performance standard orientation has been adopted, enforcement

experience with the current standard has shown that the existing

requirements do not provide sufficient specific information for

employers to comply, particularly in the areas of respirator selection,

medical surveillance, and fit testing. Therefore, this proposal is

designed to provide employers with a clear description of the

appropriate steps to follow to establish an effective respiratory

protection program.

OSHA recognizes that there may be differing opinions regarding the

particular provisions that should be included in such a comprehensive

respiratory protection standard. The Agency is hereby soliciting

information on alternative requirements to address the problems of

inadequate or improper respiratory protection. The final standard

adopted will incorporate whatever means are best for ensuring an

effective respiratory protection program and which are supported by the

public rulemaking record. The proposed standard continues the public

rulemaking process by presenting the Agency's assessment of the best

method to accomplish the development and maintenance of a respiratory

protection program given our current state of knowledge.

The following summary and explanation is designed to clarify the

intent of the proposed provisions, as well as to identify issues OSHA

is aware of and would like to receive comments on. Comments are also

invited on other relevant issues which are not specifically raised in

this discussion. All such comments should clearly identify the

provision of the standard to which they apply, as well as the position

taken on that provision. It is most helpful, and makes the record more

accessible, when comments are organized in the same order that the

standard is written and are indexed to the particular provisions of the

standard to which they refer. It should also be noted that on technical

issues, substantiation should be presented as well as opinion on the

appropriateness of a particular requirement. Such substantiation may

take the form of anecdotal evidence of experience, scientific data,

etc. Submission of substantive commments helps OSHA build a thorough

record upon which to base the final standard. A complete record on all

the issues will help ensure that the final standard is appropriately

drawn to address the issue of respiratory protection.

(A) Scope and Application

The existing OSHA respirator standard contains a methods of

compliance provision (Sec. 1910.134(a)(1)) which establishes a

hierarchy of control techniques to be used for protecting employees

from exposure to airborne contaminants, with engineering controls to be

implemented first and respirators allowed only when engineering

controls are not feasible or while they are being instituted.

This provision of the standard is not a subject of this rulemaking;

only issues relevant to the content of a respirator use program are to

be addressed at this time. OSHA is reviewing Sec. 1910.134(a)(1) and

similar hierarchy of controls provisions contained in Sec. 1910.1000 in

a separate rulemaking.

In the prepublication draft, OSHA asked whether to make the

requirements for a respirator program apply whenever the employer

either required or permitted the use of respirators. The requirement

that the program be implemented whenever employees were permitted to

wear respirators on their own was criticized by commenters (Ex. 36-11,

36-13, 36-38, 36-44, 36-47, 36-48, 36-51A) who felt that this provision

was inappropriate and would serve to discourage permission to use

respirators voluntarily and thus, in some situations, could lessen

workplace protection. Upon consideration of these comments, OSHA is now

proposing to retain the wording in paragraph (a)(2) of the current

standard which requires that respirators be provided when such

equipment is necessary to protect the health of the employee.

Paragraph (a)(2) actually addresses two issues--(1) when

respirators are required to be used and (2) that of the need to

implement a full respiratory protection program. Regarding when

respirators are required to be used, OSHA interprets paragraph (a)(2)

as clearly requiring their use in the absence of engineering controls

whenever employee exposures would exceed an OSHA permissible exposure

limit (PEL) or warrant a 5(a)(1) citation under the OSH Act. Under

these conditions, the proposal would require respirators to be provided

by the employer and a respiratory protection program that meets the

full requirements of the respirator standard to be implemented. This

interpretation continues OSHA's existing compliance policy covering the

required use of respirators.

A respiratory protection program complying with the full provisions

of this proposal would be required whenever an employer requires any

employee to wear a respirator, regardless of the exposure level and

whether the substance is regulated. The use of a respirator in itself

could constitute a hazard and improper use of a respirator can also

increase the exposure hazards and in some cases can make the exposures

more dangerous than if the respirator had not been used in the first

place.

However, OSHA requests comments on whether the respirator program,

when required by the employer in the absence of a regulatory

requirement of another standard, could be modified for certain

respirator types, uses, or conditions, to still provide the needed

protection. Comments with supporting data are requested on what

specific provisions of the proposal could be reduced or eliminated in

this case based on respirator type or environmental or workplace

conditions, and under what specific circumstances the required

provisions could be changed.

If a respirator is used by an employee but its use is not required

by OSHA standards or statute, or by the employer, which is known as a

voluntary respirator use situation, then the requirements of the

proposed standard, although recommended, are not proposed to be

mandatory.

OSHA is also seeking comment on the appropriateness of the scope of

the respirator standard, and on whether the scope of the standard

should go beyond required respirator use to include voluntary

respirator use situations as well.

OSHA requests comments on whether there are certain low risk

respirator use situations which could justify the reduction or

elimination of certain provisions in the mandatory respirator program

in order to provide additional compliance flexibility. How such lower

risk situations could be defined, and which provisions could be

modified or eliminated should be listed along with a discussion of how

changing the provisions would effect potential risks of respirator use.

The proposal contains a threshold of five hours of respirator wear

in any work week before a medical evaluation must be obtained. Is a

five hour threshold appropriate, or should it be larger, and if so,

what specific situations would serve to justify a larger time

threshold? Should there be any time limit, or should any respirator use

trigger medical provisions?

(B) Definitions

The proposed standard includes a number of definitions which are

unique, and which should be consulted to properly understand the

standard. The current respiratory protection standard has no

definitions, which may have contributed to misunderstandings in knowing

how to comply.

A number of the definitions deal with specific types of respiratory

protective devices, or with components of those devices. For example,

``air-purifying respirator'', ``disposable respirator'', ``filter'',

and ``positive pressure respirator'' are all defined in this paragraph.

Most of these definitions are based on generally recognized sources,

such as the current ANSI standard, or documents from the National

Institute for Occupational Safety and Health. Others have been

developed by OSHA for purposes of this standard. With the few

exceptions discussed in the following paragraphs, the definitions are

straight forward and self-explanatory. OSHA invites comment on the

appropriateness of these definitions and invites the submission of

alternatives. Some of the definitions require explanation as follows.

A definition for ``hazardous exposure level'' has been developed

and included for the following purpose. In order to select a respirator

which provides the proper degree of protection, it is necessary to know

both the anticipated ambient airborne exposure level and the exposure

that is acceptable in the breathing zone. One can then determine the

extent to which the respirator must reduce the ambient exposure level.

Thus in the respirator selection scheme, an exposure limit must be used

to establish a goal to determine the degree of protection needed for

employees exposed in a given work situation. Although this standard

does not set specific exposure limits, a concept of exposure must be

included in the selection criteria to be consistent with current

practice.

Since OSHA has permissible exposure limits established for about

600 substances, and there are thousands of hazardous substances to

which employees are exposed, other sources of hazard information must

be used for substances not regulated by OSHA. This does not mean that

OSHA is in effect establishing permissible exposure limits for these

other substances. It just means that where employers decide to use

respirators to control exposure, a target exposure level must be

established to determine the appropriate respirator to use. Therefore,

OSHA has defined the term ``hazardous exposure level'' for purposes of

selecting respirators, as follows.

Where OSHA does have a PEL, it must be used. If there is no PEL for

the substance, the employer must use the American Conference of

Governmental Industrial Hygienists (ACGIH) Threshold Limit Value (TLV)

for the chemical if one exists.

If there is no PEL or TLV for the chemical, the employer must

determine the ``hazardous exposure level'' based on available

scientific information including the MSDS. In some situations, the

suppliers of the chemicals may make recommendations for appropriate

exposure levels based on their own experience. In any event, the

employer must establish a protective goal, based on available

information, in order to choose the appropriate respirator, and must be

able to substantiate how that goal was chosen.

It should be noted that the OSHA PEL, ACGIH TLV, and other

available exposure limits are required to be reported on the material

safety data sheet generated by chemical manufacturers and importers

under the requirements of OSHA's Hazard Communication Standard (29 CFR

1910.1200). This information should assist downstream employers in

choosing respirators to protect their employees.

As stated in the scope paragraph, the standard is to apply when

employees are required to wear respirators to reduce their exposures to

airborne concentrations of ``hazardous chemicals'' in the workplace.

For purposes of this standard, ``hazardous chemical'' is defined as a

substance which meets the definition of ``health hazard'' under OSHA's

Hazard Communication Standard (29 CFR 1910.1200). This approach helps

to ensure that definitions of hazard are consistent in current OSHA

standards; provides a broad scope of coverage for this standard; and

incorporates a data base for employers in the form of material safety

data sheets generated under the requirements of the Hazard

Communication Standard.

The Hazard Communication Standard defines ``health hazard'' as a

substance for which there is statistically significant evidence based

on at least one study conducted in accordance with established

scientific principles, showing that acute or chronic health effects may

occur in exposed employees. The term ``health hazard'' includes

substances which are carcinogens, toxic or highly toxic agents,

reproductive toxins, irritants, corrosives, sensitizers, hepatotoxins,

nephrotoxins, neurotoxins, agents which act on the hematopoietic

system, and agents which damage the lungs, skin, eyes or mucous

membranes.

OSHA notes that the definition of ``hazardous chemical'' is used

here merely to target the broad range of substances which may entail

respirator use. However the requirements of this proposed standard only

apply when a regulated substance is being used or when an employer

requires the use of a respirator for any reason. One term which is

frequently used in regard to atmospheres which require respiratory

protection is ``immediately dangerous to life or health'' or ``IDLH.''

Such atmospheres require the most protective types of respirators for

workers. Although the term is used frequently, there has been no one

accepted definition of it. In the preproposal draft of the respirator

standard, OSHA defined an IDLH atmosphere as one ``where the

concentration of oxygen or hazardous chemical(s) would cause a person

without respiratory protection to be fatally injured or would cause

irreversible or incapacitating effects on that person's health.'' In

addition, the definition stated that in establishing the IDLH for a

workplace situation, the employer was to consider ``the maximum

concentration of the hazardous chemical at which one could escape

within ten minutes without any escape-impairing or immediate or delayed

irreversible health effects'' and ``the minimum concentration of the

hazardous chemical at which severe eye or respiratory irritation or

other reactions would inhibit escape without injury.'' This definition

was derived from the IDLH definition in the Joint NIOSH/OSHA Respirator

Decision Logic. An escape time of 30 minutes was considered in the

Decision Logic as the maximum permissible exposure time for escape from

an IDLH atmosphere. There has always been disagreement whether the

maximum escape time should be reduced to 10 minutes as OSHA recommended

in the preproposal draft, or whether some other time limit such as 15

or 30 minutes should be used. Since there is no clear evidence as to

what the time limit should be and just how such a limit would be used

in determining an IDLH atmosphere, OSHA is proposing a less specific,

but clearly protective, IDLH definition that does not refer to a

maximum escape time limit, as described below.

NIOSH revised its IDLH definition in the August 27, 1987 (52 FR

32413) proposed revision of the respiratory protective devices

certification procedures to read:

``Immediately Dangerous to Life or Health'' (IDLH): Respiratory

exposures which:

(1) Pose an immediate threat of loss of life or of irreversible or

delayed effects on health or;

(2) Eye exposures which would prevent escape from such an

atmosphere.

The OSHA Hazardous Waste Operations and Emergency Response

Standard, 29 CFR 1910.120, contains an IDLH definition that reads as

follows:

``IDLH'' or ``Immediately dangerous to life or health'' means an

atmospheric concentration of any toxic, corrosive, or asphyxiant

substance that poses an immediate threat to life or would cause

irreversible or delayed adverse health effects or would interfere with

an individual's ability to escape from a dangerous atmosphere.

The hazardous waste IDLH definition addresses all the issues

covered in the NIOSH IDLH definition and more clearly addresses

asphyxiant atmospheres. OSHA has therefore chosen to adopt the

hazardous waste operations IDLH definition for this respiratory

protection proposal which, in addition to being most appropriate, will

also assure consistency between the various OSHA standards that address

IDLH atmospheres. Comment is requested on this definition of

immediately dangerous to life or health, and on its appropriateness for

respiratory protection standards.

Since the warning properties of a gas or vapor are to be considered

in the selection of an air-purifying respirator, OSHA has included a

definition of what constitutes ``adequate warning properties.'' The

``adequate warning properties'' referred to in regard to respiratory

protection are ``the detectable characteristics of a hazardous

chemical, including odor, taste, and/or irritation effects which are

detectable and persistent at concentrations at or below a hazardous

exposure level and exposure at these low levels does not cause

olfactory fatigue.'' This definition combines the definitions for

warning properties and adequate warning properties from the preproposal

draft.

The definitions of ``oxygen deficient atmosphere'' and ``oxygen

deficient IDLH atmosphere'' have also been changed from the definitions

in the preproposal draft. An oxygen deficient atmosphere is now defined

as ``an atmosphere with an oxygen content of less than 19.5% by volume

at altitudes of 8000 feet or below.'' This definition retains the

traditional 19.5% oxygen level as the point below which an oxygen

deficient atmosphere exists. It is also consistent with the minimum

oxygen content of Grade D breathing air. Above 8000 feet, an oxygen

deficient atmosphere, one with an oxygen level below 19.5%, would also

be considered an oxygen deficient IDLH atmosphere (see below) and the

proposal treats it as such. Thus the definition for ``oxygen

deficient'' does not address altitudes above 8000 feet. This change in

definition will allow the use of air-purifying respirators in normal

atmospheric air for altitudes up to 14,000 feet.

The oxygen deficient IDLH atmosphere definition has been changed to

``an atmosphere with an oxygen content below 16% by volume at altitudes

of 3000 feet or below, or below the oxygen levels specified in Table I

for altitudes up to 8000 feet, or below 19.5% for altitudes above 8000

feet up to 14,000 feet.'' An oxygen content of 16% at 3000 feet of

altitude corresponds to an oxygen partial pressure of 100 millimeters

of mercury in the freshly inspired air in the upper portion of the

lungs which is saturated with water vapor. This oxygen partial pressure

is level which the ANSI Z88.2-1980 respirator standard defines as

``oxygen deficiency, immediately dangerous to life or health''.

However, rather than using the calculation formula from ANSI, this

proposal provides an equivalent table of the oxygen percentages for

oxygen deficient atmospheres and oxygen deficient IDLH atmospheres at

various altitudes for simplicity of use. The table provides a side-by-

side presentation of the oxygen deficient atmosphere and oxygen

deficient IDLH atmosphere levels to avoid any confusion between the

two, and removes the necessity of calculating the values from a

formula.

At altitudes above 8000 feet up to 14,000 feet an oxygen deficient

IDLH atmosphere would exist when the oxygen content in the workplace

atmosphere falls below 19.5%. The respirator selection provision of the

proposal require that an atmosphere-supplying respirator with auxiliary

escape provision or an SCBA be used in such situations. These

respirators supply the wearer with Grade D breathing air. Since the

allowable oxygen content in Grade D breathing air can range from 19.5%

to 23% oxygen, OSHA has chosen the 19.5% lowest allowable oxygen level

for Grade D air as the level below which an oxygen deficient IDLH

atmosphere would occur for altitudes above 8000 feet.

OSHA requests comments and specific data on the effects of reduced

oxygen content in workplace atmospheres and on the appropriateness of

the ``oxygen deficient'' atmosphere and ``oxygen deficient IDLH''

atmosphere definitions contained in the proposal. Alternatives to the

OSHA proposed definitions should include the physiologic basis for any

changes proposed for the oxygen levels used to determine these oxygen

deficient atmospheres.

(C) Respiratory Protection Program

Once an employer has decided to use respiratory protection, a

written respiratory protection program must be developed and

implemented. This requirement is essentially the same as that in the

existing respirator standard, 29 CFR 1910.134(b)(1), which requires

that written standard operating procedures governing the selection and

use of respirators be established. The purpose of this requirement is

to ensure that employers establish a standardized procedure for

selecting, using, and maintaining respirators for each workplace where

respirators will be used.

The ANSI Z88.2-1980 standard for respiratory protection states that

written standard operating procedures covering a complete respirator

program shall be established and implemented (Ex. 10). This performance

oriented requirement recognizes the need for a systematic respiratory

protection program to provide for consistency in protection. The ANSI

standard does not contain detailed instructions on the content of

standard operating procedures, but it does describe elements of a

minimally acceptable respirator program.

The current OSHA respirator standard requires written standard

operating procedures covering selection, use, cleaning, maintenance,

inspections, emergency use, training of supervisors and respirator

wearers, and recordkeeping. As part of the preliminary regulatory

impact analysis for this proposal, data were collected on current

respirator practices and procedures in over 2300 manufacturing plants

in 15 SIC codes. This sample was extrapolated to produce estimates of

respirator-related practices for about 123,200 manufacturing plants

with routine and occasional respirator use. Only 25.5% of these plants

are estimated to have had written standard operating procedures, and

only 7.9% had procedures that addressed all seven areas specified. Over

80% of the large plants (1000 or more employees) had written

procedures, while in small plants (less than 50 employees) only about

22% had written procedures. The survey showed that the intent of the

existing respirator standard as well as the areas to be addressed in

standard operating procedures were not clear to employers.

In a review of violations of the OSHA respirator standard from 1977

to 1982, 13% of the citations were for lack of standard operating

procedures (Ex. 33-5). This percentage of citations actually

underrepresents the total number of cases where problems were found

since it is OSHA policy not to issue citations when no overexposures

were documented.

A review of the comments received in response to the ANPR showed

wide general support for the requirement for written standard operating

procedures. Only one comment by Western Electric Co. for AT&T (Ex. 15-

51) recommended that the written program requirement be dropped. The

commenter stated that while many users of respirators require written

procedures for an effective protection program, OSHA should not be

concerned about written procedures, but only about the overall

effectiveness of the respirator program. There were several submissions

that supported the existing written standard operating procedure

requirement (Ex. 15-37, 15-42, 15-50, 15-56, 15-77) and recommended

that OSHA make no significant changes. However, OSHA's compliance

experience shows that there is a need to clarify the intent of the

requirement and make it clear to employers what OSHA expects in a

written respiratory protection program.

Several ANPR commenters felt OSHA should not include detailed

specifications in the requirement for written standard operating

procedures (Ex. 15-13, 15-22, 15-30, 15-55, 15-73, 15-75). Some felt

the requirement should be written in performance language, with the

specific contents of the procedures to be left to the employer (Ex. 15-

26, 15-41, 15-44, 15-52, 15-70, 15-76). The ANSI Z88.2-1980

specifications were considered adequate and were recommended by still

others (Ex. 15-14, 15-31, 15-33, 15-35, 15-46, 15-58). Certain

commenters presented lists of recommended elements to be covered where

appropriate in the procedures (Ex. 15-18, 15-19, 15-22, 15-34, 15-53,

15-81). These recommended areas for coverage in the written standard

operating procedures varied slightly among the commenters, but the

major areas of respirator inspection, cleaning, maintenance, selection,

training, use, fit testing, recordkeeping and program evaluation were

common to most of the lists. Others recommended OSHA use the program

specification in the Los Alamos National Laboratory (LANL) respirator

training program or in the NIOSH guide to respiratory protection (Ex.

15-27A, 15-81). The AIHA (Ex. 15-81) also stated that the standard

operating procedures should be more specific in defining employer/

employee responsibilities and the types of respirators required for

specific jobs.

Written standard operating procedures are essential to an effective

respiratory protection program. Developing and writing down standard

operating procedures requires employers to think through just how all

of the requirements of the respiratory protection standard will be met

in their workplace. The current respirator standard requires that

employers develop written standard operating procedures that include

all information and guidance necessary for respirator selection, use,

and care, along with written procedures covering safe use of

respirators in dangerous atmospheres that might be encountered in

normal operations or emergencies. The proposal in section (c) contains

additional descriptions of the elements to be included in the written

standard operating procedures to provide additional guidance for

employers. The requirement is performance oriented since the proposal

does not contain detailed specifications for the required written

standard operating procedures. The list of elements to be covered is

similar to those contained in the ANSI Z88.2-1980 standard, and

includes many of the recommended elements presented by commenters to

the preproposal draft (Ex. 15-18, 15-19, 15-22, 15-34, 15-53, 15-81).

The specific contents of the procedures are left to the employer who

can tailor them to match the many varied situations that can occur.

Many of the elements will be common to all respiratory protection

programs, such as respirator selection, care, use, training, and

program evaluation. Some elements such as air quality with supplied air

respirators are required only when those types of respirators are used.

The elements of the standard operating procedures are part of the

mandatory provisions of the proposal. Listing the requirements in a

non-mandatory appendix, as was suggested, would perpetuate a recognized

problem area. The current standard fails to clearly identify the areas

to be covered in the written standard operating procedures, and as a

result only a quarter of the written procedures that were surveyed

addressed all the needed elements (Ex. 33-5). Placing the elements in a

non-mandatory appendix would encourage the continuance of current

practice in writing standard operating procedures. The problem is not

only poorly written procedures, but failure to address some of the

necessary elements at all. Only by making the required elements

mandatory and enforceable can an improvement in written standard

operating procedures and thus an overall program be assured.

Employers are required by the proposal to designate a person

qualified by training and/or experience in the proper selection, use,

and maintenance of respirators to be responsible for implementing the

respirator protection program, and for conducting the periodic

evaluations of its effectiveness. This requirement is similar to that

in the ANSI standard (Ex. 10) which requires that responsibility and

authority for the respirator program be assigned to a single qualified

person with sufficient knowledge of respirator protection to properly

supervise the program. The OSHA standard is performance oriented since

it allows the employer to choose the person best qualified for the

assignment.

The training requirements of the respirator program supervisors was

the subject of a question in the ANPR. Several ANPR commenters said

that specifying the type of training required would be beyond the scope

of the standard (Ex. 15-13, 15-35, 15-75, 15-75A, 15-75c). Others

recommended OSHA adopt the performance language of the ANSI standard

(Ex. 15-26, 15-31, 15-38). Still others recommended that the supervisor

be under the direction of an industrial hygienist or safety

professional (Ex. 15-55, 15-70, 15-76). Some wanted the level of

training required to be commensurate with the complexity of the program

and the degree of risk. (Ex. 15-18, 15-37, 15-46, 15-47, 15-59). Most,

however, recommended that OSHA require the supervisor to have knowledge

of respirators equivalent to that obtained from taking the NIOSH

occupational respiratory protection course. (Ex. 15-30, 15-33, 15-41,

15-42, 15-52, 15-53, 15-54, 15-58, 15-62, 15-71, 15-73).

Specifying in detail the type and extent of training required for

program supervisors has not been done in this proposal. The level of

training that would be appropriate for a workplace with limited

respirator use would be quite different from that required at another

workplace with extensive respirator use that includes IDLH atmospheres,

highly toxic chemicals, or other complex respirator use operations.

Therefore, OSHA has adopted a performance language provision for

program supervisor training that is similar to the ANSI standard

requirement. The level of training for the respirator program

supervisor must be adequate to deal with the complexity of the

respirator program. OSHA has not established any one training program,

such as the NIOSH respirator course, as the level of training program

supervisors must achieve. The NIOSH course covers many different

respirator types and uses, and may provide too much information on

certain types of respirators such as SCBAs for program supervisors who

run simple programs, yet not provide enough information for respirator

program supervisors with a highly complex respirator program. The

program supervisor can also use the assistance of industrial

hygienists, safety professionals, or other respirator experts to help

run the respirator program. Therefore, the training requirements for

respirator program supervisors have been written in performance

language, to allow the training requirements to fit the needs of the

respirator program.

A number of commenters on the preproposal draft addressed the issue

of program administration. Only the American Textile Manufacturer's

Institute (Ex. 36-18) felt the requirement that a person be designated

to administer the respiratory protection program should be deleted.

Other commenters supported the requirement (Ex. 36-14, 36-31, 36-36,

36-40, 36-44, 36-47). The training requirements for the program

administrator was also the subject of comments. The Nuclear Regulatory

Commission (Ex. 36-31) recommended that both training and 6 to 12

months field experience in using respirators should be required.

Lawrence Durio (Ex. 36-36) recommended that the person responsible for

the respirator protection program be a certified industrial hygienist

or complete a NIOSH sponsored course in respiratory protection designed

specifically for the training of respiratory protection program

managers. Richard Boggs of ORC (Ex. 36-47) recommended that the

qualifications of the administrator reflect the complexity of the

respirator program. California/OSHA (Ex. 36-44) recommended that all

program administers at least have demonstrable knowledge of the

requirements of 1910.134 and where respirators may be used for entry

into IDLH atmospheres, the program administrator must attend the NIOSH

respirator course or equivalent. Donald Rapp of the Dow Chemical

Company (Ex. 36-40) recommended that OSHA allow a committee as well as

an individual to be the responsible party, since a committee is more

likely to be responsible for the program than an individual in larger

companies. ORC (Ex. 36-47) also recommended that OSHA allow

responsibility to be vested in an individual or in a committee/

department designated as the central authority.

To assure that the integrity of the respiratory protection program

is maintained through the continuous oversight of one responsible

individual, the proposal requires that a qualified person be designated

as responsible for the management and administration of the program.

That individual can work with a committee or assign responsibility for

portions of the program to other personnel, but the overall

responsibility for the operation of the program remains with the

designated person. This approach promotes coordination of all facets of

the program. The training requirement for the program administrator has

been left performance oriented. With the varying complexity of

respirator programs, specifying a uniform training requirement would be

very difficult. The level of training required varies with the

complexity of the respirator program. OSHA invites further comments on

whether specific minimum training requirements for program

administrators should be set, and on what the training should be.

Employers are required to keep the written respiratory protection

program current. The preproposal draft required that the written

respiratory protection program be maintained ``in a current fashion.''

The Motor Vehicle Manufacturer's Association (Ex. 36-37) recommended

that the phrase ``in a current fashion'' be deleted since requiring

that the employer maintain the written program implies that it be

maintained in a current fashion. In order to clarify the intent of the

provision the phrase ``in a current fashion'' has been removed and the

wording has been revised to require that the employer maintain a

written respiratory protection program that reflects current workplace

conditions and respirator use. As the workplace situation or respirator

use changes, the program is to be revised. Also the program must be

made available, upon request, to employees, designated representatives

and to OSHA.

(D) Selection of Respirators

1. Introduction

The existing OSHA respiratory standard does not contain specific

guidance for the selection of respirators. Instead, the standard

requires that the selection of respirators be made according to the

guidance of the American National Standard, Practices for Respirator

Protection Z88.2-1969. The 1969 ANSI standard recommended appropriate

respirators for use with various categories of contaminants, but did

not attempt to set individual protection levels for each type of

respirator. Although the ANSI standard was revised in 1980, the current

ANSI committee (Ex. 36-55) considered the 1980 standard to be obsolete

and was in the process of developing another revision with provisions

that differ substantially from the 1980 version. A consensus on a

revised 1992 ANSI standard was not reached by ANSI during the time of

the original OSHA rulemaking comment periods. Therefore there were no

substantive comments received by OSHA on the provisions of the revised

1992 ANSI respiratory protection standard. However, as discussed later,

OSHA has reviewed the new ANSI standard and has given it thorough

consideration in the preparation of the final OSHA proposed standard.

The joint NIOSH/OSHA respiratory decision logic, originally

published in 1975, was an early attempt to develop a logic for

respirator selection that could easily be followed and would enable an

individual to pick the appropriate respirator consistently. OSHA

believes that changes in respirator technology and new data on

respirator fit and protection levels have rendered this early decision

logic, as well as the 1980 ANSI standard obsolete, and rules for

selection are essential to avoid the risk of using respirators which

are incapable of providing the necessary protection. The current OSHA

standard lacks such rules, and an analysis of enforcement experience

(Ex. 33-5) shows that as a result, the selection of inappropriate or

unapproved respirators and failure to provide suitable respiratory

protection accounted for 26% of the violations of the respirator

standard cited during fiscal years 1977 to 1982.

The proposal requires employers to provide respiratory protection

at no cost to employees. This is consistent with the provisions of the

current respiratory protection standard, as well as with the OSH Act,

to ensure that employers provide whatever controls are necessary to

protect employees from hazards generated by the work operation.

Where elastomeric facepieces are to be used, the employer shall

provide a selection of respirators from an assortment of at least three

sizes for each type of facepiece from at least two manufacturers.

Comments were received stating that the cost of maintaining three

different sizes of two manufacturer's respirators would appear

excessive if only one or two employees require a respirator (Ex. 36-

32). Others indicated that the assortment should be required for the

initial fit (Ex. 36-28, 36-36) but not for the annual retest since each

fit test respirator must be cleaned before its next use. OSHA is

maintaining in this proposal the requirement for an assortment of

respirators for both the initial and annual fit tests. OSHA believes

that nothing in the course of respirator use is more important than

achieving the best possible fitting respirator and that this is only

possible where an adequate selection is available. Availability of

different sizes and types of respirators during retesting is especially

critical where the employee's physical conditions may have changed as

the result of a modest weight change or changed facial configuration

due to surgery or dental work, which may affect respirator fit.

2. Workplace Conditions

The first step in selecting respirators for a particular workplace

is to consider available information concerning workplace conditions

and characteristics of the hazardous chemical. The proposal lists

eleven such categories of information.

(i) Nature of the hazard. The nature of the hazard, whether it is

in the form of a gas, dust, organic vapor, fume, mist, oxygen

deficiency, or any combination of hazards needs to be taken into

account.

(ii) Physical and chemical properties of the air contaminant. The

physical and chemical properties that affect respirator selection such

as particle size for dusts, vapor pressure, breakthrough times, and the

ability of the filter material to remove, adsorb, or absorb the

contaminant.

(iii) The adverse health effects of the respiratory hazard. In

selecting a respirator any adverse physiological effects that may occur

from exposure to the hazard, including effects that may occur due to

respirator leaks or failure need to be considered.

(iv) The relevant permissible exposure limit or recommended

exposure limit. The OSHA permissible exposure limit, or in its absence,

any American Conference of Governmental Industrial Hygienists

recommended Threshold Limit Value (TLV), NIOSH recommended exposure

limit, or other exposure limit set by the employer must be considered

in selecting the appropriate respirator.

(v) The results of workplace sampling of airborne concentrations of

contaminants. Sampling and analysis of the workplace air determines

what degree of exposure is occurring, and thus what degree of

protection is required. Where such sampling and analysis have been

done, the results are to be used as a point of comparison for the

hazardous exposure level i.e. to determine how much the concentration

must be lowered by the respirator to reduce employee exposure to a safe

level.

(vi) Nature of the work operation or process. The type of job

operation, the equipment or tools that will be used, and any motion or

travel the job requires can influence the type of respirator selected.

For example, in the case where respirators are used to protect

employees who are spray painting or working at an open surface tank,

the type of operation can affect the type of respirator selected,

particularly if supplied air respirators, which require a connection to

a clean air source, are used.

(vii) Time period respirator is worn. The employer must also

consider the period of time during which the respirator will be used by

employees during a work shift. Breakthrough times for different

chemicals can vary greatly, and are dependent on the concentrations

found in the workplace. A respirator that provides adequate protection

for one chemical may be inadequate for another chemical with a

different breakthrough time. In addition, employees wearing respirators

for longer periods of time may need different types of respirators for

more comfortable wear.

(viii) Work activities and stress. The work activities of employees

while wearing respirators are also a factor. Heavy work that is

physically draining may affect an employee's capability of wearing

certain types of respirators.

Temperature and humidity conditions in the workplace may also

affect the stress level associated with wearing a respirator as well as

the effectiveness of respirator filters and cartridges. These types of

factors must be assessed in selecting the appropriate equipment for a

particular work situation.

(ix) Fit testing. The proposal includes requirements for fit

testing. The results of these tests are to be used in the selection

process. Some employees may be unable to achieve an adequate fit with

certain respirator models or a particular type of respirator--such as

half mask air-purifying respirators--so an alternative respirator model

with an adequate fit or other type of respirator that provides adequate

protection must be used. Fit test results must be used to determine

when this is the case and what alternative respirator should be

selected.

(x) Warning properties. The warning properties of a hazardous gas

or vapor must also be considered when selecting a respirator. When

using an air purifying respirator the odor, taste, or irritation

effects of the substance present should have a threshold concentration

low enough so that the substance can be detected before health effects

can occur. Also, the detection threshold should be low enough that

olfactory fatigue with subsequent loss of the warning properties of the

chemical cannot occur. This subject is discussed in more detail under

section 5 below.

(xi) Physical characteristics, functional capabilities, and

limitations of respirators. The last category of information to be

considered when selecting respiratory protection is the physical

characteristics, functional capabilities, and limitations of the

respiratory protection equipment itself. For example, airline

respirators should not be used by mobile employees around moving

machinery unless entanglement of airlines in equipment is easily

avoided.

Once the employer has determined what respirator types are

appropriate for the workplace, respirators must be selected from among

those approved and certified according to 42 CFR Part 84 by the

National Institute for Occupational Safety and Health (NIOSH) when such

respirators exist.

3. Use of NIOSH/MSHA Certified Respirators

a. Alternatives. Alternatives to requiring that NIOSH/MSHA

certified respirators be used are limited. Several ANPR commenters

stated that OSHA should allow the use of non-approved respirators for

which scientifically valid test data are available (Ex. 15-11, 15-38,

15-45, 15-53, 15-54, 15-55, 15-56, 15-58, 15-81), where the respirators

were tested by independent laboratories (Ex. 15-10, 15-53) or where the

manufacturer has sound test data (Ex. 15-10, 15-19, 15-53, 15-62, 15-

73). Others insisted that OSHA should not accept respirator

certification from any source other than NIOSH/MSHA (Ex. 15-14, 15-34,

15-46, 15-48, 15-70, 15-75A, 15-77). OSHA regards all such suggestions

as having serious flaws.

Independent certification laboratories for respirators do not yet

exist. An extensive commitment of money and resources would be required

by any private organization establishing such a testing system. Some

believe that if OSHA allows certification of respirators by independent

laboratories, this will encourage the development of such systems.

However, it would be very difficult to write a provision allowing

independent certification systems when none now exist. Developing the

respirator test protocols such independent laboratories would use would

involve a considerable level of effort and would duplicate the revision

efforts already underway by NIOSH to revise the respirator

certification standards. Moreover it would be necessary to establish a

program to certify the testing laboratories as well. The Agency does

not presently have the means to accomplish such assessments, and in

fact, does not have the personnel or resources to become certifiers of

respirators.

OSHA is therefore proposing to maintain the requirement that NIOSH

approved respirators be used when such respirators exist. For OSHA

compliance purposes, a respirator certification program is necessary in

order to assure that respirators used in industry are capable of

providing the needed protection. OSHA recognizes that there are

problems with the existing NIOSH/MSHA certification program. Several of

the comments OSHA received were related to problems with NIOSH/MSHA

respirator certification, including the issue of modifications to

respirators, interchanging of respirator parts and the use of

respirators for which NIOSH has not yet granted approval. Since these

problem areas are being addressed by NIOSH during its revision of the

respirator certification program under the new 42 CFR 84, it is

inappropriate for OSHA to try to correct problems with the present

NIOSH/MSHA regulations in the revised OSHA respirator standard.

b. Approval for modified respirators. Several commenters suggested

that OSHA should not automatically reject the use of approved

respirators that have modifications (Ex. 15-10, 15-19, 15-22, 15-26,

15-31, 15-40, 15-41, 15-45, 15-46, 15-52, 15-54, 15-55, 15-56, 15-62,

15-75c). Modifications could include interchange of parts, canisters,

air hoses, etc. These modifications would have to be evaluated, whether

through testing to demonstrate comparable protection and reliability

(Ex. 15-10, 15-22, 15-31, 15-38, 15-46, 15-50, 15-52, 15-53, 15-54, 15-

55, 15-62, 15-73, 15-75c, 15-81), by requiring that modifications be

done under the auspices of NIOSH (Ex. 15-18, 15-33, 15-38, 15-76), or

by allowing minor modifications if approved by a certified industrial

hygienist (Ex. 15-73). OSHA believes that NIOSH is the appropriate

Agency to consider this issue and that such consideration should be

part of the certification process.

OSHA also believes that the proposed 42 CFR Part 84 is the proper

forum in which to resolve any problems with respirator modifications.

Therefore, this proposal does not change OSHA's general policy of

rejecting modifications to approved respirators.

OSHA invites comment on the question of whether to require NIOSH

approval for the respirators selected, and on alternatives to this

requirement, including practical considerations of compliance and

enforcement.

c. Use of non-approved respirators. Several commenters on the

preproposal draft recommended that OSHA establish procedures for

permitting the use of non-approved respirators. (Ex. 36-22, 36-28, 36-

29, 36-30, 36-36, 36-41, 36-44, 36-45, 36-47, 36-51A, 36-52, 36-53). As

was pointed out, there are types of respiratory protection, such as

supplied air suits for which no NIOSH/MSHA approval schedule currently

exists (Ex. 36-28, 36-29, 36-36, 36-52, 36-53). California OSHA (Ex.

36-44) recommended that OSHA add wording that would give OSHA the

ability to approve respirators that do not have a NIOSH/MSHA approval

schedule. The Industrial Safety Equipment Association (Ex. 36-45)

stated that OSHA should allow the use of non-approved respirators if

data are available to show that they operate satisfactorily. The AIHA

(Ex. 36-41) also recommended that if an employer can demonstrate

effective, safe utilization of a device, then its use should be

permitted. The American Petroleum Institute (Ex. 36-51A) requested that

OSHA permit the use of non-approved respirators when OSHA accepts these

devices based on a case-by-case evaluation of evidence provided by the

employer or manufacturer. They also stated that this method had worked

well in the past for acrylonitrile, mercury, fluorides and vinyl

chloride.

While it is true that OSHA has in the past approved the use of

certain unapproved respirators, this approval has generally been as the

result of a thorough review of the respirators capabilities as part of

a substance specific standard. OSHA does not have the personnel or

facilities to perform respirator testing, and has no present plans to

set itself up as a respirator approval agency. Therefore, this proposed

respirator standard does not contain language which would formalize a

procedure for approving respirators. OSHA invites comment on whether

and how such an approval procedure should be added to the standard.

4. Assigned Protection Factors

The proposal requires that respirators be selected in accordance

with the respirator selection tables in the NIOSH proposed revision of

the tests and requirements for certification of respiratory protective

devices (42 CFR Part 84). The protection factor concept has developed

over the years since OSHA adopted its current standards. It is a

recognition of the fact that different types of equipment provide

different degrees of protection, and equipment limitations must be

considered in selecting respirators.

Three commenters in response to the preproposal draft recommended

that OSHA allow the use of other selection guidelines in addition to

those in the preproposal draft Appendix A. Motorola (Ex. 36-22) stated

that there was great controversy over the assigned protection factors,

and in order to maintain a performance standard approach OSHA should

allow the use of not only the respirator selection tables but the ANSI

Z 88.2 selection tables, or other guidelines published and peer

reviewed by other consensus groups or professional associations.

Homestake Mining (Ex. 36-30) had a similar recommendation, maintaining

that it would allow the employer to use the latest and best information

for respirator selection. They also recommended that a provision be

added to require that employers demonstrate and support their rationale

for using values other than those in the respirator selection tables.

The AIHA (Ex. 36-41) also recommended a similar approach to respirator

selection guidelines.

OSHA believes that the foregoing suggestions are inadequate.

Although the new 1992 ANSI recommendations have now been published, it

is not sufficient for OSHA to reference the ANSI recommended protection

factors because ANSI has provided no discussion of the basis for its

recommendations. Moreover, some of the provisions of the ANSI standard

appear to contradict specific information which OSHA considers

reliable. In particular, the ANSI recommended protection factors

disagree substantially with recommendations by NIOSH. Only if ANSI were

to supply detailed discussion as to how its protection factors were

derived--including reference to and complete description of specific

studies used to derive those APFs--would OSHA be able to evaluate the

merits of the latest ANSI recommendations. Moreover, allowing employers

to select respirators on the basis of different guidelines, with

different APF values, can only bring confusion as to how to comply with

the standard.

OSHA considered establishing assigned protection factor tables

based on existing studies in which performance factors were measured

both in laboratories and in workplaces. The quality of available data,

however, was seen to vary substantially from one type of respirator to

another depending on how much emphasis had been placed on a particular

type of respirator by the organization doing the testing. Moreover, the

results of studies which had been done for a particular purpose may not

necessarily be able to be extrapolated legitimately for use in drawing

other conclusions.

As an example of the widely varying results and quality of

available data, the following is a brief review of studies pertaining

to negative pressure air-purifying respirators. Similar weaknesses in

available data exist for other types of respirators as well.

Negative Pressure Air-Purifying Respirators

Lenhart and Campbell of NIOSH (Ex. 27-2) did workplace performance

testing in 1984 in a primary lead smelter for half mask negative

pressure air-purifying respirators. The resulting report stated that

98% of the workplace protection factors (WPFs) would be at or above 10,

90% above 30, and 75% above 100. It concluded that ``an assigned

protection factor of 10 is appropriate for the half mask negative

pressure air-purifying respirators evaluated in this study'' (Ex. 27-2,

p. 181). Each individual who participated in the study had first

achieved a quantitative fit factor of at least 250 with the half mask

respirator in the fit test booth. For this reason the authors

emphasized that the study's results may overestimate the WPFs that

would be achieved by a general worker population that had not achieved

quantitative fit test results of at least 250.

Skaggs and Loibl of the Los Alamos National Laboratory (Ex. 38-3)

examined the performance of half mask and full facepiece respirators

under simulated work conditions in a controlled environmental chamber.

Three different temperatures (0 deg.c, 20 deg.c, 32 deg.c) and two

humidities (15% and 85%) were examined. Half mask and full facepiece

respirators were worn by test subjects performing work type exercises

such as shoveling oiled gravel, walking up and down stairs, pounding

nails, moving cinder blocks, and pounding with a sledge hammer. During

the prefit respirator fit testing for the half mask, fit factors

ranging from a low of 32 to as high as 20,000 were measured. Fit

factors measured during the simulated work exercises ranged from 16 to

20,000. However, only one of the 49 test subjects who obtained fit

factors during the prefit testing of 100 or greater with the half mask

failed to achieve fit factors of at least 50 during the simulated work

exercises. For the full facepiece respirator the prefit fit factors

ranged from 110 to 20,000 and the simulated work fit factors ranged

between 21 and 20,000. For the 54 test subjects who achieved fit

factors of 500 or greater with the full facepiece respirator during

prefit testing, only one filed to achieve a fit factor of 100 or

greater during the simulated work fit tests.

In the case of full facepiece respirators tested with QNFT, studies

performed by the Los Alamos National Laboratory (LANL) in 1972 (Ex. 24-

2) resulted in a recommendation that full facepiece respirators be

allowed a protection factor of 50. The recommendation was based on QNFT

performed in a test booth on wearers who had been pre-screened in each

case with a qualitative test using irritant smoke. Most of the

respirators tested achieved fit factors into the thousands but one

respirator only achieved fit factors of less than 100. On the bases of

that one respirator the decision was made by LANL to restrict their

recommendation to 50. However, Edward Hyatt, the author of the study,

in his subsequent response to the ANPR, (Ex. 15-27), and in a later

comment on a variance application in 1984 (Ex. 24-11), recommended that

negative full facepiece respirators be assigned a protection factor of

100 provided a fit factor of 1000 could be obtained in the test booth.

It was understood (although not stated in his response) that his reason

for revising his recommendation was that the one respirator which

performed so poorly in the original tests had been taken off the

market.

In November, 1983 researchers from the Lawrence Livermore National

Laboratory published a paper (Ex. 24-9) on reproducibility of fit using

QNFT. One element of the research described in the paper was the

measurement of fits of two brands of full facepiece respirators as well

as fits of half mask respirators of the same two manufacturers. There

are two important aspects of the measurements. First, the poorest

fitting of the full facepiece respirators was more than five times

better than the best fitting half masks respirators. Second; the lowest

fit factor of the full facepiece models was 1,063. Nevertheless, the

range of respirators was very limited.

In October 1984, DuPont submitted to the OSHA asbestos standard

docket an unpublished study of workplace protection factors (WPF) for

disposable half mask respirators, and half mask air-purifying

respirators using either dust/fume/mist filters or high efficiency

filters (Ex. 38-7). The study concluded that all the respirators tested

could reliably provide protection factors of 10, except that one of the

disposable respirators tested could only provide a protection factor of

5. The lower protection provided by the last disposable respirator was

attributed to penetration of asbestos fibers through the filter media.

OSHA considers this study to be inadequate in establishing protection

factors for several reasons. First, asbestos is not typical, in

geometry or migration properties, of the broad range of dusts and mists

that are encountered in workplaces. To assign a general protection

factor based on the almost unique properties of asbestos would be

highly inappropriate. In addition, this particular study was conducted

under special conditions in which the respirators were used in a wet

environment whose effect on fit is difficult to evaluate and whose

effect on penetration would be different for asbestos than for most

other contaminants. In addition the study did not follow NIOSH

analytical guidelines for sampling and counting asbestos fibers. For

example, NIOSH recommends that reliable analysis requires that at least

10 fibers be counted for 100 fields. However, in the DuPont study, 89%

of the analyzable tests (71 out of 80) and filters with in-mask fiber

counts for less than 10 per 100 fields.

The 3M Corporation also submitted an unpublished protection factor

study for disposable respirators used in the presence of asbestos

fibers at the Shiloh Brake Corporation (Ex. 40). Once again, asbestos

fibers, for the reasons given above, are not sufficiently

representative of dusts and mist in most workplaces for use in

establishing general protection factors.

Another unpublished study cited in the record was performed by the

Chemical Manufacturers Association (CMA) at a cadmium pigment

production facility (Ex. 38-22). The entire submission, however,

consisted of four paragraphs of description accompanied by two computer

graphs showing results. There is no discussion of how the tests were

conducted or any description which would enable one to evaluate the

validity of the study or to duplicate the testing. OSHA considers this

submission to be inadequate for meaningful review.

In yet another unpublished study, the 3M Corporation has submitted

results of measurements of protection factors of disposable dust/mist

respirators in the presence of aluminum, titanium, and silicon

particulates (Ex. 41A) The study, which was conducted in October, 1986,

failed to include basic information on concentrations and particle size

distributions. In July, 1988 3M returned to the same site to measure

particle size distribution and in August, 1989 submitted the results to

the record (Ex. 41B). OSHA believes that, to be valid, all supporting

measurements of a study must be made at the time the primary

measurement is made. It is virtually impossible to assure that all

relevant ambient conditions will be identical almost two years later to

what they were at the time of the original test. Moreover, the data

submitted by the 3M Corporation in August, 1989 had serious anomalies

which were unaccounted for in the accompanying discussion. For example,

the mass distribution in the stages of various impactors could be

accounted for only by circumstances which would be very unusual. Some

impactors had few or no particles of any size. Others had only very

large particles and very small particles. In the latter case, the

report referred to the possibility of a bimodal distribution, but

supplied no physical reasons based on actual workplace conditions to

account for such a distribution.

In general, unpublished studies such as those cited above are

difficult to evaluate since significant details are often absent in the

discussions and there has been no peer review of the assumptions,

methods, and plausibility of results.

By contrast, a published workplace protection factor study by NIOSH

(Ex. 38-2) of the performance of disposable dust mist respirators

provides results showing lower protection factors which cannot be

ignored. The study determined the effectiveness of a disposable dust/

mist respirator against overexposure to nuisance particulate dust (Ex.

38-2). A total of 25 paired samples were taken, each consisting of a

measurement inside the probed respirator and one at the lapel. Seven

workers and two NIOSH industrial hygienists were sampled. Quantitative

facepiece fit testing was performed to check for gross leakage. NIOSH

calculated that ``95% of workplace protection factors would be expected

to be at or above 3, 87% at or above 5, 70% above 10, and only 7% would

be expected to be above 100.'' Nevertheless, despite the fact that the

data seemed to predict a protection factor of 3 at the 95% confidence

level, NIOSH concluded that an ``assigned protection factor of 5 for

disposable half mask respirators is not discredited by the results of

this study.'' However, it involved only seven subjects and thus the

range of facial sizes and structures involved were limited.

The foregoing studies pertaining to negative pressure air-purifying

respirators demonstrate the wide variability in applicability of such

studies in the determination of assigned protection factors. Therefore,

OSHA decided that these available studies as well as those in other

respirator categories are inadequate for a well founded assignment of

protection factors.

In view of this apparent inadequacy, OSHA has determined that in

order to establish assigned protection factors, there must be a program

to conduct experimental evaluations of respirator performance.

Therefore, OSHA and NIOSH have agreed that the assignment of protection

factors should be made by NIOSH. It is OSHA's intention in this

rulemaking that protection factors shall be assigned by NIOSH in its

ongoing rulemaking for its certification program. (The first phase of

this rulemaking was published in the Federal Register as a proposed

rule at 59 FR 26850 on Tuesday, May 24, 1994 as 42 CFR Part 84.) When

NIOSH completes its rulemaking process of assigned protection factors,

OSHA will issue a technical amendment to this respiratory protection

standard referring to the NIOSH final regulation. OSHA does not intend

to have notice and comment on its technical amendment because NIOSH

will have notice and comment in its rulemaking. In the period before

NIOSH has completed promulgating 42 CFR Part 84, OSHA will, in the

interim, require that respirators be selected in accordance with the

protection factors assigned by NIOSH in the current NIOSH Respirator

Decision Logic (Ex. 38-20).

The NIOSH protection factor values are not intended to replace

protection factor values which, in individual substance specific OSHA

standards, are more stringent. Thus, the OSHA provision which defers to

the NIOSH protection factor tables is not to be interpreted, for

example, as overriding the OSHA asbestos standard which does not permit

the use of disposable respirators at all. Nor does this provision

preclude OSHA's prerogative to assign more conservative protection

factors under circumstances demonstrated in the records of future

substance specific rulemakings.

Finally, it is OSHA's understanding that respirators certified

under 30 CFR Part 11, depending on the type, will continue to be NIOSH

certified for a period of time after the effective date of 42 CFR Part

84. This ``sunset'' provision will continue to allow existing

certifications while respirators that meet the new requirements of 42

CFR Part 84 are developed and certified. Following the sunset period

for each type of respirator, only those certifications granted under 42

CFR Part 84 will be valid. During the sunset period, OSHA will require

that protection be assigned as prescribed in 42 CFR Part 84 for

respirators previously certified under 30 CFR Part 11. The new NIOSH

regulation will also provide assigned protection factor values for

respirators certified under the new requirements.

5. Warning Properties

The question of whether OSHA should permit the use of air-purifying

respirators where substances have inadequate warning properties has

been of serious concern for several years. Some commenters to the ANPR

felt that air-purifying respirators should only be used for chemicals

that have adequate warning properties (Ex. 15-33, 15-34, 15-46, 15-48,

15-70). Others felt that respirator use should not be restricted based

on poor warning properties, but that OSHA should identify a control

mechanism that would allow their use (Ex. 15-18, 15-19, 15-22, 15-26,

15-50, 15-54, 15-55, 15-58, 15-62, 15-66, 15-73). Several commenters

felt it should not be necessary for a chemical always to present

distinct warning properties (Ex. 15-27A, 15-31, 15-38, 15-41, 15-44,

15-45, 15-47). For example, reliance on an industrial hygienist's

professional judgment, along with an evaluation as described in the

OSHA Industrial Hygiene Field Operations Manual (now called the

Industrial Hygiene Technical Manual), was recommended by the American

Iron and Steel Institute (Ex. 15-37). Others stated that if the

contaminant concentration was monitored and the absorption capabilities

of the respirator cartridge for that chemical are known, the service

life of the cartridge can be safely calculated (Ex. 15-17, 15-53). The

use of a monitoring device that would give sound and visual signals was

recommended as an alternative to requiring that air-purifying

respirators be used only for chemicals with adequate warning properties

(Ex. 15-10).

OSHA currently does not allow air-purifying respirators to be used

when a gas or vapor has inadequate warning properties, except in the

case of a few designated chemicals for which specific standards were

promulgated, such as vinyl chloride, ethylene oxide and acrylonitrile.

The departures from the prohibition on using air-purifying respirators

for substances with poor warning properties were established in each

case as part of an overall rulemaking for each chemical, which included

a careful examination of industry exposure levels and respirator use

factors.

Allowing such use would require an examination of the toxicity of

the chemical, its odor threshold, the health consequences of particular

exposure levels, breakthrough time for the chemical for the type of

respirator that will be used, how long the respirator will be used

during the workshift, and the concentrations of the chemical that are

found in the workplace. Calculating the service life of a particular

respirator cartridge or canister for a chemical with poor warning

properties would be possible using these facts and an appropriate

safety factor. This service life calculation may be difficult where

workplace exposure levels vary greatly throughout the day and from day

to day. Using continuous monitoring devices with alarms, as was

suggested by some of the commenters, is another possibility. Continuous

monitoring is complicated, expensive, and would require a case-by-case

review of each plant situation to determine the ability of the

monitoring system. Therefore, this proposal has not considered the use

of continuous monitoring devices when determining where respirators can

be used.

Motorola (Ex. 36-22) recommended that OSHA allow the use of air-

purifying respirators for chemicals with poor warning properties if the

respirator had a reliable end of service life indicator or an air-

purifying cartridge and/or filter change schedule had been implemented,

and the use of supplied air respirators would hamper an operation or

increase risk. If the employer could not demonstrate the acceptability

of the respirator according to these conditions, supplied air

respirators would be required. Homestake Mining (Ex. 36-30) also

recommended the same conditions along with the requirement for

biological monitoring to demonstrate respirator effectiveness, where

applicable. DuPont (Ex. 36-38) also recommended that air-purifying

respirators be allowed for chemicals with poor warning properties when

supplied air respirators cannot be used, with the conditions that a

reliable end of service life indicator and appropriate cartridge change

schedule be used. The AIHA (Ex. 36-44), Richard Boggs of ORC (Ex. 36-

47), and Thomas Nelson of the ANSI Z 88.2 respirator committee (Ex. 36-

55) described similar conditions for the use of air-purifying

respirators for chemicals with poor warning properties. Mr. Nelson also

wanted to limit their use to concentrations of the contaminant less

than 10 times the PEL or TLV.

The ANSI Z 88.2-1992 respiratory protection standard in section

7.2.2.2 (m) would allow the use of an air purifying respirator for a

gas or vapor with poor warning properties only when (1) the air

purifying respirator has a reliable end of service life indicator that

will warn the user prior to contaminant breakthrough, or (2) a

cartridge change schedule is implemented based on cartridge service

data including desorption studies (unless cartridges are changed

daily), expected concentration, pattern of use, and duration of

exposure have been established, and the chemical does not have a

ceiling limit.

OSHA agrees that there are circumstances under which it may be safe

or necessary to use air-purifying respirators despite the absence of

adequate warning properties. In doing so, however, two factors must be

considered: breakthrough of the cartridge and face seal leakage.

Cartridge breakthrough can be addressed by use of end-of-service-life

indicators that are approved by NIOSH or by implementation of a filter

change schedule based on documented service life data, exposure levels

and exposure durations. Face seal leakage is not addressed directly

except by requiring fit testing. Therefore, OSHA is proposing that the

use of air-purifying respirators in the absence of adequate warning

properties be restricted to situations where the odor, taste, or

irritation threshold is not more than three times the hazardous

exposure level. Since the least effective respirator with a chemical

cartridge in the proposed NIOSH 42 CFR Part 84 respirator selection

tables has an Assigned Protection Factor of 10, then if the level at

which the warning property exists is within three times the hazardous

exposure level, OSHA believes that a sufficient margin of safety will

be provided, since even a partial breakthrough is unlikely to reduce

the protection factor from 10 down to three under the foregoing

restrictions on use.

6. Oxygen Deficient and Oxygen Deficient IDLH Atmospheres

This proposal requires that only atmosphere-supplying respirators

be used in oxygen deficient atmospheres. In oxygen deficient IDLH

atmospheres either a full facepiece pressure demand SCBA or a

combination full facepiece pressure demand supplied air respirator with

auxiliary self-contained air supply must be used. A critical issue is

the definition of what constitutes oxygen deficient and oxygen

deficient IDLH atmospheres.

Table I of paragraph (d) presents in tabular form the oxygen

percentages below which the terms oxygen deficient and oxygen deficient

IDLH atmosphere apply--as a function of altitude above sea level.

By referring to the information in this table, an employer can

readily pick out the appropriate type of respirator required at various

altitudes and oxygen levels. OSHA chose to use an equivalent table of

oxygen levels for simplicity, rather than incorporating a calculation

formula as ANSI did in its Z88.2-1980 standard, like the table in the

ANSI Z88.2-1992 standard on the combined effects of altitude and

reduced percentage of oxygen.

Numerous comments were submitted in response to both the

preproposal draft and the ANPR on the definition of oxygen deficient

and oxygen deficient IDLH atmospheres (Ex. 15-14, 15-19, 15-26, 15-27A,

15-31, 15-33, 15-35, 15-37, 15-38, 15-46, 15-52, 15-53, 15-55, 15-58,

15-62, 15-70, 36-13, 36-17, 36-18, 36-22, 36-26, 36-27, 36-29, 36-30,

36-31, 36-32, 36-34, 36-38, 36-39, 36-40, 36-41, 36-44, 36-47, 36-52,

36-53, 36-54, 36-55). All suggestions were based on the concept of a

minimum value for oxygen partial pressure in the upper portion of the

lungs. Most commenters agreed with the ANSI Z88.2-1980 partial pressure

value of 100 mm Hg below which an oxygen deficient IDLH atmosphere

exists. There was, however, disagreement as to the oxygen partial

pressure at which an oxygen deficient atmosphere is considered to

exist.

Oxygen Deficient Atmospheres

The Los Alamos National Laboratory (LANL) recommended the use of an

oxygen partial pressure of 125 mm Hg, which corresponds to a 16.5%

oxygen level at sea level, as the point below which an oxygen deficient

atmosphere exists for altitudes up to 7,000 feet (Ex. 36-52). Above

7,000 feet LANL recommended that any reduction in ambient air oxygen

content (20.95%) be considered oxygen deficient. California OSHA (Ex.

36-44) recommended oxygen levels below 19.5% for altitudes from 0 to

5,000 feet, 20.5% for altitudes between 5,001 and 9,000 feet, and

20.95% for altitudes above 9000 feet be considered as oxygen

deficiencies.

The ANSI Z88.2-1992 standard radically lowered the recommendation

for oxygen-deficiency non-IDLH atmospheres to one with an oxygen

partial pressure ranging between 95 mm Hg pp O2 (12.5% oxygen at

sea level atmospheric pressure) to 122 mm Hg (16% oxygen at sea level).

Under these conditions a supplied air respirator is required. Where

oxygen levels are 95 mm Hg or less, an oxygen-deficiency IDLH

atmosphere would exist, and would require the use of a positive

pressure SCBA or a combination supplied air respirator with SCBA.

However, where oxygen levels are above 16% supplied air respiratory

protection would not have to be used for protection against oxygen

deficiency.

For confined spaces, the ANSI Z88.2-1992 standard would consider

any reduction in oxygen level below 20.9% an IDLH atmosphere unless the

source of the oxygen reduction is understood and controlled. However,

it would permit entry into a confined space that contains between 16%

and 20.9% oxygen (at sea level) without any respiratory protection if

extraordinary precautions are taken to assure that the worker would not

encounter any poorly ventilated areas. OSHA considers any location with

an oxygen level that is reduced below 19.5% to be an oxygen deficient

atmosphere requiring the use of at least a supplied air respirator as a

minimum.

An incident recently occurred that illustrates the problem with the

ANSI oxygen deficiency definition. Two well cleaners died in the

confined space of a shallow well. They had no fans to ventilate the

well, and only crude homemade equipment for lowering someone into the

well. After being lowered into the well, the first cleaner complained

of lightheadedness. His partner was lowered into the well to attempt a

rescue. The crude retrieval equipment broke under the weight of the two

cleaners. Both were overcome by the low oxygen levels and died of

asphyxiation and drowning. The oxygen level in the well was 17%, as

measured by the firefighters who removed the bodies. By reducing the

oxygen deficient IDLH level to 16% and permitting entry without

respiratory protection at oxygen levels between 16% and 19.5%, the ANSI

standard would permit such dangerous practices. The need for

extraordinary precautions, as ANSI recommends, will not be recognized

by many who choose only to see that the oxygen deficiency levels have

been reduced.

NIOSH approves air-purifying respirators for use only in

atmospheres containing 19.5% oxygen. Moreover, Grade D breathing air is

and has been considered the acceptable standard for such air and Grade

D breathing air contains, by definition, a minimum of 19.5% oxygen.

Since OSHA requires that NIOSH approved respirators be used, and that

grade D breathing air be used for supplied air respirators, OSHA is

proposing the 19.5% oxygen level as the point below which an oxygen

deficient atmosphere exists. Oxygen partial pressure decreases as

altitude increases. At 8,000 feet a 19.5% oxygen level still

corresponds to an oxygen partial pressure above 100 mm Hg, the level

where an oxygen deficient IDLH atmosphere would begin. Therefore, for

altitudes up to 8,000 feet any decrease in oxygen level below 19.5% is

considered an oxygen deficient atmosphere and the use of atmosphere-

supplying respirators would be required. For altitudes above 8,000

feet, an oxygen level below 19.5% would constitute an oxygen deficient

IDLH atmosphere. Column 2 of Table I presents the percent oxygen levels

below which an oxygen deficient atmosphere exists for altitudes from

sea level to 8,000 feet. Comments are requested on the values in the

table.

Oxygen Deficient IDLH Atmospheres

Many commenters felt that the ANSI Z88.2-1980 definition of an

oxygen deficiency-IDLH atmosphere was satisfactory (Ex. 15-14, 15-19,

15-26, 15-27A, 15-31, 15-33, 15-35, 15-37, 15-38, 15-46, 15-52, 15-53,

15-55, 15-58, 15-62, 15-70, 15-71). ANSI in its 1980 standard (Ex. 10)

defines an oxyge

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