DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926

[Docket No. H049]

RIN 1218-0099

Respiratory Protection

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

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

SUMMARY: OSHA is proposing to modify its existing standards on respiratory protection (29 CFR 1910.134, 29 CFR 1915.152 and 29 CFR 1926.103). The current respirator standard was adopted from a voluntary consensus standard in 1971. Since that time, changes in methodology, technology, and approach related to respiratory protection have occurred, which OSHA's standard does not include. The purpose of this rulemaking is to update the current standard to reflect these changes so that employers will provide effective protection for employees who wear respirators.

The proposed standard includes requirements for a written respiratory protection program; procedures for selecting respirators; requirements for medical evaluation; procedures for fit testing; requirements for using respirators; procedures for maintaining respirators; training; criteria for evaluating program effectiveness. Public hearings are being scheduled to provide interested parties the opportunity to orally present information and data related to the issues raised by this proposed rule.

DATES: Written comments on the proposed standard must be postmarked on or before February 13, 1995. Notices of intention to appear at the informal public hearings on the proposed standard must be postmarked by January 27, 1995. Parties who request more than 10 minutes for their presentations at the informal public hearing and parties who will submit documentary evidence at the hearing must submit the full test of their testimony and all documentary evidence postmarked no later than February 13, 1995. The hearing will take place in Washington, D.C. and is scheduled to being on March 7, 1995 and continue until Friday, March 24, 1995.

ADDRESSES: Written comments should be submitted in quadruplicate or 1 original (hardcopy) and 1 disk (5 1/4 or 3 1/2 ) in WordPerfect 5.0, 5.1, 6.0 or ASCII to: The Docket Office, Docket H-049, U.S. Department of Labor, Occupational Safety and Health Administration, Room N2625, 200 Constitution Avenue, N.W. Washington, D.C. 20210; (202) 219-7894. (Any information not contained on disk, e.g., studies, articles, etc., must be submitted in quadruplicate.) Notices of intention to appear at the informal rulemaking hearing, testimony, and documentary evidence are to be submitted in quadruplicate to: Mr. Tom Hall, OSHA Division of Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, N.W., Room N3649, Washington, D.C. 20210; (202) 219-8615. Written comments received, notices of intention to appear, and all other material related to the development of this proposed standard will be available for inspection and copying in the public record in the Docket Office, Room N2439, at the above address.

The hearing will be held in the auditorium of the U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC.

FOR FURTHER INFORMATION CONTACT: Proposal: Ms. Anne Cyr, Office of Information and Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, N.W., Room N3647, Washington, D.C. 20210; (202) 219-8151.

Hearings: Mr. Tom Hall, Division of Consumer Affairs, Occupational Safety and Health Administration, 200 Constitution Avenue, N.W., Room N3649, Washington, D.C. 20210; (202) 219-8615.

SUPPLEMENTARY INFORMATION:

I. Clearance of Information Collection Requirements

5 CFR Part 1320 sets forth procedures for agencies to follow in obtaining OMB clearance for information collection requirements under the Paperwork Reduction Act of 1980, 44 U.S.C. 3501 et seq. The proposed revised respirator standard requires employers to allow OSHA access to records. In accordance with the provisions of the Paperwork Reduction Act and the regulations issued pursuant thereto, OSHA certifies that it has submitted the information collection requirements for this proposed rule on respiratory protection to OMB for review under Section 3504(h) of that Act. OMB has approved (OMB number 1218-0099) in concept the submitted information collection activities contained in the proposed revision pending public consideration and comment.

Public reporting burden for this collection of information is estimated to be five minutes per response. Send comments regarding this burden estimate or any other aspect of this collection of information, to the Office of Information Management, Department of Labor, Room N-1301, 200 Constitution Avenue, NW., Washington, DC 20210; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Paperwork Reduction Project (1218-AA05), Washington, DC 20503.

II. Introduction

A. Format of the Preamble

The preamble accompanying this notice of proposed rulemaking is divided into fifteen parts, numbered I through XV. The following is a table of contents:

I. Clearance of Information Collection Requirements II. Introduction A. Format of the Preamble B. History of the Development of Respiratory Protection C. Respirator Use D. Types of Respiratory Hazards E. Limitations of Respiratory Use III. Legal Authority IV. Background A. Regulatory History B. Need for the Standard C. Recognition of the Need for a Standard by Other Groups V. Certification/Approval Procedures VI. Summary of the Preliminary Regulatory Impact Analysis and Regulatory Flexibility Analysis and Environmental Impact Assessment VII. Summary and Explanation of the Proposed Standard A. Scope and Application B. Definitions C. Respiratory Protection Program D. Selection of Respirators E. Medical Evaluation F. Fit Testing Procedures G. Use of Respirators H. Maintenance and Care of Respirators I. Supplied Air Quality and Use J. Identification of Filters, Cartridges, and Canisters K. Training L. Respiratory Protection Program Evaluation M. Recordkeeping and Access to Records N. Substance Specific Standards O. Maritime Standards P. Construction Advisory Committee VIII. References IX. Public Participation -- Notice of Hearings X. Federalism XI. State Plan Standards XII. List of Subjects XIII. Authority and Signature XIV. Proposed Standard and Appendices XV. Proposed Substance Specific Standards Revisions

B. History of the Development of Respiratory Protection

The concept of using respiratory protective devices to reduce or eliminate hazardous exposures to airborne contaminants first came from Pliny (c. A.D. 23-79) who discussed the use of loose fitting animal bladders in Roman mines to protect workers from the inhalation of red oxide of lead (1,2). Later, in the 1700's, the ancestors of modern atmosphere-supplying devices, such as the self-contained breathing apparatus or hose mask, were developed. Although the devices themselves have become more sophisticated in design and materials, respirators' performance is still based on one of two basic principles; purifying the air by removing contaminants before they reach the breathing zone of the worker, or providing clean air from an uncontaminated source.

In 1814, a particulate-removing filter encased in a rigid container was developed -- the predecessor of modern filters for air-purifying respirators. In 1854, it was recognized that activated charcoal could be used as a filtering medium for vapors. World War I and the use of chemical warfare also resulted in improvement in the design of respirators. Overall, there have been few major developments in the basic design of respirators over the years except for the resin-impregnated dust filter in 1930. This development has made available efficient, inexpensive filters that have good dust-loading characteristics and low breathing resistance. Another more recent development is the ultrahigh efficiency filter made from paper that contains very fine glass fibers. These extremely efficient filters are used for very small airborne particles and produce little breathing resistance.

C. Respirator Use

The purpose of a respirator is to prevent the inhalation of harmful airborne substances. Functionally, a respirator is designed as an enclosure which covers the nose and mouth or the entire face or head. Respirators are of two general "fit" types: Tight fitting (i.e., quarter masks, which cover the mouth and nose, and where the lower sealing surface rests between the chin and the mouth; the half mask, which fits over the nose and under the chin; and the full facepiece, which covers from the hairline to below the chin), and loose fitting (i.e., hoods, helmets, blouses, or full suits which cover the head completely). There are two major classes of respirators: Air-purifying respirators (devices which remove contaminants from the air), and atmosphere-supplying respirators (those which provide clean breathing air from an uncontaminated source).

Air-purifying respirators are grouped into three general types:

Particulate removing, vapor and gas removing, and combination. Elements which remove particulates are called filters, while vapor and gas removing elements are called either chemical cartridges or canisters. Filters and canisters/cartridges are the functional portion of air-purifying respirators, and they can generally be removed and replaced once their effective life has expired. The exception would be disposable respirators, those which cannot be cleaned and disinfected or resupplied with an unused filter after use. Combination elements that protect for both particulates and vapors and gases are also available.

Particulate-removing respirators are designed to reduce inhaled concentrations of nuisance dusts, fumes, mists, toxic dusts, radon daughters, asbestos containing dusts or fibers, or any combination of these substances, by filtering some of the contaminants from the inhaled air before they enter the breathing zone of the worker. They may have single use or replaceable filters. These respirators may be non-powered or powered air-purifying (using a blower to pull contaminated air through a filter; the resulting cleaned air is blown on the face).

Vapor and gas removing respirators are designed with sorbent elements (canisters or cartridges) that adsorb and/or absorb the vapors or gases from the contaminated air before they enter the breathing zone of the worker. Combination cartridges and canisters are available to protect against both particulates and vapors and gases.

Atmosphere-supplying respirators are respirators which provide air from a source independent of the surrounding atmosphere instead of removing contaminants from the atmosphere. These respirators are classified by the method by which air is supplied and the way in which the air supply is regulated. Basically, these methods are: Self-contained breathing apparatus (air or oxygen is carried in a tank on the worker's back, similar to SCUBA gear); supplied air respirators (compressed air from a stationary source is supplied through a high pressure hose connected to the respirator); and combination self-contained and supplied air respirators.

D. Types of Respiratory Hazards

Respiratory hazards may result from either an oxygen deficient atmosphere or from breathing air contaminated with toxic particles, vapors, gases, fumes or mists. The proper selection and use of a respirator depends upon an initial determination of the concentration of the hazard or hazards present in the workplace.

Contaminants are classified as particulate contaminants, which include mechanical dispersoids, condensation dispersoids, dusts, sprays, fumes, mists, fogs, smokes, and smogs; and vapors or gases which include acids, alkalines, organics, organometallics, hydrides, and inert materials.

The particulates may be dusts such as clays, limestone, gypsum, or aluminum oxides; inert pulmonary reaction producing substances such as silicates; minimal pulmonary fibrosis producing substances such as iron oxide or tin oxide; extensive pulmonary fibrosis producing substances such as free silica or asbestos; chemical irritants such as acids or alkalies; systemic poisons such as pesticides, hydrogen cyanide or lead; allergy producing substances such as cotton, isocyanates, epichlorohydrin, fur fibers, or vegetable fibers; and febrile-reaction producing agents such as bagasse, or copper and zinc oxide; and biological materials.

The gaseous air contaminants include irritants such as nitrogen dioxide, phosgene, and arsenic trichloride; asphyxiants such as carbon monoxide, and hydrogen cyanide; anesthetics such as nitrous oxide, hydrocarbons, and ethyl and isopropyl ether; and systemic poisons such as carbon tetrachloride.

E. Limitations of Respirator Use

Not all workers can wear respirators. Individuals with impaired lung function, due to asthma or emphysema for example, may be physically unable to wear a respirator. Individuals who cannot get a good facepiece fit, including those individuals whose beards or sideburns interfere with the facepiece seal, will be unable to wear tight fitting respirators. Determination of adequate fit is required for a respirator to be effective.

In addition to the problems with usage already discussed, respirators may also present communication problems, vision problems, fatigue and reduced work efficiency. Nonetheless, it is sometimes necessary to use respiratory protection as the means of control.

In principle, respirators frequently may be capable of providing adequate protection. However, problems associated with selection, fit, and use often render them ineffective in actual application, preventing the assurance of consistent and reliable protection; regardless of the theoretical capabilities of the respirator. Occupational safety and health experts have spent considerable effort over the years developing fit testing procedures and methods of measuring respirator protection so that these adverse variables can be better controlled, thereby improving protection for those employees required to wear them.

The comments which resulted from the Advance Notice of Proposed Rulemaking (ANPR) that was published by OSHA on May 14, 1982 (47 FR 20803) suggest that one method for controlling some of the problems associated with respirator selection, fit, and use is to describe clearly the steps to be followed in administering a program to protect employees required to wear respirators. The modifications in this proposal are also intended to upgrade the provisions in Sec. 1910.134 to reflect the current state of the art in respiratory methodology and technology.

III. Legal Authority

Authority for issuance of this proposed revised standard is found primarily in sections 6(b), 8(c), and 8(g)(2) of the Occupational Safety and Health Act of 1970 (the Act), 29 U.S.C. 655(b), and 657(g)(2).

Section 6(b) authorizes the Secretary to "by rule promulgate, modify, or revoke any occupational safety and health standard." This notice is the first mandatory step in the procedure prescribed for promulgating such new or modified standards.

The Congress specifically mandated that:

The Secretary, in promulgating standards dealing with toxic materials, or harmful physical agents under this subsection, shall set the standard which most adequately assure, to the extent feasible, on the basis of the best available evidence, that no employee will suffer material impairment of health or functional capacity even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life. Development of standards under this subsection shall be based upon research, demonstrations, experiments, and such other information as may be appropriate. In addition to the attainment, of highest degree of health and safety protection for the employee, other considerations shall be the latest available scientific data in the field, the feasibility of standards, and experience gained under this section and other health and safety laws. (Section 6(b)(5).

The revisions which OSHA proposes would update current standards concerning respiratory protection mainly by incorporating technological advances and by expanding certain respirator program elements such as fit testing and by clarifying other provisions.

These revisions are intended to ensure that employees who use respirators to protect them from workplace atmospheric contamination, will be protected to the technical limitations of the devices they wear. Protection from exposure to workplace airborne contaminants is one of the major goals of the Act and a major mission for the Agency, since the risk to employees of chronic and acute disease because of exposure to toxic substances is substantial and well documented (see e.g., preamble to 29 CFR Part 1910, Air Contaminants, Proposed Rule, at 53 FR 20960 et seq.) Similarly, these regulations need to be updated to assure that employees are protected to the extent that currently available technology permits. Therefore OSHA finds that revisions to these regulations governing respiratory protection are clearly necessary and appropriate to protect employees against the risk of material impairment of health or functional capacity and are issued pursuant to the authority of section 6(b)(5) of the Act).

Authority to issue this standard is also found in section 8(c) of the Act. In general, this section empowers the Secretary to require employers to make, keep, and preserve records regarding activities related to the Act. In particular, section 8(c) gives the Secretary authority to require employers to "maintain accurate records of employee exposures to potentially toxic materials or harmful physical agents which are required to be monitored or measured under section 6." Provisions of OSHA standards which require the preparation and monitoring of exposure records, such as contained in a written respirator program, are also issued pursuant to section 8(c) of the Act.

The Secretary's authority to issue this proposed standard is further supported by the general rulemaking authority granted in section 8(g)(2) of the Act. This section empowers the Secretary "to prescribe such rules and regulations as he may deem necessary to carry out [his] responsibilities under the Act" -- in this case as part of or ancillary to, a section 6(b) standard. The Secretary's responsibilities under the Act are defined largely by its enumerated purposes, which include:

Encouraging employers and employees in their efforts to reduce the number of occupational safety and health hazards at their places of employment, and to stimulate employers and employees to institute new and to perfect existing programs for providing safe and healthful working conditions (29 U.S.C. 651(b)(1));

Authorizing the Secretary of Labor to set mandatory occupational safety and health standards applicable to business affecting interstate commerce, and by creating an Occupational Safety and Health Review Commission for carrying out adjudicatory functions under the Act; (29 U.S.C. 651(b)(3));

Building upon advances already made through employee and employer initiative for providing safe and health working conditions (29 U.S.C. 651(b)(5));

By providing for the development and promulgation of occupational safety and health standards; providing for appropriate reporting procedures with respect to occupational safety and health which procedures will help achieve the objectives of this Act and accurately describe the nature of the occupational safety and health problem; exploring ways to discover latent diseases, establishing causal connections between diseases and work in environmental conditions * * * (29 U.S.C. 651(b)(6));

Encouraging joint labor-management efforts to reduce injuries and diseases arising out of employment (29 U.S.C. 651(b)(13));

And developing innovative methods, techniques, and approaches for dealing with occupational safety and health problems (29 U.S.C. 651(b)(5)).

Because this proposed revised standard is reasonably related to these statutory goals, the Secretary finds that this standard is necessary to carry out his responsibilities under the Act.

In addition, section 4(b)(2) of the Act provides for OSHA standards to apply to construction and other work places where the Secretary determines these standards to be more effective than existing standards which otherwise apply to those workplaces. So we are applying them to construction and maritime.

The Supreme Court's benzene decision (Industrial Union Department, AFL-CIO v. American Petroleum Institute. 448 U.S. 601) requires OSHA, in general, to make a "significant risk determination" before issuing health and safety standards. It is clear that exposure to hazardous air contaminants in the workplace poses significant risks to workers. Where engineering controls cannot be used to reduce exposures below hazardous levels, respirators properly selected, fitted and worn can contribute substantially to a reduction in the level of air contaminants reaching the employee's breathing zone. Under the current respiratory protection standard, which lacks adequate requirements for fit testing, selection, medical evaluation, use, maintenance, and respiratory protection program provisions, employees wearing respirators are receiving less protection than the respirators can potentially give, and in some cases may suffer exposure to hazards as a result of improper respirator use. The significant risk to employees therefore has not been adequately reduced by the existing respirator standard.

The enforcement experience of OSHA and various state health agencies demonstrate the wide-spread nature of defects in respirator programs while the unamended respirator standard has been in effect. From fiscal 1977 to 1982, 58% of inspected worksites where respirators were used to protect against excessive levels of air contamination had deficiencies in at least one respirator area, including respirator fit condition, unapproved or unsuitable respirators, and lack of continuous wear (Ex. 33-5). Inadequate supervision of respirator use was cited as a major cause of improper and ineffective usage by the North Carolina Department of Labor, Kentucky's Department of Labor and Virginia's Bureau of Occupational Health (Docket H-160, Ex. 2-69, 2-103, 2-129). These state plan states have respirator standards that are the same as OSHA's unamended standard.

OSHA cannot precisely quantify the risk to employees whose employers rely on inadequate respiratory protection programs to protect them against excessive levels of atmospheric contamination. However, the widespread levels of improper use of respirators put at significant risk employees who, at least some of the time, are overexposed to air contaminants. Based on OSHA's experience that one half of workplaces using respirators use them incorrectly under the current standard, even a small improvement in respirator use should work a significant reduction in the risk of developing adverse health effects because of preventable misuse of respirators. OSHA believes that a greater benefit will result from the imposition of these revised requirements for the following reason.

Each controllable variable of respirator performance, i.e., initial fit, appropriateness of selection, and consistency of use is addressed by these revisions. The proposed requirement for a program administrator, for example, addresses the concerns of many commenters that proper supervision is the core of an adequate respirator program and effective respirator performance. Required fit testing protocols are proposed to assure that the respirator does not leak around the face, is comfortable and that the employee is taught how to properly tension straps for optimum fit and comfort. Thus the proposed revised standard with its provisions for quantitative and qualitative fit testing, improved and clarified respirator selection, use, and maintenance, will increase the effectiveness of respirators worn in the workplace and significantly reduce the risks to employees to a greater degree than the present standard.

OSHA has quantified the risk and reduction of risk as part of the regulatory analysis and regulatory flexibility analysis, Section VI of the preamble. That analysis clearly shows that workers wearing respirators under the requirements of the current standard are exposed to a significant risk of chronic and acute health effects because of the inadequacies of the present standard. OSHA seeks comment on the issue of significant risk and how the proposed respirator standard revisions will affect that risk, along with any comment on the regulatory analysis performed by OSHA and all other issues related to significant risk.

IV. Background

A. Regulatory History

Congress created the Occupational Safety and Health Administration (OSHA) in 1970, and gave it the responsibility for promulgating standards to protect the health and safety of American workers. As directed by Congress in the Occupational Safety and Health Act, OSHA adopted existing Federal or national consensus standards, developed by various organizations such as the American Conference of Governmental Industrial Hygienists (ACGIH) and the American National Standard Institute (ANSI). The ANSI standard Z88.2-1969, "Practices for Respiratory Protection" (3), is the origin of the first six sections of OSHA's 29 CFR 1910.134, "Respiratory Protection" (4). The seventh section is a direct, complete inclusion of ANSI Standard K13.1-1969, "Identification of Gas Mask Canisters." Until the adoption of these standards by OSHA, most guidance on respiratory protective device use in hazardous environments was advisory rather than mandatory.

The construction industry standard for respiratory protection, 29 CFR 1926.103, was promulgated in April 1971. On February 9, 1979, 29 CFR 1910.134 was formally recognized as also being applicable to the construction industry (44 FR 8577) (4). OSHA is required under the OSH Act to seek the advice of an existing advisory committee when promulgating a rule which will affect an industry represented by the committee. In view of the application of the respirator protection standard to the construction industry, OSHA distributed copies of the draft of this proposed revised standard on September 20, 1985 to the Construction Advisory Committee for review and discussion at their next meeting in February 1986 so that the Construction Advisory Committee could prepare its official response. The response that was received from the committee was considered in revising the draft proposal as discussed later in this preamble.

The maritime standards were originally promulgated in the 1960's under a different codification in the CFR by agencies which preceded OSHA. The present code designations and their promulgation dates are, as follows: 29 CFR 1915.82, February 20, 1960 (25 FR 1543); 29 CFR 1916.82, January 22, 1963 (28 FR 547); 29 CFR 1917.82, March 27, 1964 (29 FR 4052); and 29 CFR 1918.102, February 20, 1960 (25 FR 1565) (4).

The current 29 CFR 1910.134 requires that the employer establish and implement a comprehensive respiratory protection program. The program is to contain written procedures and provide for proper cleaning, disinfection, storage, inspection and maintenance of the respirators. General provisions are set forth on fitting and training. Requirements are included for quality of breathing air and practices to ensure that it is not contaminated. Provisions for emergencies and for communication and rescue in atmospheres immediately dangerous to life or health are specified. A color code for gas mask cansisters is detailed and other provisions are included.

The current standard requires the employer to instruct and train employees "in the proper use of respirators and their limitations." The additional provisions of the proposal amplify the current requirements by specifying, for example, that the training program include instruction in procedures for inspection, donning and removal, checking the fit, and sufficient practice to enable the employee to become thoroughly familiar and confident with the use of the respirator. OSHA believes, based on its experience promulgating and enforcing respirator provisions in other health standards and Sec. 1910.134, that such hands-on training can materially improve the effectiveness of respirator use.

Recent OSHA health standards have imposed respirator related requirements not found in 29 CFR 1910.134 (See section 1910.1018(h), arsenic; section 1910.1025(f), lead; section 1910.1029(g), coke oven emissions; and section 1910.1043(f), cotton dust). These requirements include the following provisions.

• Quantitative fit tests have been required semiannually, (arsenic, 1910.1018(h)(3)(ii); lead, 1910.1025(f)(3)(ii).
• Employees have been given the option of using powered air-purifying respirators (PAPR) upon request (arsenic, 1910.1018(h)(5)(iii); lead, 1910.1025(f)(2)(ii); coke oven emissions, 1910.1029(g)(2)(ii); cotton dust, 1910.1043(f)(2)(iv)).
• Employees have been permitted to change the filter elements of a respirator whenever an increase in breathing resistance is detected, (arsenic, 1910.1018(h)(4)(ii); lead, 1910.1025(f)(4)(ii); coke oven emissions, 1910.1029(g)(4)(ii); cotton dust, 1910.1043(f)(4)(ii)).
• Employees have been permitted to wash their faces and respirator facepieces to prevent skin irritation associated with using respirators, (arsenic, 1910.1018(h)(4)(iii); lead 1910.1025(f)(4)(iii); coke oven emissions, 1910.1029(g)(4)(iii); cotton dust 1910.1043(f)(4)(iii).
• Employers have been required to provide respirators that exhibit minimum facepiece leakage, (arsenic, 1910.1018(h)(3)(i); lead, 1910.1025(f)(3)(i); coke oven emissions, 1910.1029(g)(4)(i); cotton dust 1910.1043(f)(4)(i)).
• Referral of an employee to a physician trained in pulmonary medicine has been required for an employee who exhibits difficulty breathing either at fit testing or during routine respirator use (arsenic, 1910.1018(h)(3)(iv); lead, 1910.1025(f)(3)(iii)).

The current respirator standard (1910.134(b)(11)) states that respirators that are "approved or accepted shall be used when available." OSHA has chosen to recognize only those respirators approved by the National Institute for Occupational Safety and Health (NIOSH), and the Mine Safety and Health Administration (MSHA). The NIOSH and MSHA respirator performance requirements are given in Title 30, Code of Federal Regulations, Part 11. A revision of that standard is now being considered by NIOSH and MSHA.

Because of differences with the respirator requirements in other OSHA standards, changes in respirator methodology and technology, and the revision of referenced documents or related codes, OSHA published an Advance Notice of Proposed Rulemaking (ANPR) on May 14, 1982 (47 FR 20803). This notice sought information on the effectiveness of the current provisions, the need for revision, and the substance of what these revisions might be. Responses were received from 81 interested parties, and generally supported revising OSHA's respiratory protection provisions and provided suggestions for approaches the Agency might take (Ex. 15).

On September 17, 1985 OSHA announced the availability of a preliminary draft of the proposed respiratory protection standard revision for public comment (the preproposal draft standard press release). This preproposal draft standard reflected the public comments received from the May 1982 ANPR and OSHA's own analysis of changes needed in the standard to take into account the current state-of-the-art for respiratory protection. Responses were received from 56 interested parties (Ex. 36) and their comments have been reviewed in preparing this proposal.

B. Need for the Standard

This rulemaking addresses an existing standard, rather than addressing a new subject area, and seeks to correct the inadequacies of that existing standard. Since the OSHA standards on respiratory protection were adopted, research on the proper use of such equipment has resulted in new technology which improves protection for the wearers. The current standards do not reflect what is now accepted practice for implementation of comprehensive respiratory protection programs to protect employees. This is particularly true in the areas of fit testing and assignment of protection factors to respirators.

The wearing of respiratory protective devices to reduce exposure to airborne contaminants is widespread in industry. It has been estimated that 2.6 million workers wear respirators, either occasionally or routinely, in non-emergency work situations. In addition, over 59,000 facilities maintain respirators for emergency use (5, Ex. 34). Although in most situations it is preferred industrial hygiene practice to use engineering controls to reduce contaminant emissions at their source, there are operations where this type of control is not technologically or economically feasible or is otherwise inappropriate. There are many variables which affect the degree of protection afforded by these respiratory protective devices.

Indeed, the misuse of respirators can actually be hazardous to employee safety and health. Selection of the wrong equipment, one of the most frequent errors made in respiratory protection, will result in the employee being unknowingly vulnerable to the hazard and thus inhaling concentrations of the contaminant that may be harmful. This may result in a broad range of health effects caused by airborne contaminants, including silicosis, asbestosis, permanent lung damage and cancer. In the report by Rosenthal and Paull (Ex. 33-5) it is shown that, on the basis of OSHA's citation records, there is a high degree of correlation between inadequate respirator programs and overexposures to respirator wearers exposed to regulated substances. Respirators which are not maintained, inspected, and cleaned, can actually increase exposure, as well as cause dermatitis or skin irritation and place a greater strain on the respiratory system. Because the wearing of the respirator gives the employee a sense of security and presumed protection which may be false, an improper respirator program presents a high degree of hazard for the employee.

The devices themselves can only provide the protection they are designed for if they are properly selected for the task; if they are fitted to the wearer and are consistently donned and worn properly; and if they are maintained and cared for so they continue to provide the protection required for the work situation. These variables can only be controlled if a comprehensive respiratory protection program is developed and implemented in each workplace where respirators are used to protect employees from inhalation of airborne contaminants. OSHA has reviewed the present rulemaking record and the record of citations for respirator standard violations. On the basis of that review it is clear that to be effective such a program must use an integrated, systematic approach that will result in consistent and appropriate choices of respiratory equipment to be used; involvement of employees to ensure that they understand why respirators are being worn, and how they contribute to their effective use; and monitoring of the equipment and its use to ensure that respirator effectiveness is optimized.

There are many examples of how respirators may not provide the protection they were designed to provide in the absence of an effective respirator program with adequate employee training. When the hazardous substance is a dust, mist or fume there are often conditions under which it is possible for the inside of the respirator to become contaminated with the hazardous substance. For example, the employee may have an itch on the cheek and scratch it with a dirty finger thus destroying the integrity of the respirator fit.

An employee may leave the respirator area, remove the respirator, and rest it on his or her chest. The inside of the respirator could then pick up the contaminant from the air or work clothes and later when the respirator is donned the employee will inhale the contaminant from within the respirator. If a respirator is not cleaned properly or if it is stored in a locker or on a ledge covered with the contaminant, the employee will again breathe in the contaminant from within the respirator.

An employee engaged in manual labor may dislodge the respirator with a tool or even a normal motion unless the respirator has been appropriately fit tested and the employee knows that a readjustment is necessary. An employee may be engaged in work which requires good vision or extensive communication. Without conscious thought the employee may push the respirator into a position that improves vision or make talking easier but which would result in a poor facepiece seal.

As discussed later in this preamble, several studies of the performance of respirators worn in the workplace have been submitted to the regulatory docket to show that in actual use, respirators can be effective. These studies of workplace protection factors (WPFs) are necessarily performed in workplaces which have good respiratory protection programs. Consequently though the studies on WPFs may provide a reasonable criterion for setting maximum protection factors, it is not the case that those levels of protection are always achieved even if employers have an adequate respirator program. In the case of a poor respirator program it should be apparent that these levels would seldom be achieved.

The complexity of the necessary program, and the extensive commitment of ongoing resources to maintain that program, are often not sufficiently considered when determining control measures to be used. As stated in one commonly used industrial hygiene text (6):

There will always be a temptation to resort to respirators as a cheap substitute for a ventilation system. If this is done it is clear that management has not carefully considered the alternatives since reliance on and effective use of respirators is definitely not cheap.

As discussed above, OSHA's current standard in 29 CFR 1910.134 was largely adopted from, and references, the ANSI Z88.2-1969 standard on respiratory protection. ANSI issued a revised version of that standard in 1980 (ANSI Z88.2-1980) (Ex. 10). ANSI's intent in issuing this revision was to ensure that the standard did "reflect the current state of the art." ANSI accomplished this by expanding and adding to the standard provisions which address technological developments in respiratory protection since the 1969 standard was published. Techniques in fit testing and the use of protection factors are two areas which have been elaborated upon in the 1980 standard to help ensure more effective protection for respirator wearers.

This change highlights the need for revising the OSHA standard, particularly since Sec. 1910.134(c) specifies that respirators are to be selected according to the 1969 ANSI standard and provides no additional guidance for employers. Moreover, it is necessary to change OSHA's standard to ensure that it too reflects current respiratory protection methodology in order to provide appropriate protection for employees.

The 1980 ANSI standard was a logical extension of the 1969 ANSI standard (and thus OSHA's) in many respects. It established requirements for a respiratory protection program so that respirator selection, fit, and use were standardized, thus controlling some of the variables which make respirators ineffective. The program was to include written standard operating procedures; assessment of the fitness of potential respirator wearers; selection of respirators; training; fit testing; maintenance; and program evaluation.

One regulatory alternative in this regard would have been to adopt the ANSI Z88.2-1980 standard, or to at least base the rulemaking largely on the latest ANSI standard as was done with the original OSHA standard. ANSI, however, was developing a major revision of its 1980 standard, recently finalized as ANSI Z88.2-1992. OSHA has given this latest ANSI standard detailed consideration in preparing this proposal. An OSHA standard based entirely on the 1980 ANSI standard would have been obsolete as soon as published. OSHA has therefore made the decision to pursue a rulemaking based on existing data and the record generated thus far by responses to the ANPR and the prepublication draft. The proposed standard has included provisions of the 1980 and 1992 ANSI standards where justified by the record. The reasons for provisions which differ from those in the ANSI standards are given in this preamble in the discussion of the content of the proposed standard. OSHA has chosen not to adopt the ANSI standard per se, but many of the provisions, as well as the general approach, are consistent with ANSI.

In the ANPR, OSHA asked if the ANSI Z88.2-1980 standard should be adopted. For the most part, respondents did not advocate that the Agency simply adopt the ANSI standard (Ex. 15-13, 15-30, 15-34, 15-40, 15-45, 15-56, 15-73, 15-80). However, a number of respondents did advocate that it be used as guidelines or a reference for the OSHA standard or that modifications to it might make it appropriate for adoption (Ex. 15-19, 15-31, 15-37, 15-43, 15-51, 15-67).

In the ANPR, OSHA requested comments on the need to revise Sec. 1910.134, and 1980 ANSI standard notwithstanding. Only five respondents indicated that the standard should not be revised (Ex. 15-10, 15-35, 15-56, 15-75 (A and B), 15-77). The overwhelming majority of respondents, representing a wide range of organizations, stated that Sec. 1910.134 needs to be revised to reflect current technology and to help ensure appropriate protection of employees (Ex. 15-11, 15-18, 15-20, 15-26, 15-30, 15-42, 15-50, 15-54, 15-62, 15-74, 15-76, 15-80).

For example, industry respondents such as the Chemical Manufacturers Association (CMA) expressed the view that (Ex. 15-22):

The requirements of 1910.134 were adequate at the time they were adopted, but have been outdated by advances in respirator technology. The standard should be updated to reflect current conditions and to permit sufficient flexibility for companies to respond to continuing technological improvements. Present standards tend to suppress innovation and have a potential for harm by retarding the adoption of technological advances.

The Los Alamos National Laboratory (LANL), an institution which has conducted considerable research on respiratory protection, also supported the need to revise OSHA's current standard, and commented upon the appropriate approach to take (Ex. 15-79):

Currently standards should be revised to reflect changes in respiratory protection capabilities, techniques, and equipment which have been developed over the past 10 years. ANSI Z88.2 (1980) provides the best basis for developing a new standard. In addition, the "Guide to Industrial Respiratory Protection" (published as Los Alamos report LA-6671-M, and Health, Education, and Welfare (HEW) Publication, National Institute for Occupational Safety and Health (NIOSH 76-189) provides detailed information relative to the requirements for an adequate respirator program. It is not recommended that direct adoption of sections, of either of these documents, be the approach used by OSHA. Both documents are several years old, and the ANSI document constitutes a compromise between various interests involved in developing and adopting a consensus standard. Development of a revised standard will require a major effort by OSHA to identify, update, and expand those sections of ANSI Z88.2 (1980) which should be made part of the new OSHA standard.

Labor representatives also supported revising the standard, as represented by this statement of the United Steelworkers of America (Ex. 15-28):

At the present time the respiratory protection standard is not effective in providing workers with any great degree of protection due to the inadequacies of the standard, lack of requirements for employers to follow so that all respiratory protection programs are uniform and equally protective, and ineffective enforcement due to the vagueness of the requirements.

Manufacturers of respiratory protective devices are also among those who support revising OSHA's current respiratory protection standards. For example, the Minnesota Mining and Manufacturing Company stated (Ex. 15-30):

When 1910.134 was promulgated nearly a decade ago it reflected the state-of-the-art for a good respiratory protection program. The state-of-the-art for respiratory protection, however, has rapidly advanced since that time and although many of the elements included in the original standard retain their relevance and importance, other elements have been developed and more efficient means for achieving the goals of an effective respiratory protection program have been introduced * * *

There are two issues in particular which have evolved technologically since the current OSHA standards were adopted: Assignment of protection factors or maximum use concentrations for particular models or types of respirators; and the development of fit testing procedures.

With respect to assigned protection factors, OSHA has decided not to establish its own set of numbers but instead to defer to NIOSH in setting assigned protection factors for the various respirator classes. NIOSH will be developing assigned protection factors as part of its revised respirator certification standard, 42 CFR Part 84. Since NIOSH may not publish 42 CFR Part 84 before this OSHA respirator standard revision is finalized, OSHA will in the interim enforce the assigned protection factors listed in the NIOSH Respirator Decision Logic (RDL). The concept of protection factors and the decision to defer to NIOSH are discussed in more detail in a later section of this preamble.

Fit testing, the other area in which considerable advances have been made since the promulgation of OSHA's current standard, also varies among the substance-specific standards. The cotton dust standard (29 CFR 1910.1043) requires that the respirator used exhibit minimum facepiece leakage and be fitted properly. The coke oven emissions standard (29 CFR 1910.1029) requires annual quantitative fit testing, but has no protocol for fit testing. The lead standard (29 CFR 1910.1025) requires either qualitative or quantitative fit testing every six months and contains specific qualitative fit test protocols to be followed. Although the current respiratory protection standard refers to the necessity for proper fit, there are no procedures to follow or specific indications of how fit factors are to be taken into account in the assignment of respirators.

There are two types of fit testing that can be used for tight fitting facepiece respirators that rely on a facepiece-to-face seal to perform adequately. Qualitative fit testing involves the introduction of a test agent into the breathing zone of the respirator wearer which can be detected by its irritant properties, taste, or smell. If the wearer detects the characteristic effect of the test agent used, it indicates that the respirator is leaking and does not fit properly, and thus a different respirator is needed to protect that employee. Quantitative fit testing involves the generation of a known concentration of a test agent outside the facepiece, and a measurement of the concentration within the facepiece of the respirator. The ratio of these concentrations yields a number which indicates the protective capability of the device. This approach does not involve the subjective response of the wearer as does the qualitative fit test.

OSHA began including requirements for the use of quantitative fit testing in substance-specific standards starting in 1976 with the coke oven emissions standard. However, no procedures were provided. In the lead standard, OSHA conducted a separate rulemaking proceeding to address the appropriateness of QLFT. It was determined at that time that qualitative fit testing can be appropriate, but only under certain conditions. It was found, for example, that such fit testing can provide a reasonable degree of reliability only when specified protocols are followed. Thus the lead standard was revised to permit qualitative fit testing as well as quantitative fit testing to protect employees in atmospheres no greater than ten times the permissible exposure limit for lead, when exposed employees are wearing half mask negative pressure air-purifying respirators.

The overall problems with respect to QLFT protocols that came to the surface in the lead standard revisions, plus the fact that there was no specified QNFT protocol, made it apparent that these subjects needed to be addressed in the overall respiratory protection standard. Proper fit is so essential to maximizing functioning of respirators that OSHA must include in its requirements the latest findings of respirator research on means to assess and assure such fit.

In assessing the need to revise Sec. 1910.134, OSHA reviewed the Agency's enforcement statistics related to this standard for a period of about ten years, from 1972 to 1982 (9). This standard is one of the most frequently cited health standards, which indicates both a lack of understanding as to what is required for compliance, and a lack of awareness as to the importance of establishing and implementing a comprehensive respiratory protection program. During the period reviewed, there were 22,662 violations of the standard recorded, of which 8,406 were serious violations (37%). Some 3,648 of the violations were for not establishing a program (1,752 of these were serious because overexposure to hazardous substances were involved). Other commonly cited provisions include development of standard operating procedures; training and fit testing; cleaning and disinfection of equipment; storage of equipment; and use of approved respirators.

Compliance should be enhanced by the provisions of the proposed standard. In those areas which are frequently cited, the new proposal provides additional guidance for employers to help ensure that they are aware of what is required to comply, and thus protect their employees adequately. OSHA expects that these revisions will improve the level of protection provided by the current standard: nothing in these revisions is intended to decrease protection provided under the current standard.

To summarize OSHA's position, the Agency has determined that promulgating a revised respiratory protection standard is necessary to ensure that employees wearing respirators in the workplace are doing so under conditions which adequately protect their health. This determination by OSHA is supported by the public in responses to the ANPR published by the Agency. It is also necessitated by changes in respiratory protection methodology and subsequent revisions to the consensus standards upon which the current standard is based, thus making the current standard outdated. The determination of the need for the standard is also supported by OSHA's experiences in promulgating substance-specific standards with respiratory protection provisions in them, and in the Agency's enforcement experiences with the current standard.

Based on an evaluation of these considerations, OSHA has prepared this proposed standard and is hereby initiating the public rulemaking process.

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

The need for standardization in this area, particularly for consistent guidance and controlled practices, can also be demonstrated by the number and extent of voluntary standards that have been adopted, as well as by the existence of standards at all levels of government.

As has already been discussed, the primary voluntary consensus standard in this area was that developed by the American National Standards Institute as ANSI Z88.2-1980, entitled "Practices for Respiratory Protection" (Ex. 10). This standard was an updated version of the 1969 ANSI standard which was used as the primary basis of OSHA's current standard, Sec. 1910.134. Following are some of the 1980 ANSI standard changes:

• Oxygen deficiency is more thoroughly discussed.
• Quantitative fit testing is now included and described.
• Qualitative fit testing is more fully described.
• The concept of protection factors is introduced and protection factors are assigned.

ANSI has also developed a new standard on physical qualifications for respirator use (ANSI Z88.6-1984) (Ex. 38-10).

The OSHA standard, based on the outdated 1969 ANSI standard, does not address these topics. The ANSI revisions reinforce OSHA's decision to revise its standard to address the same and other issues.

Other countries also recognized the need for standards governing the use of respirators. Of particular note is the consensus standard recently developed by the Canadian Standards Association (Z94.4-M1982, Selection, Care and Use of Respirators) (10). This document is a comprehensive treatment of the subject and, similar to OSHA's proposed standard, its emphasis is on the establishment and implementation of a comprehensive respiratory protection program. As stated in the preface to that standard:

The primary aim of this Standard is to give detailed instruction in the selection of the proper respirator and its use and maintenance. The emphasis is on the implementation of a respiratory protection program developed in a logical progression of steps beginning with:

(a) A very clear definition of the hazards that will be encountered and the degree of protection required;

(b) The selection and fitting of the respirator;

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

(d) The implementation of a maintenance program that will ensure that a high level of respiratory protection is maintained.

The Canadian consensus standard deals with several areas in more detail than OSHA's current standard, and some of the language used has been incorporated into this proposed standard, particularly in the areas of training and program evaluation.

Documents developed by U.S. military organizations also indicate the need for comprehensive respiratory protection programs. A military standard entitled "Respiratory Protection Program" (TB MED 223/AFOSH STD 161-1/DLAM 1000.2) has been developed for the use of the Air Force, Army, and the Defense Logistics Agency (15). This document is similar to OSHA's current standard (Sec. 1910.134), but includes sections which expand upon the requirements of that standard and provide additional guidance in critical areas. The military standard provides considerable direction on the selection of respirators, including the protection factor concept, that is not included in OSHA's current standard. It also provides additional information on fit testing and training. OSHA's proposed standard similarly recognizes the deficiencies of Sec. 1910.134, and provides additional guidance to employers in these same areas as well as others.

It can be seen from this brief discussion that there is widespread agreement among safety and health professionals that adequate respiratory protection cannot be provided in the absence of specific procedures. The range of equipment choices available, the diversity of hazards against which they are to protect, the differences in work situations, and other variables increase the complexity of the decision making process in terms of selecting the appropriate respirators, and ensuring they fit, are worn properly, and are maintained as necessary. OSHA proposes to revise its current standard to ensure that appropriate procedures are implemented by employers, and thus increase the probability that protection to the extent technologically feasible for respirators will be provided for employees.

V. Certification/Approval Procedures

Section 1910.134 requires that only those respirators approved jointly by NIOSH and MSHA be used by the employer when they exist. The current respirator testing and approval regulation, 30 CFR 11, which authorized the Bureau of Mines (BM) and NIOSH to jointly approve respiratory protection devices was promulgated on March 25, 1972 at 37 FR 6244. On November 5, 1974 the Mine Enforcement Safety Administration (MESA) joined NIOSH in jointly approving respirators. Following the transfer of MESA to the Department of Labor, where it became the Mine Safety and Health Administration (MSHA), authority was transferred on March 24, 1978 to MSHA for joint approval with NIOSH of respirators. Most of the BM respiratory testing methods, while developed in the 1950's or earlier, were changed in the 1970's to reflect changes in testing technology.

NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was held in July 1980 to address the certification program. On August 27, 1987, NIOSH published a notice of proposed rulemaking (52 FR 32402) which would allow NIOSH to certify respirators under the new 42 CFR Part 84 regulations, replacing the current joint NIOSH/MSHA 30 CFR 11 certification regulations. The proposed NIOSH certification regulations contained new and revised requirements for testing and certification of respirators, and included a set of minimum assigned protection factors for various classes of respirators. Public hearings on the first draft NIOSH proposal were held in January, 1988. On the basis of the comments received, NIOSH is preparing a revised proposal for further public comment.

Numerous commenters to the ANPR addressed the issue of NIOSH respirator certification (Ex. 15-11, 15-27A, 15-58, 15-14, 15-43, 15-50) and most agreed that the certification program should be improved. Some suggested that OSHA assume the function of certification of respirators. OSHA believes it is advisable not to undertake operation of the certification program currently operated by NIOSH and MSHA. OSHA has neither the expertise nor equipment to perform respirator performance testing. OSHA intends that information generated in this proceeding will be made available to NIOSH to use in its revision of its respirator certification standards, and that NIOSH will make its rulemaking record available to OSHA. OSHA believes that, for the present, the best course is to continue to require NIOSH respirator certification as it has in the past.

VI. Summary of the Preliminary Regulatory Impact Analysis and Regulatory Flexibility Analysis and Environmental Impact Assessment

Introduction

Executive Order 12866 requires that a regulatory impact assessment be conducted for any rule having an annual effect on the economy of $100 million or more, or adversely affecting in a material way the economy, sector of the economy, productivity, competition, jobs, or state, local or tribal governments. In addition, the Regulatory Flexibility Act of 1980 (Pub. L. 96-353, 94 Stat. 1164 (5 U.S.C. 601 et seq.)) requires the Occupational Safety and Health Administration (OSHA) to determine whether a proposed regulation will have a significant economic impact on a substantial number of small entities, and the National Environmental Policy (NEPA) of 1969 (42 U.S.C. 4321, et seq.) requires the agency to assess the environmental consequences of regulatory actions.

In order to properly assess potential impacts, in 1988 OSHA prepared a Preliminary Regulatory Impact and Regulatory Flexibility Analysis (PRIA) for the proposed revisions to the respiratory protection standard. This analysis includes a profile of the affected industries, the estimated number of workers who wear respirators, and the nonregulatory alternatives, technological feasibility, costs, benefits, and an overall economic impact of the proposed standard. The PRIA is available in the OSHA Docket Office. OSHA believes the basic data and conclusions are still correct. Inflation has increased costs but has generally increased profits and sales in reasonably similar proportions. This assessment is largely based upon the conclusions of the PRIA; cost numbers have been adjusted for inflation.

Data Sources

The primary sources of information used for this impact analysis are a report by Centaur Associates, Inc. entitled, "Preliminary Regulatory Impact Analysis of Alternative Respiratory Protection Standards" and a report by Centaur Associates, Inc. entitled, "Compliance Cost Analysis: Current and Proposed Respiratory Protection Standards", available in the docket. Most of the information contained in this report was collected from an in-depth sample survey of the current work practices in 2,300 manufacturing plants in which respirators are used. The results from the manufacturing sector were extrapolated to nonmanufacturing plants and construction firms.

A third source of data are the comments received by OSHA in response to the Advanced Notice of Proposed Rulemaking (ANPR). OSHA welcomes additional comments and all information supplied will be carefully reviewed and evaluated for incorporation into the Regulatory Impact Analysis (RIA) that will accompany the final rule.

Industries and Employees Affected

The data currently available to OSHA indicate that the proposed standard would affect approximately 3.6 million employees of whom 1.6 million are employed in the manufacturing sector, 1.5 million are employed in the nonmanufacturing sector, and 0.5 million are employed in the construction sector. Of the 3.0 million employees who wear respirators for routine or occasional work, 1.1 million use respirators routinely and 1.9 million use respirators occasionally. About 600,000 employees wear respirators for both routine and emergency use. Of these 600,000 employees, approximately 150,000 wear respirators only for emergencies. Respirators are used routinely or occasionally in about 606,200 establishments of which 123,200 are manufacturing plants, 360,100 are nonmanufacturing plants, and 122,900 are construction sites. Respirators are also used only for emergencies in another 51,800 establishments, of which 15,200 are manufacturing plants, 27,300 are nonmanufacturing plants, and 9,300 are construction sites. Each general industry and construction sector would be affected by this proposed standard because respirators are used in many different work activities in each of these sectors.

Nonregulatory Environment

In general, worker compensation systems designed to compensate employees for occupationally related illnesses have not had a significant impact upon the incidence of long-term chronic occupational illnesses. One reason is that it is extremely difficult to determine the cause of illness at the time the disease is diagnosed. The long latency period between the exposure and the onset of disease, and the mobility of employees among occupations and firms combine to make it difficult to establish a direct causal relationship between an occupational exposure and the resultant illness. The absence of a readily observable cause and effect relationship provides a disincentive for some firms to establish appropriate safety and health measures. In addition, the lack of information regarding health risks, inadequate training, or a misunderstanding of the function of a respirator may lead to employee exposure to harmful levels of hazardous substances. Thus, the nonregulatory environment does not guarantee employee safety because the economic incentives are absent, employees are improperly trained in respirator use, and employees do not have sufficient information on the resultant benefits of respirator use.

Technological Feasibility

The proposed respirator standard does not require the use of large- scale capital equipment. All of the provisions involve equipment, evaluations, and work practices that are widely used. Thus, on the basis of the information currently available, the proposed standard has been found to be technologically feasible. Additional information that is submitted will be carefully evaluated by OSHA before issuing the final rule.

Summary of Cost

OSHA derived its cost estimates by first examining the cost of coming into compliance with both the existing and proposed standards, using current work practices as its baseline. This estimate does not include the cost of purchasing the respirators; it includes only the cost of all the other activities required by the existing and proposed respiratory protection programs. The requirement to wear respirators comes from other standards or specific conditions -- not from this standard. Consequently, respirator purchase has been costed in other standards which require their use. This standard requires improvements in the respirator program when other standards require their use and this analysis costs these additional program requirements.

OSHA estimates that the total annualized incremental cost of the proposed revisions to the respirator standard are $106.8 million. As shown in Table A, approximately half of this cost ($55.6) is estimated to fall on the nonmanufacturing sector, with the remainder in manufacturing ($38.2) and construction ($13.1). The largest incremental cost is attributable to enhanced requirements for qualitative fit testing ($58.5 million). Other enhanced requirements include provisions dealing with disposable respirator practices ($16.7 million), respirator facepiece selection ($15.2 million), employee training ($14.4 million) and respirator use in IDLH atmospheres ($10.4 million).

In reviewing the original standard, some provisions were considered to impose costs on employers without providing safety, and have been modified. Cost savings would be derived from modified requirements regarding air quality in atmosphere-supplying respirators ($8 million) and eyeglass mounts ($0.4 million). These estimates are conservative, as they do not factor in savings to employers already in compliance with existing provisions.

While the proposed standard clarifies a number of existing requirements, several of them were judged in the PRIA not to actually impose a new burden on employers. However, the respirator survey found significant noncompliance with several provisions of the existing standard, and by extension, the proposed standard. Costs relating to compliance with these provisions is discussed in depth in the PRIA.

Footnote(1) Represents incremental burden over existing standard; numbers may not add precisely due to rounding

Footnote(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.

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 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 O(2) (12.5% oxygen at sea level atmospheric pressure) to 122 mm Hg (16% oxygen at sea level). Under these conditions a supplied air respirator is required. Where oxygen levels are 95 mm Hg or less, an oxygen-deficiency IDLH atmosphere would exist, and would require the use of a positive pressure SCBA or a combination supplied air respirator with SCBA. However, where oxygen levels are above 16% supplied air respiratory protection would not have to be used for protection against oxygen deficiency.

For confined spaces, the ANSI Z88.2-1992 standard would consider any reduction in oxygen level below 20.9% an IDLH atmosphere unless the source of the oxygen reduction is understood and controlled. However, it would permit entry into a confined space that contains between 16% and 20.9% oxygen (at sea level) without any respiratory protection if extraordinary precautions are taken to assure that the worker would not encounter any poorly ventilated areas. OSHA considers any location with an oxygen level that is reduced below 19.5% to be an oxygen deficient atmosphere requiring the use of at least a supplied air respirator as a minimum.

An incident recently occurred that illustrates the problem with the ANSI oxygen deficiency definition. Two well cleaners died in the confined space of a shallow well. They had no fans to ventilate the well, and only crude homemade equipment for lowering someone into the well. After being lowered into the well, the first cleaner complained of lightheadedness. His partner was lowered into the well to attempt a rescue. The crude retrieval equipment broke under the weight of the two cleaners. Both were overcome by the low oxygen levels and died of asphyxiation and drowning. The oxygen level in the well was 17%, as measured by the firefighters who removed the bodies. By reducing the oxygen deficient IDLH level to 16% and permitting entry without respiratory protection at oxygen levels between 16% and 19.5%, the ANSI standard would permit such dangerous practices. The need for extraordinary precautions, as ANSI recommends, will not be recognized by many who choose only to see that the oxygen deficiency levels have been reduced.

NIOSH approves air-purifying respirators for use only in atmospheres containing 19.5% oxygen. Moreover, Grade D breathing air is and has been considered the acceptable standard for such air and Grade D breathing air contains, by definition, a minimum of 19.5% oxygen. Since OSHA requires that NIOSH approved respirators be used, and that grade D breathing air be used for supplied air respirators, OSHA is proposing the 19.5% oxygen level as the point below which an oxygen deficient atmosphere exists. Oxygen partial pressure decreases as altitude increases. At 8,000 feet a 19.5% oxygen level still corresponds to an oxygen partial pressure above 100 mm Hg, the level where an oxygen deficient IDLH atmosphere would begin. Therefore, for altitudes up to 8,000 feet any decrease in oxygen level below 19.5% is considered an oxygen deficient atmosphere and the use of atmosphere-supplying respirators would be required. For altitudes above 8,000 feet, an oxygen level below 19.5% would constitute an oxygen deficient IDLH atmosphere. Column 2 of Table I presents the percent oxygen levels below which an oxygen deficient atmosphere exists for altitudes from sea level to 8,000 feet. Comments are requested on the values in the table.

Oxygen Deficient IDLH Atmospheres

Many commenters felt that the ANSI Z88.2-1980 definition of an oxygen deficiency-IDLH atmosphere was satisfactory (Ex. 15-14, 15-19, 15-26, 15-27A, 15-31, 15-33, 15-35, 15-37, 15-38, 15-46, 15-52, 15-53, 15-55, 15-58, 15-62, 15-70, 15-71). ANSI in its 1980 standard (Ex. 10) defines an oxygen deficiency-IDLH atmosphere as one which causes an oxygen partial pressure of 100 millimeters of mercury (mm Hg) column or less in the freshly inspired air in the upper portion of the lungs which is saturated with water vapor. This corresponds to an oxygen content of from 14% at sea level to 20.95% at 14,000 feet. The oxygen content is adjusted using a formula to account for the effects of changing altitude. AMAX (Ex. 15-55) felt the ANSI oxygen deficiency requirements (and thus the Los Alamos position as well) were overly restrictive since they would require people working at altitudes above 10,000 feet to wear supplied air respirators, and their employees have successfully used air-purifying respirators at these high altitudes for many years.

The Los Alamos National Laboratory (Ex. 36-52), and California OSHA (Ex. 36-44), agreed that the 100 mm Hg oxygen partial pressure level was the appropriate criterion for defining an oxygen deficient IDLH atmosphere, but only for altitudes from sea level to 10,000 feet. For altitudes from 10,000 feet to 14,000 feet they recommended that OSHA use 20.95% oxygen as the level below which an oxygen deficient IDLH atmosphere exists since people who are physiologically acclimated can live and work above 10,000 feet without adverse effects and the standard should account for this reality. The current ANSI Z88.2 Respirator Committee (Ex. 36-55) has concluded that for altitudes below 14,000 feet, work should be permitted without protection for oxygen deficiency when the oxygen content of ambient air (20.95%) is not reduced.

The foregoing comments are all in agreement that, up to 8,000 feet the oxygen concentration equivalent of an oxygen partial pressure of 100 mm of Hg in the upper portion of the lungs is appropriate for a threshold IDLH level. This is equivalent at sea level to an oxygen concentration of 14%. However, NIOSH has pointed out (Ex. 25-4) that in the presence of an oxygen concentration of less than 16% at sea level one can experience impaired attention, thinking and coordination. At 14% or below, NIOSH states the possibility of faulty judgment, poor muscular coordination, rapid fatigue that could cause permanent heart damage, and intermittent respiration. In an IDLH or escape situation all of the described effects could place a worker in serious jeopardy. Therefore, OSHA believes that an oxygen concentration of 16% or below at sea level should require the extra precautions that go with IDLH atmospheres. The AMAX comment that its employees have suffered no consequences of not having used supplied air respirators at greater than 10,000 feet is believed by OSHA to signify that they have not worked in atmospheres with less than 19.5% oxygen.

The ANSI Z 88.2-1992 standard defines an oxygen deficiency IDLH atmosphere to be one with an oxygen partial pressure of 95 mm Hg or less (12.5% oxygen at sea level). The oxygen deficiency may be caused by either a reduction in the normal 20.9% oxygen content, by reduced total atmospheric pressure to 450 mm Hg (8.6 psi), equivalent to 14,000 feet elevation, or any combination of reduced percentage of oxygen and reduced pressure. The ANSI rationale as stated in Appendix A.5 for these low levels is that the 12.5% oxygen content corresponds to an oxygen partial pressure of 48 mm Hg in the alveoli of the lungs, with the alveolar blood 83% saturated with oxygen. At higher alveolar oxygen partial pressures (60 to 100 mm Hg), as the ANSI appendix points out, only slight changes in hemoglobin oxygen saturation are seen. Much larger changes occur in the blood oxygen levels as the alveoli oxygen levels fall from 60 down to 30 mm Hg. By choosing such a low oxygen partial pressure for the start of an oxygen deficient IDLH atmosphere, ANSI has effectively removed any safety margin from its standard. An acclimatized individual may be able to effectively operate at the equivalent of 14,000 foot altitude. However, individuals normally used to the 20.9% oxygen present in the outside air or supplied by their respirator are not acclimatized. They could be seriously and rapidly debilitated by the quick drop in oxygen partial pressure such a 12.5% oxygen deficiency IDLH level represents if their respirator should fail. The safety margins in the ANSI Z 88.2-1992 oxygen deficiency IDLH and non IDLH definitions have been reduced to their bare minimums. OSHA has chosen to reject these less protective ANSI oxygen deficiency definitions in favor of the more forgiving levels it is proposing to adopt.

OSHA is proposing a value of 16% oxygen by volume as the level below which an oxygen deficient IDLH atmosphere exists for altitudes from sea level to 3,000 feet. For altitudes from 3,001 feet up to 8,000 feet, percent oxygen levels have been calculated that correspond to a value of 100 mm Hg oxygen partial pressure. At altitudes above 8,000 feet and up to 14,000 feet, OSHA is proposing that an oxygen level below 19.5% would be considered an oxygen deficient IDLH atmosphere. This agrees with the ANSI Z 88.2-1980 oxygen deficiency-IDLH level of 100 mm Hg, which corresponds to the point where the oxygen content of the alveolar blood is 90% saturated with oxygen and below which symptoms of hypoxia occur. Although OSHA is accepting the claim that work can be performed by acclimated persons at altitudes above 10,000 feet when the ambient air oxygen percentage is not reduced, comments and data are requested that will support or contradict this conclusion. To avoid possible confusion, OSHA has not used a formula for calculating the oxygen deficient IDLH levels as ANSI did, but instead presents in Column 3 of Table I in paragraph (d) a list of the percent oxygen levels for altitudes from sea level to 14,000 feet.

Footnote(1) For altitudes above 8000 feet, an oxygen deficient IDLH atmosphere exists when the oxygen level falls below 19.5%

(E) Medical Evaluation. Most who responded to the ANPR, although divided in their responses to many of the questions on medical surveillance, were in general agreement that the provision in the present standard is inadequate and that there should be initial and follow up evaluations of some sort. In particular, there was a consensus that it is not safe to wait for specific complaints or problems to arise before conducting such evaluations (Ex. 15-10, 15-26, 15-27A, 15-31, 15-45, 15-46, 15-48, 15-49, 15-53, 15-54, 15-55, 15-63, 15-70, 15-75, 15-76).

Experience in industry shows that most healthy workers do not have problems wearing a respirator when it is properly chosen and fitted (1, 2, 6). The most commonly found problems are claustrophobia -- which may be an intolerance of feeling enclosed or may give rise to a subjective feeling of breathing difficulty. Other common problems are chronic rhinitis, catarrh, and nasal allergies where it is necessary to remove the respirator frequently to deal with nasal discharge. Some individuals with chronic sinusitis may have breathing difficulties wearing a respirator.

Most other difficulties relate to the cardiorespiratory system. The wearing of a negative pressure respirator does increase the resistance to inspiration. The problem is reduced with powered air-purifying respirators and with positive pressure atmosphere-supplying respirators. Exhalation resistance with modern negative pressure respirators does not significantly increase expiratory effort. The types of cardiorespiratory problems which may increase the individual's breathing problems when wearing a respirator are chronic obstruction, respiratory disease, emphysema, asthma in some cases, and moderate to severe pneumoconiosis.

Cardiac or cardiorespiratory diseases that may affect respirator wear include coronary thrombosis, any type of congestive heart disease or decompensations cor pulmonale, other ischemic heart disease and some cases of hypertension.

The amount of difficulty will clearly depend on the degree of cardiorespiratory inadequacy and also on the amount of physical effort required by the work. Some people who may have difficulty wearing a negative pressure respirator should be able to manage well with a positive pressure type respirator.

The decision about the fitness of the individual to wear a respirator is clearly a judgment that can only be made by the physician taking into account the state of the individual's health as well as the physical requirements of the job.

The preproposal draft would have required that employers refer employees for medical evaluations if they would be routinely wearing a respirator for more than one hour per work shift, or five hours per week. This provision would eliminate medical surveillance for employees who wear respirators only infrequently, while ensuring that those who must rely on respirators for longer periods of time would be appropriately evaluated.

The preproposal draft provision exempting occasional respirator users from the medical evaluation requirements was the subject of many comments. Some commenters felt there could be problems with interpreting the exemption (Ex. 36-32), or that the exemption would be difficult to enforce with employers claiming exemptions for employees, and the employees claiming they should have the evaluation (Ex. 36-8). Dow Chemical (Ex. 36-40) stated that the exemption would be a tough administration problem. AMAX Inc. (Ex. 36-27) stated that the exemption limits were excessive and burdensome to industry. The Ethyl Corporation (Ex. 36-11) felt the exemption limits were too rigid and stated that a more appropriate time limit might be 10 to 13 hours per week or 25% to 33% of working hours. The Amoco Corporation (Ex. 36-35) supported the flexibility that the occasional users exemption showed and the American Textile Manufacturer's Institute (Ex. 36-18) felt medical evaluations should be provided for all individuals who wear respirators for more than "pass through" activities. Dow Chemical (Ex. 36-40) recommended that any employee required to wear respiratory protection for any reason be provided a medical evaluation, which may or may not include a medical examination.

The Mine Safety and Health Administration (MSHA) (Ex. 36-34) felt the exemption did not focus on the individuals at risk such as those wearing an SCBA in confined spaces for repairs. The AIHA (Ex. 36-41) and DuPont (Ex. 36-38) also pointed to the problem of SCBA wearers who perform heavy work for short periods of time without having been medically evaluated. California OSHA (Ex. 36-44) recommended that the occasional use exemption not apply to SCBA wearers. The Lawrence Livermore National Laboratory (Ex. 36-26) felt that the occasional use exemption would eliminate physical evaluations for emergency response activities and other short use, high risk jobs.

OSHA is removing the draft requirement that a medical evaluation be made available to any worker using a respirator more than one hour per work shift. This provision would have required an evaluation if the respirator were to be worn for one stretch of 61 minutes even if that were the only time it was worn. OSHA believes that such a requirement is unreasonable and that repeated use of the respirator will be covered by the five hour per week provision. Therefore, the proposal now requires that a written opinion be obtained from a physician that each employee who needs to wear a respirator for five hours or more during any work week is fit to wear one. However, in view of questions that have been raised, OSHA invites comments on the duration of respirator use that should constitute a threshold for the medical evaluation requirement. OSHA recognizes that problems may occur with interpretation or enforcement of the occasional use exemption and solicits comments on projected problems. OSHA emphasizes that the occasional use exemption is intended to apply only to short time respirator wearers, not those who wear respirators on a routine basis.

Medical Evaluation Procedures

Although OSHA believes that a medical evaluation is important, there appears to be considerable difference of opinion as to what circumstances should trigger a physical examination, what the physical examination should consist of, who is to administer such an examination, and what the specific criteria should be for passing or failing the examination with respect to fitness for wearing a respirator. Because there is no definitive information either in the record or, as far as OSHA can tell, in the open literature as to how to resolve these issues OSHA is raising for comment three alternative versions of the medical evaluation provision. The first, which is represented by proposed regulatory text, would require that the employer obtain a doctor's written opinion on the employee's ability to wear a respirator. The nature of the medical evaluation performed would be left up to the physician to determine. The second alternative would require the performing of a medical evaluation consisting of a medical history and medical examination, from which a physician's opinion on respirator use would be written. The third alternative would require that a health questionnaire be administered to all respirator wearers, with a medical evaluation being performed on those whose answers to any of the questions on the questionnaire show the need for such an evaluation, or who wear an SCBA for emergency or rescue operations. After reviewing the questionnaires and any medical evaluation performed, a physician's written opinion on respirator use would then be prepared.

OSHA is seeking comment on each of the three alternatives and on the specific elements that make up the required procedures of each alternative. The comments that will be received to this proposal, along with OSHA's review of other medical evaluation information, will be used to develop a single medical evaluation procedure for the final standard. Therefore, commenters should detail why they prefer one of the three alternatives in this proposal above the others, and specifically address which required elements should be contained in the medical evaluation procedures. A more detailed discussion of each of the three alternatives follows.

Alternative 1 -- Written Physician's Opinion

The first alternative of the medical evaluation procedures is part of the proposed standard as paragraph (e). It would require that, for every employee who wears a respirator more than five hours during any work week, a written opinion be obtained from a licensed physician as to the fitness of the employee to wear a respirator based on the type of respirator used, the workplace conditions and the employee's physical condition. Information regarding respirator type and workplace conditions would be required to be supplied to the physician by the employer. The decisions as to whether a physical examination is necessary, and if so its content, is left to the judgment of the physician. OSHA is proposing suggested elements of a physical examination in an appendix to guide the physician should he or she choose to perform such an examination. In addition, this proposal requires that an annual review, which in the physician's judgment may not entail an examination, be conducted by a physician.

Possible regulatory language for the other two alternatives of the medical evaluation section are presented as follows. Although they are not included in the text of the standard, OSHA will consider all three alternatives in its deliberations leading to a final standard.

Alternative 2 -- Medical History and Examination

The second alternative for a medical evaluation provision is a requirement for a mandatory medical history and medical examination. The preproposal draft standard contained this alternative, but OSHA has modified it in response to comments received. As in alternative 1, guidance for the elements of the evaluation would be supplied by nonmandatory Appendix C.

These recommended elements are basically the same as were specified as mandatory in the prepublication draft and are similar to those recommended by ANSI in its standard on physical qualifications for personnel using respirators, ANSI Z88.6-1984 (Ex. 38-10).

The preproposal draft would have required that a medical history be taken and a medical examination be conducted for each respirator user with exemptions for nonroutine users. Also included were mandatory elements to be reviewed during the performance of the medical history and medical examination. Several commenters recommended that OSHA adopt a more performance oriented approach for the medical evaluation provisions while listing in a nonmandatory appendix what the physician should consider during the examination (Ex. 36-18, 36-22, 36-38, 36-40, 36-41, 36-50, 36-55).

Comment is requested on the individual elements that make up the medical history and medical examination recommended provisions listed in Appendix C. OSHA also requests comment on whether it should set specific medical trigger levels for elements of the medical examination, and if so, what these trigger levels should be.

A mandatory requirement for pulmonary function testing was opposed by commenters on the grounds that it is not clear that pulmonary function testing would provide information that would not already be apparent to the physician from performing a normal physical exam. It was also pointed out that there are no specific pulmonary function test values that are considered to be clearly suitable thresholds for ability to wear a respirator (Ex. 36-3, 36-22, 36-30, 36-32, 36-34, 36-47, 36-55). The discussion in Appendix C on pulmonary function testing states that spirometry including FEV(1) and FVC, while not required should be performed. The recommendation for screening spirometry contains a set of values for FVC and FEV(1) which have been adopted from the ANSI Z88.6 recommended standard. These values, a FVC of less than 80 percent or a FEV(1) of less than 70 percent, represent levels at which restrictions on respirator use should be considered.

A study of clinical pulmonary function and industrial respirator wear by Raven, Moss, Page, Garmon, and Skaggs (Ex. 38-8) recommended that a standard clinical pulmonary function test, the 15 second maximum voluntary ventilation (MVV(.25)), may be the test of choice for determining worker capability to wear a respirator. A "conservative" score on this test, along with other clinical data from the medical evaluation would form the basis for screening respirator wearers. OSHA requests information and comment on the use of the (MVV(.25)) as a screening test for respirator use, and whether it should be added to the nonmandatory recommendation for FEV(1) and FVC testing.

Appendix C also contains recommendations for elements to be covered in the medical history. The provision in the preproposal draft stating that psychological problems or symptoms be noted in the medical history has been removed. Rebecca Eklund of Freeport McMoran Inc. (Ex. 36-28) pointed out that the psychological conditions requirement was too inclusive since there are many psychological conditions which in no way affect the wearing of a respirator. Because the medical examination covers psychological conditions relevant to wearing respirators, such as claustrophobia or severe anxiety, the recommendation that psychological problems be noted in the medical history is redundant and therefore has been dropped.

Comments were also received on the preproposal draft requirement that tolerance to tachycardia (i.e. excessively rapid heartbeat) be noted. OSHA notes that the recommendation that tolerance to tachycardia due to inhaling heated air be noted is part of the ANSI Z88.6 physical qualifications for respirator wearers, and for that reason was included in the preproposal draft. Closed circuit SCBA units, also known as rebreathers, supply air to the wearer at elevated temperatures of 120 deg. F or greater. A possible physiologic response to breathing heated air is tachycardia. Commenters stated that tachycardia produced by heated air was called difficult to validate (Ex. 36-8), was not necessary to note since few respirators produce heated air (Ex. 36-29), difficult to assess and attribute to heated air (Ex. 36-32), not generally accepted by the medical profession as a problem (Ex. 36-37), challenged any problem with breathing heated air (Ex. 36-47), and questioned the necessity to impose the restriction since only rebreather respirators produce heated air (Ex. 36-52).

OSHA agrees with the commenters that few closed circuit SCBAs are in use, and that checking every respirator user for tolerance to tachycardia is not necessary. Therefore, the recommendation for noting tolerance to tachycardia due to inhaling heated air has been removed. OSHA requests any information on problems that have occurred with tachycardia for wearers of closed circuit SCBAs, and comment on whether this recommendation should be included (either as a mandatory requirement or in Appendix C only) for those who will be using closed circuit SCBAs.

The suggested elements of the medical examination itself, where one is performed, have also been modified and placed in Appendix C. The recommendation for the physician to assess facial conditions that may interfere with respirator fit has been dropped. As Alan Hack of the Los Alamos National Laboratory stated, most physicians will not be familiar enough with respirator facepieces to be able to make such an evaluation (Ex. 36-29). Also, any decision on respirator facepiece fit would more properly be made when selecting the best fitting respirators during fit testing.

The need for assessing hearing ability was also questioned by commenters on the preproposal draft. Several commenters recommended the elimination of the hearing assessment provision since it is irrelevant to the wearing of a respirator (Ex. 36-8, 36-13, 36-27, 36-29, 36-47, 36-52). California OSHA (Ex. 36-44) stated that hearing ability should not be a consideration except perhaps where a worker wears a continuous flow airline respirator with hood or helmet that covers the head. The ability to hear is certainly important during IDLH entry, but this is a concern regardless of respirator use. The American Association of Occupational Health Nurses (Ex. 36-8) and Alan Hack (Ex. 36-29) pointed out that nonaudible alarms such as visual or vibration alarms could be used along with the buddy system for such situations. Monsanto (Ex. 36-32) questioned what level would constitute an acceptable hearing ability. ORC (Ex. 36-47) and California OSHA (Ex. 36-44) also questioned whether OSHA was requiring audiometric testing.

Having considered the foregoing comments, OSHA believes that the second alternative should retain a recommendation for performing a hearing assessment nonmandatory Appendix C. There are situations where the wearing of a respirator, particularly one with a full helmet or hood, can significantly reduce hearing and the ability to respond to emergency alarms or warning devices. However, OSHA recognizes that the problem of hearing ability in the workplace is peripheral to the ability to wear a respirator. Therefore, OSHA seeks further comment on the necessity of assessing hearing ability when wearing respirators and on the appropriateness of this recommendation to the respirator standard. The assessment of hearing ability to assure communication and response to instructions and alarms does not require, in the standard, audiometric testing. For most respirator wearers a simple oral assessment of hearing ability would be sufficient.

With respect to the question of perforated tympanic membranes, Shell Oil (Ex. 36-50) submitted a report by Dr. Thomas Milby which reviewed the issue of potential employee exposure to hydrogen sulfide via the route of damaged tympanic membranes. The report stated that there was no valid information in the scientific literature supporting that perforated eardrums would produce an increased risk of contamination for workers. Calculations were performed for the Shell report which showed, in a worst case analysis, ambient air concentrations of H(2)S would have to reach some 158 ppm before the worst case loss of an ear drum would permit exposure at the PEL of 10 ppm. Shell also included a study by Richard Ronk and Mary Kay White of NIOSH (Ex. 38-11) which concluded that workers with perforated eardrums should not be excluded from working in hydrogen sulfide atmospheres. They stated that in no reasonable case can the presence of a tympanic membrane defect significantly affect respiratory protection. California OSHA (Ex. 36-44) cited the NIOSH study as showing that tympanic membrane perforation was not a problem. Other commenters also recommended that this provision be dropped since it is not specifically a respirator related problem (Ex. 36-3, 36-18, 36-35, 36-47, 36-52).

In light of the scientific review of tympanic membrane perforation submitted by Shell Oil, and the report by NIOSH which also reports no significant exposure from perforated eardrums, the recommendation for checking for perforated tympanic membranes has not been included in this proposal. OSHA requests any information and data regarding problems with respirator use associated with tympanic membrane defects, and any evidence for the need for checking for perforated eardrums for respirator wearers.

The American Association of Occupational Health Nurses (Ex. 36-8), commenting on the preproposal draft provision requiring assessment of the endocrine system, pointed out that such problems should have been noted as a previously diagnosed disease during the medical history. They also stated that assessing the endocrine system for all respirator wearers would be costly and time consuming. If a history of diabetes or other endocrine disease was detected, than evaluations could be done on a case by case basis. Other commenters said that physicians would be reluctant to accept liability for signing off on such an assessment and that the evaluations should be restricted to the employee's pulmonary function and cardiovascular system (Ex. 36-10) and should eliminate the endocrine test as not relevant to the wearing of respirators (Ex. 36-13). Alan Hack (Ex. 36-29) and the Los Alamos National Laboratory (Ex. 36-52) stated that "Workers so afflicted [with endocrine conditions which result in sudden loss of consciousness] will be restricted from many employment tasks that do not require use of respirators. Such restrictions should not be applied specifically to respirator wearers." Dow Chemical (Ex. 36-40) stated that the physical manifestations of endocrine system disease would be found during the neurologic examination.

OSHA believes that endocrine conditions such as diabetes should be considered by the physician when determining whether a respirator can be worn. Previously diagnosed endocrine conditions should be picked up during the taking of the medical history. However, undiagnosed endocrine system problems can still exist. The respirator use evaluation may be the only physical examination the employee has had for some time, and a diabetic condition could have developed. The extent of the assessment suggested, from looking for signs of disease during the physical exam to more extensive testing of those with signs of disease, is at the discretion of the physician. Any general work limitations or restrictions that apply to other work activities of an individual due to endocrine disorders should also be considered when determining whether a respirator can be used. OSHA does not recommend any specific tests for endocrine conditions, leaving the determination to the physician's judgment. Because the potential for sudden loss of consciousness or response capability is something that should be considered when determining an individual's ability to wear a respirator, the proposal includes the endocrine system assessment recommendation, as derived from the ANSI Z88.6 standard, in Appendix C. OSHA requests further comment on the need for assessing the endocrine system, and on determining which endocrine system conditions would preclude the use of respirators.

The preproposal draft also contained a requirement that an exercise stress test be performed for employees who use SCBA's or rebreather type respirators. The American Association of Occupational Health Nurses (Ex. 36-8) stated that exercise stress testing would be expensive and difficult to obtain for fire departments and small companies. Brown and Root (Ex. 36-10) maintained that an exercise stress test would be costly (approximately $240) and, if not standardized, would mean very little in determining whether an SCBA or rebreather respirator can be worn. Other commenters stated that OSHA should not require a routine cardiovascular stress test, but require one only if requested by the physician (Ex. 36-35, 36-40, 36-47). They also opposed the use of electrocardiograms on a routine basis, claiming that false positives require expensive follow-up testing. Also the nature of the tests required for exercise stress was not specified by OSHA, and an example of an exercise stress test was requested. SOCMA (Ex. 36-48) commented that exercise stress tests cost between $250 and $300, and urged OSHA to consider other testing that would yield similar data in a more cost effective manner, using a performance approach. The Motor Vehicle Manufacturer's Association (Ex. 36-37) recommended the provision be deleted and a simple pulse rate count be substituted.

The exercise stress testing provision was derived from the maximum exercise stress test recommended by the ANSI Z88.6 physical qualification standard. The ANSI standard stated that individuals with apparent ischemic disease or who cannot perform well on a treadmill due to respiratory, musculoskeletal, or other physical problems should not use SCBAs or be assigned to emergency response teams. OSHA recognizes that exercise stress tests can be expensive, and that criteria for evaluating specific conditions that would disqualify workers have not yet been developed. Moreover, the requirement in the preproposal draft for stress testing would have applied only to a small group of respirator wearers, and even then it would be difficult to determine whether such a test was really appropriate. OSHA concedes that such problems would appear to render inappropriate a mandatory requirement for stress testing. Therefore, determining whether an employees' health condition precludes the wearing of an SCBA or assignment to an emergency response team has been left to the physician. However, Appendix C recommends exercise stress testing for workers who were an SCBA or rebreather respirator device under strenuous work conditions or in emergencies.

OSHA is seeking further comment on the appropriateness of the exercise stress test, the most cost effective method of performing such testing and alternative methods of determining an individuals physical ability to wear SCBAs and rebreather respirators.

OSHA is seeking general comment on which recommendations should be retained as part of Appendix C, and whether certain provisions such as pulmonary function testing and exercise stress testing should be kept in the nonmandatory appendix or made mandatory provisions of the standard. Additional comment is also sought on whether OSHA should add to the nonmandatory appendix a section which further describes health conditions that should be considered during the medical evaluation. The proposal lists specific areas to be investigated but does not attempt to develop a list of medical conditions and diseases that may preclude the use of respirators. OSHA requests comment on whether such information would be of use for evaluating the ability to wear respirators and which medical conditions and diseases should be on such a list.

The proposal contains an exemption from the required initial medical evaluation when adequate medical records show that an employee has successfully taken a medical examination, or received a written opinion from a physician within the past year, on the basis of which the employee was determined to be fit to use the same type of respirator under similar use conditions. This exemption will help avoid the expense of duplicate medical examinations for transient workers who have already passed an initial medical evaluation for respirator use on one job and later moved on to work for another employer.

The preproposal draft contained a provision requiring review of the employee's medical status when an employee experienced difficulty in breathing while using a negative pressure or demand respirator. Alan Hack (Ex. 36-29) and Los Alamos (Ex. 36-52) recommended that a review occur when an individual experiences difficulty with any respirator, not limited to negative pressure devices. Homestake Mining (Ex. 36-30) also recommended a review following breathing difficulty with any respirator. OSHA agrees that breathing difficulty while wearing any type of respirator requires a medical status review, and the language of this alternative has been changed accordingly.

The final departure from the ANSI Z88.6 physical qualification recommendations is the requirement in this alternative that the employee's medical status be reviewed annually or at any time the employee experiences difficult breathing while being fitted for or using a respirator. Although the latter requirement is implied by ANSI, the annual review is not. By such an annual review, OSHA is not necessarily requiring a physical examination. The objective of this provision is to provide a mechanism which necessitates routine review of any difficulty an employee may be experiencing. Other then being performed by or under the supervision of a physician, the specific nature of this annual review is left to the physician to determine. OSHA invites comments as to the appropriateness of this provision.

AMAX Inc. (Ex. 36-27) citing experience with the OSHA lead standard, stated that an annual review of medical status was not required and review should be required only when requested by the employee. Air Products and Chemicals Inc. agreed. (Ex. 36-13). OSHA requests comment on this approach.

In the preproposal draft, OSHA included guidelines for medical examinations suggesting that they be given every five years for employees under forty, every two years for those from forty to fifty years of age, and every year for those above fifty. ANSI in its Z88.6-1984 standard recommended examinations every 5 years for those below age 35, every 2 years up to age 45, and annually thereafter. The NIOSH Respirator Decision Logic suggests examinations every 5 years for those under 35 years of age, every 2 years for those from 35 to 45, and every 1 to 2 years for those above 45, under most working conditions requiring respirators. Under strenuous work conditions with an SCBA, NIOSH suggested exams every 3 years for those under 35, every 18 months for those from 35 to 45, and annually for those above 45 (Ex. 38-20).

OSHA requests comment on whether an annual review of medical status is needed, or whether a sliding scale of examination dates, such as recommended by NIOSH or ANSI, could be substituted for the annual medical review.

Commenters questioned the preproposal draft requirement that the medical evaluation be performed by a licensed physician. Many commenters pointed out that there were portions of the medical evaluation that could be performed by other health professionals such as occupational health nurses and physicians assistants, or nurse practitioners, certified audiometric technicians, and pulmonary function testing technicians (Ex. 36-8, 36-10, 36-13, 36-18, 36-21, 36-22, 36-30, 36-32, 36-35, 36-37, 36-40, 36-41, 36-51A, 36-53, 36-55). OSHA has revised the language for this alternative to permit other health professionals to perform whatever medical evaluation procedures the physician chooses to delegate to them. OSHA requests comments on this issue and on the extent of the role that should be given to these health professionals.

In requiring a medical evaluation, OSHA has proposed in this alternative that an examination be given to respirator wearers regardless of the type of respirator used or the conditions under which it will be used. Commenters have suggested that not all types of respirators place the same physical demands upon wearers, and that the medical evaluation criteria could be reduced for certain low resistance respirators. John Barr of Air Products and Chemicals (Ex. 36-13) stated that positive pressure respirators place no significant burdens on wearers, and that disposable dust masks have no discernable effect upon respiration. He suggested that OSHA exempt such respirators from the need for a qualifying medical exam.

OSHA requests comments on whether the medical evaluation provisions should be less extensive for less burdensome respirators, such as positive pressure respirators or single use dust masks, and if so, what provisions could be reduced or eliminated. More generally, comment is sought on whether the medical evaluation provisions should be modified to accommodate particular respirator work conditions, and if so, what those modifications should be.

OSHA requests information and data on the breathing resistance levels of respirators for wearers, and whether a medical determination could be made to select a breathing resistance level which poses no problem for respirator wearers.

OSHA's suggested regulatory language for the second alternative medical evaluation procedure reads as follows:

(e) Medical evaluation.

(1) The employer shall provide a medical evaluation for each employee required to wear a respirator for more than five hours during any work week. The medical evaluation shall be performed by a licensed physician or by a health professional operating under the physicians supervision and shall include completion of a medical history and performance of a medical examination. In advance of the medical evaluation the employer shall provide the examining professional with information concerning:

(i) The type of respiratory protection to be used;

(ii) The substances the employee will be exposed to;

(iii) Description of the work effort required;

(iv) Duration and frequency of usage;

(v) The type of work performed, including any special responsibilities that affect the safety of others such as fire fighting or rescue work;

(vi) Any special environmental conditions (such as heat or confined space entry); and

(vii) Additional requirements for protective clothing and equipment.

(2) Upon completion of the examination, the employer shall obtain from the examining physician a written opinion which states whether the employee is fit to wear a respirator and recommends any limitations on respirator use. A copy of this written opinion shall be provided to the examined employee.

(3) In the case of new employees, employers may accept an already existing medical examination or written opinion from a physician provided it was conducted within a year of the date of employment, covered the same type of respirator under similar use conditions, and meets the requirements of (e)(1).

(4) The employer shall have the employee's medical status reviewed by, or under the supervision of, a licensed physician annually and at any time the employee experiences unusual difficulty breathing while being fitted for or while using a respirator. The employer shall have the responsible licensed physician provide a written opinion resulting from the review as required under (e)(2).

Alternative 3 -- Questionnaire

A third alternative for medical evaluation would require that a medical questionnaire be used to survey respirator users and to identify those who require physical examinations on the basis of their medical history (Ex. 15-8, 15-22, 15-34, 15-41, 15-42, 15-44, 15-45, 15-47, 15-68, 15-62). The specific nature of this questionnaire and its accompanying procedures was not always clearly presented by the commenters, but the health evaluation provisions in the Organization Resources Counselors, Inc. (ORC) recommended respiratory protection program (Ex. 36-47) was suggested as a model medical evaluation procedure (Ex. 36-3, 36-22, 36-35, 36-38, 36-40, 36-41, 36-47, 36-50, 36-51A).

The program recommended by ORC requires that a screening questionnaire be administered by a health professional or trained person for each respirator wearer, prior to fit testing. Anyone who gives a "yes" answer to a question on the questionnaire, or who wears an SCBA for emergency or rescue operations would receive a medical evaluation, performed by or under the direction of a physician. The procedures to be used for the medical evaluation would be left to the judgment of the health professional performing the evaluation. The employer and employee would be notified of any restrictions on respirator wear that are identified by the health evaluation. The ORC recommended program included a nonmandatory appendix containing sample questionnaires and suggestions for medical examinations of individuals who answered yes to the screening questions.

Other commenters who stated that automatic medical exams for all respirator wearers were not necessary (Ex. 36-3, 36-13, 36-21, 36-22, 36-30, 36-35, 36-38, 36-40, 36-41, 36-47, 36-50, 36-51A) also supported a medical questionnaire to screen the respirator user population so that only those whose medical condition warrants a medical exam would get one. The commenters stated that the questionnaire could be administered quickly, and the unnecessary expense of medical exams for healthy respirator users would be avoided.

OSHA has suggested in this alternative that the question of who should administer the medical questionnaire and determine which respirator users should be referred for a medical exam be resolved by adopting the recommended procedure in the ORC respiratory protection program. Either a health professional or a person trained in administering the questionnaire by a physician would have this responsibility. This would place this critical part of the medical evaluation under a trained individual acting under the direction of the physician who has the ultimate responsibility for approving respirator use. OSHA requests comments on the administration of the medical questionnaire and on the appropriate individuals for performing this requirement.

Employees who are assigned to emergency or rescue operations with SCBA respirators would still be required under alternative 3 to have a medical examination. These individuals are placed in highly stressful environments while wearing a heavy SCBA, which places an added burden on their physical condition. A questionnaire would not serve adequately as a screening procedure for these respirator wearers, and therefore OSHA would follow the ORC recommendation for alternative 3 and require that a medical exam be performed. The extent of that examination would be left up to the physician to determine. OSHA asks for comments on the need for performing a medical exam for these SCBA wearers, and on appropriate medical procedures to be used to evaluate their ability to perform adequately during emergency or rescue operations.

As examples of medical questionnaires, OSHA has included in Appendix C the ANSI Z88.6 medical questionnaire for respirator use, as well as the three sample questionnaires from the ORC Recommended Respiratory Protection Program. OSHA has placed these questionnaires in this nonmandatory appendix in order to seek comment on the appropriateness of using such questionnaires and on which provisions in these samples are appropriate for determining an individual's ability to wear a respirator. OSHA also requests any alternative questionnaires that are used in industry.

The proposed regulatory language that has been developed for this third alternative of the medical evaluation procedures reads as follows:

(e) Medical evaluation

(1) The employer shall provide a medical evaluation before respirator use starts for each employee required to wear a respirator.

(i) The medical evaluation shall consist of the completion of a screening medical questionnaire for all respirator users.

(ii) A medical examination shall be administered to any employee whose answers to any of the questions on the questionnaire show the need for such an examination.

(iii) A medical examination shall be administered to any employee who is assigned to emergency or rescue operations while wearing an SCBA.

(iv) The questionnaire shall be administered by a health professional or a person trained in its administration by a licensed physician.

(v) Any medical examination administered shall be performed by a licensed physician or health professional under the direction of the physician. If a medical examination is given, the employer shall obtain from the examining physician a written opinion which states whether the employee has any detected medical condition which would place the employee's health at increased risk or material impairment for respirator use and any recommended limitations upon the use of respirators.

(vi) A copy of this written opinion shall be provided to the examined employee. In advance of the medical examination the employer shall provide the examining professional with information concerning:

(A) The type of respiratory protection to be used;

(B) The substances the employee will be exposed to;

(C) Description of the work effort required;

(D) Duration and frequency of usage;

(E) The type of work performed, including any special responsibilities that affect the safety of others such as fire fighting or rescue work;

(F) Any special environmental conditions (such as heat or confined space entry); and

(G) Additional requirements for protective clothing and equipment.

(2) In the case of new employees, employers may accept an already existing medical examination or written opinion from a physician provided it was conducted within a year of the date of employment, covered the same type of respirator under similar use conditions, and meets the requirements of (e)(1).

(3) The employer shall have the employee's medical status reviewed by, or under the supervision of, a licensed physician annually and at any time the employee experiences unusual difficulty breathing while being fitted for or while using a respirator. The employer shall have the responsible licensed physician provide a written opinion resulting from the review as required under (e)(1).

Other Issues

Medical Removal Protection

In some substance specific standards (e.g. cotton dust 29 CFR 1910.1043 and asbestos 29 CFR 1910.1001) OSHA has required economic protection for employees who, for medical reasons, cannot wear required respirators. California OSHA (Ex. 36-44) and the United Steel Workers of America (Ex. 36-46) recommended that OSHA request any data on the instances and types of cases where employees have been determined not to be able to wear a respirator and what happened to these workers under current respirator programs. Determining the prevalence of such rejections and the fates of those who were rejected could be useful in determining the need of employers to supply alternative respirators or the need for OSHA to require that employers provide alternative jobs for those who cannot wear a particular type of respirator. Therefore, OSHA requests the submission of any data or information regarding instances and details of cases where workers were found to be unable to wear respirators and how this determination affected the worker's job responsibilities. OSHA would also like to receive any available information on the frequency with which such situations occur, or alternatively on how many such cases are known to have happened.

Since the inability to wear a respirator, or failing to pass a medical evaluation, could result in employees losing their jobs, some commenters recommended that OSHA should add provisions to help employees in these situations. Medical removal protection, the requirement that employers provide employees who are unable to wear respirators with alternative assignments at the same seniority and pay, was recommended by several commenters (Ex. 36-14, 36-26, 36-44, 36-46). Giving employees who fail to pass the initial medical evaluation the right to a second opinion, similar to the provision for physician review in the lead standard (29 CFR 1910.1025(j)(3)) was suggested by other commenters (Ex. 36-44, 36-46). Adding a requirement that the employer provide an alternate type of respirator such as a PAPR or supplied air respirator in cases where an employee cannot use a negative pressure air-purifying respirator due to medical restrictions was recommended by California OSHA (Ex. 36-44). Although such provisions were included in recent OSHA standards such as cotton dust (29 CFR 1910.1043(f)(2)(iii), (f)(2)(iv), (h)(5)(i)(c)) and asbestos (29 CFR 1910.1001(g)(2)(ii)) OSHA does not feel that sufficient information has been submitted upon which such provisions could be included in this proposal for general application to all workplaces. Therefore, additional information and data are requested which address these issues.

(F) Fit Testing Procedures

Although it has long been recognized that respirators must fit properly in order to provide protection, it has only been within the last few years that systematic approaches for assessing and assuring fit have been developed. As a result of continuing research, a number of fit testing protocols have been developed and tested (Ex. 2, 8). In addition, because of the variability of face size characteristics among individuals, different sizes of facepieces are now available, in contrast to the recent past when a "one size fits all" approach was generally taken.

In general there are two categories of fit testing -- qualitative and quantitative. Qualitative fit testing involves the introduction of a gas, vapor, or aerosol challenge agent into an area around the respirator wearer. A determination is then made as to whether the respirator wearer can detect the presence of the challenge agent through subjective means such as odor, taste, or nasal irritation. If the presence is detected, the respirator fit is considered to be inadequate.

In a quantitative respirator fit test the respirator is worn in a stable test atmosphere containing a suitable challenge agent. The adequacy of the fit is determined by measuring the actual levels of the challenge agent, both outside and inside the facepiece of the respirator.

The current standard sets out no specific protocols for fit testing although it does require training which provides an opportunity to have the respirator "fitted properly". It also requires employees to be trained to check the fit each time the respirator is put on without specifying how the check is to be performed or even what type of check is acceptable. Experience and research over the past ten years have demonstrated that this is insufficient, as set forth in the following discussion.

Even when fit testing is performed, it may be inadequate. In the past, some manufacturers included their own qualitative fit testing protocols as part of the manufacturers instructions to the user. Numerous commenters complained that NIOSH or OSHA should check the manufacturers instructions for adequacy and consistency (Ex. 15-14, 15-16, 15-36, 15-41, 15-46, 15-47, 15-48, 15-50, 15-52, 15-75A, 15-79), since employers often use or attempt to use such instructions to fit respirators to their employees faces. Since fit testing is often done by the employer, commenters also suggested that the simplicity of the protocol be stressed.

Commenters to the ANPR suggested that a standardized protocol be developed which is oriented toward the hazard or level of exposure when determining the qualitative efficacy of a respirator (Ex. 15-10, 15-48, 15-64). In addition, it was suggested that the type of odor or irritant used should also be standardized (Ex. 15-54, 15-58, 15-70, 15-71, 15-76). Correlation of the testing done qualitatively and quantitatively would also aid in assuring that respirators being worn are effective (Ex. 15-17B, 34-8). The proposed standard attempts to standardize the protocol and also simplify the procedures.

OSHA has recognized the need for fit testing in the development of recent substance specific rulemakings. Quantitative fit tests were required in such standards as acrylonitrile (29 CFR 1910.1045) and lead (29 CFR 1910.1025). However, specific protocols were not provided in any of these substance specific standards. Later, questions arose regarding the feasibility of the requirement for quantitative fit testing in the lead standard (29 CFR 1910.1025). As a result OSHA conducted a specific rulemaking for the fit testing provisions of the lead standard. It was consequently determined that qualitative fit testing could be used with half mask negative pressure respirators, provided that one of three specified protocols was followed, and provided that lead concentrations do not exceed ten times the permissible exposure limit (47 FR 51110).

These specified qualitative fit testing (QLFT) protocols use isoamyl acetate, irritant smoke, or saccharin as the test agents. OSHA believes, based on the record of the lead supplemental rulemaking (47 FR 51110), that the three QLFT protocols accepted for use in the lead standard are generally appropriate for use with negative pressure half mask respirators and has therefore incorporated them.

This proposal would require that fit testing be performed where air-purifying respirators as well as tight fitting atmosphere-supplying respirators are used. Either qualitative fit testing or quantitative fit testing may be conducted for quarter facepiece, half mask, or full facepiece respirators. The proposal details the procedures for qualitative and quantitative fit tests in Appendix A. Commenters (Ex. 36-38) on the preproposal draft stated that the protocol exercise regimens and other elements common to both qualitative and quantitative fit testing were not consistent. Therefore the common elements of the protocols in Appendix A have been standardized in this proposal in order to provide consistency.

It is recognized that one purpose of revising the existing respiratory protection standard is to allow for changes in respiratory protection technology. Numerous comments were made suggesting that limiting the qualitative and quantitative tests to certain specified methods would freeze technology at the present state and would not allow for future changes nor provide any incentive to develop new test methods or test agents (Ex. 36-22, 36-32, 36-35, 36-51, 36-53). OSHA agrees and would like to develop more performance oriented criteria by which new or modified fit test procedures can be evaluated. Such criteria must guarantee a high level of certainty that the fit test will in fact select the best fitting respirator and give maximum assurance of reliable fit. Performance oriented criteria that will enable reliable new fit tests to be developed and implemented do not, to OSHA's knowledge, exist at the present time. OSHA seeks comment so that it can build a provision into the standard that encourages and permits improvements in fit test technology. Such comment should include specifications for validation procedures and for what organizations can be designated as credible validation performers.

In the absence of performance oriented criteria for determining the reliability of fit tests, OSHA is proposing to allow the use of qualitative or quantitative fit tests other than the methods specified in Appendix A provided they are validated to provide equivalent or better reliability.

When a qualitative fit test is properly administered for a half mask, quarter mask, or full facepiece negative pressure air-purifying respirator in accordance with the protocols in Appendix A, OSHA proposes to allow the respirator to be used in concentrations up to a maximum of ten times the established permissible exposure limit.

Quantitative fit testing (QNFT), a more recent development, measures the efficacy of a respirator by actually measuring and comparing the contaminant level inside and outside a respirator facepiece. As with qualitative fit testing, commenters stated that manufacturers' QNFT protocols differ greatly (Ex. 15-22, 15-26, 15-30, 15-44). Many objected that different test agents were used (Ex. 15-44, 15-55, 15-58, 15-79). Some manufacturers protocols only test the respirator once instead of using the average of several tests. OSHA in reviewing these comments agreed that the QNFT procedure should be standardized and for this reason includes a protocol in the proposed standard.

Either qualitative or quantitative fit testing may be used for quarter facepiece, half mask, or full facepiece respirators. However, OSHA has only limited data on the applicability of the qualitative fit test protocols for either quarter facepiece or full facepiece respirators. Therefore, although this proposal does allow the use of quarter facepiece and full facepiece respirators which pass the QLFT in atmospheres up to ten times the established exposure limit, OSHA invites interested parties to submit data which demonstrate how well the QLFT protocols can detect poor fits for full facepiece and quarter facepiece respirators.

If the employer chooses to use quantitative fit testing, a full facepiece respirator may be used up to a maximum of its assigned protection factor of 50 as shown in Table I of paragraph (d), provided that the fit factor obtained during quantitative fit testing is at least 500.

The proposal requires fit testing of tight fitting atmosphere-supplying and powered air-purifying respirators. It is recognized that demand type atmosphere-supplying respirators have negative air pressure inside the facepiece compared to the air pressure outside the respirator upon inhalation. The efficacy of these respirators therefore relies to a large degree on the integrity of the facepiece to face fit. Therefore it is clearly appropriate to require fit testing of demand or negative pressure tight fitting atmosphere-supplying respirators. Comments were also received regarding positive pressure tight fitting atmosphere-supplying respirators (Ex. 36-26, 36-45, 36-44). Such comments suggested that it is appropriate to require the fit testing of positive pressure devices since it has been determined that positive pressure respirators do not always maintain positive pressure. Further, the possible adverse effects of the negative pressure spikes can be minimized by providing positive pressure respirator users with good fitting facepieces. Therefore, it has been suggested that quantitative fit testing should be required for positive pressure equipment (Ex. 36-26). Accordingly, OSHA is proposing that tight fitting atmosphere-supplying respirators utilizing quarter facepiece, half mask, and full facepiece masks be fit tested either by a qualitative or quantitative fit test. The proposal specifies that only the mask needs to be tested, not the entire respirator unit. Since the testing of entire atmosphere-supplying respirator units may require even more specialized QNFT equipment, and since the fit of the facepiece itself is the basic consideration, only the mask is required to be tested. It is recognized that most respirator facepieces (i.e brand, model, size) are available in air-purifying models as well as atmosphere-supplying units.

The fit test is to be performed on the same brand, size, and model of an air-purifying respirator. Once a fit is achieved with a particular mask, a NIOSH approved atmosphere-supplying respirator which utilizes the same type of mask as used in the test (i.e., brand, size, model) is to be selected for use by the employee. The respirator may then be used with an assignment protection factor as noted in Table II.

OSHA is proposing that fit testing be performed before an employee first starts wearing a respirator in the work environment and at least annually thereafter. Semiannual respirator fit testing is required currently in certain OSHA substance specific standards such as lead, inorganic arsenic, acrylonitrile, and asbestos. In the preproposal draft respirator standard, OSHA proposed that fit testing be performed annually. Testing respirator fit on an annual basis was considered more appropriate for a general respirator use standard rather than the semiannual fit testing required in some substance specific OSHA standards. Commenters on the preproposal draft standard agreed with the annual testing requirement (Ex. 36-8, 36-11, 36-26, 36-30, 36-31, 36-44, 36-45, 36-47). Others disagreed. Michael Stewart of the Boeing Company (Ex. 36-24) commented that fit testing should not be required at a fixed, arbitrary frequency since changes which affect a proper respirator seal occur at random. He proposed that OSHA require fit testing whenever an employee experiences difficulty in obtaining an adequate face seal during a routinely performed positive/negative fit check. However, a study of the negative pressure fit check has shown (Ex. 24-21) that this fit check would pass respirator wearers with inadequate fits, particularly those that require protection factors above 10. Therefore, the use of positive/negative facepiece fit checks to determine when a fit test should be given would be an inadequate substitute for annual fit testing. The Monsanto Company (Ex. 36-32), Amoco Corporation (Ex. 36-35) and the Dow Chemical Company (Ex. 36-40) stated that annual fit testing was not necessary and it was their experience that fit testing every second year was adequate. It is OSHA's belief, however, that fit testing not only determines respirator fit, but also provides an opportunity to check on comfort and problems with respirator wear, and reinforces respirator training by having wearers review the proper methods of donning and wearing the respirator. Moreover, a two year interval between fit tests has not been shown to provide adequate assurance that necessary respirator fit factors will be maintained in the workplace. OSHA encourages these companies and others to provide any supporting data or specific experiences they have that would support an alternative to annual fit testing. OSHA invites comments from all interested parties on the annual fit testing requirement and on alternative fit testing frequencies. OSHA also requests any experience from fit testing programs on how frequently the annual fit test results in the changing of the previously assigned respirator for a new model or size.

The point was raised that either contractors or corporate staff members often have sole responsibility to conduct quantitative fit testing at local facilities and that a problem is created when new hires enter the work force after the annual fit test has been completed at the facility (Ex. 36-11). OSHA is proposing that where assigned protection factors higher than ten are necessary, requiring quantitative fit testing, an employer may utilize a qualitative fit test to select respirators for new employees provided that a quantitative fit test is administered within thirty days. This is allowed only when the employer is relying on an outside party to conduct quantitative fit testing. OSHA is also asking for comments on whether this provision should be broadened to cover other situations, such as when the QNFT equipment is out of service for repairs, where the thirty day exemption would prove useful.

It is generally recognized that facial configuration, and ultimately respirator fit, can be affected by factors such as weight gain or loss, and can change with time. Comments were submitted requesting that specific criteria be provided on the conditions which would require a retest, such as a set amount of weight change (Ex. 36-13, 36-28). To clarify the issue the current proposal states that retesting is required as necessary, such as when visual observations are noted regarding an employee's condition which could affect respirator fit. Further it is stated that such conditions may be facial scarring, cosmetic surgery, or an obvious change in body weight. OSHA believes that it is not possible to provide specific quantifiable criteria for the extent of such changes and that it is unavoidable that the employer will need to exercise judgment in deciding when a non-scheduled fit test is necessary.

Once fitted the employee shall be given the opportunity to wear the respirator for two weeks. If the respirator becomes unacceptably uncomfortable the employee must be given an opportunity to select a different respirator facepiece and be retested. Employers relying on contractors to conduct fit testing may wish to have the employee successfully fitted in two different respirators. This would prevent having the contractor return to the facility to retest an employee whose respirator became uncomfortable.

Appendix A

Appendix A applies to both qualitative and quantitative fit testing of quarter facepiece, half mask, and full facepiece respirators. The appendix identifies three established qualitative fit test protocols and one quantitative fit test protocol utilizing one of two test agents.

A protocol for the TSI Portacount fit testing method has not been included as an established quantitative fit test protocol at this time. The use of the Portacount is currently acceptable under a compliance interpretation which treats its use as a de minimis violation of the substance specific standards which require the use of an aerosol generation system for quantitative fit testing. As part of this rulemaking a protocol for the Portacount will be reviewed and, if appropriate, the existing substance specific standards fit test provisions will be revised to permit its use. OSHA invites the submission of other fit test protocols for public comment and OSHA approval before inclusion as established fit test methods.

In addition Appendix A contains two sets of "minimum criteria for a valid fit test". One set of criteria applies to qualitative fit tests which utilize a "non-established" test agent or method. The second set applies to quantitative fit tests which use a "non-established" test agent or test method. The purpose of including these criteria is to allow and encourage the development of new qualitative and quantitative fit test methods and/or media. This is in response to numerous comments stating that any new standard should be flexible enough to allow new methods, test agents, and respirator test technology to be developed (Ex. 36-22, 36-32, 36-35, 36-51A, 36-53). OSHA requests comments as to the appropriateness and adequacy of the proposed Minimum Criteria.

New test methods and/or agents may be accepted by OSHA after their use is proposed in a Notice of Proposed Rulemaking, and comments are requested, according to a notice and comment rulemaking procedure pursuant to the Administrative Procedure Act, 5 U.S.C. 553. OSHA believes that this procedure, authorized by the OSH Act in the last sentence of section 6(b)(7) will allow relevant public comment to be submitted for OSHA's evaluation without the need for public hearings. Since the protocols which will be adopted in this standard will have been subjected to rulemaking, additional protocols too, should be examined in a public proceeding. However, requiring full 6(b) rulemaking, with public hearings, would in OSHA's view, unduly delay decision making on the validity of new fit testing protocols and would be unnecessary. OSHA believes that this procedure strikes an appropriate balance between the need to accommodate technological advances in fit testing, and the need to obtain input from affected employers and employees.

Both the qualitative and quantitative validation criteria for new fit test methods require that the fit test data submitted for approval demonstrate statistically that the fit test method would be as protective. These requirements set a strict performance criteria for new test methods. While these criteria have generally been used in the past in evaluating test data it is not clear that these performance levels are the most appropriate ones to be used for evaluating new fit tests. Some of the existing qualitative fit test methods that are generally accepted do not meet these performance levels. The irritant smoke (Ex. 24-12) and saccharin (Ex. 24-20) QLFT protocols identified 92 percent of users with poor fits at the 95% confidence level. The isoamyl acetate QLFT protocol identified 93% of the poor respirator fits (Ex. 24-19). As an alternative, it has been suggested that OSHA allow the use of new fit test methods that are proven to meet or exceed the performance levels of the currently accepted methods. OSHA requests comments, data, and information on the appropriate performance levels that should be required for new fit test methods, and on whether the 95% of users/95% confidence level requirements contained in the validation criteria for new fit test methods should be retained or revised.

The question of whether OSHA should propose standard test aerosol particle sizes to be used in validating new qualitative fit test methods has been raised. For validation testing of respirators equipped with high efficiency particulate air (HEPA) filters a polydisperse test aerosol with a mass median aerodynamic diameter of 0.6 micrometers with a geometric standard deviation of less than 2 was considered by OSHA. For testing respirators equipped with non-HEPA filters a polydisperse test aerosol with a mass median aerodynamic diameter of 2.0 micrometers and a geometric standard deviation of less than 2 was suggested. These are the particle size ranges for silica dust that NIOSH uses for HEPA and dust/mist filter certification. Whether these particular aerosol sizes are the most appropriate ones to be specified for use in validating new qualitative fit test methods is uncertain. In the proposal OSHA has not established a standard test aerosol particle size. With respect to qualitative fit testing, OSHA invites comments and questions as to the size of aerosols acceptable for use in qualitative fit test protocols, whether OSHA should establish standard test aerosol sizes for validation testing, and if so, what the appropriate sizes should be.

It should be remembered that, regarding the minimum criteria for validation of a new fit test procedure, the test subjects of interest, and the only ones that enter into the statistical analysis, are those who have poor respirator fits. The statistics must be based on the ability of the new test procedure to detect an already established poorly fitting respirator. It must be kept in mind that the validation of a fit test measures the performance of the fit test and not of the respirator. The objective of the validation testing is to assure that the new test procedure provides results which are at least as reliable as those of the existing protocols.

The validation of new fit testing procedures has to be a carefully controlled measurement procedure using test instrumentation with an accuracy that exceeds that found in standard quantitative fit testing. The validation testing that has been done on the existing fit test procedures were performed using laboratory grade instrumentation. As a matter of caution, it is recommended that those performing validation testing for new fit test procedures submit to OSHA the test parameters of the instrumentation that will be used in advance, before extensive testing is done. OSHA invites comments to specify more precisely the performance parameters that should be established for valid comparison measurements. The section in this proposal that describes minimum criteria for validation of new QNFT protocols requires that instrumentation achieve sufficient accuracy and precision, but does not specify values for these parameters. Therefore, OSHA requests comments on appropriate values for accuracy and precision of validation instrumentation including sampling systems, detectors and processors. OSHA is aware that the ANSI Z88 respirator committee is working on minimum criteria for fit test instrumentation. If during the rulemaking process ANSI finalizes its recommendations, OSHA will give them serious consideration with respect to the minimum criteria.

New Fit Testing Technology

The minimum criteria for fit testing also contains a section that deals with minimum criteria for new technology. It contains provisions which are general in nature, since without knowing what the new fit testing technology will be it is not possible to develop specific criteria. Fit testing methods using new technology will have to be approved by OSHA on a case by case basis, taking into account the specific nature of the new technology. OSHA requests comments on how new technology for fit testing should be evaluated, and what ground rules for minimum criteria OSHA should establish concerning its use.

OSHA is aware that there are other fit testing methods under development that do not rely on particle counting, such as the controlled negative pressure fit test or fit tests that use a gas as the fit test agent. Other novel fit test methods using different technologies may be developed in the future. OSHA intends to allow for the possible acceptance of these novel fit test methods. However, there has to be a way to guarantee that any new fit test method is at least as effective as the existing particulate methods in screening out poor respirator fits. The proposed criteria in Appendix A for new fit test methods related to particle counting fit test methods, and may not be appropriate for other technologies. OSHA, therefore, would like suggestions on what criteria would be appropriate for accepting or rejecting fit test methods based on non-conventional principles.

Fit Test Exercises

Complaints were also registered on the issue that the fit test protocols specified in the prepublication draft proposal were not consistent in that the exercise regimens, length of test exercises and type of exercises were not consistent among the qualitative fit test methods and that there were corresponding differences between the qualitative and quantitative fit test protocols (Ex. 36-38). For example, the isoamyl acetate method consisted of seven exercises; the saccharin protocol, five exercises; the irritant fume protocol, six exercises; and the quantitative fit test protocol, eight exercises. Therefore the initial section of Appendix A contains uniform requirements applicable to both qualitative and quantitative fit tests. Except for minor modifications, the uniform requirements are the same as those identified in the OSHA lead standard (29 CFR 1910.1025) as a result of the rulemaking on its fit testing provisions. Only those areas where substantive changes were made and where comment has been received are addressed below.

In the course of the fit test the test subject is to seat the respirator by moving the head from side-to-side and up and down, slowly while taking a few deep slow breaths. This represents a change from the selection protocol in the lead standard, since the lead standard protocol requires the head to be moved "rapidly" from side to side and up and down. The Los Alamos National Laboratory commented that there is uncertainty regarding the ability of rapid head movement to seat a respirator, and also indicated that it may actually make the fit worse (Ex. 36-52). Therefore OSHA has revised the proposal regarding this aspect by removing the word "rapidly".

The employer is to maintain a record of the fit test administered to an employee. The fit test record is to include the date and type of test, test agent, employee information, and type of respirator. When QNFT is administered a record of the test recording (i.e. strip chart, computer integration, etc.) is to be maintained. The fit test records are to be maintained until the next fit test is administered. A record is necessary to enable OSHA to determine compliance by verifying that an employee has been fit tested before first starting respirator use and at least annually thereafter; that the tested employee passed the qualitative fit test, or achieved a sufficiently high fit factor to pass the quantitative fit test for the assigned protection factor required; that the quantitative fit test was correctly performed and the fit factor calculated properly; and that the respirator model and size as determined during fit testing are the same as being used by that employee in the workplace.

Initially OSHA proposed that a fit test card be furnished to the employee. The card was to contain information regarding the size and type of respirator fitted and the date of the test. Comment was made (Ex. 36-39) that the requirement for a fit test card created an additional recordkeeping burden. Therefore the requirement has been deleted in the current proposal.

An alternative to the required fit test recordkeeping would be to allow the employer to sign a certification that fit testing has been performed and not require that any fit test records be maintained. This certification would state that fit testing had been performed and provide the date of the certification, the employee identifier of the person certified, and the signature or initials of the responsible individual making the certification. Since a certification is not considered a record for recordkeeping purposes, and the fit test records generated during the fit test would not have to be maintained, the recordkeeping burden of the proposed standard would be reduced. However, the replacement of the requirement for retaining the fit test records by a certification requirement would have an impact on the performance of an inspection. Inspectors would have to rely on secondary sources such as interviews of employees and fit test operators to confirm compliance with the specific fit test requirements of the standard. OSHA requests comments on the burden associated with maintaining fit test records and on the feasibility of fit test certification as an alternative to the recordkeeping currently required in the proposal.

The test subject is to perform eight exercises. Seven of the exercises are to be performed for one minute while the grimace exercise is to be performed for 15 seconds. The test exercises are: normal breathing, deep breathing, turning head side to side, moving head up and down, talking out loud, grimace, bending over or jogging in place if the test unit is not large enough for the test subject to bend at the waist, and normal breathing.

Comment was received stating that requiring the test subject to bend at the waist would in effect eliminate the use of the waist length hood or shower curtain type fit test hood (Ex. 36-27, 36-52). Therefore, this proposal allows jogging to be performed in lieu of bending at the waist when the size of the fit test enclosure will not allow the test subject to bend at the waist.

Objections were also raised over requiring the test subject to read, particularly the rainbow passage (Ex. 36-8, 36-27, 36-28, 36-32, 36-36, 36-39, 36-49). Statements were made that some employees cannot read well. Therefore, the proposal now requires that the employee either talk out loud or read from a prepared text.

One comment stated that OSHA has made numerous changes to accepted protocols without verifying the effect of the changes on test performance (Ex. 36-38). It states further that the isoamyl acetate (IAA) and saccharin procedures originally presented in the lead standard would take only 3 minutes, but that the proposal changed this to 10 minutes without verifying that the concentration in the test chamber could be maintained for the duration of the test.

OSHA does not regard the foregoing as valid. The QLFT test validated and adopted in the lead standard as a result of rulemaking has 6 exercises (IAA). Five of the exercises are to be performed for one minute and the "talking" exercise is to be performed for "several" minutes. Thus the total test time would be 7 to 8 minutes. In this proposal OSHA is requiring eight exercises of which seven are to be performed for one minute and one exercise for 15 seconds, for a total time of 7 minutes and 15 seconds. Thus the total time required in this proposed standard is essentially the same length as the IAA QLFT protocol in the 29 CFR 1910.1025 lead standard. Any differences in required time are clearly minimal. Since the length of the two tests are the same, OSHA has concluded that the IAA concentration at the end of the proposed protocol would be the same as if it were performed under the QLFT IAA protocol contained in the lead standard.

Qualitative Fit Test Protocols

Isoamyl acetate protocol

With the exception of the test exercises described above, the IAA test protocol included in the proposal is the same as the IAA protocol adopted under the lead standard (29 CFR 1910.1025). Comment was received stating that the odor threshold screening test can be performed in the same room in which the fit test is conducted, provided that ventilation is adequate (Ex. 26-18), or when only a few people at a time are tested (Ex. 36-8), and that two rooms on separate ventilation systems may not be available and are unnecessary. However, in none of these comments was the specific issue of olfactory fatigue addressed.

In the proposal OSHA is requiring the odor threshold screening test and fit test to be conducted in separate rooms and that the rooms not be connected to the same recirculating ventilation system. In the rulemaking in the lead standard on qualitative fit testing OSHA, in response to the recognition of one of the shortcomings of the IAA test (i.e., olfactory fatigue), deemed it appropriate that separate rooms and ventilation systems be required for the IAA fit testing and odor threshold screening test (47 FR 51114). Since nothing in the foregoing comments responded to the olfactory fatigue concern, OSHA is maintaining the requirement for separate rooms and ventilation systems.

Saccharin Solution Aerosol Protocol

The saccharin solution aerosol protocol in the proposal is essentially identical to that contained in the lead standard (29 CFR 1910.1025 Appendix D II). Comments were received suggesting that OSHA not allow the use of saccharin as a test agent since it is a suspect carcinogen (Ex. 36-28, 36-36) and that it is listed in the National Toxicology Program's Third Annual Report on Carcinogens (Ex. 36-34). However, the saccharin fit test protocol is the only QLFT protocol that has been validated for use with disposable dust/mist respirators. Eliminating the saccharin protocol would result in prohibiting the use of disposable dust/mist respirators, since they could not be fit tested. Although OSHA acknowledges that saccharin is a suspect carcinogen, it is highly unlikely that an annual exposure of 10 minutes, during most of which time a respirator is worn, could constitute any measurable risk. OSHA considers such an exposure to be de minimis. Therefore, for the present time OSHA will allow the use of saccharin as a test agent for respirators in the absence of an acceptable alternative for testing disposable dust respirators. In this respect saccharin differs from DEHP, a test agent used in QNFT, for which acceptable substitutes exist. OSHA in this proposal is encouraging the development of new test agents and test methods as a replacement for the use of saccharin by including provisions which would allow such new protocols and test agents to be used.

Irritant Fume Protocol

Comment was received on the irritant fume protocol stating correctly that the irritant fume and IAA protocols had inadvertently been combined in the prepublication draft and that the cartridges required for the respirator are incorrect, i.e., high efficiency organic vapor-acid gas, (Ex. 26-18, 36-28, 36-45, 36-52). The prepublication draft of this proposal inadvertently contained the above referenced requirements which were contained in the amendment to the lead standard. The lead standard was corrected at a later date (3-3-83). The correction required only high efficiency filters and deleted all references to the use of IAA in the irritant fume protocol. These corrections are accordingly reflected in the current proposal.

Objections were raised over requiring the use of a low flow air pump set to deliver 200 milliliters per minute. Statements were made that an aspirator bulb should be acceptable unless justification is provided for requiring a low flow air pump (Ex. 36-27, 36-28). OSHA is maintaining in the proposal the provision requiring the use of the low flow air pump. The purpose of the pump is twofold: to provide the challenge agent at a constant and stable rate; and to prevent a large amount of irritant from being released at one time. Use of an aspirator bulb will not provide delivery of the test agent at a stable, constant rate. Further, the use of an aspirator bulb can easily result in a large amount of irritant smoke being inadvertently released at one time.

Quantitative Fit Test (QNFT)

Under the QNFT provisions the employer is to assign to one party such as a staff member or contractor the duty of implementing the QNFT program. The person assigned is to be knowledgeable about the instrumentation, calibration, use and administration of the tests. Further the employer is responsible for ensuring that the QNFT equipment is kept and maintained in such a way that it will operate at its original specifications, including maintaining the aerosol size and concentration in the test environment. OSHA is requesting comment on appropriate means/methods which should be used to ensure that the QNFT unit is producing aerosol with the particle size distribution and concentration for which the unit was originally designed.

The quantitative fit test is to be conducted according to procedures which are widely recognized and accepted in the industrial hygiene community. It is performed in a test environment containing a challenge agent such as a hood, portable booth, or chamber. Measurement of the challenge agent concentration is made inside the respirator and inside the ambient test chamber environment by appropriate detection methods such as forward light scattering photometry or flame photometry. During the test the respirators are to be fitted with high efficiency filters, or otherwise fitted with filters that offer 99.97% efficiency against 0.3 micron aerosols according to the NIOSH definition of high efficiency as stated in 30 CFR Part 11 or 42 CFR Part 84. Therefore virtually any measurable leakage will be the result of leaks between the respirator sealing surface and the respirator wearers face. If challenge agents other than particulates are used, the sorbent/filters must offer a similar degree of collection efficiency against the challenge agent.

Challenge Agents

In the ANPR OSHA requested comment on what test agents are suitable for QNFT. The ANPR also raised the question of whether it should be allowable to use substances identified as suspected carcinogens and if allowable, what basis should be used to determine that the probable dose is acceptable or unacceptable. Although it is generally recognized that QNFT fit testing equipment using test agents such as di-2-ethylhexyl phthalate (DEHP, commonly referred to as DOP), corn oil, and sodium chloride are commercially available at the present time, OSHA was and is interested in exploring all possible test agents for use in QNFT. On the issue of suitable test agents for QNFT, OSHA received a variety of comments. Some commenters suggested that the agency accept any agent demonstrated to be effective (Ex. 15-30), relatively nontoxic, easily detectable, and relatively stable (Ex. 15-13). Others provided lists of agents such as sodium chloride, di-2-ethylhexyl phthalate, di-2-ethylhexyl sebacate (DEHS), corn oil, mineral oil, and 1% ethylene in air (Ex. 15-15). Another list submitted consisted of sodium chloride, di-2-ethylhexyl phthalate, di-2-ethylhexyl sebacate, corn oil and mineral oil (Ex. 15-58). Others provided one or two test agents: sodium chloride and corn oil (Ex. 15-55); DOP and corn oil (Ex. 15-37); corn oil and vanilla extract (Ex. 15-10); sodium chloride (Ex. 15-44); or corn oil (Ex. 15-26, 15-47, 15-50). In response to the question of appropriate test agents it was suggested that "The essential characteristics for an acceptable solid or liquid aerosol agent for QNFT are described in ANSI Z88.2-1980 and/or the LANL basic protocol". The Dow Chemical Company stated that there are many suitable test agents for QNFT (Ex. 15-19). It said that within Dow, Freon 12 was used extensively and that to be suitable the agent should be readily detectable at low concentrations. Dow later stated replacement of their units would be expensive and unnecessary, should Freon 12 be excluded as a test agent under this proposal (Ex. 36-40).

The second question of whether it should be allowable to use test agents identified as carcinogens was prompted by animal studies concerning DEHP which were positive for carcinogenicity. Several commenters declared that suspect carcinogens in general should not be allowed to be used (Ex. 15-34, 15-44, 15-48, 15-50, 15-55, 15-58, 15-70). The St. Joe Lead Company (Ex. 15-44) stated: "In general, they should not be used. The problem is not so much that one could determine the doses well below any dose of concern, but rather that the concept of a health related test utilizing a known carcinogen would tend to undermine the positive psychological value of concern of the employer for the worker's health." Comment was received stating that there is insufficient toxicological evidence to eliminate materials such as DEHS or PEG as test agents and that gases should not be precluded (Ex. 36-52). Any test agent should be allowed as long as the employer can assure that employees are not exposed to hazardous concentrations.

Other comments ranged from declaring that substances known to be human carcinogens should not be used as fit test agents (Ex. 15-22, 15-26) to stating that suspect carcinogens may be used depending on potency, concentration, exposure and other safety factors (Ex. 15-22). In the information submitted by NIOSH (Ex. 16) which was incorporated into a later document entitled "Alternatives to Di-2-Ethylhexyl Phthalate (DOP) Respirator Quantitative Fit Testing" (Ex. 24-10), it was stated that di-2-ethylhexyl phthalate (DEHP) or DOP was recently found to be carcinogenic in two rodent species by the National Toxicology Program. NIOSH reviewed the evidence for carcinogenic potential and overall toxicity of DEHP as it is used in quantitative fit testing, and concluded that DEHP should be replaced. The carcinogenic risk was estimated to be minimal for the respirator wearer under normal conditions. However, NIOSH pointed out that two critical exposure factors must be considered in QNFT; (1) Exposures to the DEHP aerosol can vary for the respirator wearer being tested if QNFT is improperly conducted; (2) Field practitioners administering QNFT, especially those using portable testing equipment, where aerosol ventilation is difficult to control can be subjected to routine and varying exposures. NIOSH tested several agents as possible substitutes for DEHP in existing QNFT equipment which was originally made for DEHP aerosol. Test results revealed that refined corn oil, di-2-ethylhexyl sebacate (DEHS), and dimethecone all exhibited polydisperse aerosol particle characteristics essentially equivalent to those generated with DEHP. Further tests showed that both refined corn oil and DEHS aerosols were highly suited for conducting QNFT. Finally, reports describing the toxicity and health effects of each agent were reviewed. The review revealed that extensive tests conducted on refined corn oil show that its toxicity is very low and that it has not demonstrated carcinogenic potential during its use as a control agent in carcinogenic bioassays. NIOSH concluded that a refined corn oil aerosol is the best option to replace DEHP in quantitative fit testing.

Monsanto (Ex. 15-26) made reference to the NIOSH work which prompted Monsanto to switch from DEHP to corn oil as the prescribed challenge agent. After considering the data, OSHA has concluded that corn oil or sodium chloride aerosol systems are most appropriate for quantitative fit testing and the proposal so specifies in the QNFT protocol. OSHA cites the positive carcinogenic findings of DEHP in two rodent species by NTP (Ex. 24-10) as sufficient evidence to preclude its use in QNFT when suitable substitutes are commercially available. Corn oil has exhibited essentially equivalent polydisperse aerosol particle characteristics to that of DEHP, and it can be used in existing systems designed for DEHP with only slightly more maintenance required (Ex. 24-10). Comment was received stating that corn oil does require more maintenance and urged OSHA and NIOSH to expedite the search for other suitable test agents (Ex. 36-39).

Other test agents have been suggested such as DEHS, ethylene, vanilla extract, freon-12, and mineral oil. OSHA does not intend to exclude these test agents. However, there are insufficient data on their suitability. For example, questions have been raised on the suitability of DEHS since its metabolic fate may be similar to that of DEHP. Mineral oil was suggested as a suitable test agent but has been observed to remain in the lung for prolonged periods (Ex. 24-10).

OSHA invites comments on the suitability of other test agents such as mineral oil, freon-12, ethylene, and di-2-ethylhexyl sebacate (DEHS). OSHA will consider evidence on the suitability and reliability of other test agents and the detection systems associated with other test agents. Information on the toxicity of the agent, sensitivity and limits of detection of the system, and other pertinent data will also be useful.

Test Chamber

The proposal requires that the test chamber be large enough to permit the person being tested to freely perform the QNFT exercise regimen without disturbing the challenge agent concentration, and that the chamber effectively contains the challenge agent in uniform concentration. Uniform stable challenge agent concentration is important since the ambient challenge concentration is measured from a single point, i.e. normally a sample hose suspended from the ceiling of the test chamber/hood and connected to the aerosol detection system. Therefore, the proposal requires that a stable ambient challenge agent concentration be achieved prior to the commencement of the test exercise regimen. As long as the concentration is uniform throughout the chamber, the concentration at the respirator will be substantially the same as the concentration at the location where the ambient chamber concentration is measured. Since the results of the QNFT will be determined by calculating the concentration of the challenge agent in the respirator in relation to the average ambient chamber concentration, a large change in the test chamber challenge concentration during the course of the test would result in unreliable results.

Fit Factor Estimation

The challenge agent detection system must be coupled to a strip chart record, integrator, or computer which creates a record of the test in order to enable the calculation of the fit factor following the test. The time interval between an event such as side to side head movement and its being recorded should be minimal. This is consistent with the systems used by Los Alamos National Laboratory as well as commercially available systems. In the ANPR, OSHA requested comments on two related questions: (1) Should QNFT demonstrate the variation of contaminant concentration inside the respirator during the breathing cycle, and (2) to be an adequate test, should QNFT evaluate respirator performance for each test exercise performed by the test subject? Some responses indicated that the QNFT should be able to demonstrate the variation of contaminant concentration inside the respirator during the breathing cycle (Ex. 15-19, 15-46, 15-48, 15-50, 15-54, 15-58). It was stated by one commenter that "a chart recorder should be considered as mandatory since this would be an extremely difficult process to follow by using only a dial indicator", (Ex. 15-50). It was suggested that the peak penetration averaging method contained in ANSI Z88.2 1980 is the most acceptable method for determining respirator fit and in order to achieve this, the QNFT must be capable of demonstrating the peaks of penetration associated with the breathing cycle (Ex. 15-58).

Others disagreed (Ex. 15-15, 15-26, 15-27, 15-31, 15-55). In particular, National Draeger Inc. (Ex. 15-15) pointed out a currently available quantitative fit test system utilizes a 1% ethylene-in-air test gas. By measuring the ethylene concentration inside the respirator with a detector tube, a fit factor for the respirator is calculated. This system for quantitative fit testing does not provide an instantaneous breath-by-breath measurement that has to be averaged, but measures the maximum ethylene penetration into the respirator, which National Draeger felt was appropriate.

In response to the question raised on whether the QNFT should evaluate respirator performance for each test exercise, some commenters indicated that each a determination of efficiency is not necessary (Ex. 15-31, 15-48, 15-50, 15-62, 15-73). It was stated on one submission that there is no need to determine the respirator efficiency for each test exercise performed since in actual practice the protection achieved in the workplace is not accurately predicted by QNFT (Ex. 15-73). Other comments suggested that the respirator efficiency for each test exercise should be determined. In the data submitted by the Office of the Assistant Secretary of Defense (Ex. 15-54) it was suggested that "QNFT should be able to distinguish the respirator efficiency for each test exercise. The exercise should identify which movement(s) allow for facepiece leakage and at what level the leakage occurs." The Industrial Safety Equipment Association suggested that "not having the ability to distinguish respirator efficiency for each set of exercises could result in an overstated assigned protection factor" (Ex. 15-58). The American National Standard Practices for Respiratory Protection (ANSI Z88.2-1980) recommends that the instrument used to measure the penetration of the test agent into the respirator be connected to a fast-response recorder which records the penetration values continuously (Ex. 10). Quantitative fit test methods developed by the Los Alamos National Laboratory use a detection and recording system which detects the test agent penetration into the respirator facepiece during the breathing cycle (Ex. 2, 27-12, 24-18). Notations are made on the record at the beginning and end of each test exercise and the penetration for each exercise is determined. Comment was received following the prepublication version of the proposed standard which also stated that the standard should allow the use of other instruments such as computers or integrators which would allow integration of the aerosol penetration inside the respirator (Ex. 36-34, 36-45, 36-52).

Having considered the comments and suggestions OSHA is proposing that either a strip chart recorder be used to provide a graphic display of the fit test or that an integrator or computer be used which provides a determination of the aerosol penetration into the respirator for each test exercise performed. The detection system shall be capable of detecting the challenge agent during the breathing cycle, i.e., inspiration and expiration. This will permit the determination of the penetration of the test agent during the breathing cycle.

Comments were requested on the methods used to calculate the aerosol penetration into the respirator. Suggestions were made to allow: the use of integrator (Ex. 36-29, 36-45, 36-52); the maximum peak penetration method (Ex. 36-28, 36-36) and the average peak penetration method (Ex. 36-28, 36-36). Upon examination of these various methods OSHA has decided to allow any of the three methods to be used provided that a determination of the test agent penetration is made for each test exercise.

OSHA is proposing that the fit factor derived from QNFT be calculated by dividing the average challenge agent concentration inside the chamber, (i.e. the ambient concentration) by the average challenge agent concentration inside the respirator. The average ambient concentration is derived from the measurement of the challenge agent concentration in the test environment (outside the respirator) at the beginning and end of the test. The average challenge agent concentration inside the respirator is determined from the aerosol penetration for each test exercise by using one of the three approved methods to calculate the aerosol penetration.

The test aerosol penetration measured for the grimace exercise is not to be used in calculating the average challenge agent concentration inside the respirator. The purpose of the grimace exercise is to determine whether the respirator being fit tested will reseat itself on the face after the respirator seal is broken during the grimace exercise. With a properly fitting respirator the test instrumentation will record a rise in challenge agent concentration inside the mask during the grimace exercise and a drop in challenge agent concentration when the respirator reseats itself. If the respirator fails to reseat itself following the grimace exercise, the subsequent bending over and normal breathing exercises will show excessive leakage of challenge agent into the mask and result in failing the fit test. Since even a properly fitting respirator may show increased challenge agent penetration during the grimace exercise, the penetration measured during the grimace exercise is not used in calculating the fit factor.

OSHA invites comments on the proposed method based upon experience with the calculation of fit factors obtained from QNFT.

As stated previously OSHA is proposing that there be a clear association between the event taking place in the test environment and its being recorded. This is critical for the proper calculation of aerosol penetration for a specific test exercise and ultimately determining the fit factor. It is the short duration leaks that can occur during and as a result of a particular fit test exercise that indicate poor respirator fit. These penetration peaks are used to determine the fit factor. An inability to resolve these penetration peaks could result in the fit factor being overstated, since by averaging all the test exercise penetration levels the high penetration levels that occurred with one test exercise would be obscured. Also the grimace exercise is designed to cause a leak in the facepiece fit to determine if the respirator will reseal. An inability to clearly associate the event in the test environment with its recording would invalidate this test exercise and make correct calculating of the fit factor impossible.

Several factors can affect the time interval between an event and its being recorded, such as sample hose diameter, sampling rate, and length of sampling hose. Response time will increase with an increase in length of sampling line and/or increase in diameter of sampling line. Therefore the length of the sampling lines and their inside diameter should be as small as possible. Inside diameters of 1/8 inch or less have been commonly used (Ex. 2). Sampling rates generally vary from 1 to 2 liters per minute (Ex. 24-7, 6), depending on the detection system used. The tubing used for sampling the test chamber challenge agent concentration and the tubing used for testing the challenge agent concentration inside the respirator must be of the same length and inside diameter. This will result in an equivalent aerosol loss in the sampling lines due to aerosol deposition in each sample line.

In order to minimize potential contamination of the atmosphere in the room where tests are being conducted, and to minimize exposure of the QNFT test operator to the challenge agent, as well as to prevent interference with the detection system from room air contaminated with the challenge agent, the proposed protocol requires that any air exhausted from the test booth/chamber must pass through a high-efficiency filter (or sorbent).

Since the relative humidity in the test chamber may affect the particle size of sodium chloride aerosols the protocol further requires that the relative humidity be kept below 50 percent (Ex. 25-3 p. 40). This is consistent with manufacturer's instructions for sodium chloride units.

It is imperative that the respirator used in QNFT be in proper working order. A respirator which may fit an individual better than others could be rejected if there is leakage due to problems resulting from improper maintenance such as sticking exhalation valves, leakage around the probe port, leakage around hose connections, or missing gaskets. Therefore the proposal requires that all respirators used in QNFT be inspected for defects and cleanliness. Such inspection must include checking the condition of the facepiece body for cracking and holes or tears in the rubber, checking the inhalation and exhalation valve assemblies for cracks and/or tears in valve material, checking for foreign material between the valve and valve seats, proper installation of the valve body in the facepiece, and warped or wrinkled valves. Respirators with such conditions cannot be used for fit testing. This is consistent with practices as published by the Los Alamos National Laboratory (Ex. 25-3 p. 37, 25-4 p. 34).

An additional requirement is that either a positive or negative pressure fit check be conducted to ensure that the respirator facepiece is properly adjusted prior to starting QNFT testing. The test protocol in the preproposal draft also required that a screening QLFT be conducted after the respirator was worn for a brief time. Comments were received stating that a mandatory screening QLFT is unnecessary (Ex. 36-52). The purpose of the screening QLFT was to minimize the QNFT test time by quickly identifying poorly fitting respirators (with gross leakage) prior to the commencement of the QNFT. The screening QLFT suggested was an abbreviated IAA or irritant fume QLFT. The test agent was briefly introduced into the air near the facepiece seal area. If the agent was detected then a different respirator was tried. This screening QLFT requirement would reduce QNFT test time for employers, since poorly fitting respirators that would normally fail a QNFT would fail the screening QLFT first. However, a mandatory screening QLFT complicates the testing procedure, and poorly fitting respirators would be detected during the fit checks before starting the QNFT, or by exceeding the maximum peak leakage rate allowed during QNFT. Screening QLFT is recommended to reduce expensive testing time, but does not need to be mandatory, and therefore this requirement has been dropped.

Prior to the commencement of the QNFT a stable challenge test agent concentration must be achieved. The concentration of some test environments such as small booths or waist type hoods may be diluted significantly when the test subject enters the booth. Normally the ambient challenge agent concentration will stabilize within 2 to 5 minutes. ANSI Z88.2-1980 addressed this issue by requiring that the design of the chamber and equipment used to generate the test atmosphere should ensure that the concentration inside the chamber does not vary more than 5% during a test (Ex. 10). OSHA is proposing that the test system be checked to verify that a stable chamber concentration (+/- 10%) has been achieved prior to the QNFT and at the end of the test. It has been OSHA's experience that a +/- 10% variation in test agent concentration stability has little appreciable effect. OSHA requests comments on any problems with test agent concentration stability and on the appropriate percent variation that should be allowed.

OSHA is further proposing that in order to successfully complete a QNFT the test subject must complete three separate tests with the same respirator. Respirator research has demonstrated that variation occur in the fit factors achieved with repeated fit tests on the same individual with the same respirator. No wearer can expect to duplicate the exact same fit with a particular respirator as the respirator is removed and donned repeatedly. If only one fit test is performed, there is no guarantee that the level of fit measured during that one test will be achieved with repeated wearings. Therefore, OSHA is requiring that three tests be performed, with the lowest fit factor obtained being used to determine whether the minimum required fit factor is exceeded. Using the lowest of the three values, OSHA feels, is the most protective approach to make sure that the respirator will not be used in an atmosphere which might require a higher fit factor than that respirator can consistently give. OSHA requests comments on the three quantitative fit test requirement and any data on alternative ways of measuring continued protection levels for individual respirator wearers.

OSHA had initially proposed that the results of the three tests must be within 10% of each other. However, response to that aspect indicated that obtaining three results within 10% were not feasible and the suggestion was made that OSHA should reevaluate that requirement (Ex. 36-22, 36-29, 36-38, 36-39, 36-41, 36-45). Comment was also received stating that three tests were unnecessary (Ex. 36-34).

OSHA in the current proposal has deleted the requirement for test results to be within a 10% range since consistently obtaining tests with a 10% range may not be feasible. However, the requirement for performing three fit tests is being maintained.

The results of all three tests must be above the minimum fit factor needed for that class of tight fitting air-purifying respirator. The required fit factors are established by applying a safety factor of 10 to the NIOSH APFs. For example, quarter and half mask air-purifying respirators with a NIOSH APF of 10 would need to achieve at least a fit factor of 100; and full facepiece air-purifying respirators with a NIOSH APF of 50 would require a minimum fit factor of 500. Finally the lowest of the three values must be used as representing the fit test results.

OSHA has proposed a safety factor of 10 because of variability in the fit testing procedures themselves, and to account for other variables such as changes in facepiece fit when the respirator is worn in the workplace as opposed to during fit testing. A safety factor of 10 accounts for these variations, and is current practice.

Adjustments in the respirator are not to be made during the QNFT. Any facepiece fit adjustments must be made before starting the exercise regimen. This is consistent with existing practices (Ex. 25-3 p. 38) and is intended to prevent manipulation of the respirator in order to achieve high fit factors.

The fit test is to be terminated whenever any single peak penetration exceeds two percent for half masks and quarter facepiece respirators and one percent for full facepiece respirators. Such leaks correspond to fit factors of 50 for half masks and 100 for full facepiece respirators and indicate an unacceptably poor respirator fit. Once the test is terminated the respirator may be refitted or adjusted and the subject retested. If any of the subsequent three required QNFT tests that are performed after the respirator has been refitted or adjusted are terminated because of excessive penetration, then the respirator is considered to have an unacceptable fit and a different respirator must be selected and tested.

(G) Use of Respirators

Once the respirator has been properly selected and fitted, its protection efficiency must be maintained by proper use. The employer is required to ensure that respirators are used properly in the workplace, and to include specific procedures for doing so in the written plan for compliance. This requirement is written in performance language, with the specific content of the written procedures left for the employer to establish.

One area of particular concern involves atmospheres where oxygen deficiency or the concentrations of a hazardous chemical are unknown and/or potentially immediately dangerous to the life of health (IDLH) of employees. Care must be exercised in these situations since failure of the respirator to provide the appropriate protection may result in serious injury or death. Therefore, the employer is required to establish specific written procedures for the use of respirators in IDLH atmospheres including four specific use limitations.

The first provision requires that employees wear only positive pressure SCBAs or combination supplied air respirators with auxiliary air supply in IDLH atmospheres. Negative-pressure air-purifying respirators are subject to face seal leakage, and depend on a filtering or adsorption mechanism for protection. The positive pressure supplied air respirators allowed in IDLH atmospheres supply air from an uncontaminated source, have less of a problem with face seal leakage and have no filter penetration problems. Two types of such positive pressure respirators are listed in the respirator selection tables in paragraphs (d) of the proposed standard for use in IDLH atmospheres; the positive pressure SCBA and a positive pressure supplied respirator with auxiliary self-contained air supply. They are the only respirators to be used in IDLH work conditions to ensure that the employee has the greatest degree of protection possible.

The second IDLH provision requires a "buddy" system where employees are required to work in IDLH atmospheres. There must be at least one additional person present, in communications with the worker(s) in the IDLH area but located where he or she will be outside the IDLH atmosphere and thus would be able to provide or call for emergency assistance if necessary. The third provision specifies that retrieval equipment must be supplied or equivalent provisions for rescue be made for those entering the IDLH atmosphere. The fourth provision states that a positive pressure self-contained breathing apparatus must be provided for the person(s) responsible for emergency assistance. These provisions are essentially the same as those that are in OSHA's current standards.

A more general issue involves tight fitting facepiece respirators which rely on a good facepiece to face seal in order to achieve effective protection. Therefore, the employer could not allow employees to wear such respirators with conditions which prevent such a seal. Facial hair such as a growth of beard or sideburns, absence of dentures, or a skull cap that projects under the facepiece seal are examples of such conditions. Many ANPR commenters stated that OSHA should prohibit facial hair that interferes with the facepiece seal (Ex. 15-11, 15-18, 15-26, 15-27A, 15-30, 15-33, 15-35, 15-36, 15-41, 15-52, 15-58, 15-62, 15-73, 15-77). Others stated that beards should be allowed with respirators that do not rely on adequate face seals for protection such as supplied air hoods, helmets, or suits. (Ex. 15-14, 15-31, 15-34, 15-46, 15-47, 15-48, 15-54, 15-55, 15-79, 15-81). Research performed with half mask and full facepiece respirators on the effects of facial hair on facepiece seal show that fit cannot be assured if hair is present. (Ex. 3, 13, 15-50, 23-2, 23-3).

Two ANPR commenters recommended that OSHA allow beards when the results of a fit test indicate that a satisfactory seal has been obtained (Ex. 15-38, 15-42). A report of a study by Fergin (23-1) on carbon setters with beards which tested the protection factors of several types of disposable respirators stated that acceptable performance was achieved and that there was no significant difference in respirator performance for employees with or without beards under pot room conditions. Fergin stated that ". . . where acceptable protection factors can be demonstrated for subjects with facial hair, the no-beard rule should be waived from a regulatory viewpoint for such proven cases." However, the ability to obtain a fit factor for a bearded respirator wearer does not mean that the worker can reliably be expected to achieve that same protection level each time the respirator is used. Beards grow and change daily, even hourly. Each time a respirator is donned there is fit variability. Such variability in face seal is greatly increased for bearded workers. This large variability in fit means that a reliable seal cannot reasonably be expected. OSHA believes that the evidence supports the contention that a reliable seal cannot be achieved where facial hair interferes with the seal of tight fitting respirators.

In commenting on the preproposal draft the Association of Western Pulp and Paper Workers (Ex. 36-2) opposed the facial hair policy proposed by OSHA and recommended that OSHA prohibit blanket no beard policies of employers. The International Chemical Workers Union (Ex. 36-14) recommended that the standard specify respiratory types that could be used with facial hair. Amoco Corporation (Ex. 36-35) requested that more definitive language be added to allow employers clearer guidelines to enforce facial hair policies. Allied Corporation (Ex. 36-49) also wanted a stronger statement prohibiting facial hair. The Nuclear Regulatory Commission (Ex. 36-31) and the Industrial Safety Equipment Association (Ex. 36-45) agreed with OSHA's proposed prohibition on beards when wearing tight fitting facepiece respirators. The Organization Resources Counselors (Ex. 36-47) and 3M (Ex. 36-54) stated that the prohibition on facial hair that interferes with the facepiece seal should also include positive pressure respirators that depend upon a tight facepiece to face seal.

The draft provision prohibiting conditions such as beards that interfere with the seal of tight fitting respirators has been modified after consideration of these comments. Additional wording has been added to clarify that the provision covers not only negative pressure respirators that require a tight seal but pressure demand and positive pressure respirators as well. The provision covers only tight fitting respirators and is not meant to be a blanket prohibition on beards with respirators. There are other types of respiratory equipment such as hoods, helmets and suits which can be worn by employees with beards since they do not rely upon a tight facepiece fit. Also the wording in the examples has been changed to read "facial hair that interferes with the facepiece seal" rather than a growth of beard or sideburns since it is interference with the facepiece seal that OSHA prohibits, not the presence of facial hair. OSHA invites comments on this issue and the wording of the proposed provision of the standard, and whether OSHA should require that employers provide respirators which do not rely upon a tight facepiece fit in such circumstances.

Corrective glasses or goggles must also be worn in such a way that they do not interfere with the seal of the facepiece to the face. Although the employer is free to choose any option to comply with this, OSHA suggests that full facepiece respirators be worn where either corrective glasses or eye protection are required since corrective lenses can be mounted into the full facepiece respirators. In addition, the full facepiece may be more comfortable, and less cumbersome, than wearing a half mask and chemical goggles which seal to the face as well.

OSHA's current respirator standard does not allow contact lenses to be worn with respiratory protection. In reviewing this requirement, the main justification has been that with full facepiece respirators, if a contaminant got into the employee's eye, the involuntary response would be to remove the mask to attend to the eye, thus removing the respiratory protection. A second possible problem with contact lenses is that the dry air inside a positive pressure SCBA facepiece could dry out the contact lenses. It has also been suggested that contaminants that get into the facepiece can become lodged under the contact lens, be held against the eye, and enter into the bloodstream. While these possible problem areas have been proposed for contact lenses, OSHA has not found evidence of such problems occurring in the workplace. With the improvements that have occurred with contact lens technology, particularly in soft contact lenses, people who are able to wear contact lenses comfortably in everyday life should be able to wear contact lenses with a respirator.

OSHA funded a survey on the use of contact lenses by fire fighters which was conducted by the Lawrence National Livermore Laboratory (Ex. 38-9). Of the 403 fire fighters who regularly wore contact lenses with SCBA, only 6 responded that contact lens created a problem such as a contact lens being out of place or a particle under the lens causing the respirator facepiece to be removed in an environment where the facepiece would normally be worn. The wearing of conventional eyeglasses inside the respirator facepiece, as is required by the current OSHA standard, had a proportionately higher number of problems. The study concluded that the prohibition on wearing contact lenses with a full facepiece respirator should be withdrawn.

The Oil, Chemical and Atomic Workers Union (Ex. 36-23) supported removing the prohibition on the use of contact lenses with respirators. Alan Hack of the Los Alamos National Laboratory (Ex. 36-29) cited the Lawrence Livermore contact lens study and the lack of adverse experience with contacts as reasons for permitting their use. The Nuclear Regulatory Commission (Ex. 36-31) agreed that the contact lens prohibition needed to be examined and hoped the Lawrence Livermore survey on contact lenses would not contradict their use with respirators. MSHA (Ex. 36-34) stated that contact lenses should not be used with respirators until further data has been developed to indicate their safety with the movement of chemicals through the lens, since many of the new contact lenses allow passage of air and water through the lens. Earle Shoub (Ex. 36-17) stated that if OSHA is determined to permit the use of contact lenses under a full facepiece respirator, this permission should not extend to IDLH atmospheres.

OSHA believes the Lawrence Livermore contact lens study of fire fighters supports removing the prohibition on the use of contact lenses with respirators. No evidence shows that wearing contact lenses with respirators increases safety hazards. Therefore, OSHA is proposing to remove the prohibition in the current standard on the use of contact lenses with respirators. OSHA requests any comments or information as to the appropriateness of using contact lenses with respirators, and any problems that have occurred with the use of contact lenses in the workplace.

In dealing with skin irritation and contamination, the proposal would require the employer to permit employees to leave the respirator use area as a necessary to wash their faces and respirator facepieces. The preproposal draft provision permitted employees to leave the work area is necessary to wash their faces and respirators. Several commenters asked that the phrase "work area" be changed to "respirator area" (Ex. 36-22, 36-30, 36-40, 36-41), since employees can wash their faces and respirators at appropriate cleaning sites located outside the respirator use area without necessarily having to leave the work area. The Motor Vehicle Manufacturers Association (Ex. 36-37) recommended changing the wording of the provision from "as necessary" to "if necessary" since excessive washing of the skin may aggravate an irritated skin by removing protective oils. Richard Boggs of ORC (Ex. 36-47) recommended that this requirement be dropped since it was a labor relations issue and not all conditions of respirator use result in situations where such a requirement would make sense. OSHA agrees with the commenters that employees do not necessarily need to leave the work area to clean their faces and respirators, and the wording of the provision has been changed from work area to respirator use area. OSHA believes that potential health problems of skin irritation and contamination associated with wearing a respirator cannot properly be relegated to a labor relations issue as ORC suggests and OSHA has retained this provision in the proposal.

Another new provision involves the filter elements of air-purifying respirators. Employers are to allow employees to change such elements whenever employees detect a change in breathing resistance or chemical breakthrough. Since breathing rates differ, and workplace contamination levels may vary, it is difficult to predict the service life of a particular filtering element. Subjectively detected breathing resistance indicates that the load on the particulate filter may be approaching capacity and that the filter must be changed to ensure continuing protection. This decision was supported by several commenters in response to ANPR question 29 on service life (Ex. 15-18, 15-19, 15-38, 15-47, 15-48, 15-52, 15-54, 15-75B).

Comments on the preproposal draft also recommended that odor or chemical vapor breakthrough was a reason for changing an organic vapor cartridge or canister (Ex. 36-29, 36-30, 36-32, 36-41, 36-52, 36-55). The wording of the proposal has been changed to add chemical vapor breakthrough as a cause for changing filters. Wording has also been added to permit employees to leave the respirator use area to change filters since this should be done only in clean air.

The proposal also includes a provision that requires respirators be repaired or discarded and replaced immediately when they are no longer in their original working condition. Examples of these changes in condition would be that the strap has broken, the respirator has lost its shape, or the face seal can no longer be maintained. Since respirators must be in good working condition to function, it is imperative that they not be used if they have been impaired in any way. The respirator manufacturers can supply replacement parts for damaged portions of their elastomeric respirators. Disposable respirators cannot be repaired and must be discarded when damaged.

Many commenters to the ANPR stated that disposable respirators should be allowed to be used until they no longer can provide the protection for which they were designed (Ex. 15-13, 15-14, 15-19, 15-22, 15-30, 15-34, 15-36, 15-37, 15-41, 15-44, 15-46, 15-48, 15-53, 15-58, 15-75A, 15-75B, 15-81). How the useful service life would be determined, whether by professional judgment or by having the manufacturers of the respirators make a determination, was unclear. Such a specific service life determination is difficult to make. Support for a one day or one shift limit for the use of disposable respirators was presented by several ANPR commenters (Ex. 15-8, 15-18, 15-26, 15-33, 15-50, 15-54, 15-55, 15-70, 15-75). Disposable respirators are designed to be used and discarded. Their durability with repeated use is not great, and most of them are not designed to be easily cleaned or sanitized.

The proposal requires that disposable respirators which cannot be cleaned and sanitized be discarded at the end of the task or work shift whichever comes first. There are some disposable respirators which can be cleaned and sanitized after use, but they cannot be resupplied with an unused filter, and therefore the proposal would require disposal after their useful service life limit has been reached.

The employer is also to ensure that employees, upon donning the respirator, perform a facepiece seal check prior to entering the work area when wearing a respirator. The negative-pressure sealing check and the positive-pressure sealing check included in Appendix B, or the respirator manufacturer's recommended procedures shall be used for all respirators on which such checks are possible. The use of such seal checks are a way of helping to ensure that attention is paid to obtaining an adequate facepiece seal each time a respirator is used.

An additional requirement being proposed by OSHA is that each self- contained breathing apparatus used in IDLH atmospheres, or for emergency entry or fire fighting, be certified for a minimum service life of thirty minutes. Certified SCBA devices are available with shorter service lives, but given the types of situations encountered in IDLH or emergency situations, OSHA maintains that a minimum of thirty minutes would be required to ensure protection in these conditions. The thirty minute service life requirement does not apply to combination supplied air respirators with auxiliary air supply since the air for normal work operations is supplied by an air line. No service life requirement has been set for the auxiliary air supply bottle, but the auxiliary air supply must be sufficient to permit escape from the IDLH atmosphere should the air line fail. Emergency escape SCBAs also do not have to meet the thirty minute service life requirement, since their intended use is only for escape.

The preproposal draft contained provisions to allow the use of "buddy breathing" devices and the interchange of air cylinders between SCBAs, as is permitted under the OSHA fire brigades standard (29 CFR 1910.156(F)). Comments on the preproposal draft by NIOSH (Ex. 36-42) recommended that OSHA not allow the interchange of respirator air cylinders since differences in air cylinder backpack construction could result in the cylinder falling off while in an IDLH atmosphere. Cylinders come in several different sizes, with varying air capacities and operating pressures, and can be constructed of different materials. As NIOSH points out, this can present problems with respirator operation when some types of cylinders are interchanged. NIOSH also considered initiating an approval program for SCBAs with emergency escape breathing support systems (buddy breathers) but found from their survey of interested parties that a safe and practical emergency escape breathing support system could not be certified at this time. Current buddy breathing systems have problems with equipment reliability and with maintaining adequate airflow in the positive pressure mode. The Industrial Safety Equipment Association (Ex. 36-45) also disagreed with the air cylinder interchange and buddy breather provisions and stated that extending their use to general industry applications would present problems since rescue and specialized training are not as prevalent in general industry as in fire fighting, and recommended that the practice not be allowed. Dow Chemical (Ex. 36-40) recommended that the air cylinder interchange and buddy breather provisions be deleted or put in a nonmandatory appendix. ORC (Ex. 36-47) also recommended a nonmandatory appendix. MSHA (Ex. 36-34) stated that the use of buddy breathers or the interchanging of air cylinders voids the NIOSH/MSHA approvals and asked whether OSHA was going to certify these changes as safe for the wearer. Earle Shoub (Ex. 36-17) also pointed out that the use of these modified respirators voids their NIOSH/MSHA approval, and suggested OSHA include a specific exemption from the NIOSH/MSHA approval requirement when they are used.

Since there are problems in assuring the proper operation of respirators modified to include buddy breathing devices, and there are problems with interchanging air cylinders of different construction, pressure, and size between different SCBAs, OSHA has decided to delete the provisions dealing with buddy breathing devices and air cylinder interchange from the proposal. The problems with their use given by the preproposal draft commenters and the lack of a demonstrated need for their use in general industry work situations has lead OSHA to remove these provisions from the proposal. Their use is still allowed for fire brigades under the fire brigades standard. OSHA seeks comment on this decision and on the performance of such devices in industry.

Commenters were equally divided on the issue of requiring low flow alarms or indicators for PAPRs. The AIHA (Ex. 15-81) thought the issue was related more to equipment certification rather than use, and suggested that NIOSH consider the advisability of low flow indicators as permissible modifications. Some felt OSHA should encourage the development of low flow indicators since it is the positive pressure generated by the normal PAPR airflow rates that give PAPRs their high protection factors (Ex. 15-14, 15-22, 15-34, 15-46, 15-48, 15-50, 15-51, 15-54, 15-55, 15-62, 15-76, 15-77, 15-79). Since low airflow could be detected by the wearer, some commenters felt airflow indicators were unnecessary (Ex. 15-16, 15-19, 15-27A, 15-44, 15-53, 15-58, 15-66, 15-70, 15-73, 15-81).

OSHA has decided not to require the use of low flow alarms or indicators for PAPRs. The protection levels that PAPRs achieve are in part dependent upon maintaining an adequate airflow through the respirator. OSHA encourages the use of airflow indicators with PAPRs, but since they are not currently available on existing PAPRs it has been decided not to require them at this time.

When PAPRs should be used was also the subject of comments. Some commenters felt that OSHA should not dictate the circumstances where PAPRs should be used (Ex. 15-30, 15-53, 15-58, 15-73). Most commenters felt PAPRs should be used where the employer or safety and health professionals determine their use is appropriate (Ex. 15-13, 15-14, 15-19, 15-22, 15-51, 15-62, 15-70, 15-76). Others felt PAPRs should be used when a high level of protection must be assured (Ex. 15-27A, 15-46, 15-79). PAPR use was also recommended where a significant physiological burden would be imposed by a negative pressure respirator (Ex. 15-38, 15-44, 15-46).

OSHA has also decided not to dictate the circumstances where PAPRs may be used. The employer or safety and health professional in charge of the respirator program is in the best position to determine where and when PAPR use is most appropriate. The PAPR's ability to provide increased protection, easier breathing, and greater worker acceptance should be taken into account during respirator selection. However, the responsibility for respirator selection has been placed on the respirator program administrator, and OSHA relies on the administrator to assure that the appropriate respirator is chosen. However, OSHA asks for comments on whether employees should be able to choose PAPRs rather than negative pressure respirators because of their reduced breathing resistance. OSHA has permitted this in several standards such as the coke oven emissions (29 CFR 1910.1029) and cotton dust (29 CFR 1910.1043). However, OSHA's experience is that few employees make the request.

(H) Maintenance and Care of Respirators

In order to ensure continuing protection from respiratory protective devices, it is necessary to establish and implement proper maintenance and care procedures. A lax attitude toward this part of the respiratory protection program will negate successful selection and fit because the devices will not deliver the assumed protection unless they are kept in good working order.

OSHA believes that the provisions on maintenance and care that exist in the current standard are effective and adequate. Therefore this proposal has mainly readopted the current OSHA provisions, the primary exception being the provisions which deal with cleaning and disinfecting respirators after they are worn. The present standard, while requiring cleaning and disinfecting, does not specify when to do it or provide guidelines for how it should be done. Consequently many employers have not been following these provisions, with the consequent result that the cleaning and disinfecting provision is one of the most frequently cited for violation by OSHA compliance officers. Respirators which are not cleaned and disinfected -- particularly those used by more than one employee -- can cause skin irritation and dermatitis. Where the toxin to be protected against is a dust, mist or fume, build up of it on the respirator seal or within the respirator will reduce the protection factor given by the respirator because the toxin is in the breathing zone. In addition, the build-up of contamination on the respirator can contribute to the deterioration of the materials, and thus deterioration of the protection. Full facepieces must be cleaned to ensure that employees can see through the facepieces.

The proposal requires that routinely used respirators which are reserved for the exclusive use of a particular employee be cleaned and disinfected at least after each day's use. If a respirator is routinely used by more than one employee, it must be cleaned and disinfected after each use. Respirators maintained for emergency use must also be cleaned and disinfected after each use. Recommended procedures for cleaning and disinfection are included in Appendix B of the proposed standard.

In comments on the preproposal draft, Thomas Nelson of the ANSI Z88.2 respirator committee suggested that the cleaning instructions of the respirator manufacturer be allowed, since they may be different than these in Appendix B, or cover contaminants which cannot be cleaned using the methods in Appendix B such as radioactive materials. The Dow Chemical Company (Ex. 36-40) recommended that the reference to Appendix B be deleted and a statement to follow the manufacturer's recommended procedures be added. OSHA agrees and has added wording permitting the use of manufacturer's cleaning instructions.

Comments on the proposed draft also addressed the issue of the frequency of cleaning and disinfecting of respirators. The American Textile Manufacturers Institute (Ex. 36-18) felt that respirators should be cleaned after each day's use and disinfected periodically as needed. The Motor Vehicle Manufacturer's Association (Ex. 36-37) stated that cleaning and disinfecting of respirators should be required periodically. DuPont (Ex. 36-38) felt that the provisions of the respirator program suggested by Organization Resources Counselors (ORC) (Ex. 36-47 Attachment 1) that requires cleaning frequently enough to avoid hazardous exposures to residues was sufficient. Richard Boggs of ORC (Ex. 36-47) urged adopting the language in the ORC program since it would allow the individual organization to tailor its cleaning and sanitizing programs to the needs of the operation.

OSHA believes that allowing periodic cleaning and disinfecting without specifying the time period or requiring only that respirators be cleaned frequently enough to avoid hazardous exposures to residues are vague concepts which are not defined, which may be difficult to enforce and would perpetuate the poor cleaning practices which have already been shown to be a compliance problem (Ex. 33-5). Therefore, the proposal continues to require that routinely used respirators be cleaned and disinfected after each day's use and that respirators used by more than one employee be cleaned and disinfected after each use.

The proposal does not state who should do the cleaning and disinfecting, only that it be done. The United Steel Workers of America (Ex. 36-46) recommended that OSHA require that the employer do the cleaning and repairing of respirators. They stated that when the employer requires that employees turn in their respirators at the end of each shift to a central cleaning facility for inspection, cleaning, and repairs by trained personnel and with the respirators returned to the employees the next day, a better cleaning program results. OSHA agrees that such a centralized cleaning and repair operation can ensure that properly cleaned and disinfected respirators are available for use, but it is not the only way to do so. For example, in plants where respirator use is infrequent or where the numbers of respirators in use are small, central facilities may be inappropriate. The employer is allowed to choose the cleaning, disinfecting and repair program that best fits the requirements of the standard and the particular circumstances of the job. If the employer chooses to require that employees do the cleaning of respirators, then the employer must provide the cleaning and disinfecting equipment, supplies, facilities, and time for the job to be done. The proposal requires that the employer ensure that the cleaning is done properly, and that only properly cleaned and disinfected respirators are used.

Storage of respirators must be done properly to ensure that the equipment is protected and not subject to environmental conditions that may cause deterioration. The proposed provisions for storage are essentially the same as the current standard. The employer must protect the stored equipment from damage, dust, sunlight, extreme temperatures, excessive moisture, or damaging chemicals. The respirator manufacturer will often provide additional information on proper storage procedures which should be observed by the employer. Storage conditions are listed in performance language. For example, temperature ranges are not specified. It appears that the degree of severity of a condition would be related to the tolerance of the particular equipment in question and would thus vary from model to model. OSHA invites comment on whether this approach is appropriate, or whether the conditions of storage should be specified in more detail.

Respirators intended for emergency use shall be kept accessible to the work area. Where weathering, contamination or deterioration of the respirator could occur compartments shall be used to protect the respirator and must be clearly marked to indicate that they contain emergency respirators. This represents a change in wording of the proposed standard in response to comments on the preproposal draft (Ex. 36-45, 36-47, 36-55). Since many emergency respirators are stored in environmentally controlled areas, according to the ANSI Z88.2 respirator committee (Ex. 36-55), compartments would be unnecessary. The new wording of the proposed standard requires the use of compartments only where weathering, contamination or deterioration could occur.

Respirators that are used routinely in the work area are to be stored in a plastic bag or otherwise protected from contamination or damage. The prohibition on the use of lockers or tool boxes has been removed in response to comments in the preproposal draft (Ex. 36-47, 36-49). The requirement that respirators be stored in such a way as to prevent damage should avoid problems of damage from improper storage in lockers provided the employer takes appropriate precautions.

When respirators are packed or stored, the facepiece and exhalation valve must be stored in a manner that will prevent deformation. This is to prevent impairment of the elastomer due to stretching or reshaping of the facepiece or exhalation valve because of positioning of the equipment.

In order to assure the continued reliability of respirator equipment it must be inspected on a regular basis. The frequency of inspection is related to the frequency of use. Respirators that are used routinely are to be inspected before each use, and during cleaning after each use. Those that are maintained in the facility for emergency use must be inspected at least monthly, and checked for proper function before and after each use. However, respirators used for emergency escape must be inspected before being carried into the workplace.

The proposal has changed the requirement that employers make a record of inspection dates and findings for emergency use respirators. Employers only need certify that the required inspections have been made. The employer must perform the respirator inspection as required by paragraph (h)(3) to determine that the respirator is functioning properly and is fully charged. Then the inspection is certified by having the inspector fill in a tag or label kept with the respirator or attached to the respirator storage compartment that contains the date of the inspection, the name or signature of the inspector, and the serial number or other means of identifying the respirator that was inspected. The inspection certification need only be maintained until it is replaced by the certification of the next inspection. This replaces the requirement in the present standard that the inspection record be kept as long as the respirator is in the workplace. Since the inspection tag or label serves to indicate that the respirator has been inspected within the time limit set for inspections there is no need to maintain the first certification once a new inspection is performed and certified.

Self-contained breathing apparatus are also to be inspected monthly. Air and oxygen cylinders must be maintained in a fully charged state and recharged when pressure falls to 90% of the manufacturer's recommended pressure level, and the employer must determine that the regulator and warning devices function properly.

The standard specifies what constitutes a minimal respirator inspection:

Respirator function, the tightness of connections and the condition of the facepiece, headstraps, valves, connecting tube, and filters, canisters or cartridges must be checked. In addition, the rubber and elastomer parts must be evaluated for pliability and signs of deterioration. It should be noted that stretching and manipulating rubber or elastomer parts with a massaging action will help keep them pliable and flexible and prevent them from taking a set during storage.

The proposed standard also includes provisions related to the repair of respirators. Repairs or adjustments are to be made only by persons appropriately trained to perform them, using parts designed for that respirator. The employer is to ensure that the manufacturer's recommendations regarding the type and extent of repairs that can be performed are followed. In any case, reducing or admission valves or regulators must be returned to the manufacturer or given to an appropriately trained technician for adjustment or repair. These provisions are consistent with the requirements of the current standard.

OSHA invites comments on the provisions related to the maintenance and care of respirators, including suggestions for other items which should be considered for inclusion in or deletion from this section based on the experience of those currently implementing respiratory protection programs.

(I) Supplied Air Quality and Use

Where atmosphere-supplying respirators are being used to protect employees it is essential to ensure that the air being breathed is of sufficiently high quality. The current standard and this proposed revision reference a number of standard sources which establish parameters for breathing air quality.

For oxygen, the employer is to ensure that it meets the requirement of the latest edition of the United State Pharmacopoeia for medical or breathing oxygen. This represents no change from the current standard.

In the ANPR, comments were requested on whether acceptable respirator breathing air should continue to meet the specifications for Grade D breathing air as described in Compressed Gas Association Commodity Specification G 7.1-1966 or whether an alternate specification such as Grade E should be used. OSHA received comments stating that Grade D air is adequate and should continue to be used (Ex. 15-10, 15-18, 15-31, 15-52, 15-73, 15-75). The Los Alamos National Laboratory (Ex. 36-52) recommended that Grade E air be used, since most air that passes Grade D will also pass Grade E. However, LANL gave no specific reasons for doing so. Therefore OSHA does not believe that the need for a higher grade has been shown.

In the proposal, breathing air is to meet the requirements for the grade D air classification in the ANSI/Compressed Gas Association Commodity Specification G-7.1-1989. This is the revised and current version of the G-7.1 1966 Compressed Gas Association Commodity Specification. This means that the oxygen content (v/v) must contain the amount of oxygen normally present in atmospheric air of 19.5 to 23.5 percent oxygen for synthesized air; hydrocarbon (condensed) of 5 milligram per cubic meter of air or less; carbon monoxide of 10 ppm or less, and carbon dioxide of 1,000 ppm or less. OSHA invites comments on the appropriateness of maintaining Grade D as the required quality of air.

The proposal prohibits the use of compressed oxygen in atmosphere- supplying respirators or in open circuit self-contained breathing apparatus that have previously used compressed air. This is to prevent fire or explosion resulting from the high pressure oxygen coming in contact with oil or grease (Ex. 10). The proposed standard also specifies that oxygen not be used with supplied air respirators. These requirements are also in the current standard.

Both the current standard and the proposal allow air for respirators to be provided from cylinders or compressors. Cylinders are required to be tested and maintained as prescribed in the Shipping Container Specification Regulations of the Department of Transportation (49 CFR Part 178).

Compressors are to be constructed and situated so contaminated air cannot enter the air supply system. In addition, the compressors are to be equipped with suitable in-line air-purifying sorbent beds and filters to clean the air and assure breathing air quality. The requirement that air compressors have a receiver of sufficient capacity to permit escape from a hazardous atmosphere in the event of compressor failure has been dropped. As was pointed out in several comments on the preproposal draft, a receiver is necessary only when the wearer cannot safely stop work and leave the area without injury (Ex. 36-29, 36-32, 36-45, 36-47, 36-52, 36-54, 36-55). Since this proposal requires that respirators used in IDLH situation be either an SCBA or combination supplied air respirator with escape air supply, the need for a receiver for air compressors has been eliminated. Also the requirement for alarms to indicate compressor failure and overheating have been eliminated. In the event of compressor failure with a wearer using a combination supplied air respirator with escape air supply, the loss of air supply would be readily apparent, and the wearer can switch to the auxiliary escape air supply and leave the area.

In the ANPR, OSHA also requested comments and input on the following questions: (1) How frequently should carbon monoxide concentrations be measured from an air compressor not equipped with a carbon monoxide alarm, and (2) Is there any reason not to require a carbon monoxide alarm on all oil lubricated compressors that provide breathing air? Responses to the issue of the frequency of carbon monoxide measurements ranged from quarterly (Ex. 15-42) to twice a month provided the air intake for the compressor is located away from contamination (Ex. 15-52), to continuously (Ex. 15-14, 15-31, 15-34, 15-50, 15-65, 15-73). John L. Henshaw of Monsanto Company stated "One specified frequency would not be applicable under all conditions of breathing air compressor use." (Ex. 15-26).

In response to the ANPR question regarding carbon monoxide alarms on oil lubricated compressors, numerous comments were received stating that there was no reason not to require such an alarm (Ex. 15-10, 15-18, 15-26, 15-31, 15-46, 15-59, 15-70, 15-81). One commenter, Evan Campbell of Diamond Shamrock stated, "We recommend the installation of continuous carbon monoxide monitors with an alarm on oil lubricated air compressors operated by internal combustion engines, electric motors or auxiliary power takeoff . . ." (Ex. 15-65). In the comments of the National Constructors Association it was indicated that screw type compressors or oil free compressors do not need a carbon monoxide alarm provided the air intake is not near a potential carbon monoxide source (Ex. 15-34).

There was general recognition in the comments that contamination of the intake air on a compressor used to supply breathing air is of primary concern. Several comments cited the study published in the American Industrial Hygiene Association Journal by T.M. Distler of the Lawrence Livermore Laboratory (Ex. 32-1) entitled "Formation of Carbon Monoxide in Air Compressors" (Ex. 15-13, 15-22, 15-26, 15-30, 15-41, 15-81). The findings of this study revealed that low pressure compressors are unlikely to reach temperatures where carbon monoxide would be produced from the lubricant; synthetic lubricants do not significantly lessen carbon monoxide production; exhaust gases from combustion engines are the major threat to the quality of the compressed air; high temperature shut-offs or alarms do not significantly protect against carbon monoxide contamination of compressed air.

The preproposal draft contained provisions that required oil lubricated compressors to have carbon monoxide monitors and high temperature alarms. Freuhauf Corporation (Ex. 36-1) requested that compressors equipped with a high temperature shutdown device not be required to have carbon monoxide monitor since the compressor would be shut down before breakdown of the oil could occur. The Lawrence Livermore National Laboratory (Ex. 36-26), citing its study of compressors authored by Distler (Ex. 32-1), found no need for carbon monoxide monitors and alarms for oil lubricated compressors. However, they recommend that carbon monoxide monitoring and alarms be required for breathing air compressors powered by internal combustion engines, due to the potential for reentrainment of exhaust gases. Alan Hack (Ex. 36-29) stated that carbon monoxide alarms appear to be unreliable, there was little evidence of carbon monoxide production with oil lubricated compressors, and that OSHA should not require them. ASARCO (Ex. 36-39) recommended that OSHA allow the use of carbon monoxide absorption filters with visible color change indicators in place of carbon monoxide monitors. Richard Boggs of ORC (Ex. 36-47) recommended deleting section (i)(4)(v) requiring carbon monoxide monitors, citing the report on compressors performed by Distler. The Los Alamos National Laboratory (Ex. 36-52) stated that carbon monoxide alarms currently in use were unreliable, and that there was little evidence of carbon monoxide production with oil lubricated compressors. Lynnette Hendricks of the 3M Corporation (Ex. 36-54) stated that the requirement for carbon monoxide alarms added negligibly to the effort to provide quality breathing air, and that 3M was aware of no instances where oil lubricated compressor failures resulted in carbon monoxide exposure to workers. Thomas Nelson of the ANSI Z88.2 respirator committee (Ex. 36-55) recommended that the need for carbon monoxide alarms be dropped when the air intake is located away from sources of carbon monoxide contamination. He also recommended dropping the high temperature alarm requirement. The State of Wyoming OSHA (Ex. 36-9) recommended that continuous carbon monoxide monitors with alarms be required for oil lubricated compressors operated by internal combustion engines or electric motor auxiliary power takeoffs. The International Chemical Workers Union (Ex. 36-14) stated that continuous carbon monoxide monitors and alarms for oil lubricated compressors were the only effective methods to monitor carbon monoxide concentrations.

OSHA knows of one such incident which involved carbon monoxide production by an oil lubricated compressor. An MSHA Accident Investigation Report issued in January 1985 (Ex. 38-12) reported that a diesel engine powered two stage rotary air compressor that utilized oil for cooling had overheated during a sandblasting operation at a limestone quarry. This resulted in the near fatal carbon monoxide poisoning of the sandblaster who was wearing a continuous flow abrasive blasting hood which received its air from the compressor. The air compressor had a thermo bypass valve that should have normally directed the oil through a cooling radiator once the oil had reached a temperature of 185 deg. F. The thermo bypass valve failed, allowing the cooling oil temperature to rise above its flashpoint of 420 deg. F. The oil ignited in the oil separator and the fire spread to the combined oil receiver/air receiver, producing carbon monoxide. The compressor was equipped with a high temperature shutoff switch set for 235 deg. F, but it had been disconnected for at least 30 days prior to the incident. The compressor was not equipped with a carbon monoxide filter or alarm. The air line to the respirator had an inline filter to remove oil, water, and particulates from the compressed air as it left the air receiver, but it allowed the carbon monoxide to pass through to the respirator wearer. The sandblaster collapsed from carbon monoxide poisoning. The sandblaster's assistant shut down the compressor, removed the victim's abrasive blasting hood, and called for emergency assistance. Neither of the employees performing the sandblasting operation had received any training in proper respirator use.

This extremely rare incident raises serious questions about carbon monoxide filters and alarms as well as high temperature shutoff devices, and whether their use should be required for oil lubricated compressors. A properly functioning high temperature shutoff switch should have shut down the overheated compressor, but it is unclear whether this would have occurred before the carbon monoxide laden air went out to the respirator wearer. This compressor had no carbon monoxide filter with alarm to warn the respirator wearer. However, given that the high temperature alarm was previously disconnected, it is unclear whether that alarm would have been disabled as well. OSHA requests any further information regarding other incidents involving carbon monoxide production by oil lubricated compressors, and any comments on the necessity for carbon monoxide filters and alarms as well as high temperature alarms for air compressors.

This proposal does not contain a requirement that carbon monoxide alarms or high temperature shutoff devices be used with oil lubricated compressors. As the Distler air compressor study (Ex. 32-1) points out, air compressors are unlikely to reach temperatures where carbon monoxide production would occur. Exhaust gases from internal combustion engines and the intake of contaminated air are the major threats to air quality, and these threats occur with all compressors, not just oil lubricated ones. The proposal requires that the air intake for compressors be placed to avoid the entry of contaminated air. One way to ensure that contaminated air does not enter the air supply would be for OSHA to require carbon monoxide filters with continuous monitoring alarms for all breathing air compressors. OSHA requests comments on whether it should adopt this requirement for all compressors. OSHA requests any information about problems with air compressor air quality, filters and alarms, and invites comments on how best to ensure breathing air quality for respirators.

OSHA is aware that in recent years devices known as ambient air movers have been developed to provide air to supplied air respirators. These units are small compressors which are not oil lubricated and have no air receiver. Such compressors may have a use in non-IDLH atmospheres. The use of ambient air movers has been allowed under an OSHA compliance directive even though such devices do not have an air receiver as required by the current standard. The proposal drops the requirement for an air receiver for compressors. An ambient air mover is just another type of air compressor, and it is treated like any other compressor under the proposal.

Requirements in this proposal regarding the moisture content of compressed air for air cylinders and a provision requiring that air line couplings be incompatible with outlets for other gas systems are consistent with current accepted practice and with OSHA's current standard, having simply been updated to reflect the latest versions of the references. The proposal establishes a limitation of the moisture content of air in compressed air cylinders of no greater than 27 milliliters per cubic meter of air. This is to prevent freezing of the valves. The air coupling provision is also included to prevent inadvertent servicing of airline respirators with non-respirable gases or vapors. To accomplish this, breathing air couplings are to be made incompatible with outlets from non-respirable plant air or other gas systems.

In addition, employers must use breathing gas containers marked in accordance with the American National Standard Method of Marking Portable Compressed Gas Containers to Identify the Material Contained, Z48.1-1954 (R-1971); Federal Specification BB-A 1034a, June 21, 1968, Air, Compressed for Breathing Purposes; or Interim Federal Specification GG-13-00675b, September 23, 1976, Breathing Apparatus, Self-Contained.

(J) Identification of Filter, Cartridges, and Canisters

The current standard requires that the employer mark gas mask canisters with properly worded labels and color coding to ensure proper identification. However, as many commenters on the preproposal draft pointed out (Ex. 36-18, 36-19, 36-27, 36-30, 36-32, 36-34, 36-40, 36-45, 36-47, 36-49, 36-54, 36-55), the marking of filters, cartridges and canisters is the responsibility of the respirator manufacturer under the NIOSH 30 CFR 11 and 42 CFR 84 respirator certification standards. Therefore, this proposal has eliminated the requirements and tables relating to the marking of canisters from the standard. Two requirements have been added to replace the marking requirements. First, the employer must ensure that all filters, cartridges and canisters used are properly labeled and color coded. Since the manufacturer already does this, the employer need only check that the label is there. Second, the label may not be removed, obscured or defaced while in service since that would defeat its purpose.

(K) Training

The most thorough respiratory protection program will not be effective if employees do not wear respirators, or if wearing them, do not do so appropriately. The only way to ensure that employees are aware of the purpose of wearing respirators, and how they are to be worn, is to train them. The record shows widespread agreement that employee training is an important part of the respiratory protection program and is essential for correct respirator use (Ex. 15-13, 15-18, 15-19, 15-22, 15-30, 15-33, 15-41, 15-45, 15-50, 15-53, 15-54, 15-67, 15-79).

The current standard does not contain a separate section for training. The minimal requirements it imposes are included within other sections of the standard.

This proposal retains and clarifies the present provisions in a separate section for training and provides more comprehensive guidance than does the present standard.

In response to ANPR commenters who urged OSHA to mandate a program that is performance oriented and can be presented informally, (Ex. 15-13, 15-18, 15-22, 15-30, 15-41, 15-47, 15-62, 15-73, 15-75), this proposal is performance oriented in that it specfies categories of information to cover during training. It neither specifies how the training is to be performed nor the format of the employers training program. The employer can use whatever training method is effective for the particular worksite as long as it contains the topics discussed below. Employers can utilize prepared materials such as audio-visuals and slide presentations or they can use approaches ranging from formal classroom instruction to informal discussions during safety meetings (Ex. 15-53), or a combination of methods.

The first category of information to be included in the training program is the nature, extent and effects of respiratory hazards to which the employee may be exposed. This includes identification of the hazardous chemicals involved, what exposure levels there would be if no respiratory protection were being used, and what the potential health effects of such exposure would be if the respirator is not worn or not worn properly. This type of information will be available on the material safety data sheet for the hazardous chemical that the chemical manufacturer will be required to produce under the Hazard Communication Standard (29 CFR 1910.1200). These training requirements on health hazards of hazardous chemicals are also required under the Hazard Communication standard (29 CFR 1910.1200) and could easily be combined into the same training program. Many commenters agreed that this subject is an essential element of training (Ex. 61-3, 61-8, 15-10, 15-14, 15-18, 15-19, 15-27A, 15-41, 15-46, 15-53, 15-62, 15-73). None disagreed.

Once employees are trained regarding the nature of the hazards, employers are to provide an explanation of the operation, limitations, and capabilities of the respirators selected for the employees to wear. This would include, for example, an explanation of how the respirator provides protection by either filtering the air, absorbing the vapor, or providing clean air from an uncontaminated source. Where appropriate, it also should include limitations on the equipment such as prohibitions against using an air-purifying respirator in the event of an emergency with IDLH atmospheres and an explanation of why they should not be used in such situations. In other words the employee should be able to understand the operation of the respirator thoroughly as a result of this training, and thus know why it was selected for the task at hand. Most commenters supported covering this topic in the training program. (Ex. 61-3, 15-14, 15-18, 15-27A, 15-41, 15-46, 15-53, 15-62, 15-73). There was no disagreement.

Once the employee understands the nature of the hazards, and the particular equipment selected to protect against those hazards, the employer is to provide specific instruction regarding the type and frequency of respirator inspections. Although the employer is required to ensure that such inspections are performed, employees using the equipment may frequently be responsible for inspecting the respirators assigned to them. Therefore, it is necessary that they have this process explained and demonstrated to them so they are capable of recognizing any problems that may threaten the continued protective capability of the respirator. The training must include the steps employees are to follow if they discover any problems during inspection, i.e. who this should be reported to and where they can obtain replacement equipment if necessary.

The training must also include the procedures for donning or removing the respirator, checking the fit and seals, and actually wearing the respirator. It is very important to ensure that the everyday respirator fit is as close as possible to the fit obtained during fit testing, and therefore employees must be able to duplicate that fit through proper donning and removal. The fit testing procedure can help in training employees, particularly if quantitative fit testing is used since it can demonstrate numerically to employees the dramatic differences in measured fit when the respirator is not adjusted properly (Ex. 15-44). The proposal requires employers to include sufficient practice so that employees can perform these tasks effectively. The proposal also includes positive and negative pressure facepiece seal checks in non-mandatory Appendix B. If other tests are equally effective in testing the face seal, they may be used. Employees must be trained regarding the appropriate tests to be used for the respirators they are wearing. The inclusion of these topics in training was unanimously supported in the record (Ex. 61-3, 61-8, 15-10, 15-14, 15-22, 15-27A, 15-41, 15-46, 15-50, 15-62, 15-73).

The employer is also to explain the procedures for maintenance and storage of respirators. This provision may vary by establishment since in some cases the employees are responsible for doing some of the maintenance and for storing the respirators while not in use, but in other facilities specific people are assigned to carry out these activities. In any event, employees should be aware of the proper procedures to follow. The significance of this point was raised by a large number of commenters (Ex. 61-3, 61-8, 15-10, 15-14, 15-27A, 15-41, 15-46, 15-50, 15-62).

Respirators do malfunction on occasion, or emergency situations occur which require different respirators for the exposure levels involved. The training program must include a discussion of these possibilities, and the procedures the employer has established to deal with them. Most ANPR commenters concurred that comprehensive training is necessary where respirators are to be used in situations immediately dangerous to life or health, including oxygen deficient atmospheres, such as in fire fighting, rescue operations and confined area entry (Ex. 15-18, 15-19, 15-26, 15-31, 15-33, 15-37, 15-41, 15-47, 15-48, 15-50, 15-54, 15-55, 15-56, 15-59, 15-70).

Several commenters requested that OSHA adopt the applicable training requirements of the American National Standard Institute (ANSI) Z88.2-1980 Practices for Respiratory Protection which discussed the basic training requirements of an acceptable respirator program (Ex. 15-13, 15-14, 15-26, 15-27A, 15-31, 15-44, 15-46, 15-50, 15-54, 15-55, 15-58, 15-70, 15-76, 15-81). The new training requirements are similar to the ANSI requirements for training except that the proposal does not require a discussion on the role of engineering controls.

Although some commenters felt that the provisions covering training in the present standard are adequate (Ex. 15-37, 15-56, 15-75A), in view of the importance of training in motivating employees to wear respirators correctly and effectively, the additional information required by this proposal is deemed by OSHA to be critical for an effective respirator program. With the exception of the American Iron and Steel Institute (Ex. 15-37), A.E. Staley Manufacturing Company (Ex. 15-56), and the Sperry Corporation (Ex. 15-75A), the record supports further guidance for training than is currently contained in 1910.134 (Ex. 15-13, 15-14, 15-26, 15-27A, 15-31, 15-44, 15-46, 15-50, 15-54, 15-55, 15-58, 15-70, 15-76, 15-81).

In addition to specific training requirements regarding the proper use of respirators, the employer must inform employees of the existence and contents of the respirator standard (29 CFR 1910.134). They must also be told of the existence and contents of the written respiratory protection program required by the respirator standard, where it is kept in the facility, and how the employee can arrange to examine it if desired.

The majority of commenters agreed that annual training is necessary to assure an effective continuing program (Ex. 15-10, 15-18, 15-19, 15-20, 15-37, 15-44, 15-47, 15-48, 15-50, 15-54, 15-55, 15-71). The Sperry Corporation, however, recommended that employees be retrained every 6 months, but did not provide a rationale for their contention. In response to the preproposal draft, California OSHA (Ex. 36-44) recommended that a more comprehensive initial training and more frequent refresher training be required for employees assigned to use SCBA in potentially IDLH atmospheres; emergency response users of SCBA would receive refresher instruction in the operation inspection, and wearing of the SCBA at least every three months for the first two years following initial training, and thereafter every six months. Frank Wilcher of the International Safety Equipment Association (Ex. 36-45) also recommended that employees who use SCBAs be trained semiannually because of the higher degree of complexity of these units and the possibility of greater hazards associated with their use.

The Washington State Department of Labor and Industries (Ex. 36-20) recommended that training should be performed at least annually and be adjusted to the complexities of the respirator program and the level of respirator use. William O'Keefe of the American Petroleum Institute (Ex. 15-41) asserted that training should be repeated periodically, but at least every 2 years and more frequently as workplace conditions may warrant. Richard Boggs of ORC (Ex. 36-47) in response to the preproposal draft recommended that a 2 year cycle of retraining and refresher instruction after the initial respirator use training was reasonable. He recommended that any decision for more frequent training should be made by the employer. Annual retraining was called needlessly expensive. Amoco Corporation (Ex. 36-35) recommended that the retraining frequency for routinely used respirators be a minimum of two years, but emergency use respirators would require annual retraining. The American Textile Manufacturers Institute (Ex. 36-18) recommended retraining every two years for employees requiring an APF of 10 or less. Both the ANSI Z88.2-1980 and Z88.2-1993 respiratory protection standards call for annual retraining.

OSHA concurs with the majority of comments contending that annual training is sufficiently frequent to ensure employee cooperation and active participation in the program. Training every two years instead of annually for routinely worn respirators has been rejected, since the purpose of the training is not only to instruct wearers in proper techniques but also to encourage their cooperation and participation in the respirator program. Switching to training every two years would tend to diminish attention to proper respirator use. OSHA compliance experience has demonstrated that inadequate respirator training is a common problem (Ex. 33-5) and is often associated with respirator program deficiencies that potentially lead to employee exposures. Therefore, the proposal contains the requirement for annual training for respirator wearers. Training required by this proposal is to be given to the employee before he or she is required to wear a respirator in the workplace. Employees must receive training at least annually so they will be reminded regularly of the effects of the respiratory hazards to which they may be exposed and how they can prevent such exposure by proper wearing of respirators. OSHA requests comments on the frequency of training, particularly the need for increased training and more frequent refresher training for employees using SCBAs or emergency use respirators.

(L) Respiratory Program Evaluation

It is inherent in respirator use that problems with protection, irritation, breathing resistance, comfort, etc. will arise. While it is not possible to eliminate all problems with wearing a respirator, the employer must try to eliminate as many problems as possible to improve protection and encourage wearer acceptance of respirators. Eliminating problems is accomplished most effectively when the program is evaluated carefully and revised as necessary. Although the current standard does require that the employer perform periodic checks of the effectiveness of the respiratory protection program, little guidance is provided regarding how this evaluation is to be done. The proposal includes a paragraph dealing with this requirement and provides more information regarding what should be assessed by the employer.

The person responsible for administration of the respiratory protection program is to review the program at least annually and is to conduct frequent random inspections of the workplace to ensure that the provisions of the program are being properly implemented. The annual review is to include an assessment of each element of the program that is required to be included under paragraph (c)(1).

In addition to this review of the program itself, the employer is to consult employees wearing respirators to ascertain whether they perceive any problems with the equipment. Factors to be included in this assessment are comfort; resistance to breathing; fatigue; interference with vision; interference with communication; restriction of movement; interference with job performance; and the employee's confidence in the respirators effectiveness. The employer should attempt to correct any such problem that is brought forward. Comments are requested on these requirements. Companies which have instituted similar assessments are encouraged to submit their views.

(M) Recordkeeping and Access to Records

The final paragraph of the proposal deals with recordkeeping related to the respiratory protection program. The employer is to record, maintain and provide access to any records of medical evaluations performed under paragraph (e) of the proposal. This record consists of the employee's name, a description of the employee's duties, the physician's written opinion and recommendations on the employee's ability to use a respirator, any results of medical examinations or tests performed, and a copy of the information provided to the physician. Once generated to comply with this standard, the records are to be kept, and access is to be provided to them under the provisions of 29 CFR 1910.20, OSHA's rule on Access to Employee Exposure and Medical Records.

The present standard does not contain a separate section for recordkeeping. It simply requires employers to indicate on the respirator to whom it was assigned and the date it was issued. It also requires recording of inspection dates and findings for respirators used for emergency use.

The importance of recordkeeping as a means of verifying compliance with the respiratory protection program requirements was stated frequently in the record (Ex 15-18, 15-22, 15-33, 15-41, 15-47, 15-82). Commenters urged OSHA to require only those records necessary to demonstrate an effective program (Ex 15-19, 15-21, 15-41, 15-47, 15-71). However, there was considerable disagreement over what recordkeeping items to require. Because OSHA recognizes that recordkeeping may be administratively burdensome and time consuming, the Agency has only required employers to maintain records that are necessary for determining compliance with the requirements of the proposal.

The written respiratory protection program itself needs to be kept current as long as respirators are in use in the workplace. However, there is no specific retention period as long as the latest version of the program is available in the workplace.

Employee fit testing records are required as part of Appendix A, section (1)(L). This record consists of the employee's name, the type, brand, and size of the respirator fitted; date of the fit test; and the strip chart recording or other record of the test results where quantitative fit testing was performed. The fit test record must be maintained until the next fit test is administered. The reason for requiring that fit test records be maintained is to provide a record of the results of fit testing in order to determine whether annual fit testing has been done and if the individual tested passed the QNFT with a fit factor that was adequate for the type of respirator being used. The preproposal draft did not contain a requirement that fit test records be maintained, but several commenters had serious doubts that OSHA would be able to determine if an individual had been properly fitted and was wearing the appropriate respirator by visual observation alone (Ex 36-6, 36-17, 36-34, 36-46). OSHA agrees that fit testing records must be maintained to ensure that all respirator wearers have received a fit test, that the appropriate respirator chosen by fit testing is being worn, and that retesting is performed annually. Fit testing records can also serve other uses in the respiratory protection program. The Ethyl Corporation (Ex 36-11) uses the strip chart recording of the fit test as a training tool when it is reviewed with the fit test subject.

(N) Substance Specific Standards

This proposed standard will affect OSHA's substance specific health standards. All such standards now incorporate provisions of the existing Sec. 1910.134 as part of their requirements. Moreover, some respirator related provisions in the substance specific standards differ from their counterpart provisions in this proposal, mostly in respirator selection and the events which trigger medical examinations for respirator users.

OSHA is proposing to revise all references to Sec. 1910.134 in the existing substance specific standards to conform to the proposed revised standard. Thus, for standards such as lead, coke oven emissions, asbestos, and others which now require that "the employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134 (b), (d), (e), and (f)", the text will read "the employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l)." The revised provisions cover program elements, selection criteria for respirators, fit testing, use of respirators, maintenance and care, air quality, training, and program evaluation. Each of these subject areas was addressed in previously incorporated paragraphs (b), (d), (e), and (f) of the existing standard. For the " carcinogen" standards (Sec. 1910.1003-1016), which now require that in certain instances employees use certain kinds of respirators "in accordance with 1910.134", the regulatory text will remain unchanged. However, the employer will have to comply with the amended provisions of the revised Sec. 1910.134 rather than the earlier provisions.

OSHA is including the proposed revised paragraph (e) covering medical surveillance only in the carcinogen standards in 1910.1003-1910.1016. Each of the other substance specific standards now includes in its medical surveillance requirements a provision that the employee be evaluated concerning any potential limitations on respirator use. OSHA believes that the medical surveillance programs established under these substance specific standards are therefore sufficient to protect employees who are not medically able to wear respirators. Because each medical surveillance requirement in the substance specific standards was designed as a comprehensive program to evaluate employees for conditions and risks unrelated to respirator usage as well, OSHA believes any revision changing the required frequency or content of medical examinations would unnecessarily disturb ongoing medical surveillance programs. Comments on this approach are solicited from the public, especially those who have information concerning the sufficiency of medical evaluations for respirator use under substance specific standards.

OSHA has adopted various approaches to deal with respirator provisions in those substance specific standards which differ from this proposal. Based on the information and data in the respiratory protection docket, OSHA believes in order to maintain an effective respirator program regardless of the contaminant or workplace conditions, there should be a minimum program level. Thus, for provisions in substance specific standards which are more protective than the counterpart revised provisions of this standard, OSHA does not propose any changes. For example, the respirator selection tables of some standards provide for more restricted use of respirators than would the respirator selection criteria in this proposal. The least protective respirator allowed by the ethylene oxide standard is a full facepiece respirator with an ethylene oxide canister regardless of protection factor required, whereas respirator selection according to this proposal would allow a half mask or quarter facepiece cartridge/ canister respirator up to the NIOSH assigned protection factor of 10. OSHA believes that the more protective provisions of respirator selection adopted for specific substances after rulemaking proceedings conducted pursuant to Section 6(b) of the Act reflect the content of each rulemaking record, the toxicity and circumstances of use of each substance and therefore should be retained.

In keeping with this principle of not going below the minimum program, in those cases where existing respirator selection options in the substance specific standards are less protective than would be permitted by the proposed NIOSH respirator selection tables, OSHA proposes to revise such permitted respirator selections to conform to paragraph (d). For example, the lead standard (1910.1025 (f)(2)) now allows any powered air-purifying respirator with high efficiency filters to be used in concentrations up to 1000 times the PEL, and the coke oven emissions standard allows the use of PAPRs in any concentration, whereas under this proposal respirator selection would allow powered air-purifying respirators to be used only in atmospheres of 25 and 50 times the PEL for respirators certified under 42 CFR Part 84, depending on type. In the case of new or modified respirator types as well as existing respirator types, OSHA continues to require that they be NIOSH certified for the contaminant involved as a prerequisite to their permitted use.

OSHA is also revising the respirator related provisions in the following OSHA safety standards, Sec. 1910.94 (Ventilation), Sec. 1910.111 (Anhydrous Ammonia), Sec. 1910.252 (Welding), and Sec. 1910.262 (Pulp, Paper, and Paperboard Mills) to make them conform to the revised requirements for respirator certification, selection, and use contained in this proposal.

In addition to making existing substance specific standards conform to the revised provisions of the respiratory protection standard in general, OSHA is also requesting comments on specific respirator-related issues of three specific standards.

OSHA is intending to reinstate the provision in the lead standard that requires the use of high efficiency filters for all air purifying respirators used with lead. In 1979, OSHA had stayed that provision to allow further administrative reconsideration (44 FR 5446). The recent asbestos standard record that has been generated supports requiring the use of high efficiency filters with whatever respiratory protection equipment is used to protect against highly toxic substances. When OSHA announced the stay on the requirement for high efficiency filters in the lead standard, it was stated that NIOSH would be asked for further interpretation of the record. Partially in response to this request, NIOSH performed a study on the effectiveness of various filters in the presence of lead aerosols. The results of this study (Ex. 38-6) show a substantial difference in penetration between high efficiency filters and others. OSHA therefore believes there is a clear increase in protectiveness as a result of the use of high efficiency filters in a lead aerosol atmosphere. Moreover, OSHA believes the use of high efficiency filters does not impose an undue burden on employers in relation to the use of less efficient filters, and that requiring the use of high efficiency filters in the presence of lead -- a highly toxic substance -- is both appropriate and reasonable. As a result of these considerations, OSHA intends to lift the stay on enforcement of the requirement that high efficiency filters (type III filters as defined under 42 CFR Part 84) be used.

As a second issue, the OSHA asbestos standard requires the use of high efficiency filters with air-purifying respirators and does not allow the use of disposable respirators with asbestos. Reasons for not permitting the use of such respirators were that it was determined in the asbestos standard record that high efficiency filters are necessary to provide the necessary protection against penetration; and that disposable respirators for the most part also were not shown to provide adequate fit and were not by virtue of design amenable to the performance of a fit check. However, it has come to OSHA's attention that there are disposable respirators with elastomeric facepieces and high efficiency filters which are said to provide fits as good as provided by half mask elastomeric respirators which have replaceable high efficiency filters. Such disposable respirators can be quantitatively fit tested, and are designed so that fit check procedures can be performed. OSHA is asking for comments on whether such respirators should be allowed to be used under the asbestos standard.

The third issue concerns the OSHA standard for inorganic arsenic. At the time this standard was promulgated in May 1978, disposable respirators with high efficiency filters were not available. Therefore, disposable respirators were not addressed in the respirator selection tables of the standard. Now that there are such respirators, OSHA needs to determine whether they can provide adequate assurance of fit so as to be suitable for inorganic arsenic which is known to be carcinogenic. OSHA is proposing that disposable respirators not be permitted under the inorganic arsenic standard for the same reasons as stated for the asbestos standard. OSHA is seeking comment on whether disposable respirators with and without elastomeric facepieces should or should not be allowed to be used under the inorganic arsenic standard in view of facepiece sealability or any other considerations.

O. Maritime Standards: Parts 1915, 1917, 1918

In this document OSHA is proposing to update the respiratory provisions in Shipyards, Sec. 1915.152. OSHA requests comments on the proposal and whether any changes in the proposed language is appropriate for shipyards based on relevant unique circumstances. Currently, the respiratory provision for Marine Terminals is a cross reference to Sec. 1910.134. See Secs. 1917.92 and 1917 (a)(2)(viii). The current respiratory provision for Longshoring is at Sec. 1918.102 and is many years out of date. OSHA proposed on June 2, 1994 at 59 FR 28594, 28622-3, 28690 to replace it with a cross reference to Sec. 1910.134. See proposed Sec. 1918.1(a)(12).

OSHA requests comments on whether the proposed respirator standards are appropriately incorporated into the Marine Terminal and Longshoring Parts by cross reference or directly. OSHA requests comments on costs and feasibility issues for these sectors. OSHA also requests comments on whether provisions different from the general industry standard are appropriate based on unique circumstances in these sectors.

P. Construction Advisory Committee

The revised respirator standard that results from this rulemaking will replace the existing respiratory protection standards in the construction industry (29 CFR 1926.103) and in maritime operations (29 CFR 1915.152). Since this revision affects the construction industry, the September 1985 preproposal draft standard was presented to the Construction Advisory Committee for Occupational Safety and Health (CACOSH) for their comments. The CACOSH comments, combined with the other comments received, were considered in preparing a revision of the September 1985 draft proposal.

As part of the Notice of Proposed Rulemaking (NPRM) approval process, the revised NPRM was presented at the March 1987 CACOSH meeting and the Committee's comments were presented to OSHA at the August 1987 meeting (Ex. 39). The following discussion summarizes the issues raised in these comments and presents OSHA's response to them.

The proposal would replace the existing construction industry standard for respiratory protection, 29 CFR 1926.103, with the provisions of the revised 29 CFR 1910.134 respirator standard. The Construction Advisory Committee recommended that there should be a separate respirator standard for construction. Whether there were particular changes that should be made to the provisions of the standard to reflect respirator usage in the construction industry was not clearly addressed by the Committee since the comments they presented were equally applicable to general industry respirator use. OSHA believes that there is no need for a separate rulemaking for the construction industry since no differences in content would appear to be appropriate. Consequently this recommendation was not incorporated. However, OSHA is establishing these respiratory provisions explicitly in the construction standards as 29 CFR 1926.103.

Paragraph (a) -- Scope and Application

The Construction Advisory Committee recommended that the scope and application section, paragraph (a)(1) of the standard, require that all feasible engineering controls be used by employers and that the employer demonstrate that engineering controls are not feasible before respirators are used. The proposed change would eliminate the requirement that appropriate respirators be used while engineering controls are being installed. Since the only effect of this proposed language change would be to eliminate the required use of respirators during the installation of engineering controls, it has not been adopted.

The Committee proposed that paragraph (a)(2) be modified to require that employers provide respirators at one half the PEL or TLV, and that employees be required to wear them before the PEL is exceeded. To accompany this revision the Committee proposed a new definition establishing an "action level" at one half the PEL for all regulated substances. OSHA does not believe it to be within the scope of this proposed standard for respirator use to trigger action levels and is therefore not incorporating this CACOSH recommendation.

Paragraph (b) -- Definitions

The Committee suggested that the definition of an atmosphere-supplying respirator be revised to include reference to "Grade D breathing air". This definition was intended by OSHA to describe a particular technical device, the atmosphere-supplying respirator. The requirement for Grade D breathing air is contained in paragraph (i)(1)(i) of the proposed standard and is not relevant to the definition of the type of respirator. Therefore, the definition of atmosphere-supplying respirator has not been changed.

CACOSH suggested that OSHA add a definition for "Grade D breathing air"

to the proposal. While this term is already described in paragraph (i), Supplied Air Quality and Use, a definition for Grade D breathing air has been added in the definition section of the proposal.

A definition for "competent person" was proposed to be added as follows:

"`Competent Person' means one who is capable of identifying existing respiratory hazards in the workplace and who has the authority to take prompt corrective measures to eliminate them, as specified in 29 CFR 1926.32(f). The duties of the competent person include at least the following: reviewing the respiratory protection program, ensuring that the employer conducts the training, fit testing, tests and maintains the records for respirators and ensuring that engineering controls in use are in proper operating condition and are functioning properly." This proposed definition would establish duties and authority for the competent person, who would perform the function of the respiratory program administrator required in paragraph (c)(2) of the proposal. However, the definition contains duties and responsibilities that go beyond the requirements set for a program administrator. These duties, such as ensuring that engineering controls are in proper operating condition and are functioning properly, are the responsibility of whomever the employer chooses to designate. Although the competent person definition has not been included in this proposal, OSHA is asking for comments on the need for this definition or for alternative definitions to accomplish the same purpose.

In the proposal's definition of hazardous exposure level, the ACGIH TLVs are used to determine the hazardous exposure level in the absence of a PEL. The Construction Advisory Committee recommended that the NIOSH Recommended Exposure Limit (REL) should also be used along with the TLV, and that whichever was lowest to be used in determining the hazardous exposure level. OSHA agrees that the NIOSH Recommended Exposure Limits are an appropriate source for exposure limits in the absence of a PEL. However, it is not clear that the lowest value from either the TLV or REL for a particular substance should be used. OSHA has received no comment on the appropriateness of the NIOSH RELs in the docket, and is requesting comment on how OSHA should require the use of the RELs by employers in establishing hazardous exposure levels for respirator use. Language has been added to the hazardous exposure level definition to require the use of the RELs, but only in the absence of a PEL or TLV, since these values are widely recognized as appropriate for such uses. OSHA requests comments on this addition and on the use of RELs in relation to TLVs.

The proposal states in paragraph (d)(6) that air-purifying respirators may not be used for a hazardous chemical with poor or inadequate warning properties. The proposed standard defines adequate warning properties as detectable odor, taste, or irritation effects which are detectable and persistent at or below the hazardous exposure level. CACOSH recommended inclusion of a definition of "inadequate warning properties" as those associated with an odor or taste threshold equal to or greater than one-half of the substance's PEL or TLV. The CACOSH definition reduces the cutoff level for warning properties to one-half the PEL or TLV. This would reduce the number of chemicals with adequate warning properties with which air-purifying respirators can be used. OSHA requests comments and information on the appropriateness of using a cutoff level of one-half the PEL or TLV as the point where inadequate warning properties start, and on the effects such a level would have on air-purifying respirator use.

The definition of "maximum use concentration" (MUC) in the proposal limits the use of gas and vapor air-purifying elements to a maximum level which cannot exceed the NIOSH limits on the respirator approval label. CACOSH suggested that OSHA add a sentence to the definition to limit the MUC to a maximum of 1000 ppm. NIOSH in Table 5 of their Respirator Decision Logic (Ex. 38-20) presents recommended MUC levels for gas and vapor air-purifying elements. The 1000 ppm MUC is used only for organic vapor cartridges. Different MUCs are given, based on whether the element is a cartridge, chin canister, or front-or-back-mounted canister. The MUC is limited by the NIOSH Decision Logic to the maximum listed in the table or the IDLH level of the specific organic vapor, whichever is lower. OSHA requests comments on whether it should adopt the NIOSH limitations on MUC for use in the revised OSHA respirator standard.

CACOSH also suggested that OSHA add a definition for "odor threshold" as the concentration at which 100 percent of a human test group would detect the odor of a substance. However, odor thresholds vary greatly among individuals, a few of whom may be virtually insensitive to a large number of chemicals. A requirement that 100 percent of a human test group be able to identify the chemical could result in the elimination of most chemicals as having no odor threshold. OSHA has therefore not adopted this definition. However, OSHA is requesting comment on the appropriate levels that should be used in determining odor thresholds, the test methods used, and the appropriateness of requiring that odor threshold testing be performed for individuals who must wear air-purifying respirators.

The Construction Advisory Committee also recommended replacing the proposal's definition of "respirator" with the following: "`Respirator' means any device worn by an individual and intended to reduce an exposure to airborne contaminants or supply the wearer with Grade D breathing air in a contaminated or oxygen deficient atmosphere." OSHA believes that performance characteristics of respirators should be stated where appropriate in the standard. Some respirators are adequate while others are not. However, an inadequate respirator is still a respirator. Therefore OSHA has not adopted this CACOSH change in the definition of respirator.

The Committee also proposed revising the language in the definition of service life in the proposal with the following: "`Service Life' means the period of time it takes for a specified substance to break through a chemical or organic vapor cartridge or canister." Service life, as the definition in the proposal states, is a function not only of the type of substance but also of the specific concentration of that substance. Removing the specific concentration of the substance from the definition, as the CACOSH revised definition does, obscures the meaning of the definition, and therefore it has not been adopted. The NIOSH Respirator Decision Logic (Ex. 38-20) uses a broader definition that covers all air-purifying respirators as well as SCBA. It reads as follows: "SERVICE LIFE: The length of time required for an air-purifying element to reach a specific effluent concentration. Service life is determined by the type of substance being removed, the concentration of the substance, the ambient temperature, the specific elements being tested (cartridge or canister), the flow rate resistance, and the selected breakthrough value. The service life for a self-contained breathing apparatus (SCBA) is the period of time, as determined by the NIOSH certification tests, in which adequate breathing gas is supplied." OSHA requests comments on whether it should adopt the broader NIOSH definition of service life, replacing the definition in this proposal.

Paragraph (c) -- Respirator Program

Paragraph (c)(1) of the proposal contains a requirement that the employer establish and implement a written respirator program that covers certain elements, as applicable. The Construction Advisory Committee recommended that OSHA change the word "cover" to "include" and remove the phrase "as applicable." The phrase as applicable was included in the requirements to cover situations where not all the elements listed in the paragraph would be appropriate for some particular written respiratory program. For instance, if only air-purifying respirators are to be used, it would not be applicable to include in the written program the elements covering supplied air quality, the maintenance and cleaning of supplied air respirators, or fit testing of SCBAs. Therefore, OSHA has not changed the wording in the proposal.

The Committee raised the issue of monitoring exposure levels in construction. They recommended that OSHA add a new element to the existing elements of the written respirator program in paragraph (c)(1) that would read as follows: "(i) Procedures for monitoring the work environment and selecting respirators based on monitoring results for use in the workplace." Discussion by the Committee brought out that construction work situations are not stable, and that monitoring results for a particular individual operation would likely not be returned in time by a laboratory before that task was completed. Previous monitoring results can be used, along with past experience with similar work operations, to estimate exposure levels. The Committee then recommended that OSHA add to the standard a requirement that "If monitoring is not done, the most protective respirator shall be used." In most cases this would mean using supplied air respirators or SCBAs in the absence of monitoring. The proposal does not now require monitoring, but it does require that where monitoring results exist, the employer evaluate them in selecting the proper respirator. OSHA requests comments and suggestions on whether monitoring should be made mandatory for making respirator selections, and what monitoring procedures should be used. OSHA also requests comments on the recommendation by CACOSH that the most protective respirator must be used in the absence of monitoring.

One of the elements in the written respirator program, paragraph (c)(1)(vi), states that the program shall include procedures to ensure proper air quality for atmosphere-supplying respirators. CACOSH proposed adding the words "quantity and flow" to this element on air quality procedures. OSHA agrees that adding these words will provide more direction for employers on what the procedures should cover, and has revised the wording of this element accordingly.

In paragraph (c)(2) CACOSH recommended that OSHA substitute the term "competent person" for the language "person qualified by appropriate training and/or experience." This has been discussed previously in the CACOSH recommendation for a definition of "competent person." The language in the proposal has not been changed, but will be reviewed in light of any comments received on the "competent person" definition.

The written respiratory protection program, in paragraph (c)(3), is required to reflect current workplace conditions and respirator use. The Committee wanted to add the term "training", to require that the program reflect current workplace conditions, training and respirator use. This suggestion has not been adopted since OSHA believes that training should reflect current workplace conditions and the written respirator program, and not the reverse. It was recommended by the Committee that OSHA add to paragraph (c) a paragraph that would allow employees and designated representatives access to exposure and medical records maintained by the employer. OSHA has not adopted this suggestion, since this requirement is already included in 29 CFR 1910.20, the medical and exposure records access standard, which is referenced in this proposed standard.

In paragraph (c)(5), the employer is required to make the written program available to affected employees, designated representatives, and OSHA. The Committee requested that employers be required to send a copy of the program to the OSHA Special Assistant for Construction. This suggestion has not been adopted, since no procedures exist in the Special Assistant's Office that would utilize these written programs if they were sent in. However, language has been added that would require the sending of a copy of the program to the Assistant Secretary upon request. This should meet any possible need that may arise for copies of the written program without creating an unreasonable burden.

The Committee further recommended that the respirator program should be maintained and made available to employees at the job site, and that the medical and monitoring results pertaining to respirator use be available at the work site as well. How the latter would be performed, given the highly mobile nature of construction activities, was not clear. OSHA requests comments on this recommendation and any suggestions on how to provide the above information at the job site in a reasonable manner without placing an inappropriate burden on employers.

Paragraph (d) -- Selection of Respirators

In its review of paragraph (d) of the proposal on selection of respirators, the Committee requested a new provision that would require monitoring for contaminants when air-purifying respirators are used to be sure that the maximum use concentration for the respirator type would not be exceeded. This provision is related to the requirement for monitoring that was previously discussed, and on which comments are requested.

In paragraph (d)(3) of the respirator selection section of the proposal, the employer is required to evaluate certain information when selecting respirators. The information to be evaluated is listed in paragraphs (d)(3) (i) to (xi). The Committee recommended that the word "obtain" be added to paragraph (d)(3), to require that employers "obtain and evaluate the following information for each work situation". By requiring that employers both obtain and evaluate the information, the intent of the provision would be clarified. OSHA has adopted this changed language to better clarify the provision for employers.

The proposal in paragraph (d)(4) requires that respirators approved by NIOSH be selected when they exist. The Committee wanted to remove the phrase "when they exist" since they felt that one should use the most protective respirator available, an SCBA or supplied air respirator, in cases where no approved air-purifying respirator exists. As stated in the proposal, OSHA has the option of allowing the use of non-approved respirators for certain types of exposures. The option of allowing the use of non-approved respirators has been of value in the past. An example is the ethylene oxide standard, 29 CFR 1910.1047, where the use of certain air-purifying respirators is permitted, while the use of these respirators would not have been approved by NIOSH. OSHA wants to continue to have this option with any future standard. Therefore, this recommendation has not been adopted.

In paragraph (d)(6) the proposal states that air-purifying respirators shall not be used for hazardous chemicals with poor or inadequate warning properties. However, in paragraphs (d)(6) (i) and (ii) their use with such substances is allowed when permitted under an OSHA substance specific standard or when certain conditions for use are met. As discussed previously in this section the Committee wanted to include poor odor threshold as a reason for prohibiting use, and to remove paragraph (d)(6)(ii) which allows their use under limited circumstances. OSHA has asked for comments on this issue.

In oxygen deficient atmospheres, the proposal in paragraph (d)(8) allows the use of air-purifying respirators in an atmosphere with an oxygen content of 19.5 percent or greater at altitudes of 14,000 feet or below. The Committee wanted to remove this provision, thus requiring the use of supplied air respirators for many work sites at altitudes where the use of air-purifying respirators has caused no problems. There was nothing presented at the meeting to support this request. The record on the issue has been discussed previously in this preamble, and OSHA is inviting further comment on this issue and on the use of air-purifying respirators at high altitudes on construction worksites.

Paragraph (e) -- Medical Evaluations

In the medical section of the proposed standard, the Committee recommended that a mandatory medical examination be required in accordance with ANSI Z88.2 and that the standard include a list of diseases and conditions which should be considered by the physician in determining an individual's ability to wear a respirator. As discussed in the section of this preamble on medical surveillance, OSHA is inviting comment on three specific alternatives for medical surveillance requirements.

The medical evaluation section of the proposal in paragraph (e)(1) states that the medical provisions apply for each employee required to wear a respirator for more than five hours in any work week. The Committee wanted to eliminate the five hour per work week exemption. Their concern was that there would be many times on a construction project where employees would use respiratory protection for periods much shorter than five hours, and a situation would develop where respirators could be used without requiring a respirator physical. This issue has been discussed in the medical evaluation section of the preamble, and comments have been requested on the five-hour-in-any-work-week provision. OSHA will consider the Committee's comment, along with any other comments received, in resolving this issue.

In paragraph (e)(1) of the medical evaluation provision that the Committee reviewed, the employer is required to obtain a physician's written opinion which states whether the employee has any detected medical condition which would place the employee's health at increased risk of material impairment from respirator use and any recommended limitations upon the use of respirators. The Committee suggested that OSHA revise the language in this provision to read: "For each employee required to wear a respirator the employer shall obtain from a licensed physician a written opinion based upon any detected medical condition, which states whether the employee can wear the respirator and perform the work or whether there are limitations to type of respirator worn or work performed." The Committee was concerned that the original language could be interpreted as permitting the employer to know what the medical conditions were that limit respirator use. They wanted to limit the language so that the employer would only receive from the physician an opinion on whether the employee can perform the required work while wearing a respirator or whether there is some restriction on the respirator type that can be used. The current proposal now requests comments on three alternatives for medical surveillance requirements, one of which is the provision reviewed by CACOSH. OSHA requests comments on all three alternatives and, in particular, on the need for restricting the medical opinion to only the individual's ability to wear a respirator.

Employers are required in the proposal to provide the physician performing a medical evaluation with certain information concerning the types of respirators to be used and conditions under which they will be used by employees. The Committee recommended that OSHA add a provision requiring that the employer inform the physician of the contaminants the employee will be exposed to. OSHA agrees with this comment, and has added such a provision to paragraph (e)(1).

In paragraph (e)(2) the employer is allowed to accept a new employee's previous medical examination or written physician's opinion on respirator use, provided it was conducted within a year of the date of employment. The Committee recommended that OSHA also require that these previously performed exams or written opinions meet the same conditions required of medical evaluations provided by the employer under paragraph (e)(1). This suggestion has been accepted, and appropriate language has been added to paragraph (e)(2) to require that the previously performed exams or opinions meet the requirements of paragraph (e)(1) for medical evaluations.

It was recommended that OSHA add a new provision to paragraph (e) to require that the employer provide a powered air-purifying respirator or atmosphere-supplying respirator to any employee found medically unable to wear a negative pressure respirator but otherwise able to perform the task to be done. There is no applicable record in the docket upon which to base a decision. OSHA therefore, is requesting comments or information on this issue.

Paragraph (f) -- Fit Testing

With respect to fit testing procedures, the Committee recommended that paragraph (f)(1) be rewritten to state that respirators shall fit the employee so no exposure above the TLV or ceiling level shall occur. OSHA has added a new provision to require that the respirator used shall reduce employee exposures in the breathing zone to below the hazardous exposure limit. This change answers the Committee comment and preserves the language of the original proposal.

In paragraph (f)(2) the Committee suggested revising the language to clarify that a fit test is required whenever a different make or size respirator is used if the facial characteristics of the employee change. Facial changes are already addressed in paragraph (f)(7). Passing a fit test with one particular make and size respirator does not mean that a different respirator can be used without further fit testing. Therefore, reference to different makes and sizes has been added to paragraph (f)(2) to cover variations in respirator make and size.

The Committee also wanted to limit fit testing to only tight fitting negative pressure respirators. For the reasons previously discussed in the fit testing section of the preamble, OSHA does not feel this is sufficient. Therefore, the proposal continues to require fit testing of both tight fitting air-purifying as well as tight fitting atmosphere-supplying respirators.

In paragraph (f)(9) the employer is allowed to use a qualitative fit test for selecting respirators for employees who require fit factors greater than 10 in situations where outside contractors who do the quantitative fit testing are not available. A thirty day time limit is placed on this exemption from the requirement for quantitative fit testing. The Committee felt this exemption is not safe and should not be allowed. An employee who is hired between the normal visits of the quantitative fit test contractor therefore could not be assigned to any work area requiring fit factors greater than 10 until a quantitative fit test was passed. OSHA requests comments on this issue and on the Construction Advisory Committee suggestion to delete paragraph (f)(9) from the standard.

Paragraph (g) -- Respirator Use

In paragraph (g)(3) of the respirator use section of the proposal, the employer is required to refuse the use of respirators that rely on a tight facepiece fit when facial conditions such as a beard or scarring would prevent such fits. The Committee wanted this provision to cover loose fitting respirators as well as tight fitting ones. However, conditions such as a beard or facial scarring would have no effect on the performance of loose fitting hoods or helmets, and OSHA therefore does not regard it as appropriate to make this change.

Employees who wear corrective glasses are required in paragraph (g)(4) to wear them in a manner that does not interfere with the facepiece seal of the respirator. The Committee suggested an additional requirement that, where the employee must wear corrective lenses and the respirator requires that these be of special design, the employer shall provide the lenses at no cost to the employee. The question of who pays for respirator corrective lenses has not previously been addressed, and OSHA has no information in the docket on this issue. Therefore, OSHA requests comments and information on the responsibility for paying for specially designed corrective lenses for respirators.

The cleaning, sanitizing, and discarding of disposable respirators is addressed in paragraph (g)(9) of the proposal. The Committee recommended that OSHA delete this provision since it refers to disposable respirators. In an earlier discussion of assigned protection factors, the Committee recommended that OSHA only permit the use of respirators that achieve a minimum assigned protection factor of ten. Since disposable respirators, in the Committee's opinion, could only achieve an assigned protection factor of five, their use should not be permitted. The Committee therefore recommended that paragraph (g)(9), which refers to disposable respirators, be deleted since it refers to a class of respirators which could not be used. However, after further discussion the recommendation for a minimum assigned protection factor of ten was withdrawn. Since it was this withdrawn provision that supported the Committee's recommendation to deleting any reference to disposable respirators, and disposable respirators as a class are still covered by the proposal, the provision covering their cleaning, sanitizing and disposal has not been deleted.

Paragraph (h) -- Maintenance and Care of Respirators

In the Maintenance and Care of Respirators section of the proposal, paragraph (h)(1) requires that respirators be cleaned and disinfected by following certain procedures. The Committee wanted to add the phrase "on paid time" in order to require that the cleaning not be required to be performed by employees on their own time. OSHA believes that this is not a respiratory protection issue but a labor relations issue that should be addressed by labor/management negotiation. Therefore, the suggested wording has not been added.

Paragraph (k) -- Training

The training section of the proposal requires that employers provide a training program for employees who are required to wear respirators. The Committee wanted to add language to paragraph (k)(1) to require employers to provide, conduct and document the effectiveness of the training program. The proposal already contains the requirement that employers provide a training program, which has always been interpreted by OSHA as requiring that the training be conducted. Documenting the effectiveness would mean that some sort of testing of employee capabilities to properly use respirators after training would have to be performed. OSHA currently evaluates training programs by other means such as by seeing how respirators are being used by employees on the job and by interviewing respirator users. OSHA does not regard the suggested additional requirements proposed by the Committee as necessary for enforcement of the standard and has therefore not included them.

Paragraph (m) -- Recordkeeping

The recordkeeping section of the proposal requires that employers maintain the medical evaluation record in accordance with 29 CFR 1910.20, the records access standard. The Committee wanted to add the phrase, "and make available", to this provision. Although already implied by the reference to the records access standard, the suggested language has been added to paragraph (m)(1)(iii) to require that employers maintain and make available this record in accordance with 29 CFR 1910.20.

The Committee further wanted to add a provision that all records required by this standard be retained for a period of 30 years. The records retention provisions of the records access standard already address this issue, and duplicating those requirements is felt by OSHA to be unnecessary.

Appendix B -- Recommended Practices

Appendix B of the proposal contains recommended practices for performing positive and negative pressure faceseal checks. Respirator wearers are required by paragraph (g)(10) to perform a faceseal check before entering the work area by following either the recommended faceseal check methods or by following the respirator manufacturer's recommended method. The Construction Advisory Committee wanted OSHA to add a new fit check method covering the use of isoamyl acetate or irritant smoke in an abbreviated fit check procedure. OSHA request comments on the use of isoamyl acetate or irritant smoke fit check procedures for daily faceseal tests and on appropriate procedures for performing such fit check testing using these test agents.

VIII. References

1. Pritchard, John A., A Guide to Industrial Respiratory Protection, HEW Publication No. (NIOSH) 76-189, June 1976.

2. Teresinski, Michael F. and Paul N. Cheremisino, Industrial Respiratory Protection, Ann Arbor Science Publishers; Ann Arbor, Michigan, 1983.

3. American National Standards Institute, Practices for Respiratory Protection, ANSI Z88.2-1969.

4. Occupational Safety and Health Administration, General Industry Standards, 29 CFR Part 1910, Construction Standards, 29 CFR Part 1926; and Maritime Standards, 29 CFR Parts 1915 through 1918.

5. Centaur Associates, Inc. Preliminary Regulatory Impact Analysis of Alternative Respiratory Protection Standards, 1984.

6. Schulte, Harry F. "Personal Protection Devices" in The Industrial Environment -- Its Evaluation and Control, U.S. Government Printing Office, Washington, D.C. 20402.

7. American National Standard Institute, Practices for Respiratory Protection, ANSI Z88.2-1980.

8. NIOSH/OSHA Respirator Decision Logic, in A Guide to Industrial Respiratory Protection, HEW Publication No. (NIOSH) 76-189, June 1976.

9. Occupational Safety and Health Administration, Management Information System Print-Out, 1983.

10. Canadian Standards Association, Selection, Care, and Use of Respirators, Z94.4-M1982, Ontario, Canada, 1982.

11. Luxon, Stuart G. "Harmonization of Respirator Standards in Europe", American Industrial Hygiene Association Journal, April 1973, pp. 143-149.

12. Ryan C. et. al. "Critical Review of International Standards for Respiratory Protective Equipment -- I. Respiratory Protective Equipment for Particulate-Laden Atmospheres," American Industrial Hygiene Association Journal, 44 (10): 756-761 (1983).

13. Breysse, P.N., et. al. "Critical Review of International Standards for Respiratory Protective Equipment -- II. Gas and Vapor Removal Efficiency and Fit Testing":, American Industrial Hygiene Association Journal, 44 (10): 762-767 (1983).

14. White, N. et. al. "Critical Review of International Standards for Respiratory Protective Equipment III. Practical Performance Tests", American Industrial Hygiene Association Journal, 44 (10): 768-773 (1983).

15. Department of the Army, the Air Force, and the Defense Logistics Agency. Respiratory Protection Program, TB MED 223/AFOSH STD 161-1/ OCAM 1000.2, Washington, DC, April 1977.

IX. Public Participation -- Notice of Hearing

Interested persons are invited to submit written data, views, and arguments on all issues with respect to this proposed standard. These comments must be postmarked on or before February 13, 1995. Comments are to submitted in quadruplicate or 1 original (hardcopy) and 1 disk (5 1/4 or 3 1/2) on WordPerfect 5.0, 5.1, 6.0 or ASCII. Note: any information not contained on disk, e.g., studies, articles, etc., must be submitted in quadruplicate to the Docket Office, Docket No. H-049, Room N2625, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210.

Writtent submissions must clearly identify the provisions of the proposal which are addressed and the position taken with respect to each issue.

All written comments, data, views, and arguments that are received within the specific comment period will be made a part of the record and will be available for public inspection and copying at the above Docket Office address.

Notice of Intention to Appear at the Informal Hearing

Pursuant to section 6(b)(3) of the Act, an opportunity to submit oral testimony concerning the issues raised by the proposed standard including economic and environmental impacts, will be provided at an informal public hearing to be held in Washington, DC from March 7 to March 24, 1995. If OSHA receives sufficient requests to participate in the hearing, the hearing period may be extended or shortened if there are few requests.

The hearing will commence at 9:30 a.m. on March 7, 1995, in the Auditorium, Frances Perkins Building, U.S. Department of Labor, 3rd Street and Constitution Avenue N.W., Washington, DC 20210.

All persons desiring to participate at the hearing must file in quadruplicate a notice of intention to appear, postmarked on or before January 27, 1995. The notice of intention to appear, which will be available for inspection and copying at the OSHA Technical Data Center Docket Office (Room N2625), telephone (202) 219-7894, must contain the following information:

1. The name, address, and telephone number of each person to appear;

2. The capacity in which the person will appear;

3. The approximate amount of time required for the presentation;

4. The issues that will be addressed;

5. A brief statement of the position that will be taken with respect to each issue; and

6. Whether the party intends to submit documentary evidence and, if so, a brief summary of it.

The notice of intention to appear shall be mailed to Mr. Thomas Hall, OSHA Division of Consumer Affairs, Docket H-049, Room N3649, U.S. Department of Labor, 200 Constitution Avenue N.W., Washington, DC 20210; telephone (202) 219-8617.

A notice of intention to appear also may be transmitted by facsimile to (202) 219-5986, by the same date, provided the original and 3 copies are sent to the same address and postmarked no more than 3 days later.

Filing of Testimony and Evidence Before the Hearing

Any party requesting more than ten (10) minutes for a presentation at the hearing, or who will submit documentary evidence, must provide in quadruplicate the complete text of the testimony, including any documentary evidence to be presented at the hearing. One copy shall not be stapled or bound and be suitable for copying. These materials must be provided to Mr. Thomas Hall, OSHA Division of Consumer Affairs at the address above and be postmarked no later than February 13, 1995.

Each such submission will be reviewed in light of the amount of time requested in the notice of intention to appear. In those instances where the information contained in the submission does not justify the amount of time requested, a more appropriate amount of time will be allocated and the participant will be notified of that fact prior to the informal public hearing.

Any party who has not substantially complied with this requirement may be limited to a ten-minute presentation, and may be requested to return for questioning at a later time.

Any party who has not filed a notice of intention to appear may be allowed to testify for no more than 10 minutes as time permits, at the discretion of the Administrative Law Judge, but will not be allowed to question witnesses.

Notice of intention to appear, testimony and evidence will be available for inspection and copying at the Docket Office at the address above.

Conduct and Nature of Hearing

The hearing will commence at 9:30 a.m. on the first day. At that time, any procedural matters relating to the proceeding will be resolved.

The nature of an informal rulemaking hearing is established in the legislative history of section 6 of the OSH Act and is reflected by OSHA's rules of procedure for hearings (29 CFR 1911.15(a)). Although the presiding officer is an Administrative Law Judge and limited questioning by persons who have filed notices of intention to appear is allowed on crucial issues, the proceeding is informal and legislative in type. The Agency's intent, in essence, is to provide interested persons with an opportunity to make effective oral presentations which can proceed expeditiously in the absence of procedural restraints which impede or protract the rulemaking process.

Additionally, since the hearing is primarily for information gathering and clarification, it is an informal administrative proceeding rather than an adjudicative one. The technical rules of evidence, for example do not apply. The regulations that govern hearings and the pre-hearing guidelines to be issued for this hearing will ensure fairness and due process and also facilitate the development of a clear, accurate and complete record. Those rules and guidelines will be interpreted in a manner that furthers that development. Thus, questions of relevance, procedure and participation generally will be decided so as to favor development of the record.

The hearing will be conducted in accordance with 29 CFR Part 1911. It should be noted that Sec. 1911.4 specifies the Assistant Secretary may upon reasonable notice issue alternative procedures to expedite proceedings or for other good cause.

The hearing will be presided over by an Administrative Law Judge who makes no decision or recommendation on the merits of OSHA's proposal. The responsibility of the Administrative Law Judge is to ensure that the hearing proceeds at a reasonable pace and in an orderly manner. The Administrative Law Judge, therefore, will have all the powers necessary and appropriate to conduct a full and fair informal hearing as provided in 29 CFR Part 1911 including the powers:

1. To regulate the course of the proceedings;

2. To dispose of procedural requests, objections and comparable matters;

3. To confine the presentations to the matters pertinent to the issues raised;

4. To regulate the conduct of those present at the hearing by appropriate means;

5. In the Judge's discretion, to question and permit the questioning of any witnesses and to limit the time for questioning; and

6. In the Judge's discretion, to keep the record open for a reasonable, stated time (known as the post-hearing comment period) to receive written information and additional data, views and arguments from any person who has participated in the oral proceedings.

OSHA recognizes that there may be interested persons or organizations who, through their knowledge of the subject matter or their experience in the field, would wish to endorse or support the whole proposal or certain provisions of the proposal. OSHA welcomes such supportive comments, including any pertinent data and cost information which may be available, in order that the record of this rulemaking will present a balanced picture of the public response on the issues involved.

X. Federalism

This Notice of Proposed Rulemaking has been reviewed in accordance with Executive Order 12612 (52 FR 41685, October 30, 1987), regarding Federalism. This Order requires that agencies, to the extent possible, refrain from limiting state policy options, consult with states prior to taking any actions which would restrict state policy options, and take such actions only when there is clear constitutional authority and the presence of a problem of national scope. The Order provides for preemption of state law only if there is a clear Congressional intent for the Agency to do so. Any such preemption is to be limited to the extent possible.

Section 18 of the Occupational Safety and Health Act (OSH Act) expresses Congress' clear intent to preempt state laws relating to issues on which Federal OSHA has promulgated occupational safety and health standards. Under the OSH Act, a state can avoid preemption only if it submits, and obtains Federal approval of, a plan for the development of such standards and their enforcement. Occupational safety and health standards developed by such Plan-States must, among other things, be at least as effective in providing safe and healthful employment and places of employment as the Federal standards. Where such standards are applicable to products distributed or used in interstate commerce, they may not unduly burden commerce and must be justified by compelling local conditions (see OSH Act, Section 18 C).

The proposed Federal standards on respiratory protection addresses hazards which are not unique to any one state or region of the country. Nonetheless, states with occupational safety and health plans approved under Section 18 of the OSH Act will be able to develop their own state standards to deal with any special problems which might be encountered in a particular state. Moreover, because this standard is written in general, performance-oriented terms, there is considerable flexibility for state plans to require, and for affected employers to use, methods of compliance which are appropriate to the working conditions covered by the standard.

In brief, this Notice of Proposed Rulemaking addresses a clear national problem related to occupational safety and health in general industry. Those states which have elected to participate under Section 18 of the OSH Act are not preempted by this standard, and will be able to address any special conditions within the framework of the Federal Act while ensuring that the state standards are at least as effective as that standard.

XI. State Plan Standards

The 25 states and territories with their own OSHA-approved occupational safety and health plans must adopt a comparable standard within six months of the publication dates of a final standard. These 25 states are: Alaska, Arizona, California, Connecticut, New York (for state and local government employees only), Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Until such time as a state standard is promulgated, Federal OSHA will provide interim enforcement assistance, as appropriate, in these states.

XII. List of Subjects in 29 CFR Parts 1910, 1915, and 1926

Health, Occupational safety and health, Reporting and recordkeeping requirements.

XIII. Authority and Signature

This document was prepared under the direction of Joseph A. Dear, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210.

Accordingly, pursuant to sections 4, 6(b), 8(c), and (8)g of the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657), Sec. 107, Contract Work Hours and Safety Standards Act (Construction Safety Act), (40 U.S.C. 333); Sec. 41, Longshoremen's and Harbor Worker's Compensation Act (33 U.S.C. 941); 29 CFR Part 1911 and Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033) as applicable, 29 CFR Part 1910 is proposed to be amended as set forth below. In addition, pursuant to section 4(b)(2) of the Act, OSHA has determined that this amended standard would be more effective than the corresponding standards now in Parts 1915 and 1926 of Title 29, Code of Federal Regulations. Therefore, these corresponding standards would be superseded by these changes.

Signed at Washington, DC, this 28th day of October, 1994.

Joseph A. Dear,

Assistant Secretary of Labor for Occupational Safety and Health.

XIV. Proposed Standard and Appendices

It is hereby proposed to amend Parts 1910, 1915, and 1926 of Title 29 of the Code of Federal Regulations as follows:

PARTS 1910, 1915, 1926 -- [AMENDED]

1. The authority citation for Subpart I of 29 CFR part 1910 is revised to read as follows:

Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as applicable. Section 1910.134 also issued under 29 CFR Part 1911.

PART 1915 -- [AMENDED]

2. The authority citation for 29 CFR part 1915 is revised to read as follows:

Authority: Sec. 41, Longshore and Harbor Workers' Compensation Act (33 U.S.C. 941); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as applicable. Section 1915.99 also issued under 5 U.S.C. 553. Section 1915.152 also issued under 29 CFR Part 1911.

PART 1926 -- [AMENDED]

3. The authority citation for Subpart E of 29 CFR part 1926 is revised to read as follows:

Authority: Sec. 107, Contract Work Hours and Safety Standards Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as applicable. Section 1916.103 also issued under 29 CFR Part 1911.

1910.134, 1915.152 and 1926.103 [Amended]

4. Parts 1910, subpart I; 1915, subpart I; and 1926, subpart E of Title 29 of the Code of Federal Regulations are amended by adding identical sections are Secs. 1910.134, 1915.152 and 1926.103 to read as follows:

****.*** Respiratory protection.

(a) Scope and application. (1) In the control of those occupational diseases caused by breathing air contaminated with harmful dusts, fogs, fumes, mists, gases, smokes, sprays, or vapors, the primary objective shall be to prevent atmospheric contamination. This shall be accomplished as far as feasible by accepted engineering control measures (for example, enclosure or confinement of the operation, general and local ventilation, and substitution of less toxic materials). When effective engineering controls are not feasible, or while they are being instituted, appropriate respirators shall be used pursuant to this section.

(2) Respirators shall be provided by the employer when such equipment is necessary to protect the health of the employee. The employer shall provide the respirators which are applicable and suitable for the purpose intended. The employer shall be responsible for the establishment and maintenance of a respiratory protective program which shall include the requirements outlined in paragraph (c) of this section.

(b) Definitions. Adequate warning properties means the detectable characteristics of a hazardous chemical including odor, taste, and/or irritation effects which are detectable and persistent at concentrations at or below the hazardous exposure level, and exposure at these low levels does not cause olfactory fatigue.

Air-purifying respirators means a respirator which is designed to remove air contaminants (i.e. dust, fumes, mists, gases, vapors, or aerosols) from the ambient air or air surrounding the respirator.

Assigned protection factor means the number assigned by NIOSH to indicate the capability of a respirator to afford a certain degree of protection in terms of fit and filter/cartridge penetration.

Assistant Secretary means the Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, or designee.

Atmosphere-supplying respirator means a respirator which supplies the wearer with air or oxygen from a source independent of the immediate ambient atmosphere. This includes air-supplied respirators and self-contained breathing apparatus (SCBA) units.

Canister or cartridge means the element of a gas and vapor or particulate air-purifying respirator which contains the sorbent, filter and/or catalyst which removes specific contaminants from air drawn through it.

Closed circuit respirator means a SCBA in which the air is rebreathed after exhaled carbon dioxide has been removed and the oxygen content restored by a compressed or liquid oxygen source or an oxygen generating solid.

Demand means a mode of operation for atmosphere-supplying respirators in which air flows into the respirator only when inhalation creates a lower pressure within the facepiece than the ambient atmospheric pressure.

Director means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designee.

Disposable respirator means a respiratory protective device which cannot be resupplied with an unused filter or cartridge and which is to be discarded in its entirety after its useful service life has been reached.

Filter means a media component used in respirators to remove solid and/or liquid particles from the inspired air.

Fit factor means an estimate of the ratio of the average concentration of a challenge agent in a test chamber to the average concentration inside the respirator as worn with a high-efficiency filter.

Hazardous chemical means a substance which meets the definitions for "health hazard" under the Hazard Communication Standard (29 CFR 1910.1200(c)).

Hazardous exposure level means:

(1) The permissible exposure limit (PEL) for the hazardous chemical in 29 CFR Part 1910, Subpart Z, of the General Industry Standards of the Occupational Safety and Health Administration (OSHA); or,

(2) If there is no PEL for the hazardous chemical, the Threshold Limit Values (TLV) recommended by the American Conference of Governmental Industrial Hygienists (ACGIH) in the latest edition of Threshold Limit Values for Chemical Substances and Physical Agents in the Work Environment: or,

(3) If there is no PEL or TLV for the hazardous chemical, the NIOSH Recommended Exposure Limit (REL); or,

(4) If there is no PEL, TLV, or REL for the hazardous chemical, an exposure level based on available scientific information including material safety data sheets.

Immediately dangerous to life or health or IDLH means an atmospheric concentration of any toxic, corrosive or asphyxiant substance that poses an immediate threat to life or would cause irreversible or delayed adverse health effects or would interfere with an individual's ability to escape from a dangerous atmosphere.

Maximum use concentration (MUC) means the maximum concentration of an air contaminant in which a particular respirator can be used, based on the respirator's assigned protection factor. The MUC cannot exceed the use limitations specified on the NIOSH approval label for the cartridge, canister, or filter. The MUC can be determined by multiplying the assigned protection factor for the respirator by the permissible exposure limit for the air contaminant for which the respirator will be used.

Negative pressure respirator means a respirator in which the air pressure inside the facepiece is positive during exhalation in relation to the outside air pressure and negative during inhalation in relation to the outside air pressure.

Oxygen deficient atmosphere means an atmosphere with an oxygen content of less than 19.5% by volume at altitudes of 8000 feet or below. (For altitudes above 8000 feet, see the oxygen deficient IDLH atmosphere definition.) Oxygen deficient IDLH atmosphere means an atmosphere with an oxygen content below 16% by volume at altitudes of 3000 feet or below, or below the oxygen levels specified in Table III for altitudes up to 8000 feet, or below 19.5% for altitudes above 8000 up to 14,000 feet.

Positive pressure respirator means an atmosphere-supplying respirator which is designed so that air pressure inside the facepiece is positive in relation to the outside air pressure during inhalation and exhalation.

Powered air-purifying respirator means an air-purifying respirator which uses a blower to deliver air through the air-purifying element to the wearer's breathing zone.

Pressure demand means a mode of operation for atmosphere-supplying respirators in which the air pressure inside the respirator is substantially maintained at a specific positive pressure differential with respect to the ambient air pressure. To maintain this pressure differential additional air is admitted on demand to the facepiece when the wearer inhales.

Qualitative fit test (QLFT) means an assessment of the adequacy of respirator fit by determining whether or not an individual wearing the respirator can detect the odor, taste, or irritation of a contaminant introduced into the vicinity of the wearer's head.

Quantitative fit test (QNFT) means an assessment of the adequacy of respirator fit by numerically measuring concentrations of a challenge agent inside and outside the facepiece. The ratio of the two measurements is an index of leakage of the seal between the respirator facepiece and the wearer's face.

Rebreather respirator. See closed circuit respirator. Respirator means any device worn by an individual and intended to provide the wearer with respiratory protection against inhalation of airborne contaminants or oxygen deficient air.

Self-contained breathing apparatus (SCBA) means an atmosphere-supplying respirator for which the source of air or oxygen is contained within the respirator independent of any other source.

Service life of a chemical or organic vapor cartridge or canister means the period of time it takes for a specified concentration of a specific substance to break through the cartridge or canister. This concentration is determined by the manufacturer for each type of cartridge or canister for particular substances.

Supplied air respirator means a respirator which receives breathing air through an air line or hose from a portable or stationary source of compressed air.

(c) Respiratory protection program -- (1) The employer in accordance with this section shall establish and implement a written respiratory protection program which shall ensure that the respirators are properly selected, fitted, used, and maintained as necessary to protect the health of employees. The program shall cover the following elements as applicable:

(i) Procedures for selecting respirators for use in the workplace;

(ii) Medical evaluations of employees required to wear respirators;

(iii) Use of respirators;

(iv) Fit testing procedures for air-purifying respirators and tight fitting positive pressure respirators;

(v) Procedures and schedules for cleaning, disinfecting, storing, inspecting, repairing, or otherwise maintaining respirators;

(vi) Procedures to ensure proper air quality, quantity and flow for atmosphere-supplying respirator;

(vii) Training of employees in the respiratory and health hazards of the hazardous chemicals to which they are potentially exposed as required under the Hazard Communication standard (29 CFR 1910.1200);

(viii) Training of employees to ensure the proper use and maintenance of the respirators; and, (iv) Procedures for periodically evaluating the effectiveness of the program.

(2) The employer shall designate a person qualified by appropriate training and/or experience to be responsible for the management and administration of the respiratory protection program and for conducting the required periodic evaluations of its effectiveness.

(3) The written respiratory protection program shall reflect current workplace conditions and respirator use.

(4) Employers shall, upon request, make the written respiratory protection program available to affected employees, their designated representatives, the Assistant Secretary, and the Director. A copy of the program shall be submitted to the Assistant Secretary and/or the Director, if requested.

(d) Selection of respirators -- (1) The employer shall provide respirators and respiratory equipment at no cost to employees.

(2) Where elastomeric facepiece respirators are to be used, the employer shall provide a selection of respirators from an assortment of at least three sizes for each type of facepiece and from at least two different manufacturers.

(3) In addition, the employer shall obtain and evaluate the following information for each work situation:

(i) The nature of the hazard;

(ii) The physical and chemical properties of the air contaminant;

(iii) The adverse health effects of the respiratory hazard;

(iv) The relevant hazardous exposure level;

(v) The results of workplace sampling of airborne concentrations of contaminants;

(vi) The nature of the work operation or process;

(vii) The period of time respiratory protection will be worn by employees during the work shift;

(viii) The work activities of the employees and the potential stress of these work conditions on employees wearing the respirators;

(ix) Fit test results;

(x) Warning properties of the hazardous chemical; and,

(xi) The physical characteristics, functional capabilities, and limitations of the various types of respirators.

(4) The employer shall select appropriate respirators from among those approved and certified by the National Institute for Occupational Safety and Health (NIOSH).

(5) The employer shall make types of respirators available for selection and shall assure that employees use respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, NW., Washington, DC 20210.

(6) [Reserved]

(7) The employer shall not allow use of any respirator where the maximum use concentration for an air contaminant exceeds the limitations specified on the NIOSH approval label for the cartridge, canister or filter for such respirators.

(8) Air-purifying respirators shall not be used for a hazardous chemical with poor or inadequate warning properties unless either:

(i) Their use is permitted under the provisions of a substance specific OSHA standard, or (ii) The odor or irritation threshold is not in excess of three times the hazardous exposure level and there is no associated ceiling limit.

(9) In addition, in order to use an air-purifying respirator for hazardous chemicals with poor or inadequate warning properties, at least one of the following conditions must be met:

(i) The respirator has an end of service life indicator approved by NIOSH for use with the specific chemical, or (ii) A change schedule has been implemented to assure that air- purifying cartridges, canisters and/or filters are replaced before 80% of their useful service life has expired, based upon documented service life data, airborne concentration of the chemical, and duration of exposure.

(10) Where an oxygen deficient atmosphere or an oxygen deficient IDLH atmosphere exists, appropriate respirators shall be selected as follows:

(i) Either an air-purifying respirator or atmosphere supplying respirator may be used where an atmosphere has a measured oxygen content of 19.5% by volume or greater at altitudes of 14,000 feet or below.

(ii) An atmosphere-supplying respirator shall be used for oxygen deficient atmospheres with a measured oxygen content level above that level defined as oxygen deficient IDLH but which is less than 19.5% by volume at altitudes of 8000 feet or below.

(iii) For oxygen deficient IDLH atmospheres with a measured oxygen content below 16% by volume at altitudes up to 3000 feet, or below the oxygen levels specified in Table III at altitudes up to 8000 feet, or below 19.5% at altitudes above 8000 feet up to 14,000 feet, or in atmospheres where the concentration of the hazardous chemical is unknown or in other IDLH atmospheres, either a full facepiece pressure demand SCBA or a combination full facepiece pressure demand supplied air respirator with auxiliary self-contained air supply shall be used.

Footnote(1) For altitudes above 8000 feet, an oxygen deficient IDLH atmosphere exists when the oxygen level falls below 19.5%.

(e) Medical evaluation -- (1) For each employee required to wear a respirator for more than five hours during any work week, the employer shall obtain from a licensed physician a written opinion which states whether the employee has any detected medical condition which would place the employee's health at increased risk of material impairment from respirator use and any recommended limitations upon the use of respirators. In requesting the written medical opinion, the employer shall provide the licensed physician with information concerning:

(i) The type of respiratory protection to be used;

(ii) The substances the employee will be exposed to;

(iii) Description of the work effort required;

(iv) Duration and frequency of usage;

(v) The type of work performed, including any special responsibilities that affect the safety of others such as fire fighting or rescue work;

(vi) Any special environmental conditions (such as heat or confined space entry); and,

(vii) Additional requirements for protective clothing and equipment.

(2) In the case of new employees, employers may accept an already existing medical examination or written opinion from a physician provided it was conducted within a year of the date of employment, covered the same type of respirator under similar use conditions, and meets the requirements of paragraph (e)(1).

(3) The employer shall have the employee's medical status reviewed by, or under the supervision of, a licensed physician annually and at any time the employee experiences unusual difficulty breathing while being fitted for or while using a respirator. The employer shall have the responsible licensed physician provide a written opinion resulting from the review as required under paragraph (e)(1).

(f) Fit testing -- (1) The employer shall ensure that the respirator selected fits the employee well enough to reduce employee exposures inside the mask to below the hazardous exposure level.

(2) The employer shall ensure that an employee is fit tested prior to initial use of the respirator, whenever a different make or size respirator is used, and annually thereafter.

(3) The employer shall fit test employees required to wear tight fitting air-purifying respirators and tight fitting atmosphere-supplying respirators. The fit test shall be administered using either an established qualitative or quantitative fit test procedure contained in section II of Appendix A or an alternative procedure which has been developed and approved which meets the Minimum Criteria as defined in section I of Appendix A.

(4) In order to use an alternative fit test procedure which meets the Minimum Criteria as defined in section I of Appendix A, the employer shall obtain advance approval from the Assistant Secretary. Once such a procedure is published by OSHA as an approved procedure in the Federal Register, any employer may use it without further approval.

(5) The employer shall present relevant data as required by Appendix A to demonstrate that any new method used provides results comparable to or better than one or more of the established methods contained in Appendix A for the type of test, i.e. qualitative or quantitative. The employer shall be permitted to use any method for which such data have already been submitted to and approved by the Assistant Secretary. (6) Fit testing protocols. (i) The employer shall use either qualitative or quantitative fit testing for tight fitting air-purifying respirators with quarter and half mask facepieces.

(A) Qualitative fit testing shall be performed in accordance with the established protocols specified in section II of Appendix A or new protocols that meet the minimum criteria contained in section I of Appendix A. If the respirator passes the qualitative test the employees may wear it in atmospheres no greater than ten times the hazardous exposure level.

(B) Quantitative fit testing shall be performed in accordance with an established protocol specified in section II of Appendix A or a protocol that meets the minimum criteria contained in section I of Appendix A. The test subject shall not be permitted to wear a half mask or quarter facepiece respirator unless a minimum fit factor of one hundred (100) is obtained in the test chamber. The respirator may not be worn in concentrations greater than ten (10) times the hazardous exposure level regardless of the measured fit factor in the chamber.

(ii) The employer shall use either qualitative or quantitative fit testing for tight fitting air-purifying respirators with full facepieces.

(A) Qualitative fit testing shall be performed in accordance with the established protocols specified in section II of Appendix A or new protocols that meet the minimum criteria contained in section I of Appendix A. If the respirator passes the qualitative fit test the employees may wear it in atmospheres no greater than ten (10) times the hazardous exposure level.

(B) Quantitative fit testing shall be performed in accordance with the established protocol specified in section II of Appendix A or a new protocol that meets the minimum criteria contained in section I of Appendix A. The test subject shall not be permitted to wear a full facepiece respirator unless a minimum fit factor of five hundred (500) is obtained in the test chamber. The full facepiece respirator may not be worn in concentrations greater than fifty (50) times the hazardous exposure level regardless of the measured fit factor in the chamber.

(iii) Fit testing of tight fitting atmosphere-supplying respirators and tight fitting powered air-purifying respirators.

(A) Tight fitting atmosphere-supplying respirators and tight fitting powered air-purifying respirators, i.e. half mask, quarter facepiece, and full facepiece, shall be fit tested using either qualitative or quantitative fit testing pursuant to paragraphs (f)(6)(i) (A) and (B).

(B) During the test only the facepiece shall be tested without any air-supplying equipment or attachments. This may be accomplished by testing a particular respirator facepiece make, model and size (which is available for use on atmosphere-supplying air units as well as on air-purifying respirators) which is equipped with appropriate air- purifying elements.

(1) Qualitative fit testing shall be performed in accordance with the established protocols specified in section II of Appendix A or a new protocol that meets the minimum criteria contained in section I of Appendix A. If the respirator wearer passes the fit test then the same respirator facepiece (i.e. make and model and size), which is available on a NIOSH approved atmosphere-supplying respirator shall be used by the employee. The respirator shall be used with an assigned protection factor as provided in paragraphs (d) (5) and (6) of this section.

(2) Quantitative fit testing shall be performed in accordance with the protocol specified in Appendix A or a protocol that meets the minimum criteria contained in Appendix A. A NIOSH approved atmosphere-supplying respirator with the same respirator facepiece (make, model, size) with which the employee passed the quantitative fit test shall be used. The respirator shall be used with an assigned protection factor as provided in paragraphs (d) (5) and (6) of this section.

(7) The employee shall be refitted as necessary, such as when visual observations are noted regarding an employee's condition which could affect respirator fit. Conditions to look for include facial scarring, cosmetic surgery, or an obvious change in body weight.

(8) The employee, once successfully fitted, shall be given the opportunity to wear the respirator for a period of two weeks. If the respirator becomes unacceptably uncomfortable at any time, the employee shall be given the opportunity to select a different respirator facepiece and be retested.

(9) Where an employer relies on an outside contractor/party to conduct quantitative fit testing and the contractor is not readily available, and where assigned protection factors greater than 10 are necessary, the employer may administer a qualitative fit test to enable the selection of a respirator provided that a quantitative fit is administered in accordance with Appendix A within thirty (30) days.

(g) Use of respirators -- (1) The employer shall develop and implement written standard operating procedures for the use of respirators which anticipate possible emergency as well as routine use of respirators based on the conditions in the workplace in which they are to be used.

(2) The employer shall develop and implement specific procedures for the use of respirators in atmospheres where oxygen deficiency or the concentrations of a hazardous chemical are unknown and/or potentially immediately dangerous to the life or health (IDLH) of the employees. These procedures shall include the following provisions:

(i) The employees shall wear positive pressure self-contained breathing apparatus (SCBA) or combination full facepiece pressure demand supplied air respirator with auxiliary self-contained air supply.

(ii) When an employee(s) wears a respirator in IDLH, unknown or potentially IDLH atmospheres where the employee(s) could be overcome if the respiratory protection fails, the employer shall ensure that at least one additional person located outside the IDLH atmosphere is in communication with the employee(s) in the IDLH atmosphere, and able to provide effective emergency assistance; and, (iii) Where employees enter IDLH atmospheres, the employer shall ensure that they are equipped with retrieval equipment for lifting or removing them from the hazardous area, or shall ensure that equivalent provisions for rescue have been made.

(iv) The emergency assistance personnel present shall be equipped with a positive pressure self-contained breathing apparatus.

(3) The employer shall not permit negative pressure, pressure demand or positive pressure respirators which depend for effective performance on a tight facepiece-to-face seal to be worn by employees with conditions that prevent such fits. Examples of these conditions include facial hair that interferes with the facepiece seal, absence of normally worn dentures, facial scars or headgear that projects under the facepiece seal.

(4) If an employee wears corrective glasses or goggles, the employer shall ensure that they are worn in such a manner that they do not interfere with the seal of the facepiece to the face of the wearer.

(5) The employer shall permit employees to leave the respirator use area to wash their faces and respirator facepieces as necessary to prevent skin irritation associated with respirator use.

(6) The employer shall permit employees to leave the respirator use area to change the filter elements or replace air-purifying respirators whenever they detect the warning properties of the contaminant.

(7) The employer shall permit employees to leave the respirator use area to change the filter elements of air-purifying respirators whenever they detect a change in breathing resistance or chemical vapor breakthrough.

(8) The employer shall ensure that respirators are immediately repaired, or discarded and replaced when they are no longer in proper original working condition.

(9) The employer shall ensure that disposable respirators which cannot be cleaned and sanitized are discarded at the end of the task or the work shift, whichever comes first. A disposable respirator which can be cleaned and sanitized shall be disposed of after its useful service life has been reached.

(10) The employer shall ensure that employees upon donning the respirator perform a facepiece seal check prior to entering the work area for all respirators on which such a check is possible to be performed. The recommended procedures in Appendix B or the respirator manufacturer's recommended procedures shall be used.

(11) The employer shall ensure that each self-contained breathing apparatus used in IDLH atmospheres, or for emergency entry or fire fighting, is certified for a minimum service life of thirty minutes. This requirement does not apply to combination supplied air respirators with auxiliary air supply or to emergency escape SCBAs.

(h) Maintenance and care of respirators -- (1) Cleaning and disinfecting. The employer shall ensure that respirators are cleaned and disinfected using the cleaning procedures recommended by the respirator manufacturer or cleaning procedures recommended in Appendix B at the following intervals.

(i) Routinely used respirators issued for the exclusive use of an employee shall be cleaned and disinfected after each day's use;

(ii) Routinely used respirators issued to more than one employee shall be cleaned and disinfected after each use; and, (iii) Respirators maintained for emergency use shall be cleaned and disinfected after each use.

(2) Storage. The employer shall store respirators as follows:

(i) All respirators shall be stored in a manner that protects them from damage, dust, sunlight, extreme temperatures, excessive moisture, or damaging chemicals;

(ii) Emergency respirators shall be kept accessible to the work area. In locations where weathering, contamination, or deterioration of the respirator could occur, respirators shall be stored in compartments built to protect them. Such compartments shall be clearly marked as containing emergency respirators and shall be used in accordance with any applicable manufacturer instructions;

(iii) Non-emergency respirators shall be stored in plastic bags or otherwise protected from contamination or damage; and, (iv) Respirators shall be packed or stored to prevent deformation of the facepiece or exhalation valve.

(3) Inspection. (i) The employer shall ensure that respirators are inspected as follows:

(A) All respirators used in non-emergency circumstances shall be inspected before each use and during cleaning after each use;

(B) All respirators maintained for emergency situations shall be inspected at least monthly, and checked for proper function before and after each use. Emergency escape respirators shall be inspected before being carried into the workplace; and, (C) Self-contained breathing apparatus shall be inspected monthly. Air and oxygen cylinders shall be maintained in a fully charged state and recharged when the pressure falls to 90% of the manufacturer's recommended pressure level. The employer shall determine that the regulator and warning devices function properly.

(ii) The employer shall ensure that the respirator inspections include the following:

(A) A check of respirator function, tightness of connections and the condition of the facepiece, headstraps, valves, connecting tube, and cartridges, canisters or filters; and, (B) A check of rubber or elastomer parts for pliability and signs of deterioration.

(iii) The employer shall certify in writing the inspection of respirators maintained for emergency use. Certification shall include the date the inspection was performed, the name (or signature) of the person that made the inspection, and a serial number or other means of identifying the inspected respirator. This certification may be in the form of a tag or label attached to the storage compartment for the respirator, or kept with the respirator, and shall be maintained until replaced by the certification of the next inspection.

(4) Repairs. The employer shall ensure that respirators which fail to pass inspection are removed from service and repaired or adjusted in accordance with the following:

(i) Repairs or adjustments to respirators are to be made only by persons appropriately trained to perform such operations, using parts designed for the respirator;

(ii) No repairs shall be performed that are outside the manufacturer's recommendations concerning the type and extent of repairs that can be performed; and

(iii) Reducing or admission valves or regulators shall be returned to the manufacturer or given to an appropriately trained technician for adjustment or repair.

(i) Supplied air quality and use -- (1) The employer shall ensure that compressed air, compressed oxygen, liquid air, and liquid oxygen used for respiration is of high purity, and in accordance with the following specifications: Compressed and liquid oxygen shall meet the requirements of the latest edition of the United States Pharmacopoeia for medical or breathing oxygen; and compressed breathing air shall at least meet the requirements of the specification for Grade D breathing air as described in ANSI/Compressed Gas Association Commodity Specification G-7.1-1989 (oxygen content (v/v) of 19.5-23.5% (atmospheric air); hydrocarbon (condensed) of 5 milligrams per cubic meter of air or less; carbon monoxide of 10 ppm or less, and carbon dioxide of 1,000 ppm or less).

(2) Compressed oxygen shall not be used in atmosphere-supplying respirators or in open circuit self-contained breathing apparatus that have previously used compressed air.

(3) Oxygen shall not be used with supplied air respirators.

(4) Breathing air to respirators shall be provided from cylinders or air compressors:

(i) Cylinders shall be tested and maintained as prescribed in the Shipping Container Specification Regulations of the Department of Transportation (49 CFR part 178);

(ii) Compressors shall be constructed and situated so as to avoid entry of contaminated air into the air-supply system and shall be equipped with suitable in-line air-purifying sorbent beds and filters to further assure breathing air quality, and to minimize moisture content so that the dew point at line pressure is 10 deg. C below the ambient temperature; and

(iii) The moisture content in compressed air cylinders shall not exceed 27 milliliters per cubic meter.

(5) The employer shall ensure that breathing air couplings are incompatible with outlets for non-respirable plant air or other gas systems to prevent inadvertent servicing of air line respirators with non-respirable gases or oxygen.

(6) The employer shall use breathing gas containers marked in accordance with the American National Standard Method of Marking Portable Compressed Gas Containers to Identify the Material Contained, Z48.1-1954 (R 1971); Federal Specification BB-A-1034a, June 21, 1968, Air, Compressed for Breathing Purposes; or Interim Federal Specification GG-13-00676b, September 23, 1976, Breathing Apparatus, Self-Contained.

(j) Identification of filters, cartridges, and canisters -- (1) The employer shall ensure that all filters, cartridges and canisters used in the workplace are properly labeled and color coded with the NIOSH approval label before they are placed in service.

(2) The employer shall ensure that the existing NIOSH approval label on a filter, cartridge, or canister is not removed, obscured or defaced while they are in service in the workplace.

(k) Training -- (1) The employer shall provide a training program for employees required by the employer to wear respirators which includes the following:

(i) Nature, extent, and effects of respiratory hazards to which the employee may be exposed as required under the Hazard Communication standard (29 CFR 1910.1200);

(ii) Explanation of the operation, limitations, and capabilities of the selected respirator(s);

(iii) Instruction in procedures for inspection, donning and removal, checking the fit and seals, and in the wearing of the respirator, including sufficient practice to enable the employee to become thoroughly familiar with, confident, and effective in performing these tasks;

(iv) Explanation of the procedures for maintenance and storage of the respirator;

(v) Instruction on how to deal with emergency situations involving the use of respirators or with respirator malfunctions; and

(vi) The contents of this section (29 CFR 1910.134), and of the written respiratory protection program, its location and availability.

(2) The employer shall provide the training prior to requiring the employee to wear a respirator in the workplace, and annually thereafter.

(l) Respiratory protection program evaluation -- (1) The employer shall review the respiratory protection program at least annually, and shall conduct frequent random inspections of the workplace to ensure that the provisions of the program are being properly implemented for all affected employees. The review of the program shall include an assessment of each element required under paragraph (c)(1) of this section.

(2) The employer shall periodically consult employees wearing respirators to assess wearer acceptance and attempt to correct any problems that are revealed during this assessment. Factors to be included in the assessment are whether the respirators being used are:

(i) Preventing the occurrence of illness;

(ii) Properly fitted;

(iii) Properly selected for the hazards encountered;

(iv) Being worn when necessary; and

(v) Being maintained properly.

(m) Recordkeeping and access torecords -- (1) Medical evaluation.

(i) The employer shall establish and maintain an accurate record for each employee subject to medical evaluation required by paragraph (e) of this section, in accordance with 29 CFR 1910.20, Access to Employee Exposure and Medical Records.

(ii) This record shall include:

(A) The name, social security number and description of the duties of the employee;

(B) The employer's copy of the physician's written opinion on the initial, periodic and special examinations, including results of medical examination and all tests, opinions and recommendations;

(C) A copy of the information provided to the physician as required by paragraph (e)(1) of this section.

(iii) The employer shall maintain and make available this record in accordance with 29 CFR 1910.20.

(2) Availability. (i) The employer shall assure that all records required to be maintained by this section shall be available or submitted upon request to the Assistant Secretary and the Director for examination and copying.

(ii) Employee medical records required by this paragraph shall be provided upon request for examination and copying to the subject employee, to anyone having the specific written consent of the subject employee, and to the Assistant Secretary and the Director in accordance with 29 CFR 1910.20.

(3) Transfer of records. (i) The employer shall comply with the requirements involving transfer of records set forth in 29 CFR 1910.20.

(ii) If the employer ceases to do business and there is no successor employer to receive and retain the records for the prescribed period, the employer shall notify the Director at least 90 days prior to disposal, and transmit them to the Director if requested by the Director within that period.

(n) Effective date. The standard in this section is effective [90 days after date of publication of the final rule in the Federal Register.

(o) Appendixes. The protocols in Appendix A on fit testing procedures are mandatory. The recommended practices in Appendix B and the medical evaluation procedures in Appendix C are nonmandatory.

Appendix A: Fit Testing Procedures (Mandatory)

I. New Fit Test Protocols

1. In order for a new fit test method to be used by an employer a description of the fit test method and validation testing data must be submitted to OSHA for evaluation.

2. OSHA will evaluate the method and data and if the method is found to conform to the validation criteria OSHA has established, OSHA will publish a proposed revision of 29 CFR 1910.134 under the section 6(b)(7) limited rulemaking provision of the Occupational Safety and Health Act of 1970 for public comment. OSHA will invite comments and make a final decision on the protocol after consideration of comments received on the proposal.

3. OSHA will publish a revised 29 CFR 1910.134 incorporating the new fit test method into Appendix A.

A. Minimum Criteria for a Valid Qualitative Fit Test

1. This section applies in addition to section II.A. of Appendix A where a test method and/or test agent not identified in section II.B. of Appendix A is to be used for testing the fit of a respirator. Fit tests which meet the criteria of this section may be used to verify the fit of respirators for use up to the assigned protection factors specified in the respirator selection table in paragraph (d) of this section.

2. Test Agents. (a) The test agent shall be relatively non, toxic. The concentrations generated during the test shall not exceed an OSHA permissible exposure limit, the ACGIH threshold limit value, or any known recommended exposure limit when there is no OSHA PEL or ACGIH TLV, and not create a health or physical hazard for the test subject or operator.

(b) It shall be demonstrated that the test agent used will penetrate deficiencies in the respirator facepiece to face sealing area.

(c) It shall be demonstrated that the test agent can elicit a subjective response in the test subject without fatiguing the response mechanism (i.e., smell, taste, or other relevant sensation) of the test subject.

(d) A reference concentration shall be established for the test agent. It shall be demonstrated that the test subject can detect by subjective means the test agent at the reference concentration prior to commencement of the test.

(e) A stable test agent concentration shall be established for purposes of challenging the fit of the respirator.

(f) Where a test enclosure is used, the concentration of test agent inside the test enclosure shall exceed the product of the reference concentration of the test agent, the assigned protection factor of the respirator being tested, and a safety factor of 10. For example, if the reference concentration is 1 ppm, and the respirator being tested is a half mask with an assigned protection factor of 10, then the minimum test agent concentration would be 100 ppm.

(g) Where gases/vapors are used as test agents to test air-purifying respirators, an appropriate cartridge/canister shall be utilized which affords a high degree of collection efficiency for the test agent.

(h) Precautions shall be taken to avoid allowing the test agent from the fit test area to contaminate the area where the test subjects are tested to determine their response to the threshold screening concentrations. Contamination of the area where the threshold screening test is administered by the test agent from the fit test area will render any tests unacceptable.

B. Validation Criteria for Qualitative Fit Tests

1. In order to establish a QLFT method/agent as being acceptable for an APF of 10, it shall be demonstrated that at the 95% confidence level 95% of the facepieces with a fit factor less than 100 as determined by an established QNFT method will be identified.

2. Means of establishing the 95% confidence level shall include the following procedures:

(a) The respirators used in the validation procedure shall be equipped so as to permit valid QNFT testing as specified in Appendix A of this section.

(b) The hoses on the test respirators shall be clamped shut and the new QLFT test administered. Immediately following the new QLFT method a QNFT shall be administered using the protocol established in section II.C. of Appendix A except that a strip chart recording of the test shall be made. The numbers of respirators, test subject size population, exercises sizes of respirators, and numbers of tests shall be sufficient to enable a determination to be made as to whether or not the 95% confidence level is attained in identifying whether 95% of facepieces with less than a fit factor or 100 will be identified by the new QLFT method.

C. Minimum Criteria for a Valid Particle Counting Quantitative Fit Test

1. This section applies in addition to sections II.A. and II.C.4.(j) of Appendix A where a test method and/or test agent not identified in section II.C. of Appendix A is to be used for testing the fit of a respirator. Fit tests which meet the criteria of this section may be used to verify the fit of respirators for use up to the assigned protection factors in paragraph (d) of this section.

2. Aerosol/Gas Generation.

(a) The aerosol/gas generator shall produce a stable test agent concentration (+/- 10%) throughout the test environment. The test agent concentration shall not vary as a function of time more than +/- 10 percent.

(b) The concentration of the aerosol/gas shall not exceed an OSHA permissible exposure limit, the ACGIH threshold limit value, or any known recommended exposure limit when there is no OSHA PEL or ACGIH TLV, and not create a health or physical hazard for the test subject or operator.

(c) Aerosols used to test respirators with high efficiency particulate air (HEPA) filters shall be polydisperse with a mass median aerodynamic diameter of 0.6 micrometers and a geometric standard deviation of 2. The test agent shall not be appreciably absorbed or retained in the lungs upon inhalation.

(d) A test agent detection system shall be able to reliably monitor the agent concentration in the test environment and inside the respirator during the breathing cycle.

(e) If it is desired to use a test agent aerosol larger than 0.6 micrometers in diameter to test respirators with other than high efficiency filters, it shall be demonstrated that the particle size is capable of penetrating deficiencies in the respirator facepiece to face sealing area, will be reliably detected by the measurement instruments, and that a significant portion will not be retained by the lungs upon inhalation.

D. Validation Criteria for Quantitative Fit Test Protocols

1. In determining the acceptability of a new method, its accuracy across the full range of measurement must be at least as great as the QNFT protocol established in section II.C. of Appendix A.

2. Means of establishing the accuracy across the full range of measurements shall include the following procedures:

(a) The respirators used in the validation procedure shall be probed and equipped with hoses as established in the QNFT procedures in Appendix A of this section.

(b) Validation of a proposed new QNFT shall be accomplished using instrumentation with sufficient accuracy and precision. Accuracy and precision of the validation instrumentation shall be considered by the Assistant Secretary in determining whether to approve a proposed new protocol.

(c) The numbers of respirators, test subject size population, exercises sizes of respirators, and numbers of tests shall be sufficient to enable a determination to be made as to whether or not the 95% confidence level is attained with respect to agreement between the two methods.

E. Minimum Criteria for New Technology

1. Test methods/equipment shall not alter the design, balance, integrity, manner of respirator fitting, nor distort the respirator in a manner which would result in the test respirator having different characteristics than under normal use.

2. Equipment measuring: respirator efficiency; test agent penetration; protection factors; or fit factors must be capable of reliably detecting and measuring the test agent, protection factor or fit factor with a high degree of accuracy. The limitations of detection and test sensitivity must be known.

3. Test respirators must be donned and adjusted in the same manner in which it will be used in the workplace.

4. It must be demonstrated that the new technology used will produce reliable and reproducible results.

5. There shall be a sufficient safety factor applied to account for variations in the use of the respirator and reproducibility of test results.

6. Where test agents, aerosol or gases/vapors are used in a test environment the following shall apply:

(a) The test agent concentration must be maintained below an established PEL, ACGIH TLV, or recommended exposure level and not create a health hazard or physical hazard for the test subject or associated personnel.

(b) For particulate test agents:

-- The particle size must be uniform, the concentration stable. -- Particles must be able to penetrate deficiencies in the respirator to face seal, but not be retained by the airways of respiratory tract, (c) Filters, cartridges used on the test respirator must be capable of removing 99.97% of the test agent (i.e. large particles collected on dust filters, small particles collected on high efficiency filters).

(d) Detection system for test agents must be capable of detecting the concentration of test agent inside the respirator during the entire breathing cycle.

F. Validation for New Technological Methods of Determining Respirator Fit

1. In determining the acceptability of a new method, its accuracy across the full range of measurement must be at least as great as that of the QNFT protocol established in section II.C. of Appendix A.

2. Means of establishing the accuracy across the full range of measurements shall include the following:

(a) For particle counting methods, the respirators used in the validation procedure shall be probed and equipped with hoses as established in the QNFT procedures in Appendix A of this section.

(b) For any method, the new test method shall be administered first. Immediately following the new method, a QNFT shall be administered using the protocol established in section II of Appendix A except that a strip chart recording of the test shall be made. The numbers of respirators, test subject size population, exercises sizes of respirators, and numbers of tests shall be sufficient to enable a determination to be made as to whether or not the 95% confidence level is attained with respect to agreement between the two methods.

II. Current Fit Test Protocols

A. The employer shall include the following provisions in the fit test procedures. These provisions apply to both QLFT and QNFT.

1. The test subject shall be allowed to pick the most comfortable respirator from a selection including respirators of various sizes from different manufacturers.

2. Prior to the selection process, the test subject shall be shown how to put on a respirator, how it should be positioned on the face, how to get strap tension and how to determine a comfortable fit. A mirror shall be available to assist the subject in evaluating the fit and positioning the respirator. This instruction may not constitute the subject's formal training on respirator use, as it is only a review.

3. The test subject shall be informed that he/she is being asked to select the respirator which provides the most comfortable fit. Each respirator represents a different size and shape, and if fitted and used properly, will provide adequate protection.

4. The test subject shall be instructed to hold each facepiece up to the face and eliminate those which obviously do not give a comfortable fit.

5. The more comfortable facepieces are noted; the most comfortable mask is donned and worn at least five minutes to assess comfort. Assistance in assessing comfort can be given by discussing the points in item II A.6. of this appendix. If the test subject is not familiar with using a particular respirator, the test subject shall be directed to don the mask several times and to adjust the straps each time to become adept at setting proper tension on the straps.

6. Assessment of comfort shall include reviewing the following points with the test subject and allowing the test subject adequate time to determine the comfort of the respirator: (a) Position of the mask on the nose (b) Room for eye protection (c) Room to talk (d) Position of mask on face and cheeks 7. The following criteria shall be used to help determine the adequacy of the respirator fit:

(a) Chin properly placed;

(b) Adequate strap tension, not overly tightened;

(c) Fit across nose bridge;

(d) Respirator of proper size to span distance from nose to chin;

(e) Tendency of respirator to slip;

(f) Self-observation in mirror to evaluate fit and respirator position.

8. The test subject shall conduct the negative and positive pressure fit checks as described in Appendix B or ANSI Z88.2-1980. Before conducting the negative or positive pressure test, the subject shall be told to seat the mask on the face by moving the head from side-to-side and up and down slowly while taking in a few slow deep breaths. Another facepiece shall be selected and retested if the test subject fails the fit check tests.

9. The test shall not be conducted if there is any hair growth between the skin and the facepiece sealing surface, such as stubble beard growth, beard, or long sideburns which cross the respirator sealing surface. Any type of apparel which interferes with a satisfactory fit shall be altered or removed.

10. If a test subject exhibits difficulty in breathing during the tests, she or he shall be referred to a physician to determine whether the test subject can wear a respirator while performing her or his duties.

11. If at any time within the first two weeks of use the respirator becomes uncomfortable, the test subject shall be given the opportunity to select a different facepiece and to be retested.

12. The employer shall maintain a record of the fit test administered to an employee. The record shall contain at least the following information:

(a) Name of employee;

(b) Type of respirator;

(c) Brand, size of respirator;

(d) Date of test;

(e) Where QNFT is used: the fit factor, strip chart recording or other recording of the results of the test. The record shall be maintained until the next fit test is administered.

13. Exercise regimen. Prior to the commencement of the fit test, the test subject shall be given a description of the fit test and the test subject's responsibilities during the test procedure. The description of the process shall include a description of the test exercises that the subject will be performing. The respirator to be tested shall be worn for at least 5 minutes before the start of the fit test.

14. Test Exercises. The test subject shall perform exercises, in the test environment, in the manner described below;

(a) Normal breathing. In a normal standing position, without talking, the subject shall breathe normally.

(b) Deep breathing. In a normal standing position, the subject shall breathe slowly and deeply, taking caution so as to not hyperventilate.

(c) Turning head side to side. Standing in place, the subject shall slowly turn his/her head from side to side between the extreme positions on each side. The head shall be held at each extreme momentarily so the subject can inhale at each side.

(d) Moving head up and down. Standing in place, the subject shall slowly move his/her head up and down. The subject shall be instructed to inhale in the up position (i.e., when looking toward the ceiling).

(e) Talking. The subject shall talk out loud slowly and loud enough so as to be heard clearly by the test conductor. The subject can read from a prepared text such as the Rainbow Passage, count backward from 100, or recite a memorized poem or song.

(f) Grimace. The test subject shall grimace by smiling or frowning.

(g) Bending over. The test subject shall bend at the waist as if he/she were to touch his/her toes. Jogging in place shall be substituted for this exercise in those test environments such as shroud type QNFT units which prohibit bending at the waist.

(h) Normal breathing. Same as exercise 1. Each test exercise shall be performed for one minute except for the grimace exercise which shall be performed for 15 seconds.

The test subject shall be questioned by the test conductor regarding the comfort of the respirator upon completion of the protocol. If it has become uncomfortable, another model of respirator shall be tried.

B. Qualitative Fit Test (QLFT) Protocols.

1. General

(a) The employer shall assign specific individuals who shall assume full responsibility for implementing the respirator qualitative fit test program.

(b) The employer shall ensure that persons administering QLFT are able to prepare test solutions, calibrate equipment and perform tests properly, recognize invalid tests, and assure that test equipment is in proper working order.

(c) The employer shall assure that QLFT equipment is kept clean and well maintained so as to operate at the parameters for which it was designed.

2. Isoamyl Acetate Protocol

(a) Odor threshold screening. The odor threshold screening test, performed without wearing a respirator, is intended to determine if the individual tested can detect the odor of isoamyl acetate.

(1) Three 1 liter glass jars with metal lids are required.

(2) Odor free water (e.g. distilled or spring water) at approximately 25 degrees C shall be used for the solutions.

(3) The isoamyl acetate (IAA) (also known as isopentyl acetate) stock solution is prepared by adding 1 cc of pure IAA to 800 cc of odor free water in a 1 liter jar and shaking for 30 seconds. A new solution shall be prepared at least weekly.

(4) The screening test shall be conducted in a room separate from the room used for actual fit testing. The two rooms shall be well ventilated but shall not be connected to the same recirculating ventilation system.

(5) The odor test solution is prepared in a second jar by placing 0.4 cc of the stock solution into 500 cc of odor free water using a clean dropper or pipette. The solution shall be shaken for 30 seconds and allowed to stand for two to three minutes so that the IAA concentration above the liquid may reach equilibrium. This solution shall be used for only one day.

(6) A test blank shall be prepared in a third jar by adding 500 cc of odor free water.

(7) The odor test and test blank jars shall be labeled 1 and 2 for jar identification. Labels shall be placed on the lids so they can be periodically peeled, dried off and switched to maintain the integrity of the test.

(8) The following instruction shall be typed on a card and placed on the table in front of the two test jars (i.e., 1 and 2): "The purpose of this test is to determine if you can smell banana oil at a low concentration. The two bottles in front of you contain water. One of these bottles also contains a small amount of banana oil. Be sure the covers are on tight, then shake each bottle for two seconds. Unscrew the lid of each bottle, one at a time, and sniff at the mouth of the bottle. Indicate to the test conductor which bottle contains banana oil."

(9) The mixtures used in the IAA odor detection test shall be prepared in an area separate from where the test is performed, in order to prevent olfactory fatigue in the subject.

(10) If the test subject is unable to correctly identify the jar containing the odor test solution, the IAA qualitative fit test shall not be performed.

(11) If the test subject correctly identifies the jar containing the odor test solution, the test subject may proceed to respirator selection and fit testing.

(b) Isoamyl acetate fit test.

(1) The fit test chamber shall be similar to a clear 55-gallon drum liner suspended inverted over a 2-foot diameter frame so that the top of the chamber is about 6 inches above the test subject's head. The inside top center of the chamber shall have a small hook attached.

(2) Each respirator used for the fitting and fit testing shall be equipped with organic vapor cartridges or offer protection against organic vapors. The cartridges or masks shall be changed at least weekly.

(3) After selecting, donning, and properly adjusting a respirator, the test subject shall wear it to the fit testing room. This room shall be separate from the room used for odor threshold screening and respirator selection, and shall be well ventilated, as by an exhaust fan or lab hood, to prevent general room contamination.

(4) A copy of the test exercises and any prepared text from which the subject is to read shall be taped to the inside of the test chamber.

(5) Upon entering the test chamber, the test subject shall be given a 6-inch by 5-inch piece of paper towel, or other porous, absorbent, single-ply material, folded in half and wetted with 0.75 cc of pure IAA. The test subject shall hang the wet towel on the hook at the top of the chamber.

(6) Allow two minutes for the IAA test concentration to stabilize before starting the fit test exercises. This would be an appropriate time to talk with the test subject; to explain the fit test, the importance of his/her cooperation, and the purpose for the head exercises; or to demonstrate some of the exercises.

(7) If at any time during the test, the subject detects the banana like odor of IAA, the test has failed. The subject shall quickly exit from the test chamber and leave the test area to avoid olfactory fatigue.

(8) If the test has failed, the subject shall return to the selection room and remove the respirator, repeat the odor sensitivity test, select and put on another respirator, return to the test chamber and again begin the procedure described in B.2.(b) (1) through (7) of this appendix. The process continues until a respirator that fits well has been found. Should the odor sensitivity test be failed, the subject shall wait about 5 minutes before retesting. Odor sensitivity will usually have returned by this time.

(9) When a respirator is found that passes the test, its efficiency shall be demonstrated for the subject by having the subject break the face seal and take a breath before exiting the chamber.

(10) When the test subject leaves the chamber, the subject shall remove the saturated towel and return it to the person conducting the test. To keep the test area from becoming contaminated, the used towels shall be kept in a self sealing bag so there is no significant IAA concentration build-up in the test chamber during subsequent tests.

3. Saccharin Solution Aerosol Protocol

The saccharin solution aerosol QLFT protocol is the only currently available, validated test protocol for use with particulate disposable dust respirators not equipped with high-efficiency filters. The entire screening and testing procedure shall be explained to the test subject prior to the conduct of the screening test.

(a) Taste threshold screening. The saccharin taste threshold screening, performed without wearing a respirator, is intended to determine whether the individual being tested can detect the taste of saccharin.

(1) During threshold screening as well as during fit testing, subjects shall wear an enclosure about the head and shoulders that is approximately 12 inches in diameter by 14 inches tall with at least the front portion clear and that allows free movements of the head when a respirator is worn. An enclosure substantially similar to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is adequate.

(2) The test enclosure shall have a 3/4-inch hole in front of the test subject's nose and mouth area to accommodate the nebulizer nozzle.

(3) The test subject shall don the test enclosure. Throughout the threshold screening test, the test subject shall breathe through his/her wide open mouth with tongue extended.

(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer the test conductor shall spray the Threshold check solution into the enclosure. This Nebulizer shall be clearly marked to distinguish it from the fit test solution nebulizer.

(5) The threshold check solution consists of 0.83 grams of sodium saccharin USP in 1 cc of warm water. It can be prepared by putting 1 cc of the fit test solution (see (b)(5) below) in 100 cc of distilled water.

(6) To produce the aerosol, the nebulizer bulb is firmly squeezed so that it collapses completely, then released and allowed to fully expand.

(7) Ten squeezes are repeated rapidly and then the test subject is asked whether the saccharin can be tasted.

(8) If the first response is negative, ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

(9) If the second response is negative, ten more squeezes are repeated rapidly and the test subject is again asked whether the saccharin is tasted.

(10) The test conductor will take note of the number of squeezes required to solicit a taste response.

(11) If the saccharin is not tasted after 30 squeezes (step 10), the test subject may not perform the saccharin fit test.

(12) If a taste response is elicited, the test subject shall be asked to take note of the taste for reference in the fit test.

(13) Correct use of the nebulizer means that approximately 1 cc of liquid is used at a time in the nebulizer body.

(14) The nebulizer shall be thoroughly rinsed in water, shaken dry, and refilled at least each morning and afternoon or at least every four hours.

(b) Saccharin solution aerosol fit test procedure.

(1) The test subject may not eat, drink (except plain water), or chew gum for 15 minutes before the test.

(2) The fit test uses the same enclosure described in (a) above.

(3) The test subject shall don the enclosure while wearing the respirator selected in section B.3.(a) of this appendix. The respirator shall be properly adjusted and equipped with a particulate filter(s).

(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer is used to spray the fit test solution into the enclosure. This nebulizer shall be clearly marked to distinguish it from the screening test solution nebulizer.

(5) The fit test solution is prepared by adding 83 grams of sodium saccharin to 100 cc of warm water.

(6) As before, the test subject shall breathe through the wide open mouth with tongue extended.

(7) The nebulizer is inserted into the hole in the front of the enclosure and the fit test solution is sprayed into the enclosure using the same number of squeezes required to elicit a taste response in the screening test.

(8) After generating the aerosol the test subject shall be instructed to perform the exercises in section VII. A. 14 of this appendix.

(9) Every 30 seconds the aerosol concentration shall be replenished using one half the number of squeezes as initially.

(10) The test subject shall indicate to the test conductor if at any time during the fit test the taste of saccharin is detected.

(11) If the taste of saccharin is detected, the fit is deemed unsatisfactory and a different respirator shall be tried.

4. Irritant Fume Protocol

(a) The respirator to be tested shall be equipped with high-efficiency particulate air (HEPA) filters.

(b) The test subject shall be allowed to smell a weak concentration of the irritant smoke before the respirator is donned to become familiar with its characteristic odor.

(c) Break both ends of a ventilation smoke tube containing stannic oxychloride, such as the MSA part No. 5645, or equivalent. Attach one end of the smoke tube to a low flow air pump set to deliver 200 milliliters per minute.

(d) Advise the test subject that the smoke can be irritating to the eyes and instruct the subject to keep his/her eyes closed while the test is performed.

(e) The test conductor shall direct the stream of irritant smoke from the smoke tube towards the face seal area of the test subject. He/She shall begin at least 12 inches from the facepiece and gradually move to within one inch, moving around the whole perimeter of the mask.

(f) The exercises identified in section VII. A. 14 above shall be performed by the test subject while the respirator seal is being challenged by the smoke.

(g) Each test subject passing the smoke test without evidence of a response shall be given a sensitivity check of the smoke from the same tube once the respirator has been removed to determine whether he/she reacts to the smoke. Failure to evoke a response shall void the fit test.

(h) The fit test shall be performed in a location with exhaust ventilation sufficient to prevent general contamination of the testing area by the test agent.

C. Quantitative Fit Test (QNFT) Protocol.

1. General

(a) The employer shall assign specific individuals who shall assume full responsibility for implementing the respirator quantitative fit test program.

(b) The employer shall ensure that persons administering QNFT are able to calibrate equipment and perform tests properly, recognize invalid tests, calculate fit factors properly and assure that test equipment is in proper working order.

(c) The employer shall assure that QNFT equipment is kept clean and well maintained so as to operate at the parameters for which it was designed.

2. Definitions

(a) Quantitative fit test. The test is performed in a test chamber. The normal air-purifying element of the respirator is replaced by a high-efficiency particulate air (HEPA) filter in the case of particulate QNFT aerosols or a sorbent offering contaminant penetration protection equivalent to high-efficiency filters where the QNFT test agent is a gas or vapor.

(b) Challenge agent means the aerosol, gas or vapor introduced into a test chamber so that its concentration inside and outside the respirator may be measured.

(c) Test subject means the person wearing the respirator for quantitative fit testing.

(d) Normal standing position means standing erect and straight with arms down along the sides and looking straight ahead.

(e) Maximum peak penetration method means the method of determining test agent penetration in the respirator as determined by strip chart recordings of the test. The highest peak penetration for a given exercise is taken to be representative of average penetration into the respirator for that exercise.

(f) Average peak penetration method means the method of determining test agent penetration into the respirator utilizing a strip chart recorder, integrator, or computer. The agent penetration is determined by an average of the peak heights on the graph or by computer integration for each exercise except the grimace exercise. Integrators or computers which calculate the actual test agent penetration into the respirator for each exercise will also be considered to meet the requirements of the average peak penetration method.

3. Apparatus

(a) Instrumentation. Aerosol generation, dilution, and measurement systems using corn oil or sodium chloride as test aerosols shall be used for quantitative fit testing except as provided for by Section I of this Appendix.

(b) Test chamber. The test chamber shall be large enough to permit all test subjects to perform freely all required exercises without disturbing the challenge agent concentration or the measurement apparatus. The test chamber shall be equipped and constructed so that the challenge agent is effectively isolated from the ambient air, yet uniform in concentration throughout the chamber.

(c) When testing air-purifying respirators, the normal filter or cartridge element shall be replaced with a high-efficiency particulate filter supplied by the same manufacturer.

(d) The sampling instrument shall be selected so that a strip chart record may be made of the test showing the rise and fall of the challenge agent concentration with each inspiration and expiration at fit factors of at least 2,000. Integrators or computers which integrate the amount of test agent penetration leakage into the respirator for each exercise may be used provided a record of the readings is made.

(e) The combination of substitute air-purifying elements, challenge agent and challenge agent concentration in the test chamber shall be such that the test subject is not exposed in excess of an established exposure limit for the challenge agent at any time during the testing process.

(f) The sampling port on the test specimen respirator shall be placed and constructed so that no leakage occurs around the port (e.g. where the respirator is probed), a free air flow is allowed into the sampling line at all times and so that there is no interference with the fit or performance of the respirator.

(g) The test chamber and test set up shall permit the person administering the test to observe the test subject inside the chamber during the test.

(h) The equipment generating the challenge atmosphere shall maintain the concentration of challenge agent inside the test chamber constant to within a 10 percent variation for the duration of the test.

(i) The time lag (interval between an event and the recording of the event on the strip chart or computer or integrator) shall be kept to a minimum. There shall be a clear association between the occurrence of an event inside the test chamber and its being recorded.

(j) The sampling line tubing for the test chamber atmosphere and for the respirator sampling port shall be of equal diameter and of the same material. The length of the two lines shall be equal.

(k) The exhaust flow from the test chamber shall pass through a high-efficiency filter before release.

(l) When sodium chloride aerosol is used, the relative humidity inside the test chamber shall not exceed 50 percent.

(m) The limitations of instrument detection shall be taken into account when determining the fit factor.

(n) Test respirators shall be maintained in proper working order and inspected for deficiencies such as cracks, missing valves and gaskets, etc.

4. Procedural Requirements

(a) When performing the initial positive or negative pressure test the sampling line shall be crimped closed in order to avoid air pressure leakage during either of these tests.

(b) An abbreviated screening isoamyl acetate test or irritant fume test may be utilized in order to quickly identify poor fitting respirators which passed the positive and/or negative pressure test and thus reduce the amount of QNFT time. When performing a screening isoamyl acetate test, combination high-efficiency organic vapor cartridges/canisters shall be used.

(c) A reasonably stable challenge agent concentration shall be measured in the test chamber prior to testing. For canopy or shower curtain type of test units the determination of the challenge agent stability may be established after the test subject has entered the test environment.

(d) Immediately after the subject enters the test chamber, the challenge agent concentration inside the respirator shall be measured to ensure that the peak penetration does not exceed 5 percent for a half mask or 1 percent for a full facepiece respirator.

(e) A stable challenge concentration shall be obtained prior to the actual start of testing.

(f) Respirator restraining straps shall not be overtightened for testing. The straps shall be adjusted by the wearer without assistance from other persons to give a reasonable comfortable fit typical of normal use.

(g) The test shall be terminated whenever any single peak penetration exceeds 5 percent for half masks and 1 percent for full facepiece respirators. The test subject shall be refitted and retested. If two of the three required tests are terminated, the fit shall be deemed inadequate.

(h) In order to successfully complete a QNFT, three successful fit tests are required. The results of each of the three independent fit tests must exceed the minimum fit factor needed for the class of respirator (e.g. quarter facepiece respirator, half mask respirator, full facepiece respirator) as specified in paragraph (f) of this section.

(i) Calculation of fit factors.

(1) The fit factor shall be determined for the quantitative fit test by taking the ratio of the average chamber concentration to the concentration measured inside the respirator for each test exercise except the grimace exercise.

(2) The average test chamber concentration is the arithmetic average of the test chamber concentration at the beginning and of the end of the test.

(3) The concentration of the challenge agent inside the respirator shall be determined by one of the following methods:

(i) Average peak concentration

(ii) Maximum peak concentration

(iii) Integration by calculation of the area under the individual peak for each exercise except the grimace exercise. This includes computerized integration.

(j) Interpretation of test results. The fit factor established by the quantitative fit testing shall be the lowest of the three fit factor values calculated from the three required fit tests.

(k) The test subject shall not be permitted to wear a half mask or quarter facepiece respirator unless a minimum fit factor of 100 is obtained, or a full facepiece respirator unless a minimum fit factor of 500 is obtained.

(l) Filters used for quantitative fit testing shall be replaced at least weekly or whenever increased breathing resistance is encountered, or when the test agent has altered the integrity of the filter media. Organic vapor cartridges/canisters shall be replaced daily (when used) or sooner if there is any indication of breakthrough by a test agent.

Appendix B: Recommended Practices (Nonmandatory)

I. Facepiece Seal Checks

A. Positive Pressure Check

Close off the exhalation valve and exhale gently into the facepiece. The face fit is considered satisfactory if a slight positive pressure can be built up inside the facepiece without any evidence of outward leakage of air at the seal. For most respirators this method of leak testing requires the wearer to first remove the exhalation valve cover before closing off the exhalation valve and then carefully replacing it after the test.

B. Negative Pressure Check

Close off the inlet opening of the canister or cartridge(s) by covering with the palm of the hand(s) or by replacing the filter seal(s), inhale gently so that the facepiece collapses slightly, and hold the breath for ten seconds. If the facepiece remains in its slightly collapsed condition and no inward leakage of air is detected, the tightness of the respirator is considered satisfactory.

II. Recommended Procedures for Cleaning Respirators

A. Remove filters, cartridges, or canisters. Disassemble facepieces by removing speaking diaphragms, demand and pressure-demand valve assemblies, hoses, or any components recommended by the manufacturer. Discard or repair any defective parts.

B. Wash components in 50 deg. C water with a mild detergent or with a cleaner recommended by the manufacturer. A stiff bristle (not wire) brush may be used to facilitate the removal of dirt.

C. Rinse components thoroughly in clean, warm (50 deg. C maximum), preferably running water. Drain.

D. When the cleaner used does not contain a disinfecting agent, respirator components should be immersed for two minutes in one of the following:

1. Hypochlorite solution (50 ppm of chlorine) made by adding approximately one milliliter of laundry bleach to one liter of water at 50 deg. C; or, 2. Aqueous solution of iodine (50 ppm iodine) made by adding approximately 0.8 milliliters of tincture of iodine (6-8 grams ammonium and/or potassium iodine/100 cc of 45% alcohol) to one liter of water at 50 deg. C; or, 3. Other commercially available cleansers of equivalent disinfectant quality when used as directed, unless their use is recommended against by the respirator manufacturer.

E. Rinse components thoroughly in clean, warm (50 deg. C maximum), preferably running water. Drain. The importance of thorough rinsing cannot be overemphasized. Detergents or disinfectants that dry on facepieces may result in dermatitis. In addition, some disinfectants may cause deterioration of rubber or corrosion of metal parts if not completely removed.

F. Components should be hand-dried with a clean lint-free cloth or air-dried.

G. Reassemble facepiece, replacing filters, cartridges, and canisters where necessary.

H. Test the respirator to ensure that all components work properly.

Appendix C: Medical Evaluation Procedures (Nonmandatory)

This appendix contains recommended elements that should be taken into account during the performance of the required medical evaluation for respirator use. These elements should be evaluated in taking the medical history and performing the medical examination. However, the specific nature of the medical evaluation and the extent of testing performed is left for the responsible physician to determine. This recommended list of elements to be covered is not meant to limit the physician to the testing procedures recommended, since the examining physician is free to perform additional tests if necessary to determine an individual's ability to wear a respirator. This appendix is informational and is not intended, by itself, to create any additional obligations not otherwise imposed or to detract from any existing obligations.

(A) The medical history should include:

(1) Previously diagnosed diseases, particularly stressing known cardiovascular or respiratory diseases;

(2) Problems associated with breathing during normal work activities;

(3) Past problems with respirator use;

(4) Past and current usage of medication;

(5) Any known physical conditions which may interfere with respirator use;

(6) Previous occupations; and,

(7) Use of medications whose side effects might impact upon cardiopulmonary fitness.

(B) The medical examination should assess:

(1) Hearing ability (should be sufficient to assure communication and response to instructions and alarm systems);

(2) Pulmonary function testing including spirometry for FEV(1) and FVC(*) (presence and degree of restrictive or obstructive disease or perfusion disorders);

___________

Footnote(*) In interpreting spirometry, if the FVC is less than 80 percent or the FEV(1) is less than 70 percent, restriction from respirator use should be considered.

(3) Cardiovascular system (evidence of symptomatic coronary artery disease, significant arrhythmias; occurrence of frequent premature ventricular contractions (PVC's) with elevated pulse rates or uncontrolled hypertension symptoms;

(4) Endocrine system (conditions which may result in sudden loss of consciousness or response capability);

(5) Neurological system (inability to perform coordinated movements and conditions affecting response and consciousness);

(6) Psychological condition (claustrophobia; severe anxiety);

(7) Miscellaneous conditions specific to the work situation (skin conditions where occlusive materials may result in symptoms or aggravation of a pre-existing dermatitis); and,

(8) Exercise stress (for those employees who use a self-contained breathing apparatus or rebreather type respirator under strenuous work conditions or in emergencies, particularly in fire and rescue operations).

XV. Proposed Substance Specific Standards Revisions

PART 1910 -- [AMENDED]

Subpart Z -- [Amended]

5. The authority citation for Subpart Z of Part 1910 continues to read as follows:

Authority: Secs. 4, 6, and 8, Occupational Safety and Health Act, 29 U.S.C. 653, 655, 657; Secretary of Labor's Orders Nos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), as applicable, and 29 CFR Part 1911.

All of subpart Z issued under section 6(b) of the Occupational Safety and Health Act, 29 U.S.C. 655(b), except those substances listed in the Final Rule Limits column of Table Z-1-A, which have identical limits listed in the Transitional Limits columns of Table Z-1-A, Table Z-2 or Table Z-3. The latter were issued under section 6(a) (29 U.S.C. 655(a)).

Section 1910.1000, the Transitional Limits columns of Table Z-1-A, Table Z-2 and Z-3 also issued under 5 U.S.C. 553. Section 1910.1000, Tables Z-1-A, Z-2 and Z-3 not issued under 29 CFR part 1911 except for the arsenic, benzene, cotton dust and formaldehyde listings.

Section 1910.1001 also issued under Sec. 107 of Contract Work Hours and Safety Standards Act, 40 U.S.C. 333.

Section 1910.1002 not issued under 29 U.S.C. 655 or 29 CFR Part 1911; also issued under 5 U.S.C. 553.

Section 1910.1003 through 1910.1018 also issued under 29 U.S.C. 653. Section 1910.1025 also issued under 29 U.S.C. 653 and 5 U.S.C. 553. Section 1910.1028 also issued under 29 U.S.C. 653. Section 1910.1043 also issued under 5 U.S.C. 551 et seq. Section 1910.1045 and 1910.1047 also issued under 29 U.S.C. 653. Section 1910.1048 also issued under 29 U.S.C. 653. Section 1910.1051 also issued under 29 U.S.C. 653. Section 1910.1200, 1910.1499 and 1910.1500 also issued under 5 U.S.C.

553.

6. Section 1910.1001 is amended by revising paragraphs (g)(3)(i) and (g)(4)(ii) and by removing and reserving Appendix C as follows:

1910.1001 Asbestos. * * * * * (g) * * * (3) Respirator program. (i) When respiratory protection is required, the employer shall institute a respirator program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

(4) * * * (ii) For each employee wearing negative pressure respirators or tight fitting positive pressure respirators, employers shall perform either quantitative or qualitative face fit tests at the time of initial fitting and at least every six months thereafter. The qualitative fit tests may be used only for testing the fit of half mask respirators where they are permitted to be worn, and shall be conducted in accordance with Appendix A of Sec. 1910.134. The tests shall be used to select facepieces that provide the required protection as prescribed in Table I of this section.

* * * * *

7. Sections 1910.1003, 1910.1004, and 1910.1006 through 1910.1016 are amended by adding a new paragraph (d)(1) to each section to read as follows:

1910.1003 4-Nitrobiphenyl.

1910.1004 alpha-Naphthylamine.

1910.1006 Methyl chloromethyl ether.

1910.1007 3,3'-Dichlorobenzidine (and its salts).

1910.1008 bis-Chloromethyl ether.

1910.1009 beta-Naphthylamine.

1910.1010 Benzidine.

1910.1011 4-Aminodiphenyl.

1910.1012 Ethyleneimine.

1910.1013 beta-Propiolactone.

1910.1014 2-Acetylaminofluorene.

1910.1015 4-Dimethylaminoazobenzene.

1910.1016 N-Nitrosodimethylamine. * * * * *

(d)(1) Respirator program. When respiratory protection is used pursuant to this section, employers shall institute a respiratory protection program in accordance with Sec. 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

8. Section 1910.1017 is amended by revising paragraphs (g)(3) and (g)(4) to read as follows:

1910.1017 Vinyl chloride. * * * * * (g) * * * (3) A respiratory protection program meeting the requirements of Sec.

1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l) shall be estabished and maintained.

(4) The employer shall make types of respirators available for selection and shall assure that employees use respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. The table that follows shows the NIOSH RDL values.

* * * * *

9. Section 1910.1018 is amended by revising paragraphs (h)(2)(i), Table I and Table II, (h)(2)(iii), (h)(3)(ii), (h)(3)(iii), and (h)(4)(i) as follows:

1910.1018 Inorganic arsenic. * * * * * (h) * * * (2) Respirator selection. (i) Where respirators are required under this section the employer shall select, provide at no cost to the employee and assure the use of the appropriate respirator or combination of respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table I of this section for inorganic arsenic compounds without significant vapor pressure, or Table II of this section for inorganic arsenic compounds which have significant vapor pressure show the NIOSH RDL assigned protection factor values.

(ii) * * *

Footnote(1) High efficiency filter -- 99.97% efficiency against 0.3 micrometer monodisperse diethylhexyl phthalate (DOP) particles.

Footnote(2) This category does not include disposable respirators, use of which is not permitted under this standard.

Footnote(1) High efficiency filter -- 99.97% efficiency against 0.3 micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

Footnote(2) Half mask respirators shall not be used for protection against arsenic trichloride, as it is rapidly absorbed through the skin.

Footnote(3) This category does not include disposable respirators, use of which is not permitted under this standard.

(iii) The employer shall select respirators from among those approved by NIOSH.

(3) * * * (ii) The employer shall perform qualitative fit tests at the time of initial fitting and at least semiannually thereafter for each employee wearing respirators, where quantitative fit tests are not required. The protocols for qualitative fit testing set out in Appendix A to Sec. 1910.134 shall be followed in administering qualitative fit tests pursuant to this section.

(iii) Employers with more than 20 employees wearing respirators shall perform a quantitative face fit test at the time of initial fitting and at least semiannually thereafter for each employee wearing negative pressure respirators. The test shall be used to select facepieces that provide the required protection as prescribed in Table I or II. The protocols for quantitative fit testing set out in Appendix A to Sec. 1910.134 shall be followed in administering quantitative fit tests pursuant to this section.

* * * * *

(4) Respirator program. (i) The employer shall institute a respiratory protection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

10. Section 1910.1025 is amended by revising paragraphs (f)(2)(i) and Table II, (f)(2)(iii), (f)(3)(ii) and (f)(4)(i) and the fourth paragraph of section IV of Appendix B and removing Appendix D as follows:

1910.1025 Lead. * * * * * (f) * * * (2) Respirator selection. (i) Where respirators are required under this section the employer shall make types of respirators available for selection and shall assure that employees use respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table II of this section shows the NIOSH RDL values.

* * * * *

Footnote(1) Respirators specified for high concentrations can be used at lower concentrations of lead.

Footnote(2) Full facepiece is required if the lead aerosols cause eye or skin irritation at the use concentrations.

Footnote(3) A high efficiency particulate filter means 99.97 percent efficiency against 0.3 micron size particles.

* * * * *

(iii) The employer shall select respirators from among those approved for protection against lead dust, fume, and mist by NIOSH.

(3)* * * (ii) Employers shall perform either quantitative or qualitative face fit tests at the time of initial fitting and at least every six months thereafter for each employee wearing negative pressure respirators. The qualitative fit tests may be used only for testing the fit of half mask respirators where they are permitted to be worn. Quantitative and qualitative fit tests shall be conducted in accordance with Appendix A of Sec. 1910.134. The tests shall be used to select facepieces that provide the required protection as prescribed in Table II of this section.

* * * * *

(4)* * * (i) The employer shall institute a respiratory protection program in accordance with 29 CFR 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

Appendix B to Section 1910.1025 -- Employee Standard Summary

* * * * *

IV. Respiratory Protection -- Paragraph (F)

* * * * *

Your employer must assure that your respirator facepiece fits properly. Proper fit of a respirator is critical. Obtaining a proper fit on each employee may require your employer to make available two or three different mask types. In order to assure that your respirator fits properly and that facepiece leakage is minimized, your employer must give you either a qualitative or quantitative fit test in accordance with Appendix A of 29 CFR 1910.134.

* * * * *

11. Section 1910.1029 is amended by revising paragraphs (g)(2)(i) and Table I, (g)(2)(iii) and (g)(3) to read as follows:

1910.1029 Coke oven emissions. * * * * * (g)* * * (2) Selection. (i) Where respirators are required under this section, the employer shall make types of respirators available for selection and shall assure that employees use respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, NW., Washington, DC 20210. Table I of this section shows the NIOSH RDL values.

* * * * *

(ii) * * * (iii) The employer shall select respirators from among those approved for protection against coke oven emissions by NIOSH.

(3) Respirator program. The employer shall institute a respiratory protection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

12. Section 1910.1043 is amended by revising paragraphs (f)(2)(i), deleting Table I, revising (f)(2)(ii), (f)(2)(iii) and (f)(3), and adding a new Appendix F to read as follows:

* * * * *

1910.1043 Cotton dust. * * * * * (f) * * * (2) Respirator selection. (i) Where respirators are required under this section, the employer shall make types of respirators available for selection and shall assure that employees use respirators in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 of Appendix F of this section shows the NIOSH RDL values.

(ii) The employer shall select respirators from those tested and certified for protection against dust by NIOSH.

(iii) Whenever negative pressure air-purifying respirators are required by this section, the employer shall, upon the request of the employee, provide the appropriate powered air-purifying respirator with a high efficiency particulate filter selected pursuant to Table 1 of this section in lieu of the negative pressure air-purifying respirator specified in Table 1 of this section.

* * * * *

(3) Respirator program. The employer shall institute a respiratory protection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

Appendix F -- Respirator Selection

13. Section 1910.1044 is amended by revising paragraphs (h)(2)(i), (h)(2)(ii) and Table 1, and (h)(3)(i) to read as follows:

1910.1044 1,2-dibromo-3-chloropropane. * * * * * (h) * * * (2) Respirator selection (i) Where respirators are required under this section, the employer shall select, provide at no cost to the employee, and assure that the employee uses the appropriate respirator in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 shows the NIOSH RDL values.

(ii) The employer shall select respirators from among those approved by NIOSH.

* * * * *

(3) Respirator program. (i) The employer shall institute a respiratory protection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

14. Section 1910.1045 is amended by revising paragraphs (h)(2)(i) and Table 1, (h)(2)(ii), (h)(3)(i) and (h)(3)(iii) to read as follows:

1910.1045 Acrylonitrile. * * * * * (h) * * * (2) Respirator selection. (i) Where respiratory protection is required under this section, the employer shall select, provide at no cost to the employee, and assure that the employee uses the appropriate respirator in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 shows the NIOSH RDL values.

(ii) The employer shall select respirators from among those approved for use with organic vapors by NIOSH.

(3) Respirator program. (i) The employer shall institute a respiratory protection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

(iii) Testing. Fit testing of respirators shall be performed to assure that the respirator selected provides the protection required by Table 1. Fit testing shall be performed pursuant to the protocols set out in Appendix A to Sec. 1910.134.

(A) Qualitative fit. The employer shall perform qualitative fit tests at the time of initial fitting and at least semiannually thereafter for each employee wearing respirators.

(B) Quantitative fit. Each employer with more than 10 employees wearing negative pressure respirators shall perform quantitative fit testing at the time of initial fitting and at least semiannually thereafter for each such employee.

* * * * *

15. Section 1910.1047 is amended by revising paragraphs (g)(2)((i), (g)(2)(ii) and (g)(3) and redesignating Table 1 of paragraph (h)(2) introductory text as Table 1 of paragraph (g)(2)(i) and revising Table 1 to read as follows:

1910.1047 Ethylene oxide. * * * * * (g) * * * (2) Respirator selection. (i) Where respiratory protection is required under this section, the employer shall select, provide at no cost to the employee, and assure that the employee uses the appropriate respirator in accordance with the assigned protection factor tables in the NIOSH Respirator Decision Logic published in May 1987. This is available from the NIOSH Publication Dissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200 Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 shows the NIOSH RDL values.

Note -- Respirators approved for use in higher concentrations are permitted to be used in lower concentrations.

(ii) The employer shall select respirators from among those approved for protection against EtO by NIOSH.

(3) Respirator program. Where respiratory protection is required by this section, the employer shall institute a respirator program in accordance with 29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

* * * * *

16. The authority citation for Subpart D of Part 1926 continues to read as follows:

Authority: Secs. 4, 5, 6, 8, Occupational Safety and Health Act of 1970, 29 U.S.C. 653, 655, 657; Sec. 107, Contract Work Hours and Safety Standards Act (Construction Safety Act), 40 U.S.C. 333; and Secretary of Labor's Orders 12-17 (36 FR 8754, 8-76 (41 FR 25059), or 9-83 (48 FR 35736), as applicable. Sections 1926.55(c) and 1926.1101 also issued under 29 CFR Part 1911.

17. Section 1926.1101 is amended by revising paragraphs (h)(3)(i) and (h)(4)(ii) and removing and reserving Appendix C as follows:

1926.1101 Asbestos. * * * * * (h) * * * (3) * * * (i) Where respiratory protection is used the employer shall institute a respirator program in accordance with Sec. 1910.134(b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

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(4) * * * (i) * * * (ii) For each employee wearing negative pressure respirators or tight fitting positive pressure respirators, employers shall perform either quantitative or qualitative face fit tests at the time of initial fitting and at least every six months thereafter. The qualitative fit tests may be used only for testing the fit of half mask respirators where they are permitted to be worn, and shall be conducted in accordance with Appendix A of Sec. 1910.134. The tests shall be used to select facepieces that provide the required protection as prescribed in Table I of this section.

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18. Section 1926.103 is revised to read as follows:

1926.103 Respiratory protection.

Respiratory protection for construction employment is covered by 29 CFR 1910.134.

19. The authority citation for Part 1915 continues to read as follows:

Authority: Sec. 41, Longshoremen's and Harbor Worker's Compensation Act (33 U.S.C. 941), secs. 4, 6, and 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-72 (36 FR 8754), 8-76 (41 FR 25059), or 9-83 (48 FR 35736) as applicable; and 29 CFR Part 1911.

20. 29 CFR Part 1915 is amended by revising Subpart I to read as follows:

Subpart I -- Personal Protective Equipment

1915.152 Respiratory protection.

Respiratory protection for shipyard employment is covered by 29 CFR 1910.134.

21. The authority citation for Subpart G of Part 1910 continues to read as follows:

Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as applicable.

Sections 1910.94 and 1910.99 also issued under 29 CFR Part 1911.

22. Section 1910.94 is amended by revising paragraphs (a)(5)(i), (a)(5)(iv), (a)(6), (c)(6)(iii)(a), and (d)(9)(vi) to read as follows:

1910.94 Ventilation. * * * * * (a) * * * (5) Personal protective equipment. (i) Only respiratory protective equipment approved by the National Institute for Occupational Safety and Health (NIOSH) shall be used for protection of personnel against dusts produced during abrasive-blasting operations.

* * * * *

(iv) A respiratory protection program as defined and described in Sec. 1910.134 shall be established wherever it is necessary to use respiratory protective equipment.

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(6) Air supply and air compressors. The air for abrasive-blasting respirators shall be free of harmful quantities of dusts, mists, or noxious gases, and shall meet the requirements for supplied air quality and use contained in Sec. 1910.134(i).

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(c) * * * (6) * * * (iii) (a) When an operator must position himself in a booth downstream of the object being sprayed, an air supplied respirator or other type of respirator approved by the National Institute for Occupational Safety and Health (NIOSH) for the material being sprayed shall be used by the operator.

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(d) * * * (9) * * * (vi) When, during emergencies as described in paragraph (d)(11)(v) of this section, workers must be in areas where concentrations of air contaminants are greater than the limit set by paragraph (d)(2)(iii) of this section or oxygen concentrations are less than 19.5 percent, they shall be required to wear respirators adequate to reduce their exposure to a level below these limits, or to provide adequate oxygen. Such respirators shall also be provided in marked, quickly accessible storage compartments built for the purpose, when there exists the possibility of accidental release of hazardous concentrations of air contaminants. Respirators shall be approved by the National Institute for Occupational Safety and Health (NIOSH) and shall be selected by a competent industrial hygienist or other technically qualified source. Respirators shall be used in accordance with Sec. 1910.134, and persons who may require them shall be trained in their use.

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23. The authority citation for Subpart H of Part 1910 continues to read as follows:

Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as applicable.

Sections 1910.106, 1910.107, 1910.108 and 1910.109 also issued under 29 CFR Part 1911.

24. Section 1910.111 is amended by revising paragraphs (a)(2)(x) and (b)(10)(ii) to read as follows:

1910.111 Storage and handling of anhydrous ammonia

(a) * * * (2) * * * (x) Gas mask -- Gas masks approved by the National Institute for Occupational Safety and Health (NIOSH) for anhydrous ammonia.

* * * * *

(b) * * * (10) * * * (ii) All stationary storage installations shall have at least two suitable gas masks in readily accessible locations. Full face masks with ammonia canisters as approved by the National Institute for Occupational Safety and Health (NIOSH) are suitable for emergency action for most leaks, particularly those that occur outdoors. For protection in concentrated ammonia atmospheres self-contained breathing air apparatus is required.

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25. The authority citation for Subpart Q of Part 1910 continues to read as follows:

Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as applicable.

Section 1910.252 also issued under 29 CFR Part 1911. 26. Section 1910.252 is amended by revising paragraphs (c)(4)(ii), (c)(4)(iii), (c)(7)(iii), (c)(9)(i), and (c)(10) to read as follows:

1910.252 General requirements. * * * * * (c) * * * (4) * * * (ii) Airline respirators. In such circumstances where it is impossible to provide such ventilation, airline respirators or hose masks approved by the National Institute for Occupational Safety and Health (NIOSH) for this purpose shall be used.

(iii) Self-contained units. In areas immediately hazardous to life, a full facepiece pressure demand self-contained breathing apparatus or combination full facepiece pressure demand supplied air respirator with auxiliary self-contained air supply approved by NIOSH shall be used.

* * * * *

(7) * * * (iii) Local ventilation. In confined spaces or indoors, welding or cutting involving metals containing lead, other than as an impurity, or involving metals coated with lead-bearing materials, including paint shall be done using local exhaust ventilation or airline respirators. Outdoors such operations shall be done using respiratory protective equipment approved by the National Institute for Occupational Safety and Health (NIOSH) for such purposes. In all cases, workers in the immediate vicinity of the cutting operation shall be protected by local exhaust ventilation or airline respirators.

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(9) * * * (i) General. Welding or cutting indoors or in confined spaces involving cadmium-bearing or cadmium-coated base metals shall be done using local exhaust ventilation or airline respirators unless atmospheric tests under the most adverse conditions have established that the workers' exposure is within the acceptable concentrations defined by Sec. 1910.1000. Outdoors such operations shall be done using respiratory protective equipment such as fume respirators approved by the National Institute for Occupational Safety and Health (NIOSH) for such purposes.

* * * * *

(10) Mercury. Welding or cutting indoors or in a confined space involving metals coated with mercury-bearing materials including paint, shall be done using local exhaust ventilation or airline respirators unless atmospheric tests under the most adverse conditions have established that the workers' exposure is within the acceptable concentrations defined by Sec. 1910.1000. Outdoors such operations shall be done using respiratory protective equipment approved by the National Institute for Occupational Safety and Health (NIOSH) for such purposes.

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27. The authority citation for Subpart R of Part 1910 continues to read as follows:

Authority: Secs. 4, 6, 8, Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-71 (36 FR 8754), 8-76 (41 FR 25059) or 9-83 (48 FR 35736), as applicable.

Sections 1910.261, 1910.262, 1910.265, 1910.267, 1910.268, 1910.269, 1910.274 and 1910.275 also issued under 29 CFR Part 1911.

28. Section 1910.261 is amended by revising paragraphs (b)(2), (g)(10), (h)(2)(iii) and (h)(2)(iv) to read as follows:

1910.261 Pulp, paper, and paperboard mills. * * * * * (b) * * * (2) Personal protective clothing and equipment. Foot protection, shin-guards, hard hats, noise attenuation devices, or other personal protective clothing and equipment shall be worn when the extent of the hazard is such as to warrant their use. Such equipment shall be worn whenever specifically required by other paragraphs of this section. All equipment shall be maintained in accordance with applicable American National Standards. Respirators, goggles, and protective masks, rubber gloves, rubber boots, and other such equipment shall be cleaned and disinfected before being used by another employee. Eye, head, and ear protection, where specified, shall conform to American National Standards Z24.22-1957, Z87.1-1968, and Z89.1-1969. Respiratory protection shall conform to the requirements of Sec. 1910.134.

* * * * *

(g) * * * (10) Gas masks (digester building). Gas masks shall be available. These masks shall furnish adequate protection against sulfurous acid and chlorine gases, and shall be inspected and tested at frequent intervals, not to exceed 1 month, in accordance with American National Standard Z87.1-1968, and Sec. 1910.134.

* * * * *

(h) * * * (2) * * * (iii) Gas masks shall be provided for emergency use, in accordance with Sec. 1910.134.

(iv) For emergency and rescue work, a self-contained breathing apparatus or supplied air respirator in accordance with the requirements of Sec. 1910.134 shall be provided.

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[FR Doc. 94-27197 Filed 11-14-94; 8:45 am]