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 onrespiratory protection (29 CFR 1910.134, 29 CFR 1915.152 and 29 CFR1926.103). The current respirator standard was adopted from a voluntaryconsensus 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 toupdate the current standard to reflect these changes so that employers willprovide effective protection for employees who wear respirators.

The proposed standard includes requirements for a written respiratoryprotection program; procedures for selecting respirators; requirements formedical evaluation; procedures for fit testing; requirements for usingrespirators; procedures for maintaining respirators; training; criteria forevaluating program effectiveness. Public hearings are being scheduled toprovide interested parties the opportunity to orally present information anddata related to the issues raised by this proposed rule.

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

ADDRESSES: Written comments should be submitted in quadruplicate or 1original (hardcopy) and 1 disk (5 1/4 or 3 1/2 ) in WordPerfect 5.0, 5.1, 6.0or ASCII to: The Docket Office, Docket H-049, U.S. Department of Labor,Occupational Safety and Health Administration, Room N2625, 200 ConstitutionAvenue, N.W. Washington, D.C. 20210; (202) 219-7894. (Any information notcontained on disk, e.g., studies, articles, etc., must be submitted inquadruplicate.) Notices of intention to appear at the informal rulemakinghearing, testimony, and documentary evidence are to be submitted inquadruplicate 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 commentsreceived, notices of intention to appear, and all other material related tothe development of this proposed standard will be available for inspectionand copying in the public record in the Docket Office, Room N2439, at theabove 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 ofInformation and Consumer Affairs, Occupational Safety and HealthAdministration, 200 Constitution Avenue, N.W., Room N3647, Washington, D.C.20210; (202) 219-8151.

Hearings: Mr. Tom Hall, Division of Consumer Affairs, Occupational Safetyand 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 obtainingOMB clearance for information collection requirements under the PaperworkReduction Act of 1980, 44 U.S.C. 3501 et seq. The proposed revised respiratorstandard requires employers to allow OSHA access to records. In accordancewith the provisions of the Paperwork Reduction Act and the regulations issuedpursuant thereto, OSHA certifies that it has submitted the informationcollection requirements for this proposed rule on respiratory protection toOMB for review under Section 3504(h) of that Act. OMB has approved (OMBnumber 1218-0099) in concept the submitted information collection activitiescontained in the proposed revision pending public consideration and comment.

Public reporting burden for this collection of information is estimated tobe five minutes per response. Send comments regarding this burden estimate orany other aspect of this collection of information, to the Office ofInformation Management, Department of Labor, Room N-1301, 200 ConstitutionAvenue, NW., Washington, DC 20210; and to the Office of Information andRegulatory Affairs, Office of Management and Budget, Paperwork ReductionProject (1218-AA05), Washington, DC 20503.

II. Introduction

A. Format of the Preamble

The preamble accompanying this notice of proposed rulemaking is divided intofifteen 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 RespiratoryProtection C. Respirator Use D. Types of Respiratory Hazards E. Limitationsof Respiratory Use III. Legal Authority IV. Background A. Regulatory HistoryB. Need for the Standard C. Recognition of the Need for a Standard by OtherGroups V. Certification/Approval Procedures VI. Summary of the PreliminaryRegulatory Impact Analysis and Regulatory Flexibility Analysis andEnvironmental Impact Assessment VII. Summary and Explanation of the ProposedStandard A. Scope and Application B. Definitions C. Respiratory ProtectionProgram D. Selection of Respirators E. Medical Evaluation F. Fit TestingProcedures G. Use of Respirators H. Maintenance and Care of Respirators I.Supplied Air Quality and Use J. Identification of Filters, Cartridges, andCanisters 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 PlanStandards XII. List of Subjects XIII. Authority and Signature XIV. ProposedStandard 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 eliminatehazardous exposures to airborne contaminants first came from Pliny (c. A.D.23-79) who discussed the use of loose fitting animal bladders in Roman minesto protect workers from the inhalation of red oxide of lead (1,2). Later, inthe 1700's, the ancestors of modern atmosphere-supplying devices, such as theself-contained breathing apparatus or hose mask, were developed. Although thedevices 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 breathingzone of the worker, or providing clean air from an uncontaminated source.

In 1814, a particulate-removing filter encased in a rigid container wasdeveloped -- the predecessor of modern filters for air-purifying respirators.In 1854, it was recognized that activated charcoal could be used as afiltering medium for vapors. World War I and the use of chemical warfare alsoresulted in improvement in the design of respirators. Overall, there havebeen few major developments in the basic design of respirators over the yearsexcept for the resin-impregnated dust filter in 1930. This development hasmade available efficient, inexpensive filters that have good dust-loadingcharacteristics and low breathing resistance. Another more recent developmentis the ultrahigh efficiency filter made from paper that contains very fineglass fibers. These extremely efficient filters are used for very smallairborne particles and produce little breathing resistance.

C. Respirator Use

The purpose of a respirator is to prevent the inhalation of harmful airbornesubstances. Functionally, a respirator is designed as an enclosure whichcovers the nose and mouth or the entire face or head. Respirators are of twogeneral "fit" types: Tight fitting (i.e., quarter masks, which cover themouth and nose, and where the lower sealing surface rests between the chinand 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 coverthe 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 airfrom an uncontaminated source).

Air-purifying respirators are grouped into three general types:

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

Particulate-removing respirators are designed to reduce inhaledconcentrations 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 enterthe breathing zone of the worker. They may have single use or replaceablefilters. These respirators may be non-powered or powered air-purifying (usinga blower to pull contaminated air through a filter; the resulting cleaned airis 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 fromthe contaminated air before they enter the breathing zone of the worker.Combination cartridges and canisters are available to protect against bothparticulates and vapors and gases.

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

D. Types of Respiratory Hazards

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

Contaminants are classified as particulate contaminants, which includemechanical 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 aluminumoxides; inert pulmonary reaction producing substances such as silicates;minimal pulmonary fibrosis producing substances such as iron oxide or tinoxide; extensive pulmonary fibrosis producing substances such as free silicaor asbestos; chemical irritants such as acids or alkalies; systemic poisonssuch as pesticides, hydrogen cyanide or lead; allergy producing substancessuch as cotton, isocyanates, epichlorohydrin, fur fibers, or vegetablefibers; and febrile-reaction producing agents such as bagasse, or copper andzinc oxide; and biological materials.

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

E. Limitations of Respirator Use

Not all workers can wear respirators. Individuals with impaired lungfunction, due to asthma or emphysema for example, may be physically unable towear a respirator. Individuals who cannot get a good facepiece fit, includingthose individuals whose beards or sideburns interfere with the facepieceseal, will be unable to wear tight fitting respirators. Determination ofadequate fit is required for a respirator to be effective.

In addition to the problems with usage already discussed, respirators mayalso present communication problems, vision problems, fatigue and reducedwork efficiency. Nonetheless, it is sometimes necessary to use respiratoryprotection as the means of control.

In principle, respirators frequently may be capable of providing adequateprotection. However, problems associated with selection, fit, and use oftenrender them ineffective in actual application, preventing the assurance ofconsistent and reliable protection; regardless of the theoreticalcapabilities of the respirator. Occupational safety and health experts havespent considerable effort over the years developing fit testing proceduresand methods of measuring respirator protection so that these adversevariables can be better controlled, thereby improving protection for thoseemployees 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 thatone method for controlling some of the problems associated with respiratorselection, fit, and use is to describe clearly the steps to be followed inadministering a program to protect employees required to wear respirators.The modifications in this proposal are also intended to upgrade theprovisions in Sec. 1910.134 to reflect the current state of the art inrespiratory methodology and technology.

III. Legal Authority

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

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

The Congress specifically mandated that:

The Secretary, in promulgating standards dealing with toxic materials, orharmful physical agents under this subsection, shall set the standard whichmost adequately assure, to the extent feasible, on the basis of the bestavailable evidence, that no employee will suffer material impairment ofhealth or functional capacity even if such employee has regular exposure tothe 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 beappropriate. In addition to the attainment, of highest degree of health andsafety protection for the employee, other considerations shall be the latestavailable scientific data in the field, the feasibility of standards, andexperience gained under this section and other health and safety laws.(Section 6(b)(5).

The revisions which OSHA proposes would update current standards concerningrespiratory protection mainly by incorporating technological advances and byexpanding certain respirator program elements such as fit testing and byclarifying other provisions.

These revisions are intended to ensure that employees who use respirators toprotect them from workplace atmospheric contamination, will be protected tothe technical limitations of the devices they wear. Protection from exposureto workplace airborne contaminants is one of the major goals of the Act and amajor mission for the Agency, since the risk to employees of chronic andacute disease because of exposure to toxic substances is substantial and welldocumented (see e.g., preamble to 29 CFR Part 1910, Air Contaminants,Proposed Rule, at 53 FR 20960 et seq.) Similarly, these regulations need tobe updated to assure that employees are protected to the extent thatcurrently available technology permits. Therefore OSHA finds that revisionsto these regulations governing respiratory protection are clearly necessaryand appropriate to protect employees against the risk of material impairmentof health or functional capacity and are issued pursuant to the authority ofsection 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. Inparticular, section 8(c) gives the Secretary authority to require employersto "maintain accurate records of employee exposures to potentially toxicmaterials or harmful physical agents which are required to be monitored ormeasured under section 6." Provisions of OSHA standards which require thepreparation and monitoring of exposure records, such as contained in awritten respirator program, are also issued pursuant to section 8(c) of theAct.

The Secretary's authority to issue this proposed standard is furthersupported by the general rulemaking authority granted in section 8(g)(2) ofthe Act. This section empowers the Secretary "to prescribe such rules andregulations as he may deem necessary to carry out [his] responsibilitiesunder 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 largelyby its enumerated purposes, which include:

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

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

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

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

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

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

Because this proposed revised standard is reasonably related to thesestatutory goals, the Secretary finds that this standard is necessary to carryout his responsibilities under the Act.

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

The Supreme Court's benzene decision (Industrial Union Department, AFL-CIOv. American Petroleum Institute. 448 U.S. 601) requires OSHA, in general, tomake a "significant risk determination" before issuing health and safetystandards. It is clear that exposure to hazardous air contaminants in theworkplace poses significant risks to workers. Where engineering controlscannot be used to reduce exposures below hazardous levels, respiratorsproperly selected, fitted and worn can contribute substantially to areduction in the level of air contaminants reaching the employee's breathingzone. Under the current respiratory protection standard, which lacks adequaterequirements for fit testing, selection, medical evaluation, use,maintenance, and respiratory protection program provisions, employees wearingrespirators are receiving less protection than the respirators canpotentially give, and in some cases may suffer exposure to hazards as aresult of improper respirator use. The significant risk to employeestherefore has not been adequately reduced by the existing respiratorstandard.

The enforcement experience of OSHA and various state health agenciesdemonstrate the wide-spread nature of defects in respirator programs whilethe unamended respirator standard has been in effect. From fiscal 1977 to1982, 58% of inspected worksites where respirators were used to protectagainst excessive levels of air contamination had deficiencies in at leastone respirator area, including respirator fit condition, unapproved orunsuitable respirators, and lack of continuous wear (Ex. 33-5). Inadequatesupervision of respirator use was cited as a major cause of improper andineffective usage by the North Carolina Department of Labor, Kentucky'sDepartment of Labor and Virginia's Bureau of Occupational Health (DocketH-160, Ex. 2-69, 2-103, 2-129). These state plan states have respiratorstandards that are the same as OSHA's unamended standard.

OSHA cannot precisely quantify the risk to employees whose employers rely oninadequate respiratory protection programs to protect them against excessivelevels of atmospheric contamination. However, the widespread levels ofimproper use of respirators put at significant risk employees who, at leastsome of the time, are overexposed to air contaminants. Based on OSHA'sexperience that one half of workplaces using respirators use them incorrectlyunder the current standard, even a small improvement in respirator use shouldwork a significant reduction in the risk of developing adverse health effectsbecause of preventable misuse of respirators. OSHA believes that a greaterbenefit will result from the imposition of these revised requirements for thefollowing reason.

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

OSHA has quantified the risk and reduction of risk as part of the regulatoryanalysis and regulatory flexibility analysis, Section VI of the preamble.That analysis clearly shows that workers wearing respirators under therequirements of the current standard are exposed to a significant risk ofchronic and acute health effects because of the inadequacies of the presentstandard. OSHA seeks comment on the issue of significant risk and how theproposed respirator standard revisions will affect that risk, along with anycomment on the regulatory analysis performed by OSHA and all other issuesrelated to significant risk.

IV. Background

A. Regulatory History

Congress created the Occupational Safety and Health Administration (OSHA) in1970, and gave it the responsibility for promulgating standards to protectthe health and safety of American workers. As directed by Congress in theOccupational Safety and Health Act, OSHA adopted existing Federal or nationalconsensus standards, developed by various organizations such as the AmericanConference of Governmental Industrial Hygienists (ACGIH) and the AmericanNational Standard Institute (ANSI). The ANSI standard Z88.2-1969, "Practicesfor Respiratory Protection" (3), is the origin of the first six sections ofOSHA's 29 CFR 1910.134, "Respiratory Protection" (4). The seventh section isa direct, complete inclusion of ANSI Standard K13.1-1969, "Identification ofGas Mask Canisters." Until the adoption of these standards by OSHA, mostguidance on respiratory protective device use in hazardous environments wasadvisory rather than mandatory.

The construction industry standard for respiratory protection, 29 CFR1926.103, was promulgated in April 1971. On February 9, 1979, 29 CFR 1910.134was 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 anexisting advisory committee when promulgating a rule which will affect anindustry represented by the committee. In view of the application of therespirator protection standard to the construction industry, OSHA distributedcopies of the draft of this proposed revised standard on September 20, 1985to the Construction Advisory Committee for review and discussion at theirnext meeting in February 1986 so that the Construction Advisory Committeecould prepare its official response. The response that was received from thecommittee was considered in revising the draft proposal as discussed later inthis preamble.

The maritime standards were originally promulgated in the 1960's under adifferent codification in the CFR by agencies which preceded OSHA. Thepresent code designations and their promulgation dates are, as follows: 29CFR 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 CFR1918.102, February 20, 1960 (25 FR 1565) (4).

The current 29 CFR 1910.134 requires that the employer establish andimplement a comprehensive respiratory protection program. The program is tocontain written procedures and provide for proper cleaning, disinfection,storage, inspection and maintenance of the respirators. General provisionsare set forth on fitting and training. Requirements are included for qualityof breathing air and practices to ensure that it is not contaminated.Provisions for emergencies and for communication and rescue in atmospheresimmediately dangerous to life or health are specified. A color code for gasmask 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 additionalprovisions of the proposal amplify the current requirements by specifying,for example, that the training program include instruction in procedures forinspection, donning and removal, checking the fit, and sufficient practice toenable the employee to become thoroughly familiar and confident with the useof the respirator. OSHA believes, based on its experience promulgating andenforcing respirator provisions in other health standards and Sec. 1910.134,that such hands-on training can materially improve the effectiveness ofrespirator use.

Recent OSHA health standards have imposed respirator related requirementsnot found in 29 CFR 1910.134 (See section 1910.1018(h), arsenic; section1910.1025(f), lead; section 1910.1029(g), coke oven emissions; and section1910.1043(f), cotton dust). These requirements include the followingprovisions.

• 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-purifyingrespirators (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 arespirator whenever an increase in breathing resistance is detected,(arsenic, 1910.1018(h)(4)(ii); lead, 1910.1025(f)(4)(ii); coke ovenemissions, 1910.1029(g)(4)(ii); cotton dust, 1910.1043(f)(4)(ii)).
• Employees have been permitted to wash their faces and respiratorfacepieces to prevent skin irritation associated with using respirators,(arsenic, 1910.1018(h)(4)(iii); lead 1910.1025(f)(4)(iii); coke ovenemissions, 1910.1029(g)(4)(iii); cotton dust 1910.1043(f)(4)(iii).
• Employers have been required to provide respirators that exhibit minimumfacepiece 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 hasbeen required for an employee who exhibits difficulty breathing either at fittesting 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 respiratorsthat are "approved or accepted shall be used when available." OSHA has chosento recognize only those respirators approved by the National Institute forOccupational Safety and Health (NIOSH), and the Mine Safety and HealthAdministration (MSHA). The NIOSH and MSHA respirator performance requirementsare given in Title 30, Code of Federal Regulations, Part 11. A revision ofthat standard is now being considered by NIOSH and MSHA.

Because of differences with the respirator requirements in other OSHAstandards, changes in respirator methodology and technology, and the revisionof referenced documents or related codes, OSHA published an Advance Notice ofProposed Rulemaking (ANPR) on May 14, 1982 (47 FR 20803). This notice soughtinformation on the effectiveness of the current provisions, the need forrevision, and the substance of what these revisions might be. Responses werereceived from 81 interested parties, and generally supported revising OSHA'srespiratory protection provisions and provided suggestions for approaches theAgency might take (Ex. 15).

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

B. Need for the Standard

This rulemaking addresses an existing standard, rather than addressing a newsubject area, and seeks to correct the inadequacies of that existingstandard. Since the OSHA standards on respiratory protection were adopted,research on the proper use of such equipment has resulted in new technologywhich improves protection for the wearers. The current standards do notreflect what is now accepted practice for implementation of comprehensiverespiratory protection programs to protect employees. This is particularlytrue in the areas of fit testing and assignment of protection factors torespirators.

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

Indeed, the misuse of respirators can actually be hazardous to employeesafety and health. Selection of the wrong equipment, one of the most frequenterrors made in respiratory protection, will result in the employee beingunknowingly vulnerable to the hazard and thus inhaling concentrations of thecontaminant that may be harmful. This may result in a broad range of healtheffects 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 ahigh degree of correlation between inadequate respirator programs andoverexposures to respirator wearers exposed to regulated substances.Respirators which are not maintained, inspected, and cleaned, can actuallyincrease exposure, as well as cause dermatitis or skin irritation and place agreater strain on the respiratory system. Because the wearing of therespirator gives the employee a sense of security and presumed protectionwhich may be false, an improper respirator program presents a high degree ofhazard for the employee.

The devices themselves can only provide the protection they are designed forif they are properly selected for the task; if they are fitted to the wearerand are consistently donned and worn properly; and if they are maintained andcared for so they continue to provide the protection required for the worksituation. These variables can only be controlled if a comprehensiverespiratory protection program is developed and implemented in each workplacewhere respirators are used to protect employees from inhalation of airbornecontaminants. OSHA has reviewed the present rulemaking record and the recordof citations for respirator standard violations. On the basis of that reviewit is clear that to be effective such a program must use an integrated,systematic approach that will result in consistent and appropriate choices ofrespiratory equipment to be used; involvement of employees to ensure thatthey understand why respirators are being worn, and how they contribute totheir effective use; and monitoring of the equipment and its use to ensurethat respirator effectiveness is optimized.

There are many examples of how respirators may not provide the protectionthey were designed to provide in the absence of an effective respiratorprogram with adequate employee training. When the hazardous substance is adust, mist or fume there are often conditions under which it is possible forthe inside of the respirator to become contaminated with the hazardoussubstance. For example, the employee may have an itch on the cheek andscratch it with a dirty finger thus destroying the integrity of therespirator fit.

An employee may leave the respirator area, remove the respirator, and restit on his or her chest. The inside of the respirator could then pick up thecontaminant from the air or work clothes and later when the respirator isdonned 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 ona ledge covered with the contaminant, the employee will again breathe in thecontaminant from within the respirator.

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

As discussed later in this preamble, several studies of the performance ofrespirators worn in the workplace have been submitted to the regulatorydocket to show that in actual use, respirators can be effective. Thesestudies of workplace protection factors (WPFs) are necessarily performed inworkplaces which have good respiratory protection programs. Consequentlythough the studies on WPFs may provide a reasonable criterion for settingmaximum protection factors, it is not the case that those levels ofprotection are always achieved even if employers have an adequate respiratorprogram. In the case of a poor respirator program it should be apparent thatthese levels would seldom be achieved.

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

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

As discussed above, OSHA's current standard in 29 CFR 1910.134 was largelyadopted from, and references, the ANSI Z88.2-1969 standard on respiratoryprotection. ANSI issued a revised version of that standard in 1980 (ANSIZ88.2-1980) (Ex. 10). ANSI's intent in issuing this revision was to ensurethat the standard did "reflect the current state of the art." ANSIaccomplished this by expanding and adding to the standard provisions whichaddress technological developments in respiratory protection since the 1969standard was published. Techniques in fit testing and the use of protectionfactors are two areas which have been elaborated upon in the 1980 standard tohelp ensure more effective protection for respirator wearers.

This change highlights the need for revising the OSHA standard, particularlysince Sec. 1910.134(c) specifies that respirators are to be selectedaccording to the 1969 ANSI standard and provides no additional guidance foremployers. Moreover, it is necessary to change OSHA's standard to ensure thatit too reflects current respiratory protection methodology in order toprovide 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 arespiratory protection program so that respirator selection, fit, and usewere standardized, thus controlling some of the variables which makerespirators ineffective. The program was to include written standardoperating procedures; assessment of the fitness of potential respiratorwearers; selection of respirators; training; fit testing; maintenance; andprogram evaluation.

One regulatory alternative in this regard would have been to adopt the ANSIZ88.2-1980 standard, or to at least base the rulemaking largely on the latestANSI standard as was done with the original OSHA standard. ANSI, however, wasdeveloping a major revision of its 1980 standard, recently finalized as ANSIZ88.2-1992. OSHA has given this latest ANSI standard detailed considerationin preparing this proposal. An OSHA standard based entirely on the 1980 ANSIstandard would have been obsolete as soon as published. OSHA has thereforemade the decision to pursue a rulemaking based on existing data and therecord generated thus far by responses to the ANPR and the prepublicationdraft. The proposed standard has included provisions of the 1980 and 1992ANSI standards where justified by the record. The reasons for provisionswhich differ from those in the ANSI standards are given in this preamble inthe discussion of the content of the proposed standard. OSHA has chosen notto adopt the ANSI standard per se, but many of the provisions, as well as thegeneral 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 adoptthe 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 asguidelines or a reference for the OSHA standard or that modifications to itmight 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 thatthe 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 rangeof organizations, stated that Sec. 1910.134 needs to be revised to reflectcurrent 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 ManufacturersAssociation (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 standardshould be updated to reflect current conditions and to permit sufficientflexibility for companies to respond to continuing technologicalimprovements. Present standards tend to suppress innovation and have apotential for harm by retarding the adoption of technological advances.

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

Currently standards should be revised to reflect changes in respiratoryprotection capabilities, techniques, and equipment which have been developedover the past 10 years. ANSI Z88.2 (1980) provides the best basis fordeveloping a new standard. In addition, the "Guide to Industrial RespiratoryProtection" (published as Los Alamos report LA-6671-M, and Health, Education,and Welfare (HEW) Publication, National Institute for Occupational Safety andHealth (NIOSH 76-189) provides detailed information relative to therequirements for an adequate respirator program. It is not recommended thatdirect adoption of sections, of either of these documents, be the approachused by OSHA. Both documents are several years old, and the ANSI documentconstitutes a compromise between various interests involved in developing andadopting a consensus standard. Development of a revised standard will requirea major effort by OSHA to identify, update, and expand those sections of ANSIZ88.2 (1980) which should be made part of the new OSHA standard.

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

At the present time the respiratory protection standard is not effective inproviding workers with any great degree of protection due to the inadequaciesof the standard, lack of requirements for employers to follow so that allrespiratory protection programs are uniform and equally protective, andineffective enforcement due to the vagueness of the requirements.

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

When 1910.134 was promulgated nearly a decade ago it reflected thestate-of-the-art for a good respiratory protection program. Thestate-of-the-art for respiratory protection, however, has rapidly advancedsince that time and although many of the elements included in the originalstandard retain their relevance and importance, other elements have beendeveloped and more efficient means for achieving the goals of an effectiverespiratory protection program have been introduced * * *

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

With respect to assigned protection factors, OSHA has decided not toestablish its own set of numbers but instead to defer to NIOSH in settingassigned protection factors for the various respirator classes. NIOSH will bedeveloping assigned protection factors as part of its revised respiratorcertification standard, 42 CFR Part 84. Since NIOSH may not publish 42 CFRPart 84 before this OSHA respirator standard revision is finalized, OSHA willin the interim enforce the assigned protection factors listed in the NIOSHRespirator Decision Logic (RDL). The concept of protection factors and thedecision to defer to NIOSH are discussed in more detail in a later section ofthis preamble.

Fit testing, the other area in which considerable advances have been madesince the promulgation of OSHA's current standard, also varies among thesubstance-specific standards. The cotton dust standard (29 CFR 1910.1043)requires that the respirator used exhibit minimum facepiece leakage and befitted properly. The coke oven emissions standard (29 CFR 1910.1029) requiresannual quantitative fit testing, but has no protocol for fit testing. Thelead standard (29 CFR 1910.1025) requires either qualitative or quantitativefit testing every six months and contains specific qualitative fit testprotocols to be followed. Although the current respiratory protectionstandard refers to the necessity for proper fit, there are no procedures tofollow or specific indications of how fit factors are to be taken intoaccount in the assignment of respirators.

There are two types of fit testing that can be used for tight fittingfacepiece respirators that rely on a facepiece-to-face seal to performadequately. Qualitative fit testing involves the introduction of a test agentinto the breathing zone of the respirator wearer which can be detected by itsirritant properties, taste, or smell. If the wearer detects thecharacteristic effect of the test agent used, it indicates that therespirator is leaking and does not fit properly, and thus a differentrespirator is needed to protect that employee. Quantitative fit testinginvolves the generation of a known concentration of a test agent outside thefacepiece, and a measurement of the concentration within the facepiece of therespirator. The ratio of these concentrations yields a number which indicatesthe protective capability of the device. This approach does not involve thesubjective response of the wearer as does the qualitative fit test.

OSHA began including requirements for the use of quantitative fit testing insubstance-specific standards starting in 1976 with the coke oven emissionsstandard. However, no procedures were provided. In the lead standard, OSHAconducted a separate rulemaking proceeding to address the appropriateness ofQLFT. It was determined at that time that qualitative fit testing can beappropriate, but only under certain conditions. It was found, for example,that such fit testing can provide a reasonable degree of reliability onlywhen specified protocols are followed. Thus the lead standard was revised topermit qualitative fit testing as well as quantitative fit testing to protectemployees in atmospheres no greater than ten times the permissible exposurelimit for lead, when exposed employees are wearing half mask negativepressure air-purifying respirators.

The overall problems with respect to QLFT protocols that came to the surfacein the lead standard revisions, plus the fact that there was no specifiedQNFT protocol, made it apparent that these subjects needed to be addressed inthe overall respiratory protection standard. Proper fit is so essential tomaximizing functioning of respirators that OSHA must include in itsrequirements the latest findings of respirator research on means to assessand assure such fit.

In assessing the need to revise Sec. 1910.134, OSHA reviewed the Agency'senforcement statistics related to this standard for a period of about tenyears, from 1972 to 1982 (9). This standard is one of the most frequentlycited health standards, which indicates both a lack of understanding as towhat is required for compliance, and a lack of awareness as to the importanceof establishing and implementing a comprehensive respiratory protectionprogram. During the period reviewed, there were 22,662 violations of thestandard recorded, of which 8,406 were serious violations (37%). Some 3,648of the violations were for not establishing a program (1,752 of these wereserious because overexposure to hazardous substances were involved). Othercommonly cited provisions include development of standard operatingprocedures; 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. Inthose areas which are frequently cited, the new proposal provides additionalguidance for employers to help ensure that they are aware of what is requiredto comply, and thus protect their employees adequately. OSHA expects thatthese revisions will improve the level of protection provided by the currentstandard: nothing in these revisions is intended to decrease protectionprovided under the current standard.

To summarize OSHA's position, the Agency has determined that promulgating arevised respiratory protection standard is necessary to ensure that employeeswearing respirators in the workplace are doing so under conditions whichadequately protect their health. This determination by OSHA is supported bythe public in responses to the ANPR published by the Agency. It is alsonecessitated by changes in respiratory protection methodology and subsequentrevisions to the consensus standards upon which the current standard isbased, thus making the current standard outdated. The determination of theneed for the standard is also supported by OSHA's experiences in promulgatingsubstance-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 thisproposed 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 consistentguidance and controlled practices, can also be demonstrated by the number andextent of voluntary standards that have been adopted, as well as by theexistence of standards at all levels of government.

As has already been discussed, the primary voluntary consensus standard inthis area was that developed by the American National Standards Institute asANSI Z88.2-1980, entitled "Practices for Respiratory Protection" (Ex. 10).This standard was an updated version of the 1969 ANSI standard which was usedas the primary basis of OSHA's current standard, Sec. 1910.134. Following aresome 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 protectionfactors is introduced and protection factors are assigned.

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

The OSHA standard, based on the outdated 1969 ANSI standard, does notaddress these topics. The ANSI revisions reinforce OSHA's decision to reviseits standard to address the same and other issues.

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

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

(a) A very clear definition of the hazards that will be encountered and thedegree 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 highlevel of respiratory protection is maintained.

The Canadian consensus standard deals with several areas in more detail thanOSHA's current standard, and some of the language used has been incorporatedinto this proposed standard, particularly in the areas of training andprogram evaluation.

Documents developed by U.S. military organizations also indicate the needfor comprehensive respiratory protection programs. A military standardentitled "Respiratory Protection Program" (TB MED 223/AFOSH STD 161-1/DLAM1000.2) has been developed for the use of the Air Force, Army, and theDefense Logistics Agency (15). This document is similar to OSHA's currentstandard (Sec. 1910.134), but includes sections which expand upon therequirements of that standard and provide additional guidance in criticalareas. The military standard provides considerable direction on the selectionof respirators, including the protection factor concept, that is not includedin OSHA's current standard. It also provides additional information on fittesting and training. OSHA's proposed standard similarly recognizes thedeficiencies of Sec. 1910.134, and provides additional guidance to employersin these same areas as well as others.

It can be seen from this brief discussion that there is widespread agreementamong safety and health professionals that adequate respiratory protectioncannot be provided in the absence of specific procedures. The range ofequipment choices available, the diversity of hazards against which they areto protect, the differences in work situations, and other variables increasethe complexity of the decision making process in terms of selecting theappropriate respirators, and ensuring they fit, are worn properly, and aremaintained as necessary. OSHA proposes to revise its current standard toensure that appropriate procedures are implemented by employers, and thusincrease the probability that protection to the extent technologicallyfeasible for respirators will be provided for employees.

V. Certification/Approval Procedures

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

NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was held inJuly 1980 to address the certification program. On August 27, 1987, NIOSHpublished a notice of proposed rulemaking (52 FR 32402) which would allowNIOSH 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 revisedrequirements for testing and certification of respirators, and included a setof 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 proposalfor further public comment.

Numerous commenters to the ANPR addressed the issue of NIOSH respiratorcertification (Ex. 15-11, 15-27A, 15-58, 15-14, 15-43, 15-50) and most agreedthat the certification program should be improved. Some suggested that OSHAassume the function of certification of respirators. OSHA believes it isadvisable not to undertake operation of the certification program currentlyoperated by NIOSH and MSHA. OSHA has neither the expertise nor equipment toperform respirator performance testing. OSHA intends that informationgenerated in this proceeding will be made available to NIOSH to use in itsrevision of its respirator certification standards, and that NIOSH will makeits rulemaking record available to OSHA. OSHA believes that, for the present,the best course is to continue to require NIOSH respirator certification asit has in the past.

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

Introduction

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

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

Data Sources

The primary sources of information used for this impact analysis are areport by Centaur Associates, Inc. entitled, "Preliminary Regulatory ImpactAnalysis of Alternative Respiratory Protection Standards" and a report byCentaur Associates, Inc. entitled, "Compliance Cost Analysis: Current andProposed Respiratory Protection Standards", available in the docket. Most ofthe information contained in this report was collected from an in-depthsample survey of the current work practices in 2,300 manufacturing plants inwhich respirators are used. The results from the manufacturing sector wereextrapolated to nonmanufacturing plants and construction firms.

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

Industries and Employees Affected

The data currently available to OSHA indicate that the proposed standardwould affect approximately 3.6 million employees of whom 1.6 million areemployed in the manufacturing sector, 1.5 million are employed in thenonmanufacturing sector, and 0.5 million are employed in the constructionsector. Of the 3.0 million employees who wear respirators for routine oroccasional work, 1.1 million use respirators routinely and 1.9 million userespirators occasionally. About 600,000 employees wear respirators for bothroutine and emergency use. Of these 600,000 employees, approximately 150,000wear respirators only for emergencies. Respirators are used routinely oroccasionally in about 606,200 establishments of which 123,200 aremanufacturing plants, 360,100 are nonmanufacturing plants, and 122,900 areconstruction sites. Respirators are also used only for emergencies in another51,800 establishments, of which 15,200 are manufacturing plants, 27,300 arenonmanufacturing plants, and 9,300 are construction sites. Each generalindustry and construction sector would be affected by this proposed standardbecause respirators are used in many different work activities in each ofthese sectors.

Nonregulatory Environment

In general, worker compensation systems designed to compensate employees foroccupationally related illnesses have not had a significant impact upon theincidence of long-term chronic occupational illnesses. One reason is that itis extremely difficult to determine the cause of illness at the time thedisease is diagnosed. The long latency period between the exposure and theonset of disease, and the mobility of employees among occupations and firmscombine to make it difficult to establish a direct causal relationshipbetween an occupational exposure and the resultant illness. The absence of areadily observable cause and effect relationship provides a disincentive forsome firms to establish appropriate safety and health measures. In addition,the lack of information regarding health risks, inadequate training, or amisunderstanding of the function of a respirator may lead to employeeexposure to harmful levels of hazardous substances. Thus, the nonregulatoryenvironment does not guarantee employee safety because the economicincentives are absent, employees are improperly trained in respirator use,and employees do not have sufficient information on the resultant benefits ofrespirator 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 ofthe information currently available, the proposed standard has been found tobe technologically feasible. Additional information that is submitted will becarefully evaluated by OSHA before issuing the final rule.

Summary of Cost

OSHA derived its cost estimates by first examining the cost of coming intocompliance with both the existing and proposed standards, using current workpractices as its baseline. This estimate does not include the cost ofpurchasing the respirators; it includes only the cost of all the otheractivities required by the existing and proposed respiratory protectionprograms. The requirement to wear respirators comes from other standards orspecific conditions -- not from this standard. Consequently, respiratorpurchase has been costed in other standards which require their use. Thisstandard requires improvements in the respirator program when other standardsrequire their use and this analysis costs these additional programrequirements.

OSHA estimates that the total annualized incremental cost of the proposedrevisions 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 thenonmanufacturing sector, with the remainder in manufacturing ($38.2) andconstruction ($13.1). The largest incremental cost is attributable toenhanced requirements for qualitative fit testing ($58.5 million). Otherenhanced requirements include provisions dealing with disposable respiratorpractices ($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 toimpose costs on employers without providing safety, and have been modified.Cost savings would be derived from modified requirements regarding airquality in atmosphere-supplying respirators ($8 million) and eyeglass mounts($0.4 million). These estimates are conservative, as they do not factor insavings 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 burdenon employers. However, the respirator survey found significant noncompliancewith several provisions of the existing standard, and by extension, theproposed standard. Costs relating to compliance with these provisions isdiscussed 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 respiratoryprotection program can prevent fatalities and illnesses from both acute andchronic exposures to hazardous substances. Based on data found in the OSHAIntegrated Management Information System (IMIS), OSHA determined that thereis an annual average of 66,500 illnesses that are due to acute exposures toairborne hazardous substances. OSHA estimated that compliance with theexisting standard could have prevented about 20 percent of these incidents,and that the proposed revisions to the existing standard could prevent anadditional 5 to 10 percent. Thus, full compliance with proposed revisions tothe existing standard could prevent between 3,325 and 6,650 illnesses due toacute exposures annually.

In addition, using an Office of Technology Assessment estimate that 5percent of all cancers are occupationally related, OSHA estimated that thereare annually between 9,085 and 15,660 new cancer cases, between 6,850 and11,000 cancer deaths, due to chronic exposures to occupational airbornecarcinogens. In addition, airborne exposure to hazardous substances such assilica are estimated to account for another 4,200 chronic illnesses annually.OSHA anticipates that full compliance with the existing standard wouldprevent about 10 percent of these cases, and that proposed revisions to theexisting standard would prevent an additional 2.5 to 5 percent. Thus, after aperiod of time, between 227 and 783 new cancer cases, between 171 and 550cancer fatalities, and between 105 and 210 chronic illnesses could beprevented each year by full compliance with the proposed revisions to therespirator standard.

OSHA requests public comment on these benefits estimates in general and themethodology used in making them. The agency requests comment on how much aneffective respiratory protection program, as proposed, would reduce the levelof occupational illness currently found. In addition, information and dataare requested on current respirator use patterns as related to exposure (i.e.percentage of respirator users with potential exposures at levels up to 10times the PEL; 50 times the PEL, etc.) and any anticipated impact thisproposed standard would have on respirator use.

Economic Impact and Feasibility

In assessing the economic feasibility of the respirator standard, the Agencyexamined the costs of compliance of the standard, in relation to sales andprofits in affected industries. This analysis was based on data in the 1986Centaur report for manufacturing, and on industry profile information fromOSHA's 1989 PPE survey and 1992 Dun and Bradstreet financial data.

OSHA assessed the potential economic impacts and has preliminarilydetermined that the standard is economically feasible for each of the majorindustry groups that will be affected. OSHA conducted its analysis at thetwo-digit SIC level. This has been OSHA's procedure for doing regulatoryimpact analyses for other proposed standards. OSHA preliminarily concludesthat this is reflective of the actual impact on the average firm within eachsubsector. It does not appear that the affected groups will experiencesignificant adverse economic impact as a result of the standard. However, ifany interested person has information to show that the analysis at thetwo-digit level is not representative of the potential economic impact of theproposal, OSHA requests the following information: reasons why thepreliminary regulatory impact analysis is not reflective of the actualanticipated costs in any particular sector; specific information as to whythe analysis at the two-digit level fails to adequately represent theeconomic impact; and specific information to help OSHA to better predict theimpact on the sector in question. Such information should be included in thecomments 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 ofsales, meaning that less than a 0.1 percent increase in prices would benecessary to cover these costs. At this level, businesses should have notrouble passing these costs onto consumers, as it is unlikely consumers wouldnotice the difference, in the face of other market fluctuations. Even if thiswere somehow not possible, in the worst case, any reduction in profits wouldbe less than 1% in any industry. For these reasons, the Agency anticipatesthe standard should be economically feasible in all industries.

The Agency invites comment by any industries that anticipate problems witheconomic feasibility in complying with these revisions to the respiratorstandard.

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

Regulatory Flexibility Analysis

Pursuant to the Regulatory Flexibility Act of 1980, the Assistant Secretarypreliminarily determined that the proposed standard would not be asignificant burden upon a substantial number of small entities. There may,however, be a higher cost per respirator-wearing-employee for some smallentities. In particular, larger plants that have in-house testing facilitiesand in-house medical facilities would be able to provide the necessaryservices at lower unit costs than could smaller companies. OSHA is solicitinginformation on this issue, and any comments received will be carefullyreviewed 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 withthe requirements of the National Environmental Policy Act (NEPA) of 1969 (42U.S.C. 4321, et seq.), the regulations of the Council on EnvironmentalQuality (CEQ) (40 CFR Part 1500), and the Department of Labor's (DOL's) NEPAProcedures (29 CFR Part 11). As a result of this review, the AssistantSecretary for OSHA determined that the proposed rule will have no significantenvironmental impact.

The focus of the proposed standard is on reducing risks to employees whomust wear respiratory protection in order to reduce their exposures tohazardous airborne substances when effective engineering controls are notfeasible, while they are being installed, or during emergencies. The proposedprovisions 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 therespirator program would remove hazardous airborne particulates andcontaminants from the breathing zone of the worker and not from the generalambient atmosphere in the work environment. In general, the procedures andapplications of the proposed provisions do not impact on air, water or soilquality, plant or animal life, the use of land, or other aspects of theenvironment and therefore are not anticipated to have any significant effecton the environment.

VII. Summary and Explanation of the Proposed Standard

In developing the proposed standard, OSHA received and analyzed all of theregulations, documents, and comments described above, as well as otherinformation the Agency has obtained during the developmental process. Thisinformation can be found in the public record, Docket H-049. The materialcollected and reviewed generally supports OSHA's finding that in order toensure adequate respiratory protection, employers requiring employees to wearrespirators must develop and maintain an appropriate respiratory protectionprogram.

Setting clear protective requirements for selecting, fitting, using, andmaintaining respiratory protective devices will help employers to provide theappropriate protection for their employees, and thus reduce their exposure tohazardous chemicals.

This proposal is intended to replace OSHA's current respiratory protectionstandard for general industry, 29 CFR 1910.134, and the respiratoryprotection provisions in the OSHA construction standards, 29 CFR 1926, andmaritime standards, 29 CFR 1915-1918. Although a performance standardorientation has been adopted, enforcement experience with the currentstandard has shown that the existing requirements do not provide sufficientspecific information for employers to comply, particularly in the areas ofrespirator selection, medical surveillance, and fit testing. Therefore, thisproposal is designed to provide employers with a clear description of theappropriate steps to follow to establish an effective respiratory protectionprogram.

OSHA recognizes that there may be differing opinions regarding theparticular provisions that should be included in such a comprehensiverespiratory protection standard. The Agency is hereby soliciting informationon alternative requirements to address the problems of inadequate or improperrespiratory protection. The final standard adopted will incorporate whatevermeans are best for ensuring an effective respiratory protection program andwhich are supported by the public rulemaking record. The proposed standardcontinues the public rulemaking process by presenting the Agency's assessmentof the best method to accomplish the development and maintenance of arespiratory protection program given our current state of knowledge.

The following summary and explanation is designed to clarify the intent ofthe proposed provisions, as well as to identify issues OSHA is aware of andwould like to receive comments on. Comments are also invited on otherrelevant issues which are not specifically raised in this discussion. Allsuch comments should clearly identify the provision of the standard to whichthey apply, as well as the position taken on that provision. It is mosthelpful, and makes the record more accessible, when comments are organized inthe same order that the standard is written and are indexed to the particularprovisions of the standard to which they refer. It should also be noted thaton technical issues, substantiation should be presented as well as opinion onthe appropriateness of a particular requirement. Such substantiation may takethe form of anecdotal evidence of experience, scientific data, etc.Submission of substantive commments helps OSHA build a thorough record uponwhich to base the final standard. A complete record on all the issues willhelp ensure that the final standard is appropriately drawn to address theissue of respiratory protection.

(A) Scope and Application

The existing OSHA respirator standard contains a methods of complianceprovision (Sec. 1910.134(a)(1)) which establishes a hierarchy of controltechniques to be used for protecting employees from exposure to airbornecontaminants, with engineering controls to be implemented first andrespirators allowed only when engineering controls are not feasible or whilethey are being instituted.

This provision of the standard is not a subject of this rulemaking; onlyissues relevant to the content of a respirator use program are to beaddressed at this time. OSHA is reviewing Sec. 1910.134(a)(1) and similarhierarchy of controls provisions contained in Sec. 1910.1000 in a separaterulemaking.

In the prepublication draft, OSHA asked whether to make the requirements fora respirator program apply whenever the employer either required or permittedthe use of respirators. The requirement that the program be implementedwhenever employees were permitted to wear respirators on their own wascriticized 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 todiscourage permission to use respirators voluntarily and thus, in somesituations, could lessen workplace protection. Upon consideration of thesecomments, OSHA is now proposing to retain the wording in paragraph (a)(2) ofthe current standard which requires that respirators be provided when suchequipment is necessary to protect the health of the employee.

Paragraph (a)(2) actually addresses two issues -- (1) when respirators arerequired to be used and (2) that of the need to implement a full respiratoryprotection program. Regarding when respirators are required to be used, OSHAinterprets paragraph (a)(2) as clearly requiring their use in the absence ofengineering controls whenever employee exposures would exceed an OSHApermissible exposure limit (PEL) or warrant a 5(a)(1) citation under the OSHAct. Under these conditions, the proposal would require respirators to beprovided by the employer and a respiratory protection program that meets thefull requirements of the respirator standard to be implemented. Thisinterpretation continues OSHA's existing compliance policy covering therequired use of respirators.

A respiratory protection program complying with the full provisions of thisproposal would be required whenever an employer requires any employee to weara respirator, regardless of the exposure level and whether the substance isregulated. The use of a respirator in itself could constitute a hazard andimproper use of a respirator can also increase the exposure hazards and insome cases can make the exposures more dangerous than if the respirator hadnot been used in the first place.

However, OSHA requests comments on whether the respirator program, whenrequired by the employer in the absence of a regulatory requirement ofanother standard, could be modified for certain respirator types, uses, orconditions, to still provide the needed protection. Comments with supportingdata are requested on what specific provisions of the proposal could bereduced or eliminated in this case based on respirator type or environmentalor workplace conditions, and under what specific circumstances the requiredprovisions could be changed.

If a respirator is used by an employee but its use is not required by OSHAstandards or statute, or by the employer, which is known as a voluntaryrespirator 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 thebeyond required respirator use to include voluntary respirator use situationsas well.

OSHA requests comments on whether there are certain low risk respirator usesituations which could justify the reduction or elimination of certainprovisions in the mandatory respirator program in order to provide additionalcompliance flexibility. How such lower risk situations could be defined, andwhich provisions could be modified or eliminated should be listed along witha discussion of how changing the provisions would effect potential risks ofrespirator use.

The proposal contains a threshold of five hours of respirator wear in anywork week before a medical evaluation must be obtained. Is a five hourthreshold appropriate, or should it be larger, and if so, what specificsituations would serve to justify a larger time threshold? Should there beany time limit, or should any respirator use trigger medical provisions?

(B) Definitions

The proposed standard includes a number of definitions which are unique, andwhich should be consulted to properly understand the standard. The currentrespiratory protection standard has no definitions, which may havecontributed to misunderstandings in knowing how to comply.

A number of the definitions deal with specific types of respiratoryprotective devices, or with components of those devices. For example,"air-purifying respirator", "disposable respirator", "filter", and "positivepressure respirator" are all defined in this paragraph. Most of thesedefinitions are based on generally recognized sources, such as the currentANSI standard, or documents from the National Institute for OccupationalSafety and Health. Others have been developed by OSHA for purposes of thisstandard. With the few exceptions discussed in the following paragraphs, thedefinitions are straight forward and self-explanatory. OSHA invites commenton the appropriateness of these definitions and invites the submission ofalternatives. Some of the definitions require explanation as follows.

A definition for "hazardous exposure level" has been developed and includedfor the following purpose. In order to select a respirator which provides theproper degree of protection, it is necessary to know both the anticipatedambient airborne exposure level and the exposure that is acceptable in thebreathing zone. One can then determine the extent to which the respiratormust reduce the ambient exposure level. Thus in the respirator selectionscheme, an exposure limit must be used to establish a goal to determine thedegree of protection needed for employees exposed in a given work situation.Although this standard does not set specific exposure limits, a concept ofexposure must be included in the selection criteria to be consistent withcurrent practice.

Since OSHA has permissible exposure limits established for about 600substances, and there are thousands of hazardous substances to whichemployees are exposed, other sources of hazard information must be used forsubstances not regulated by OSHA. This does not mean that OSHA is in effectestablishing permissible exposure limits for these other substances. It justmeans that where employers decide to use respirators to control exposure, atarget exposure level must be established to determine the appropriaterespirator to use. Therefore, OSHA has defined the term "hazardous exposurelevel" for purposes of selecting respirators, as follows.

Where OSHA does have a PEL, it must be used. If there is no PEL for thesubstance, the employer must use the American Conference of GovernmentalIndustrial Hygienists (ACGIH) Threshold Limit Value (TLV) for the chemical ifone exists.

If there is no PEL or TLV for the chemical, the employer must determine the"hazardous exposure level" based on available scientific informationincluding the MSDS. In some situations, the suppliers of the chemicals maymake recommendations for appropriate exposure levels based on their ownexperience. In any event, the employer must establish a protective goal,based on available information, in order to choose the appropriaterespirator, and must be able to substantiate how that goal was chosen.

It should be noted that the OSHA PEL, ACGIH TLV, and other availableexposure limits are required to be reported on the material safety data sheetgenerated by chemical manufacturers and importers under the requirements ofOSHA's Hazard Communication Standard (29 CFR 1910.1200). This informationshould assist downstream employers in choosing respirators to protect theiremployees.

As stated in the scope paragraph, the standard is to apply when employeesare required to wear respirators to reduce their exposures to airborneconcentrations of "hazardous chemicals" in the workplace. For purposes ofthis standard, "hazardous chemical" is defined as a substance which meets thedefinition of "health hazard" under OSHA's Hazard Communication Standard (29CFR 1910.1200). This approach helps to ensure that definitions of hazard areconsistent in current OSHA standards; provides a broad scope of coverage forthis standard; and incorporates a data base for employers in the form ofmaterial safety data sheets generated under the requirements of the HazardCommunication Standard.

The Hazard Communication Standard defines "health hazard" as a substance forwhich there is statistically significant evidence based on at least one studyconducted in accordance with established scientific principles, showing thatacute or chronic health effects may occur in exposed employees. The term"health hazard" includes substances which are carcinogens, toxic or highlytoxic agents, reproductive toxins, irritants, corrosives, sensitizers,hepatotoxins, nephrotoxins, neurotoxins, agents which act on thehematopoietic system, and agents which damage the lungs, skin, eyes or mucousmembranes.

OSHA notes that the definition of "hazardous chemical" is used here merelyto target the broad range of substances which may entail respirator use.However the requirements of this proposed standard only apply when aregulated substance is being used or when an employer requires the use of arespirator for any reason. One term which is frequently used in regard toatmospheres which require respiratory protection is "immediately dangerous tolife or health" or "IDLH." Such atmospheres require the most protective typesof respirators for workers. Although the term is used frequently, there hasbeen no one accepted definition of it. In the preproposal draft of therespirator standard, OSHA defined an IDLH atmosphere as one "where theconcentration of oxygen or hazardous chemical(s) would cause a person withoutrespiratory protection to be fatally injured or would cause irreversible orincapacitating effects on that person's health." In addition, the definitionstated that in establishing the IDLH for a workplace situation, the employerwas to consider "the maximum concentration of the hazardous chemical at whichone could escape within ten minutes without any escape-impairing or immediateor delayed irreversible health effects" and "the minimum concentration of thehazardous chemical at which severe eye or respiratory irritation or otherreactions would inhibit escape without injury." This definition was derivedfrom the IDLH definition in the Joint NIOSH/OSHA Respirator Decision Logic.An escape time of 30 minutes was considered in the Decision Logic as themaximum permissible exposure time for escape from an IDLH atmosphere. Therehas always been disagreement whether the maximum escape time should bereduced to 10 minutes as OSHA recommended in the preproposal draft, orwhether some other time limit such as 15 or 30 minutes should be used. Sincethere is no clear evidence as to what the time limit should be and just howsuch a limit would be used in determining an IDLH atmosphere, OSHA isproposing a less specific, but clearly protective, IDLH definition that doesnot 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 certificationprocedures to read:

"Immediately Dangerous to Life or Health" (IDLH): Respiratory exposureswhich:

(1) Pose an immediate threat of loss of life or of irreversible or delayedeffects on health or;

(2) Eye exposures which would prevent escape from such anatmosphere. The OSHA Hazardous Waste Operations and Emergency ResponseStandard, 29 CFR 1910.120, contains an IDLH definition that reads asfollows:

"IDLH" or "Immediately dangerous to life or health" means an atmosphericconcentration of any toxic, corrosive, or asphyxiant substance that poses animmediate threat to life or would cause irreversible or delayed adversehealth effects or would interfere with an individual's ability to escape froma dangerous atmosphere.

The hazardous waste IDLH definition addresses all the issues covered in theNIOSH IDLH definition and more clearly addresses asphyxiant atmospheres. OSHAhas therefore chosen to adopt the hazardous waste operations IDLH definitionfor this respiratory protection proposal which, in addition to being mostappropriate, will also assure consistency between the various OSHA standardsthat address IDLH atmospheres. Comment is requested on this definition ofimmediately dangerous to life or health, and on its appropriateness forrespiratory protection standards.

Since the warning properties of a gas or vapor are to be considered in theselection of an air-purifying respirator, OSHA has included a definition ofwhat constitutes "adequate warning properties." The "adequate warningproperties" referred to in regard to respiratory protection are "thedetectable characteristics of a hazardous chemical, including odor, taste,and/or irritation effects which are detectable and persistent atconcentrations at or below a hazardous exposure level and exposure at theselow levels does not cause olfactory fatigue." This definition combines thedefinitions for warning properties and adequate warning properties from thepreproposal draft.

The definitions of "oxygen deficient atmosphere" and "oxygen deficient IDLHatmosphere" have also been changed from the definitions in the preproposaldraft. An oxygen deficient atmosphere is now defined as "an atmosphere withan oxygen content of less than 19.5% by volume at altitudes of 8000 feet orbelow." This definition retains the traditional 19.5% oxygen level as thepoint below which an oxygen deficient atmosphere exists. It is alsoconsistent with the minimum oxygen content of Grade D breathing air. Above8000 feet, an oxygen deficient atmosphere, one with an oxygen level below19.5%, would also be considered an oxygen deficient IDLH atmosphere (seebelow) and the proposal treats it as such. Thus the definition for "oxygendeficient" does not address altitudes above 8000 feet. This change indefinition will allow the use of air-purifying respirators in normalatmospheric air for altitudes up to 14,000 feet.

The oxygen deficient IDLH atmosphere definition has been changed to "anatmosphere with an oxygen content below 16% by volume at altitudes of 3000feet or below, or below the oxygen levels specified in Table I for altitudesup to 8000 feet, or below 19.5% for altitudes above 8000 feet up to 14,000feet." An oxygen content of 16% at 3000 feet of altitude corresponds to anoxygen partial pressure of 100 millimeters of mercury in the freshly inspiredair 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 respiratorstandard defines as "oxygen deficiency, immediately dangerous to life orhealth". However, rather than using the calculation formula from ANSI, thisproposal provides an equivalent table of the oxygen percentages for oxygendeficient atmospheres and oxygen deficient IDLH atmospheres at variousaltitudes for simplicity of use. The table provides a side-by-sidepresentation of the oxygen deficient atmosphere and oxygen deficient IDLHatmosphere levels to avoid any confusion between the two, and removes thenecessity of calculating the values from a formula.

At altitudes above 8000 feet up to 14,000 feet an oxygen deficient IDLHatmosphere would exist when the oxygen content in the workplace atmospherefalls below 19.5%. The respirator selection provision of the proposal requirethat an atmosphere-supplying respirator with auxiliary escape provision or anSCBA be used in such situations. These respirators supply the wearer withGrade D breathing air. Since the allowable oxygen content in Grade Dbreathing 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 anoxygen deficient IDLH atmosphere would occur for altitudes above 8000 feet.

OSHA requests comments and specific data on the effects of reduced oxygencontent in workplace atmospheres and on the appropriateness of the "oxygendeficient" atmosphere and "oxygen deficient IDLH" atmosphere definitionscontained in the proposal. Alternatives to the OSHA proposed definitionsshould include the physiologic basis for any changes proposed for the oxygenlevels used to determine these oxygen deficient atmospheres.

(C) Respiratory Protection Program

Once an employer has decided to use respiratory protection, a writtenrespiratory protection program must be developed and implemented. Thisrequirement is essentially the same as that in the existing respiratorstandard, 29 CFR 1910.134(b)(1), which requires that written standardoperating procedures governing the selection and use of respirators beestablished. The purpose of this requirement is to ensure that employersestablish a standardized procedure for selecting, using, and maintainingrespirators for each workplace where respirators will be used.

The ANSI Z88.2-1980 standard for respiratory protection states that writtenstandard operating procedures covering a complete respirator program shall beestablished and implemented (Ex. 10). This performance oriented requirementrecognizes the need for a systematic respiratory protection program toprovide for consistency in protection. The ANSI standard does not containdetailed instructions on the content of standard operating procedures, but itdoes describe elements of a minimally acceptable respirator program.

The current OSHA respirator standard requires written standard operatingprocedures covering selection, use, cleaning, maintenance, inspections,emergency use, training of supervisors and respirator wearers, andrecordkeeping. As part of the preliminary regulatory impact analysis for thisproposal, data were collected on current respirator practices and proceduresin over 2300 manufacturing plants in 15 SIC codes. This sample wasextrapolated to produce estimates of respirator-related practices for about123,200 manufacturing plants with routine and occasional respirator use. Only25.5% of these plants are estimated to have had written standard operatingprocedures, and only 7.9% had procedures that addressed all seven areasspecified. Over 80% of the large plants (1000 or more employees) had writtenprocedures, while in small plants (less than 50 employees) only about 22% hadwritten procedures. The survey showed that the intent of the existingrespirator standard as well as the areas to be addressed in standardoperating 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 numberof cases where problems were found since it is OSHA policy not to issuecitations when no overexposures were documented.

A review of the comments received in response to the ANPR showed widegeneral support for the requirement for written standard operatingprocedures. Only one comment by Western Electric Co. for AT&T (Ex. 15-51)recommended that the written program requirement be dropped. The commenterstated that while many users of respirators require written procedures for aneffective protection program, OSHA should not be concerned about writtenprocedures, but only about the overall effectiveness of the respiratorprogram. There were several submissions that supported the existing writtenstandard operating procedure requirement (Ex. 15-37, 15-42, 15-50, 15-56,15-77) and recommended that OSHA make no significant changes. However, OSHA'scompliance experience shows that there is a need to clarify the intent of therequirement and make it clear to employers what OSHA expects in a writtenrespiratory protection program.

Several ANPR commenters felt OSHA should not include detailed specificationsin 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 bewritten in performance language, with the specific contents of the proceduresto 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 wererecommended 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 coveredwhere 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 standardoperating procedures varied slightly among the commenters, but the majorareas of respirator inspection, cleaning, maintenance, selection, training,use, fit testing, recordkeeping and program evaluation were common to most ofthe lists. Others recommended OSHA use the program specification in the LosAlamos National Laboratory (LANL) respirator training program or in the NIOSHguide to respiratory protection (Ex. 15-27A, 15-81). The AIHA (Ex. 15-81)also stated that the standard operating procedures should be more specific indefining employer/ employee responsibilities and the types of respiratorsrequired for specific jobs.

Written standard operating procedures are essential to an effectiverespiratory protection program. Developing and writing down standardoperating procedures requires employers to think through just how all of therequirements of the respiratory protection standard will be met in theirworkplace. The current respirator standard requires that employers developwritten standard operating procedures that include all information andguidance necessary for respirator selection, use, and care, along withwritten procedures covering safe use of respirators in dangerous atmospheresthat might be encountered in normal operations or emergencies. The proposalin section (c) contains additional descriptions of the elements to beincluded in the written standard operating procedures to provide additionalguidance for employers. The requirement is performance oriented since theproposal does not contain detailed specifications for the required writtenstandard operating procedures. The list of elements to be covered is similarto those contained in the ANSI Z88.2-1980 standard, and includes many of therecommended 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 theprocedures are left to the employer who can tailor them to match the manyvaried situations that can occur. Many of the elements will be common to allrespiratory protection programs, such as respirator selection, care, use,training, and program evaluation. Some elements such as air quality withsupplied air respirators are required only when those types of respiratorsare used.

The elements of the standard operating procedures are part of the mandatoryprovisions of the proposal. Listing the requirements in a non-mandatoryappendix, as was suggested, would perpetuate a recognized problem area. Thecurrent standard fails to clearly identify the areas to be covered in thewritten standard operating procedures, and as a result only a quarter of thewritten procedures that were surveyed addressed all the needed elements (Ex.33-5). Placing the elements in a non-mandatory appendix would encourage thecontinuance of current practice in writing standard operating procedures. Theproblem is not only poorly written procedures, but failure to address some ofthe necessary elements at all. Only by making the required elements mandatoryand enforceable can an improvement in written standard operating proceduresand thus an overall program be assured.

Employers are required by the proposal to designate a person qualified bytraining and/or experience in the proper selection, use, and maintenance ofrespirators to be responsible for implementing the respirator protectionprogram, and for conducting the periodic evaluations of its effectiveness.This requirement is similar to that in the ANSI standard (Ex. 10) whichrequires that responsibility and authority for the respirator program beassigned to a single qualified person with sufficient knowledge of respiratorprotection to properly supervise the program. The OSHA standard isperformance oriented since it allows the employer to choose the person bestqualified for the assignment.

The training requirements of the respirator program supervisors was thesubject of a question in the ANPR. Several ANPR commenters said thatspecifying the type of training required would be beyond the scope of thestandard (Ex. 15-13, 15-35, 15-75, 15-75A, 15-75c). Others recommended OSHAadopt the performance language of the ANSI standard (Ex. 15-26, 15-31,15-38). Still others recommended that the supervisor be under the directionof an industrial hygienist or safety professional (Ex. 15-55, 15-70, 15-76).Some wanted the level of training required to be commensurate with thecomplexity 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 tohave knowledge of respirators equivalent to that obtained from taking theNIOSH 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 programsupervisors has not been done in this proposal. The level of training thatwould be appropriate for a workplace with limited respirator use would bequite different from that required at another workplace with extensiverespirator use that includes IDLH atmospheres, highly toxic chemicals, orother complex respirator use operations. Therefore, OSHA has adopted aperformance language provision for program supervisor training that issimilar to the ANSI standard requirement. The level of training for therespirator program supervisor must be adequate to deal with the complexity ofthe respirator program. OSHA has not established any one training program,such as the NIOSH respirator course, as the level of training programsupervisors must achieve. The NIOSH course covers many different respiratortypes and uses, and may provide too much information on certain types ofrespirators such as SCBAs for program supervisors who run simple programs,yet not provide enough information for respirator program supervisors with ahighly complex respirator program. The program supervisor can also use theassistance of industrial hygienists, safety professionals, or otherrespirator experts to help run the respirator program. Therefore, thetraining requirements for respirator program supervisors have been written inperformance language, to allow the training requirements to fit the needs ofthe respirator program.

A number of commenters on the preproposal draft addressed the issue ofprogram administration. Only the American Textile Manufacturer's Institute(Ex. 36-18) felt the requirement that a person be designated to administerthe respiratory protection program should be deleted. Other commenterssupported the requirement (Ex. 36-14, 36-31, 36-36, 36-40, 36-44, 36-47). Thetraining requirements for the program administrator was also the subject ofcomments. The Nuclear Regulatory Commission (Ex. 36-31) recommended that bothtraining and 6 to 12 months field experience in using respirators should berequired. Lawrence Durio (Ex. 36-36) recommended that the person responsiblefor the respirator protection program be a certified industrial hygienist orcomplete a NIOSH sponsored course in respiratory protection designedspecifically for the training of respiratory protection program managers.Richard Boggs of ORC (Ex. 36-47) recommended that the qualifications of theadministrator reflect the complexity of the respirator program.California/OSHA (Ex. 36-44) recommended that all program administers at leasthave demonstrable knowledge of the requirements of 1910.134 and whererespirators may be used for entry into IDLH atmospheres, the programadministrator must attend the NIOSH respirator course or equivalent. DonaldRapp of the Dow Chemical Company (Ex. 36-40) recommended that OSHA allow acommittee as well as an individual to be the responsible party, since acommittee is more likely to be responsible for the program than an individualin larger companies. ORC (Ex. 36-47) also recommended that OSHA allowresponsibility to be vested in an individual or in a committee/ departmentdesignated as the central authority.

To assure that the integrity of the respiratory protection program ismaintained through the continuous oversight of one responsible individual,the proposal requires that a qualified person be designated as responsiblefor the management and administration of the program. That individual canwork with a committee or assign responsibility for portions of the program toother personnel, but the overall responsibility for the operation of theprogram remains with the designated person. This approach promotescoordination of all facets of the program. The training requirement for theprogram administrator has been left performance oriented. With the varyingcomplexity of respirator programs, specifying a uniform training requirementwould be very difficult. The level of training required varies with thecomplexity of the respirator program. OSHA invites further comments onwhether specific minimum training requirements for program administratorsshould be set, and on what the training should be.

Employers are required to keep the written respiratory protection programcurrent. The preproposal draft required that the written respiratoryprotection program be maintained "in a current fashion." The Motor VehicleManufacturer's Association (Ex. 36-37) recommended that the phrase "in acurrent fashion" be deleted since requiring that the employer maintain thewritten program implies that it be maintained in a current fashion. In orderto clarify the intent of the provision the phrase "in a current fashion" hasbeen removed and the wording has been revised to require that the employermaintain a written respiratory protection program that reflects currentworkplace conditions and respirator use. As the workplace situation orrespirator use changes, the program is to be revised. Also the program mustbe made available, upon request, to employees, designated representatives andto OSHA.

(D) Selection of Respirators

1. Introduction

The existing OSHA respiratory standard does not contain specific guidancefor the selection of respirators. Instead, the standard requires that theselection of respirators be made according to the guidance of the AmericanNational Standard, Practices for Respirator Protection Z88.2-1969. The 1969ANSI standard recommended appropriate respirators for use with variouscategories of contaminants, but did not attempt to set individual protectionlevels for each type of respirator. Although the ANSI standard was revised in1980, the current ANSI committee (Ex. 36-55) considered the 1980 standard tobe obsolete and was in the process of developing another revision withprovisions that differ substantially from the 1980 version. A consensus on arevised 1992 ANSI standard was not reached by ANSI during the time of theoriginal OSHA rulemaking comment periods. Therefore there were no substantivecomments received by OSHA on the provisions of the revised 1992 ANSIrespiratory protection standard. However, as discussed later, OSHA hasreviewed the new ANSI standard and has given it thorough consideration in thepreparation of the final OSHA proposed standard.

The joint NIOSH/OSHA respiratory decision logic, originally published in1975, was an early attempt to develop a logic for respirator selection thatcould easily be followed and would enable an individual to pick theappropriate respirator consistently. OSHA believes that changes in respiratortechnology and new data on respirator fit and protection levels have renderedthis early decision logic, as well as the 1980 ANSI standard obsolete, andrules for selection are essential to avoid the risk of using respiratorswhich are incapable of providing the necessary protection. The current OSHAstandard lacks such rules, and an analysis of enforcement experience (Ex.33-5) shows that as a result, the selection of inappropriate or unapprovedrespirators and failure to provide suitable respiratory protection accountedfor 26% of the violations of the respirator standard cited during fiscalyears 1977 to 1982.

The proposal requires employers to provide respiratory protection at no costto employees. This is consistent with the provisions of the currentrespiratory protection standard, as well as with the OSH Act, to ensure thatemployers provide whatever controls are necessary to protect employees fromhazards generated by the work operation.

Where elastomeric facepieces are to be used, the employer shall provide aselection of respirators from an assortment of at least three sizes for eachtype of facepiece from at least two manufacturers. Comments were receivedstating that the cost of maintaining three different sizes of twomanufacturer's respirators would appear excessive if only one or twoemployees require a respirator (Ex. 36-32). Others indicated that theassortment should be required for the initial fit (Ex. 36-28, 36-36) but notfor the annual retest since each fit test respirator must be cleaned beforeits next use. OSHA is maintaining in this proposal the requirement for anassortment of respirators for both the initial and annual fit tests. OSHAbelieves that nothing in the course of respirator use is more important thanachieving the best possible fitting respirator and that this is only possiblewhere an adequate selection is available. Availability of different sizes andtypes of respirators during retesting is especially critical where theemployee's physical conditions may have changed as the result of a modestweight 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 toconsider available information concerning workplace conditions andcharacteristics of the hazardous chemical. The proposal lists eleven suchcategories of information.

(i) Nature of the hazard. The nature of the hazard, whether it is in theform of a gas, dust, organic vapor, fume, mist, oxygen deficiency, or anycombination of hazards needs to be taken into account.

(ii) Physical and chemical properties of the air contaminant. The physicaland chemical properties that affect respirator selection such as particlesize for dusts, vapor pressure, breakthrough times, and the ability of thefilter material to remove, adsorb, or absorb the contaminant.

(iii) The adverse health effects of the respiratory hazard. In selecting arespirator any adverse physiological effects that may occur from exposure tothe hazard, including effects that may occur due to respirator leaks orfailure need to be considered.

(iv) The relevant permissible exposure limit or recommended exposure limit.The OSHA permissible exposure limit, or in its absence, any AmericanConference of Governmental Industrial Hygienists recommended Threshold LimitValue (TLV), NIOSH recommended exposure limit, or other exposure limit set bythe employer must be considered in selecting the appropriate respirator.

(v) The results of workplace sampling of airborne concentrations ofcontaminants. Sampling and analysis of the workplace air determines whatdegree of exposure is occurring, and thus what degree of protection isrequired. Where such sampling and analysis have been done, the results are tobe used as a point of comparison for the hazardous exposure level i.e. todetermine how much the concentration must be lowered by the respirator toreduce employee exposure to a safe level.

(vi) Nature of the work operation or process. The type of job operation, theequipment or tools that will be used, and any motion or travel the jobrequires can influence the type of respirator selected. For example, in thecase where respirators are used to protect employees who are spray paintingor working at an open surface tank, the type of operation can affect the typeof respirator selected, particularly if supplied air respirators, whichrequire a connection to a clean air source, are used.

(vii) Time period respirator is worn. The employer must also consider theperiod of time during which the respirator will be used by employees during awork shift. Breakthrough times for different chemicals can vary greatly, andare dependent on the concentrations found in the workplace. A respirator thatprovides adequate protection for one chemical may be inadequate for anotherchemical with a different breakthrough time. In addition, employees wearingrespirators for longer periods of time may need different types ofrespirators for more comfortable wear.

(viii) Work activities and stress. The work activities of employees whilewearing respirators are also a factor. Heavy work that is physically drainingmay affect an employee's capability of wearing certain types of respirators.

Temperature and humidity conditions in the workplace may also affect thestress level associated with wearing a respirator as well as theeffectiveness of respirator filters and cartridges. These types of factorsmust be assessed in selecting the appropriate equipment for a particular worksituation.

(ix) Fit testing. The proposal includes requirements for fit testing. Theresults of these tests are to be used in the selection process. Someemployees may be unable to achieve an adequate fit with certain respiratormodels or a particular type of respirator -- such as half mask air-purifyingrespirators -- so an alternative respirator model with an adequate fit orother type of respirator that provides adequate protection must be used. Fittest results must be used to determine when this is the case and whatalternative respirator should be selected.

(x) Warning properties. The warning properties of a hazardous gas or vapormust also be considered when selecting a respirator. When using an airpurifying respirator the odor, taste, or irritation effects of the substancepresent should have a threshold concentration low enough so that thesubstance can be detected before health effects can occur. Also, thedetection threshold should be low enough that olfactory fatigue withsubsequent loss of the warning properties of the chemical cannot occur. Thissubject is discussed in more detail under section 5 below.

(xi) Physical characteristics, functional capabilities, and limitations ofrespirators. The last category of information to be considered when selectingrespiratory protection is the physical characteristics, functionalcapabilities, and limitations of the respiratory protection equipment itself.For example, airline respirators should not be used by mobile employeesaround moving machinery unless entanglement of airlines in equipment iseasily avoided.

Once the employer has determined what respirator types are appropriate forthe workplace, respirators must be selected from among those approved andcertified according to 42 CFR Part 84 by the National Institute forOccupational Safety and Health (NIOSH) when such respirators exist.

3. Use of NIOSH/MSHA Certified Respirators

a. Alternatives. Alternatives to requiring that NIOSH/MSHA certifiedrespirators be used are limited. Several ANPR commenters stated that OSHAshould allow the use of non-approved respirators for which scientificallyvalid 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 independentlaboratories (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 notaccept 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 suchsuggestions as having serious flaws.

Independent certification laboratories for respirators do not yet exist. Anextensive commitment of money and resources would be required by any privateorganization establishing such a testing system. Some believe that if OSHAallows certification of respirators by independent laboratories, this willencourage the development of such systems. However, it would be verydifficult to write a provision allowing independent certification systemswhen none now exist. Developing the respirator test protocols suchindependent laboratories would use would involve a considerable level ofeffort and would duplicate the revision efforts already underway by NIOSH torevise the respirator certification standards. Moreover it would be necessaryto establish a program to certify the testing laboratories as well. TheAgency does not presently have the means to accomplish such assessments, andin fact, does not have the personnel or resources to become certifiers ofrespirators.

OSHA is therefore proposing to maintain the requirement that NIOSH approvedrespirators be used when such respirators exist. For OSHA compliancepurposes, a respirator certification program is necessary in order to assurethat respirators used in industry are capable of providing the neededprotection. OSHA recognizes that there are problems with the existingNIOSH/MSHA certification program. Several of the comments OSHA received wererelated to problems with NIOSH/MSHA respirator certification, including theissue of modifications to respirators, interchanging of respirator parts andthe use of respirators for which NIOSH has not yet granted approval. Sincethese problem areas are being addressed by NIOSH during its revision of therespirator certification program under the new 42 CFR 84, it is inappropriatefor OSHA to try to correct problems with the present NIOSH/MSHA regulationsin the revised OSHA respirator standard.

b. Approval for modified respirators. Several commenters suggested that OSHAshould not automatically reject the use of approved respirators that havemodifications (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 couldinclude interchange of parts, canisters, air hoses, etc. These modificationswould have to be evaluated, whether through testing to demonstrate comparableprotection 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 thatmodifications 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 certifiedindustrial hygienist (Ex. 15-73). OSHA believes that NIOSH is the appropriateAgency to consider this issue and that such consideration should be part ofthe certification process.

OSHA also believes that the proposed 42 CFR Part 84 is the proper forum inwhich to resolve any problems with respirator modifications. Therefore, thisproposal does not change OSHA's general policy of rejecting modifications toapproved respirators.

OSHA invites comment on the question of whether to require NIOSH approvalfor 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 preproposaldraft recommended that OSHA establish procedures for permitting the use ofnon-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 aretypes of respiratory protection, such as supplied air suits for which noNIOSH/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 wordingthat would give OSHA the ability to approve respirators that do not have aNIOSH/MSHA approval schedule. The Industrial Safety Equipment Association(Ex. 36-45) stated that OSHA should allow the use of non-approved respiratorsif data are available to show that they operate satisfactorily. The AIHA (Ex.36-41) also recommended that if an employer can demonstrate effective, safeutilization of a device, then its use should be permitted. The AmericanPetroleum Institute (Ex. 36-51A) requested that OSHA permit the use ofnon-approved respirators when OSHA accepts these devices based on acase-by-case evaluation of evidence provided by the employer or manufacturer.They also stated that this method had worked well in the past foracrylonitrile, mercury, fluorides and vinyl chloride.

While it is true that OSHA has in the past approved the use of certainunapproved respirators, this approval has generally been as the result of athorough review of the respirators capabilities as part of a substancespecific standard. OSHA does not have the personnel or facilities to performrespirator testing, and has no present plans to set itself up as a respiratorapproval agency. Therefore, this proposed respirator standard does notcontain language which would formalize a procedure for approving respirators.OSHA invites comment on whether and how such an approval procedure should beadded to the standard.

4. Assigned Protection Factors

The proposal requires that respirators be selected in accordance with therespirator selection tables in the NIOSH proposed revision of the tests andrequirements for certification of respiratory protective devices (42 CFR Part84). The protection factor concept has developed over the years since OSHAadopted its current standards. It is a recognition of the fact that differenttypes of equipment provide different degrees of protection, and equipmentlimitations must be considered in selecting respirators.

Three commenters in response to the preproposal draft recommended that OSHAallow the use of other selection guidelines in addition to those in thepreproposal draft Appendix A. Motorola (Ex. 36-22) stated that there wasgreat controversy over the assigned protection factors, and in order tomaintain a performance standard approach OSHA should allow the use of notonly the respirator selection tables but the ANSI Z 88.2 selection tables, orother guidelines published and peer reviewed by other consensus groups orprofessional associations. Homestake Mining (Ex. 36-30) had a similarrecommendation, maintaining that it would allow the employer to use thelatest and best information for respirator selection. They also recommendedthat a provision be added to require that employers demonstrate and supporttheir rationale for using values other than those in the respirator selectiontables. The AIHA (Ex. 36-41) also recommended a similar approach torespirator selection guidelines.

OSHA believes that the foregoing suggestions are inadequate. Although thenew 1992 ANSI recommendations have now been published, it is not sufficientfor OSHA to reference the ANSI recommended protection factors because ANSIhas provided no discussion of the basis for its recommendations. Moreover,some of the provisions of the ANSI standard appear to contradict specificinformation which OSHA considers reliable. In particular, the ANSIrecommended protection factors disagree substantially with recommendations byNIOSH. Only if ANSI were to supply detailed discussion as to how itsprotection factors were derived -- including reference to and completedescription of specific studies used to derive those APFs -- would OSHA beable to evaluate the merits of the latest ANSI recommendations. Moreover,allowing employers to select respirators on the basis of differentguidelines, with different APF values, can only bring confusion as to how tocomply with the standard.

OSHA considered establishing assigned protection factor tables based onexisting studies in which performance factors were measured both inlaboratories and in workplaces. The quality of available data, however, wasseen to vary substantially from one type of respirator to another dependingon how much emphasis had been placed on a particular type of respirator bythe organization doing the testing. Moreover, the results of studies whichhad been done for a particular purpose may not necessarily be able to beextrapolated 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 pressureair-purifying respirators. Similar weaknesses in available data exist forother types of respirators as well.

Negative Pressure Air-Purifying Respirators

Lenhart and Campbell of NIOSH (Ex. 27-2) did workplace performance testingin 1984 in a primary lead smelter for half mask negative pressureair-purifying respirators. The resulting report stated that 98% of theworkplace 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 isappropriate for the half mask negative pressure air-purifying respiratorsevaluated in this study" (Ex. 27-2, p. 181). Each individual who participatedin the study had first achieved a quantitative fit factor of at least 250with the half mask respirator in the fit test booth. For this reason theauthors emphasized that the study's results may overestimate the WPFs thatwould be achieved by a general worker population that had not achievedquantitative fit test results of at least 250.

Skaggs and Loibl of the Los Alamos National Laboratory (Ex. 38-3) examinedthe performance of half mask and full facepiece respirators under simulatedwork conditions in a controlled environmental chamber. Three differenttemperatures (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 testsubjects performing work type exercises such as shoveling oiled gravel,walking up and down stairs, pounding nails, moving cinder blocks, andpounding with a sledge hammer. During the prefit respirator fit testing forthe half mask, fit factors ranging from a low of 32 to as high as 20,000 weremeasured. Fit factors measured during the simulated work exercises rangedfrom 16 to 20,000. However, only one of the 49 test subjects who obtained fitfactors during the prefit testing of 100 or greater with the half mask failedto achieve fit factors of at least 50 during the simulated work exercises.For the full facepiece respirator the prefit fit factors ranged from 110 to20,000 and the simulated work fit factors ranged between 21 and 20,000. Forthe 54 test subjects who achieved fit factors of 500 or greater with the fullfacepiece respirator during prefit testing, only one filed to achieve a fitfactor of 100 or greater during the simulated work fit tests.

In the case of full facepiece respirators tested with QNFT, studiesperformed by the Los Alamos National Laboratory (LANL) in 1972 (Ex. 24-2)resulted in a recommendation that full facepiece respirators be allowed aprotection factor of 50. The recommendation was based on QNFT performed in atest booth on wearers who had been pre-screened in each case with aqualitative test using irritant smoke. Most of the respirators testedachieved fit factors into the thousands but one respirator only achieved fitfactors of less than 100. On the bases of that one respirator the decisionwas made by LANL to restrict their recommendation to 50. However, EdwardHyatt, 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 protectionfactor of 100 provided a fit factor of 1000 could be obtained in the testbooth. It was understood (although not stated in his response) that hisreason for revising his recommendation was that the one respirator whichperformed so poorly in the original tests had been taken off the market.

In November, 1983 researchers from the Lawrence Livermore NationalLaboratory published a paper (Ex. 24-9) on reproducibility of fit using QNFT.One element of the research described in the paper was the measurement offits of two brands of full facepiece respirators as well as fits of half maskrespirators of the same two manufacturers. There are two important aspects ofthe measurements. First, the poorest fitting of the full facepiecerespirators was more than five times better than the best fitting half masksrespirators. Second; the lowest fit factor of the full facepiece models was1,063. Nevertheless, the range of respirators was very limited.

In October 1984, DuPont submitted to the OSHA asbestos standard docket anunpublished study of workplace protection factors (WPF) for disposable halfmask respirators, and half mask air-purifying respirators using eitherdust/fume/mist filters or high efficiency filters (Ex. 38-7). The studyconcluded that all the respirators tested could reliably provide protectionfactors of 10, except that one of the disposable respirators tested couldonly provide a protection factor of 5. The lower protection provided by thelast disposable respirator was attributed to penetration of asbestos fibersthrough the filter media. OSHA considers this study to be inadequate inestablishing protection factors for several reasons. First, asbestos is nottypical, in geometry or migration properties, of the broad range of dusts andmists that are encountered in workplaces. To assign a general protectionfactor based on the almost unique properties of asbestos would be highlyinappropriate. In addition, this particular study was conducted under specialconditions in which the respirators were used in a wet environment whoseeffect on fit is difficult to evaluate and whose effect on penetration wouldbe different for asbestos than for most other contaminants. In addition thestudy did not follow NIOSH analytical guidelines for sampling and countingasbestos fibers. For example, NIOSH recommends that reliable analysisrequires that at least 10 fibers be counted for 100 fields. However, in theDuPont study, 89% of the analyzable tests (71 out of 80) and filters within-mask fiber counts for less than 10 per 100 fields.

The 3M Corporation also submitted an unpublished protection factor study fordisposable respirators used in the presence of asbestos fibers at the ShilohBrake Corporation (Ex. 40). Once again, asbestos fibers, for the reasonsgiven above, are not sufficiently representative of dusts and mist in mostworkplaces for use in establishing general protection factors.

Another unpublished study cited in the record was performed by the ChemicalManufacturers Association (CMA) at a cadmium pigment production facility (Ex.38-22). The entire submission, however, consisted of four paragraphs ofdescription accompanied by two computer graphs showing results. There is nodiscussion of how the tests were conducted or any description which wouldenable 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 resultsof measurements of protection factors of disposable dust/mist respirators inthe presence of aluminum, titanium, and silicon particulates (Ex. 41A) Thestudy, which was conducted in October, 1986, failed to include basicinformation on concentrations and particle size distributions. In July, 19883M returned to the same site to measure particle size distribution and inAugust, 1989 submitted the results to the record (Ex. 41B). OSHA believesthat, to be valid, all supporting measurements of a study must be made at thetime the primary measurement is made. It is virtually impossible to assurethat all relevant ambient conditions will be identical almost two years laterto what they were at the time of the original test. Moreover, the datasubmitted by the 3M Corporation in August, 1989 had serious anomalies whichwere unaccounted for in the accompanying discussion. For example, the massdistribution in the stages of various impactors could be accounted for onlyby circumstances which would be very unusual. Some impactors had few or noparticles of any size. Others had only very large particles and very smallparticles. In the latter case, the report referred to the possibility of abimodal distribution, but supplied no physical reasons based on actualworkplace conditions to account for such a distribution.

In general, unpublished studies such as those cited above are difficult toevaluate since significant details are often absent in the discussions andthere has been no peer review of the assumptions, methods, and plausibilityof results.

By contrast, a published workplace protection factor study by NIOSH (Ex.38-2) of the performance of disposable dust mist respirators provides resultsshowing lower protection factors which cannot be ignored. The studydetermined the effectiveness of a disposable dust/ mist respirator againstoverexposure to nuisance particulate dust (Ex. 38-2). A total of 25 pairedsamples were taken, each consisting of a measurement inside the probedrespirator and one at the lapel. Seven workers and two NIOSH industrialhygienists were sampled. Quantitative facepiece fit testing was performed tocheck for gross leakage. NIOSH calculated that "95% of workplace protectionfactors would be expected to be at or above 3, 87% at or above 5, 70% above10, and only 7% would be expected to be above 100." Nevertheless, despite thefact that the data seemed to predict a protection factor of 3 at the 95%confidence level, NIOSH concluded that an "assigned protection factor of 5for disposable half mask respirators is not discredited by the results ofthis study." However, it involved only seven subjects and thus the range offacial sizes and structures involved were limited.

The foregoing studies pertaining to negative pressure air-purifyingrespirators demonstrate the wide variability in applicability of such studiesin the determination of assigned protection factors. Therefore, OSHA decidedthat these available studies as well as those in other respirator categoriesare inadequate for a well founded assignment of protection factors.

In view of this apparent inadequacy, OSHA has determined that in order toestablish assigned protection factors, there must be a program to conductexperimental evaluations of respirator performance. Therefore, OSHA and NIOSHhave agreed that the assignment of protection factors should be made byNIOSH. It is OSHA's intention in this rulemaking that protection factorsshall be assigned by NIOSH in its ongoing rulemaking for its certificationprogram. (The first phase of this rulemaking was published in the FederalRegister as a proposed rule at 59 FR 26850 on Tuesday, May 24, 1994 as 42CFR Part 84.) When NIOSH completes its rulemaking process of assignedprotection factors, OSHA will issue a technical amendment to this respiratoryprotection standard referring to the NIOSH final regulation. OSHA does notintend to have notice and comment on its technical amendment because NIOSHwill have notice and comment in its rulemaking. In the period before NIOSHhas completed promulgating 42 CFR Part 84, OSHA will, in the interim, requirethat respirators be selected in accordance with the protection factorsassigned by NIOSH in the current NIOSH Respirator Decision Logic (Ex. 38-20).

The NIOSH protection factor values are not intended to replace protectionfactor values which, in individual substance specific OSHA standards, aremore stringent. Thus, the OSHA provision which defers to the NIOSH protectionfactor tables is not to be interpreted, for example, as overriding the OSHAasbestos standard which does not permit the use of disposable respirators atall. Nor does this provision preclude OSHA's prerogative to assign moreconservative protection factors under circumstances demonstrated in therecords of future substance specific rulemakings.

Finally, it is OSHA's understanding that respirators certified under 30 CFRPart 11, depending on the type, will continue to be NIOSH certified for aperiod of time after the effective date of 42 CFR Part 84. This "sunset"provision will continue to allow existing certifications while respiratorsthat meet the new requirements of 42 CFR Part 84 are developed and certified.Following the sunset period for each type of respirator, only thosecertifications granted under 42 CFR Part 84 will be valid. During the sunsetperiod, OSHA will require that protection be assigned as prescribed in 42 CFRPart 84 for respirators previously certified under 30 CFR Part 11. The newNIOSH regulation will also provide assigned protection factor values forrespirators certified under the new requirements.

5. Warning Properties

The question of whether OSHA should permit the use of air-purifyingrespirators where substances have inadequate warning properties has been ofserious concern for several years. Some commenters to the ANPR felt thatair-purifying respirators should only be used for chemicals that haveadequate warning properties (Ex. 15-33, 15-34, 15-46, 15-48, 15-70). Othersfelt that respirator use should not be restricted based on poor warningproperties, but that OSHA should identify a control mechanism that wouldallow 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 fora 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 industrialhygienist's professional judgment, along with an evaluation as described inthe OSHA Industrial Hygiene Field Operations Manual (now called theIndustrial Hygiene Technical Manual), was recommended by the American Ironand Steel Institute (Ex. 15-37). Others stated that if the contaminantconcentration was monitored and the absorption capabilities of the respiratorcartridge for that chemical are known, the service life of the cartridge canbe safely calculated (Ex. 15-17, 15-53). The use of a monitoring device thatwould give sound and visual signals was recommended as an alternative torequiring that air-purifying respirators be used only for chemicals withadequate warning properties (Ex. 15-10).

OSHA currently does not allow air-purifying respirators to be used when agas or vapor has inadequate warning properties, except in the case of a fewdesignated chemicals for which specific standards were promulgated, such asvinyl chloride, ethylene oxide and acrylonitrile. The departures from theprohibition on using air-purifying respirators for substances with poorwarning properties were established in each case as part of an overallrulemaking for each chemical, which included a careful examination ofindustry exposure levels and respirator use factors.

Allowing such use would require an examination of the toxicity of thechemical, its odor threshold, the health consequences of particular exposurelevels, breakthrough time for the chemical for the type of respirator thatwill be used, how long the respirator will be used during the workshift, andthe concentrations of the chemical that are found in the workplace.Calculating the service life of a particular respirator cartridge or canisterfor a chemical with poor warning properties would be possible using thesefacts and an appropriate safety factor. This service life calculation may bedifficult where workplace exposure levels vary greatly throughout the day andfrom day to day. Using continuous monitoring devices with alarms, as wassuggested by some of the commenters, is another possibility. Continuousmonitoring is complicated, expensive, and would require a case-by-case reviewof each plant situation to determine the ability of the monitoring system.Therefore, this proposal has not considered the use of continuous monitoringdevices 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 therespirator had a reliable end of service life indicator or an air-purifyingcartridge and/or filter change schedule had been implemented, and the use ofsupplied air respirators would hamper an operation or increase risk. If theemployer could not demonstrate the acceptability of the respirator accordingto these conditions, supplied air respirators would be required. HomestakeMining (Ex. 36-30) also recommended the same conditions along with therequirement for biological monitoring to demonstrate respiratoreffectiveness, where applicable. DuPont (Ex. 36-38) also recommended thatair-purifying respirators be allowed for chemicals with poor warningproperties when supplied air respirators cannot be used, with the conditionsthat a reliable end of service life indicator and appropriate cartridgechange 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 forchemicals with poor warning properties. Mr. Nelson also wanted to limit theiruse 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 withpoor warning properties only when (1) the air purifying respirator has areliable end of service life indicator that will warn the user prior tocontaminant breakthrough, or (2) a cartridge change schedule is implementedbased on cartridge service data including desorption studies (unlesscartridges are changed daily), expected concentration, pattern of use, andduration of exposure have been established, and the chemical does not have aceiling limit.

OSHA agrees that there are circumstances under which it may be safe ornecessary to use air-purifying respirators despite the absence of adequatewarning properties. In doing so, however, two factors must be considered:breakthrough of the cartridge and face seal leakage. Cartridge breakthroughcan be addressed by use of end-of-service-life indicators that are approvedby NIOSH or by implementation of a filter change schedule based on documentedservice life data, exposure levels and exposure durations. Face seal leakageis not addressed directly except by requiring fit testing. Therefore, OSHA isproposing that the use of air-purifying respirators in the absence ofadequate warning properties be restricted to situations where the odor,taste, or irritation threshold is not more than three times the hazardousexposure level. Since the least effective respirator with a chemicalcartridge in the proposed NIOSH 42 CFR Part 84 respirator selection tableshas an Assigned Protection Factor of 10, then if the level at which thewarning property exists is within three times the hazardous exposure level,OSHA believes that a sufficient margin of safety will be provided, since evena partial breakthrough is unlikely to reduce the protection factor from 10down 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 inoxygen deficient atmospheres. In oxygen deficient IDLH atmospheres either afull facepiece pressure demand SCBA or a combination full facepiece pressuredemand supplied air respirator with auxiliary self-contained air supply mustbe used. A critical issue is the definition of what constitutes oxygendeficient and oxygen deficient IDLH atmospheres.

Table I of paragraph (d) presents in tabular form the oxygen percentagesbelow which the terms oxygen deficient and oxygen deficient IDLH atmosphereapply -- as a function of altitude above sea level.

By referring to the information in this table, an employer can readily pickout the appropriate type of respirator required at various altitudes andoxygen levels. OSHA chose to use an equivalent table of oxygen levels forsimplicity, rather than incorporating a calculation formula as ANSI did inits Z88.2-1980 standard, like the table in the ANSI Z88.2-1992 standard onthe combined effects of altitude and reduced percentage of oxygen.

Numerous comments were submitted in response to both the preproposal draftand the ANPR on the definition of oxygen deficient and oxygen deficient IDLHatmospheres (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 basedon the concept of a minimum value for oxygen partial pressure in the upperportion of the lungs. Most commenters agreed with the ANSI Z88.2-1980 partialpressure value of 100 mm Hg below which an oxygen deficient IDLH atmosphereexists. There was, however, disagreement as to the oxygen partial pressure atwhich an oxygen deficient atmosphere is considered to exist.

Oxygen Deficient Atmospheres

The Los Alamos National Laboratory (LANL) recommended the use of an oxygenpartial pressure of 125 mm Hg, which corresponds to a 16.5% oxygen level atsea level, as the point below which an oxygen deficient atmosphere exists foraltitudes up to 7,000 feet (Ex. 36-52). Above 7,000 feet LANL recommendedthat any reduction in ambient air oxygen content (20.95%) be consideredoxygen deficient. California OSHA (Ex. 36-44) recommended oxygen levels below19.5% for altitudes from 0 to 5,000 feet, 20.5% for altitudes between 5,001and 9,000 feet, and 20.95% for altitudes above 9000 feet be considered asoxygen deficiencies.

The ANSI Z88.2-1992 standard radically lowered the recommendation foroxygen-deficiency non-IDLH atmospheres to one with an oxygen partial pressureranging between 95 mm Hg pp O(2) (12.5% oxygen at sea level atmosphericpressure) to 122 mm Hg (16% oxygen at sea level). Under these conditions asupplied air respirator is required. Where oxygen levels are 95 mm Hg orless, an oxygen-deficiency IDLH atmosphere would exist, and would require theuse of a positive pressure SCBA or a combination supplied air respirator withSCBA. However, where oxygen levels are above 16% supplied air respiratoryprotection would not have to be used for protection against oxygendeficiency.

For confined spaces, the ANSI Z88.2-1992 standard would consider anyreduction in oxygen level below 20.9% an IDLH atmosphere unless the source ofthe oxygen reduction is understood and controlled. However, it would permitentry into a confined space that contains between 16% and 20.9% oxygen (atsea level) without any respiratory protection if extraordinary precautionsare taken to assure that the worker would not encounter any poorly ventilatedareas. OSHA considers any location with an oxygen level that is reduced below19.5% to be an oxygen deficient atmosphere requiring the use of at least asupplied air respirator as a minimum.

An incident recently occurred that illustrates the problem with the ANSIoxygen deficiency definition. Two well cleaners died in the confined space ofa shallow well. They had no fans to ventilate the well, and only crudehomemade equipment for lowering someone into the well. After being loweredinto the well, the first cleaner complained of lightheadedness. His partnerwas lowered into the well to attempt a rescue. The crude retrieval equipmentbroke under the weight of the two cleaners. Both were overcome by the lowoxygen levels and died of asphyxiation and drowning. The oxygen level in thewell was 17%, as measured by the firefighters who removed the bodies. Byreducing the oxygen deficient IDLH level to 16% and permitting entry withoutrespiratory protection at oxygen levels between 16% and 19.5%, the ANSIstandard would permit such dangerous practices. The need for extraordinaryprecautions, as ANSI recommends, will not be recognized by many who chooseonly to see that the oxygen deficiency levels have been reduced.

NIOSH approves air-purifying respirators for use only in atmospherescontaining 19.5% oxygen. Moreover, Grade D breathing air is and has beenconsidered the acceptable standard for such air and Grade D breathing aircontains, by definition, a minimum of 19.5% oxygen. Since OSHA requires thatNIOSH approved respirators be used, and that grade D breathing air be usedfor supplied air respirators, OSHA is proposing the 19.5% oxygen level as thepoint below which an oxygen deficient atmosphere exists. Oxygen partialpressure decreases as altitude increases. At 8,000 feet a 19.5% oxygen levelstill corresponds to an oxygen partial pressure above 100 mm Hg, the levelwhere an oxygen deficient IDLH atmosphere would begin. Therefore, foraltitudes up to 8,000 feet any decrease in oxygen level below 19.5% isconsidered an oxygen deficient atmosphere and the use of atmosphere-supplyingrespirators would be required. For altitudes above 8,000 feet, an oxygenlevel below 19.5% would constitute an oxygen deficient IDLH atmosphere.Column 2 of Table I presents the percent oxygen levels below which an oxygendeficient 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 oxygendeficiency-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 oxygendeficiency-IDLH atmosphere as one which causes an oxygen partial pressure of100 millimeters of mercury (mm Hg) column or less in the freshly inspired airin the upper portion of the lungs which is saturated with water vapor. Thiscorresponds to an oxygen content of from 14% at sea level to 20.95% at 14,000feet. The oxygen content is adjusted using a formula to account for theeffects of changing altitude. AMAX (Ex. 15-55) felt the ANSI oxygendeficiency requirements (and thus the Los Alamos position as well) wereoverly restrictive since they would require people working at altitudes above10,000 feet to wear supplied air respirators, and their employees havesuccessfully used air-purifying respirators at these high altitudes for manyyears.

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 theappropriate criterion for defining an oxygen deficient IDLH atmosphere, butonly for altitudes from sea level to 10,000 feet. For altitudes from 10,000feet to 14,000 feet they recommended that OSHA use 20.95% oxygen as the levelbelow which an oxygen deficient IDLH atmosphere exists since people who arephysiologically acclimated can live and work above 10,000 feet withoutadverse effects and the standard should account for this reality. The currentANSI Z88.2 Respirator Committee (Ex. 36-55) has concluded that for altitudesbelow 14,000 feet, work should be permitted without protection for oxygendeficiency 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 theoxygen concentration equivalent of an oxygen partial pressure of 100 mm of Hgin 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 oxygenconcentration of less than 16% at sea level one can experience impairedattention, thinking and coordination. At 14% or below, NIOSH states thepossibility of faulty judgment, poor muscular coordination, rapid fatiguethat could cause permanent heart damage, and intermittent respiration. In anIDLH or escape situation all of the described effects could place a worker inserious jeopardy. Therefore, OSHA believes that an oxygen concentration of16% or below at sea level should require the extra precautions that go withIDLH atmospheres. The AMAX comment that its employees have suffered noconsequences of not having used supplied air respirators at greater than10,000 feet is believed by OSHA to signify that they have not worked inatmospheres with less than 19.5% oxygen.

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

OSHA is proposing a value of 16% oxygen by volume as the level below whichan oxygen deficient IDLH atmosphere exists for altitudes from sea level to3,000 feet. For altitudes from 3,001 feet up to 8,000 feet, percent oxygenlevels have been calculated that correspond to a value of 100 mm Hg oxygenpartial pressure. At altitudes above 8,000 feet and up to 14,000 feet, OSHAis proposing that an oxygen level below 19.5% would be considered an oxygendeficient IDLH atmosphere. This agrees with the ANSI Z 88.2-1980 oxygendeficiency-IDLH level of 100 mm Hg, which corresponds to the point where theoxygen content of the alveolar blood is 90% saturated with oxygen and belowwhich symptoms of hypoxia occur. Although OSHA is accepting the claim thatwork can be performed by acclimated persons at altitudes above 10,000 feetwhen the ambient air oxygen percentage is not reduced, comments and data arerequested that will support or contradict this conclusion. To avoid possibleconfusion, OSHA has not used a formula for calculating the oxygen deficientIDLH levels as ANSI did, but instead presents in Column 3 of Table I inparagraph (d) a list of the percent oxygen levels for altitudes from sealevel to 14,000 feet.

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

(E) Medical Evaluation. Most who responded to the ANPR, although divided intheir responses to many of the questions on medical surveillance, were ingeneral agreement that the provision in the present standard is inadequateand that there should be initial and follow up evaluations of some sort. Inparticular, there was a consensus that it is not safe to wait for specificcomplaints 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 problemswearing a respirator when it is properly chosen and fitted (1, 2, 6). Themost commonly found problems are claustrophobia -- which may be anintolerance of feeling enclosed or may give rise to a subjective feeling ofbreathing difficulty. Other common problems are chronic rhinitis, catarrh,and nasal allergies where it is necessary to remove the respirator frequentlyto deal with nasal discharge. Some individuals with chronic sinusitis mayhave breathing difficulties wearing a respirator.

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

Cardiac or cardiorespiratory diseases that may affect respirator wearinclude coronary thrombosis, any type of congestive heart disease ordecompensations cor pulmonale, other ischemic heart disease and some cases ofhypertension.

The amount of difficulty will clearly depend on the degree ofcardiorespiratory inadequacy and also on the amount of physical effortrequired by the work. Some people who may have difficulty wearing a negativepressure respirator should be able to manage well with a positive pressuretype respirator.

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

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

The preproposal draft provision exempting occasional respirator users fromthe medical evaluation requirements was the subject of many comments. Somecommenters felt there could be problems with interpreting the exemption (Ex.36-32), or that the exemption would be difficult to enforce with employersclaiming exemptions for employees, and the employees claiming they shouldhave the evaluation (Ex. 36-8). Dow Chemical (Ex. 36-40) stated that theexemption 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 rigidand stated that a more appropriate time limit might be 10 to 13 hours perweek or 25% to 33% of working hours. The Amoco Corporation (Ex. 36-35)supported the flexibility that the occasional users exemption showed and theAmerican Textile Manufacturer's Institute (Ex. 36-18) felt medicalevaluations should be provided for all individuals who wear respirators formore than "pass through" activities. Dow Chemical (Ex. 36-40) recommendedthat any employee required to wear respiratory protection for any reason beprovided a medical evaluation, which may or may not include a medicalexamination.

The Mine Safety and Health Administration (MSHA) (Ex. 36-34) felt theexemption did not focus on the individuals at risk such as those wearing anSCBA 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 forshort periods of time without having been medically evaluated. CaliforniaOSHA (Ex. 36-44) recommended that the occasional use exemption not apply toSCBA wearers. The Lawrence Livermore National Laboratory (Ex. 36-26) feltthat the occasional use exemption would eliminate physical evaluations foremergency response activities and other short use, high risk jobs.

OSHA is removing the draft requirement that a medical evaluation be madeavailable 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 beworn for one stretch of 61 minutes even if that were the only time it wasworn. OSHA believes that such a requirement is unreasonable and that repeateduse of the respirator will be covered by the five hour per week provision.Therefore, the proposal now requires that a written opinion be obtained froma physician that each employee who needs to wear a respirator for five hoursor more during any work week is fit to wear one. However, in view ofquestions that have been raised, OSHA invites comments on the duration ofrespirator use that should constitute a threshold for the medical evaluationrequirement. OSHA recognizes that problems may occur with interpretation orenforcement of the occasional use exemption and solicits comments onprojected problems. OSHA emphasizes that the occasional use exemption isintended to apply only to short time respirator wearers, not those who wearrespirators on a routine basis.

Medical Evaluation Procedures

Although OSHA believes that a medical evaluation is important, there appearsto be considerable difference of opinion as to what circumstances shouldtrigger a physical examination, what the physical examination should consistof, who is to administer such an examination, and what the specific criteriashould be for passing or failing the examination with respect to fitness forwearing a respirator. Because there is no definitive information either inthe record or, as far as OSHA can tell, in the open literature as to how toresolve these issues OSHA is raising for comment three alternative versionsof the medical evaluation provision. The first, which is represented byproposed regulatory text, would require that the employer obtain a doctor'swritten opinion on the employee's ability to wear a respirator. The nature ofthe medical evaluation performed would be left up to the physician todetermine. The second alternative would require the performing of a medicalevaluation consisting of a medical history and medical examination, fromwhich a physician's opinion on respirator use would be written. The thirdalternative would require that a health questionnaire be administered to allrespirator wearers, with a medical evaluation being performed on those whoseanswers to any of the questions on the questionnaire show the need for suchan evaluation, or who wear an SCBA for emergency or rescue operations. Afterreviewing the questionnaires and any medical evaluation performed, aphysician's written opinion on respirator use would then be prepared.

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

Alternative 1 -- Written Physician's Opinion

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

Possible regulatory language for the other two alternatives of the medicalevaluation section are presented as follows. Although they are not includedin the text of the standard, OSHA will consider all three alternatives in itsdeliberations leading to a final standard.

Alternative 2 -- Medical History and Examination

The second alternative for a medical evaluation provision is a requirementfor a mandatory medical history and medical examination. The preproposaldraft standard contained this alternative, but OSHA has modified it inresponse to comments received. As in alternative 1, guidance for the elementsof the evaluation would be supplied by nonmandatory Appendix C.

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

The preproposal draft would have required that a medical history be takenand a medical examination be conducted for each respirator user withexemptions for nonroutine users. Also included were mandatory elements to bereviewed during the performance of the medical history and medicalexamination. Several commenters recommended that OSHA adopt a moreperformance oriented approach for the medical evaluation provisions whilelisting in a nonmandatory appendix what the physician should consider duringthe 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 medicalhistory and medical examination recommended provisions listed in Appendix C.OSHA also requests comment on whether it should set specific medical triggerlevels for elements of the medical examination, and if so, what these triggerlevels should be.

A mandatory requirement for pulmonary function testing was opposed bycommenters on the grounds that it is not clear that pulmonary functiontesting would provide information that would not already be apparent to thephysician from performing a normal physical exam. It was also pointed outthat there are no specific pulmonary function test values that are consideredto 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 onpulmonary function testing states that spirometry including FEV(1) and FVC,while not required should be performed. The recommendation for screeningspirometry contains a set of values for FVC and FEV(1) which have beenadopted from the ANSI Z88.6 recommended standard. These values, a FVC of lessthan 80 percent or a FEV(1) of less than 70 percent, represent levels atwhich restrictions on respirator use should be considered.

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

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

Comments were also received on the preproposal draft requirement thattolerance to tachycardia (i.e. excessively rapid heartbeat) be noted. OSHAnotes that the recommendation that tolerance to tachycardia due to inhalingheated air be noted is part of the ANSI Z88.6 physical qualifications forrespirator wearers, and for that reason was included in the preproposaldraft. Closed circuit SCBA units, also known as rebreathers, supply air tothe wearer at elevated temperatures of 120 deg. F or greater. A possiblephysiologic response to breathing heated air is tachycardia. Commentersstated that tachycardia produced by heated air was called difficult tovalidate (Ex. 36-8), was not necessary to note since few respirators produceheated 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), andquestioned the necessity to impose the restriction since only rebreatherrespirators 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 notnecessary. Therefore, the recommendation for noting tolerance to tachycardiadue to inhaling heated air has been removed. OSHA requests any information onproblems that have occurred with tachycardia for wearers of closed circuitSCBAs, and comment on whether this recommendation should be included (eitheras a mandatory requirement or in Appendix C only) for those who will be usingclosed circuit SCBAs.

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

The need for assessing hearing ability was also questioned by commenters onthe preproposal draft. Several commenters recommended the elimination of thehearing assessment provision since it is irrelevant to the wearing of arespirator (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 exceptperhaps where a worker wears a continuous flow airline respirator with hoodor helmet that covers the head. The ability to hear is certainly importantduring IDLH entry, but this is a concern regardless of respirator use. TheAmerican Association of Occupational Health Nurses (Ex. 36-8) and Alan Hack(Ex. 36-29) pointed out that nonaudible alarms such as visual or vibrationalarms could be used along with the buddy system for such situations.Monsanto (Ex. 36-32) questioned what level would constitute an acceptablehearing ability. ORC (Ex. 36-47) and California OSHA (Ex. 36-44) alsoquestioned whether OSHA was requiring audiometric testing.

Having considered the foregoing comments, OSHA believes that the secondalternative should retain a recommendation for performing a hearingassessment nonmandatory Appendix C. There are situations where the wearing ofa respirator, particularly one with a full helmet or hood, can significantlyreduce hearing and the ability to respond to emergency alarms or warningdevices. However, OSHA recognizes that the problem of hearing ability in theworkplace is peripheral to the ability to wear a respirator. Therefore, OSHAseeks further comment on the necessity of assessing hearing ability whenwearing respirators and on the appropriateness of this recommendation to therespirator standard. The assessment of hearing ability to assurecommunication and response to instructions and alarms does not require, inthe standard, audiometric testing. For most respirator wearers a simple oralassessment 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 issueof potential employee exposure to hydrogen sulfide via the route of damagedtympanic membranes. The report stated that there was no valid information inthe scientific literature supporting that perforated eardrums would producean increased risk of contamination for workers. Calculations were performedfor the Shell report which showed, in a worst case analysis, ambient airconcentrations of H(2)S would have to reach some 158 ppm before the worstcase loss of an ear drum would permit exposure at the PEL of 10 ppm. Shellalso 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 excludedfrom working in hydrogen sulfide atmospheres. They stated that in noreasonable case can the presence of a tympanic membrane defect significantlyaffect respiratory protection. California OSHA (Ex. 36-44) cited the NIOSHstudy as showing that tympanic membrane perforation was not a problem. Othercommenters also recommended that this provision be dropped since it is notspecifically 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 submittedby Shell Oil, and the report by NIOSH which also reports no significantexposure from perforated eardrums, the recommendation for checking forperforated tympanic membranes has not been included in this proposal. OSHArequests any information and data regarding problems with respirator useassociated with tympanic membrane defects, and any evidence for the need forchecking 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 theendocrine system, pointed out that such problems should have been noted as apreviously diagnosed disease during the medical history. They also statedthat assessing the endocrine system for all respirator wearers would becostly and time consuming. If a history of diabetes or other endocrinedisease was detected, than evaluations could be done on a case by case basis.Other commenters said that physicians would be reluctant to accept liabilityfor signing off on such an assessment and that the evaluations should berestricted to the employee's pulmonary function and cardiovascular system(Ex. 36-10) and should eliminate the endocrine test as not relevant to thewearing of respirators (Ex. 36-13). Alan Hack (Ex. 36-29) and the Los AlamosNational Laboratory (Ex. 36-52) stated that "Workers so afflicted [withendocrine conditions which result in sudden loss of consciousness] will berestricted 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 endocrinesystem disease would be found during the neurologic examination.

OSHA believes that endocrine conditions such as diabetes should beconsidered by the physician when determining whether a respirator can beworn. Previously diagnosed endocrine conditions should be picked up duringthe taking of the medical history. However, undiagnosed endocrine systemproblems can still exist. The respirator use evaluation may be the onlyphysical examination the employee has had for some time, and a diabeticcondition could have developed. The extent of the assessment suggested, fromlooking for signs of disease during the physical exam to more extensivetesting of those with signs of disease, is at the discretion of thephysician. Any general work limitations or restrictions that apply to otherwork activities of an individual due to endocrine disorders should also beconsidered when determining whether a respirator can be used. OSHA does notrecommend any specific tests for endocrine conditions, leaving thedetermination to the physician's judgment. Because the potential for suddenloss of consciousness or response capability is something that should beconsidered when determining an individual's ability to wear a respirator, theproposal includes the endocrine system assessment recommendation, as derivedfrom the ANSI Z88.6 standard, in Appendix C. OSHA requests further comment onthe need for assessing the endocrine system, and on determining whichendocrine system conditions would preclude the use of respirators.

The preproposal draft also contained a requirement that an exercise stresstest be performed for employees who use SCBA's or rebreather typerespirators. The American Association of Occupational Health Nurses (Ex.36-8) stated that exercise stress testing would be expensive and difficult toobtain 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 anSCBA or rebreather respirator can be worn. Other commenters stated that OSHAshould not require a routine cardiovascular stress test, but require one onlyif requested by the physician (Ex. 36-35, 36-40, 36-47). They also opposedthe use of electrocardiograms on a routine basis, claiming that falsepositives require expensive follow-up testing. Also the nature of the testsrequired for exercise stress was not specified by OSHA, and an example of anexercise stress test was requested. SOCMA (Ex. 36-48) commented that exercisestress tests cost between $250 and $300, and urged OSHA to consider othertesting that would yield similar data in a more cost effective manner, usinga performance approach. The Motor Vehicle Manufacturer's Association (Ex.36-37) recommended the provision be deleted and a simple pulse rate count besubstituted.

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

OSHA is seeking further comment on the appropriateness of the exercisestress test, the most cost effective method of performing such testing andalternative methods of determining an individuals physical ability to wearSCBAs and rebreather respirators.

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

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

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

The final departure from the ANSI Z88.6 physical qualificationrecommendations is the requirement in this alternative that the employee'smedical status be reviewed annually or at any time the employee experiencesdifficult breathing while being fitted for or using a respirator. Althoughthe latter requirement is implied by ANSI, the annual review is not. By suchan annual review, OSHA is not necessarily requiring a physical examination.The objective of this provision is to provide a mechanism which necessitatesroutine review of any difficulty an employee may be experiencing. Other thenbeing performed by or under the supervision of a physician, the specificnature of this annual review is left to the physician to determine. OSHAinvites comments as to the appropriateness of this provision.

AMAX Inc. (Ex. 36-27) citing experience with the OSHA lead standard, statedthat an annual review of medical status was not required and review should berequired 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 examinationssuggesting 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 yearfor those above fifty. ANSI in its Z88.6-1984 standard recommendedexaminations every 5 years for those below age 35, every 2 years up to age45, and annually thereafter. The NIOSH Respirator Decision Logic suggestsexaminations every 5 years for those under 35 years of age, every 2 years forthose from 35 to 45, and every 1 to 2 years for those above 45, under mostworking conditions requiring respirators. Under strenuous work conditionswith an SCBA, NIOSH suggested exams every 3 years for those under 35, every18 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 isneeded, or whether a sliding scale of examination dates, such as recommendedby NIOSH or ANSI, could be substituted for the annual medical review.

Commenters questioned the preproposal draft requirement that the medicalevaluation be performed by a licensed physician. Many commenters pointed outthat there were portions of the medical evaluation that could be performed byother health professionals such as occupational health nurses and physiciansassistants, or nurse practitioners, certified audiometric technicians, andpulmonary 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). OSHAhas revised the language for this alternative to permit other healthprofessionals to perform whatever medical evaluation procedures the physicianchooses to delegate to them. OSHA requests comments on this issue and on theextent of the role that should be given to these health professionals.

In requiring a medical evaluation, OSHA has proposed in this alternativethat an examination be given to respirator wearers regardless of the type ofrespirator used or the conditions under which it will be used. Commentershave suggested that not all types of respirators place the same physicaldemands upon wearers, and that the medical evaluation criteria could bereduced for certain low resistance respirators. John Barr of Air Products andChemicals (Ex. 36-13) stated that positive pressure respirators place nosignificant burdens on wearers, and that disposable dust masks have nodiscernable effect upon respiration. He suggested that OSHA exempt suchrespirators from the need for a qualifying medical exam.

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

OSHA requests information and data on the breathing resistance levels ofrespirators for wearers, and whether a medical determination could be made toselect a breathing resistance level which poses no problem for respiratorwearers.

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

(e) Medical evaluation.

(1) The employer shall provide a medicalevaluation for each employee required to wear a respirator for more than fivehours during any work week. The medical evaluation shall be performed by alicensed physician or by a health professional operating under the physicianssupervision and shall include completion of a medical history and performanceof a medical examination. In advance of the medical evaluation the employershall provide the examining professional with informationconcerning:

(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 thataffect the safety of others such as fire fighting or rescue work;

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

(vii) Additional requirements for protective clothing and equipment.

(2) Upon completion of the examination, the employer shall obtain from theexamining physician a written opinion which states whether the employee isfit to wear a respirator and recommends any limitations on respirator use. Acopy of this written opinion shall be provided to the examinedemployee.

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

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

Alternative 3 -- Questionnaire

A third alternative for medical evaluation would require that a medicalquestionnaire be used to survey respirator users and to identify those whorequire 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). Thespecific nature of this questionnaire and its accompanying procedures was notalways clearly presented by the commenters, but the health evaluationprovisions in the Organization Resources Counselors, Inc. (ORC) recommendedrespiratory protection program (Ex. 36-47) was suggested as a model medicalevaluation 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 beadministered by a health professional or trained person for each respiratorwearer, prior to fit testing. Anyone who gives a "yes" answer to a questionon the questionnaire, or who wears an SCBA for emergency or rescue operationswould receive a medical evaluation, performed by or under the direction of aphysician. The procedures to be used for the medical evaluation would be leftto the judgment of the health professional performing the evaluation. Theemployer and employee would be notified of any restrictions on respiratorwear that are identified by the health evaluation. The ORC recommendedprogram included a nonmandatory appendix containing sample questionnaires andsuggestions for medical examinations of individuals who answered yes to thescreening questions.

Other commenters who stated that automatic medical exams for all respiratorwearers 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 medicalquestionnaire to screen the respirator user population so that only thosewhose medical condition warrants a medical exam would get one. The commentersstated that the questionnaire could be administered quickly, and theunnecessary expense of medical exams for healthy respirator users would beavoided.

OSHA has suggested in this alternative that the question of who shouldadminister the medical questionnaire and determine which respirator usersshould be referred for a medical exam be resolved by adopting the recommendedprocedure in the ORC respiratory protection program. Either a healthprofessional or a person trained in administering the questionnaire by aphysician would have this responsibility. This would place this critical partof the medical evaluation under a trained individual acting under thedirection of the physician who has the ultimate responsibility for approvingrespirator use. OSHA requests comments on the administration of the medicalquestionnaire and on the appropriate individuals for performing thisrequirement.

Employees who are assigned to emergency or rescue operations with SCBArespirators would still be required under alternative 3 to have a medicalexamination. These individuals are placed in highly stressful environmentswhile wearing a heavy SCBA, which places an added burden on their physicalcondition. A questionnaire would not serve adequately as a screeningprocedure for these respirator wearers, and therefore OSHA would follow theORC recommendation for alternative 3 and require that a medical exam beperformed. The extent of that examination would be left up to the physicianto determine. OSHA asks for comments on the need for performing a medicalexam for these SCBA wearers, and on appropriate medical procedures to be usedto evaluate their ability to perform adequately during emergency or rescueoperations.

As examples of medical questionnaires, OSHA has included in Appendix C theANSI Z88.6 medical questionnaire for respirator use, as well as the threesample questionnaires from the ORC Recommended Respiratory ProtectionProgram. OSHA has placed these questionnaires in this nonmandatory appendixin order to seek comment on the appropriateness of using such questionnairesand on which provisions in these samples are appropriate for determining anindividual's ability to wear a respirator. OSHA also requests any alternativequestionnaires that are used in industry.

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

(e) Medical evaluation

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

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

(ii) A medical examination shall be administered to any employee whoseanswers to any of the questions on the questionnaire show the need for suchan examination.

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

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

(v) Any medical examination administered shall be performed by a licensedphysician or health professional under the direction of the physician. If amedical examination is given, the employer shall obtain from the examiningphysician a written opinion which states whether the employee has anydetected medical condition which would place the employee's health atincreased risk or material impairment for respirator use and any recommendedlimitations upon the use of respirators.

(vi) A copy of this written opinion shall be provided to the examinedemployee. In advance of the medical examination the employer shall providethe 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 thataffect the safety of others such as fire fighting or rescue work;

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

(G) Additional requirements for protective clothing and equipment.

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

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

Other Issues

Medical Removal Protection

In some substance specific standards (e.g. cotton dust 29 CFR 1910.1043 andasbestos 29 CFR 1910.1001) OSHA has required economic protection foremployees 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 ofcases where employees have been determined not to be able to wear arespirator and what happened to these workers under current respiratorprograms. Determining the prevalence of such rejections and the fates ofthose who were rejected could be useful in determining the need of employersto supply alternative respirators or the need for OSHA to require thatemployers provide alternative jobs for those who cannot wear a particulartype of respirator. Therefore, OSHA requests the submission of any data orinformation regarding instances and details of cases where workers were foundto be unable to wear respirators and how this determination affected theworker's job responsibilities. OSHA would also like to receive any availableinformation on the frequency with which such situations occur, oralternatively on how many such cases are known to have happened.

Since the inability to wear a respirator, or failing to pass a medicalevaluation, could result in employees losing their jobs, some commentersrecommended that OSHA should add provisions to help employees in thesesituations. Medical removal protection, the requirement that employersprovide employees who are unable to wear respirators with alternativeassignments at the same seniority and pay, was recommended by severalcommenters (Ex. 36-14, 36-26, 36-44, 36-46). Giving employees who fail topass the initial medical evaluation the right to a second opinion, similar tothe provision for physician review in the lead standard (29 CFR1910.1025(j)(3)) was suggested by other commenters (Ex. 36-44, 36-46). Addinga requirement that the employer provide an alternate type of respirator suchas a PAPR or supplied air respirator in cases where an employee cannot use anegative pressure air-purifying respirator due to medical restrictions wasrecommended by California OSHA (Ex. 36-44). Although such provisions wereincluded in recent OSHA standards such as cotton dust (29 CFR1910.1043(f)(2)(iii), (f)(2)(iv), (h)(5)(i)(c)) and asbestos (29 CFR1910.1001(g)(2)(ii)) OSHA does not feel that sufficient information has beensubmitted upon which such provisions could be included in this proposal forgeneral application to all workplaces. Therefore, additional information anddata are requested which address these issues.

(F) Fit Testing Procedures

Although it has long been recognized that respirators must fit properly inorder to provide protection, it has only been within the last few years thatsystematic approaches for assessing and assuring fit have been developed. Asa result of continuing research, a number of fit testing protocols have beendeveloped and tested (Ex. 2, 8). In addition, because of the variability offace size characteristics among individuals, different sizes of facepiecesare 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 andquantitative. 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 detectthe presence of the challenge agent through subjective means such as odor,taste, or nasal irritation. If the presence is detected, the respirator fitis considered to be inadequate.

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

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

Even when fit testing is performed, it may be inadequate. In the past, somemanufacturers included their own qualitative fit testing protocols as part ofthe manufacturers instructions to the user. Numerous commenters complainedthat NIOSH or OSHA should check the manufacturers instructions for adequacyand 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 suchinstructions to fit respirators to their employees faces. Since fit testingis often done by the employer, commenters also suggested that the simplicityof the protocol be stressed.

Commenters to the ANPR suggested that a standardized protocol be developedwhich is oriented toward the hazard or level of exposure when determining thequalitative 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 bestandardized (Ex. 15-54, 15-58, 15-70, 15-71, 15-76). Correlation of thetesting done qualitatively and quantitatively would also aid in assuring thatrespirators being worn are effective (Ex. 15-17B, 34-8). The proposedstandard attempts to standardize the protocol and also simplify theprocedures.

OSHA has recognized the need for fit testing in the development of recentsubstance specific rulemakings. Quantitative fit tests were required in suchstandards as acrylonitrile (29 CFR 1910.1045) and lead (29 CFR 1910.1025).However, specific protocols were not provided in any of these substancespecific standards. Later, questions arose regarding the feasibility of therequirement for quantitative fit testing in the lead standard (29 CFR1910.1025). As a result OSHA conducted a specific rulemaking for the fittesting provisions of the lead standard. It was consequently determined thatqualitative fit testing could be used with half mask negative pressurerespirators, provided that one of three specified protocols was followed, andprovided that lead concentrations do not exceed ten times the permissibleexposure limit (47 FR 51110).

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

This proposal would require that fit testing be performed whereair-purifying respirators as well as tight fitting atmosphere-supplyingrespirators are used. Either qualitative fit testing or quantitative fittesting may be conducted for quarter facepiece, half mask, or full facepiecerespirators. The proposal details the procedures for qualitative andquantitative fit tests in Appendix A. Commenters (Ex. 36-38) on thepreproposal draft stated that the protocol exercise regimens and otherelements common to both qualitative and quantitative fit testing were notconsistent. Therefore the common elements of the protocols in Appendix A havebeen standardized in this proposal in order to provide consistency.

It is recognized that one purpose of revising the existing respiratoryprotection standard is to allow for changes in respiratory protectiontechnology. Numerous comments were made suggesting that limiting thequalitative and quantitative tests to certain specified methods would freezetechnology at the present state and would not allow for future changes norprovide 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 moreperformance oriented criteria by which new or modified fit test procedurescan be evaluated. Such criteria must guarantee a high level of certainty thatthe fit test will in fact select the best fitting respirator and give maximumassurance of reliable fit. Performance oriented criteria that will enablereliable new fit tests to be developed and implemented do not, to OSHA'sknowledge, exist at the present time. OSHA seeks comment so that it can builda provision into the standard that encourages and permits improvements in fittest technology. Such comment should include specifications for validationprocedures and for what organizations can be designated as crediblevalidation performers.

In the absence of performance oriented criteria for determining thereliability of fit tests, OSHA is proposing to allow the use of qualitativeor quantitative fit tests other than the methods specified in Appendix Aprovided 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 inaccordance with the protocols in Appendix A, OSHA proposes to allow therespirator to be used in concentrations up to a maximum of ten times theestablished permissible exposure limit.

Quantitative fit testing (QNFT), a more recent development, measures theefficacy of a respirator by actually measuring and comparing the contaminantlevel inside and outside a respirator facepiece. As with qualitative fittesting, commenters stated that manufacturers' QNFT protocols differ greatly(Ex. 15-22, 15-26, 15-30, 15-44). Many objected that different test agentswere used (Ex. 15-44, 15-55, 15-58, 15-79). Some manufacturers protocols onlytest the respirator once instead of using the average of several tests. OSHAin reviewing these comments agreed that the QNFT procedure should bestandardized and for this reason includes a protocol in the proposedstandard.

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

If the employer chooses to use quantitative fit testing, a full facepiecerespirator may be used up to a maximum of its assigned protection factor of50 as shown in Table I of paragraph (d), provided that the fit factorobtained during quantitative fit testing is at least 500.

The proposal requires fit testing of tight fitting atmosphere-supplying andpowered air-purifying respirators. It is recognized that demand typeatmosphere-supplying respirators have negative air pressure inside thefacepiece compared to the air pressure outside the respirator uponinhalation. The efficacy of these respirators therefore relies to a largedegree on the integrity of the facepiece to face fit. Therefore it is clearlyappropriate to require fit testing of demand or negative pressure tightfitting atmosphere-supplying respirators. Comments were also receivedregarding positive pressure tight fitting atmosphere-supplying respirators(Ex. 36-26, 36-45, 36-44). Such comments suggested that it is appropriate torequire the fit testing of positive pressure devices since it has beendetermined that positive pressure respirators do not always maintain positivepressure. Further, the possible adverse effects of the negative pressurespikes can be minimized by providing positive pressure respirator users withgood fitting facepieces. Therefore, it has been suggested that quantitativefit testing should be required for positive pressure equipment (Ex. 36-26).Accordingly, OSHA is proposing that tight fitting atmosphere-supplyingrespirators utilizing quarter facepiece, half mask, and full facepiece masksbe fit tested either by a qualitative or quantitative fit test. The proposalspecifies that only the mask needs to be tested, not the entire respiratorunit. Since the testing of entire atmosphere-supplying respirator units mayrequire even more specialized QNFT equipment, and since the fit of thefacepiece itself is the basic consideration, only the mask is required to betested. It is recognized that most respirator facepieces (i.e brand, model,size) are available in air-purifying models as well as atmosphere-supplyingunits.

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

OSHA is proposing that fit testing be performed before an employee firststarts wearing a respirator in the work environment and at least annuallythereafter. Semiannual respirator fit testing is required currently incertain 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 fiton an annual basis was considered more appropriate for a general respiratoruse standard rather than the semiannual fit testing required in somesubstance specific OSHA standards. Commenters on the preproposal draftstandard 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 theBoeing Company (Ex. 36-24) commented that fit testing should not be requiredat a fixed, arbitrary frequency since changes which affect a properrespirator seal occur at random. He proposed that OSHA require fit testingwhenever an employee experiences difficulty in obtaining an adequate faceseal during a routinely performed positive/negative fit check. However, astudy of the negative pressure fit check has shown (Ex. 24-21) that this fitcheck would pass respirator wearers with inadequate fits, particularly thosethat require protection factors above 10. Therefore, the use ofpositive/negative facepiece fit checks to determine when a fit test should begiven would be an inadequate substitute for annual fit testing. The MonsantoCompany (Ex. 36-32), Amoco Corporation (Ex. 36-35) and the Dow ChemicalCompany (Ex. 36-40) stated that annual fit testing was not necessary and itwas their experience that fit testing every second year was adequate. It isOSHA's belief, however, that fit testing not only determines respirator fit,but also provides an opportunity to check on comfort and problems withrespirator wear, and reinforces respirator training by having wearers reviewthe proper methods of donning and wearing the respirator. Moreover, a twoyear interval between fit tests has not been shown to provide adequateassurance that necessary respirator fit factors will be maintained in theworkplace. OSHA encourages these companies and others to provide anysupporting data or specific experiences they have that would support analternative to annual fit testing. OSHA invites comments from all interestedparties on the annual fit testing requirement and on alternative fit testingfrequencies. OSHA also requests any experience from fit testing programs onhow frequently the annual fit test results in the changing of the previouslyassigned respirator for a new model or size.

The point was raised that either contractors or corporate staff membersoften have sole responsibility to conduct quantitative fit testing at localfacilities and that a problem is created when new hires enter the work forceafter the annual fit test has been completed at the facility (Ex. 36-11).OSHA is proposing that where assigned protection factors higher than ten arenecessary, requiring quantitative fit testing, an employer may utilize aqualitative fit test to select respirators for new employees provided that aquantitative fit test is administered within thirty days. This is allowedonly when the employer is relying on an outside party to conduct quantitativefit testing. OSHA is also asking for comments on whether this provisionshould be broadened to cover other situations, such as when the QNFTequipment is out of service for repairs, where the thirty day exemption wouldprove useful.

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

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

Appendix A

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

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

In addition Appendix A contains two sets of "minimum criteria for a validfit test". One set of criteria applies to qualitative fit tests which utilizea "non-established" test agent or method. The second set applies toquantitative fit tests which use a "non-established" test agent or testmethod. The purpose of including these criteria is to allow and encourage thedevelopment of new qualitative and quantitative fit test methods and/ormedia. This is in response to numerous comments stating that any new standardshould be flexible enough to allow new methods, test agents, and respiratortest 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 proposedMinimum Criteria.

New test methods and/or agents may be accepted by OSHA after their use isproposed in a Notice of Proposed Rulemaking, and comments are requested,according to a notice and comment rulemaking procedure pursuant to theAdministrative Procedure Act, 5 U.S.C. 553. OSHA believes that thisprocedure, 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 evaluationwithout the need for public hearings. Since the protocols which will beadopted in this standard will have been subjected to rulemaking, additionalprotocols too, should be examined in a public proceeding. However, requiringfull 6(b) rulemaking, with public hearings, would in OSHA's view, undulydelay decision making on the validity of new fit testing protocols and wouldbe unnecessary. OSHA believes that this procedure strikes an appropriatebalance between the need to accommodate technological advances in fittesting, and the need to obtain input from affected employers and employees.

Both the qualitative and quantitative validation criteria for new fit testmethods require that the fit test data submitted for approval demonstratestatistically that the fit test method would be as protective. Theserequirements set a strict performance criteria for new test methods. Whilethese criteria have generally been used in the past in evaluating test datait is not clear that these performance levels are the most appropriate onesto be used for evaluating new fit tests. Some of the existing qualitative fittest methods that are generally accepted do not meet these performancelevels. The irritant smoke (Ex. 24-12) and saccharin (Ex. 24-20) QLFTprotocols identified 92 percent of users with poor fits at the 95% confidencelevel. The isoamyl acetate QLFT protocol identified 93% of the poorrespirator fits (Ex. 24-19). As an alternative, it has been suggested thatOSHA allow the use of new fit test methods that are proven to meet or exceedthe performance levels of the currently accepted methods. OSHA requestscomments, data, and information on the appropriate performance levels thatshould be required for new fit test methods, and on whether the 95% ofusers/95% confidence level requirements contained in the validation criteriafor new fit test methods should be retained or revised.

The question of whether OSHA should propose standard test aerosol particlesizes to be used in validating new qualitative fit test methods has beenraised. For validation testing of respirators equipped with high efficiencyparticulate air (HEPA) filters a polydisperse test aerosol with a mass medianaerodynamic diameter of 0.6 micrometers with a geometric standard deviationof less than 2 was considered by OSHA. For testing respirators equipped withnon-HEPA filters a polydisperse test aerosol with a mass median aerodynamicdiameter of 2.0 micrometers and a geometric standard deviation of less than 2was suggested. These are the particle size ranges for silica dust that NIOSHuses for HEPA and dust/mist filter certification. Whether these particularaerosol sizes are the most appropriate ones to be specified for use invalidating new qualitative fit test methods is uncertain. In the proposalOSHA has not established a standard test aerosol particle size. With respectto qualitative fit testing, OSHA invites comments and questions as to thesize of aerosols acceptable for use in qualitative fit test protocols,whether OSHA should establish standard test aerosol sizes for validationtesting, and if so, what the appropriate sizes should be.

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

The validation of new fit testing procedures has to be a carefullycontrolled measurement procedure using test instrumentation with an accuracythat exceeds that found in standard quantitative fit testing. The validationtesting that has been done on the existing fit test procedures were performedusing laboratory grade instrumentation. As a matter of caution, it isrecommended that those performing validation testing for new fit testprocedures submit to OSHA the test parameters of the instrumentation thatwill be used in advance, before extensive testing is done. OSHA invitescomments to specify more precisely the performance parameters that should beestablished for valid comparison measurements. The section in this proposalthat describes minimum criteria for validation of new QNFT protocols requiresthat instrumentation achieve sufficient accuracy and precision, but does notspecify values for these parameters. Therefore, OSHA requests comments onappropriate values for accuracy and precision of validation instrumentationincluding sampling systems, detectors and processors. OSHA is aware that theANSI Z88 respirator committee is working on minimum criteria for fit testinstrumentation. If during the rulemaking process ANSI finalizes itsrecommendations, OSHA will give them serious consideration with respect tothe minimum criteria.

New Fit Testing Technology

The minimum criteria for fit testing also contains a section that deals withminimum criteria for new technology. It contains provisions which are generalin nature, since without knowing what the new fit testing technology will beit is not possible to develop specific criteria. Fit testing methods usingnew 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 requestscomments on how new technology for fit testing should be evaluated, and whatground rules for minimum criteria OSHA should establish concerning its use.

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

Fit Test Exercises

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

In the course of the fit test the test subject is to seat the respirator bymoving the head from side-to-side and up and down, slowly while taking a fewdeep slow breaths. This represents a change from the selection protocol inthe lead standard, since the lead standard protocol requires the head to bemoved "rapidly" from side to side and up and down. The Los Alamos NationalLaboratory commented that there is uncertainty regarding the ability of rapidhead movement to seat a respirator, and also indicated that it may actuallymake the fit worse (Ex. 36-52). Therefore OSHA has revised the proposalregarding this aspect by removing the word "rapidly".

The employer is to maintain a record of the fit test administered to anemployee. The fit test record is to include the date and type of test, testagent, employee information, and type of respirator. When QNFT isadministered a record of the test recording (i.e. strip chart, computerintegration, etc.) is to be maintained. The fit test records are to bemaintained until the next fit test is administered. A record is necessary toenable OSHA to determine compliance by verifying that an employee has beenfit tested before first starting respirator use and at least annuallythereafter; that the tested employee passed the qualitative fit test, orachieved a sufficiently high fit factor to pass the quantitative fit test forthe assigned protection factor required; that the quantitative fit test wascorrectly performed and the fit factor calculated properly; and that therespirator model and size as determined during fit testing are the same asbeing 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 respiratorfitted and the date of the test. Comment was made (Ex. 36-39) that therequirement 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 theemployer to sign a certification that fit testing has been performed and notrequire that any fit test records be maintained. This certification wouldstate that fit testing had been performed and provide the date of thecertification, the employee identifier of the person certified, and thesignature 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 bemaintained, the recordkeeping burden of the proposed standard would bereduced. However, the replacement of the requirement for retaining the fittest records by a certification requirement would have an impact on theperformance of an inspection. Inspectors would have to rely on secondarysources such as interviews of employees and fit test operators to confirmcompliance with the specific fit test requirements of the standard. OSHArequests comments on the burden associated with maintaining fit test recordsand on the feasibility of fit test certification as an alternative to therecordkeeping currently required in the proposal.

The test subject is to perform eight exercises. Seven of the exercises areto be performed for one minute while the grimace exercise is to be performedfor 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 largeenough for the test subject to bend at the waist, and normal breathing.

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

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 loudor read from a prepared text.

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

OSHA does not regard the foregoing as valid. The QLFT test validated andadopted 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 timewould be 7 to 8 minutes. In this proposal OSHA is requiring eight exercisesof which seven are to be performed for one minute and one exercise for 15seconds, for a total time of 7 minutes and 15 seconds. Thus the total timerequired in this proposed standard is essentially the same length as the IAAQLFT protocol in the 29 CFR 1910.1025 lead standard. Any differences inrequired time are clearly minimal. Since the length of the two tests are thesame, OSHA has concluded that the IAA concentration at the end of theproposed protocol would be the same as if it were performed under the QLFTIAA protocol contained in the lead standard.

Qualitative Fit Test Protocols

Isoamyl acetate protocol

With the exception of the test exercises described above, the IAA testprotocol included in the proposal is the same as the IAA protocol adoptedunder the lead standard (29 CFR 1910.1025). Comment was received stating thatthe odor threshold screening test can be performed in the same room in whichthe 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 roomson separate ventilation systems may not be available and are unnecessary.However, in none of these comments was the specific issue of olfactoryfatigue addressed.

In the proposal OSHA is requiring the odor threshold screening test and fittest to be conducted in separate rooms and that the rooms not be connected tothe same recirculating ventilation system. In the rulemaking in the leadstandard on qualitative fit testing OSHA, in response to the recognition ofone of the shortcomings of the IAA test (i.e., olfactory fatigue), deemed itappropriate that separate rooms and ventilation systems be required for theIAA fit testing and odor threshold screening test (47 FR 51114). Sincenothing in the foregoing comments responded to the olfactory fatigue concern,OSHA is maintaining the requirement for separate rooms and ventilationsystems.

Saccharin Solution Aerosol Protocol

The saccharin solution aerosol protocol in the proposal is essentiallyidentical to that contained in the lead standard (29 CFR 1910.1025 Appendix DII). Comments were received suggesting that OSHA not allow the use ofsaccharin 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 AnnualReport on Carcinogens (Ex. 36-34). However, the saccharin fit test protocolis the only QLFT protocol that has been validated for use with disposabledust/mist respirators. Eliminating the saccharin protocol would result inprohibiting the use of disposable dust/mist respirators, since they could notbe fit tested. Although OSHA acknowledges that saccharin is a suspectcarcinogen, it is highly unlikely that an annual exposure of 10 minutes,during most of which time a respirator is worn, could constitute anymeasurable 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 forrespirators in the absence of an acceptable alternative for testingdisposable dust respirators. In this respect saccharin differs from DEHP, atest agent used in QNFT, for which acceptable substitutes exist. OSHA in thisproposal is encouraging the development of new test agents and test methodsas a replacement for the use of saccharin by including provisions which wouldallow such new protocols and test agents to be used.

Irritant Fume Protocol

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

Objections were raised over requiring the use of a low flow air pump set todeliver 200 milliliters per minute. Statements were made that an aspiratorbulb should be acceptable unless justification is provided for requiring alow flow air pump (Ex. 36-27, 36-28). OSHA is maintaining in the proposal theprovision requiring the use of the low flow air pump. The purpose of the pumpis twofold: to provide the challenge agent at a constant and stable rate; andto prevent a large amount of irritant from being released at one time. Use ofan 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 alarge 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 astaff member or contractor the duty of implementing the QNFT program. Theperson assigned is to be knowledgeable about the instrumentation,calibration, use and administration of the tests. Further the employer isresponsible for ensuring that the QNFT equipment is kept and maintained insuch a way that it will operate at its original specifications, includingmaintaining the aerosol size and concentration in the test environment. OSHAis requesting comment on appropriate means/methods which should be used toensure that the QNFT unit is producing aerosol with the particle sizedistribution and concentration for which the unit was originally designed.

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

Challenge Agents

In the ANPR OSHA requested comment on what test agents are suitable forQNFT. The ANPR also raised the question of whether it should be allowable touse substances identified as suspected carcinogens and if allowable, whatbasis should be used to determine that the probable dose is acceptable orunacceptable. Although it is generally recognized that QNFT fit testingequipment using test agents such as di-2-ethylhexyl phthalate (DEHP, commonlyreferred to as DOP), corn oil, and sodium chloride are commercially availableat the present time, OSHA was and is interested in exploring all possibletest agents for use in QNFT. On the issue of suitable test agents for QNFT,OSHA received a variety of comments. Some commenters suggested that theagency accept any agent demonstrated to be effective (Ex. 15-30), relativelynontoxic, easily detectable, and relatively stable (Ex. 15-13). Othersprovided lists of agents such as sodium chloride, di-2-ethylhexyl phthalate,di-2-ethylhexyl sebacate (DEHS), corn oil, mineral oil, and 1% ethylene inair (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 cornoil (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 wassuggested that "The essential characteristics for an acceptable solid orliquid aerosol agent for QNFT are described in ANSI Z88.2-1980 and/or theLANL basic protocol". The Dow Chemical Company stated that there are manysuitable test agents for QNFT (Ex. 15-19). It said that within Dow, Freon 12was used extensively and that to be suitable the agent should be readilydetectable at low concentrations. Dow later stated replacement of their unitswould be expensive and unnecessary, should Freon 12 be excluded as a testagent under this proposal (Ex. 36-40).

The second question of whether it should be allowable to use test agentsidentified as carcinogens was prompted by animal studies concerning DEHPwhich were positive for carcinogenicity. Several commenters declared thatsuspect 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 somuch that one could determine the doses well below any dose of concern, butrather that the concept of a health related test utilizing a known carcinogenwould tend to undermine the positive psychological value of concern of theemployer for the worker's health." Comment was received stating that there isinsufficient toxicological evidence to eliminate materials such as DEHS orPEG as test agents and that gases should not be precluded (Ex. 36-52). Anytest agent should be allowed as long as the employer can assure thatemployees are not exposed to hazardous concentrations.

Other comments ranged from declaring that substances known to be humancarcinogens should not be used as fit test agents (Ex. 15-22, 15-26) tostating that suspect carcinogens may be used depending on potency,concentration, exposure and other safety factors (Ex. 15-22). In theinformation submitted by NIOSH (Ex. 16) which was incorporated into a laterdocument entitled "Alternatives to Di-2-Ethylhexyl Phthalate (DOP) RespiratorQuantitative Fit Testing" (Ex. 24-10), it was stated that di-2-ethylhexylphthalate (DEHP) or DOP was recently found to be carcinogenic in two rodentspecies by the National Toxicology Program. NIOSH reviewed the evidence forcarcinogenic potential and overall toxicity of DEHP as it is used inquantitative fit testing, and concluded that DEHP should be replaced. Thecarcinogenic risk was estimated to be minimal for the respirator wearer undernormal conditions. However, NIOSH pointed out that two critical exposurefactors must be considered in QNFT; (1) Exposures to the DEHP aerosol canvary for the respirator wearer being tested if QNFT is improperly conducted;(2) Field practitioners administering QNFT, especially those using portabletesting equipment, where aerosol ventilation is difficult to control can besubjected to routine and varying exposures. NIOSH tested several agents aspossible substitutes for DEHP in existing QNFT equipment which was originallymade for DEHP aerosol. Test results revealed that refined corn oil,di-2-ethylhexyl sebacate (DEHS), and dimethecone all exhibited polydisperseaerosol particle characteristics essentially equivalent to those generatedwith DEHP. Further tests showed that both refined corn oil and DEHS aerosolswere highly suited for conducting QNFT. Finally, reports describing thetoxicity and health effects of each agent were reviewed. The review revealedthat extensive tests conducted on refined corn oil show that its toxicity isvery low and that it has not demonstrated carcinogenic potential during itsuse as a control agent in carcinogenic bioassays. NIOSH concluded that arefined corn oil aerosol is the best option to replace DEHP in quantitativefit testing.

Monsanto (Ex. 15-26) made reference to the NIOSH work which promptedMonsanto to switch from DEHP to corn oil as the prescribed challenge agent.After considering the data, OSHA has concluded that corn oil or sodiumchloride aerosol systems are most appropriate for quantitative fit testingand the proposal so specifies in the QNFT protocol. OSHA cites the positivecarcinogenic findings of DEHP in two rodent species by NTP (Ex. 24-10) assufficient evidence to preclude its use in QNFT when suitable substitutes arecommercially available. Corn oil has exhibited essentially equivalentpolydisperse aerosol particle characteristics to that of DEHP, and it can beused in existing systems designed for DEHP with only slightly moremaintenance required (Ex. 24-10). Comment was received stating that corn oildoes require more maintenance and urged OSHA and NIOSH to expedite the searchfor other suitable test agents (Ex. 36-39).

Other test agents have been suggested such as DEHS, ethylene, vanillaextract, freon-12, and mineral oil. OSHA does not intend to exclude thesetest agents. However, there are insufficient data on their suitability. Forexample, questions have been raised on the suitability of DEHS since itsmetabolic fate may be similar to that of DEHP. Mineral oil was suggested as asuitable test agent but has been observed to remain in the lung for prolongedperiods (Ex. 24-10).

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

Test Chamber

The proposal requires that the test chamber be large enough to permit theperson being tested to freely perform the QNFT exercise regimen withoutdisturbing the challenge agent concentration, and that the chambereffectively contains the challenge agent in uniform concentration. Uniformstable challenge agent concentration is important since the ambient challengeconcentration is measured from a single point, i.e. normally a sample hosesuspended from the ceiling of the test chamber/hood and connected to theaerosol detection system. Therefore, the proposal requires that a stableambient challenge agent concentration be achieved prior to the commencementof the test exercise regimen. As long as the concentration is uniformthroughout the chamber, the concentration at the respirator will besubstantially the same as the concentration at the location where the ambientchamber concentration is measured. Since the results of the QNFT will bedetermined by calculating the concentration of the challenge agent in therespirator in relation to the average ambient chamber concentration, a largechange in the test chamber challenge concentration during the course of thetest would result in unreliable results.

Fit Factor Estimation

The challenge agent detection system must be coupled to a strip chartrecord, integrator, or computer which creates a record of the test in orderto enable the calculation of the fit factor following the test. The timeinterval between an event such as side to side head movement and its beingrecorded should be minimal. This is consistent with the systems used by LosAlamos National Laboratory as well as commercially available systems. In theANPR, OSHA requested comments on two related questions: (1) Should QNFTdemonstrate the variation of contaminant concentration inside the respiratorduring the breathing cycle, and (2) to be an adequate test, should QNFTevaluate respirator performance for each test exercise performed by the testsubject? Some responses indicated that the QNFT should be able to demonstratethe variation of contaminant concentration inside the respirator during thebreathing cycle (Ex. 15-19, 15-46, 15-48, 15-50, 15-54, 15-58). It was statedby one commenter that "a chart recorder should be considered as mandatorysince this would be an extremely difficult process to follow by using only adial indicator", (Ex. 15-50). It was suggested that the peak penetrationaveraging method contained in ANSI Z88.2 1980 is the most acceptable methodfor determining respirator fit and in order to achieve this, the QNFT must becapable of demonstrating the peaks of penetration associated with thebreathing 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 availablequantitative fit test system utilizes a 1% ethylene-in-air test gas. Bymeasuring the ethylene concentration inside the respirator with a detectortube, a fit factor for the respirator is calculated. This system forquantitative fit testing does not provide an instantaneous breath-by-breathmeasurement that has to be averaged, but measures the maximum ethylenepenetration into the respirator, which National Draeger felt was appropriate.

In response to the question raised on whether the QNFT should evaluaterespirator performance for each test exercise, some commenters indicated thateach 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 todetermine the respirator efficiency for each test exercise performed since inactual practice the protection achieved in the workplace is not accuratelypredicted by QNFT (Ex. 15-73). Other comments suggested that the respiratorefficiency for each test exercise should be determined. In the data submittedby the Office of the Assistant Secretary of Defense (Ex. 15-54) it wassuggested that "QNFT should be able to distinguish the respirator efficiencyfor each test exercise. The exercise should identify which movement(s) allowfor facepiece leakage and at what level the leakage occurs." The IndustrialSafety Equipment Association suggested that "not having the ability todistinguish respirator efficiency for each set of exercises could result inan overstated assigned protection factor" (Ex. 15-58). The American NationalStandard Practices for Respiratory Protection (ANSI Z88.2-1980) recommendsthat the instrument used to measure the penetration of the test agent intothe respirator be connected to a fast-response recorder which records thepenetration values continuously (Ex. 10). Quantitative fit test methodsdeveloped by the Los Alamos National Laboratory use a detection and recordingsystem which detects the test agent penetration into the respirator facepieceduring the breathing cycle (Ex. 2, 27-12, 24-18). Notations are made on therecord at the beginning and end of each test exercise and the penetration foreach exercise is determined. Comment was received following theprepublication version of the proposed standard which also stated that thestandard should allow the use of other instruments such as computers orintegrators which would allow integration of the aerosol penetration insidethe respirator (Ex. 36-34, 36-45, 36-52).

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

Comments were requested on the methods used to calculate the aerosolpenetration into the respirator. Suggestions were made to allow: the use ofintegrator (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 allowany of the three methods to be used provided that a determination of the testagent penetration is made for each test exercise.

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

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

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

As stated previously OSHA is proposing that there be a clear associationbetween the event taking place in the test environment and its beingrecorded. This is critical for the proper calculation of aerosol penetrationfor a specific test exercise and ultimately determining the fit factor. It isthe short duration leaks that can occur during and as a result of aparticular fit test exercise that indicate poor respirator fit. Thesepenetration peaks are used to determine the fit factor. An inability toresolve these penetration peaks could result in the fit factor beingoverstated, since by averaging all the test exercise penetration levels thehigh penetration levels that occurred with one test exercise would beobscured. Also the grimace exercise is designed to cause a leak in thefacepiece fit to determine if the respirator will reseal. An inability toclearly associate the event in the test environment with its recording wouldinvalidate this test exercise and make correct calculating of the fit factorimpossible.

Several factors can affect the time interval between an event and its beingrecorded, such as sample hose diameter, sampling rate, and length of samplinghose. Response time will increase with an increase in length of sampling lineand/or increase in diameter of sampling line. Therefore the length of thesampling 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 testchamber challenge agent concentration and the tubing used for testing thechallenge agent concentration inside the respirator must be of the samelength and inside diameter. This will result in an equivalent aerosol loss inthe sampling lines due to aerosol deposition in each sample line.

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

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

It is imperative that the respirator used in QNFT be in proper workingorder. A respirator which may fit an individual better than others could berejected if there is leakage due to problems resulting from impropermaintenance such as sticking exhalation valves, leakage around the probeport, leakage around hose connections, or missing gaskets. Therefore theproposal requires that all respirators used in QNFT be inspected for defectsand cleanliness. Such inspection must include checking the condition of thefacepiece body for cracking and holes or tears in the rubber, checking theinhalation and exhalation valve assemblies for cracks and/or tears in valvematerial, checking for foreign material between the valve and valve seats,proper installation of the valve body in the facepiece, and warped orwrinkled valves. Respirators with such conditions cannot be used for fittesting. This is consistent with practices as published by the Los AlamosNational Laboratory (Ex. 25-3 p. 37, 25-4 p. 34).

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

Prior to the commencement of the QNFT a stable challenge test agentconcentration must be achieved. The concentration of some test environmentssuch as small booths or waist type hoods may be diluted significantly whenthe test subject enters the booth. Normally the ambient challenge agentconcentration will stabilize within 2 to 5 minutes. ANSI Z88.2-1980 addressedthis issue by requiring that the design of the chamber and equipment used togenerate the test atmosphere should ensure that the concentration inside thechamber does not vary more than 5% during a test (Ex. 10). OSHA is proposingthat 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. Ithas been OSHA's experience that a +/- 10% variation in test agentconcentration stability has little appreciable effect. OSHA requests commentson any problems with test agent concentration stability and on theappropriate percent variation that should be allowed.

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

OSHA had initially proposed that the results of the three tests must bewithin 10% of each other. However, response to that aspect indicated thatobtaining three results within 10% were not feasible and the suggestion wasmade 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 wereunnecessary (Ex. 36-34).

OSHA in the current proposal has deleted the requirement for test results tobe within a 10% range since consistently obtaining tests with a 10% range maynot be feasible. However, the requirement for performing three fit tests isbeing maintained.

The results of all three tests must be above the minimum fit factor neededfor that class of tight fitting air-purifying respirator. The required fitfactors 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 APFof 10 would need to achieve at least a fit factor of 100; and full facepieceair-purifying respirators with a NIOSH APF of 50 would require a minimum fitfactor of 500. Finally the lowest of the three values must be used asrepresenting the fit test results.

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

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

The fit test is to be terminated whenever any single peak penetrationexceeds two percent for half masks and quarter facepiece respirators and onepercent for full facepiece respirators. Such leaks correspond to fit factorsof 50 for half masks and 100 for full facepiece respirators and indicate anunacceptably poor respirator fit. Once the test is terminated the respiratormay be refitted or adjusted and the subject retested. If any of thesubsequent three required QNFT tests that are performed after the respiratorhas been refitted or adjusted are terminated because of excessivepenetration, then the respirator is considered to have an unacceptable fitand a different respirator must be selected and tested.

(G) Use of Respirators

Once the respirator has been properly selected and fitted, its protectionefficiency must be maintained by proper use. The employer is required toensure that respirators are used properly in the workplace, and to includespecific procedures for doing so in the written plan for compliance. Thisrequirement is written in performance language, with the specific content ofthe written procedures left for the employer to establish.

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

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

The second IDLH provision requires a "buddy" system where employees arerequired to work in IDLH atmospheres. There must be at least one additionalperson present, in communications with the worker(s) in the IDLH area butlocated where he or she will be outside the IDLH atmosphere and thus would beable to provide or call for emergency assistance if necessary. The thirdprovision specifies that retrieval equipment must be supplied or equivalentprovisions for rescue be made for those entering the IDLH atmosphere. Thefourth provision states that a positive pressure self-contained breathingapparatus must be provided for the person(s) responsible for emergencyassistance. These provisions are essentially the same as those that are inOSHA's current standards.

A more general issue involves tight fitting facepiece respirators which relyon a good facepiece to face seal in order to achieve effective protection.Therefore, the employer could not allow employees to wear such respiratorswith conditions which prevent such a seal. Facial hair such as a growth ofbeard or sideburns, absence of dentures, or a skull cap that projects underthe facepiece seal are examples of such conditions. Many ANPR commentersstated that OSHA should prohibit facial hair that interferes with thefacepiece 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 shouldbe allowed with respirators that do not rely on adequate face seals forprotection 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 performedwith half mask and full facepiece respirators on the effects of facial hairon 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 afit 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 beardswhich tested the protection factors of several types of disposablerespirators stated that acceptable performance was achieved and that therewas no significant difference in respirator performance for employees with orwithout beards under pot room conditions. Fergin stated that ". . . whereacceptable protection factors can be demonstrated for subjects with facialhair, the no-beard rule should be waived from a regulatory viewpoint for suchproven cases." However, the ability to obtain a fit factor for a beardedrespirator wearer does not mean that the worker can reliably be expected toachieve that same protection level each time the respirator is used. Beardsgrow and change daily, even hourly. Each time a respirator is donned there isfit variability. Such variability in face seal is greatly increased forbearded workers. This large variability in fit means that a reliable sealcannot reasonably be expected. OSHA believes that the evidence supports thecontention that a reliable seal cannot be achieved where facial hairinterferes with the seal of tight fitting respirators.

In commenting on the preproposal draft the Association of Western Pulp andPaper Workers (Ex. 36-2) opposed the facial hair policy proposed by OSHA andrecommended that OSHA prohibit blanket no beard policies of employers. TheInternational Chemical Workers Union (Ex. 36-14) recommended that thestandard specify respiratory types that could be used with facial hair. AmocoCorporation (Ex. 36-35) requested that more definitive language be added toallow employers clearer guidelines to enforce facial hair policies. AlliedCorporation (Ex. 36-49) also wanted a stronger statement prohibiting facialhair. The Nuclear Regulatory Commission (Ex. 36-31) and the Industrial SafetyEquipment Association (Ex. 36-45) agreed with OSHA's proposed prohibition onbeards when wearing tight fitting facepiece respirators. The OrganizationResources Counselors (Ex. 36-47) and 3M (Ex. 36-54) stated that theprohibition on facial hair that interferes with the facepiece seal shouldalso include positive pressure respirators that depend upon a tight facepieceto face seal.

The draft provision prohibiting conditions such as beards that interferewith the seal of tight fitting respirators has been modified afterconsideration of these comments. Additional wording has been added to clarifythat the provision covers not only negative pressure respirators that requirea tight seal but pressure demand and positive pressure respirators as well.The provision covers only tight fitting respirators and is not meant to be ablanket prohibition on beards with respirators. There are other types ofrespiratory equipment such as hoods, helmets and suits which can be worn byemployees with beards since they do not rely upon a tight facepiece fit. Alsothe wording in the examples has been changed to read "facial hair thatinterferes with the facepiece seal" rather than a growth of beard orsideburns since it is interference with the facepiece seal that OSHAprohibits, not the presence of facial hair. OSHA invites comments on thisissue and the wording of the proposed provision of the standard, and whetherOSHA should require that employers provide respirators which do not rely upona tight facepiece fit in such circumstances.

Corrective glasses or goggles must also be worn in such a way that they donot interfere with the seal of the facepiece to the face. Although theemployer is free to choose any option to comply with this, OSHA suggests thatfull facepiece respirators be worn where either corrective glasses or eyeprotection are required since corrective lenses can be mounted into the fullfacepiece respirators. In addition, the full facepiece may be morecomfortable, and less cumbersome, than wearing a half mask and chemicalgoggles which seal to the face as well.

OSHA's current respirator standard does not allow contact lenses to be wornwith respiratory protection. In reviewing this requirement, the mainjustification has been that with full facepiece respirators, if a contaminantgot into the employee's eye, the involuntary response would be to remove themask to attend to the eye, thus removing the respiratory protection. A secondpossible problem with contact lenses is that the dry air inside a positivepressure SCBA facepiece could dry out the contact lenses. It has also beensuggested that contaminants that get into the facepiece can become lodgedunder the contact lens, be held against the eye, and enter into thebloodstream. While these possible problem areas have been proposed forcontact lenses, OSHA has not found evidence of such problems occurring in theworkplace. With the improvements that have occurred with contact lenstechnology, particularly in soft contact lenses, people who are able to wearcontact lenses comfortably in everyday life should be able to wear contactlenses with a respirator.

OSHA funded a survey on the use of contact lenses by fire fighters which wasconducted by the Lawrence National Livermore Laboratory (Ex. 38-9). Of the403 fire fighters who regularly wore contact lenses with SCBA, only 6responded that contact lens created a problem such as a contact lens beingout of place or a particle under the lens causing the respirator facepiece tobe removed in an environment where the facepiece would normally be worn. Thewearing of conventional eyeglasses inside the respirator facepiece, as isrequired by the current OSHA standard, had a proportionately higher number ofproblems. The study concluded that the prohibition on wearing contact lenseswith a full facepiece respirator should be withdrawn.

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

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

In dealing with skin irritation and contamination, the proposal wouldrequire the employer to permit employees to leave the respirator use area asa necessary to wash their faces and respirator facepieces. The preproposaldraft provision permitted employees to leave the work area is necessary towash 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 cleaningsites located outside the respirator use area without necessarily having toleave the work area. The Motor Vehicle Manufacturers Association (Ex. 36-37)recommended changing the wording of the provision from "as necessary" to "ifnecessary" since excessive washing of the skin may aggravate an irritatedskin by removing protective oils. Richard Boggs of ORC (Ex. 36-47)recommended that this requirement be dropped since it was a labor relationsissue and not all conditions of respirator use result in situations wheresuch a requirement would make sense. OSHA agrees with the commenters thatemployees do not necessarily need to leave the work area to clean their facesand respirators, and the wording of the provision has been changed from workarea to respirator use area. OSHA believes that potential health problems ofskin irritation and contamination associated with wearing a respirator cannotproperly be relegated to a labor relations issue as ORC suggests and OSHA hasretained this provision in the proposal.

Another new provision involves the filter elements of air-purifyingrespirators. Employers are to allow employees to change such elementswhenever employees detect a change in breathing resistance or chemicalbreakthrough. Since breathing rates differ, and workplace contaminationlevels may vary, it is difficult to predict the service life of a particularfiltering element. Subjectively detected breathing resistance indicates thatthe load on the particulate filter may be approaching capacity and that thefilter must be changed to ensure continuing protection. This decision wassupported by several commenters in response to ANPR question 29 on servicelife (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 chemicalvapor breakthrough was a reason for changing an organic vapor cartridge orcanister (Ex. 36-29, 36-30, 36-32, 36-41, 36-52, 36-55). The wording of theproposal has been changed to add chemical vapor breakthrough as a cause forchanging filters. Wording has also been added to permit employees to leavethe respirator use area to change filters since this should be done only inclean air.

The proposal also includes a provision that requires respirators be repairedor discarded and replaced immediately when they are no longer in theiroriginal working condition. Examples of these changes in condition would bethat the strap has broken, the respirator has lost its shape, or the faceseal can no longer be maintained. Since respirators must be in good workingcondition to function, it is imperative that they not be used if they havebeen impaired in any way. The respirator manufacturers can supply replacementparts for damaged portions of their elastomeric respirators. Disposablerespirators cannot be repaired and must be discarded when damaged.

Many commenters to the ANPR stated that disposable respirators should beallowed to be used until they no longer can provide the protection for whichthey 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). Howthe useful service life would be determined, whether by professional judgmentor by having the manufacturers of the respirators make a determination, wasunclear. Such a specific service life determination is difficult to make.Support for a one day or one shift limit for the use of disposablerespirators 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 aredesigned to be used and discarded. Their durability with repeated use is notgreat, and most of them are not designed to be easily cleaned or sanitized.

The proposal requires that disposable respirators which cannot be cleanedand sanitized be discarded at the end of the task or work shift whichevercomes first. There are some disposable respirators which can be cleaned andsanitized after use, but they cannot be resupplied with an unused filter, andtherefore the proposal would require disposal after their useful service lifelimit 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 arespirator. The negative-pressure sealing check and the positive-pressuresealing check included in Appendix B, or the respirator manufacturer'srecommended procedures shall be used for all respirators on which such checksare possible. The use of such seal checks are a way of helping to ensure thatattention is paid to obtaining an adequate facepiece seal each time arespirator is used.

An additional requirement being proposed by OSHA is that each self-contained breathing apparatus used in IDLH atmospheres, or for emergencyentry or fire fighting, be certified for a minimum service life of thirtyminutes. Certified SCBA devices are available with shorter service lives, butgiven the types of situations encountered in IDLH or emergency situations,OSHA maintains that a minimum of thirty minutes would be required to ensureprotection in these conditions. The thirty minute service life requirementdoes not apply to combination supplied air respirators with auxiliary airsupply 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 theIDLH atmosphere should the air line fail. Emergency escape SCBAs also do nothave to meet the thirty minute service life requirement, since their intendeduse is only for escape.

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

Since there are problems in assuring the proper operation of respiratorsmodified to include buddy breathing devices, and there are problems withinterchanging air cylinders of different construction, pressure, and sizebetween different SCBAs, OSHA has decided to delete the provisions dealingwith buddy breathing devices and air cylinder interchange from the proposal.The problems with their use given by the preproposal draft commenters and thelack of a demonstrated need for their use in general industry work situationshas lead OSHA to remove these provisions from the proposal. Their use isstill allowed for fire brigades under the fire brigades standard. OSHA seekscomment on this decision and on the performance of such devices in industry.

Commenters were equally divided on the issue of requiring low flow alarms orindicators for PAPRs. The AIHA (Ex. 15-81) thought the issue was related moreto equipment certification rather than use, and suggested that NIOSH considerthe advisability of low flow indicators as permissible modifications. Somefelt OSHA should encourage the development of low flow indicators since it isthe positive pressure generated by the normal PAPR airflow rates that givePAPRs 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 airflowcould be detected by the wearer, some commenters felt airflow indicators wereunnecessary (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 forPAPRs. The protection levels that PAPRs achieve are in part dependent uponmaintaining an adequate airflow through the respirator. OSHA encourages theuse of airflow indicators with PAPRs, but since they are not currentlyavailable on existing PAPRs it has been decided not to require them at thistime.

When PAPRs should be used was also the subject of comments. Some commentersfelt that OSHA should not dictate the circumstances where PAPRs should beused (Ex. 15-30, 15-53, 15-58, 15-73). Most commenters felt PAPRs should beused where the employer or safety and health professionals determine theiruse 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 mustbe assured (Ex. 15-27A, 15-46, 15-79). PAPR use was also recommended where asignificant physiological burden would be imposed by a negative pressurerespirator (Ex. 15-38, 15-44, 15-46).

OSHA has also decided not to dictate the circumstances where PAPRs may beused. The employer or safety and health professional in charge of therespirator program is in the best position to determine where and when PAPRuse is most appropriate. The PAPR's ability to provide increased protection,easier breathing, and greater worker acceptance should be taken into accountduring respirator selection. However, the responsibility for respiratorselection has been placed on the respirator program administrator, and OSHArelies on the administrator to assure that the appropriate respirator ischosen. However, OSHA asks for comments on whether employees should be ableto choose PAPRs rather than negative pressure respirators because of theirreduced breathing resistance. OSHA has permitted this in several standardssuch as the coke oven emissions (29 CFR 1910.1029) and cotton dust (29 CFR1910.1043). However, OSHA's experience is that few employees make therequest.

(H) Maintenance and Care of Respirators

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

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

The proposal requires that routinely used respirators which are reserved forthe exclusive use of a particular employee be cleaned and disinfected atleast after each day's use. If a respirator is routinely used by more thanone employee, it must be cleaned and disinfected after each use. Respiratorsmaintained for emergency use must also be cleaned and disinfected after eachuse. Recommended procedures for cleaning and disinfection are included inAppendix B of the proposed standard.

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

Comments on the proposed draft also addressed the issue of the frequency ofcleaning and disinfecting of respirators. The American Textile ManufacturersInstitute (Ex. 36-18) felt that respirators should be cleaned after eachday's use and disinfected periodically as needed. The Motor VehicleManufacturer's Association (Ex. 36-37) stated that cleaning and disinfectingof respirators should be required periodically. DuPont (Ex. 36-38) felt thatthe provisions of the respirator program suggested by Organization ResourcesCounselors (ORC) (Ex. 36-47 Attachment 1) that requires cleaning frequentlyenough to avoid hazardous exposures to residues was sufficient. Richard Boggsof ORC (Ex. 36-47) urged adopting the language in the ORC program since itwould allow the individual organization to tailor its cleaning and sanitizingprograms to the needs of the operation.

OSHA believes that allowing periodic cleaning and disinfecting withoutspecifying the time period or requiring only that respirators be cleanedfrequently enough to avoid hazardous exposures to residues are vague conceptswhich are not defined, which may be difficult to enforce and would perpetuatethe poor cleaning practices which have already been shown to be a complianceproblem (Ex. 33-5). Therefore, the proposal continues to require thatroutinely used respirators be cleaned and disinfected after each day's useand that respirators used by more than one employee be cleaned anddisinfected 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 repairingof respirators. They stated that when the employer requires that employeesturn in their respirators at the end of each shift to a central cleaningfacility for inspection, cleaning, and repairs by trained personnel and withthe respirators returned to the employees the next day, a better cleaningprogram results. OSHA agrees that such a centralized cleaning and repairoperation can ensure that properly cleaned and disinfected respirators areavailable for use, but it is not the only way to do so. For example, inplants where respirator use is infrequent or where the numbers of respiratorsin use are small, central facilities may be inappropriate. The employer isallowed to choose the cleaning, disinfecting and repair program that bestfits the requirements of the standard and the particular circumstances of thejob. If the employer chooses to require that employees do the cleaning ofrespirators, then the employer must provide the cleaning and disinfectingequipment, supplies, facilities, and time for the job to be done. Theproposal requires that the employer ensure that the cleaning is doneproperly, and that only properly cleaned and disinfected respirators areused.

Storage of respirators must be done properly to ensure that the equipment isprotected and not subject to environmental conditions that may causedeterioration. The proposed provisions for storage are essentially the sameas the current standard. The employer must protect the stored equipment fromdamage, dust, sunlight, extreme temperatures, excessive moisture, or damagingchemicals. The respirator manufacturer will often provide additionalinformation on proper storage procedures which should be observed by theemployer. Storage conditions are listed in performance language. For example,temperature ranges are not specified. It appears that the degree of severityof a condition would be related to the tolerance of the particular equipmentin question and would thus vary from model to model. OSHA invites comment onwhether this approach is appropriate, or whether the conditions of storageshould be specified in more detail.

Respirators intended for emergency use shall be kept accessible to the workarea. Where weathering, contamination or deterioration of the respiratorcould occur compartments shall be used to protect the respirator and must beclearly marked to indicate that they contain emergency respirators. Thisrepresents a change in wording of the proposed standard in response tocomments on the preproposal draft (Ex. 36-45, 36-47, 36-55). Since manyemergency respirators are stored in environmentally controlled areas,according to the ANSI Z88.2 respirator committee (Ex. 36-55), compartmentswould be unnecessary. The new wording of the proposed standard requires theuse of compartments only where weathering, contamination or deteriorationcould occur.

Respirators that are used routinely in the work area are to be stored in aplastic bag or otherwise protected from contamination or damage. Theprohibition on the use of lockers or tool boxes has been removed in responseto comments in the preproposal draft (Ex. 36-47, 36-49). The requirement thatrespirators be stored in such a way as to prevent damage should avoidproblems of damage from improper storage in lockers provided the employertakes appropriate precautions.

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

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

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

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

The standard specifies what constitutes a minimal respirator inspection:

Respirator function, the tightness of connections and the condition of thefacepiece, headstraps, valves, connecting tube, and filters, canisters orcartridges must be checked. In addition, the rubber and elastomer parts mustbe evaluated for pliability and signs of deterioration. It should be notedthat stretching and manipulating rubber or elastomer parts with a massagingaction will help keep them pliable and flexible and prevent them from takinga set during storage.

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

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

(I) Supplied Air Quality and Use

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

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

In the ANPR, comments were requested on whether acceptable respiratorbreathing air should continue to meet the specifications for Grade Dbreathing air as described in Compressed Gas Association CommoditySpecification G 7.1-1966 or whether an alternate specification such as GradeE should be used. OSHA received comments stating that Grade D air is adequateand 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 GradeE 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 notbelieve that the need for a higher grade has been shown.

In the proposal, breathing air is to meet the requirements for the grade Dair classification in the ANSI/Compressed Gas Association CommoditySpecification G-7.1-1989. This is the revised and current version of theG-7.1 1966 Compressed Gas Association Commodity Specification. This meansthat the oxygen content (v/v) must contain the amount of oxygen normallypresent in atmospheric air of 19.5 to 23.5 percent oxygen for synthesizedair; 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 therequired quality of air.

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

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

Compressors are to be constructed and situated so contaminated air cannotenter the air supply system. In addition, the compressors are to be equippedwith suitable in-line air-purifying sorbent beds and filters to clean the airand assure breathing air quality. The requirement that air compressors have areceiver of sufficient capacity to permit escape from a hazardous atmospherein the event of compressor failure has been dropped. As was pointed out inseveral comments on the preproposal draft, a receiver is necessary only whenthe 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 proposalrequires that respirators used in IDLH situation be either an SCBA orcombination supplied air respirator with escape air supply, the need for areceiver for air compressors has been eliminated. Also the requirement foralarms to indicate compressor failure and overheating have been eliminated.In the event of compressor failure with a wearer using a combination suppliedair respirator with escape air supply, the loss of air supply would bereadily apparent, and the wearer can switch to the auxiliary escape airsupply and leave the area.

In the ANPR, OSHA also requested comments and input on the followingquestions: (1) How frequently should carbon monoxide concentrations bemeasured 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 oillubricated compressors that provide breathing air? Responses to the issue ofthe frequency of carbon monoxide measurements ranged from quarterly (Ex.15-42) to twice a month provided the air intake for the compressor is locatedaway 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 "Onespecified frequency would not be applicable under all conditions of breathingair compressor use." (Ex. 15-26).

In response to the ANPR question regarding carbon monoxide alarms on oillubricated compressors, numerous comments were received stating that therewas 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 Shamrockstated, "We recommend the installation of continuous carbon monoxide monitorswith an alarm on oil lubricated air compressors operated by internalcombustion engines, electric motors or auxiliary power takeoff . . ." (Ex.15-65). In the comments of the National Constructors Association it wasindicated that screw type compressors or oil free compressors do not need acarbon monoxide alarm provided the air intake is not near a potential carbonmonoxide source (Ex. 15-34).

There was general recognition in the comments that contamination of theintake air on a compressor used to supply breathing air is of primaryconcern. Several comments cited the study published in the AmericanIndustrial Hygiene Association Journal by T.M. Distler of the LawrenceLivermore Laboratory (Ex. 32-1) entitled "Formation of Carbon Monoxide in AirCompressors" (Ex. 15-13, 15-22, 15-26, 15-30, 15-41, 15-81). The findings ofthis study revealed that low pressure compressors are unlikely to reachtemperatures 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 ofthe compressed air; high temperature shut-offs or alarms do not significantlyprotect against carbon monoxide contamination of compressed air.

The preproposal draft contained provisions that required oil lubricatedcompressors to have carbon monoxide monitors and high temperature alarms.Freuhauf Corporation (Ex. 36-1) requested that compressors equipped with ahigh temperature shutdown device not be required to have carbon monoxidemonitor since the compressor would be shut down before breakdown of the oilcould occur. The Lawrence Livermore National Laboratory (Ex. 36-26), citingits study of compressors authored by Distler (Ex. 32-1), found no need forcarbon monoxide monitors and alarms for oil lubricated compressors. However,they recommend that carbon monoxide monitoring and alarms be required forbreathing air compressors powered by internal combustion engines, due to thepotential for reentrainment of exhaust gases. Alan Hack (Ex. 36-29) statedthat carbon monoxide alarms appear to be unreliable, there was littleevidence of carbon monoxide production with oil lubricated compressors, andthat OSHA should not require them. ASARCO (Ex. 36-39) recommended that OSHAallow the use of carbon monoxide absorption filters with visible color changeindicators in place of carbon monoxide monitors. Richard Boggs of ORC (Ex.36-47) recommended deleting section (i)(4)(v) requiring carbon monoxidemonitors, citing the report on compressors performed by Distler. The LosAlamos National Laboratory (Ex. 36-52) stated that carbon monoxide alarmscurrently in use were unreliable, and that there was little evidence ofcarbon monoxide production with oil lubricated compressors. LynnetteHendricks of the 3M Corporation (Ex. 36-54) stated that the requirement forcarbon monoxide alarms added negligibly to the effort to provide qualitybreathing air, and that 3M was aware of no instances where oil lubricatedcompressor failures resulted in carbon monoxide exposure to workers. ThomasNelson of the ANSI Z88.2 respirator committee (Ex. 36-55) recommended thatthe need for carbon monoxide alarms be dropped when the air intake is locatedaway from sources of carbon monoxide contamination. He also recommendeddropping the high temperature alarm requirement. The State of Wyoming OSHA(Ex. 36-9) recommended that continuous carbon monoxide monitors with alarmsbe required for oil lubricated compressors operated by internal combustionengines or electric motor auxiliary power takeoffs. The InternationalChemical Workers Union (Ex. 36-14) stated that continuous carbon monoxidemonitors and alarms for oil lubricated compressors were the only effectivemethods to monitor carbon monoxide concentrations.

OSHA knows of one such incident which involved carbon monoxide production byan oil lubricated compressor. An MSHA Accident Investigation Report issued inJanuary 1985 (Ex. 38-12) reported that a diesel engine powered two stagerotary air compressor that utilized oil for cooling had overheated during asandblasting operation at a limestone quarry. This resulted in the near fatalcarbon monoxide poisoning of the sandblaster who was wearing a continuousflow abrasive blasting hood which received its air from the compressor. Theair compressor had a thermo bypass valve that should have normally directedthe oil through a cooling radiator once the oil had reached a temperature of185 deg. F. The thermo bypass valve failed, allowing the cooling oiltemperature to rise above its flashpoint of 420 deg. F. The oil ignited inthe oil separator and the fire spread to the combined oil receiver/airreceiver, producing carbon monoxide. The compressor was equipped with a hightemperature shutoff switch set for 235 deg. F, but it had been disconnectedfor at least 30 days prior to the incident. The compressor was not equippedwith a carbon monoxide filter or alarm. The air line to the respirator had aninline filter to remove oil, water, and particulates from the compressed airas it left the air receiver, but it allowed the carbon monoxide to passthrough to the respirator wearer. The sandblaster collapsed from carbonmonoxide poisoning. The sandblaster's assistant shut down the compressor,removed the victim's abrasive blasting hood, and called for emergencyassistance. Neither of the employees performing the sandblasting operationhad received any training in proper respirator use.

This extremely rare incident raises serious questions about carbon monoxidefilters and alarms as well as high temperature shutoff devices, and whethertheir use should be required for oil lubricated compressors. A properlyfunctioning high temperature shutoff switch should have shut down theoverheated compressor, but it is unclear whether this would have occurredbefore the carbon monoxide laden air went out to the respirator wearer. Thiscompressor had no carbon monoxide filter with alarm to warn the respiratorwearer. However, given that the high temperature alarm was previouslydisconnected, it is unclear whether that alarm would have been disabled aswell. OSHA requests any further information regarding other incidentsinvolving carbon monoxide production by oil lubricated compressors, and anycomments on the necessity for carbon monoxide filters and alarms as well ashigh temperature alarms for air compressors.

This proposal does not contain a requirement that carbon monoxide alarms orhigh temperature shutoff devices be used with oil lubricated compressors. Asthe Distler air compressor study (Ex. 32-1) points out, air compressors areunlikely to reach temperatures where carbon monoxide production would occur.Exhaust gases from internal combustion engines and the intake of contaminatedair are the major threats to air quality, and these threats occur with allcompressors, not just oil lubricated ones. The proposal requires that the airintake for compressors be placed to avoid the entry of contaminated air. Oneway to ensure that contaminated air does not enter the air supply would befor OSHA to require carbon monoxide filters with continuous monitoring alarmsfor all breathing air compressors. OSHA requests comments on whether itshould adopt this requirement for all compressors. OSHA requests anyinformation about problems with air compressor air quality, filters andalarms, and invites comments on how best to ensure breathing air quality forrespirators.

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

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

In addition, employers must use breathing gas containers marked inaccordance with the American National Standard Method of Marking PortableCompressed Gas Containers to Identify the Material Contained, Z48.1-1954(R-1971); Federal Specification BB-A 1034a, June 21, 1968, Air, Compressedfor 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 withproperly 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 therespirator manufacturer under the NIOSH 30 CFR 11 and 42 CFR 84 respiratorcertification standards. Therefore, this proposal has eliminated therequirements and tables relating to the marking of canisters from thestandard. Two requirements have been added to replace the markingrequirements. First, the employer must ensure that all filters, cartridgesand canisters used are properly labeled and color coded. Since themanufacturer already does this, the employer need only check that the labelis there. Second, the label may not be removed, obscured or defaced while inservice since that would defeat its purpose.

(K) Training

The most thorough respiratory protection program will not be effective ifemployees do not wear respirators, or if wearing them, do not do soappropriately. The only way to ensure that employees are aware of the purposeof wearing respirators, and how they are to be worn, is to train them. Therecord shows widespread agreement that employee training is an important partof the respiratory protection program and is essential for correct respiratoruse (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. Theminimal requirements it imposes are included within other sections of thestandard.

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

In response to ANPR commenters who urged OSHA to mandate a program that isperformance 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 isperformance oriented in that it specfies categories of information to coverduring training. It neither specifies how the training is to be performed northe format of the employers training program. The employer can use whatevertraining method is effective for the particular worksite as long as itcontains the topics discussed below. Employers can utilize prepared materialssuch as audio-visuals and slide presentations or they can use approachesranging from formal classroom instruction to informal discussions duringsafety meetings (Ex. 15-53), or a combination of methods.

The first category of information to be included in the training program isthe nature, extent and effects of respiratory hazards to which the employeemay be exposed. This includes identification of the hazardous chemicalsinvolved, what exposure levels there would be if no respiratory protectionwere being used, and what the potential health effects of such exposure wouldbe if the respirator is not worn or not worn properly. This type ofinformation will be available on the material safety data sheet for thehazardous chemical that the chemical manufacturer will be required to produceunder the Hazard Communication Standard (29 CFR 1910.1200). These trainingrequirements on health hazards of hazardous chemicals are also required underthe Hazard Communication standard (29 CFR 1910.1200) and could easily becombined into the same training program. Many commenters agreed that thissubject 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, employersare to provide an explanation of the operation, limitations, and capabilitiesof the respirators selected for the employees to wear. This would include,for example, an explanation of how the respirator provides protection byeither filtering the air, absorbing the vapor, or providing clean air from anuncontaminated source. Where appropriate, it also should include limitationson the equipment such as prohibitions against using an air-purifyingrespirator in the event of an emergency with IDLH atmospheres and anexplanation of why they should not be used in such situations. In other wordsthe employee should be able to understand the operation of the respiratorthoroughly as a result of this training, and thus know why it was selectedfor the task at hand. Most commenters supported covering this topic in thetraining 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 particularequipment selected to protect against those hazards, the employer is toprovide specific instruction regarding the type and frequency of respiratorinspections. Although the employer is required to ensure that suchinspections are performed, employees using the equipment may frequently beresponsible for inspecting the respirators assigned to them. Therefore, it isnecessary that they have this process explained and demonstrated to them sothey are capable of recognizing any problems that may threaten the continuedprotective capability of the respirator. The training must include the stepsemployees are to follow if they discover any problems during inspection, i.e.who this should be reported to and where they can obtain replacementequipment if necessary.

The training must also include the procedures for donning or removing therespirator, checking the fit and seals, and actually wearing the respirator.It is very important to ensure that the everyday respirator fit is as closeas possible to the fit obtained during fit testing, and therefore employeesmust be able to duplicate that fit through proper donning and removal. Thefit testing procedure can help in training employees, particularly ifquantitative fit testing is used since it can demonstrate numerically toemployees the dramatic differences in measured fit when the respirator is notadjusted properly (Ex. 15-44). The proposal requires employers to includesufficient practice so that employees can perform these tasks effectively.The proposal also includes positive and negative pressure facepiece sealchecks in non-mandatory Appendix B. If other tests are equally effective intesting the face seal, they may be used. Employees must be trained regardingthe appropriate tests to be used for the respirators they are wearing. Theinclusion 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 storageof respirators. This provision may vary by establishment since in some casesthe employees are responsible for doing some of the maintenance and forstoring the respirators while not in use, but in other facilities specificpeople are assigned to carry out these activities. In any event, employeesshould be aware of the proper procedures to follow. The significance of thispoint 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 whichrequire different respirators for the exposure levels involved. The trainingprogram must include a discussion of these possibilities, and the proceduresthe employer has established to deal with them. Most ANPR commentersconcurred that comprehensive training is necessary where respirators are tobe used in situations immediately dangerous to life or health, includingoxygen deficient atmospheres, such as in fire fighting, rescue operations andconfined 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 trainingrequirements of the American National Standard Institute (ANSI) Z88.2-1980Practices for Respiratory Protection which discussed the basic trainingrequirements 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 requirementsfor training except that the proposal does not require a discussion on therole of engineering controls.

Although some commenters felt that the provisions covering training in thepresent standard are adequate (Ex. 15-37, 15-56, 15-75A), in view of theimportance of training in motivating employees to wear respirators correctlyand effectively, the additional information required by this proposal isdeemed by OSHA to be critical for an effective respirator program. With theexception of the American Iron and Steel Institute (Ex. 15-37), A.E. StaleyManufacturing Company (Ex. 15-56), and the Sperry Corporation (Ex. 15-75A),the record supports further guidance for training than is currently containedin 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 ofrespirators, the employer must inform employees of the existence and contentsof the respirator standard (29 CFR 1910.134). They must also be told of theexistence and contents of the written respiratory protection program requiredby the respirator standard, where it is kept in the facility, and how theemployee can arrange to examine it if desired.

The majority of commenters agreed that annual training is necessary toassure 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 SperryCorporation, however, recommended that employees be retrained every 6 months,but did not provide a rationale for their contention. In response to thepreproposal draft, California OSHA (Ex. 36-44) recommended that a morecomprehensive initial training and more frequent refresher training berequired for employees assigned to use SCBA in potentially IDLH atmospheres;emergency response users of SCBA would receive refresher instruction in theoperation inspection, and wearing of the SCBA at least every three months forthe first two years following initial training, and thereafter every sixmonths. Frank Wilcher of the International Safety Equipment Association (Ex.36-45) also recommended that employees who use SCBAs be trained semiannuallybecause of the higher degree of complexity of these units and the possibilityof 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 beadjusted to the complexities of the respirator program and the level ofrespirator use. William O'Keefe of the American Petroleum Institute (Ex.15-41) asserted that training should be repeated periodically, but at leastevery 2 years and more frequently as workplace conditions may warrant.Richard Boggs of ORC (Ex. 36-47) in response to the preproposal draftrecommended that a 2 year cycle of retraining and refresher instruction afterthe initial respirator use training was reasonable. He recommended that anydecision for more frequent training should be made by the employer. Annualretraining was called needlessly expensive. Amoco Corporation (Ex. 36-35)recommended that the retraining frequency for routinely used respirators be aminimum of two years, but emergency use respirators would require annualretraining. The American Textile Manufacturers Institute (Ex. 36-18)recommended retraining every two years for employees requiring an APF of 10or less. Both the ANSI Z88.2-1980 and Z88.2-1993 respiratory protectionstandards call for annual retraining.

OSHA concurs with the majority of comments contending that annual trainingis sufficiently frequent to ensure employee cooperation and activeparticipation in the program. Training every two years instead of annuallyfor routinely worn respirators has been rejected, since the purpose of thetraining is not only to instruct wearers in proper techniques but also toencourage their cooperation and participation in the respirator program.Switching to training every two years would tend to diminish attention toproper respirator use. OSHA compliance experience has demonstrated thatinadequate respirator training is a common problem (Ex. 33-5) and is oftenassociated with respirator program deficiencies that potentially lead toemployee exposures. Therefore, the proposal contains the requirement forannual training for respirator wearers. Training required by this proposal isto be given to the employee before he or she is required to wear a respiratorin the workplace. Employees must receive training at least annually so theywill be reminded regularly of the effects of the respiratory hazards to whichthey may be exposed and how they can prevent such exposure by proper wearingof respirators. OSHA requests comments on the frequency of training,particularly the need for increased training and more frequent refreshertraining 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 toeliminate all problems with wearing a respirator, the employer must try toeliminate as many problems as possible to improve protection and encouragewearer acceptance of respirators. Eliminating problems is accomplished mosteffectively when the program is evaluated carefully and revised as necessary.Although the current standard does require that the employer perform periodicchecks of the effectiveness of the respiratory protection program, littleguidance is provided regarding how this evaluation is to be done. Theproposal includes a paragraph dealing with this requirement and provides moreinformation regarding what should be assessed by the employer.

The person responsible for administration of the respiratory protectionprogram is to review the program at least annually and is to conduct frequentrandom inspections of the workplace to ensure that the provisions of theprogram are being properly implemented. The annual review is to include anassessment of each element of the program that is required to be includedunder paragraph (c)(1).

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

(M) Recordkeeping and Access to Records

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

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

The importance of recordkeeping as a means of verifying compliance with therespiratory protection program requirements was stated frequently in therecord (Ex 15-18, 15-22, 15-33, 15-41, 15-47, 15-82). Commenters urged OSHAto require only those records necessary to demonstrate an effective program(Ex 15-19, 15-21, 15-41, 15-47, 15-71). However, there was considerabledisagreement over what recordkeeping items to require. Because OSHArecognizes that recordkeeping may be administratively burdensome and timeconsuming, the Agency has only required employers to maintain records thatare necessary for determining compliance with the requirements of theproposal.

The written respiratory protection program itself needs to be kept currentas long as respirators are in use in the workplace. However, there is nospecific retention period as long as the latest version of the program isavailable 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, andsize of the respirator fitted; date of the fit test; and the strip chartrecording or other record of the test results where quantitative fit testingwas performed. The fit test record must be maintained until the next fit testis administered. The reason for requiring that fit test records be maintainedis to provide a record of the results of fit testing in order to determinewhether annual fit testing has been done and if the individual tested passedthe QNFT with a fit factor that was adequate for the type of respirator beingused. The preproposal draft did not contain a requirement that fit testrecords be maintained, but several commenters had serious doubts that OSHAwould be able to determine if an individual had been properly fitted and waswearing the appropriate respirator by visual observation alone (Ex 36-6,36-17, 36-34, 36-46). OSHA agrees that fit testing records must be maintainedto ensure that all respirator wearers have received a fit test, that theappropriate respirator chosen by fit testing is being worn, and thatretesting is performed annually. Fit testing records can also serve otheruses 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 isreviewed with the fit test subject.

(N) Substance Specific Standards

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

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

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

OSHA has adopted various approaches to deal with respirator provisions inthose substance specific standards which differ from this proposal. Based onthe information and data in the respiratory protection docket, OSHA believesin order to maintain an effective respirator program regardless of thecontaminant or workplace conditions, there should be a minimum program level.Thus, for provisions in substance specific standards which are moreprotective than the counterpart revised provisions of this standard, OSHAdoes not propose any changes. For example, the respirator selection tables ofsome standards provide for more restricted use of respirators than would therespirator selection criteria in this proposal. The least protectiverespirator allowed by the ethylene oxide standard is a full facepiecerespirator with an ethylene oxide canister regardless of protection factorrequired, whereas respirator selection according to this proposal would allowa half mask or quarter facepiece cartridge/ canister respirator up to theNIOSH assigned protection factor of 10. OSHA believes that the moreprotective provisions of respirator selection adopted for specific substancesafter rulemaking proceedings conducted pursuant to Section 6(b) of the Actreflect the content of each rulemaking record, the toxicity and circumstancesof use of each substance and therefore should be retained.

In keeping with this principle of not going below the minimum program, inthose cases where existing respirator selection options in the substancespecific standards are less protective than would be permitted by theproposed NIOSH respirator selection tables, OSHA proposes to revise suchpermitted respirator selections to conform to paragraph (d). For example, thelead standard (1910.1025 (f)(2)) now allows any powered air-purifyingrespirator with high efficiency filters to be used in concentrations up to1000 times the PEL, and the coke oven emissions standard allows the use ofPAPRs in any concentration, whereas under this proposal respirator selectionwould allow powered air-purifying respirators to be used only in atmospheresof 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 asexisting respirator types, OSHA continues to require that they be NIOSHcertified for the contaminant involved as a prerequisite to their permitteduse.

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

In addition to making existing substance specific standards conform to therevised provisions of the respiratory protection standard in general, OSHA isalso requesting comments on specific respirator-related issues of threespecific standards.

OSHA is intending to reinstate the provision in the lead standard thatrequires the use of high efficiency filters for all air purifying respiratorsused with lead. In 1979, OSHA had stayed that provision to allow furtheradministrative reconsideration (44 FR 5446). The recent asbestos standardrecord that has been generated supports requiring the use of high efficiencyfilters with whatever respiratory protection equipment is used to protectagainst highly toxic substances. When OSHA announced the stay on therequirement for high efficiency filters in the lead standard, it was statedthat NIOSH would be asked for further interpretation of the record. Partiallyin response to this request, NIOSH performed a study on the effectiveness ofvarious filters in the presence of lead aerosols. The results of this study(Ex. 38-6) show a substantial difference in penetration between highefficiency filters and others. OSHA therefore believes there is a clearincrease in protectiveness as a result of the use of high efficiency filtersin a lead aerosol atmosphere. Moreover, OSHA believes the use of highefficiency filters does not impose an undue burden on employers in relationto the use of less efficient filters, and that requiring the use of highefficiency filters in the presence of lead -- a highly toxic substance -- isboth appropriate and reasonable. As a result of these considerations, OSHAintends to lift the stay on enforcement of the requirement that highefficiency filters (type III filters as defined under 42 CFR Part 84) beused.

As a second issue, the OSHA asbestos standard requires the use of highefficiency filters with air-purifying respirators and does not allow the useof disposable respirators with asbestos. Reasons for not permitting the useof such respirators were that it was determined in the asbestos standardrecord that high efficiency filters are necessary to provide the necessaryprotection against penetration; and that disposable respirators for the mostpart also were not shown to provide adequate fit and were not by virtue ofdesign amenable to the performance of a fit check. However, it has come toOSHA's attention that there are disposable respirators with elastomericfacepieces and high efficiency filters which are said to provide fits as goodas provided by half mask elastomeric respirators which have replaceable highefficiency filters. Such disposable respirators can be quantitatively fittested, and are designed so that fit check procedures can be performed. OSHAis asking for comments on whether such respirators should be allowed to beused under the asbestos standard.

The third issue concerns the OSHA standard for inorganic arsenic. At thetime this standard was promulgated in May 1978, disposable respirators withhigh efficiency filters were not available. Therefore, disposable respiratorswere not addressed in the respirator selection tables of the standard. Nowthat there are such respirators, OSHA needs to determine whether they canprovide adequate assurance of fit so as to be suitable for inorganic arsenicwhich is known to be carcinogenic. OSHA is proposing that disposablerespirators not be permitted under the inorganic arsenic standard for thesame reasons as stated for the asbestos standard. OSHA is seeking comment onwhether disposable respirators with and without elastomeric facepieces shouldor should not be allowed to be used under the inorganic arsenic standard inview 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 inShipyards, Sec. 1915.152. OSHA requests comments on the proposal and whetherany changes in the proposed language is appropriate for shipyards based onrelevant unique circumstances. Currently, the respiratory provision forMarine Terminals is a cross reference to Sec. 1910.134. See Secs. 1917.92 and1917 (a)(2)(viii). The current respiratory provision for Longshoring is atSec. 1918.102 and is many years out of date. OSHA proposed on June 2, 1994 at59 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 areappropriately incorporated into the Marine Terminal and Longshoring Parts bycross reference or directly. OSHA requests comments on costs and feasibilityissues for these sectors. OSHA also requests comments on whether provisionsdifferent from the general industry standard are appropriate based on uniquecircumstances in these sectors.

P. Construction Advisory Committee

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

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

The proposal would replace the existing construction industry standard forrespiratory protection, 29 CFR 1926.103, with the provisions of the revised29 CFR 1910.134 respirator standard. The Construction Advisory Committeerecommended that there should be a separate respirator standard forconstruction. Whether there were particular changes that should be made tothe provisions of the standard to reflect respirator usage in theconstruction industry was not clearly addressed by the Committee since thecomments they presented were equally applicable to general industryrespirator use. OSHA believes that there is no need for a separate rulemakingfor the construction industry since no differences in content would appear tobe appropriate. Consequently this recommendation was not incorporated.However, OSHA is establishing these respiratory provisions explicitly in theconstruction standards as 29 CFR 1926.103.

Paragraph (a) -- Scope and Application

The Construction Advisory Committee recommended that the scope andapplication section, paragraph (a)(1) of the standard, require that allfeasible engineering controls be used by employers and that the employerdemonstrate that engineering controls are not feasible before respirators areused. The proposed change would eliminate the requirement that appropriaterespirators be used while engineering controls are being installed. Since theonly effect of this proposed language change would be to eliminate therequired 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 thatemployers provide respirators at one half the PEL or TLV, and that employeesbe required to wear them before the PEL is exceeded. To accompany thisrevision the Committee proposed a new definition establishing an "actionlevel" at one half the PEL for all regulated substances. OSHA does notbelieve it to be within the scope of this proposed standard for respiratoruse to trigger action levels and is therefore not incorporating this CACOSHrecommendation.

Paragraph (b) -- Definitions

The Committee suggested that the definition of an atmosphere-supplyingrespirator be revised to include reference to "Grade D breathing air". Thisdefinition was intended by OSHA to describe a particular technical device,the atmosphere-supplying respirator. The requirement for Grade D breathingair is contained in paragraph (i)(1)(i) of the proposed standard and is notrelevant to the definition of the type of respirator. Therefore, thedefinition 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 beenadded 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 existingrespiratory hazards in the workplace and who has the authority to take promptcorrective measures to eliminate them, as specified in 29 CFR 1926.32(f). Theduties of the competent person include at least the following: reviewing therespiratory protection program, ensuring that the employer conducts thetraining, fit testing, tests and maintains the records for respirators andensuring that engineering controls in use are in proper operating conditionand are functioning properly." This proposed definition would establishduties and authority for the competent person, who would perform the functionof the respiratory program administrator required in paragraph (c)(2) of theproposal. However, the definition contains duties and responsibilities thatgo beyond the requirements set for a program administrator. These duties,such as ensuring that engineering controls are in proper operating conditionand are functioning properly, are the responsibility of whomever the employerchooses to designate. Although the competent person definition has not beenincluded in this proposal, OSHA is asking for comments on the need for thisdefinition or for alternative definitions to accomplish the same purpose.

In the proposal's definition of hazardous exposure level, the ACGIH TLVs areused to determine the hazardous exposure level in the absence of a PEL. TheConstruction Advisory Committee recommended that the NIOSH RecommendedExposure Limit (REL) should also be used along with the TLV, and thatwhichever was lowest to be used in determining the hazardous exposure level.OSHA agrees that the NIOSH Recommended Exposure Limits are an appropriatesource for exposure limits in the absence of a PEL. However, it is not clearthat the lowest value from either the TLV or REL for a particular substanceshould be used. OSHA has received no comment on the appropriateness of theNIOSH RELs in the docket, and is requesting comment on how OSHA shouldrequire the use of the RELs by employers in establishing hazardous exposurelevels for respirator use. Language has been added to the hazardous exposurelevel definition to require the use of the RELs, but only in the absence of aPEL or TLV, since these values are widely recognized as appropriate for suchuses. OSHA requests comments on this addition and on the use of RELs inrelation to TLVs.

The proposal states in paragraph (d)(6) that air-purifying respirators maynot be used for a hazardous chemical with poor or inadequate warningproperties. The proposed standard defines adequate warning properties asdetectable odor, taste, or irritation effects which are detectable andpersistent at or below the hazardous exposure level. CACOSH recommendedinclusion of a definition of "inadequate warning properties" as thoseassociated with an odor or taste threshold equal to or greater than one-halfof the substance's PEL or TLV. The CACOSH definition reduces the cutoff levelfor warning properties to one-half the PEL or TLV. This would reduce thenumber of chemicals with adequate warning properties with which air-purifyingrespirators can be used. OSHA requests comments and information on theappropriateness of using a cutoff level of one-half the PEL or TLV as thepoint where inadequate warning properties start, and on the effects such alevel would have on air-purifying respirator use.

The definition of "maximum use concentration" (MUC) in the proposal limitsthe use of gas and vapor air-purifying elements to a maximum level whichcannot exceed the NIOSH limits on the respirator approval label. CACOSHsuggested that OSHA add a sentence to the definition to limit the MUC to amaximum of 1000 ppm. NIOSH in Table 5 of their Respirator Decision Logic (Ex.38-20) presents recommended MUC levels for gas and vapor air-purifyingelements. The 1000 ppm MUC is used only for organic vapor cartridges.Different MUCs are given, based on whether the element is a cartridge, chincanister, or front-or-back-mounted canister. The MUC is limited by the NIOSHDecision Logic to the maximum listed in the table or the IDLH level of thespecific organic vapor, whichever is lower. OSHA requests comments on whetherit should adopt the NIOSH limitations on MUC for use in the revised OSHArespirator standard.

CACOSH also suggested that OSHA add a definition for "odor threshold" as theconcentration at which 100 percent of a human test group would detect theodor of a substance. However, odor thresholds vary greatly among individuals,a few of whom may be virtually insensitive to a large number of chemicals. Arequirement that 100 percent of a human test group be able to identify thechemical could result in the elimination of most chemicals as having no odorthreshold. OSHA has therefore not adopted this definition. However, OSHA isrequesting comment on the appropriate levels that should be used indetermining odor thresholds, the test methods used, and the appropriatenessof requiring that odor threshold testing be performed for individuals whomust wear air-purifying respirators.

The Construction Advisory Committee also recommended replacing theproposal's definition of "respirator" with the following: "`Respirator' meansany device worn by an individual and intended to reduce an exposure toairborne contaminants or supply the wearer with Grade D breathing air in acontaminated or oxygen deficient atmosphere." OSHA believes that performancecharacteristics of respirators should be stated where appropriate in thestandard. Some respirators are adequate while others are not. However, aninadequate respirator is still a respirator. Therefore OSHA has not adoptedthis CACOSH change in the definition of respirator.

The Committee also proposed revising the language in the definition ofservice life in the proposal with the following: "`Service Life' means theperiod of time it takes for a specified substance to break through a chemicalor organic vapor cartridge or canister." Service life, as the definition inthe proposal states, is a function not only of the type of substance but alsoof the specific concentration of that substance. Removing the specificconcentration of the substance from the definition, as the CACOSH reviseddefinition does, obscures the meaning of the definition, and therefore it hasnot been adopted. The NIOSH Respirator Decision Logic (Ex. 38-20) uses abroader definition that covers all air-purifying respirators as well as SCBA.It reads as follows: "SERVICE LIFE: The length of time required for anair-purifying element to reach a specific effluent concentration. Servicelife is determined by the type of substance being removed, the concentrationof the substance, the ambient temperature, the specific elements being tested(cartridge or canister), the flow rate resistance, and the selectedbreakthrough 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 onwhether 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 employerestablish and implement a written respirator program that covers certainelements, as applicable. The Construction Advisory Committee recommended thatOSHA change the word "cover" to "include" and remove the phrase "asapplicable." The phrase as applicable was included in the requirements tocover situations where not all the elements listed in the paragraph would beappropriate for some particular written respiratory program. For instance, ifonly air-purifying respirators are to be used, it would not be applicable toinclude in the written program the elements covering supplied air quality,the maintenance and cleaning of supplied air respirators, or fit testing ofSCBAs. Therefore, OSHA has not changed the wording in the proposal.

The Committee raised the issue of monitoring exposure levels inconstruction. They recommended that OSHA add a new element to the existingelements of the written respirator program in paragraph (c)(1) that wouldread as follows: "(i) Procedures for monitoring the work environment andselecting respirators based on monitoring results for use in the workplace."Discussion by the Committee brought out that construction work situations arenot stable, and that monitoring results for a particular individual operationwould likely not be returned in time by a laboratory before that task wascompleted. Previous monitoring results can be used, along with pastexperience with similar work operations, to estimate exposure levels. TheCommittee then recommended that OSHA add to the standard a requirement that"If monitoring is not done, the most protective respirator shall be used." Inmost cases this would mean using supplied air respirators or SCBAs in theabsence of monitoring. The proposal does not now require monitoring, but itdoes require that where monitoring results exist, the employer evaluate themin selecting the proper respirator. OSHA requests comments and suggestions onwhether monitoring should be made mandatory for making respirator selections,and what monitoring procedures should be used. OSHA also requests comments onthe recommendation by CACOSH that the most protective respirator must be usedin 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 qualityfor atmosphere-supplying respirators. CACOSH proposed adding the words"quantity and flow" to this element on air quality procedures. OSHA agreesthat adding these words will provide more direction for employers on what theprocedures should cover, and has revised the wording of this elementaccordingly.

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

The written respiratory protection program, in paragraph (c)(3), is requiredto reflect current workplace conditions and respirator use. The Committeewanted to add the term "training", to require that the program reflectcurrent workplace conditions, training and respirator use. This suggestionhas not been adopted since OSHA believes that training should reflect currentworkplace conditions and the written respirator program, and not the reverse.It was recommended by the Committee that OSHA add to paragraph (c) aparagraph that would allow employees and designated representatives access toexposure and medical records maintained by the employer. OSHA has not adoptedthis suggestion, since this requirement is already included in 29 CFR1910.20, the medical and exposure records access standard, which isreferenced in this proposed standard.

In paragraph (c)(5), the employer is required to make the written programavailable to affected employees, designated representatives, and OSHA. TheCommittee requested that employers be required to send a copy of the programto the OSHA Special Assistant for Construction. This suggestion has not beenadopted, since no procedures exist in the Special Assistant's Office thatwould utilize these written programs if they were sent in. However, languagehas been added that would require the sending of a copy of the program to theAssistant Secretary upon request. This should meet any possible need that mayarise for copies of the written program without creating an unreasonableburden.

The Committee further recommended that the respirator program should bemaintained and made available to employees at the job site, and that themedical and monitoring results pertaining to respirator use be available atthe work site as well. How the latter would be performed, given the highlymobile nature of construction activities, was not clear. OSHA requestscomments on this recommendation and any suggestions on how to provide theabove information at the job site in a reasonable manner without placing aninappropriate 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 forcontaminants when air-purifying respirators are used to be sure that themaximum use concentration for the respirator type would not be exceeded. Thisprovision is related to the requirement for monitoring that was previouslydiscussed, and on which comments are requested.

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

The proposal in paragraph (d)(4) requires that respirators approved by NIOSHbe selected when they exist. The Committee wanted to remove the phrase "whenthey exist" since they felt that one should use the most protectiverespirator available, an SCBA or supplied air respirator, in cases where noapproved air-purifying respirator exists. As stated in the proposal, OSHA hasthe option of allowing the use of non-approved respirators for certain typesof exposures. The option of allowing the use of non-approved respirators hasbeen of value in the past. An example is the ethylene oxide standard, 29 CFR1910.1047, 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 shallnot be used for hazardous chemicals with poor or inadequate warningproperties. However, in paragraphs (d)(6) (i) and (ii) their use with suchsubstances is allowed when permitted under an OSHA substance specificstandard or when certain conditions for use are met. As discussed previouslyin this section the Committee wanted to include poor odor threshold as areason for prohibiting use, and to remove paragraph (d)(6)(ii) which allowstheir use under limited circumstances. OSHA has asked for comments on thisissue.

In oxygen deficient atmospheres, the proposal in paragraph (d)(8) allows theuse of air-purifying respirators in an atmosphere with an oxygen content of19.5 percent or greater at altitudes of 14,000 feet or below. The Committeewanted to remove this provision, thus requiring the use of supplied airrespirators for many work sites at altitudes where the use of air-purifyingrespirators has caused no problems. There was nothing presented at themeeting to support this request. The record on the issue has been discussedpreviously in this preamble, and OSHA is inviting further comment on thisissue and on the use of air-purifying respirators at high altitudes onconstruction worksites.

Paragraph (e) -- Medical Evaluations

In the medical section of the proposed standard, the Committee recommendedthat a mandatory medical examination be required in accordance with ANSIZ88.2 and that the standard include a list of diseases and conditions whichshould be considered by the physician in determining an individual's abilityto wear a respirator. As discussed in the section of this preamble on medicalsurveillance, OSHA is inviting comment on three specific alternatives formedical surveillance requirements.

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

In paragraph (e)(1) of the medical evaluation provision that the Committeereviewed, the employer is required to obtain a physician's written opinionwhich states whether the employee has any detected medical condition whichwould place the employee's health at increased risk of material impairmentfrom respirator use and any recommended limitations upon the use ofrespirators. The Committee suggested that OSHA revise the language in thisprovision to read: "For each employee required to wear a respirator theemployer shall obtain from a licensed physician a written opinion based uponany detected medical condition, which states whether the employee can wearthe respirator and perform the work or whether there are limitations to typeof respirator worn or work performed." The Committee was concerned that theoriginal language could be interpreted as permitting the employer to knowwhat the medical conditions were that limit respirator use. They wanted tolimit the language so that the employer would only receive from the physicianan opinion on whether the employee can perform the required work whilewearing a respirator or whether there is some restriction on the respiratortype that can be used. The current proposal now requests comments on threealternatives for medical surveillance requirements, one of which is theprovision reviewed by CACOSH. OSHA requests comments on all threealternatives and, in particular, on the need for restricting the medicalopinion to only the individual's ability to wear a respirator.

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

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

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

Paragraph (f) -- Fit Testing

With respect to fit testing procedures, the Committee recommended thatparagraph (f)(1) be rewritten to state that respirators shall fit theemployee so no exposure above the TLV or ceiling level shall occur. OSHA hasadded a new provision to require that the respirator used shall reduceemployee exposures in the breathing zone to below the hazardous exposurelimit. This change answers the Committee comment and preserves the languageof the original proposal.

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

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

In paragraph (f)(9) the employer is allowed to use a qualitative fit testfor selecting respirators for employees who require fit factors greater than10 in situations where outside contractors who do the quantitative fittesting are not available. A thirty day time limit is placed on thisexemption from the requirement for quantitative fit testing. The Committeefelt this exemption is not safe and should not be allowed. An employee who ishired between the normal visits of the quantitative fit test contractortherefore could not be assigned to any work area requiring fit factorsgreater than 10 until a quantitative fit test was passed. OSHA requestscomments on this issue and on the Construction Advisory Committee suggestionto delete paragraph (f)(9) from the standard.

Paragraph (g) -- Respirator Use

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

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

The cleaning, sanitizing, and discarding of disposable respirators isaddressed in paragraph (g)(9) of the proposal. The Committee recommended thatOSHA delete this provision since it refers to disposable respirators. In anearlier discussion of assigned protection factors, the Committee recommendedthat OSHA only permit the use of respirators that achieve a minimum assignedprotection factor of ten. Since disposable respirators, in the Committee'sopinion, could only achieve an assigned protection factor of five, their useshould not be permitted. The Committee therefore recommended that paragraph(g)(9), which refers to disposable respirators, be deleted since it refers toa class of respirators which could not be used. However, after furtherdiscussion the recommendation for a minimum assigned protection factor of tenwas withdrawn. Since it was this withdrawn provision that supported theCommittee's recommendation to deleting any reference to disposablerespirators, and disposable respirators as a class are still covered by theproposal, the provision covering their cleaning, sanitizing and disposal hasnot 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 byfollowing certain procedures. The Committee wanted to add the phrase "on paidtime" in order to require that the cleaning not be required to be performedby employees on their own time. OSHA believes that this is not a respiratoryprotection issue but a labor relations issue that should be addressed bylabor/management negotiation. Therefore, the suggested wording has not beenadded.

Paragraph (k) -- Training

The training section of the proposal requires that employers provide atraining program for employees who are required to wear respirators. TheCommittee wanted to add language to paragraph (k)(1) to require employers toprovide, conduct and document the effectiveness of the training program. Theproposal already contains the requirement that employers provide a trainingprogram, which has always been interpreted by OSHA as requiring that thetraining be conducted. Documenting the effectiveness would mean that somesort of testing of employee capabilities to properly use respirators aftertraining would have to be performed. OSHA currently evaluates trainingprograms by other means such as by seeing how respirators are being used byemployees on the job and by interviewing respirator users. OSHA does notregard the suggested additional requirements proposed by the Committee asnecessary for enforcement of the standard and has therefore not includedthem.

Paragraph (m) -- Recordkeeping

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

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

Appendix B -- Recommended Practices

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

VIII. References

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

2. Teresinski, Michael F. andPaul N. Cheremisino, Industrial Respiratory Protection, Ann Arbor SciencePublishers; Ann Arbor, Michigan, 1983.

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

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

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

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

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

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

9. Occupational Safety and Health Administration, Management InformationSystem 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 forRespiratory Protective Equipment -- I. Respiratory Protective Equipment forParticulate-Laden Atmospheres," American Industrial Hygiene AssociationJournal, 44 (10): 756-761 (1983).

13. Breysse, P.N., et. al. "Critical Review of International Standards forRespiratory Protective Equipment -- II. Gas and Vapor RemovalEfficiency and Fit Testing":, American Industrial Hygiene AssociationJournal, 44 (10): 762-767 (1983).

14. White, N. et. al. "Critical Review of International Standards forRespiratory 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 LogisticsAgency. 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 argumentson all issues with respect to this proposed standard. These comments must bepostmarked on or before February 13, 1995. Comments are to submitted inquadruplicate or 1 original (hardcopy) and 1 disk (5 1/4 or 3 1/2) onWordPerfect 5.0, 5.1, 6.0 or ASCII. Note: any information not contained ondisk, e.g., studies, articles, etc., must be submitted in quadruplicate tothe 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 proposalwhich are addressed and the position taken with respect to each issue.

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

Notice of Intention to Appear at the Informal Hearing

Pursuant to section 6(b)(3) of the Act, an opportunity to submit oraltestimony concerning the issues raised by the proposed standard includingeconomic and environmental impacts, will be provided at an informal publichearing to be held in Washington, DC from March 7 to March 24, 1995. If OSHAreceives sufficient requests to participate in the hearing, the hearingperiod 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 andConstitution Avenue N.W., Washington, DC 20210.

All persons desiring to participate at the hearing must file inquadruplicate a notice of intention to appear, postmarked on or beforeJanuary 27, 1995. The notice of intention to appear, which will be availablefor inspection and copying at the OSHA Technical Data Center Docket Office(Room N2625), telephone (202) 219-7894, must contain the followinginformation:

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 eachissue; and

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

The notice of intention to appear shall be mailed to Mr. Thomas Hall, OSHADivision of Consumer Affairs, Docket H-049, Room N3649, U.S. Department ofLabor, 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 sentto 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 thehearing, or who will submit documentary evidence, must provide inquadruplicate the complete text of the testimony, including any documentaryevidence to be presented at the hearing. One copy shall not be stapled orbound and be suitable for copying. These materials must be provided to Mr.Thomas Hall, OSHA Division of Consumer Affairs at the address above and bepostmarked no later than February 13, 1995.

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

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

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

Notice of intention to appear, testimony and evidence will be available forinspection 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 thattime, any procedural matters relating to the proceeding will beresolved.

The nature of an informal rulemaking hearing is established in thelegislative history of section 6 of the OSH Act and is reflected by OSHA'srules of procedure for hearings (29 CFR 1911.15(a)). Although the presidingofficer is an Administrative Law Judge and limited questioning by persons whohave filed notices of intention to appear is allowed on crucial issues, theproceeding is informal and legislative in type. The Agency's intent, inessence, is to provide interested persons with an opportunity to makeeffective oral presentations which can proceed expeditiously in the absenceof procedural restraints which impede or protract the rulemaking process.

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

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

The hearing will be presided over by an Administrative Law Judge who makesno decision or recommendation on the merits of OSHA's proposal. Theresponsibility of the Administrative Law Judge is to ensure that the hearingproceeds at a reasonable pace and in an orderly manner. The AdministrativeLaw Judge, therefore, will have all the powers necessary and appropriate toconduct a full and fair informal hearing as provided in 29 CFR Part 1911including 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 issuesraised;

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

5. In the Judge's discretion, to question and permit the questioning of anywitnesses 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 writteninformation and additional data, views and arguments from any person who hasparticipated 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 thefield, would wish to endorse or support the whole proposal or certainprovisions of the proposal. OSHA welcomes such supportive comments, includingany pertinent data and cost information which may be available, in order thatthe record of this rulemaking will present a balanced picture of the publicresponse on the issues involved.

X. Federalism

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

Section 18 of the Occupational Safety and Health Act (OSH Act) expressesCongress' clear intent to preempt state laws relating to issues on whichFederal OSHA has promulgated occupational safety and health standards. Underthe OSH Act, a state can avoid preemption only if it submits, and obtainsFederal approval of, a plan for the development of such standards and theirenforcement. Occupational safety and health standards developed by suchPlan-States must, among other things, be at least as effective in providingsafe and healthful employment and places of employment as the Federalstandards. Where such standards are applicable to products distributed orused in interstate commerce, they may not unduly burden commerce and must bejustified by compelling local conditions (see OSH Act, Section 18 C).

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

In brief, this Notice of Proposed Rulemaking addresses a clear nationalproblem related to occupational safety and health in general industry. Thosestates which have elected to participate under Section 18 of the OSH Act arenot preempted by this standard, and will be able to address any specialconditions within the framework of the Federal Act while ensuring that thestate standards are at least as effective as that standard.

XI. State Plan Standards

The 25 states and territories with their own OSHA-approved occupationalsafety and health plans must adopt a comparable standard within six months ofthe publication dates of a final standard. These 25 states are: Alaska,Arizona, California, Connecticut, New York (for state and local governmentemployees only), Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan,Minnesota, Nevada, New Mexico, North Carolina, Oregon, Puerto Rico, SouthCarolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, Washington, andWyoming. Until such time as a state standard is promulgated, Federal OSHAwill 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 recordkeepingrequirements.

XIII. Authority and Signature

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

Accordingly, pursuant to sections 4, 6(b), 8(c), and (8)g of theOccupational 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) asapplicable, 29 CFR Part 1910 is proposed to be amended as set forth below. Inaddition, pursuant to section 4(b)(2) of the Act, OSHA has determined thatthis amended standard would be more effective than the correspondingstandards now in Parts 1915 and 1926 of Title 29, Code of FederalRegulations. Therefore, these corresponding standards would be superseded bythese 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 theCode of Federal Regulations as follows:

PARTS 1910, 1915, 1926 -- [AMENDED]

1. The authority citation for Subpart I of 29 CFR part 1910 is revised toread 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 FR8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), asapplicable. 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 FR8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55 FR 9033), asapplicable. Section 1915.99 also issued under 5 U.S.C. 553. Section 1915.152also issued under 29 CFR Part 1911.

PART 1926 -- [AMENDED]

3. The authority citation for Subpart E of 29 CFR part 1926 is revised toread 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 Safetyand Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's OrderNos. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), or 1-90 (55FR 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 29of the Code of Federal Regulations are amended by adding identical sectionsare 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 diseasescaused by breathing air contaminated with harmful dusts, fogs, fumes, mists,gases, smokes, sprays, or vapors, the primary objective shall be to preventatmospheric contamination. This shall be accomplished as far as feasible byaccepted engineering control measures (for example, enclosure or confinementof the operation, general and local ventilation, and substitution of lesstoxic materials). When effective engineering controls are not feasible, orwhile they are being instituted, appropriate respirators shall be usedpursuant to this section.

(2) Respirators shall be provided by the employer when such equipment isnecessary to protect the health of the employee. The employer shall providethe respirators which are applicable and suitable for the purpose intended.The employer shall be responsible for the establishment and maintenance of arespiratory protective program which shall include the requirements outlinedin paragraph (c) of this section.

(b) Definitions. Adequate warning properties means the detectablecharacteristics of a hazardous chemical including odor, taste, and/orirritation effects which are detectable and persistent at concentrations ator below the hazardous exposure level, and exposure at these low levels doesnot cause olfactory fatigue.

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

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

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

Atmosphere-supplying respirator means a respirator which supplies the wearerwith air or oxygen from a source independent of the immediate ambientatmosphere. This includes air-supplied respirators and self-containedbreathing apparatus (SCBA) units.

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

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

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

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

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

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

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

Hazardous chemical means a substance which meets the definitions for "healthhazard" 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 29CFR Part 1910, Subpart Z, of the General Industry Standards of theOccupational Safety and Health Administration (OSHA); or,

(2) If there is noPEL for the hazardous chemical, the Threshold Limit Values (TLV) recommendedby the American Conference of Governmental Industrial Hygienists (ACGIH) inthe latest edition of Threshold Limit Values for Chemical Substances andPhysical Agents in the Work Environment: or,

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

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

Immediately dangerous to life or health or IDLH means an atmosphericconcentration of any toxic, corrosive or asphyxiant substance that poses animmediate threat to life or would cause irreversible or delayed adversehealth effects or would interfere with an individual's ability to escape froma dangerous atmosphere.

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

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

Oxygen deficient atmosphere means an atmosphere with an oxygen content ofless than 19.5% by volume at altitudes of 8000 feet or below. (For altitudesabove 8000 feet, see the oxygen deficient IDLH atmosphere definition.) Oxygendeficient IDLH atmosphere means an atmosphere with an oxygen content below16% by volume at altitudes of 3000 feet or below, or below the oxygen levelsspecified in Table III for altitudes up to 8000 feet, or below 19.5% foraltitudes above 8000 up to 14,000 feet.

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

Powered air-purifying respirator means an air-purifying respirator whichuses a blower to deliver air through the air-purifying element to thewearer's breathing zone.

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

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

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

Rebreather respirator. See closed circuit respirator. Respiratormeans any device worn by an individual and intended to provide the wearerwith respiratory protection against inhalation of airborne contaminants oroxygen deficient air.

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

Service life of a chemical or organic vapor cartridge or canister means theperiod of time it takes for a specified concentration of a specific substanceto break through the cartridge or canister. This concentration is determinedby the manufacturer for each type of cartridge or canister for particularsubstances.

Supplied air respirator means a respirator which receives breathing airthrough an air line or hose from a portable or stationary source ofcompressed air.

(c) Respiratory protection program -- (1) The employer in accordance withthis section shall establish and implement a written respiratory protectionprogram 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 fittingpositive 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 foratmosphere-supplying respirator;

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

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

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

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

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

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

(2) Where elastomeric facepiece respirators are to be used, the employershall provide a selection of respirators from an assortment of at least threesizes for each type of facepiece and from at least two differentmanufacturers.

(3) In addition, the employer shall obtain and evaluate the followinginformation 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 ofcontaminants;

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

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

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

(ix) Fit test results;

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

(xi) Thephysical characteristics, functional capabilities, and limitations of thevarious types of respirators.

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

(5) The employer shall make types of respirators available for selection andshall assure that employees use respirators in accordance with the assignedprotection factor tables in the NIOSH Respirator Decision Logic published inMay 1987. This is available from the NIOSH Publication Dissemination Office,DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200Constitution Avenue, NW., Washington, DC 20210.

(6) [Reserved]

(7) The employer shall not allow use of anyrespirator where the maximum use concentration for an air contaminant exceedsthe 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 chemicalwith poor or inadequate warning properties unless either:

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

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

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

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

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

(ii) An atmosphere-supplying respirator shall be used for oxygen deficientatmospheres with a measured oxygen content level above that level defined asoxygen deficient IDLH but which is less than 19.5% by volume at altitudes of8000 feet or below.

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

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

(e) Medical evaluation -- (1) For each employee required to wear arespirator for more than five hours during any work week, the employer shallobtain from a licensed physician a written opinion which states whether theemployee has any detected medical condition which would place the employee'shealth at increased risk of material impairment from respirator use and anyrecommended limitations upon the use of respirators. In requesting thewritten medical opinion, the employer shall provide the licensed physicianwith 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 thataffect the safety of others such as fire fighting or rescue work;

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

(vii) Additional requirements for protective clothing andequipment.

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

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

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

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

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

(4) In order to use an alternative fit test procedure which meets theMinimum Criteria as defined in section I of Appendix A, the employer shallobtain advance approval from the Assistant Secretary. Once such a procedureis 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 todemonstrate that any new method used provides results comparable to or betterthan one or more of the established methods contained in Appendix A for thetype of test, i.e. qualitative or quantitative. The employer shall bepermitted to use any method for which such data have already been submittedto and approved by the Assistant Secretary.(6) Fit testing protocols. (i) The employer shall use eitherqualitative or quantitative fit testing for tight fitting air-purifyingrespirators with quarter and half mask facepieces.

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

(B) Quantitative fit testing shall be performed in accordance with anestablished protocol specified in section II of Appendix A or a protocol thatmeets the minimum criteria contained in section I of Appendix A. The testsubject shall not be permitted to wear a half mask or quarter facepiecerespirator unless a minimum fit factor of one hundred (100) is obtained inthe test chamber. The respirator may not be worn in concentrations greaterthan ten (10) times the hazardous exposure level regardless of the measuredfit factor in the chamber.

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

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

(B) Quantitative fit testing shall be performed in accordance with theestablished protocol specified in section II of Appendix A or a new protocolthat meets the minimum criteria contained in section I of Appendix A. Thetest subject shall not be permitted to wear a full facepiece respiratorunless a minimum fit factor of five hundred (500) is obtained in the testchamber. The full facepiece respirator may not be worn in concentrationsgreater than fifty (50) times the hazardous exposure level regardless of themeasured fit factor in the chamber.

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

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

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

(1) Qualitative fit testing shall be performed in accordance with theestablished protocols specified in section II of Appendix A or a new protocolthat meets the minimum criteria contained in section I of Appendix A. If therespirator wearer passes the fit test then the same respirator facepiece(i.e. make and model and size), which is available on a NIOSH approvedatmosphere-supplying respirator shall be used by the employee. The respiratorshall 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 theprotocol specified in Appendix A or a protocol that meets the minimumcriteria contained in Appendix A. A NIOSH approved atmosphere-supplyingrespirator with the same respirator facepiece (make, model, size) with whichthe employee passed the quantitative fit test shall be used. The respiratorshall 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 visualobservations are noted regarding an employee's condition which could affectrespirator fit. Conditions to look for include facial scarring, cosmeticsurgery, or an obvious change in body weight.

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

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

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

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

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

(ii) When an employee(s) wears a respirator in IDLH, unknown or potentiallyIDLH atmospheres where the employee(s) could be overcome if the respiratoryprotection fails, the employer shall ensure that at least one additionalperson located outside the IDLH atmosphere is in communication with theemployee(s) in the IDLH atmosphere, and able to provide effective emergencyassistance; and, (iii) Where employees enter IDLH atmospheres, the employershall ensure that they are equipped with retrieval equipment for lifting orremoving them from the hazardous area, or shall ensure that equivalentprovisions for rescue have been made.

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

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

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

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

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

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

(8) The employer shall ensure that respirators are immediately repaired, ordiscarded and replaced when they are no longer in proper original workingcondition.

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

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

(11) The employer shall ensure that each self-contained breathing apparatusused in IDLH atmospheres, or for emergency entry or fire fighting, iscertified for a minimum service life of thirty minutes. This requirement doesnot apply to combination supplied air respirators with auxiliary air supplyor to emergency escape SCBAs.

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

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

(ii) Routinely used respirators issued to more than one employee shall becleaned and disinfected after each use; and, (iii) Respirators maintained foremergency 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 fromdamage, dust, sunlight, extreme temperatures, excessive moisture, or damagingchemicals;

(ii) Emergency respirators shall be kept accessible to the work area. Inlocations where weathering, contamination, or deterioration of the respiratorcould occur, respirators shall be stored in compartments built to protectthem. Such compartments shall be clearly marked as containing emergencyrespirators and shall be used in accordance with any applicable manufacturerinstructions;

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

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

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

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

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

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

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

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

(i) Repairs or adjustments to respirators are to be made only by personsappropriately trained to perform such operations, using parts designed forthe respirator;

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

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

(i) Supplied air quality and use -- (1) The employer shall ensure thatcompressed air, compressed oxygen, liquid air, and liquid oxygen used forrespiration is of high purity, and in accordance with the followingspecifications: Compressed and liquid oxygen shall meet the requirements ofthe latest edition of the United States Pharmacopoeia for medical orbreathing oxygen; and compressed breathing air shall at least meet therequirements of the specification for Grade D breathing air as described inANSI/Compressed Gas Association Commodity Specification G-7.1-1989 (oxygencontent (v/v) of 19.5-23.5% (atmospheric air); hydrocarbon (condensed) of 5milligrams 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 respiratorsor in open circuit self-contained breathing apparatus that have previouslyused compressed air.

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

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

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

(ii) Compressors shall be constructed and situated so as to avoid entry ofcontaminated air into the air-supply system and shall be equipped withsuitable in-line air-purifying sorbent beds and filters to further assurebreathing air quality, and to minimize moisture content so that the dew pointat line pressure is 10 deg. C below the ambient temperature; and

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

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

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

(j) Identification of filters, cartridges, and canisters -- (1) The employershall ensure that all filters, cartridges and canisters used in the workplaceare properly labeled and color coded with the NIOSH approval label beforethey are placed in service.

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

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

(i) Nature, extent, and effects of respiratory hazards to which the employeemay be exposed as required under the Hazard Communication standard (29 CFR1910.1200);

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

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

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

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

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

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

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

(2) The employer shall periodically consult employees wearing respirators toassess wearer acceptance and attempt to correct any problems that arerevealed during this assessment. Factors to be included in the assessment arewhether 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 andmaintain an accurate record for each employee subject to medical evaluationrequired 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 theemployee;

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

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

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

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

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

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

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

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

(o) Appendixes. The protocols in Appendix A on fit testing procedures aremandatory. The recommended practices in Appendix B and the medical evaluationprocedures 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 adescription of the fit test method and validation testing data must besubmitted to OSHA for evaluation.

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

3. OSHA will publish a revised 29 CFR 1910.134 incorporating the new fittest 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 atest method and/or test agent not identified in section II.B. of Appendix Ais to be used for testing the fit of a respirator. Fit tests which meet thecriteria of this section may be used to verify the fit of respirators for useup to the assigned protection factors specified in the respirator selectiontable in paragraph (d) of this section.

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

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

(c) It shall be demonstrated that the test agent can elicit a subjectiveresponse 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. Itshall be demonstrated that the test subject can detect by subjective meansthe test agent at the reference concentration prior to commencement of thetest.

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

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

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

(h) Precautions shall be taken to avoid allowing the test agent from the fittest area to contaminate the area where the test subjects are tested todetermine their response to the threshold screening concentrations.Contamination of the area where the threshold screening test is administeredby 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 APFof 10, it shall be demonstrated that at the 95% confidence level 95% of thefacepieces with a fit factor less than 100 as determined by an establishedQNFT method will be identified.

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

(a) The respirators used in the validation procedure shall be equipped so asto 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 QLFTtest administered. Immediately following the new QLFT method a QNFT shall beadministered using the protocol established in section II.C. of Appendix Aexcept that a strip chart recording of the test shall be made. The numbers ofrespirators, test subject size population, exercises sizes of respirators,and numbers of tests shall be sufficient to enable a determination to be madeas to whether or not the 95% confidence level is attained in identifyingwhether 95% of facepieces with less than a fit factor or 100 will beidentified 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) ofAppendix A where a test method and/or test agent not identified in sectionII.C. of Appendix A is to be used for testing the fit of a respirator. Fittests which meet the criteria of this section may be used to verify the fitof respirators for use up to the assigned protection factors in paragraph (d)of this section.

2. Aerosol/Gas Generation.

(a) The aerosol/gas generator shallproduce a stable test agent concentration (+/- 10%) throughout the testenvironment. The test agent concentration shall not vary as a function oftime more than +/- 10 percent.

(b) The concentration of the aerosol/gas shall not exceed an OSHApermissible exposure limit, the ACGIH threshold limit value, or any knownrecommended exposure limit when there is no OSHA PEL or ACGIH TLV, and notcreate 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 diameterof 0.6 micrometers and a geometric standard deviation of 2. The test agentshall not be appreciably absorbed or retained in the lungs upon inhalation.

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

(e) If it is desired to use a test agent aerosol larger than 0.6 micrometersin diameter to test respirators with other than high efficiency filters, itshall be demonstrated that the particle size is capable of penetratingdeficiencies in the respirator facepiece to face sealing area, will bereliably detected by the measurement instruments, and that a significantportion 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 thefull range of measurement must be at least as great as the QNFT protocolestablished in section II.C. of Appendix A.

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

(a) The respirators used in the validation procedure shall be probed andequipped with hoses as established in the QNFT procedures in Appendix A ofthis section.

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

(c) The numbers of respirators, test subject size population, exercisessizes of respirators, and numbers of tests shall be sufficient to enable adetermination to be made as to whether or not the 95% confidence level isattained 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 whichwould result in the test respirator having different characteristics thanunder normal use.

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

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

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

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

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

(a) The test agent concentration must be maintained below an establishedPEL, ACGIH TLV, or recommended exposure level and not create a health hazardor 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 faceseal, 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% ofthe test agent (i.e. large particles collected on dust filters, smallparticles collected on high efficiency filters).

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

F. Validation for New Technological Methods of Determining Respirator Fit

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

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

(a) For particle counting methods, the respirators used in the validationprocedure shall be probed and equipped with hoses as established in the QNFTprocedures 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 theprotocol established in section II of Appendix A except that a strip chartrecording of the test shall be made. The numbers of respirators, test subjectsize population, exercises sizes of respirators, and numbers of tests shallbe sufficient to enable a determination to be made as to whether or not the95% confidence level is attained with respect to agreement between the twomethods.

II. Current Fit Test Protocols

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

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

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

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

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

5. The more comfortable facepieces are noted; the most comfortable mask isdonned and worn at least five minutes to assess comfort. Assistance inassessing comfort can be given by discussing the points in item II A.6. ofthis appendix. If the test subject is not familiar with using a particularrespirator, the test subject shall be directed to don the mask several timesand to adjust the straps each time to become adept at setting proper tensionon the straps.

6. Assessment of comfort shall include reviewing the following points withthe test subject and allowing the test subject adequate time to determine thecomfort of the respirator: (a) Position of the mask on the nose (b) Room foreye 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 therespirator 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 respiratorposition.

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

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

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

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

12. The employer shall maintain a record of the fit test administered to anemployee. 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 otherrecording of the results of the test. The record shall be maintained untilthe next fit test is administered.

13. Exercise regimen. Prior to the commencement of the fit test, the testsubject shall be given a description of the fit test and the test subject'sresponsibilities during the test procedure. The description of the processshall include a description of the test exercises that the subject will beperforming. The respirator to be tested shall be worn for at least 5 minutesbefore the start of the fit test.

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

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

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

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

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

(e) Talking. The subject shall talk out loud slowly and loud enough so as tobe heard clearly by the test conductor. The subject can read from a preparedtext such as the Rainbow Passage, count backward from 100, or recite amemorized 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 wereto touch his/her toes. Jogging in place shall be substituted for thisexercise in those test environments such as shroud type QNFT units whichprohibit bending at the waist.

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

The test subject shall be questioned by the test conductor regarding thecomfort of the respirator upon completion of the protocol. If it has becomeuncomfortable, 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 fullresponsibility for implementing the respirator qualitative fit test program.

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

(c) The employer shall assure that QLFT equipment is kept clean and wellmaintained 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 theindividual tested can detect the odor of isoamyl acetate.

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

(2) Odorfree water (e.g. distilled or spring water) at approximately 25 degrees Cshall be used for the solutions.

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

(4) The screening test shall be conducted in a room separate from the roomused for actual fit testing. The two rooms shall be well ventilated but shallnot be connected to the same recirculating ventilation system.

(5) The odor test solution is prepared in a second jar by placing 0.4 cc ofthe stock solution into 500 cc of odor free water using a clean dropper orpipette. The solution shall be shaken for 30 seconds and allowed to stand fortwo to three minutes so that the IAA concentration above the liquid may reachequilibrium. 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 odorfree water.

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

(8) The following instruction shall be typed on a card and placed on thetable in front of the two test jars (i.e., 1 and 2): "The purpose of thistest is to determine if you can smell banana oil at a low concentration. Thetwo bottles in front of you contain water. One of these bottles also containsa small amount of banana oil. Be sure the covers are on tight, then shakeeach 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 whichbottle contains banana oil."

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

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

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

(b) Isoamyl acetate fit test.

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

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

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

(4) A copy of the test exercises and any prepared text from which thesubject 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-inchby 5-inch piece of paper towel, or other porous, absorbent, single-plymaterial, folded in half and wetted with 0.75 cc of pure IAA. The testsubject 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 beforestarting the fit test exercises. This would be an appropriate time to talkwith the test subject; to explain the fit test, the importance of his/hercooperation, and the purpose for the head exercises; or to demonstrate someof the exercises.

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

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

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

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

3. Saccharin Solution Aerosol Protocol

The saccharin solution aerosol QLFT protocol is the only currentlyavailable, validated test protocol for use with particulate disposable dustrespirators not equipped with high-efficiency filters. The entire screeningand testing procedure shall be explained to the test subject prior to theconduct of the screening test.

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

(1) During threshold screening as well as during fit testing, subjects shallwear an enclosure about the head and shoulders that is approximately 12inches in diameter by 14 inches tall with at least the front portion clearand that allows free movements of the head when a respirator is worn. Anenclosure 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 testsubject's nose and mouth area to accommodate the nebulizer nozzle.

(3) The test subject shall don the test enclosure. Throughout the thresholdscreening test, the test subject shall breathe through his/her wide openmouth with tongue extended.

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

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

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

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

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

(9) If the second response is negative, ten more squeezes are repeatedrapidly 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 tosolicit a taste response.

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

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

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

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

(b) Saccharin solution aerosol fit test procedure.

(1) The testsubject may not eat, drink (except plain water), or chew gum for 15 minutesbefore 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 respiratorselected in section B.3.(a) of this appendix. The respirator shall beproperly adjusted and equipped with a particulate filter(s).

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

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

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

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

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

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

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

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

4. Irritant Fume Protocol

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

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

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

(d) Advise the test subject that the smoke can be irritating to the eyes andinstruct 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 thesmoke tube towards the face seal area of the test subject. He/She shall beginat 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 performedby the test subject while the respirator seal is being challenged by thesmoke.

(g) Each test subject passing the smoke test without evidence of a responseshall be given a sensitivity check of the smoke from the same tube once therespirator 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 ventilationsufficient to prevent general contamination of the testing area by the testagent.

C. Quantitative Fit Test (QNFT) Protocol.

1. General

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

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

(c) The employer shall assure that QNFT equipment is kept clean and wellmaintained 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. Thenormal air-purifying element of the respirator is replaced by ahigh-efficiency particulate air (HEPA) filter in the case of particulate QNFTaerosols or a sorbent offering contaminant penetration protection equivalentto 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 testchamber so that its concentration inside and outside the respirator may bemeasured.

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

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

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

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

3. Apparatus

(a) Instrumentation. Aerosol generation, dilution, and measurement systemsusing corn oil or sodium chloride as test aerosols shall be used forquantitative fit testing except as provided for by Section I of thisAppendix.

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

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

(d) The sampling instrument shall be selected so that a strip chart recordmay be made of the test showing the rise and fall of the challenge agentconcentration with each inspiration and expiration at fit factors of at least2,000. Integrators or computers which integrate the amount of test agentpenetration leakage into the respirator for each exercise may be usedprovided a record of the readings is made.

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

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

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

(h) The equipment generating the challenge atmosphere shall maintain theconcentration of challenge agent inside the test chamber constant to within a10 percent variation for the duration of the test.

(i) The time lag (interval between an event and the recording of the eventon 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 insidethe test chamber and its being recorded.

(j) The sampling line tubing for the test chamber atmosphere and for therespirator 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 ahigh-efficiency filter before release.

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

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

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

4. Procedural Requirements

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

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

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

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

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

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

(g) The test shall be terminated whenever any single peak penetrationexceeds 5 percent for half masks and 1 percent for full facepiecerespirators. The test subject shall be refitted and retested. If two of thethree required tests are terminated, the fit shall be deemed inadequate.

(h) In order to successfully complete a QNFT, three successful fit tests arerequired. The results of each of the three independent fit tests must exceedthe minimum fit factor needed for the class of respirator (e.g. quarterfacepiece respirator, half mask respirator, full facepiece respirator) asspecified in paragraph (f) of this section.

(i) Calculation of fit factors.

(1) The fit factor shall bedetermined for the quantitative fit test by taking the ratio of the averagechamber concentration to the concentration measured inside the respirator foreach test exercise except the grimace exercise.

(2) The average test chamber concentration is the arithmetic average of thetest chamber concentration at the beginning and of the end of the test.

(3) The concentration of the challenge agent inside the respirator shall bedetermined 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 eachexercise except the grimace exercise. This includes computerizedintegration.

(j) Interpretation of test results. The fit factor established by thequantitative fit testing shall be the lowest of the three fit factor valuescalculated from the three required fit tests.

(k) The test subject shall not be permitted to wear a half mask or quarterfacepiece respirator unless a minimum fit factor of 100 is obtained, or afull facepiece respirator unless a minimum fit factor of 500 is obtained.

(l) Filters used for quantitative fit testing shall be replaced at leastweekly or whenever increased breathing resistance is encountered, or when thetest agent has altered the integrity of the filter media. Organic vaporcartridges/canisters shall be replaced daily (when used) or sooner if thereis 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. Theface fit is considered satisfactory if a slight positive pressure can bebuilt up inside the facepiece without any evidence of outward leakage of airat the seal. For most respirators this method of leak testing requires thewearer to first remove the exhalation valve cover before closing off theexhalation 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 withthe palm of the hand(s) or by replacing the filter seal(s), inhale gently sothat the facepiece collapses slightly, and hold the breath for ten seconds.If the facepiece remains in its slightly collapsed condition and no inwardleakage of air is detected, the tightness of the respirator is consideredsatisfactory.

II. Recommended Procedures for Cleaning Respirators

A. Remove filters, cartridges, or canisters. Disassemble facepieces byremoving speaking diaphragms, demand and pressure-demand valve assemblies,hoses, or any components recommended by the manufacturer. Discard or repairany defective parts.

B. Wash components in 50 deg. C water with a mild detergent or with acleaner recommended by the manufacturer. A stiff bristle (not wire) brush maybe 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, respiratorcomponents should be immersed for two minutes in one of the following:

1. Hypochlorite solution (50 ppm of chlorine) made by adding approximatelyone 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 0.8milliliters of tincture of iodine (6-8 grams ammonium and/or potassiumiodine/100 cc of 45% alcohol) to one liter of water at 50 deg. C; or, 3.Other commercially available cleansers of equivalent disinfectant qualitywhen used as directed, unless their use is recommended against by therespirator manufacturer.

E. Rinse components thoroughly in clean, warm (50 deg. C maximum),preferably running water. Drain. The importance of thorough rinsing cannot beoveremphasized. Detergents or disinfectants that dry on facepieces may resultin dermatitis. In addition, some disinfectants may cause deterioration ofrubber 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 wherenecessary.

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 intoaccount during the performance of the required medical evaluation forrespirator use. These elements should be evaluated in taking the medicalhistory and performing the medical examination. However, the specific natureof the medical evaluation and the extent of testing performed is left for theresponsible physician to determine. This recommended list of elements to becovered is not meant to limit the physician to the testing proceduresrecommended, since the examining physician is free to perform additionaltests if necessary to determine an individual's ability to wear a respirator.This appendix is informational and is not intended, by itself, to create anyadditional obligations not otherwise imposed or to detract from any existingobligations.

(A) The medical history should include:

(1) Previously diagnosed diseases, particularly stressing knowncardiovascular 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 sideeffects might impact upon cardiopulmonary fitness.

(B) The medical examination should assess:

(1) Hearing ability (should be sufficient to assure communication andresponse 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 perfusiondisorders);

___________

Footnote(*) In interpreting spirometry, if the FVC is less than 80 percentor the FEV(1) is less than 70 percent, restriction from respirator use shouldbe considered.

(3) Cardiovascular system (evidence of symptomatic coronary artery disease,significant arrhythmias; occurrence of frequent premature ventricularcontractions (PVC's) with elevated pulse rates or uncontrolled hypertensionsymptoms;

(4) Endocrine system (conditions which may result in sudden loss ofconsciousness or response capability);

(5) Neurological system (inability to perform coordinated movements andconditions affecting response and consciousness);

(6) Psychological condition (claustrophobia; severe anxiety);

(7) Miscellaneous conditions specific to the work situation (skin conditionswhere occlusive materials may result in symptoms or aggravation of apre-existing dermatitis); and,

(8) Exercise stress (for those employees whouse a self-contained breathing apparatus or rebreather type respirator understrenuous work conditions or in emergencies, particularly in fire and rescueoperations).

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 asfollows:

Authority: Secs. 4, 6, and 8, Occupational Safety and Health Act, 29U.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 andHealth Act, 29 U.S.C. 655(b), except those substances listed in the FinalRule Limits column of Table Z-1-A, which have identical limits listed in theTransitional Limits columns of Table Z-1-A, Table Z-2 or Table Z-3. Thelatter 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-2and Z-3 also issued under 5 U.S.C. 553. Section 1910.1000, Tables Z-1-A, Z-2and 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 andSafety 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. Section1910.1028 also issued under 29 U.S.C. 653. Section 1910.1043 also issuedunder 5 U.S.C. 551 et seq. Section 1910.1045 and 1910.1047 also issued under29 U.S.C. 653. Section 1910.1048 also issued under 29 U.S.C. 653. Section1910.1051 also issued under 29 U.S.C. 653. Section 1910.1200, 1910.1499 and1910.1500 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) Respiratorprogram. (i) When respiratory protection is required, the employer shallinstitute 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 pressurerespirators or tight fitting positive pressure respirators, employers shallperform either quantitative or qualitative face fit tests at the time ofinitial fitting and at least every six months thereafter. The qualitative fittests may be used only for testing the fit of half mask respirators wherethey are permitted to be worn, and shall be conducted in accordance withAppendix A of Sec. 1910.134. The tests shall be used to select facepiecesthat provide the required protection as prescribed in Table I of thissection.

* * * * *

7. Sections 1910.1003, 1910.1004, and 1910.1006 through 1910.1016 areamended 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 tothis section, employers shall institute a respiratory protection program inaccordance 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) toread as follows:

1910.1017 Vinyl chloride. * * * * * (g) * * * (3) Arespiratory protection program meeting the requirements of Sec.

1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l) shall beestabished and maintained.

(4) The employer shall make types of respirators available for selection andshall assure that employees use respirators in accordance with the assignedprotection factor tables in the NIOSH Respirator Decision Logic published inMay 1987. This is available from the NIOSH Publication Dissemination Office,DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200Constitution Avenue, N.W., Washington, D.C. 20210. The table that followsshows the NIOSH RDL values.

* * * * *

9. Section 1910.1018 is amended by revising paragraphs (h)(2)(i), Table Iand 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 sectionthe employer shall select, provide at no cost to the employee and assure theuse of the appropriate respirator or combination of respirators in accordancewith the assigned protection factor tables in the NIOSH Respirator DecisionLogic published in May 1987. This is available from the NIOSH PublicationDissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 ColumbiaParkway, 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 significantvapor pressure, or Table II of this section for inorganic arsenic compoundswhich have significant vapor pressure show the NIOSH RDL assigned protectionfactor values.

(ii) * * *

Footnote(1) High efficiency filter -- 99.97% efficiency against 0.3micrometer monodisperse diethylhexyl phthalate (DOP) particles.

Footnote(2) This category does not include disposable respirators, useof which is not permitted under this standard.

Footnote(1) High efficiency filter -- 99.97% efficiency against 0.3micrometer monodisperse diethyl-hexyl phthalate (DOP) particles.

Footnote(2) Half mask respirators shall not be used for protectionagainst 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 byNIOSH.

(3) * * * (ii) The employer shall perform qualitative fit tests atthe time of initial fitting and at least semiannually thereafter for eachemployee 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 tothis section.

(iii) Employers with more than 20 employees wearing respirators shallperform a quantitative face fit test at the time of initial fitting and atleast semiannually thereafter for each employee wearing negative pressurerespirators. The test shall be used to select facepieces that provide therequired protection as prescribed in Table I or II. The protocols forquantitative fit testing set out in Appendix A to Sec. 1910.134 shall befollowed in administering quantitative fit tests pursuant to this section.

* * * * *

(4) Respirator program. (i) The employer shall institute a respiratoryprotection 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 TableII, (f)(2)(iii), (f)(3)(ii) and (f)(4)(i) and the fourth paragraph of sectionIV of Appendix B and removing Appendix D as follows:

1910.1025 Lead. * * * * * (f) * * * (2) Respiratorselection. (i) Where respirators are required under this section the employershall make types of respirators available for selection and shall assure thatemployees use respirators in accordance with the assigned protection factortables in the NIOSH Respirator Decision Logic published in May 1987. This isavailable from the NIOSH Publication Dissemination Office, DHHS (NIOSH)Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio 45226 or fromthe OSHA Docket Office, Exhibit No. 38-20, room N2439, 200 ConstitutionAvenue, N.W., Washington, D.C. 20210. Table II of this section shows theNIOSH RDL values.

* * * * *

Footnote(1) Respirators specified for high concentrations can be used atlower concentrations of lead.

Footnote(2) Full facepiece is required if the lead aerosols cause eye orskin irritation at the use concentrations.

Footnote(3) A high efficiency particulate filter means 99.97 percentefficiency against 0.3 micron size particles.

* * * * *

(iii) The employer shall select respirators from among those approved forprotection against lead dust, fume, and mist by NIOSH.

(3)* * * (ii) Employers shall perform either quantitative orqualitative face fit tests at the time of initial fitting and at least everysix months thereafter for each employee wearing negative pressurerespirators. The qualitative fit tests may be used only for testing the fitof half mask respirators where they are permitted to be worn. Quantitativeand qualitative fit tests shall be conducted in accordance with Appendix A ofSec. 1910.134. The tests shall be used to select facepieces that provide therequired protection as prescribed in Table II of this section.

* * * * *

(4)* * * (i) The employer shall institute a respiratory protectionprogram 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 eachemployee may require your employer to make available two or three differentmask types. In order to assure that your respirator fits properly and thatfacepiece leakage is minimized, your employer must give you either aqualitative or quantitative fit test in accordance with Appendix A of 29 CFR1910.134.

* * * * *

11. Section 1910.1029 is amended by revising paragraphs (g)(2)(i) and TableI, (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, theemployer shall make types of respirators available for selection and shallassure that employees use respirators in accordance with the assignedprotection factor tables in the NIOSH Respirator Decision Logic published inMay 1987. This is available from the NIOSH Publication Dissemination Office,DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200Constitution Avenue, NW., Washington, DC 20210. Table I of this section showsthe NIOSH RDL values.

* * * * *

(ii) * * * (iii) The employer shall select respirators from amongthose approved for protection against coke oven emissions by NIOSH.

(3) Respirator program. The employer shall institute a respiratoryprotection 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), deletingTable I, revising (f)(2)(ii), (f)(2)(iii) and (f)(3), and adding a newAppendix 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 andshall assure that employees use respirators in accordance with the assignedprotection factor tables in the NIOSH Respirator Decision Logic published inMay 1987. This is available from the NIOSH Publication Dissemination Office,DHHS (NIOSH) Publication No. 87-108, 4676 Columbia Parkway, Cincinnati, Ohio45226 or from the OSHA Docket Office, Exhibit No. 38-20, Room N2439, 200Constitution Avenue, N.W., Washington, D.C. 20210. Table 1 of Appendix F ofthis section shows the NIOSH RDL values.

(ii) The employer shall select respirators from those tested and certifiedfor protection against dust by NIOSH.

(iii) Whenever negative pressure air-purifying respirators are required bythis section, the employer shall, upon the request of the employee, providethe appropriate powered air-purifying respirator with a high efficiencyparticulate filter selected pursuant to Table 1 of this section in lieu ofthe negative pressure air-purifying respirator specified in Table 1 of thissection.

* * * * *

(3) Respirator program. The employer shall institute a respiratoryprotection 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 thissection, the employer shall select, provide at no cost to the employee, andassure that the employee uses the appropriate respirator in accordance withthe assigned protection factor tables in the NIOSH Respirator Decision Logicpublished in May 1987. This is available from the NIOSH PublicationDissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 ColumbiaParkway, 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 byNIOSH.

* * * * *

(3) Respirator program. (i) The employer shall institute a respiratoryprotection program in accordance with Sec. 1910.134(b), (c), (d), (f), (g),(h), (i), (j), (k), and (l).

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14. Section 1910.1045 is amended by revising paragraphs (h)(2)(i) and Table1, (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 thissection, the employer shall select, provide at no cost to the employee, andassure that the employee uses the appropriate respirator in accordance withthe assigned protection factor tables in the NIOSH Respirator Decision Logicpublished in May 1987. This is available from the NIOSH PublicationDissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 ColumbiaParkway, 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 usewith organic vapors by NIOSH.

(3) Respirator program. (i) The employer shall institute a respiratoryprotection 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 thatthe respirator selected provides the protection required by Table 1. Fittesting shall be performed pursuant to the protocols set out in Appendix A toSec. 1910.134.

(A) Qualitative fit. The employer shall perform qualitative fit tests at thetime of initial fitting and at least semiannually thereafter for eachemployee wearing respirators.

(B) Quantitative fit. Each employer with more than 10 employees wearingnegative pressure respirators shall perform quantitative fit testing at thetime of initial fitting and at least semiannually thereafter for each suchemployee.

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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 toread as follows:

1910.1047 Ethylene oxide. * * * * * (g) * * * (2)Respirator selection. (i) Where respiratory protection is required under thissection, the employer shall select, provide at no cost to the employee, andassure that the employee uses the appropriate respirator in accordance withthe assigned protection factor tables in the NIOSH Respirator Decision Logicpublished in May 1987. This is available from the NIOSH PublicationDissemination Office, DHHS (NIOSH) Publication No. 87-108, 4676 ColumbiaParkway, 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 permittedto be used in lower concentrations.

(ii) The employer shall select respirators from among those approved forprotection against EtO by NIOSH.

(3) Respirator program. Where respiratory protection is required by thissection, the employer shall institute a respirator program in accordance with29 CFR 1910.134 (b), (c), (d), (f), (g), (h), (i), (j), (k), and (l).

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16. The authority citation for Subpart D of Part 1926 continues to read asfollows:

Authority: Secs. 4, 5, 6, 8, Occupational Safety and Health Act of1970, 29 U.S.C. 653, 655, 657; Sec. 107, Contract Work Hours and SafetyStandards Act (Construction Safety Act), 40 U.S.C. 333; and Secretary ofLabor'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 CFRPart 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 arespirator program in accordance with Sec. 1910.134(b), (c), (d), (f), (g),(h), (i), (j), (k), and (l).

* * * * *

(4) * * * (i) * * * (ii) For each employee wearing negativepressure respirators or tight fitting positive pressure respirators,employers shall perform either quantitative or qualitative face fit tests atthe time of initial fitting and at least every six months thereafter. Thequalitative fit tests may be used only for testing the fit of half maskrespirators where they are permitted to be worn, and shall be conducted inaccordance with Appendix A of Sec. 1910.134. The tests shall be used toselect facepieces that provide the required protection as prescribed in TableI of this section.

* * * * *

18. Section 1926.103 is revised to read as follows:

1926.103 Respiratory protection.

Respiratory protection for construction employment is covered by 29 CFR1910.134.

19. The authority citation for Part 1915 continues to read as follows:

Authority: Sec. 41, Longshoremen's and Harbor Worker's CompensationAct (33 U.S.C. 941), secs. 4, 6, and 8, Occupational Safety and Health Act of1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order No. 12-72 (36 FR8754), 8-76 (41 FR 25059), or 9-83 (48 FR 35736) as applicable; and 29 CFRPart 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 asfollows:

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) Personalprotective equipment. (i) Only respiratory protective equipment approved bythe National Institute for Occupational Safety and Health (NIOSH) shall beused for protection of personnel against dusts produced duringabrasive-blasting operations.

* * * * *

(iv) A respiratory protection program as defined and described in Sec.1910.134 shall be established wherever it is necessary to use respiratoryprotective equipment.

* * * * *

(6) Air supply and air compressors. The air for abrasive-blastingrespirators shall be free of harmful quantities of dusts, mists, or noxiousgases, and shall meet the requirements for supplied air quality and usecontained in Sec. 1910.134(i).

* * * * *

(c) * * * (6) * * * (iii) (a) When an operator must positionhimself in a booth downstream of the object being sprayed, an air suppliedrespirator or other type of respirator approved by the National Institute forOccupational Safety and Health (NIOSH) for the material being sprayed shallbe used by the operator.

* * * * *

(d) * * * (9) * * * (vi) When, during emergencies as describedin paragraph (d)(11)(v) of this section, workers must be in areas whereconcentrations of air contaminants are greater than the limit set byparagraph (d)(2)(iii) of this section or oxygen concentrations are less than19.5 percent, they shall be required to wear respirators adequate to reducetheir exposure to a level below these limits, or to provide adequate oxygen.Such respirators shall also be provided in marked, quickly accessible storagecompartments built for the purpose, when there exists the possibility ofaccidental release of hazardous concentrations of air contaminants.Respirators shall be approved by the National Institute for OccupationalSafety and Health (NIOSH) and shall be selected by a competent industrialhygienist or other technically qualified source. Respirators shall be used inaccordance with Sec. 1910.134, and persons who may require them shall betrained in their use.

* * * * *

23. The authority citation for Subpart H of Part 1910 continues to read asfollows:

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 CFRPart 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 theNational Institute for Occupational Safety and Health (NIOSH) for anhydrousammonia.

* * * * *

(b) * * * (10) * * * (ii) All stationary storage installationsshall have at least two suitable gas masks in readily accessible locations.Full face masks with ammonia canisters as approved by the National Institutefor Occupational Safety and Health (NIOSH) are suitable for emergency actionfor most leaks, particularly those that occur outdoors. For protection inconcentrated ammonia atmospheres self-contained breathing air apparatus isrequired.

* * * * *

25. The authority citation for Subpart Q of Part 1910 continues to read asfollows:

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. Section1910.252 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 isimpossible to provide such ventilation, airline respirators or hose masksapproved 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 fullfacepiece pressure demand self-contained breathing apparatus or combinationfull facepiece pressure demand supplied air respirator with auxiliaryself-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 animpurity, or involving metals coated with lead-bearing materials, includingpaint shall be done using local exhaust ventilation or airline respirators.Outdoors such operations shall be done using respiratory protective equipmentapproved by the National Institute for Occupational Safety and Health (NIOSH)for such purposes. In all cases, workers in the immediate vicinity of thecutting operation shall be protected by local exhaust ventilation or airlinerespirators.

* * * * *

(9) * * * (i) General. Welding or cutting indoors or in confinedspaces involving cadmium-bearing or cadmium-coated base metals shall be doneusing local exhaust ventilation or airline respirators unless atmospherictests 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 equipmentsuch as fume respirators approved by the National Institute for OccupationalSafety and Health (NIOSH) for such purposes.

* * * * *

(10) Mercury. Welding or cutting indoors or in a confined space involvingmetals coated with mercury-bearing materials including paint, shall be doneusing local exhaust ventilation or airline respirators unless atmospherictests 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 equipmentapproved by the National Institute for Occupational Safety and Health (NIOSH)for such purposes.

* * * * *

27. The authority citation for Subpart R of Part 1910 continues to read asfollows:

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 personalprotective clothing and equipment shall be worn when the extent of the hazardis such as to warrant their use. Such equipment shall be worn wheneverspecifically required by other paragraphs of this section. All equipmentshall be maintained in accordance with applicable American NationalStandards. Respirators, goggles, and protective masks, rubber gloves, rubberboots, and other such equipment shall be cleaned and disinfected before beingused by another employee. Eye, head, and ear protection, where specified,shall conform to American National Standards Z24.22-1957, Z87.1-1968, andZ89.1-1969. Respiratory protection shall conform to the requirements of Sec.1910.134.

* * * * *

(g) * * * (10) Gas masks (digester building). Gas masks shall beavailable. These masks shall furnish adequate protection against sulfurousacid and chlorine gases, and shall be inspected and tested at frequentintervals, not to exceed 1 month, in accordance with American NationalStandard Z87.1-1968, and Sec. 1910.134.

* * * * *

(h) * * * (2) * * * (iii) Gas masks shall be provided foremergency use, in accordance with Sec. 1910.134.

(iv) For emergency and rescue work, a self-contained breathing apparatus orsupplied air respirator in accordance with the requirements of Sec. 1910.134shall be provided.

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[FR Doc. 94-27197 Filed 11-14-94; 8:45 am]