`[Federal Register Volume 63, Number 5 (Thursday, January 8, 1998)]
[Rules and Regulations]
[Pages 1152-1300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33843]



[[Page 1151]]

_______________________________________________________________________

Part II





Department of Labor





_______________________________________________________________________



Occupational Safety and Health Administration



_______________________________________________________________________



29 CFR Parts 1910 and 1926



Respiratory Protection; Final Rule

  Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules 
and Regulations  

[[Page 1152]]



DEPARTMENT OF LABOR

Occupational Safety and Health Administration

29 CFR Parts 1910 and 1926

[Docket No. H-049]
RIN 1218-AA05


Respiratory Protection

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

ACTION: Final rule; Request for comment on paperwork requirements.

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

SUMMARY: This final standard, which replaces the respiratory protection 
standards adopted by OSHA in 1971 (29 CFR 1910.134 and 29 CFR 
1926.103), applies to general industry, construction, shipyard, 
longshoring, and marine terminal workplaces. The standard requires 
employers to establish or maintain a respiratory protection program to 
protect their respirator-wearing employees. The standard contains 
requirements for program administration; worksite-specific procedures; 
respirator selection; employee training; fit testing; medical 
evaluation; respirator use; respirator cleaning, maintenance, and 
repair; and other provisions. The final standard also simplifies 
respirator requirements for employers by deleting respiratory 
provisions in other OSHA health standards that duplicate those in the 
final standard and revising other respirator-related provisions to make 
them consistent. In addition, the standard addresses the use of 
respirators in Immediately Dangerous to Life or Health (IDLH) 
atmospheres, including interior structural firefighting. During 
interior structural firefighting (an IDLH atmosphere by definition), 
self-contained breathing apparatus is required, and two firefighters 
must be on standby to provide assistance or perform rescue when two 
firefighters are inside the burning building.
    Based on the record in this rulemaking and the Agency's own 
experience in enforcing its prior respiratory protection standards, 
OSHA has concluded that compliance with the final rule will assist 
employers in protecting the health of employees exposed in the course 
of their work to airborne contaminants, physical hazards, and 
biological agents, and that the standard is therefore necessary and 
appropriate. The final respiratory protection standard covers an 
estimated 5 million respirator wearers working in an estimated 1.3 
million workplaces in the covered sectors. OSHA's benefits analysis 
predicts that the standard will prevent many deaths and illnesses among 
respirator-wearing employees every year by protecting them from 
exposure to acute and chronic health hazards. OSHA estimates that 
compliance with this standard will avert hundreds of deaths and 
thousands of illnesses annually. The annual costs of the standard are 
estimated to be $111 million, or an average of $22 per covered employee 
per year.

DATES: The final rule becomes effective April 8, 1998.
    Compliance: Start-up dates for specific provisions are set forth in 
Sec. 1910.134(n) of the regulatory text. However, until the Department 
of Labor publishes in the Federal Register the control numbers assigned 
by the Office of Management and Budget (OMB), affected parties are not 
required to comply with the new or revised information collection 
requirements contained in the following paragraphs: Sec. 1910.134(c) 
written procedures for selecting respirators, medical evaluations, fit 
testing, use of respirators, maintaining respirators, training, and 
periodically evaluating the effectiveness of the program; (e)(3)-(6) 
medical questionnaire, examination, and information for the physician 
or other licensed health care professional (PLHCP); (f)(1) fit testing; 
(i)(4) tagging sorbent beds and filters; and (m)(1)-(2) and (4) 
recordkeeping. Publication of the control numbers notifies the public 
that the OMB has approved these information collection requirements 
under the Paperwork Reduction Act of 1995. Although affected parties 
will not have to comply with the revised standard's information 
collection requirements until these have been approved by OMB, they 
must comply with those requirements of 29 CFR 1910.134 (OSHA's existing 
respirator protection standard) that have already been approved by the 
OMB under the Paperwork Reduction Act. Approved requirements include 
the written program, emergency-use respirator certification records, 
and emergency-use respirator compartment marking.
    Comments: Interested parties may submit comments on the information 
collection requirements for this standard until March 9, 1998.

ADDRESSES: In compliance with 28 U.S.C. 2112(a), the Agency designates 
the Associate Solicitor for Occupational Safety and Health, Office of 
the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution 
Avenue, N.W., Washington, D.C. 20210, as the recipient of petitions for 
review of the standard.
    Comments on the information collection requirements of this final 
rule (see Supplementary Information) are to be submitted to the Docket 
Office, Docket No. ICR 97-5, U.S. Department of Labor, Room N-2625, 200 
Constitution Avenue, N.W., Washington, D.C. 20210, telephone (202) 219-
7894. Written comments limited to 10 pages or less in length may also 
be transmitted by facsimile to (202) 219-5046.
    Copies of the referenced information collection request are 
available for inspection and copying in the Docket Office and will be 
mailed immediately to persons who request copies by telephoning Adrian 
Corsey at (202) 219-7075. For electronic copies of the Respiratory 
Protection Final Standard and the Information Collection Request, 
contact OSHA's WebPage on the Internet at http://www.osha.gov/.

FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Director, OSHA Office 
of Public Affairs, Room N-3647, U.S. Department of Labor, 200 
Constitution Avenue, N.W., Washington, D.C. 20210; Telephone (202) 219-
8148. For additional copies of this regulation contact: OSHA, Office of 
Publications, U.S. Department of Labor, Room N-3101, 200 Constitution 
Avenue, N.W., Washington, D.C. 20210; Telephone (202) 219-4667.

SUPPLEMENTARY INFORMATION:

1. Collection of Information: Request for Comment

    This final Respiratory Protection standard contains information 
collection requirements that are subject to review by OMB under the 
Paperwork Reduction Act of 1995 (PRA95), 44 U.S.C. 3501 et seq. (see 
also 5 CFR 1320). PRA95 defines collection of information to mean, 
``the obtaining, causing to be obtained, soliciting, or requiring the 
disclosure to third parties or the public of facts or opinions by or 
for an agency regardless of form or format.'' [44 U.S.C. 
Sec. 3502(3)(A)]
    The title, the need for and proposed use of the information, a 
summary of the collections of information, description of the 
respondents, and frequency of response required to implement the 
required information collection are described below with an estimate of 
the annual cost and reporting burden (as required by 5 CFR 1320.5 
(a)(1)(iv) and Sec. 1320.8 (d)(2)). Included in the estimate is the 
time for reviewing instructions, gathering and maintaining the data 
needed, and completing and reviewing the collection of information.

[[Page 1153]]

    OSHA invites comments on whether the proposed collection of 
information:
     Ensures that the collection of information is necessary 
for the proper performance of the functions of the agency, including 
whether the information will have practical utility;
     Estimates the projected burden accurately, including 
whether the methodology and assumptions used are valid;
     Enhances the quality, utility, and clarity of the 
information to be collected; and
     Minimizes the burden of the collection of information on 
those who are to respond, including the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.
    Title: Respiratory Protection, 29 CFR 1910.134.
    Description: The final Respiratory Protection standard is an 
occupational health standard that will minimize occupational exposure 
to toxic substances. The standard's information collection requirements 
are essential components that will protect employees from occupational 
exposure to these toxins. The information will be used by employers and 
employees to implement the protection required by the standard. OSHA 
will use some of the information to determine compliance with the 
standard.
    Respondents: The total number of respondents for the first year is 
1,300,000, and for the second year 1,430,000 (1,300,000 (1st year) plus 
10% (130,000)).
    Average Time Per Response: 2.21 hours (this is the result of 
dividing the total number of responses (19,767,461) by the total number 
of burden hours (8,926,558)).
    Average Time Per Firm: 6.87 hours (this represents the average time 
a firm would need to comply with all of the information collection 
provisions, including the written respiratory protection program. This 
is a result of dividing the total number of burden hours (8,926,558) by 
the total number of firms (1,300,000)).

                                                        Summary of the Collections of Information                                                       
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                            No. of       No. of                                                                                         
  Information collection  requirement     responses    responses      Frequency of response        Time per  response     Total 1st year  Estimated cost
                                            (Yr 1)       (Yr 2)                                                               burden        (1st year)  
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respiratory Protection Program             1,274,000       26,000  All Existing Firms to       2 Hours for Small Firms;        2,652,000     $60,916,440
 1910.134(c).                                                       Update Existing Program.    4 Hours for Large Firms.                                
                                             127,400        2,600  Initially for New           8 Hours to Develop.......                                
                                                                    Employers.                                                                          
                                                                   Updates (Every 5 Years)...  30 Minutes for Small                                     
                                                                                                Firms; 1 Hour for Large                                 
                                                                                                Firms.                                                  
Questionnaire Administration               5,000,000      575,000  All Employees Will Receive  15 Minutes for Employees          740,000     $13,593,800
 1910.134(e)(3).                                                    in the First Year.          to Complete.                                            
                                                                   50% of those Receiving                                                               
                                                                    Exams Will Receive Follow-                                                          
                                                                    up Questionnaires.                                                                  
Medical Examinations 1910.134(e)(4)....    1,150,000      287,500  23% of the Existing         All Medical Exams will          1,021,200     $18,759,444
                                                                    Employees.                  Take 1.5 Hours to                                       
                                                                   2nd & Recurring Yrs--25%     Complete which includes                                 
                                                                    of the 23% would receive    travel time.                                            
                                                                    Follow-up Exams.                                                                    
Information Provided to PLHCP              1,150,000      287,500  Dependent on the Number of  15 Minutes for Each               170,200      $2,358,972
 1910.134(e)(5).                                                    Exams.                      Employee.                                               
Fit Testing 1910.134(f)(1).............    4,335,000    4,335,000  346,800 Employees to        30 Minutes for Employees        3,780,140     $76,813,315
                                                                    Receive Quantitative Fit    to be Fitted                                            
                                                                    Tests.                      (Quantitative and                                       
                                                                   799,640 Employees to         Qualitative Fit Testing).                               
                                                                    Receive Qualitative Fit    30 Additional Minutes for                                
                                                                    Tests.                      Employers to Conduct                                    
                                                                   3,188,560 Employees to       (Only for In-House Fit                                  
                                                                    Receive In-House Fit        Testing).                                               
                                                                    Tests.                                                                              
                                                                   4,335,000 Total Employees.                                                           
Emergency-Use Respirator Marking                   0      260,000  Only New Employers E......  5 Minutes per Emergency-                0              $0
 1910.134(h)(2)(ii)(B).                                            xisting Employers Have       Use Respirator.                                         
                                                                    Already Complied (Old                                                               
                                                                    Requirement).                                                                       

[[Page 1154]]

                                                                                                                                                        
Emergency-Use Respirator Certification       671,880       67,200  Currently, 27,995           Assuming 2 Per Employer:          114,220      $2,098,221
 1910.134(h)(3)(iv)(A)&(B).                                         Employers Using Emergency-  10 Minutes (Total Time                                  
                                                                    Use Respirators (1st        Per Month).                                             
                                                                    Year).                                                                              
                                                                   2nd Year = 1st Year                                                                  
                                                                    Employers plus 10%.                                                                 
Certificate of Analysis of Cylinders               0            0  All Existing and New        Provided by Supplier,                   0              $0
 1910.134(i)(4)(i)(B).                                              Employers.                  therefore no burden                                     
                                                                                                incurred.                                               
Sorbent Beds and Filters                      74,181       74,181  Currently, 24,727           3 Changes Per Year,                 5,934        $109,008
 1910.134(i)(4)(iii)(B).                                            Compressors in Use.         assuming 5 minutes per                                  
                                                                                                change.                                                 
Medical Records 1910.134(m)(1).........    1,150,000      287,500  Dependent on the Number of  5 Minutes Per Employee             54,464        $754,871
                                                                    Exams.                      Examined.                                               
Fit Testing Records 1910.134(m)(2).....    4,335,000    4,335,000  Dependent on the Number of  5 Minutes Per Fit Test...         348,400      $4,828,824
                                                                    Fit Tests.                                                                          
Employee Access 1910.134(m)(4).........      500,000      500,000  10% of the Total Number of  5 Minutes per Request....          40,000        $554,400
                                                                    Employees.                                                                          
                                        --------------------------                                                       -------------------------------
      Totals...........................   19,767,461   11,037,481    ........................    .......................       8,926,558    $180,787,295
--------------------------------------------------------------------------------------------------------------------------------------------------------


                            Marginal Differences in Burden Hours and Costs (I.E., Between the Existing and Revised Standards)                           
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Current OMB                                                        2nd &                    
                                                             inventory    Adjustment (to  1st yr. burden                   recurring yr.                
           Information collection requirement                existing     1st year only)      revised     Estimated cost  burden revised  Estimated cost
                                                             1910.134                        1910.134                        1910.134                   
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respiratory Protection Program..........................         395,489       2,256,511       2,652,000     $60,916,440       1,570,400     $36,072,088
Questionnaire Administration............................               -         740,000         740,000     $13,593,800          85,100      $1,563,287
Medical Examinations....................................               -       1,021,200       1,021,200     $18,759,444         255,300      $4,689,861
Information Provided to PLHCP...........................               -         170,200         170,200      $2,358,972          42,550        $589,743
Fit Testing.............................................               -       3,780,140       3,780,140     $76,813,315       3,780,140     $76,813,315
Emergency-Use Respirator Marking........................             433            -433               0              $0             448          $8,230
Emergency-Use Respirator Certification..................         785,842        -671,622         114,220      $2,098,221          11,424        $209,859
Certificate of Analysis of Cylinders....................               -               0               0              $0               0              $0
Sorbent Beds and Filters................................               -           5,934           5,934        $109,008           5,934        $109,008
Medical Records.........................................               -          54,464          54,464        $754,871          13,616        $188,718
Fit Testing Records.....................................               -         348,400         348,400      $4,828,824         348,400      $4,828,824
Employee Access.........................................               -          40,000          40,000        $554,400          40,000        $554,400
Hour Kept in Inventory for Revised 1910.134.............               1              -1               0              $0               0              $0
                                                         -----------------------------------------------------------------------------------------------
      Totals............................................       1,181,765       7,744,793       8,926,558    $180,787,295       6,153,312   $125,627,333 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Under the column for ``Current OMB Inventory,'' dashes denote burdens that were not taken for the Existing Respiratory Protection Standard, but are     
  counted in the Revised Respiratory Protection Standard. Both Medical Examinations and Fit Testing are required by the existing standard; however,     
  because these requirements are not accompanied by a recordkeeping requirement, no burden was taken. In the revised standard, recordkeeping is required
  for these provisions, and thus burden is counted for these provisions.                                                                                

    Interested parties are requested to send comments regarding this 
information collection to the OSHA Docket Office, Docket No. ICR 97-5 , 
U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, N.W., 
Washington, D.C. 20210. Written comments limited to 10 pages or fewer 
may also be transmitted by facsimile to (202) 219-5046.
    Comments submitted in response to this notice will be summarized 
and included in the request for Office of Management and Budget 
approval of the final information collection request; they will also 
become a matter of public record.
    Copies of the referenced information collection request are 
available for inspection and copying in the OSHA Docket Office and will 
be mailed to persons who request copies by telephoning Adrian Corsey at 
(202) 219-7075. Electronic copies of the Respiratory Protection Final 
information collection request are available on the OSHA WebPage on the 
internet at http://www.osha.gov/ under Standards.

[[Page 1155]]

2. Federalism

    This final standard has been reviewed in accordance with Executive 
Order 12612 (52 FR 41685, October 30, 1987), regarding Federalism. This 
Order requires that agencies, to the extent possible, refrain from 
limiting state policy options, consult with states prior to taking any 
actions which would restrict state policy options, and take such 
actions only when there is clear constitutional authority and the 
presence of a problem of national scope. The Order provides for 
preemption of state law only if there is a clear Congressional intent 
for the Agency to do so. Any such preemption is to be limited to the 
extent possible.
    Section 18 of the Occupational Safety and Health Act (OSH Act) 
expresses Congress' clear intent to preempt state laws relating to 
issues on which Federal OSHA has promulgated occupational safety and 
health standards. Under the OSH Act, a state can avoid preemption only 
if it submits, and obtains Federal approval of, a plan for the 
development of such standards and their enforcement. Occupational 
safety and health standards developed by such Plan-States must, among 
other things, be at least as effective in providing safe and healthful 
employment and places of employment as the Federal standards. Where 
such standards are applicable to products distributed or used in 
interstate commerce, they may not unduly burden commerce and must be 
justified by compelling local conditions (see OSH Act, Section 18(c)).
    The final Federal standard on respiratory protection addresses 
hazards which are not unique to any one state or region of the country. 
Nonetheless, states with occupational safety and health plans approved 
under Section 18 of the OSH Act will be able to develop their own state 
standards to deal with any special problems which might be encountered 
in a particular state. Moreover, because this standard is written in 
general, performance-oriented terms, there is considerable flexibility 
for state plans to require, and for affected employers to use, methods 
of compliance which are appropriate to the working conditions covered 
by the standard.
    In brief, this final standard addresses a clear national problem 
related to occupational safety and health in general industry, 
construction, and maritime employment. Those states which have elected 
to participate under Section 18 of the OSH Act are not preempted by 
this standard, and will be able to address any special conditions 
within the framework of the Federal Act while ensuring that the state 
standards are at least as effective as that standard.

3. State Plans

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

4. Unfunded Mandates

    The final respiratory protection rule has been reviewed in 
accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2 
U.S.C. 1501 et seq.) and Executive Order 12875. As discussed below in 
the Summary of the Final Economic Analysis (FEA) (Section VI of this 
document), OSHA estimates that compliance with the revised respiratory 
protection standard will require the expenditure of more than $100 
million each year by employers in the private sector. Therefore, the 
final rule establishes a Federal private sector mandate and is a 
significant regulatory action, within the meaning of section 202 of 
UMRA (2 U.S.C. 1532). OSHA has included this statement to address the 
anticipated effects of the final respiratory protection rule pursuant 
to section 202.
    OSHA standards do not apply to state and local governments, except 
in states that have voluntarily elected to adopt an OSHA State Plan. 
Consequently, the respiratory protection standard does not meet the 
definition of a ``Federal intergovernmental mandate'' (Section 421(5) 
of UMRA (2 U.S.C. 658(5)). Thus, the final respiratory protection 
standard does not impose unfunded mandates on state or local 
governments.
    The anticipated benefits and costs of this final standard, and 
other issues raised in section 202 of the UMRA, are addressed in the 
Summary of the FEA (Section VI of this preamble), below, and in the FEA 
(Ex. 196). In addition, pursuant to section 205 of the UMRA (2 U.S.C. 
1535), having considered a reasonable number of alternatives as 
outlined in the preambles to the proposal and the final rule and in the 
FEA (Ex. 196), the Agency has concluded that the final rule is the most 
cost-effective alternative for implementation of OSHA's statutory 
objective of reducing significant risk to the extent feasible. This is 
discussed in the FEA (Ex. 196) and in the Summary and Explanation 
(Section VII of this preamble) for the various provisions of the final 
standard.

5. Executive Order 13045--Protection of Children From Environmental 
Health and Safety Risks

    Executive Order 13045, signed by the President on April 21, 1997, 
requires that for certain Federal agency ``regulatory actions submitted 
to OMB's Office of Information and Regulatory Affairs (OIRA) for review 
pursuant to Executive Order 12866, the issuing agency shall provide to 
OIRA the following information developed as part of the Agency's 
decisionmaking process, unless prohibited by law:
    (a) An evaluation of the environmental health or safety effects of 
the planned regulation on children; and
    (b) An explanation of why the planned regulation is preferable to 
other potentially effective and reasonably feasible alternatives 
considered by the agency.''
    ``Covered Regulatory Actions'' under this Order are rules that may:
    (a) Be ``economically significant'' under Executive Order 12866 (a 
rulemaking that has an annual effect on the economy of $100 million or 
more or would adversely affect in a material way the economy, a sector 
of the economy, productivity, competition, jobs, the environment, 
public health or safety, or State, local, or tribal governments or 
communities); and
    (b) Concern an environmental health risk or safety risk that an 
agency has reason to believe may disproportionately affect children.
    ``Environmental health risks and safety risks' mean risks to health 
or to safety that are attributable to products or substances that the 
child is likely to come in contact with or ingest (such as the air we 
breathe, the food we eat, the water we drink or use for recreation, the 
soil we live on, and the products we use or are exposed to).
    The final standard on respiratory protection does not concern 
``Environmental health risks and safety risks'' to children as defined 
under the Executive order. The respirator standard is only concerned 
with means of limiting employee exposures to toxic substances. The 
Agency believes, therefore, that the requirement noted above to provide 
OIRA with certain information does not apply since the respiratory 
protection standard is not a

[[Page 1156]]

``covered regulatory action'' under Executive Order 13045.
    Section 6(b) (8) of the OSH Act requires OSHA to explain ``why a 
rule promulgated by the Secretary differs substantially from an 
existing national consensus standard,'' by publishing ``a statement of 
the reasons why the rule as adopted will better effectuate the purposes 
of the Act than the national consensus standard.'' In compliance with 
the requirement, the Agency has reviewed the standards proposed through 
this rulemaking with reference to the ANSI Z88.2-1992 standard for 
Respiratory Protection. OSHA has discussed the relationship between 
individual regulatory provisions and the corresponding consensus 
standards in the Summary and Explanation of the final rule.

6. Reasons Why the Revised Rule Will Better Effectuate the Purposes 
of the Act Than the Existing Consensus Standard

    This process was facilitated by the fact that the previous OSHA 
standards on respiratory protection were start-up standards adopted 
directly from the ANSI Z88.2-1969 standard, ``Practices for Respiratory 
Protection'' under section 6(a) of the OSH Act, 29 U.S.C. 655(a). 
Therefore, even with subsequent revisions to the ANSI standards and the 
Agency's consideration of a widely varied and substantial body of 
information in the rulemaking record, the requirements of the OSHA 
final rule would tend to resemble the corresponding provisions of the 
current ANSI standards. In a number of instances, OSHA has utilized 
language identical to that in the current ANSI standard. These 
instances are noted in the Summary and Explanation. Where the Agency 
has determined that the pertinent ANSI language is not appropriate for 
this OSHA standard, the Summary and Explanation provides the basis for 
that decision.

I. General

    The preamble accompanying this final standard discusses events 
leading to the final rule, the types of respiratory hazards experienced 
by employees, the degree and significance of the risk presented by 
failure to comply with this revised standard, the Final Economic 
Analysis, and the rationale behind the specific provisions set forth in 
the final standard. The discussion follows this outline:

I. General
II. Pertinent Legal Authority
III. Events Leading to the Final Standard
    A. Regulatory History
    B. Justification for Revising the Previous Standard
    1. Purpose of Revision
    2. Respirator Use and Hazards
    C. Responses to Advisory Committee
    D. Assigned Protection Factors
    E. Small Business Considerations
IV. Certification/Approval Procedures
V. Significance of Risk
VI. Summary of the Final Economic Analysis And Environmental Impact 
Assessment
VII. Summary And Explanation of the Final Standard
    A. Permissible Practice
    B. Definitions
    C. Respiratory Protection Program
    D. Selection of Respirators
    E. Medical Evaluation
    F. Fit Testing Procedures
    G. Use of Respirators
    H. Maintenance and Care of Respirators
    I. Breathing Air Quality and Use
    J. Identification of Filters, Cartridges, and Canisters
    K. Training
    L. Respiratory Protection Program Evaluation
    M. Recordkeeping and Access to Records
    N. Dates
    O. Appendices
    P. Revisions to Specific Standards
VIII. Authority And Signature
IX. Amended Standards

II. Pertinent Legal Authority

    The purpose of the Occupational Safety and Health Act, 29 U.S.C. 
651 et seq. (``the Act'') is to ``assure so far as possible every 
working man and woman in the nation safe and healthful working 
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To 
achieve this goal, Congress authorized the Secretary of Labor to 
promulgate and enforce occupational safety and health standards. U.S.C. 
655(a) (authorizing summary adoption of existing consensus and Federal 
standards within two years of Act's enactment), 655(b) (authorizing 
promulgation of standards pursuant to notice and comment), 654(b) 
(requiring employers to comply with OSHA standards).
    A safety or health standard is a standard ``which requires 
conditions, or the adoption or use of one or more practices, means, 
methods, operations, or processes, reasonably necessary or appropriate 
to provide safe or healthful employment or places of employment.'' 29 
U.S.C. 652(8).
    A standard is reasonably necessary or appropriate within the 
meaning of section 652(8) if it substantially reduces or eliminates 
significant risk or prevents it from developing, and is economically 
feasible, technologically feasible, cost effective, consistent with 
prior Agency action or supported by a reasoned justification for 
departing from prior Agency actions, supported by substantial evidence, 
and is better able to effectuate the Act's purposes than any national 
consensus standard it supersedes. See 58 FR 16612-16616 (March 30, 
1993).
    A standard is technologically feasible if the protective measures 
it requires already exist, can be brought into existence with available 
technology, or can be created with technology that can reasonably be 
expected to be developed. American Textile Mfrs. Institute v. OSHA, 452 
U.S. 490, 513 (1981) (``ATMI''), American Iron and Steel Institute v. 
OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991)(``AISI'').
    A standard is economically feasible if industry can absorb or pass 
on the cost of compliance without threatening its long term 
profitability or competitive structure. See ATMI, 452 U.S. at 530 n. 
55; AISI, 939 F. 2d at 980.
    A standard is cost effective if the protective measures it requires 
are the least costly of the available alternatives that achieve the 
same level of protection. ATMI, 453 U.S. at 514 n. 32; International 
Union, UAW v. OSHA, 37 F.3d 665, 668 (D.C. Cir. 1994)(``LOTO III'').
    All standards must be highly protective. See 58 FR 16614-16615; 
LOTO III, 37 F.3d at 668. However, standards regulating exposure to 
toxic substances or hazardous physical agents must also meet the 
``feasibility mandate'' of Section 6(b)(5) of the Act, 29 U.S.C. 
655(b)(5). Section 6(b)(5) requires OSHA to select ``the most 
protective standard consistent with feasibility'' that is needed to 
reduce significant risk when regulating these hazards. ATMI, 452 U.S. 
at 509.
    Section 6(b)(5) also directs OSHA to base health standards on ``the 
best available evidence,'' including research, demonstrations, and 
experiments, 29 U.S.C. 655(b)(5). OSHA shall consider ``in addition to 
the attainment of the highest degree of health and safety protection * 
* * the latest scientific data * * * feasibility and experience gained 
under this and other health and safety laws.'' Id.
    Section 6(b)(7) of the Act authorizes OSHA to include among a 
standard's requirements labeling, monitoring, medical testing and other 
information gathering and transmittal provisions. 29 U.S.C. 655(b)(7).
    Finally, whenever practical, standards shall ``be expressed in 
terms of objective criteria and of the performance desired.'' Id.
    Respiratory protection is a backup method which is used to protect 
employees from toxic materials in the workplace in those situations 
where feasible engineering controls and work practices are not 
available, have not yet been implemented, are not in themselves 
sufficient to protect

[[Page 1157]]

employee health, or in emergencies. The revisions to the respirator 
standard made in this rulemaking are intended to ensure that, when 
employers require employees to wear respirators to be protected from 
significant risk, protective respirators will be selected and those 
respirators will be used effectively to meet their design capabilities. 
Otherwise respirators will not reduce significant risk. The standard's 
provisions are designed to be feasible and cost effective, and are 
expressed in terms of objective criteria and the performance desired.
    Further authority is provided by section 8(c)of the Act, which 
authorizes OSHA to require employers to maintain certain records. 
Section 8(g)(2) authorizes OSHA ``to prescribe such rules and 
regulations as (it) may deem necessary to carry out its 
responsibilities under the Act.''

III. Events Leading to the Final Standard

A. Regulatory History

    Congress created the Occupational Safety and Health Administration 
(OSHA) in 1970, and gave it the responsibility for promulgating 
standards to protect the health and safety of American workers. As 
directed by Congress in the Occupational Safety and Health Act of 1970 
(OSH Act; 29 U.S.C. 651 et seq.), OSHA adopted existing Federal 
standards and national consensus standards developed by various 
organizations such as the American Conference of Governmental 
Industrial Hygienists (ACGIH), the National Fire Protection Association 
(NFPA), and the American National Standards Institute (ANSI). The ANSI 
standard Z88.2-1969, ``Practices for Respiratory Protection,'' is the 
basis of the first six sections of OSHA's previous standard, 29 CFR 
1910.134, ``Respiratory Protection.'' The seventh section was a direct, 
complete incorporation of ANSI Standard K13.1-1969, ``Identification of 
Gas Mask Canisters.'' OSHA's previous construction industry standard 
for respiratory protection, 29 CFR 1926.103, was promulgated in April 
1971. On February 9, 1979, 29 CFR 1910.134 was formally recognized as 
also being applicable to the construction industry (44 FR 8577). Until 
the adoption of these standards by OSHA, most guidance on respiratory 
protective device use in hazardous environments was advisory rather 
than mandatory.
    OSHA's maritime standards were originally promulgated in the 1960s 
by agencies that preceded OSHA. The original OSHA code designations of 
these standards and their promulgation dates are: Shipyards--29 CFR 
1915.82, February 20, 1960 (25 FR 1543); Marine Terminals--29 CFR 
1917.82, March 27, 1964 (29 FR 4052); and Longshoring--29 CFR 1918.102, 
February 20, 1960 (25 FR 1565). Section 1910.134 was incorporated by 
reference into OSHA's Marine Terminals standard (part 1917) on July 5, 
1983 (48 FR 30909). OSHA has recently updated and strengthened its 
Longshoring and Marine Terminal standards, and both standards 
incorporate 29 CFR 1910.134 by reference.
    OSHA did not propose to expand coverage of 29 CFR 1910.134 to 
agricultural workplaces covered by 29 CFR part 1928, and this final 
Respiratory Protection standard, like the proposal, does not apply to 
agricultural operations. The prior standard likewise did not apply to 
agricultural operations. (See 29 CFR 1928.21.) OSHA received no public 
comment requesting a change in coverage. Accordingly, the issue of 
respirator use during agricultural operations was not a part of this 
rulemaking. OSHA notes, however, that respirator use during pesticide 
operations and handling is covered by EPA's Worker Protection Standard, 
40 U.S.C. part 170, adopted under the authority of the Federal 
Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-
136y).
    Under OSHA's previous standard, employers needed to follow the 
guidance of the Z88.2-1969 ANSI standard to ensure proper selection of 
respirators (see discussion 59 FR 58887). OSHA published an Advance 
Notice of Proposed Rulemaking (ANPR) to revise the respirator standard 
on May 14, 1982 (47 FR 20803). Part of the impetus for this notice was 
OSHA's inclusion of new respirator requirements in comprehensive 
substance-specific standards promulgated under section 6(b) of the Act, 
e.g., fit tests; use of powered air-purifying respirators (PAPRs) upon 
request; change of the filter elements of a respirator whenever an 
increase in breathing resistance is detected; employee permission to 
wash faces and respirator facepieces; and referral to a physician 
trained in pulmonary medicine for an employee who exhibits difficulty 
breathing, either at fit testing or during routine respirator use (see, 
e.g, 29 CFR 1910.1025 (lead standard)). The respirator provisions in 
these substance-specific standards took account of advances in 
respirator technology and changes in related guidance documents, 
particularly the recognition that standardized fit testing protocols 
greatly increase the effectiveness of respirators.
    OSHA's 1982 ANPR sought information on the effectiveness of the 
current respiratory protection provisions, the need for revision of 
those provisions, and the substance of the revisions. Responses were 
received from 81 interested parties. The commenters generally supported 
revising OSHA's respiratory protection provisions and provided 
suggestions for approaches the Agency might take (Ex. 15).
    On September 17, 1985, OSHA announced the availability of a 
preliminary draft of the proposed Respiratory Protection standard. The 
preproposal draft standard reflected the public comments received on 
the May 1982 ANPR, and OSHA's own analysis of changes needed in the 
standard to take into account the current state-of-the-art for 
respiratory protection. Responses were received from 56 interested 
parties (Ex. 36), and their comments were reviewed in preparing the 
proposal.
    On November 15, 1994, OSHA published the proposed rule to revise 29 
CFR 1910.134, and announced its intention to convene an informal public 
hearing on the proposal (59 FR 58884). The informal public hearing was 
convened on June 6, 1995, pursuant to notice and in accordance with 
Section 6(b) of the OSH Act, 29 U.S.C. 655(b)(3). Post-hearing 
submissions of data from parties at the hearing were received through 
September 20, 1995.
    On November 7, 1995, OSHA reopened the record (60 FR 56127) and 
requested additional comment on a study performed for OSHA by Dr. Mark 
Nicas titled ``The Analysis of Workplace Protection Factor Data and 
Derivation of Assigned Protection Factors.'' That study, which was 
placed in the rulemaking docket on September 20, 1995, addressed the 
use of statistical modeling for determining respirator APFs. Comments 
on the Nicas study were received through the end of January 1996. The 
Nicas report, and comments received in response to the November 1995 
notice, have convinced OSHA to deliberate further on the complex issues 
surrounding the establishment of APFs.
    The entire record including 200 exhibits, more than 3,000 
individual items, and approximately 2,300 transcript pages, was 
certified by the presiding administrative law judge on June 30, 1997, 
in accordance with 29 CFR 1911.17. Copies of materials contained in the 
record may be obtained from the OSHA Docket Office, Room N-2439, U.S. 
Department of Labor, 200 Constitution Avenue, N.W.,

[[Page 1158]]

Washington, D.C. 20210; (202) 219-7894.
    The final revisions to 29 CFR 1910.134 are based on consideration 
of the entire record of this proceeding, including materials discussed 
or relied upon in the proposal, the record of the informal hearing, and 
all written comments and exhibits received.

B. Justification for Revising the Previous Standard

1. Purpose of the Revision
    The intent of this revision is to enhance the protection of worker 
health, promote more effective use of respirators, provide greater 
compliance flexibility, and clarify the policies and procedures 
employers must follow when implementing a respiratory protection 
program. Evidence in the record, including case reports and studies of 
respirator use among workers, indicates that selecting or using 
respirators improperly can result in employee illness and even death. 
(See discussion below.) The revised standard is therefore expected to 
reduce the number of occupational illnesses and deaths among workers 
who wear respirators. OSHA is also consolidating many of its 
respirator-related provisions in other substance-specific health 
standards into one standard to make these provisions easier for 
employers to administer. Through consolidation, repetitive and 
duplicative respirator requirements have been deleted from many 
existing OSHA health standards, and future health standards will 
reference the revised final rule for many respirator requirements.
    Advances in technology also made the previous standard out-of-date 
in many areas. Nearly all rulemaking participants, including 
representatives of private industry, other Federal agencies, respirator 
manufacturers, and unions, agreed that revision is necessary to address 
these advances (e.g., NIOSH, Ex. 28; Eastman Chemical Co., Ex. 54-245; 
3M, Ex. 54-218A; AFL-CIO, Ex. 54-315; Building and Construction Trades 
Department/AFL-CIO, Ex. 29; American Petroleum Institute, Ex. 37; ISEA, 
Ex. 54-363). (See also 59 FR 58889.) Other agencies and committees have 
already updated their guidance on respirator use. For example, the ANSI 
standard has been revised twice (Exs. 10, 50), and NIOSH has revised 
its certification standard (42 CFR part 84; 60 FR 30336; 6/8/95), as 
well as developed a Respiratory Decision Logic (1987) to provide 
guidance to employers on the selection of respirators.
    OSHA's experience in enforcing the previous standard also indicated 
that some of that standard's requirements were not understood clearly 
by the regulated community, and so were not adequately effective in 
protecting workers. The clarifications in this new standard will 
contribute to enhanced compliance by reducing misinterpretations and 
inconsistencies. A review of OSHA enforcement data for 1994 and 1995 
revealed that failure to comply with the previous standard was a 
critical factor in at least 47 fatalities and 126 catastrophic 
injuries. The most frequently cited deficiencies included failure to 
provide respirators at all or to have standard operating procedures 
governing respirator use, and failure to train or fit test respirator 
users adequately [Source: OSHA's Federal Inspection Compliance Data 
(IMIS; 10/92 to 12/95)].
    In addition, considerable research has been performed to determine 
the extent to which respirators used in workplaces actually reduce the 
quantity of contaminant breathed by the respirator user. Researchers 
have compared the in-mask concentrations of contaminants to the 
concentration levels outside the masks. This work was begun by NIOSH 
during the mid-seventies to assess respirator effectiveness in coal 
mines and abrasive blasting operations (Ex. 64-5) and spray paint 
operations (Ex. 64-68). The studies assessed the effectiveness of 
respirators under various conditions, and measured employee exposure in 
situations when respirators were not worn. The effectiveness ratings 
obtained in these studies are usually termed ``Effective Protection 
Factors'' (EPF).
    More recent studies by NIOSH and private researchers have monitored 
respirator use even more closely to isolate variables that may affect 
the levels of respirator performance. Many of these studies concerned 
the performance of powered air-purifying respirators (PAPRs), which 
were not achieving in workplaces the levels of performance that had 
been predicted based on laboratory tests (see, e.g., Exs. 64-46, 64-42, 
and 64-47).
    A third group of studies, ``workplace protection factor studies,'' 
conducted mostly by manufacturers and other private interests, was 
designed to determine the optimum performance of respirators by 
eliminating the impact of program defects under very tightly supervised 
workplace conditions. The results of these studies may overstate the 
degree of respirator effectiveness most employers can expect under 
conditions of workplace use because study conditions are rarely 
replicated in the field; nevertheless, these studies show the potential 
for respirators to reduce employee exposure to workplace contaminants 
(see, e.g., Exs. 64-25, 64-42, 64-47, 64-513).
    This revised standard is intended to take account of up-to-date 
knowledge and technology and to make the requirements in the standard 
easier to understand. The standard now reflects current technology and 
research, as well as the findings and guidance of other expert bodies. 
OSHA has also included a new definitions section to enhance clarity. 
The revised standard includes detailed protocols for performing fit 
tests and lists the topics in which respirator users must be trained. 
It also contains provisions addressing skin and eye irritation, both of 
which must be considered in respirator selection. Wherever possible, 
OSHA has used performance-oriented language to allow for flexibility in 
accommodating future changes in respirator technology and to address 
the needs of small businesses and unusual operations. Through these 
improvements, OSHA expects to reduce the number of respirator-related 
illnesses, fatalities, and catastrophic injuries occurring among 
respirator wearers in U.S. workplaces.
2. Respirator Use and Hazards
    The purpose of a respirator is to prevent the inhalation of harmful 
airborne substances or oxygen-deficient air. Basically, a respirator is 
an enclosure that covers the nose and mouth or the entire face or head. 
Respirators are of two general ``fit'' types: (1) Tight-fitting 
(quarter masks, which cover the mouth and nose; half masks, which fit 
over the nose and under the chin; and full facepiece, which cover the 
face from the hairline to below the chin); and (2) loose-fitting 
(hoods, helmets, blouses, or full suits which cover the head 
completely). There are also two major classes of respirators: air-
purifying respirators (which remove contaminants from the air), and 
atmosphere-supplying respirators (which provide clean breathing air 
from an uncontaminated source). In general, atmosphere-supplying 
respirators are used for more hazardous exposures.
    Effective respirator use can protect employees from exposure to a 
wide variety of toxic chemicals. In 1994, approximately 215 deaths, or 
five percent of all workplace fatalities, occurred as a result of 
exposure to harmful substances and environments [CFOI, BLS, 6/11/96; 
CFOI/FAX]. There are a number of workplace situations that involve 
toxic substances and for which engineering controls may be inadequate 
to control exposures, and respirators are used in these situations

[[Page 1159]]

as a back-up method of protection. Substances that have been associated 
with death or serious incidents include carbon monoxide, 
trichloroethylene, carbon dioxide, chromic acid, coal tar, several 
toxic metal fumes and dusts, sulphur dioxide, wood dust, and welding 
fumes; these substances cause adverse health effects ranging from 
transient, reversible effects such as irritation or narcosis, through 
disabling diseases such as silicosis and asbestosis, to death caused 
either by acute exposure or by a cancer resulting from chronic 
exposures (Rom, W., Environmental and Occupational Medicine, 2nd ed., 
Little, Brown & Co., Boston; 1992, p. 598.) Respirators are available 
that can provide protection against inhalation of these toxic 
substances.
    Airborne contaminants may also be radioactive (``Radiologic Health 
in Occupational Medicine Practice,'' George L. Voelz, pg. 500 in 
Occupational Medicine, Carl Zenz, ed., Year Book Medical Publishers, 
Inc., Chicago, 1975; Jacob Shapiro, Radiation Protection, 3rd ed., 
Harvard University Press, Cambridge, MA, 1990, pg. 273). (See also 29 
CFR 1910.1096.) Exposure to ionizing radiation can cause acute effects 
such as nausea and vomiting, malaise and fatigue, increased 
temperature, and blood changes. More severe delayed effects include 
leukemia, bone and lung cancer, sterility, chromosomal and teratogenic 
damage, shortened life span, cataracts, and radiodermatitis, a dry, 
hairless, red, atrophic skin condition which can include skin cracking 
and depigmentation (George L. Voelz, M.D., ``Radiologic Health in 
Occupational Medicine Practice'', in Zenz, Occupational Medicine, pp. 
513-519; Herman Cember, Introduction to Health Physics, 2nd edition, 
Pergamon Press, New York, 1983, pg. 181-194). Respirators to provide 
protection against the inhalation of radioactive particles are commonly 
used by workers exposed to these hazards.
    ``Bioaerosols'' are airborne contaminants that are alive or were 
released from a living organism (OSHA Docket No. H-122; ACGIH 
Guidelines; Ex. 3-61C, page 1; 1994). Pulmonary effects associated with 
exposure to certain bioaerosols include rhinitis, asthma, allergies, 
hypersensitivity diseases, humidifier fever, and epidemics of 
infections including colds, viruses, tuberculosis, and Legionnaires 
Disease. Cardiovascular effects manifested as chest pain, and nervous 
system effects manifested as headache, blurred vision, and impaired 
judgment, have occurred in susceptible people following exposure to 
bioaerosols. Viral infections caused by the inhalation of bioaerosols 
can result in health effects that range in intensity from undetected or 
mild to more severe and even death. Bacterial infections resulting from 
inhalation of bacteria and their products cause a range of diseases, 
including tuberculosis, Legionnaires Disease, and hypersensitivity 
pneumonitis. Among workers in sewage treatment plants, health-related 
problems can be associated with occupational exposures to protozoa 
[Burge, H., 1990, ``Bioaerosols: Prevalence and health effects in the 
indoor environment,'' J. Allergy and Clinical Immunology; 86 (5); see 
also Exs. 3-61B and 3-61C in Docket No. H-122.] Allergic asthma and 
allergic rhinitis can be induced by chronic exposure to low levels of 
antigens. Hypersensitivity pneumonitis can occur when a worker inhales 
concentrated aerosols of particles released by bacteria, fungi, and 
protozoa (Exs. 3-61B and 3-61C in Docket No. H-122). In 1994, the 
Centers for Disease Control reported 41 deaths of workers for which 
there was evidence of work-related hypersensitivity pneumonitis (Work-
Related Lung Disease Surveillance Report, 1994; USDHHS, CDC, DHHS 
(NIOSH) Number 94-120). Respirators to protect against the inhalation 
of biological agents are widely used in healthcare and other workplace 
settings where exposure to such agents presents a hazard to workers.
    Respirators can also provide protection from oxygen-deficient 
atmospheres. Human beings must breathe oxygen in order to survive, and 
begin to suffer adverse health effects when the oxygen level of their 
breathing air drops below the normal atmospheric level. Below 19.5 
percent oxygen by volume, air is considered oxygen-deficient. At 
concentrations of 16 to 19.5 percent, workers engaged in any form of 
exertion can rapidly become symptomatic as their tissues fail to obtain 
the oxygen necessary to function properly (Rom, W., Env. Occup. Med., 
2nd ed; Little, Brown; Boston, 1992). Increased breathing rates, 
accelerated heartbeat, and impaired thinking or coordination occur more 
quickly in an oxygen-deficient environment. Even a momentary loss of 
coordination may be devastating to a worker if it occurs while the 
worker is performing a potentially dangerous activity, such as climbing 
a ladder. Concentrations of 12 to 16 percent oxygen cause tachypnea 
(increased breathing rates), tachycardia (accelerated heartbeat), and 
impaired attention, thinking, and coordination (e.g., Ex. 25-4), even 
in people who are resting.
    At oxygen levels of 10 to 14 percent, faulty judgment, intermittent 
respiration, and exhaustion can be expected even with minimal exertion 
(Exs. 25-4 and 150). Breathing air containing 6 to 10 percent oxygen 
results in nausea, vomiting, lethargic movements, and perhaps 
unconsciousness. Breathing air containing less than 6 percent oxygen 
produces convulsions, then apnea (cessation of breathing), followed by 
cardiac standstill. These symptoms occur immediately. Even if a worker 
survives the hypoxic insult, organs may show evidence of hypoxic 
damage, which may be irreversible (Exs. 25-4 and 150; also reported in: 
Rom, W., Environmental and Occupational Medicine, 2nd ed; Little, 
Brown; Boston, 1992).
    A number of workplace conditions can lead to oxygen deficiency. 
Simple asphyxiants, or gases that are physiologically inert, can cause 
asphyxiation when present in high enough concentrations to lower the 
oxygen content in the air. Other toxic or chemical asphyxiants poison 
hemoglobin, cytochromes, or other enzyme systems (Rom, W., 
Environmental and Occupational Medicine, 2nd ed., Little, Brown, and 
Co., Boston, 1992). A number of asphyxiants are gases that can evolve 
from explosions, combustion, chemical reactions, or heating. A high-
temperature electrical fire or arc welding accident causing a complete 
flashover in an enclosed area can temporarily eliminate oxygen from 
that area. Asphyxiation and the severe lung damage it can cause are 
major concerns for firefighters; of 30 firefighter deaths investigated 
by OSHA recently, five resulted from either asphyxiation, smoke 
inhalation, or flashovers (IMIS; 8 State plan states; 10/91-3/97). (See 
also mortality study of causes of death among firefighters, Guidotti, 
37 JOEM 1348, 1995.)
    In 1994, 110 employees died from oxygen deficiency [National Census 
of Fatal Occupational Injuries (CFOI); BLS; CFOI/FAX; 6/11/96)], i.e., 
about two percent of the total number of employees who died of 
occupational injuries. OSHA believes that many of these deaths could 
have been prevented if the victims' employers had realized that 
respirators were needed (BLS; CFOI/FAX, 6/96).
    In some cases, respirator use itself can cause illness and injury 
to employees. There are a number of physiological burdens that are 
associated with the use of certain types of respirators. The

[[Page 1160]]

weight of the respirator, breathing resistances during both normal 
operation and if the air-purifying element is overloaded, and 
rebreathing exhaled air from respirator ``dead space'' can all increase 
the physiologic burden of respirator use (Exs. 113, 22-1, 64-427). Job 
and workplace conditions, such as the length of time a respirator must 
be worn, the level of physical exertion required of a respirator user, 
and environmental conditions, can also affect the physiological burden 
(Exs. 113, 64-363). In addition, workers who wear glasses or hearing 
aids may have problems achieving appropriate fit with some respirator 
facepieces.
    Evidence of Adverse Health Effects From Respiratory Hazards. There 
is ample evidence that the previous standard was not doing an adequate 
job of protecting workers from these respiratory hazards, and that 
exposure to these hazards has continued to cause adverse health effects 
among exposed workers. An analysis of OSHA inspection data from 1976 
through 1982, when the previous standard had been in effect for between 
five and eleven years (Ex. 33-5), found that in most cases (55.6%) 
where respirators were used to protect employees from excessive levels 
of air contaminants, respiratory protection programs were deficient in 
one or more elements, thus increasing the potential for employee 
exposure. Even more significant was the fact that in 72.1% of 
inspections in which an overexposure to a substance listed under 29 CFR 
1910.1000 was cited, respirator use did not comply with the respiratory 
protection standard. OSHA performed a similar analysis of enforcement 
data for 1990-1996, and found similar levels of noncompliance. [See 
also Work-Related Lung Disease Surveillance Report, 1994; USDHHS, CDC, 
DHHS (NIOSH) Number 94-120.] The provisions of the new respirator 
standard are designed to regulate how an employer selects, maintains, 
fit tests, and trains employees in the proper use of respiratory 
equipment, and to provide employers with the tools needed to implement 
an effective respiratory protection program. OSHA has concluded that 
the new standard will eliminate many of the unnecessary illnesses and 
deaths described in this section.

C. Responses to Advisory Committee on Construction Safety and Health

    The revised respirator standard replaces the previous respiratory 
protection standard in the construction industry (29 CFR 1926.103). 
Since this revision affects the construction industry, the September 
1985 preproposal draft standard was presented to the Advisory Committee 
for Construction Safety and Health (ACCSH) for its comments. The ACCSH 
comments, combined with the other comments received, were considered in 
preparing a revision of the September 1985 draft proposal.
    As part of the Notice of Proposed Rulemaking (NPRM) approval 
process, the revised NPRM was presented at the March 1987 ACCSH meeting 
and the Committee's comments were presented to OSHA at the August 1987 
meeting (Ex. 39). OSHA responded to the Committee's comments in the 
NPRM, published in November, 1994. As noted in that response, OSHA 
modified the draft proposal to respond to the concerns of the Committee 
(59 FR 58931-58935).
    The final standard replaces the previous construction industry 
standard for respiratory protection, 29 CFR 1926.103, with an amended 
29 CFR 1926.103. The provisions of the previous respiratory protection 
standard (29 CFR 1926.103) are deleted by this action. The title, 
Respiratory Protection, will remain in the Code of Federal Regulations 
but will now be followed by the statement ``Respiratory protection for 
construction employment is covered by 29 CFR 1910.134.'' The full text 
of this new standard will be printed in the general industry standards, 
and the construction standard will reference the revised 29 CFR 
1910.134.
    The Agency's responses to the Committee's specific concerns follow:
Paragraph (a)--Permissible Practice
    The Construction Advisory Committee recommended that paragraph 
(a)(1) of the standard be changed to require that all feasible 
engineering controls be used by employers and that the employer 
demonstrate that engineering controls are not feasible before 
respirators may be used. The recommended change also would have 
eliminated the requirement that appropriate respirators be used while 
engineering controls are being installed. OSHA has stated elsewhere in 
the summary and explanation section of this preamble that paragraph 
(a)(1) of the previous standard remains unchanged in the new final 
standard because this paragraph was not proposed for revision and was 
therefore not a subject of rulemaking in this proceeding. The purpose 
of the Respiratory Protection standard is to improve the level of 
protection provided to employees who use respirators to protect them 
from respiratory hazards, regardless of whether that use occurs in an 
environment where engineering controls are in place.
    The Committee proposed that paragraph (a)(2) be modified to require 
that employers provide respirators to employees exposed to contaminant 
concentrations when the concentration reaches one-half the PEL or TLV, 
and that employees be required to wear them before the PEL is exceeded. 
To accompany this revision the Committee proposed a new definition 
establishing an ``action level'' of one-half the PEL for all regulated 
substances. OSHA has not adopted this ACCSH recommendation because the 
recommended changes are beyond the scope of this rulemaking.
Paragraph (b)--Definitions
    ACCSH suggested that OSHA add a definition for ``Grade D breathing 
air'' to the standard. The properties of Grade D breathing air are 
listed in paragraph (i) of the final standard, Supplied Air Quality and 
Use. OSHA believes that repeating these elements in the definition 
section is redundant and unnecessary.
    The Committee also recommended that the rule include a definition 
for ``competent person,'' as defined in 29 CFR 1926.32(f). The 
competent person would review the respiratory protection program and 
perform the function of the respiratory program administrator required 
in paragraph (c)(2) of the proposal. OSHA has not included a definition 
of competent person in the standard because 29 CFR 1926.32(f) already 
has such a definition. OSHA recognizes, however, that, in construction 
settings, the competent person is often also the administrator of the 
respirator program.
    The Committee also recommended that the NIOSH Recommended Exposure 
Limits (RELs) be used along with the TLVs, to define a hazardous 
exposure level in the absence of a PEL. This point is no longer 
relevant because the concept of ``hazardous exposure level'' is not 
included in the final respiratory protection standard.
    The proposal would have limited the use of air-purifying 
respirators for hazardous chemicals with poor or inadequate warning 
properties. ACCSH recommended a change to the definitions of 
``inadequate warning properties'' and that OSHA add a new definition 
for ``odor threshold.'' Because the final standard takes a different 
approach to determining when air-purifying respirators are appropriate, 
OSHA has not adopted the changes recommended by ACCSH.
    ACCSH also suggested that OSHA revise the proposed definition of 
maximum use concentration (MUC). In

[[Page 1161]]

the final standard the definition of MUC has been reserved, pending 
completion of a subsequent stage of this rulemaking that will 
concentrate on establishing OSHA Assigned Protection Factors (APFs).
    The Construction Advisory Committee also recommended replacing the 
proposal's definition of ``respirator;'' because the final standard 
contains no definition of ``respirator,'' this suggestion has not been 
adopted. The Committee also recommened revising the proposed definition 
of ``service life.'' However, since OSHA's definition of this term has 
been broadened in the final rule and the rule contains detailed 
requirements for change schedules for cartridges and canisters, ACCSH's 
concerns have largely been addressed.
Paragraph (c)--Respirator Program
    Paragraph (c)(1) of the proposal contained a requirement that the 
employer establish a respirator program that ``covers'' certain 
elements, as applicable. OSHA has followed the Commitee's 
recommendation that OSHA change the word ``cover'' to ``include'' but 
not removed the phrase ``as applicable,'' as recommended by the 
Committee, because not all elements of the program apply in all 
situations, and thus the ``as applicable'' language is appropriate.
    The Committee also recommended that OSHA add an element to the 
written respirator program on procedures for monitoring the work 
environment, using monitoring results when selecting respirators, and 
selecting the most protective respirators in situations where 
monitoring cannot be performed (as is often the case in construction). 
OSHA considered this comment in drafting the final standard, which 
permits the employer to make reasonable estimates of exposure as part 
of the respirator selection process. In most cases, as discussed in the 
summary and explanation of paragraph (d), monitoring results will form 
the basis of a reasonable estimate. Where the employer cannot estimate 
exposure, the atmosphere must be considered immediately dangerous to 
life or health (IDLH). For IDLH atmospheres, the most protective 
respirators are required.
    One of the elements in the written respirator program, paragraph 
(c)(1)(vi), states that the program shall include procedures to ensure 
proper air quality for atmosphere-supplying respirators. ACCSH asked 
OSHA to add the words ``quantity and flow'' to provide more direction 
for employers on what the procedures should cover. OSHA agrees and has 
revised the wording of this element accordingly.
    ACCSH recommended that OSHA substitute the term ``competent 
person'' in paragraph (c)(2) for the language ``person qualified by 
appropriate training and/or experience.'' This recommendation has 
already been discussed above, in connection with ACCSH's comments on 
paragraph (b).
    The written respiratory protection program, in paragraph (c)(3), is 
required to reflect current workplace conditions and respirator use. 
The Committee urged OSHA to add the term ``training'' to this element. 
OSHA has not done so because training is addressed in another program 
element. The Committee also recommended that OSHA add to paragraph (c) 
a provision allowing employees and designated representatives access to 
exposure and medical records maintained by the employer. Because this 
requirement is already included in 29 CFR 1910.1020, the medical and 
exposure records access standard, and referenced in this final 
respiratory protection standard, the Agency has not done so.
    Proposed paragraph (c)(5) required employers to make the written 
program available to affected employees, designated representatives, 
and OSHA. The Committee requested that employers be required to send a 
copy of the program to the OSHA Special Assistant for Construction. 
However, the proposed requirement has been moved to paragraph (m) of 
the final standard, which requires that all written materials 
maintained under the standard be made available upon request to 
affected employees and the Assistant Secretary. This requirement should 
meet any need that may arise for copies of the written program.
    The Committee further recommended that the written respirator 
program be maintained and made available to employees at the job site, 
and that the medical and monitoring results pertaining to respirator 
use be available at the work site as well. The final standard in 
paragraph (m) now requires employers to allow employees to examine and 
copy written programs upon request. Access to medical and monitoring 
records for employees exposed to toxic substances or harmful physical 
agents is regulated by OSHA in a separate standard, 29 CFR 1910.1020. 
That standard applies to construction workplaces as well as general 
industry workplaces and requires the employer to ensure that access to 
medical and monitoring records is provided in a reasonable time, place, 
and manner (1910.1020(e)(1)(i)). Nothing in the final respiratory 
protection standard is intended to alter this requirement.
Paragraph (d)--Selection of Respirators
    In its review of paragraph (d) of the proposal on selection of 
respirators, the Committee requested OSHA to add a new provision that 
would require monitoring for contaminants when air-purifying 
respirators are used. This request is related to the recommendation for 
mandatory monitoring, discussed above. The final standard requires that 
employers make reasonable estimates of employee exposure levels when 
selecting all respirators, not just air-purifying ones. Even if current 
monitoring results are unavailable, employers must base their exposure 
estimates on reliable data, which might include, for example, the 
results of past monitoring for similar construction jobs. Extensive 
discussion of this issue is contained in the summary and explanation 
section of this preamble for paragraph (d). OSHA believes that allowing 
exposure estimates that may be based on past monitoring and other 
representative data makes sense for the construction industry, where 
jobs are often short-lived and current monitoring data relating to 
specific employees/operations may not be available when respirators 
must be selected. Because the final standard allows employers to rely 
on reasonable estimates of exposure as well as monitoring results, OSHA 
has not added a requirement to the standard mandating that employers 
``obtain'' needed information, as recommended by the Committee.
    The Committee also recommended removal of the proposed phrase 
``when they exist'' to modify the requirement that employers select 
only NIOSH-approved respirators. Instead, the Committee recommended use 
of the most protective respirator available, an SCBA or supplied air 
respirator, in cases where no approved air-purifying respirator exists. 
OSHA has removed the phrase ``when they exist'' from the final 
standard, for reasons explained in the summary and explanation 
discussion relating to paragraph (d).
    The Committee urged OSHA to include poor odor warning properties as 
a reason for prohibiting the use of air-purifying respirators, and to 
remove proposed paragraph (d)(6)(ii), which, under limited 
circumstances, would have allowed their use with substances with poor 
odor warning properties. Final paragraph (d)(3) modifies the proposal, 
and places many limitations on air-purifying respirator use with gases 
and vapors, regardless of the existence of warning properties.
    The Committee objected to the use of air-purifying respirators in 
an

[[Page 1162]]

atmosphere with an oxygen content of 19.5 percent at altitudes of 
14,000 feet or below; in the Committee's view, supplied air respirators 
should be required in this situation. OSHA continues to treat 
atmospheres at altitudes of 14,000 feet or below that have oxygen 
concentrations of at least 19.5% as non-oxygen-deficient, and to 
require atmosphere-supplying respirators in these atmospheres. OSHA's 
reasons for this determination are detailed in the summary and 
explanation section for paragraph (d).
Paragraph (e)--Medical Evaluations
    The Committee recommended that a mandatory medical examination be 
required in accordance with ANSI Z88.2, and that the standard include a 
list of diseases and conditions that should be considered in 
determining an individual's ability to wear a respirator. The final 
standard allows employers to rely on a screening questionnaire to 
identify employees with specified conditions that will require follow-
up medical examinations. The questionnaire specifies medical conditions 
that OSHA has determined often relate to an employee's ability to use a 
respirator. OSHA believes that this provision responds to the 
Committee's concern.
    Based on the comments of ACCSH and others, OSHA has decided to 
eliminate the proposed exemption for employees wearing respirators for 
no more than 5 hours per week, for the reasons explained below in the 
Summary and Explanation. The final rule also reflects the Committee's 
recommendation that the medical opinion provided to the employer 
include only limitations on the employee's ability to use a respirator.
    The Committee recommended that OSHA add a provision to this 
paragraph requiring the employer to inform the person performing the 
medical examination of the atmospheric contaminants to which the 
employee would be exposed. The final standard meets this concern by 
requiring that the physician or other licensed health care professional 
(PLHCP) receive a copy of the employer's written respirator program, 
and information about other environmental conditions an employee may 
encounter; this information will allow the medical professional to 
judge whether the employee is medically capable of wearing the 
respirator.
    The final rule allows an employer who has, within the preceding 12 
months, provided his or her employees with a medical evaluation that 
fulfills the requirements of the revised standard to rely on the 
results of that evaluation. OSHA believes that this provision is 
responsive to the Committee's concern that limitations be placed on the 
``portability'' of medical evaluations.
    The Committee recommended that OSHA add a new provision to 
paragraph (e) to require that the employer provide a powered air-
purifying respirator or atmosphere-supplying respirator to any employee 
found medically unable to wear a negative pressure respirator but 
otherwise able to perform the task to be done. The final standard 
requires the employer to provide a PAPR to an employee when the PLHCP 
informs the employer that the employee has a medical condition that may 
place the employee's health at increased risk of material impairment if 
the employee uses a negative pressure respirator (paragraph (e)(6)(ii)) 
and is thus responsive to the Committee's concern.
Paragraph (f)--Fit Testing
    With respect to fit testing procedures, the Committee recommended 
that proposed paragraph (f)(1) be rewritten to state that respirators 
must fit the employee so as to ensure that no exposure above the TLV or 
ceiling level occurs. OSHA agrees with the Committee's emphasis on fit 
testing and believes that the final rule's fit testing requirements and 
the fit test protocols in an appendix to the standard will ensure that 
employees are protected from the overexposures of concern to the 
Committee.
    The Committee also suggested clarifying that a fit test is required 
whenever a different make or size respirator is used or when the facial 
characteristics of the employee change. The final rule addresses both 
of these points.
    The Committee recommended limiting the fit testing requirements to 
tight-fitting negative pressure respirators. This issue, and OSHA's 
reasons for requiring fit testing of all tight-fitting respirators, is 
discussed in the fit testing section of the Summary and Explanation. 
OSHA has also deleted the proposed provision, objected to by the 
Committee, that would have allowed the employer to use a qualitative 
fit test for selecting respirators for employees who require fit 
factors greater than 10 in situations where outside contractors who do 
the quantitative fit testing are not available.
Paragraph (g)--Respirator Use
    Paragraph (g)(1) of the final standard adopts the proposed 
provision prohibiting the use of respirators that rely on a tight 
facepiece fit when facial conditions such as a beard or scarring would 
prevent such fits. The Committee urged OSHA to extend this provision to 
cover loose-fitting respirators as well as tight-fitting ones. OSHA 
explains in the Summary and Explanation for this paragraph that 
conditions such as a beard or facial scarring would have no effect on 
the performance of loose-fitting hoods or helmets, and OSHA therefore 
does not regard it as appropriate to make this change.
    Employees who wear glasses were required in proposed paragraph 
(g)(4) to wear them in a manner that does not interfere with the 
facepiece seal of the respirator. The final standard continues this 
requirement (paragraph (g)(l)(ii)). The Committee suggested an 
additional requirement stating that, where the employee must wear 
corrective lenses and the respirator requires that these be of special 
design, the employer provide the lenses at no cost to the employee. 
OSHA believes, however, that such a requirement is not necessary 
because, in most cases where negative pressure respirators may be worn, 
half-masks are acceptable, and half-masks eliminate the concern about 
corrective glasses interfering with facepiece seal. Because the final 
standard allows contact lenses to be worn, full facepiece respirators 
can be worn by persons needing corrective lenses; contact lenses 
obviously do not interfere with facepiece seal. Thus, the final rule 
gives employers several options for addressing this concern of the 
Committee's.
Paragraph (h)--Maintenance and Care of Respirators
    The Committee urged OSHA to add the phrase ``on paid time'' to this 
paragraph to ensure that employers not require employees to clean their 
respirators on their own time. OSHA has decided in the final rule 
simply to require employers to ensure that respirators are cleaned 
according to mandatory procedures or their equivalents. OSHA believes 
that this approach is appropriate because the record demonstrates that 
on-site, employer-supervised cleaning is the prevalent cleaning 
procedure and the standard's rigorous requirements for cleaning 
respirators will limit off-site cleaning of respirators by employees.
Paragraph (k)--Training
    The training section of the proposal would have required that 
employers provide a training program for employees who are required to 
wear respirators. The Committee urged OSHA to add language to paragraph 
(k)(1) to require employers to provide, conduct and document the 
effectiveness of the training program. The final standard takes a more 
integrated approach in that

[[Page 1163]]

it requires employers to evaluate the entire respiratory protection 
program rather than the training program specifically.
Paragraph (m)--Recordkeeping
    OSHA has adopted the Committee's recommendation to add the phrase 
``and make available'' to proposed paragraph (m)(1)(iii), which 
required employers to maintain records of medical evaluations in 
accordance with 29 CFR 1910.1020, the Access to Employee Exposure and 
Medical Records standard (see paragraph (n)(1) of the final rule).
Appendix B--Recommended Practices
    Appendix B-1 of the standard contains practices for performing 
positive and negative pressure faceseal checks. Respirator wearers are 
required by paragraph (g)(iii) to perform a faceseal check before 
entering the work area either by following the mandatory faceseal check 
methods in Appendix B-1 or by following the respirator manufacturer's 
recommended method, if the employer shows that the manufacturer's 
method is as effective as the required methods. The Committee urged 
OSHA to add new fit check methods to Appendix B-1, and OSHA has 
responded to this recommendation by allowing the methods suggested by 
the Committee if they are as effective as the methods in the Appendix.
    ACCSH also recommended that OSHA issue a separate respirator 
standard for the construction industry. OSHA has reviewed the 
Committee's comments to identify which construction-specific concerns 
call for provisions that differ from those applicable to general 
industry. First, many of the final standard's provisions are stated in 
performance language, which is flexible enough to accommodate 
differences in particular workplaces or industries. For example, 
approved fit test systems, both quantitative and qualitative, are 
portable and can be used on construction work sites as well as in fixed 
industrial facilities. Another example is the final rule's requirement 
for medical surveillance; the frequency of medical reevaluation is now 
event driven, which will greatly simplify evaluations for employees who 
frequently change employment, as is the case with many construction 
workers. Thus, OSHA believes that the final rule is responsive to the 
Committee's concerns about the uniqueness of the construction industry 
and is sufficiently flexible to be used on worksites in this sector.

D. Assigned Protection Factors

    OSHA is reserving the sections of this standard addressing assigned 
protection factors (APFs) pending further rulemaking. OSHA is working 
diligently to complete the reserved portions of the standard. In the 
interim, OSHA expects employers to take the best available information 
into account in selecting respirators. As it did under the previous 
standard, OSHA itself will continue to refer to the NIOSH APFs in cases 
where it has not made a different determination in a substance-specific 
standard.

E. Small Business Considerations

    Pursuant to 5 U.S.C. 605(b) of the Regulatory Flexibility Act, OSHA 
certified to the Small Business Administration that the proposed 
respiratory protection standard would not have a significant impact on 
a substantial number of small entities.
    For the purposes of fulfilling the requirements of the Regulatory 
Flexibility Act, the Agency in its Preliminary Regulatory Impact 
Analysis (PRIA) [Ex. 57] examined the impact of the standard on a 
number of different small establishment-size classes (1-7 employees, 8-
19 employees, etc). Although some economies of scale associated with 
the proposed standard were noted, the Agency found that, given the 
modest costs per establishment and the limited impact of the proposed 
regulatory revisions as a whole, the standard would not impose a 
significant economic impact on a substantial number of small entities. 
These findings were summarized in the NPRM (59 FR 58894). At the time 
that OSHA published the NPRM for this rulemaking (Nov. 15, 1994), the 
Agency transmitted the certification setting forth this conclusion, 
along with the full PRIA, to the Small Business Administration.
    In developing the final standard, the Agency has conducted a 
screening analysis to identify any significant impacts on a substantial 
number of small entities. The details of the screening analysis are 
presented in the Final Economic Analysis, which is available in the 
docket; a summary of the analysis appears in section VI. Based on this 
screening OSHA has again determined that the final rule will not impose 
a significant impact on a substantial number of small entities. The 
costs of the standard will equal no more than 0.02 percent of revenues 
for small firms in any affected industry, and will therefore pose no 
threat of business disruption, whether these costs are absorbed by 
affected firms or passed on to consumers. OSHA therefore certifies that 
the final rule will not have a significant impact on a substantial 
number of small entities.
    Nevertheless, the Agency has designed the standard to minimize 
impacts on all affected establishments, and particularly on small 
entities. OSHA's special consideration of small businesses is in accord 
with the Agency's continuing policy to remain sensitive to the needs of 
small entities affected by Agency regulations.
    Provisions that recognize the special needs of small businesses are 
discussed in more detail under specific sections of the Summary and 
Explanation of the standard, Section VIII. Examples of provisions where 
consideration was given to small businesses in making regulatory 
decisions include:

--Reduction in the number of repeat fit tests required for quantitative 
fit testing;
--Allowing employers to use a questionnaire (Appendix C is an example) 
as a minimal medical evaluation tool to ascertain an employee's ability 
to use respirators, rather than requiring a hands-on physical 
examination;
--Allowing medical evaluations to be conducted either by a physician or 
by another licensed health care professional (PLHCP), which will reduce 
medical surveillance costs without compromising employee protection;
--Making the frequency of medical evaluations, after the initial 
assessment, event-related instead of time-related, e.g., only requiring 
such evaluations when specific conditions indicate a need for a 
reevaluation;
--Reducing the amount of paperwork required in connection with medical 
evaluations. OSHA's previous standard required a physician to determine 
pertinent health and physical conditions, and further required that the 
respirator user's medical status be reviewed periodically (for 
instance, annually). Historically, employers have had physicians 
evaluate their employees' physical conditions, and have maintained 
records documenting those evaluations;
--Revising the requirements for disinfecting respirators from ``after 
each use'' to ``as necessary to be maintained in a sanitary condition'' 
to allow flexibility for small businesses;
--Requiring only that tags be used to document respirator inspections, 
rather than requiring written records; and
--Allowing the employer to obtain a certificate of analysis of 
breathing gas

[[Page 1164]]

from the supplier rather than requiring employers to conduct gas 
analyses themselves.

    In the Small Business Administration's Annual Report to Congress, a 
summary of SBA's comments to the respirator docket (Ex. 54-318) was 
provided. (Note that these comments pertain to the proposed rather than 
final rule.) SBA's comments have been examined alongside others with 
regard both to the proposal and its supporting economic analysis. As 
indicated, many of SBA's suggestions have been adopted; the SBA's 
comments on the Preliminary Regulatory Impact Analysis are discussed in 
detail in the economic impact chapter of the Final Economic Analysis.
    Revised 29 CFR 1910.134 is intended to serve as a ``building 
block'' standard with respect to future standards that may contain 
respiratory protection requirements; that is, future standards that 
regulate respirator use in controlling employee exposure to hazardous 
conditions will refer to provisions in the final respiratory protection 
standard. Further, OSHA has found that the respirator provisions of 
existing substance-specific standards (Asbestos, Cadmium, Lead, etc.) 
were especially in need of revision in view of newly revised 
Sec. 1910.134. Except for a limited number of respirator provisions 
unique to each substance-specific standard, the remaining regulatory 
text on respirators now reads virtually the same for each of these 
standards. For example, all provisions addressing respirator use, 
selection, and fit testing were deleted from the substance-specific 
standards, making these standards consistent with the final respiratory 
protection standard with respect to these requirements. The Agency 
believes that the revisions being made to 29 CFR 1910.134 are 
sufficiently comprehensive to allow deletion of those provisions in the 
substance-specific standards that duplicated provisions in the revised 
final rule. A provision was retained only when it addressed conditions 
(for example, medical evaluation) that were unique and/or integral to 
the substance-specific standard.
    The Agency concludes that deletion of duplicative provisions from 
the substance-specific standards will enhance compliance, especially 
for small businesses, and will thus will improve the protection 
afforded to employees who use respirators.

IV. Certification/Approval Procedures

    Section 1910.134(b)(8) of the previous standard required that only 
those respirators approved jointly by NIOSH and MSHA be used by the 
employer. The current respirator testing and approval regulation, 30 
CFR 11, which authorized the Bureau of Mines and NIOSH to jointly 
approve respiratory protection devices, was promulgated on March 25, 
1972 at 37 FR 6244. On November 5, 1974 the Mine Enforcement Safety 
Administration (MESA) succeeded the Bureau of Mines and joined NIOSH in 
jointly approving respirators. Following the transfer of MESA to the 
Department of Labor, where it became the Mine Safety and Health 
Administration (MSHA), authority was transferred on March 24, 1978 to 
MSHA for joint approval with NIOSH of respirators. Most of the Bureau's 
respiratory testing methods, developed in the 1950s or earlier, were 
changed in the 1970s to reflect changes in testing technology.
    NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was 
held in July 1980 to address the certification program. On August 27, 
1987, NIOSH published a notice of proposed rulemaking (52 FR 32402) 
that would have allowed NIOSH to certify respirators under the new 42 
CFR part 84 regulations, replacing the current joint NIOSH/MSHA 30 CFR 
11 certification regulations. The proposed NIOSH certification 
regulations contained new and revised requirements for testing and 
certification of respirators, and included a set of assigned protection 
factors for various classes of respirators. Public hearings on the 
first draft of the NIOSH proposal were held in January 1988. On the 
basis of the comments received, NIOSH prepared a revised proposal for 
further public comment. On June 8, 1995 NIOSH published revised 
respirator certification procedures for particulate respirators (60 FR 
30336) and recodified the previous certification standards for the 
other respirator classes as 42 CFR Part 84. These certification 
procedures address N, P and R class particulate respirators at 95%, 
99%, and 99.7% levels of effectiveness. Additional public comment was 
sought at public meetings convened in June 1996 to assist NIOSH in 
preparation of future rulemakings that will continue the revision of 
the certification procedures for other classes of respirators. In 
October 1997, NIOSH announced the intended priority order for these 
future rulemakings. Relevant aspects of these proceedings are discussed 
in the Summary and Explanation.

V. Significance of Risk

    Respirators are used by American workers as a means of protection 
against a multitude of respiratory hazards that include chemical, 
biological, and radiological agents. Situations in which respirators 
are relied upon to provide protection from these hazards include those 
that involve immediately life-threatening situations as well as routine 
operations where engineering controls and work practices are not able 
to provide sufficient protection from these hazards. In these 
situations, respirators must ``seal off'' and isolate the worker's 
respiratory system from the contaminated environment. The risk that a 
worker will experience an adverse health outcome when relying on 
respiratory protection is a function of the toxicity or hazardous 
nature of the air contaminants present, the concentrations of the 
contaminants in the air, the duration of exposure, and the degree of 
isolation provided by the respirator. When respirators fail or do not 
provide the degree of protection expected by the user, the user is 
placed at an increased risk of any adverse health effects that are 
associated with exposure to the respiratory hazards present. Therefore, 
it is critical that respirators perform as they are designed to do to 
ensure that users are not at an increased risk of experiencing adverse 
effects caused by exposure to respiratory hazards.
    OSHA has discussed the nature of adverse health effects caused by 
exposure to airborne chemical hazards many times in previous rulemaking 
efforts (see, for example, Appendix A of the Hazard Communication 
standard, 29 CFR 1910.1200 and the preambles to any of OSHA's single 
substance standards codified in 29 CFR 1910.1001 to 1910.1052). In all 
instances where OSHA has promulgated new or revised PELs for chemical 
air contaminants, OSHA has determined that the health effects 
associated with exposure to the contaminants represent material 
impairment of health because the effects are life-threatening, cause 
permanent damage, or significantly impair the worker's ability to 
perform his or her job in a safe manner. As discussed in Section VI of 
this preamble, OSHA expects that thousands of illnesses and hundreds of 
fatalities that are presently being caused by exposure to hazardous 
substances will be avoided annually among respirator wearers as a 
result of improvements and clarifications made to the earlier standard 
by this final rule.
    Evidence on current workplace exposure levels confirms that 
respirators are needed in many work situations to protect workers 
against serious work-related illness. To illustrate, OSHA identified 
several substances that represent a range of adverse effects and

[[Page 1165]]

for which OSHA's Integrated Management Information System (IMIS) 
database has documented workplace exposures that exceed the current 
PELs for these substances. The effects represented by this subset of 
the IMIS and the associated substances for which there are documented 
overexposures include:

--Sudden death/asphyxiation--carbon monoxide, carbon dioxide;
--Loss of lung function--wood dust, welding fume, manganese fume, 
copper fume, cobalt metal fume, silica;
--Central nervous system disturbances--carbon monoxide, 
trichloroethylene;
--Cancer--chromic acid, wood dust, silica; and
--Cardiovascular effects--carbon monoxide.

    When respirators are used during operations where exposures exceed 
OSHA's PEL, OSHA believes that there is little or no margin that would 
protect the worker in the event that the respirator does not perform as 
well as designed or expected. For all of the substances for which OSHA 
has promulgated a comprehensive health standard (i.e., Arsenic, 29 CFR 
1910.1018; Asbestos, 29 CFR 1910.1001; Benzene, 29 CFR 1910.1028; Lead, 
29 CFR 1910.1025; Ethylene Oxide, 29 CFR 1910.1047), OSHA has 
determined that exposure above the PEL is associated with a significant 
risk of material impairment of health, and believes as a matter of 
policy that exposures below the PEL may be associated with risk levels 
that are significant. That is, there is no exposure level near or 
somewhat above the PEL that can be considered to be at a low or 
insignificant risk level. Therefore, where workers perform jobs that 
result in exposures above the PEL for any of these substances, use of 
properly functioning respirators is essential to ensure that workers 
are not placed at significant risk of material impairment of health.
    Throughout this preamble, OSHA has demonstrated that adequate fit 
testing, proper respirator selection, worker training, and thorough 
inspection and maintenance are essential elements of a respirator 
program. Without these requirements, OSHA believes that there is a 
greater chance that a respirator user will inhale potentially dangerous 
air contaminants, either by improper selection of equipment, excessive 
respirator leakage, improper use of the respirator, or any combination 
of these. This section presents an analysis conducted by OSHA to 
evaluate the improved protection to workers who use respiratory 
protection equipment by the type of effective respirator program 
required by the final rule.
    In the context of a respiratory protection program, the health risk 
presented to workers can be represented as the risk that a respirator 
will fail to provide some minimum expected level of protection, which 
increases the possibility that the user of the respirator will be 
overexposed to a harmful air contaminant. This presumes that 
respirators will be selected and used in work settings where exposure 
to ambient concentrations of air contaminants poses an unacceptable 
health risk, and, if the respirator performs as expected, the wearer 
will be protected from that risk. For example, an employer who provides 
a half-mask, chemical cartridge respirator for employee use might 
typically assume that the respirator will filter out 90 percent of the 
contaminant and base his or her choice of respirator on that 
assumption. If the respirator performs less effectively than expected, 
the employer's expectation that the respirator will provide effective 
protection will not be fulfilled.
    This concept of risk differs from that used by OSHA in its 
substance-specific health standards, in which the Agency typically 
defines risk as the probability that a worker will acquire a specific 
work-related illness. Quantifying that kind of risk requires the 
analysis of data that relates the magnitude or intensity of exposure to 
the incidence or prevalence of adverse effects seen among exposed 
populations or experimental animals. In contrast, the kinds of 
hazardous situations covered by the final respiratory protection 
standard are varied in terms of the nature of the hazard present (i.e., 
acute, chronic, or both), the frequency and magnitude of exposure, and 
the types of illnesses associated with exposure to those hazards. As a 
consequence, the health risks addressed by the final rule cannot be 
described in terms of an illness-specific risk, but instead relate to 
the more general probability that a respirator will provide 
insufficient protection causing the wearer to be exposed to a dangerous 
level of one or more air contaminants.
    Certain studies, referred to as ``workplace protection factor'' 
(WPF) studies, have attempted to measure the effectiveness of 
respirators under actual conditions of use in the workplace. The WPF is 
a measure of the reduction in exposure achieved by using respiratory 
protection and is represented by an estimate of the ratio of the 
concentration of a contaminant found in the workplace air to the 
concentration found inside the respirator facepiece while the 
respirator is being worn. As the degree of protection afforded by the 
respirator increases, the WPF increases. Alternatively, the degree of 
protection provided by a respirator can be expressed as a penetration 
value, which is the reciprocal of the WPF and reflects the ratio of the 
concentration of contaminant inside the facepiece to the concentration 
outside. For example, a WPF of 50 equates to a penetration value of 
0.02 and means that the concentration inside the respirator facepiece 
is one-fiftieth of the ambient level.
    Because WPF studies are designed to evaluate the field 
effectiveness of respiratory protection equipment, study protocols 
usually have been designed to minimize factors that can reduce 
respirator performance. Such factors include selecting the wrong type 
of respirator for the working conditions under which the study is being 
conducted, use of poorly fitting respirator facepieces (i.e., testing 
of respirator fit is routinely done in well-conducted WPF studies), 
inadequate training of wearers in proper respirator adjustment and use, 
or excessive leakage caused by malfunctioning or dirty respirator 
parts. Typically, WPF study protocols include procedures for properly 
selecting respirators and ensuring that they are in good working order, 
assigning respirators to workers on the basis of valid qualitative or 
quantitative fit tests, training wearers on how to adjust strap tension 
properly and use the respirator, and ensuring that neither facial hair 
nor other personal protective equipment is likely to interfere with 
respirator fit. In addition, workers included in WPF studies are 
usually monitored throughout the period that respirators are worn to 
verify that the equipment is being properly used. All of these 
conditions reflect the principal elements of a strong respirator 
program in which respirator performance is optimized; therefore, the 
results from a good WPF study can mirror the results obtained by an 
employer who implements a well-run respiratory protection program.
    To quantitatively evaluate the impact of implementing a good 
respirator program on respirator performance, OSHA identified several 
WPF studies that were conducted using methods that reflect a 
comprehensive program, and compared these results to other workplace 
studies that did not employ all of the elements of a good program. 
Quantitative approaches are used to develop (1) aggregate estimates of 
respirator effectiveness in both the presence and absence of a good

[[Page 1166]]

respiratory protection program, and (2) estimates of the frequency with 
which workers are likely to achieve inadequate protection while using a 
respirator, given the presence or absence of a good underlying program. 
All of the studies used in this analysis pertain to the effectiveness 
of half-mask, negative-pressure respirators, and all are contained in 
OSHA's rulemaking docket (H-049).
    Many of the well monitored WPF studies conducted were reviewed by 
Nelson et al. in 1995 (Ex. 64-514); these authors selected data from 
seven such studies to evaluate the overall field effectiveness of half-
mask, negative-pressure respirators. Each of the studies described by 
Nelson et al. ensured selection of properly fitted respirators either 
by an accepted qualitative fit test (QLFT) (i.e., isoamyl acetate or 
saccharin) or by a quantitative fit test (QNFT) where only respirators 
that provided a minimum protection factor to the wearer of at least 100 
were selected. Each of these studies provided for worker instruction in 
proper respirator use, and workers were monitored during each study to 
ensure proper use. An additional six studies were reviewed by Nelson et 
al. but were rejected either because they allegedly used biased 
sampling methods to determine ambient and in-facepiece contaminant 
concentrations or because the authors believed that improper or 
invalidated fit test procedures were employed.
    In the studies selected by Nelson et al. for analysis, workers used 
elastomeric or disposable respirators equipped with dust-mist, dust-
mist-fume, or high-efficiency particulate (HEPA) filters, and the 
collection of studies represented a range of workplace exposure 
situations, including pigment production, metals refining, asbestos 
exposure during brake-repair work, welding, and spray painting. 
Geometric Mean (GM) WPF values from these studies ranged from 47 to 
3,360, with an overall GM WPF of 290. The 5th percentile WPF from the 
data set was estimated to be 13, with a 95% confidence interval of 10-
18. Nelson et al. concluded from the analysis of the overall data set 
that the assigned protection factor of 10 for half-mask, negative-
pressure respirators was reasonable given that a WPF of less than 10 
would not likely occur more than 5 percent of the time. In addition, 
Nelson et al. found no significant difference in the field performance 
of disposable respirators compared to elastomeric models. OSHA has not 
conducted a detailed comparative evaluation of WPF values obtained from 
disposable vs. elastomeric respirators; if, in fact, disposable 
respirators provide less protection than elastomeric respirators, the 
WPFs that can be achieved under a good respirator program will be 
overstated in this analysis since Nelson et al.'s compiled data reflect 
the use of both types of respirators.
    Each of the studies reviewed by Nelson involved worker exposures to 
dusts. OSHA could identify only one WPF study, by Galvin et al. in 1990 
(Ex. 64-22), that examined respirator effectiveness against exposure to 
a vapor-phase contaminant rather than a particulate. In this study, WPF 
measurements were taken on a group of 13 styrene workers who used half-
mask, air-purifying respirators equipped with chemical cartridge 
filters. All employees were assigned respirators based on passing an 
irritant smoke fit test, and all were trained on how to properly don 
the respirator and conduct fit checks. In-mask and ambient styrene 
concentrations were measured over one-hour periods, during which 
employees were instructed not to readjust the facepiece. Chemical 
cartridges were changed with each new sampling period to ensure that 
there was no breakthrough. In-mask styrene concentrations were adjusted 
upwards by 40 percent to account for pulmonary retention, which avoided 
potentially overestimating the WPF. The GM WPF for the overall cohort 
was reported to be 79, with a geometric standard deviation (GSD) of 
3.51. There was no significant difference in WPF values between those 
workers engaged in relatively physical operations, such as spraying, 
compared to those performing less physical work tasks. The GM WPF found 
by Galvin et al. for styrene-exposed workers lies within the range of 
GM WPF values reported in the studies reviewed by Nelson for worker 
cohorts exposed to particulate-contaminated environments.
    Nelson in his 1995 report (Ex. 64-514) excluded the Galvin et al. 
study from his analysis because fit tests were performed using the 
irritant smoke protocol. As discussed in the Summary and Explanation 
section of this preamble, OSHA has determined that the irritant smoke 
qualitative fit test provides a valid, effective test of respirator 
facepiece fit. The procedures used by Galvin et al. to ensure adequate 
worker training and respirator use are consistent with the elements of 
a permissible respirator program, and OSHA, therefore, finds it 
appropriate to include this study in the set of WPF studies that are 
representative of effective respiratory program practices.
    In contrast, OSHA has identified three studies where investigators 
also determined WPF values for half-mask, negative-pressure 
respirators, but where few steps were taken to ensure maximum 
respirator performance. OSHA believes that these studies illustrate the 
relative lack of protection afforded by respirators when certain 
critical elements of the respiratory protection program are missing or 
inadequate. The studies identified by OSHA are those by Toney and 
Barnhart in 1972 (Ex. 64-68), Moore and Smith in 1976 (Ex. 64-49), and 
Harris et al. in 1974 (Ex. 27-11).
    Toney and Barnhart (Ex. 64-68) conducted a WPF study to evaluate 
the effectiveness of half-mask, chemical-cartridge respirators on 
reducing exposures of spray painters to solvent vapors and aerosols. 
Data were obtained from painters working at 39 different sites and 
included both in-mask and ambient concentrations. WPFs were found to be 
low; from the raw data presented in the study, OSHA calculated a GM WPF 
of 3.8 for solvent exposure (GSD=2.28, N=39) and a GM WPF of 11.4 for 
aerosol exposure (GSD=4.12, N=40). Penetration tests performed on 
unused respirator cartridges of the same types used in the field 
indicated that the poor WPFs achieved in the field tests were caused by 
poor respirator fit and a lack of respirator maintenance, and were not 
due to any inherent defect in the cartridges. The authors concluded 
that respirators being used by painters were not effective and cited 
several reasons, all pointing to the lack of a respiratory protection 
program at the facilities tested. For example, 28 percent of 
respirators used by the painters were poorly maintained. Some of the 
conditions found by the investigators included deteriorating rubber on 
the facepieces, the presence of stuck or warped valves, missing head 
straps, and evidence of leakage around the cartridge seal. In addition, 
it was apparent that some of the cartridges had not been changed for 
extended periods of time. Many of the facilities studied supplied non-
approved respiratory protective devices (respirators were approved by 
the Bureau of Mines at the time of the study), and most had no formal 
training or maintenance program in place. The authors found that ``* * 
* management and workers are extremely uninformed on the subject of 
selection, use, and care of respiratory protective devices.'' (Ex. 64-
68, p. 93).
    The second study, conducted by Moore and Smith in 1976 (Ex. 64-49), 
measured WPF values obtained by workers exposed to sulfur dioxide 
(SO2) during a furnace charging operation at a copper 
smelter. Three models of half-mask, chemical cartridge respirators

[[Page 1167]]

were tested on each of nine workers; in-mask and ambient SO2 
concentrations were measured during the furnace charging operation 
while the respirators were worn. There is no indication in the study 
that qualitative or quantitative fit testing was performed to verify 
adequate facepiece fit. A total of 81 samples were collected, 5 of 
which were excluded from the analysis because the subjects removed or 
lifted the respirator facepiece during the sampling period. Average 
ambient SO2 concentrations varied in the range of 53 to 61 
mg/m3 (20.4 to 23.5 ppm) during the sampling period. 
Geometric mean WPF values reported for each of the three models of 
respirator were 22.1 (SD=22.6), 18.4 (SD=14.2), and 12.9 (SD = 11.0). 
Moore and Smith concluded that the overall protection afforded by the 
respirators was poor, and that between one-third and one-half of the 
protection factors achieved would be below 10, the accepted minimum 
protection factor for that type of respirator. Reasons given by the 
authors for the poor fits observed among the subject workers included 
the possibility that strap tension was not properly adjusted (the 
authors did not control or monitor strap tension), variation in facial 
hair (despite the lack of beards or wide sideburns), and normal work 
activities that caused head motion and deep breathing associated with 
heavy work.
    The third study is that of Harris et al. in 1974 (Ex. 27-11), who 
evaluated the performance of five half-mask dust respirators among 37 
miners working in 4 coal mines. In-mask and ambient dust measurements 
were made throughout the workshifts, during which miners intermittently 
used respiratory protection. Thus, this study differs from the others 
described above in that the ratio of in-mask to outside concentrations 
included periods of time where the respirator was not worn, in contrast 
to the typical WPF study. The ratio of in-mask to outside concentration 
determined during periods of intermittent respirator use, termed the 
``effective protection factor'' (EPF), is not directly comparable to 
WPF values because, to the extent that workers spend time in 
contaminated atmospheres without respiratory protection, the WPF will 
tend to understate the actual protection obtained while the respirator 
is being worn. However, according to Poppendorf in 1995 (Ex. 54-512), 
it is possible to use EPF data to estimate the WPF that was likely to 
have been achieved during periods of respirator use if both of the 
following are known or can be estimated: (1) The fraction of time 
during which the respirator was not worn by the subject, and (2) the 
ratio of contaminant concentration in areas where the respirator was 
worn to that in areas where the respirator was not worn. Poppendorf 
(Ex. 54-512) described the mathematical relationship between the EPF 
and WPF and suggested that the likely range of average WPF values 
achieved by the miners during periods of respirator use was 3.6 to 5.7. 
This estimate of WPF is based on an observation by Harris et al. that 
miners wore their respirators about half of the time during the 
sampling periods, and an assumption by Poppendorf (Ex. 54-512) that the 
dust levels in the air while respirators were worn were at least 5 
times higher than airborne dust levels during periods of respirator 
non-use. OSHA believes that the latter assumption is reasonable given 
that Harris et al. reported that, for the most part, miners wore their 
respirators only when visible airborne dust was present. Harris et al. 
noted that the hard hats worn by the miners interfered with proper 
respirator strap positioning and adjustment; OSHA believes that this 
factor, as well as the apparent lack of fit testing, is likely to have 
contributed to the low protection factors experienced by the miners.
    OSHA believes that the studies described above demonstrate that 
improved respirator performance can be achieved under actual workplace 
conditions if fit testing is used to select respirators, if respirators 
are clean and in good working order, and if employees are properly 
trained and supervised in their use. This is evident when the summary 
statistics from aggregate protection factor data obtained from field 
studies on groups of employees using respirators in the absence of a 
strong respirator program (i.e., Moore and Smith, Toney and Barnhart, 
Harris et al.) are compared with those obtained from cohorts using 
respirators under the condition of a strong program (i.e., the studies 
reviewed by Nelson and the study by Galvin et al.). Summary protection 
factor data from these studies are presented in Table V-1 as geometric 
mean and mean WPF values, and the geometric standard deviation (GSD) of 
the distribution of WPF values. From these summary statistics, OSHA 
computed a weighted geometric mean WPF across cohorts exposed to 
particulate contaminants to compare the central tendency in protection 
factors achieved both with and without an adequate underlying 
respirator program (see footnote on Table V-1).
    In general, groups of employees using respirators against 
particulate exposures under a strong program achieved an overall GM 
protection factor about 25-fold higher than groups using respirators 
without the elements of a strong respiratory protection program. In 
studies that did not implement all of these elements, mean WPF values 
among the particulate-exposed worker cohorts tested ranged from about 6 
to 22. Mean WPF values for particulate-exposed worker cohorts included 
in the WPF studies where elements of a good program were implemented 
ranged from 72 to 2,400, with the mean WPF from one study estimated to 
be 11,500. The results from studies that examined respirator 
effectiveness against gas or vapor, also included in Table V-1, show an 
8-fold difference in overall GM WPF values. With only one exception, 
the 95 percent confidence intervals around the GM WPF values computed 
from the studies reflecting inadequate program practices do not overlap 
with those computed from the studies reflecting strong program elements 
(see Table V-1); thus, the hypothesis that there are no differences in 
the GM WPF values between the two groups of studies is rejected. This 
analysis suggests that implementation of a good respiratory protection 
program containing the elements described by the final rule can 
contribute to a substantial increase in the overall performance of 
respirators used in actual workplace settings, as measured by the mean 
WPF across groups of workers.

[[Page 1168]]



 Table V-1.--Summary Results From Workplace Protection Factor (WPF) Studies and Estimated Frequencies of Respirator Failure, Based on a One-Factor ANOVA
                                             Analysis of Data From Workplace Protection Factor (WPF) Studies                                            
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                        Estimated percent of workers with:              
                                                                                         ---------------------------------------------------------------
                                                                   Geometric                                                  WPF 10 at       eq>2 at  
                                               WPF (95% C.I.\1\)   deviation              Mean WPF 10 \2\       thn-eq>2 \2\    the time \3\  the time \3\
                                                                                                                                                        
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Studies Reflecting Inadequate Program Elements                                                     
                                                                                                                                                        
             Particulate Exposure                                                                                                                       
                                                                                                                                                        
Toney and Barnhart [1972] (Ex. 64-68)........     \4\ 11.4 (3.2-                                                                                        
                                                           39.6)    \4\ 4.12        31.1          76.8               9.0           100            60.4  
Harris et al. [1974] (Ex. 27-11)                                                                                                                        
    Low Estimate.............................   \5\ 3.6 (1-17.9)  \5\ 2-93           6.4          99.7              38.8           100            96.4  
    High Estimate............................      \5\ 5.7 (1.6-                                                                                        
                                                           20.4)    \5\ 2.93        10.2          97.0              12.5           100            82.3  
      Weighted Geometric Mean................            \6\ 5.6                                                                                        
              Gas/Vapor Exposure                                                                                                                        
                                                                                                                                                        
Moore and Smith [1976] (Ex. 64-69)                                                                                                                      
    Respirator A.............................   15.29 (8.3-28.1)    \7\ 2.36        22.1          36.2              <0.01           98.9           1.9  
    Respirator B.............................   13.72 (7.7-24.4)    \7\ 2.15        18.4          41.3              <0.01           99.7           0.5  
    Respirator C.............................    9.59 (4.8-19.2)    \7\ 2.16        12.9          83.1              <0.01          100             9.0  
Toney and Barnhart [1972] (Ex. 64-68)........      \4\ 3.8 (1.2-                                                                                        
                                                           11.9)    \4\ 2.28         5.3         100                14.7           100            95.7  
      Weighted Geometric Mean................            \6\ 9.4                                                                                        
                                                                                                                                                        
                                                        Studies Reflecting Good Program Elements                                                        
                                                                                                                                                        
             Particulate Exposure                                                                                                                       
                                                                                                                                                        
Dixon and Nelson [1984] \8\..................   3360 (3101-3640)        4.8     11,498            <0.01             <0.01           <0.01         <0.01 
Gaboury and Burd [1989] \8\..................         47 (31-72)        2.5         72             0.2              <0.01           30.1          <0.01 
Lenhart and Campbell [1984] \8\..............      166 (120-228)        3.8        405             0.1              <0.01            9.0           0.02 
Nelson and Dixon [1985] \8\..................      258 (192-347)        5.2       1004             0.7              <0.01           14.5           0.3  
Gosselink et al. [1986] \8\..................        96 (75-123)        2.3        136            <0.01             <0.01            0.1          <0.01 
Colton and Mullins [1992] \8\................      147 (117-185)        2.5        224            <0.01             <0.01            0.1          <0.01 
Myers [1990] \8\.............................      346 (256-468)        7.2      2,428             2.8               0.1            22.2           1.7  
      Weighted Geometric Mean................            \6\ 142                                                                                        
              Gas/Vapor Exposure                                                                                                                        
                                                                                                                                                        
Galvin et al. [1990] (Ex. 64-22).............        79 (54-115)        3.5        173             1.1              <0.01           31.7           0.2  
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 95% confidence interval of the geometric mean WPF calculated as follows for simultaneous confidence intervals: ySDnc tn-
  1,1-/2, =1-(1-0.05)1/N                                                                                                              
where n is the number of WPF measurements in each study and N is the number of studies being compared (i.e., 10 for particulate studies and 5 for gas/  
  vapor studies).                                                                                                                                       
\2\ Calculated from equation 9 as described in the text;  = 0.1 for WPF = 10,  = 0.5 for WPF = 2.                                     
\3\ Calculated from equation 10 as described in the text;  = 0.1 for WPF = 10,  = 0.5 for WPF = 2.                                    
\4\ Calculated by OSHA from raw data presented by the authors.                                                                                          
\5\ Range of WPF values estimated by Popendorf [1995] (Ex. 54-512), from effective protection factor values (EPF) reported by Harris et al. GSDs        
  calculated by OSHA from median and mean EPF values reported by Harris et al.                                                                          
\6\ Calculated as a weighted geometric mean as follows: exp[(lnGM/(lnGSD)\2\)/(1/(lnGSD)\2\)].                                        
\7\ Calculated by OSHA from median and mean WPF values reported by Moore and Smith.                                                                     
\8\ Studies reviewed by Nelson [1995] (Ex. 64-514).                                                                                                     

    The three WPF studies representing deficient program practices were 
all conducted 10 to 20 years earlier than the WPF studies reflecting 
good program elements. Thus, differences between the two groups of 
studies in working conditions, processes and exposures, or respirator 
equipment and technology could confound the comparison of respirator 
effectiveness measures. OSHA is not aware of any recent studies that 
have been conducted that were designed to evaluate the impact of 
respirator program elements on respirator effectiveness, nor are recent 
studies available that have attempted to measure respirator 
effectiveness under conditions of a poor respiratory protection 
program. OSHA believes that this analysis of program impacts on 
respirator performance is based on the best available data. However, 
OSHA has considered whether confounding factors related to the elements 
of a good respirator program may also have contributed to the 
differences in respirator performance reported by the two groups of WPF 
studies. For example, respirator fit can be adversely affected by 
vigorous work activity requiring head motion and deep breathing. Heavy 
work loads also contribute to respirator discomfort, which may cause a 
worker to wear a respirator too loosely. The nature of the air 
contaminant affects respirator performance in that different types of 
respirator filters have different capabilities in purifying 
contaminated air and gas-phase contaminants and small-particulate 
aerosols pass more readily through leak points than do aerosols 
comprised mostly of larger particles.
    OSHA does not believe that any systematic differences in working 
conditions or respirator technology contribute substantially to the 
differences in respirator effectiveness found between the two groups of 
studies included in the analysis. For example, both groups of studies 
represent a range of workplace situations that involve strenuous and 
non-strenuous work. In the studies that do not reflect good program 
practices, workers were engaged in active, strenuous work (smelter 
operations and coal mining) as well as less active work (spray 
painting). Similarly, studies that reflect good program practices have 
also been conducted on worker cohorts engaged in both active work 
(metals refining) and less active work (spray painting, brake repair). 
Both groups of studies also involve a range of contaminants, including 
both gas-phase and various kinds of particulate. Some of the studies 
reviewed by Nelson included information on the size distribution of

[[Page 1169]]

particulates to which workers were exposed, with the range across these 
studies including both respirable and non-respirable particles. Other 
studies included in the Nelson analysis reported that workers were 
exposed to both dust and fume. Therefore, the differences in WPFs found 
between the two groups of studies cannot be explained by differences in 
particulate sizes or characteristics. Both groups of studies also 
represent a variety of half-mask respirator designs and filters, 
including single-use respirators and respirators equipped with dust/
mist (i.e., non-HEPA) filters. OSHA believes it unlikely that the 14-
fold difference in overall WPFs between the two groups of studies can 
be primarily attributed to any fundamental differences in respirator 
equipment or technology. Therefore, OSHA finds that the differences in 
WPF values obtained from the two groups of studies are more likely to 
reflect differences in how well the respirators fit the subject 
workers, the condition of the respiratory equipment used, and the 
extent to which the equipment was used properly, rather than any 
confounding caused by systematic differences in work settings, the 
nature of the exposures, or the age of the WPF studies.
    The kinds of summary statistics presented in Table V-1 have been 
used by several investigators to demonstrate how poorly or how well 
respirators can protect workers under actual conditions of use (see, 
for example, Moore and Smith (Ex. 64-69), Nelson et al. (Ex. 64-514)). 
However, such descriptive measures can only provide information on the 
aggregate frequency distribution of protection factor values in a group 
of workers. Although it is useful to rely on summary statistics from 
aggregate protection factor data to make general statements about the 
effectiveness of respirators, such measures do not adequately convey 
information on the number or proportion of workers who remain at risk 
of overexposure to air contaminants despite the use of respiratory 
protection, or how frequently an individual worker might experience 
poor fits.
    Nicas (Ex. 156) and Nicas and Spear in 1992 (Ex. 64-425) have 
suggested that using statistics from aggregate protection factor data 
does not adequately describe the true risk of overexposure to workers 
using respirators because the approach fails to recognize that there 
are two different sources of variability that account for the overall 
variation in protection factor values measured from a given cohort of 
workers. One source of variability in protection factors is the 
variation typically experienced by a single worker from one day to the 
next; this is termed within-worker variability. The second source of 
variability reflects the observation that different workers within a 
group will achieve different average protection factors over a given 
period of time; this is termed between-worker variability. In a peer-
reviewed article, Nicas and Spear (Ex. 64-425) have described a 
statistical model that accounts for both sources of variability. This 
model has been used by OSHA to estimate the following from the 
protection factor studies described above to better characterize risks 
to workers who use respirators both in the absence of and under a 
strong respiratory protection program:

    (1) The proportion of workers who fail to achieve a long-term 
average protection factor at or above some specified target level, 
exposing the worker to an increased risk of a chronic health hazard 
(i.e., a health hazard that is typically associated with long-term 
cumulative exposure); and
    (2) The proportion of workers who achieve a protection factor 
below some specified target level at least 5 percent of the time 
that the respirator is worn, thus increasing the frequency with 
which a worker may be exposed above an effect concentration 
associated with an acute health hazard.
    The Nicas and Spear model (Exs. 64-425, 156) used by OSHA in this 
analysis is a one-factor analysis of variance and is described briefly 
as follows. Let P denote a penetration value experienced by the wearer 
of a respirator during a randomly selected wearing time (P is defined 
as the reciprocal of the protection factor PF measured in the 
workplace, or 1/PF). For example, a P value of 0.1 for a respirator 
wearer reflects that a protection factor of 10 was achieved in the 
workplace for that individual. If one were to measure the penetration 
values among members of a group of workers over time and aggregate the 
results, the total distribution of P values can be described by the 
following parameters:
[GRAPHIC] [TIFF OMITTED] TR08JA98.000

Where:

P = the penetration value for a worker for a particular wearing period,
p = the arithmetic mean penetration value for the 
population,
B = a lognormally distributed factor that transforms 
p to the arithmetic mean penetration value for the 
individual worker, and
W = a lognormally distributed factor that transforms 
p  x  B to the P value experienced by the 
individual worker for a particular wearing time.

The factors W and B describe within-worker variability and between-
worker variability, respectively.
    Since workplace protection factor studies typically report the 
geometric mean and geometric standard deviation of protection factor 
values obtained from a cohort of respirator wearers (i.e., GM[P] and 
GSD[P]), the parameters described above for within-worker and between 
worker variability can be estimated as follows if the relationship 
between GSD[B] and GSD[W] are known or assumed. Let R represent the 
ratio of GSD[W]/GSD[B]; then GSD[B] can be estimated from GSD[P] and R 
by the relationship
[GRAPHIC] [TIFF OMITTED] TR08JA98.001


[[Page 1170]]


GSD[W], GM[B], and GM[W] are estimated by:
[GRAPHIC] [TIFF OMITTED] TR08JA98.002

The arithmetic mean of the total distribution of penetration values 
across the whole cohort, p, is estimated by:
[GRAPHIC] [TIFF OMITTED] TR08JA98.003

    Nicas (Ex. 156) defines two additional values,  and 
, that are based on the parameters described above. The value 
 represents the 95th percentile of the between-wearer 
distribution of average penetration values among a cohort of respirator 
wearers; thus, there is a 5 percent chance that a respirator wearer in 
the cohort could have an average penetration value of  or 
higher. If  is set to some penetration value reflecting some 
minimum acceptable value of protection, the probability that a 
respirator wearer would fail, on average, to achieve the minimum 
acceptable penetration value is Pr(Z>z), where
[GRAPHIC] [TIFF OMITTED] TR08JA98.004

and Z is the standard normal deviate. By estimating the parameters 
p, GM[B], and GSD[B] from WPF data, one can 
estimate the probability that a respirator wearer could have an average 
penetration value greater than some specified value .
    The value  is defined by Nicas (Ex. 154) based on the 
distribution of each worker's 95th percentile P value and represented 
the P value experienced at least 5 percent of the time by 95 percent of 
workers in the cohort. If  is set to some minimum acceptable P 
value, the estimated probability that a respirator wearer could fail to 
achieve the minimum P value at least 5% of the time is Pr(Z>z), where
[GRAPHIC] [TIFF OMITTED] TR08JA98.005

and Z is the standard normal deviate. Thus, the proportion of workers 
who fail to achieve a P value of  at least 5 percent of the 
time can be determined by estimating the parameters 
p, GM[B], and GSD[W] from WPF data.
    The following hypothetical example illustrates OSHA's use of the 
model to estimate the risk to workers of experiencing an overexposure 
while using respiratory protection. Suppose that the WPF values 
obtained from a group of workers using half-mask, negative-pressure 
respirators are found to have a geometric mean of 50 (i.e., GM[P] = 1/
50 = 0.02) and a geometric standard deviation of 3.0 (GSD[P] = 3.0). 
Furthermore, from one of the WPF studies reviewed by OSHA (Galvin et 
al.) (Ex. 64-22), it was reported that within-worker variability 
exceeded between-worker variability in workplace protection factors, 
with the ratio GSD[W]/GSD[B] = 1.5. From equations 4 through 7 above, 
and assuming that R = 1.5, then GSD[B] = 1.73, GSD[W] = 2.60, GM[W] = 
0.63, and GM[B] = 0.86. The arithmetic average of the cohort's P 
values, p, is estimated from equation 8 to be 
0.037. If a protection factor of less than 10 (the NIOSH minimum 
assigned PF for half-mask respirators) is considered to place the 
worker at risk of an overexposure, then equation 9 predicts a 
probability of 1.8 percent that a worker in the group would be expected 
to have an average WPF value of 10 or less (i.e.,  is set to 
0.1 in equation 9); that is, 1.8 percent of the group of respirator 
wearers would frequently encounter situations where they are working in 
a hazardous environment without the minimum protection expected from 
the respirators being used. By equation 10, there is a substantial 
probability (47 percent) that a worker in the cohort would not achieve 
a minimum protection factor of 10 at least 5 percent of the time that 
respirators are used (i.e.,  is set to 0.1 in equation 10).
    OSHA used the Nicas and Spear model, the summary data from the WPF 
studies reviewed above, and the method outlined in the example 
described above to estimate the probability that a respirator wearer 
would fail to receive adequate protection from their respirator; the 
detailed results of this analysis appear in Table V-1, and summary 
findings are listed in Table V-2. From the studies that reflect the 
lack of an adequate respiratory protection program, the Nicas and Spear 
model predicts a high probability (between 36 and 100 percent) that a 
wearer would

[[Page 1171]]

not achieve an average protection factor of 10. Data from two of these 
studies by Toney and Barnhart (Ex. 64-68), and Harris et al. (Ex. 27-
11), when used in the model, suggest a probability of between 13 and 39 
percent that the average WPF for a respirator wearer could be 2 or 
less, which may be considered equivalent to receiving no long-term 
protection at all. In contrast, workers included in the studies 
reflecting good respirator program elements would be expected to 
experience low WPFs much less frequently. The probability that a wearer 
would attain an average WPF of 10 or less is estimated to be between 
<0.01 and 3 percent. Results from the studies that reflect good 
respiratory program practices also indicate that long-term average WPF 
values at or below 2 would rarely occur. The results from this analysis 
demonstrate that deficiencies in implementing a good respirator program 
can greatly increase the chance that the wearer of a negative-pressure 
respirator will receive less than the minimum expected average 
protection from the respirator over the long-term, thus increasing the 
chance that the worker will be exposed to a higher chronic health risk.

Table V-2.--Summary Estimates of the Probability of Achieving Inadequate
  Fits for Half-Mask, Negative-Pressure Respirators Under Deficient and 
                  Good Respiratory Protection Programs                  
------------------------------------------------------------------------
                                    Percent probability that wearer will
                                                   achieve              
                                   -------------------------------------
                                                         Workplace fit  
   Quality of respirator program                         factor of less 
                                    Average workplace   than 10 at least
                                      fit factor of    5 percent of time
                                       less than 10     that respirator 
                                                            is worn     
------------------------------------------------------------------------
Deficient.........................         36-100             99-100    
Good..............................        <0.01-3           <0.01-32    
------------------------------------------------------------------------

    OSHA's analysis (Tables V-1 and V-2) also demonstrates that workers 
using respiratory protection under a deficient program will be exposed 
more frequently to higher concentrations of airborne contaminants, 
which may increase the risk that the worker will experience acute 
health effects. The Nicas and Spear model applied to the studies that 
reflect inadequate respirator programs predicts nearly a 100 percent 
chance that a protection factor of less than or equal to 10 would be 
experienced at least 5 percent of the time. Under conditions of a good 
respirator program, use of the model suggests no more than a 32 percent 
chance that WPFs of less than or equal to 10 will occur more than 5 
percent of the time.
    OSHA finds that, without an adequate respiratory protection program 
in place, a substantial fraction of respirator users are at risk of 
being overexposed to hazardous air contaminants due to poor respirator 
performance. The studies conducted under conditions of a poor 
respirator program, when analyzed using the Nicas and Spear model, 
suggest a greater than 50 percent probability that the wearer of a 
half-mask, negative-pressure respirator will regularly fail to attain 
the expected minimum level of protection, and that the chance of 
receiving essentially no protection is substantial. OSHA considers 
these risks of overexposure to be significant. The studies reviewed by 
Nelson and the Galvin study indicate that these risks are considerably 
lower in situations where respirators are used in conjunction with the 
implementation of strong respiratory protection program elements such 
as appropriate fit testing, adequate employee training, use of clean 
respirators in good working order, and regular monitoring of employees 
to ensure proper respirator use. Thus, OSHA finds that implementation 
of a comprehensive respiratory protection program, such as the one 
prescribed by the final rule, will substantially reduce the risk of 
overexposure that is due to respirator failure. Because such 
overexposures can place workers at a significant risk of health 
impairment, as described earlier in this section, OSHA also finds that 
promulgation of the final rule will substantially reduce the 
significant health risks associated with those overexposures.

VI. Summary of the Final Economic Analysis

    In the Final Economic Analysis, OSHA addresses the significant 
issues related to technological and economic feasibility and small 
business impacts raised in the rulemaking process. This analysis also 
explains in detail the Agency's findings and conclusions concerning 
pre-standard (baseline) conditions, such as respirator program 
practices, in establishments in the regulated community, and discusses 
how and why the requirements of the standard are expected to reduce 
employee exposures. The preamble to the revised rule and the Final 
Economic Analysis are integrally related and together present the 
fullest statement of OSHA's reasoning concerning this standard. The 
Final Economic Analysis has been placed in the rulemaking docket.
    This analysis of OSHA's revised Respiratory Protection standard (29 
CFR 1910.134) has been conducted in accordance with Executive Orders 
(EOs) 12866 and 12875, the Regulatory Flexibility Act (as amended in 
1996), the Small Business Regulatory Enforcement Fairness Act (SBREFA), 
the Unfunded Mandates Reform Act (UMRA) and the Occupational Safety and 
Health Act. The standard is a ``significant'' rule as defined by EO 
12866, a ``major'' rule as defined by Sec. 804 of SBREFA, and a 
``significant'' rule as defined by UMRA.
    The purposes of this Final Economic Analysis are to:
     Describe the need for a revised standard governing the use 
of respirators;
     Identify the establishments, industries and employees 
potentially affected by the standard;
     Evaluate the costs, benefits, economic impacts and small 
business impacts of the standard on affected firms;
     Assess the technological and economic feasibility of the 
standard for affected establishments, industries, and small businesses; 
and
     Identify the availability of effective non-regulatory and 
alternative regulatory approaches.
    OSHA's final Respiratory Protection standard covers the use of 
respiratory protection in general industry, construction and shipyard 
employment, as well as marine terminals and longshoring. In all, about 
5 million

[[Page 1172]]

employees are estimated to use respirators. 1 Workers use 
respirators to protect themselves from a wide variety of occupational 
exposures. Respirators are used, at least to some extent, in virtually 
every industry, although the extent of respirator use varies by 
industry. Manufacturing and construction have relatively heavy 
respirator use; in contrast, use in many service industries is very 
limited.
---------------------------------------------------------------------------

    \1\ Approximately 5% of these respirator-using employees would 
be subject to OSHA's substance-specific health standards rather than 
to this standard.
---------------------------------------------------------------------------

    Chapter II of the economic analysis describes the pattern of 
respirator use within each affected industry. To develop this profile, 
the Agency analyzed the results of several OSHA-sponsored nationwide 
surveys. The results of OSHA's analysis appear in Table VI-1. The 
Agency estimates that approximately five percent of workers wear 
respirators at some time, and that approximately 1.3 million 
establishments, or about 20 percent of all establishments, have 
employees who use respirators. Approximately 900,000 of these 
establishments are very small, i.e., have fewer than 20 employees. For 
a discussion of the number of firms identified by the Small Business 
Administration (SBA) as small, see Chapter V.

                     Table VI-1.--Number of Respirator Users and Their Employers by Industry                    
----------------------------------------------------------------------------------------------------------------
                                                                                                     Number of  
                                                                     Number of     Total number   establishments
                SIC and industry                       Total        respirator          of             with     
                                                    employment        wearers     establishments    respirator  
                                                                                                      wearers   
----------------------------------------------------------------------------------------------------------------
07  Agricultural services.......................         555,686          48,262          95,956          25,464
08  Forestry....................................          17,716           2,764           2,251             950
13  Oil and gas extraction......................         257,694          46,180          18,502           3,313
15  General contractors and operative builders..       1,096,289         202,284         180,998          70,835
16  Heavy construction, except building.........         679,578          99,668          34,332          13,403
17  Special trade contractors...................       2,731,774         491,928         382,528         115,380
20  Food and kindred products...................       1,498,078          87,589          21,049           8,899
21  Tobacco products............................          37,189           2,022             119              47
22  Textile mill products.......................         615,683          66,989           6,245           1,937
23  Apparel and other textile products..........         972,060          26,431          24,293           5,238
24  Lumber and wood products....................         675,081          89,970          37,087          15,922
25  Furniture and fixtures......................         476,488          56,141          11,515           7,675
26  Paper and allied products...................         627,746          41,313           6,478           2,616
27  Printing and publishing.....................       1,500,580          19,185          65,416           6,393
28  Chemicals and allied products...............         851,720         230,405          12,371          10,744
29  Petroleum and coal products.................         112,984          29,647           2,117           1,398
30  Rubbber and miscellaneous plastics products.         915,166          53,800          16,048           6,805
31  Leather and leather products................         104,747           4,406           2,025             324
32  Stone, clay, and glass products.............         471,639          69,904          16,208           8,798
33  Primary metal industries....................         655,556         133,012           6,726           4,105
34  Fabricated metal products...................       1,371,072         124,289          36,416          17,134
35  Industrial machinery and equipment..........       1,749,735          96,161          54,436          25,545
36  Electronic and other electronic equipment...       1,424,351          65,930          17,073           6,895
37  Transportation equipment....................       1,601,554         185,783          11,420           7,649
38  Instruments and related products............         878,379          35,188          11,419           4,207
39  Miscellaneous manufacturing industries......         375,501          22,751          17,183           6,793
40  Railroad transportation.....................          49,200           1,790           1,000             225
41  Local and interurban passenger transit......         366,657          13,337          18,603           4,194
42  Trucking and warehousing....................       1,633,543          59,497         115,531          26,049
44  Water transportation........................         162,478           7,458           8,412             605
45  Transportation by air.......................         344,822          12,543          11,436             822
46  Pipelines, except natural gas...............          17,143           2,808             811             521
47  Transportation services.....................         363,103          22,428          47,858           3,441
48  Communication...............................       1,299,658          15,176          40,399           3,457
49  Electric, gas, and sanitary services........         924,373         187,298          21,040          10,148
50  Wholesale trade--durable goods..............       3,414,441         373,644         317,418         118,387
51  Wholesale trade--nondurable goods...........       2,504,260         289,619         185,908          70,196
52  Building materials and garden supplies......         696,228          95,688          69,965          19,822
53  General merchandise stores..................       2,141,964          21,420          35,646           3,565
54  Food stores.................................       3,027,828          30,278         181,850          18,185
55  Automotive dealers and service stations.....       1,992,774         245,662         198,905          80,121
56  Apparel and accessory stores................       1,194,121          15,788         143,526          14,353
57  Furniture and homefurnishings stores........         754,024          12,348         112,254          11,225
58  Eating and drinking places..................       6,727,618          67,276         441,512          44,151
59  Miscellaneous retail........................       2,422,923          38,734         352,129          35,213
60  Depository institutions.....................       2,095,049          20,950         102,622          10,262
61  Nondepository institutions..................         483,133           4,831          41,869           4,187
62  Security and commodity brokers..............         449,826           4,498          34,325           3,433
63  Insurance carriers..........................       1,570,356          15,704          43,784           4,378
64  Insurance agents, brokers, and service......         656,007          13,452         122,292          12,229
65  Real estate.................................       1,335,048          25,846         234,961          23,496
67  Holding and other investment offices........         254,172           3,016          27,420           2,742
70  Hotels and other lodging places.............       1,527,126          15,271          52,874           5,287

[[Page 1173]]

                                                                                                                
72  Personal services...........................       1,252,777          45,854         200,520          23,848
73  Business services...........................       5,832,261         255,034         322,668          38,375
75  Auto repair, services, and parking..........         903,806         110,528         174,635          70,345
76  Miscellaneous repair services...............         439,495           5,103          72,763           3,810
78  Motion pictures.............................         500,889           5,009          42,457           4,246
79  Amusements and recreation services..........       1,201,248          12,012          88,077           8,808
80  Health services.............................      10,403,118         217,118         471,873         108,337
81  Legal services..............................         962,374          17,417         158,335          15,834
82  Educational services........................       1,967,024          19,670          42,867           4,287
83  Social services.............................       2,028,694          20,287         145,998          14,600
84  Museums, botanical, zoological gardens......          73,874             739           3,607             361
86  Membership organizations....................       2,062,501          26,275         238,868          23,887
87  Engineering and management services.........       2,589,839          27,483         249,846          24,985
89  Services, n.e.c.............................          84,960           1,607          14,606           1,461
92  Fire Departments (State Plan States)........         126,500         126,500           9,283           9,283
    Other public sector (State Plan States).....       7,677,000         114,570         203,158          20,316
                                                 ---------------------------------------------------------------
      Total.....................................      98,768,281       4,953,568       6,494,122       1,281,945
----------------------------------------------------------------------------------------------------------------
Sources: DOL, OSHA Office of Regulatory Analysis; County Business Patterns, 1993; OSHA's respirator, PEL, PPE,  
  and Construction PEL surveys.                                                                                 

    The new standard is programmatic in nature, reflects current 
practice at many facilities, and does not require the use of new 
technology. Thus, OSHA finds that the standard is clearly 
technologically feasible for affected firms of all sizes.
    The benefits that will accrue to respirator users and their 
employers are substantial and take a number of forms. Chapter IV of the 
analysis describes these benefits, both in quantitative and qualitative 
forms. The standard will benefit workers by reducing their exposures to 
respiratory hazards. Improved respirator selection procedures, better 
fit test procedures, and improved training, all areas strengthened by 
the revised standard, will contribute substantially to greater worker 
protection. Estimates of the benefits of the standard are complicated 
by uncertainties about the effectiveness of the standard and the number 
of covered work-related illnesses. The Agency estimates that the 
standard will avert between 843 and 9,282 work-related injuries and 
illnesses annually, with a best estimate (expected value) 2 
of 4,046 averted illnesses and injuries annually. In addition, the 
standard is estimated to prevent between 351 and 1,626 deaths annually 
from cancer and many other chronic diseases, including cardiovascular 
disease, with a best estimate (expected value) of 932 averted deaths 
from these causes.3
---------------------------------------------------------------------------

    \2\ OSHA believes that, for the purposes of this rulemaking, the 
most reasonable way to summarize the uncertainties in benefits 
estimates via a single numerical estimate is to use the expected 
value; that is, the average of all plausible values weighted by 
their relative probabilities. For simplicity's sake, OSHA will refer 
to this point estimate as the ``best estimate.''
    \3\ Because this regulation will not directly affect the 
benefits for the estimated 5% of employees who wear respirators as a 
result of OSHA's substance-specific health standards (except to the 
extent that uniformity of provisions improve compliance), and these 
respirator-wearing employees are included in the benefits estimates 
presented here, the benefits of the revised respiratory protection 
standard are somewhat overestimated. In particular, deaths and 
illnesses caused by exposures to such OSHA-regulated substances as 
asbestos and lead may in fact account for a disproportionate share 
(more than 5%) of the occupational illnesses and deaths attributed 
by this analysis to the respirator standard. This means that OSHA's 
benefits estimates are likely to be overstated by more than 5%. 
Nevertheless, OSHA believes that the substantial majority of the 
benefits resulting from appropriate respirator use can be properly 
attributed to the respirator standard.
---------------------------------------------------------------------------

    The annual costs employers in the affected establishments are 
estimated to incur to comply with the revised respirator standard total 
$111 million.4 These costs, which are presented in detail in 
Chapter III of the full economic analysis, are annualized over a 10-
year horizon at a discount rate of 7 percent; Table VI-2 shows 
annualized costs by provision of the standard. The most costly 
provisions are those requiring annual fit testing of respirators and 
annual refresher training. These two provisions together account for 
approximately 90 percent of the standard's compliance costs. As a rule, 
costs are largely determined by the extensiveness of respirator use in 
affected establishments. This analysis did not attempt to factor in the 
offsetting value of cost savings from regulatory changes, such as 
dropping the existing standard's prohibition against contact lens use, 
providing for greater uniformity for substance-specific health standard 
respirator provisions, or allowing employers to use licensed health 
care providers in addition to physicians to perform medical 
evaluations.
---------------------------------------------------------------------------

    \4\ Because this regulation does not directly affect the costs 
for the estimated 5% of employees who wear respirators as a result 
of OSHA's substance-specific health standards, and these respirator 
users are included in the cost estimates, the costs are somewhat 
overestimated. Because costs are approximately proportional to the 
number of employees affected, the magnitude of this overestimate is 
likely to be about 5%.

[[Page 1174]]



                       Table VI-2.--Annual Cost of Respirator Standard Revisions for Respirator-Using Establishments, by Provision                      
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Labeling                                
                                                           Revision                             Certification      for                                  
                    SIC and industry                        written    Annual fit     Annual    for emergency    sorbent   Recordkeeping       Total    
                                                             plans      testing      training     respirator       bed                                  
                                                                                                 inspections     changes                                
--------------------------------------------------------------------------------------------------------------------------------------------------------
07  Agricultural services...............................     $31,755     $441,836     $298,047            $0           $0       $35,858         $807,497
08  Forestry............................................       1,228       25,475       13,849             0            0         2,054           42,606
13  Oil and gas extraction..............................       8,769      734,048      315,180        41,551            0        34,312        1,133,860
15  General contractors and operative builders..........     141,534    2,992,402    1,909,631             0          479       150,297        5,194,342
16  Heavy construction, except building.................      32,027    1,534,132      736,976             0        2,109        74,053        2,379,297
17  Special trade contractors...........................     256,681    7,820,459    4,340,977             0        1,344       365,502       12,784,963
20  Food and kindred products...........................      21,109    1,006,778      428,004        86,371            0        65,078        1,607,339
21  Tobacco products....................................         210       37,254       16,252             0            0         1,502           55,218
22  Textile mill products...............................       4,349      728,823      286,222         9,703            0        49,773        1,078,870
23  Apparel and other textile products..................       7,864      226,658      101,380             0            0        19,638          355,540
24  Lumber and wood products............................      27,997      972,293      489,510        16,750            0        66,848        1,573,397
25  Furniture and fixtures..............................      13,119      623,774      289,781        53,627            0        41,712        1,022,013
26  Paper and allied products...........................       8,373      877,037      280,715        66,279          105        30,696        1,263,205
27  Printing and publishing.............................      15,217      221,275      139,295             0            0        14,255          390,041
28  Chemicals and allied products.......................      33,159    4,194,240    1,656,678       741,170          763       171,191        6,797,201
29  Petroleum and coal products.........................       4,699      646,431      277,684       108,927           16        22,028        1,059,785
30  Rubber and miscellaneous plastics products..........      14,100      676,734      284,187         2,068            0        39,974        1,017,063
31  Leather and leather products........................         456       37,208       15,800         1,502            0         3,274           58,239
32  Stone, clay, and glass products.....................      20,743    1,018,192      464,833        28,365           11        51,939        1,584,083
33  Primary metal industries............................      14,028    2,263,416      951,396        44,664           28        98,828        3,372,360
34  Fabricated metal products...........................      41,510    1,663,770      765,562       178,892            0        92,346        2,742,081
35  Industrial machinery and equipment..................      64,626    1,498,968      786,251             0          868        71,447        2,422,161
36  Electronic and other electronic equipment...........      17,103      917,414      388,929        24,483          657        48,986        1,397,572
37  Transportation equipment............................      23,876    3,413,486    1,568,463       100,401        8,775       138,037        5,253,038
38  Instruments and related products....................      10,299      516,278      230,813         1,626          333        26,145          785,493
39  Miscellaneous manufacturing industries..............      12,007      250,490      136,104             0          176        16,904          415,682
40  Railroad transportation.............................         937       37,818       16,134             0            0         1,330           56,219
41  Local and interurban passenger transit..............       9,002      167,510       86,710             0            0         9,910          273,131
42  Trucking and warehousing............................      64,666      791,301      511,259           570            0        44,206        1,412,003
44  Water transportation................................       1,588      136,318       65,312             0            0         5,541          208,760
45  Transportation by air...............................       2,015      199,061       85,196             0            0         9,320          295,592
46  Pipelines, except natural gas.......................       1,637       87,121       31,182             0           15         2,086          122,041
47  Transportation services.............................       6,150      256,532      135,948             0            0        16,664          415,294
48  Communication.......................................       9,141      282,097      141,518             0            0        11,276          444,032
49  Electric, gas, and sanitary services................      32,542    3,736,483    1,662,243       359,209        4,581       139,162        5,934,220
50  Wholesale trade--durable goods......................     241,074    5,545,911    2,737,719         6,687            0       277,618        8,809,008
51  Wholesale trade--nondurable goods...................     134,760    3,979,336    1,728,752       126,854            0       215,187        6,184,888
52  Building materials and garden supplies..............      24,193      922,814      418,187             0            0        71,096        1,436,291
53  General merchandise stores..........................       5,369      135,056       56,819             0            0        15,915          213,160
54  Food stores.........................................      27,336      208,820      154,036             0            0        22,497          412,689
55  Automotive dealers and service stations.............     112,276    1,920,333    1,281,723             0            0       182,527        3,496,858
56  Apparel and accessory stores........................      19,022       91,801       92,713             0            0        11,730          215,266
57  Furniture and homefurnishings stores................      20,225      111,532      106,953             0            0         9,175          247,884
58  Eating and drinking places..........................      47,123      257,557      214,860             0            0        49,986          569,526
59  Miscellaneous retail................................      53,098      275,565      269,808             0            0        28,780          627,250
60  Depository institutions.............................      20,271      207,313      135,320             0            0        15,566          378,470
61  Nondepository institutions..........................      10,608       51,626       53,951             0            0         3,590          119,776
62  Security and commodity brokers......................      10,508       64,998       58,550             0            0         3,342          137,397
63  Insurance carriers..................................      13,360      226,063      123,889             0            0        11,668          374,979
64  Insurance agents, brokers, and service..............      36,394      200,209      199,277             0            0         9,995          445,875
65  Real estate.........................................      70,079      348,877      368,891             0            0        19,203          807,051
67  Holding and other investment offices................       8,272       43,583       43,970             0            0         2,241           98,066
70  Hotels and other lodging places.....................       8,119      101,853       57,381             0            0        11,347          178,699
72  Personal services...................................      26,015      552,641      270,488             0            0        34,069          883,214
73  Business services...................................      58,974    3,325,952    1,172,726             0            0       189,490        4,747,142
75  Auto repair, services, and parking..................      93,387      970,308      881,030             0            0        82,122        2,026,846
76  Miscellaneous repair services.......................       5,735       61,214       54,759             0            0         3,791          125,499
78  Motion pictures.....................................      11,425       62,923       61,091             0            0         3,722          139,160
79  Amusement and recreation services...................      14,128       93,683       76,484             0            0         8,925          193,220
80  Health services.....................................     183,206    2,510,780    1,948,071             0            0       161,319        4,803,376
81  Legal services......................................      47,661      253,320      256,703             0            0        12,941          570,625
82  Educational services................................      10,933      259,816      125,365             0            0        14,615          410,729
83  Social services.....................................      23,601      166,510      130,949             0            0        15,073          336,133
84  Museums, botanical, zoological gardens..............         891        8,995        6,036             0            0           549           16,471
86  Membership organizations............................      57,115      316,483      304,939             0            0        19,523          698,060
87  Engineering and management services.................      74,480      380,740      390,356             0            0        20,420          865,997
89  Services, n.e.c.....................................       4,082       28,754       22,201             0            0         1,194           56,231

[[Page 1175]]

                                                                                                                                                        
92  Fire Departments....................................      24,723    2,265,377    1,005,792             0            0        93,990        3,389,882
    Other public sector.................................      48,361       49,739    1,147,899             0            0        85,126        1,331,125
                                                         -----------------------------------------------------------------------------------------------
Total...................................................   2,501,319   67,033,593   35,865,707     1,999,699       20,259     3,680,501      111,101,079
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Department of Labor, Safety and Health Administration, Office of Regulatory Analysis.                                                           

    Chapter V of the economic analysis analyzes the impact of these 
compliance costs on establishments in affected industries. The standard 
is clearly economically feasible: the cost in the average affected 
establishment is 0.002 percent of sales and 0.03 percent of profits; in 
the most heavily impacted industry--business services, SIC 73--
annualized compliance costs amount to only 0.1 percent of estimated 
sales and 1.22 percent of profits. In the next most heavily impacted 
industry--Special Trade Contractors, SIC 17--costs amount only to 0.02 
percent of sales and 0.46 percent of profits. These results are shown 
in Table VI-3.

     TABLE VI-3.--Annual Cost of Final Respiratory Protection Standard as a Percent of Sales and Profits of     
                                         Respirator-using Establishments                                        
----------------------------------------------------------------------------------------------------------------
                                              Average                                    Compliance   Compliance
                                             compliance   Average sales/    Average      cost as a    cost as a 
             SIC and industry                  cost/      establishment     profit/      percent of   percent of
                                           establishment                 establishment     sales       profits  
----------------------------------------------------------------------------------------------------------------
07  Agricultural services................           $32        $269,290         17,425         0.01         0.18
08  Forestry.............................            45         897,908         69,720         0.00         0.06
13  Oil and gas extraction...............           364      11,234,630      1,021,330         0.00         0.04
15  General contractors and operative                                                                           
 builders................................            73       1,131,765         52,585         0.01         0.14
16  Heavy construction, except building..           178       2,709,660        146,028         0.01         0.12
17  Special trade contractors............           111         476,348         24,098         0.02         0.46
20  Food and kindred products............           192      20,620,629        999,788         0.00         0.02
21  Tobacco products.....................         1,169     869,935,367    204,319,114         0.00         0.00
22  Textile mill products................           578       7,611,245        438,223         0.01         0.13
23  Apparel and other textile products...            68       3,228,588        194,177         0.00         0.03
24  Lumber and wood products.............            99       2,539,729        146,588         0.00         0.07
25  Furniture and fixtures...............           140       3,571,798        216,729         0.00         0.06
26  Paper and allied products............           551      22,478,383      1,260,152         0.00         0.04
27  Printing and publishing..............            61       2,096,632        152,975         0.00         0.04
28  Chemicals and allied products........           909      29,454,052      2,231,368         0.00         0.04
29  Petroleum and coal products..........         1,053     143,210,471      6,292,581         0.00         0.02
30  Rubber and miscellaneous plastics                                                                           
 products................................           150       8,202,235        584,099         0.00         0.03
31  Leather and leather products.........           187       7,267,252        429,429         0.00         0.04
32  Stone, clay, and glass products......           183       4,184,931        228,219         0.00         0.08
33  Primary metal industries.............           864      18,123,180      1,015,996         0.00         0.08
34  Fabricated metal products............           170       4,348,383        266,070         0.00         0.06
35  Industrial machinery and equipment...            95       6,924,099        482,589         0.00         0.02
36  Electronic and other electronic                                                                             
 equipment...............................           207      11,591,397        684,946         0.00         0.03
37  Transportation equipment.............           724      44,334,058      1,948,012         0.00         0.04
38  Instruments and related products.....           187      10,720,444        763,426         0.00         0.02
39  Miscellaneous manufacturing                                                                                 
 industries..............................            61       1,568,937        111,245         0.00         0.06
40  Railroad transportation..............           249              NA             NA           NA           NA
41  Local and interurban passenger                                                                              
 transit.................................            65       1,014,732         43,699         0.01         0.15
42  Trucking and warehousing.............            54       1,286,872         58,437         0.00         0.09
44  Water transportation.................           345              NA             NA           NA           NA
45  Transportation by air................           359       3,106,975        197,717         0.01         0.18
46  Pipelines, except natural gas........           234      13,802,633        585,566         0.00         0.04
47  Transportation services..............           121      23,585,180      8,076,137         0.00         0.00
48  Communication........................           128       1,894,095         82,755         0.01         0.16
49  Electric, gas, and sanitary services.           677      15,622,527      2,485,402         0.00         0.03
50  Wholesale trade--durable goods.......            74      14,371,043      1,350,007         0.00         0.01
51  Wholesale trade--nondurable goods....            89       2,282,652        102,134         0.00         0.09
52  Building materials and garden                                                                               
 supplies................................            72       4,447,849        172,734         0.00         0.04
53  General merchandise stores...........            60       1,075,912         36,708         0.01         0.16
54  Food stores..........................            23       8,648,964        471,762         0.00         0.00
55  Automotive dealers and service                                                                              
 stations................................            44       2,179,673         61,031         0.00         0.07
56  Apparel and accessory stores.........            15       2,010,075         47,296         0.00         0.03
57  Furniture and homefurnishings stores.            22         737,603         47,246         0.00         0.05
58  Eating and drinking places...........            13         672,234         34,798         0.00         0.04

[[Page 1176]]

                                                                                                                
59  Miscellaneous retail.................            18         734,358         34,558         0.00         0.05
60  Depository institutions..............            37         547,141         30,254         0.01         0.12
61  Nondepository institutions...........            29       8,651,403             NA         0.00           NA
62  Security and commodity brokers.......            40       9,094,686      1,419,322         0.00         0.00
63  Insurance carriers...................            86       6,131,429        631,723         0.00         0.01
64  Insurance agents, brokers, and                                                                              
 service.................................            36      65,412,387             NA         0.00           NA
65  Real estate..........................            34         674,913             NA         0.01           NA
67  Holding and other investment offices.            36         500,929         46,869         0.01         0.08
70  Hotels and other lodging places......            34       5,183,873        573,368         0.00         0.01
72  Personal services....................            37       1,243,240         97,027         0.00         0.04
73  Business services....................           124         128,952         10,164         0.10         1.22
75  Auto repair, services, and parking...            29         975,693         74,455         0.00         0.04
76  Miscellaneous repair services........            33         358,494         22,775         0.01         0.14
78  Motion pictures......................            33         181,478         11,743         0.02         0.28
79  Amusement and recreation services....            22       1,597,336        142,792         0.00         0.02
80  Health services......................            44         631,398         31,198         0.01         0.14
81  Legal services.......................            36       1,167,682         71,435         0.00         0.05
82  Educational services.................            96         421,539         67,758         0.02         0.14
83  Social services......................            23       2,613,764        174,383         0.00         0.01
84  Museums, botanical, zoological                                                                              
 gardens.................................            46         351,713         16,137         0.01         0.28
86  Membership organizations.............            29         560,217         40,331         0.01         0.07
87  Engineering and management services..            35         320,236         15,070         0.01         0.23
89  Services, n.e.c......................            38       1,030,962         81,876         0.00         0.05
92  Fire Departments.....................           365              NA             NA           NA           NA
    other public sector  ................            66              NA             NA           NA           NA
----------------------------------------------------------------------------------------------------------------
Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.      

    In the Preliminary Regulatory Impact Analysis developed in support 
of OSHA's 1994 Respiratory Protection proposal [Ex. 57], the Agency 
examined the impact of the proposal on different sizes of 
establishments. Based on that analysis, the Agency certified that the 
proposed standard would not have a significant economic impact on a 
substantial number of small entities. Upon review of comments and other 
data submitted to the record of this rulemaking, the Agency has 
analyzed the final rule's impact on small entities, as defined by the 
Small Business Administration (SBA) and in accordance with the 
Regulatory Flexibility Act. In addition, in order to ensure that even 
the smallest entities are not significantly impacted, the Agency 
performed an analysis of impacts on the smallest establishments, i.e., 
those with fewer than 20 employees.
    The impacts of the standard on sales and profits did not exceed 1 
percent for small firms in any covered industry, whether the analysis 
used the SBA's definitions or the fewer-than-20-employee size class 
definition. Because the incremental costs of the final rule are 
primarily related to the number of respirator users per establishment 
and because small entities do not have a higher percentage of 
respirator users than large establishments, the standard does not have 
a differential impact on small entities. If the costs of compliance 
were influenced by economies of scale, such effects would have been 
demonstrated by OSHA's analysis of the smallest firms, i.e., those with 
fewer than 20 employees. However, no such effects were seen, even among 
firms in this smallest size-class. Therefore, the Agency has no reason 
to believe that establishments or firms in intermediate size groupings, 
i.e., those in the range between 20 employees and the employment size 
cutoff for the applicable SBA definition, would experience larger 
impacts. Finding this, the Agency certifies that the final Respiratory 
Protection standard will not have a significant adverse economic impact 
on a substantial number of small entities. The results of OSHA's 
analysis of small business impacts on firms 5 within the 
SBA's size classifications are shown in Table VI-4.
---------------------------------------------------------------------------

    \5\ The Agency also examined the impact of the costs of 
compliance on governmental entities serving communities with fewer 
than 50,000 people, and also found small impacts.

               Table VI-4.--Annual Cost of the Respiratory Protection Standard as a Percent of Sales for Respirator-Using Small Firms \1\               
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                 Number     Average                 Compliance                Compliance
                                                                                   of     compliance     Average     cost as a     Average     cost as a
            SIC and industry                  Small business definition \1\     affected   cost per     sales per   percent of   profit per   percent of
                                                                                  firms      firm         firm         sales        firm        profits 
--------------------------------------------------------------------------------------------------------------------------------------------------------
07  Agricultural services...............  $5 million \2\......................    23,313        $36       $223,567       0.02        $14,466       0.25 
08  Forestry............................  $5 million..........................       860         41        470,247       0.01         36,513       0.11 
13  Oil and gas extraction..............  500 employees.......................     2,565        222      2,017,392       0.00        226,361       0.10 

[[Page 1177]]

                                                                                                                                                        
15  General contractors and operative     $17 million.........................    70,232         75        954,486       0.01         43,794       0.17 
 builders.                                                                                                                                              
16  Heavy construction, except building.  $17 million.........................    12,628        135      1,611,092       0.00         72,025       0.19 
17  Special trade contractors...........  $7 million..........................   114,097        117        490,343       0.02         24,806       0.47 
20  Food and kindred products...........  500 employees.......................     5,583        143      7,070,622       0.00        288,666       0.05 
21  Tobacco products....................  500 employees.......................        27        434    419,423,746       0.00     98,271,892       0.00 
22  Textile mill products...............  500 employees.......................     1,306        243      4,485,467       0.00        236,814       0.10 
23  Apparel and other textile products..  500 employees.......................     4,227         49      1,717,339       0.00         84,857       0.06 
24  Lumber and wood products............  500 employees.......................    13,854         96      1,520,435       0.00         80,494       0.12 
25  Furniture and fixtures..............  500 employees.......................     5,860        135      2,063,881       0.00        101,980       0.13 
26  Paper and allied products...........  500 employees.......................     1,082        364      7,356,895       0.00        389,269       0.09 
27  Printing and publishing.............  500 employees.......................     4,612         63      1,349,101       0.00         82,533       0.08 
28  Chemicals and allied products.......  500 employees.......................     3,794        388      7,758,606       0.00        573,110       0.07 
29  Petroleum and coal products.........  500 employees.......................       373        505     11,906,004       0.00        523,143       0.10 
30  Rubber and miscellaneous plastics     500 employees.......................     3,926        192      4,132,970       0.00        252,124       0.08 
 products.                                                                                                                                              
31  Leather and leather products........  500 employees.......................       224        246      2,312,572       0.00        106,106       0.23 
32  Stone, clay, and glass products.....  500 employees.......................     5,529        209      2,337,003       0.00        101,728       0.21 
33  Primary metal industries............  500 employees.......................     2,260        530      6,447,895       0.00        359,703       0.15 
34  Fabricated metal products...........  500 employees.......................    12,435        167      2,782,599       0.00        138,568       0.12 
35  Industrial machinery and equipment..  500 employees.......................    18,625        152      2,001,196       0.00        118,786       0.13 
36  Electronic and other electronic       500 employees.......................     4,356        237      3,836,835       0.00        184,646       0.13 
 equipment.                                                                                                                                             
37  Transportation equipment............  500 employees.......................     5,999        281      3,362,262       0.00        120,155       0.23 
38  Instruments and related products....  500 employees.......................     3,266        163      3,239,263       0.00        211,242       0.08 
39  Miscellaneous manufacturing           500 employees.......................     5,149        102      1,539,311       0.00         95,981       0.11 
 industries.                                                                                                                                            
40  Railroad transportation.............  1500 employees......................        NA         NA             NA         NA             NA         NA 
41  Local and interurban passenger        $5 million..........................     2,582        106        417,934       0.01         17,701       0.60 
 transit.                                                                                                                                               
42  Trucking and warehousing............  $18.5 million.......................    15,626         79        670,885       0.01         29,993       0.26 
44  Water transportation................  500 employees.......................       187        243      1,781,166       0.01         90,917       0.27 
45  Transportation by air...............  1500 employees......................       157        449      2,031,762       0.00         70,300       0.64 
46  Pipelines, except natural gas.......  1500 employees......................        11        888     15,403,556       0.00      5,274,551       0.02 
47  Transportation services.............  $5 million..........................       879         55        377,507       0.02         15,544       0.35 
48  Communication.......................  1500 employees......................     1,279        172      2,132,980       0.01        335,309       0.05 
49  Electric, gas, and sanitary services  $5 million..........................     3,809         65        883,319       0.01         72,099       0.09 
50  Wholesale trade--durable goods......  100 employees.......................    52,553         43      1,828,263       0.00         73,131       0.06 
51  Wholesale trade--nondurable goods...  100 employees.......................    30,785         44      2,682,104       0.00         85,196       0.05 
52  Building materials and garden         $5 million..........................    13,619         19        712,058       0.01         24,294       0.08 
 supplies.                                                                                                                                              
53  General merchandise stores..........  $5 million..........................       482         14        398,828       0.01         16,892       0.08 
54  Food stores.........................  $5 million..........................     6,419        140        763,042       0.00         20,647       0.68 
55  Automotive dealers and service        $5 million..........................    38,985         26        774,574       0.01         18,225       0.14 
 stations.                                                                                                                                              
56  Apparel and accessory stores........  $5 million..........................       289         41      1,346,240       0.00         85,526       0.05 
57  Furniture and homefurnishings stores  $5 milion...........................       438         71      1,685,231       0.00         87,235       0.08 
58  Eating and drinking places..........  $5 million..........................    16,852         24        374,691       0.00         17,633       0.14 
59  Miscellaneous retail................  $5 million..........................    12,619         18        406,958       0.01         22,502       0.08 
60  Depository institutions.............  $5 million..........................       788        123      1,060,910       0.00             NA         NA 
61  Nondepository institutions..........  $5 million..........................       840         25        728,626       0.00        106,401       0.02 
62  Security and commodity brokers......  $5 million..........................       921         33        631,139       0.01         55,488       0.06 
63  Insurance carriers..................  $5 million..........................       365         92        740,731       0.01             NA         NA 
64  Insurance agents, brokers, and        $5 million..........................     5,583         54        335,823       0.01             NA         NA 
 service.                                                                                                                                               
65  Real estate.........................  $5 million..........................    10,714         56        533,940       0.01         48,369       0.12 
67  Holding and other investment offices  $5 million..........................     1,036         36        889,373       0.00         95,534       0.04 
70  Hotels and other lodging places.....  $5 million..........................     2,163         41        472,311       0.00         32,784       0.13 
72  Personal services...................  $5 million..........................     9,786         80        190,546       0.02         15,019       0.53 
73  Business services...................  $5 million..........................    14,343        160        517,986       0.01         37,783       0.42 
75  Auto repair, services, and parking..  $5 million..........................    43,985         47        342,341       0.01         21,749       0.22 
76  Miscellaneous repair services.......  $5 million..........................     2,631         34        340,605       0.01         22,039       0.15 
78  Motion pictures.....................  $5 million..........................     1,494         29        350,142       0.01         24,304       0.12 
79  Amusement and recreation services...  $5 million..........................     4,052         46        469,977       0.00         23,222       0.20 
80  Health services.....................  $5 million..........................    39,536         82        521,074       0.01         31,877       0.26 
81  Legal services......................  $5 million..........................     7,288         41        314,988       0.01         48,175       0.09 
82  Educational services................  $5 million..........................     1,739         99        649,462       0.01         35,911       0.28 
83  Social services.....................  $5 million..........................     5,194         43        354,060       0.01         16,245       0.26 
84  Museums, botanical, zoological        $5 million..........................       158         80        492,341       0.01         35,333       0.23 
 gardens.                                                                                                                                               
86  Membership organizations............  $5 million..........................    11,589         55        296,761       0.01         13,965       0.39 
87  Engineering and management services.  $5 million..........................    11,383         62        457,931       0.01         34,480       0.18 
89  Services, n.e.c.....................  $5 million..........................       679         58        423,854       0.01         36,402       0.16 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As defined by the Small Business Administration, 61 FR 3289.                                                                                        
\2\ Annual receipts.                                                                                                                                    
                                                                                                                                                        

[[Page 1178]]

                                                                                                                                                        
Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.                                              

Unfunded Mandates Analysis

    The final Respiratory Protection standard has been reviewed by OSHA 
in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2 
USC 1501 et seq.) and Executive Order 12875. As discussed in Chapter V, 
OSHA estimates that compliance with the revised Respiratory Protection 
standard will require expenditures of more than $100 million each year 
by employers in the private sector. Therefore, the Respiratory 
Protection final rule establishes a Federal private sector mandate and 
is a significant regulatory action within the meaning of Section 202 of 
UMRA (2 U.S.C. 1532). OSHA has included this statement to address the 
anticipated effects of the final rule pursuant to Section 202.
    OSHA standards do not apply to state and local governments except 
in states that have voluntarily elected to adopt an OSHA State plan and 
have then adopted the specific standard in question or one that has 
been deemed by OSHA to be equally effective. Consequently, the 
Respiratory Protection standard does not impose a ``federal 
intergovernmental mandate'' as defined by Section 421(5) of UMRA (2 USC 
658 (5)). The revised Respiratory Protection standard therefore does 
not impose an unfunded mandate on state and local governments.
    Further, OSHA has found that the costs incurred by state and local 
governments in those states that choose to adopt the standard will be 
small compared to corresponding state and local government 
expenditures. If State-plan states adopt the standard, the greatest 
impact in some states would be on public fire departments. Bureau of 
the Census data on the amount of revenue dedicated to fire protection 
by local governments indicate that $14.4 billion was spent on this 
service in 1992, the latest year for which such data are available 
[Government Finances]. NFPA data indicate that 75.3 percent of the U.S. 
population is served by fire departments that employ at least some 
career firemen [NFPA, p. 15]. This means that approximately 37.7 
percent of the population (approximately half of all state and local 
government employees work in State-plan states) is served by at least 
partly career fire departments in State-plan states. Assuming the 
expenditures for fire protection are spread fairly evenly across the 
population, approximately $5.3 billion is spent on fire protection 
annually by affected fire departments. As indicated in the cost 
analysis (see Table VI-2), the total annual cost of the standard for 
public fire departments in State-plan states is approximately $3.5 
million, which means that the costs of compliance constitute less than 
0.1 percent of the revenue devoted by these states to fire protection. 
Costs of this magnitude are clearly an insignificant portion of the 
total fire protection budget.
    The remainder of this section summarizes OSHA's findings, as 
required by Section 202 of UMRA (2 USC 1532):
    This standard is issued under Section 6(b) of the OSH Act.
    This standard has annualized costs estimated at $111 million, 
primarily in the private sector, and is estimated to save hundreds of 
lives per year from cancer and cardiovascular disease. Compliance will 
also prevent thousands of illnesses annually that would have been 
caused by acute and chronic overexposures. The standard will impose no 
more than minimal costs on state, local or tribal governments, 
substantially less than $100 million. OSHA pays 50 percent of State 
plan costs, although the Agency does not provide funding for state, 
local or tribal governments to comply with its rules as employers.
    OSHA does not anticipate any disproportionate budgetary effects 
upon any particular region of the nation or particular state, local, or 
tribal governments, or urban or rural or other types of communities. 
The principal costs of this standard are to control worker exposures 
associated with programmatic provisions such as annual fit testing and 
training, activities that are engaged in by thousands of establishments 
in hundreds of SIC codes that are widely distributed throughout the 
country. Chapters III and V have provided detailed analyses of the 
costs and impacts of the standard on particular segments of the private 
sector. OSHA has analyzed the economic impacts of the standard on the 
industries affected and found that compliance costs are no more than 
0.1 percent of sales for establishments in any industry, and 
consequently that no plant closures or job losses are anticipated in 
the affected industries. As a result, impacts on the national economy 
would be too small to be measurable by economic models.
    Pursuant to Section 205 of the UMRA (2 USC 1535), after having 
considered a variety of alternatives outlined in the Preamble and in 
the Regulatory Flexibility Analysis, the Agency has concluded that the 
final rule is the most cost-effective alternative for implementation of 
OSHA's statutory objective of reducing significant risk to the extent 
feasible.

Environmental Impact Analysis

    The final Respiratory Protection standard has been reviewed in 
accordance with the requirements of the National Environmental Policy 
Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the regulations of the 
Council of Environmental Quality (CEQ) (40 CFR part 1500), and DOL NEPA 
procedures (29 CFR part 11). As a result of this review, OSHA has 
concluded that the rule will have no significant environmental impact.

References

    Bureau of the Census, Government Finances, Series GF, No. 5, 
annual, as reported in the Statistical Abstract of the United 
States, 1995. GPO, 1995.

VII. Summary and Explanation

    This section of the preamble summarizes and explains the provisions 
of the final respiratory protection standard. It describes changes made 
to the rule since the proposal was issued, discusses the comments 
received by the Agency on the proposal, and presents OSHA's rationale 
for making these changes. The record evidence supporting each of the 
requirements of the final rule is also described in detail in this 
section.
    This final rule clarifies, updates, and strengthens OSHA's previous 
respiratory protection standard, which was adopted by the Agency in 
1971 and has remained essentially unchanged since that time. This 
rulemaking is thus the first major revision to OSHA's respiratory 
protection standard in more than 25 years. As discussed in connection 
with several of the individual paragraphs of the revised standard, not 
all of the provisions of the standard have been revised; in some cases, 
OSHA found, and the record supported, leaving individual provisions 
unchanged.
    The final respiratory protection standard applies to respirator use 
in general industry, construction, shipyards, marine terminals, and 
longshoring operations. When used properly, respirators can help to 
protect employees from the acute and chronic effects of exposure to 
hazardous airborne contaminants, whether in the form of particulates, 
vapors, or gases. Generally, OSHA requires respirators to be used to 
protect employee health in

[[Page 1179]]

situations where engineering controls and work practices are not 
feasible, where such controls have not yet been instituted, in 
emergencies, or where such controls are not sufficient, by themselves, 
to protect the health of employees.
    As noted above, this final standard applies to respirator use in 
general industry, construction, shipyards, marine terminals, and 
longshoring operations. In the 1994 proposal, OSHA proposed to cover 
general industry, shipyards and construction. The longshoring and 
marine terminals final rule (48 FR 30908) already made this standard 
applicable to those industries as well. To provide clarity, the final 
respiratory standard explicitly contains a note setting forth the scope 
of the respirator standard.
    The preamble to the proposed rule asked for comments about the 
appropriateness of applying the final rule to construction and maritime 
workplaces. In the case of the construction industry, OSHA specifically 
provided the Advisory Committee for Construction Safety and Health 
(ACCSH) with a copy of the proposal for review and comment, and ACCSH 
recommended that the revised standard apply to construction industry 
workplaces. OSHA's responses to these comments are discussed above in 
the introduction to this preamble.
    In response to the question raised about the applicability of the 
standard to the construction and shipyard industries, OSHA received 
several comments from participants concerned about the rule's impact on 
the construction industry (Exs. 54-102, 54-231, 54-288). These 
commenters noted that the costs of the standard for construction 
employers may be higher than for their counterparts in general industry 
because of the higher turnover, decentralization of workplaces, and 
multi-employer work arrangements typical of construction sites. 
However, as reported in the Final Economic Analysis (Ex. 196), OSHA has 
determined that the final rule is both technologically and economically 
feasible for employers in the construction industry. There is no 
question that many workers in this industry need respiratory protection 
to prevent material impairment of their health; in fact, some of the 
most hazardous exposures occur in this industry. For example, workers 
engaged in the abrasive blasting of bridges are often exposed to high 
concentrations of silica and other hazardous substances (contained in 
the abrasive blasting media), as well as to lead, chromates, and other 
toxic materials (contained in the paints, coatings, or preservatives 
covering the substrate). Welders, demolition workers, tunnel workers, 
and painters are other examples of construction trades that often 
involve overexposure to toxic substances and require respirators for 
control. In fact, respirators may be even more necessary in 
construction than in general industry because the transient and 
constantly changing nature of many construction worksites makes the use 
of engineering controls more difficult in these environments. Finally, 
OSHA's previous respiratory protection standard has applied to the 
construction industry since 1971 (it is codified at 29 CFR 1926.103); 
removing this protection for construction workers would thus decrease 
existing safety and health protections despite the significant risk 
confronting construction workers in many situations. Decreasing 
feasible worker protections in the face of significant risk of material 
impairment of health would clearly be contrary to the Agency's mandate.
    OSHA received no comments on the applicability of the final rule to 
shipyard employment. Like construction workers, shipyard workers have 
been covered by the Agency's previous standard since 1971. In addition, 
employees in shipyards engage in many of the same highly hazardous 
operations as construction workers, including abrasive blasting, 
welding, painting, and drilling. The Final Economic Analysis (Ex. 196) 
has determined that it is both technologically and economically 
feasible for employers in shipyard operations to achieve compliance 
with the final rule.
    OSHA has recently issued a revised final rule for the Longshoring 
(shipboard) portion of marine cargo-handling operations, along with 
revisions to the Agency's Marine Terminals (dockside) marine cargo-
handling standard. The scope and application sections of both final 
maritime rules specifically incorporate OSHA's respiratory protection 
standard (29 CFR 1910.134) by reference. Thus, consistent with the 
proposal, this final respiratory protection standard will apply to 
workplaces in general industry and in the construction, shipyards, 
longshoring, and marine terminals industries.
    At the public hearing, the Brotherhood of Maintenance of Way 
Employees (BMWE) submitted testimony on the issue of OSHA's respiratory 
protection standard's coverage of railroad construction and maintenance 
employees (Ex. 122). The BMWE stated:

    * * * the BMWE respectfully requests that * * * formal 
recognition of the applicability of OSHA 1910.134 for railroad 
employees be published in the Federal Register to remove any 
lingering questions regarding the applicability of OSHA's 
respiratory protection standards to working conditions which, 
although located within the railroad industry, are in fact similar 
to those of any industrial workplace.

    In response to this comment, OSHA notes that both the prior 
respiratory protection standard and the final revised standard being 
published will apply to railway workers unless the Federal Railroad 
Administration (FRA) exercises statutory authority to issue a separate 
respirator standard for those workers. To date, the FRA has not issued 
a respiratory protection standard applicable to railway workers. Unless 
and until it does, this standard will apply to those workers.
    This Summary and Explanation section follows the order of the final 
rule. The abbreviation ``Ex.'' denotes exhibits in the docket for this 
rulemaking, Docket H-049. The abbreviation ``Tr.'' denotes the 
transcripts of the hearings conducted in connection with this 
rulemaking.

Paragraph (a)--Permissible practice

    Paragraphs (a)(1) and (a)(2) of the final rule are essentially 
unchanged from the corresponding paragraphs of the prior rule and the 
proposed rule. Indeed, in the proposal OSHA explained that this 
rulemaking was not intended to address the substantive portion of 
paragraph (a)(12). The only changes proposed by OSHA to the regulatory 
language of paragraph (a) were non-substantive: (1) In the proposal, 
the Agency titled this paragraph ``Scope and Application'' rather than 
``Permissible Practice,'' which had been the title of this paragraph 
since 1971; and (2) a cross-reference to paragraph (b) in the prior 
standard was proposed to be changed to paragraph (c), because a new 
paragraph (b), ``Definitions,'' was proposed to be added to the final 
rule. In the final rule, OSHA has determined that the original title of 
paragraph (a), ``Permissible Practice,'' better describes paragraph 
(a), and thus this continues to be the title of this paragraph. The 
proposed cross-reference to paragraph (c) is retained in the final 
rule.
    Paragraph (a)(1) requires the use of appropriate respiratory 
protection when ``effective engineering controls are not feasible, or 
while they are being instituted.'' This paragraph also stipulates that 
the prevention of atmospheric contamination caused by ``harmful dusts, 
fogs, fumes, mists, gases, smokes, sprays, or vapors'' shall

[[Page 1180]]

be accomplished, to the extent feasible, by the use of engineering 
control measures.
    As stated in the preamble of the proposed rule (59 FR 58895), OSHA 
did not in this rulemaking open the record on the issue of the 
hierarchy of industrial hygiene controls; the hierarchy language is 
merely brought forward, verbatim, from this paragraph of the prior 
rule. Paragraph (a)(1), which was adopted by OSHA in 1971 from the 1969 
American National Standards Institute (ANSI) standard, Z88.2-1969, 
established that a hierarchy of controls is to be used to protect 
employees from hazardous airborne contaminants. According to this 
hierarchy, engineering controls are the preferred method of compliance 
for protecting employees from airborne contaminants and are to be 
implemented first, before respiratory protection is used. According to 
paragraph (a)(1), respirators are permitted to be used only where 
engineering controls are not feasible or during an interim period while 
such controls are being implemented.
    Paragraph (a)(2) requires employers to provide employees with 
respirators ``when such equipment is necessary to protect the health of 
the employee.'' In addition, this paragraph specifies that the employer 
must provide employees with respirators that are ``applicable and 
suitable'' for the purpose intended, i.e., for the protection of 
employee health. This paragraph thus clearly recognizes that, when 
properly selected, used, and maintained, respiratory protection can 
play an essential role in preventing adverse effects on the health of 
employees exposed to hazardous airborne contaminants.
    By leaving paragraphs (a)(1) and (a)(2) of the final rule unchanged 
from the corresponding paragraphs of the respiratory protection 
standard that has been in effect since 1971, OSHA accomplishes several 
objectives. First, it continues the protection that employees have 
relied on throughout OSHA's history. Second, it retains the language 
that employers are familiar with and thus will not require them to 
become familiar with new regulatory language. Third, leaving the 
regulatory text of paragraphs (a)(1) and (a)(2) unchanged allows OSHA 
and the affected public to continue to rely on OSHA interpretations, 
decisions, and case law that have developed over the years.
    As noted above, this standard is a respiratory protection standard. 
OSHA has enforced this standard when employers fail to provide 
respirators, when the respirators that are provided are inappropriate 
for the form of the contaminant or for the atmospheric concentration of 
the contaminant, when they are inappropriately used, and when they are 
improperly maintained.
    Although OSHA clearly stated in the preamble to the proposal that 
the hierarchy of controls was not an issue in this rulemaking, the 
Agency did receive comment on this provision. For example, one 
commenter stated that, in its opinion, OSHA has ``a legal obligation to 
provide interested parties with an opportunity to comment on the 
methods of compliance provisions'' (Ex. 54-307). In the opinion of this 
commenter, the American Iron and Steel Institute (AISI), ``Section 
6(b)(2) of the OSH Act requires that OSHA provide interested persons an 
opportunity to submit written data and comments on a proposed rule in 
total'' [emphasis added].
    The unchanged language of paragraph (a)(1) was included in the 
proposed rule only to enable interested parties to view the rule as it 
would ultimately appear in the Code of Federal Regulations in its 
entirety. Since OSHA neither proposed nor adopted modifications to 
paragraph (a)(1), the Agency believes that it is not legally required 
to reconsider this issue at this time. OSHA has the authority to 
identify which regulatory requirements it is proposing to revise and 
which issues are to receive regulatory priority. Limiting this 
rulemaking to issues concerning respirator programs is appropriate 
because such programs are the exclusive focus of this rulemaking and to 
collect comments and data on additional issues would divert resources 
from the task at hand.
    The preference for engineering controls has been reaffirmed in each 
substance-specific health standard OSHA has published, most recently in 
the Methylene Chloride standard (29 CFR 1910.1052). OSHA does not 
believe that it is necessary or appropriate, in a rulemaking dealing 
with respiratory protection, to reconsider its long-established policy 
with regard to the hierarchy of controls.
    A number of commenters raised another issue in connection with 
paragraph (a)(1), and that is whether biological hazards, such as the 
hazard posed by exposure to Mycobacterium tuberculosis, the infectious 
agent that causes tuberculosis (TB), are covered by this paragraph 
(Exs. 54-213, 54-239, 54-249). In response, OSHA emphasizes that this 
respiratory protection standard does apply to biological hazards (see 
Mahone Grain Corp., 10 OSHRC 1275, 1981). However, specifically with 
regard to the use of respirators to protect employees from the risk of 
occupational exposure to M. tuberculosis, OSHA stated at the public 
hearing on this respiratory protection standard (Tr. 16-17), that the 
Agency's tuberculosis standard, which has just been proposed (62 FR 
54160) would contain specific requirements covering all aspects of 
respirator use in environments where occupational transmission of 
tuberculosis is possible. As explained in the preamble to that 
standard, OSHA is committed to ensuring consistency between the 
respirator requirements in the two standards.
    As stated at the hearing, ``until the final tuberculosis standard 
is promulgated, we will continue to enforce respirator usage for TB 
under the current, unrevised respirator standard, 1910.134.'' (Tr. 18). 
There was little comment on this issue during the rulemaking. The 
entire previous respiratory protection standard is being redesignated 
as 29 CFR 1910.139. It will be published in the next edition of the 
Code of Federal Regulations under that designation. OSHA's enforcement 
policy concerning required respirator use for TB is set out in OSHA's 
Compliance Directive, ``Enforcement Procedures and Scheduling for 
Occupational Exposure to Tuberculosis'' (OSHA Instruction CPL 2.106). 
These enforcement procedures are based, in part, on the Centers for 
Disease Control and Prevention's (CDC) ``Guidelines for Preventing the 
Transmission of Mycobacterium Tuberculosis in Health-Care Settings, 
1994.'' Like the CDC recommendations, OSHA's directive clarifies that 
respiratory protection for employees exposed to TB is required when: 
(1) Workers enter rooms housing individuals with suspected or confirmed 
infectious TB; (2) workers are present during the performance of high-
hazard procedures on individuals who have suspected or confirmed 
infectious TB; and (3) emergency medical response personnel or others 
transport, in enclosed vehicles, an individual with suspected or 
confirmed infectious TB. Under the directive, OSHA also enforces the 
performance criteria recommended by CDC for selecting a respirator 
suitable for use against TB. OSHA's directive further specifies that 
where respirator use is required against TB, the program elements of 
OSHA's respiratory protection standard apply. A copy of OSHA's 
Compliance Directive can be obtained from OSHA's Office of Publications 
(Telephone Number, 202-219-4667). Copies of the CDC Guidelines can be 
obtained by calling CDC (Telephone Number, 1-800-342-2437).
    As noted above, paragraph (a)(2) of the final rule is identical 
both to the corresponding paragraph of the respiratory protection 
standard in place

[[Page 1181]]

since 1971 and to proposed paragraph (a)(2). It specifies that 
respirators must be provided by the employer ``when such equipment is 
necessary to protect the health of the employee.'' OSHA considers 
respirators to be necessary to protect the health of the employee 
whenever feasible engineering and work practice controls are not 
available, are not sufficient to protect employee health, have not yet 
been instituted, in emergencies, and where the health of an employee is 
at risk (e.g., whenever employee exposure exceeds an OSHA permissible 
exposure limit (PEL)).
    A violation of paragraph (a)(2) could exist, for example, if it can 
be shown that exposure to an airborne contaminant could result in 
illness or injury to the employee's health and that this could be 
prevented by the appropriate selection and use of a respirator. An OSHA 
Review Commission case illustrates such a situation: an employer was 
held to have violated paragraph (a)(2) because his employees either did 
not use respirators when working in an atmosphere contaminated with 
grain dust or used respirators that were ``so caked with dust that 
employees could not breathe through them'' and contracted a potentially 
fatal disease caused by the inhalation of grain dust contaminated with 
Histoplasma capsulatum spores (Mahone Grain Corporation, 10 OSHRC 1275, 
1981). Paragraph (a)(2) was cited in this case even though OSHA has no 
specific PEL for grain dust or for H. capsulatum spores.
    In the past 5 years, OSHA has issued 99 citations for violations of 
paragraph (a)(2) in conjunction with a citation of the General Duty 
Clause (i.e., Sec. 5(a)(1) of the Act). These citations concerned 
various situations involving the failure of the employer: (1) To 
control exposures in emergencies; (2) to control exposure to unknown 
concentrations of a toxic substance; (3) to control exposure to a 
contaminant that was clearly a recognized hazard even though no OSHA 
PEL existed; (4) to provide and require the use of a respirator for a 
confined space entry; or (5) to ensure the proper use of a respirator 
in a situation involving the improper storage of a chemical(s). OSHA 
will continue to view these situations as citable under this standard 
because they involve failure to implement the appropriate exposure 
control necessary to protect the health of the employee from adverse 
effects.
    As proposed, paragraph (a)(3) of OSHA's prior standard does not 
appear in the final rule. This paragraph, which was adopted by OSHA in 
1971 from the ANSI Z88.2-1969 standard, stated that employees must use 
the respiratory protection provided in accordance with instructions and 
training they have received.
    Several commenters (Exs. 54-79, 54-181, 54-226, 54-234, 54-295, 54-
307, 54-334) urged OSHA to retain this paragraph in the final rule. 
According to these commenters, this paragraph is necessary to ensure 
that employees take responsibility for their actions and that employees 
are actively involved in the respirator program and conform to program 
procedures. OSHA agrees that active employee involvement in the 
respirator program is essential to program effectiveness but does not 
believe that this principle should be stated in the standard, for a 
number of reasons. First, the OSH Act itself, at Sec. 5(b), states that 
``Each employee shall comply with occupational safety and health 
standards and all rules, regulations, and orders issued pursuant to the 
OSH Act which are applicable to his own actions and conduct.'' In 
addition, the courts have repeatedly held that employers are 
responsible under Section 5(a)(2) of the Act (29 U.S.C. 654(a)(2)) for 
ensuring worker protection (see, e.g., Brock v. City Oil Well Service 
Co., 795 F.2d 507, 511 (5th Cir. 1986)). In this case, the court held, 
``it is the employer's responsibility to ensure that the employees are 
protected. It may accomplish this objective through others if it 
chooses, but the duty to provide the protection remains the 
employer's.'' Accordingly, the final rule does not contain this 
paragraph.
    An issue raised by OSHA in connection with paragraph (a) of the 
proposal, the use of respirators by employees when such use is required 
by an individual employer or is chosen voluntarily by employees but not 
mandated by OSHA in this final rule, is addressed below in connection 
with paragraph (c) of this Summary and Explanation.

Paragraph (b)--Definitions

    The final standard includes definitions of important terms used in 
the regulatory text of the final rule. The previous and proposed 
respiratory protection standards contained no definitions; however, 
OSHA is adding a number of definitions to the final rule because the 
Agency believes that employers and employees will benefit from this 
additional information. This is consistent with the Agency's desire to 
clarify its respiratory protection requirements, including those that 
are not being substantively changed in this rulemaking.
    A number of the definitions relate to specific types of respiratory 
protection devices or to components or design characteristics of those 
devices. For example, the terms ``air-purifying respirator,'' ``filter 
or air-purifying element,'' and ``positive pressure respirator'' are 
defined in the final rule. These definitions, which are derived from 
generally recognized sources such as the current ANSI Z88.2-1992 
respiratory protection standard, the NIOSH requirements for particulate 
respirators in 42 CFR part 84, and the 1987 NIOSH Respirator Decision 
Logic (Ex. 38-20), have been revised for clarity, consistency with 
compliance interpretations of the Agency's respiratory protection 
standard, and to respond to comments received during the rulemaking.
    A number of commenters (Exs. 54-208, 54-218, 54-219, 54-410, 54-
424) suggested that OSHA adopt several of the definitions in the ANSI 
Z88.2-1992 respiratory protection standard. The regulated community is 
already familiar with the ANSI definitions of these terms, and OSHA 
agrees that the potential for confusion will be reduced if terms mean 
the same thing in both the OSHA and ANSI standards. Therefore, the ANSI 
definitions of ``airline respirator (supplied-air respirator or airline 
respirator),'' ``canister or cartridge,'' ``demand respirator,'' ``end-
of-service-life indicator,'' ``escape-only respirator,'' ``filter,'' 
``fit check (user seal check),'' ``fit test,'' ``helmet,'' ``hood,'' 
``loose-fitting facepiece,'' ``negative pressure respirator,'' 
``pressure demand respirator,'' ``powered air-purifying respirator 
(PAPR),'' ``respiratory inlet covering,'' ``self contained breathing 
apparatus (SCBA),'' ``service life,'' and ``tight-fitting facepiece'' 
have all been added to the final standard, with some minor word changes 
to improve clarity and to recognize the mandatory nature of OSHA 
standards. In other cases, OSHA has substituted an ANSI definition for 
one the Agency originally proposed.
    Several commenters urged OSHA to add other definitions to those in 
the proposal (Exs. 54-208, 54-218, 54-219, 54-222, 54-251 54-267, 54-
283, 54-289, 54-363, 54-410, 54-437, 54-455). OSHA did not add some of 
the suggested definitions, such as one for ``health screening,'' 
because the term is no longer used in the standard. Other terms, such 
as ``medical evaluation,'' are defined where they appear in the 
regulatory text.
    The following discussion addresses changes made since the proposed 
standard.
    Adequate warning properties. The proposed definition of ``adequate 
warning properties'' has not been

[[Page 1182]]

retained in the final standard because the term is no longer used in 
the regulatory text. OSHA deleted the term after concluding that the 
two major warning properties, odor and irritation, are unreliable or 
inappropriate to use as indicators of sorbent exhaustion. This issue is 
discussed further in this Summary and Explanation in connection with 
paragraph (d).
    Air-purifying respirator. The final standard defines the term 
``air-purifying respirator'' as ``a respirator with an air-purifying 
filter, cartridge, or canister that removes specific air contaminants 
by passing ambient air through the air-purifying element.'' Marc Evans 
of Baxter Diagnostics, Inc. (Ex. 54-38) stated that the proposed 
definition, ``a respirator which is designed to remove air contaminants 
[i.e., dust, fumes, mists, gases, vapors, or aerosols] from the ambient 
air or air surrounding the respirator,'' was inaccurate since filter 
elements can only remove air contaminants when air passes through the 
filters; he stated that the ANSI definition was more accurate in this 
regard.
    Another commenter wanted to add the term ``biologicals'' to the 
list of air contaminants removed by air-purifying respirators (Ex. 54-
249). In response, the definition has been revised to state more 
clearly that an air-purifying respirator removes specific contaminants 
from the ambient air by drawing air through appropriate filters, 
cartridges, or canisters. Deleting the proposed definition's examples 
of air contaminants makes clear that no type of air contaminant, 
including biological agents, is excluded from the definition. Also, the 
term ``filter'' has been changed to ``filter or air-purifying 
element,'' which is also defined in the standard, and includes the 
broad range of filters, cartridges, canisters and other air-purifying 
elements used with respirators.
    Assigned protection factor. The definition of ``assigned protection 
factor'' has been reserved as part of OSHA's decision to address the 
entire Assigned Protection Factor (APF) issue in a subsequent phase of 
this rulemaking. OSHA proposed to reference the NIOSH assigned 
protection factors from the 1987 NIOSH Respirator Decision Logic in the 
respiratory protection standard and then to adopt new APF values issued 
by NIOSH after that Agency had conducted rulemaking on APFs. In the 
course of this rulemaking, OSHA has concluded that it should instead 
develop its own set of assigned protection factors based on a thorough 
review and analysis of all relevant evidence. Both the NIOSH and the 
ANSI APFs, as well as all relevant data and information, will be 
considered by OSHA at that time.
    Atmosphere-supplying respirator. This term means ``a respirator 
that supplies the respirator user with breathing air from a source 
independent of the ambient atmosphere, and includes supplied-air 
respirators (SARs) and self-contained breathing apparatus (SCBA) 
units.'' As it has done in many of the definitions in this section, 
OSHA has substituted the term ``breathing air'' for a number of 
synonymous, but confusingly diverse, terms used in the proposal and in 
the ANSI Z88.2-1992 standard. The minor changes from the proposed 
definition have been made solely to enhance clarity.
    Canister or cartridge. The final standard adopts the ANSI Z88.2-
1992 standard's definition: ``a container with a filter, sorbent, or 
catalyst, or combination of these items, which removes specific 
contaminants from the air passed through the container.'' Several 
commenters suggested that this definition be added to the final rule 
(Exs. 54-208, 54-218, 54-219, 54-410, 54-424).
    Demand respirator is defined as ``an atmosphere-supplying 
respirator that admits breathing air to the facepiece only when a 
negative pressure is created inside the facepiece by inhalation.'' This 
term was not defined in the proposal but is defined by ANSI, and 
several commenters (Exs. 54-208, 54-218, 54-219, 54-410, 54-424) urged 
that it be included in the final rule. As in other definitions, the 
phrase ``breathing air'' has been substituted for ``respirable gas'' 
for clarity.
    The proposal's definition of ``demand'' has been deleted from the 
final standard because the addition of a definition for ``demand 
respirator'' makes its inclusion unnecessary. (See the definition of 
pressure demand respirator below for the distinction between the two 
types of respirator.)
    Dust mask. See the definition for ``filtering facepiece'' below.
    Emergency situation. In the final rule, OSHA is adding this term to 
paragraph (b) to clarify its use in the regulatory text. ``Emergency 
situation'' is defined as ``any occurrence such as, but not limited to, 
equipment failure, rupture of containers, or failure of control 
equipment that may or does result in an uncontrolled substantial 
release of an airborne contaminant.'' Under this definition, OSHA 
intends that a potential release, and not just an actual release, be 
considered an emergency situation requiring appropriate respiratory 
protection. This definition is the same or similar to those used to 
define emergency situations in other OSHA health standards (e.g., 
1910.1051, Butadiene; 1910.1028, Benzene; 1910.1048, Formaldehyde).
    Employee Exposure. OSHA has added this term to paragraph (b) of the 
final rule and has defined it to mean ``exposure to a concentration of 
an airborne contaminant that would occur if the employee were not using 
respiratory protection.'' This is the same definition that has been 
used in many of OSHA's substance-specific health standards. It is 
included to clarify that employee exposure is measured outside any 
respiratory protection worn.
    End-of-service-life indicator (ESLI) means ``a system that warns 
the respirator user of the approach of the end of adequate respiratory 
protection, for example, that the sorbent is approaching saturation or 
is no longer effective.'' This definition was not in the proposal, but 
has been derived from the definition in the ANSI Z88.2-1992 standard, 
as requested by several commenters (Exs. 54-208, 54-218, 54-219, 54-
410, 54-424). OSHA has included the example at the end of the 
definition to clarify the function of an ESLI.
    Escape-only respirator. This term was not defined in the proposal, 
but the final standard defines an escape-only respirator as ``a 
respirator intended to be used only for emergency exit.'' The Dow 
Chemical Company (Ex. 54-278) and the Chlorine Institute (Ex. 54-439) 
recommended adding definitions for an ``escape'' respirator and an 
``emergency'' respirator. Partially in response to these comments, and 
to clarify OSHA's intent, OSHA has described in paragraph (d) the 
narrow function of an ``escape-only respirator,'' and has added a 
definition for ``escape-only respirator'' to this paragraph (b). The 
definition of ``escape-only respirator'' derives from the ANSI Z88.2-
1992 standard, with the phrase ``egress from a hazardous atmosphere'' 
replaced by the word ``exit.''
    Filter or air-purifying element. The final standard's definition of 
this term is ``a component used in respirators to remove solid or 
liquid aerosols from the inspired air.'' The parallel definition in the 
proposal used ``filter'' instead of ``filter or air-purifying element'' 
and has been changed in response to comments (Exs. 54-208, 54-218, 54-
219, 54-410, 54-424). The phrase ``or air-purifying element'' has been 
added to clarify that this definition applies to all filtration 
mechanisms, not only to mechanical or electrostatic filtration of 
particulates. The new definition derives from the definition of 
``filter'' in the ANSI Z88.2-1992 standard.

[[Page 1183]]

    Filtering facepiece (dust mask). The definition of ``filtering 
facepiece'' in the final rule is ``a negative pressure particulate 
respirator with a filter as an integral part of the facepiece or with 
the entire facepiece composed of the filtering medium.'' This new 
definition is derived from the definition of ``filtering facepiece'' in 
the NIOSH Respirator Decision Logic (Ex. 38-20). As described in the 
discussion of paragraph (c) below, employers who allow the use of these 
respirators when such use is not required need to comply with only 
paragraph (c)(2) of this standard, which requires that the employer 
provide the employee with the information contained in Appendix D.
    Fit factor. The definition of ``fit factor'' in the final rule is a 
quantitative estimate of the fit of a particular respirator to a 
specific individual, and typically estimates the ratio of the 
concentration of a substance in ambient air to its concentration inside 
the respirator when worn. In the proposal, OSHA's definition included 
the terms ``challenge agent'' and ``test chamber.'' Several commenters 
(Baxter Diagnostics, Ex. 54-38; American Subcontractors Association, 
Ex. 54-293) stated that using these terms would have the unintended 
effect of prohibiting the use of several existing QNFT test methods, 
such as the TSI Portacount,TM and recommended that OSHA rely 
on the ANSI definition of ``fit factor'' instead. OSHA agrees with this 
point, and the final standard's definition derives primarily from the 
ANSI Z88.2-1992 standard's definition, as commenters suggested (Exs. 
54-208, 54-218, 54-219, 54-410, 54-424). The final definition uses the 
word ``estimate'' instead of the ANSI definition's word ``measure'' 
because fit factors estimate, rather than measure, the fit obtained 
during use. The phrase ``specific individual'' has been substituted for 
``particular individual'' for clarity.
    Fit test. A definition of ``fit test'' has been added to the final 
rule and is defined as ``the use of a protocol to qualitatively or 
quantitatively evaluate the fit of a respirator on an individual.'' 
(See also QLFT and QNFT.) This definition has been added because OSHA 
is of the opinion, based on comments to the record, that such a 
definition is needed (Exs. 54-208, 54-218, 54-219, 54-410, 54-424). 
ANSI also has a definition of fit test, but OSHA's definition differs 
from that in the ANSI Z88.2-1992 standard in that the term ``challenge 
agent'' has been eliminated and replaced by the phrase ``protocol to 
quantitatively or qualitatively evaluate.'' The use of the term 
``challenge agent'' would limit the development of future fit test 
technologies that do not involve a test agent (Exs. 54-208, 54-250, 54-
330, 54-424).
    Hazardous exposure level. Because the final standard does not use 
the term ``hazardous exposure level,'' it is not defined. The proposal 
defined such levels as including the Permissible Exposure Limits (PELs) 
contained in OSHA's Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000; the 
American Conference of Governmental Industrial Hygienists (ACGIH) 
Threshold Limit Values (TLVs), as published in the latest edition of 
that organization's ``Threshold Limit Values for Chemical Substances 
and Physical Agents,'' for those substances without an OSHA PEL; the 
NIOSH Recommended Exposure Limits (RELs) for those hazardous chemicals 
without either an OSHA PEL or ACGIH TLV; and any exposure level based 
on available scientific information, including Material Safety Data 
Sheets, for those hazardous chemicals for which no OSHA PEL, ACGIH TLV, 
or NIOSH REL has yet been published.
    The proposed rule would have required employers to identify the 
``hazardous exposure level'' applicable to each hazardous chemical in 
the workplace and then to use this information in selecting the 
appropriate respirator to provide protection against exposure to that 
chemical. The final rule takes a different and much simpler approach to 
assisting employers in the selection of appropriately protective 
respirators in those cases where OSHA has not yet promulgated a PEL for 
a hazardous chemical. OSHA has taken the approach reflected in the 
final standard because there was widespread objection to the proposed 
approach (Exs. 54-94, 54-175, 54-212, 54-226, 54-232, 54-275x, 54-283, 
54-293, 54-306, 54-312, 54-324, 54-334, 54-347, 54-352, 54-361, 54-397, 
54-443, 54-445). Some commenters (Exs. 54-91, 54-165, 54-181, 54-291, 
54-316, 54-347, 54-397, 54-445) interpreted the proposed approach as an 
attempt by OSHA to expand the number of hazardous chemicals with OSHA-
enforceable exposure limits, while others believed that implementing 
the proposed approach would require employers to have risk assessment 
expertise or to perform complex analyses, and pointed out that many 
employers lacked such expertise (Exs. 54-106, 54-175, 54-210). In 
general, rulemaking participants stated that OSHA's approach to this 
problem should rely on the professional judgment of employers, based on 
readily available information (Exs. 54-206, 54-210).
    OSHA has decided, after a thorough review of the record, to follow 
these recommendations, and in the final rule has adopted an approach 
that requires employers to select appropriately protective respirators 
on the basis of informed professional judgment. Accordingly, the final 
rule does not identify the ACGIH TLVs or the NIOSH RELs as references 
that would trigger required respirator use. The approach taken in the 
final rule provides employers with the flexibility to rely on 
professional judgment and available data sources when selecting 
respirators for protection against hazardous chemicals that have no 
OSHA PEL.
    OSHA believes that it is prudent in such cases for employers to 
select more rather than less protective respirators, i.e., to select a 
respirator that will reduce employee exposure to a level below the 
concentration indicated as hazardous by the scientific literature. OSHA 
also believes that many employers will choose to rely on the ACGIH TLV 
or NIOSH REL in those cases where OSHA has no PEL at the present time. 
However, whatever approach employers choose to take, the respirator 
selected must ``be applicable and suitable for the purpose intended,'' 
as required by paragraph (a).
    Helmet. The final standard defines a helmet as ``a rigid 
respiratory inlet covering that also provides head protection against 
impact and penetration.'' This definition, which was not in the 
proposal, has been added to the final standard at the request of 
several commenters ( Exs. 54-208, 54-218, 54-219, 54-410, and 54-424). 
The OSHA definition uses the term ``respiratory inlet covering'' 
instead of the word ``hood'' used in the ANSI definition in order to 
include helmet-style powered air-purifying respirators (PAPRs).
    High efficiency particulate air (HEPA) filter is defined as ``a 
filter that is at least 99.97% efficient in removing monodisperse 
particles of 0.3 micrometers in diameter. The equivalent NIOSH 42 CFR 
84 particulate filters are the N100, R100, and P100 filters.'' Although 
NIOSH has revised the particulate filter descriptions under the new 42 
CFR Part 84 respirator certification regulation, and no longer uses the 
term HEPA, this definition is included because ``HEPA filter'' is used 
in many of OSHA's substance-specific standards. The definition, which 
is similar to that used by ANSI, lists the NIOSH 42 CFR part 84 
particulate filters that are equivalent, in terms of

[[Page 1184]]

efficiency, to the HEPA filter, i.e., the N100, R100, and P100 filters.
    Hood. The final standard includes the following definition of 
``hood'': ``a respiratory inlet covering that completely covers the 
head and neck and may also cover portions of the shoulders and torso.'' 
This definition has been added to the final standard in response to 
commenters (Exs. 54-208, 54-218, 54-219, 54-410, and 54-424). The 
definition derives from the ANSI Z88.2-1992 standard; the word ``also'' 
has been added for clarity.
    Immediately dangerous to life or health (IDLH). The final standard 
defines IDLH as ``an atmosphere that poses an immediate threat to life, 
would cause irreversible adverse health effects, or would impair an 
individual's ability to escape from a dangerous atmosphere.'' In the 
proposal, the definition of IDLH was ``an atmospheric concentration of 
any toxic, corrosive, or asphyxiant substance that poses an immediate 
threat to life or would cause irreversible or delayed adverse health 
effects or would interfere with an individual's ability to escape from 
a dangerous atmosphere.'' In the final rule, OSHA has decided that 
including all atmospheres capable of causing the listed health effects 
is more consistent with OSHA's intent than limiting the definition to 
toxic, corrosive, and asphyxiant atmospheres and has also deleted the 
word ``delayed'' from the definition because including it caused 
considerable confusion among commenters.
    Under the final standard's definition, atmospheres where a short, 
one-time exposure (i.e., an acute exposure) may cause death or 
irreversible adverse health effects immediately, within a few hours, or 
within a few days or weeks are considered IDLH atmospheres. The 
severity of the adverse effects and the certainty that health 
impairment will occur following an acute exposure are more important 
considerations in defining a potential IDLH situation than is the time 
course of the health effect. For example, an atmosphere containing 
life-threatening or health-impairing concentrations of fluorides, 
cadmium fumes, or radioactive substances would be considered IDLH even 
though a single exposure might not cause death or permanent impairment 
for as long as days or even weeks after the exposure. On the other 
hand, many situations involving atmospheres exceeding short-term or 
ceiling exposure limits are not IDLH atmospheres; most short-term or 
ceiling limits are designed to reduce the risk of less serious effects, 
such as sensory irritation. Thus, only those situations where the acute 
exposure would threaten life, initiate an irreversible process that 
threatens life or health, or impede the ability of the worker to escape 
from the atmosphere would constitute IDLH conditions. In contrast, if 
chronic exposure to a toxic atmosphere is required to produce health 
impairment or cause death, the atmosphere is not IDLH. Thus, the 
relatively low atmospheric concentrations of carcinogenic substances 
that cause work-related cancers are not considered IDLH atmospheres, 
even though the effect of long-term exposure at such concentrations is 
death or serious illness.
    Paragraphs (d) and (g) of the final standard require employers 
whose employees are exposed to an IDLH atmosphere to provide them with 
the most protective and reliable respiratory protection, i.e., a full 
facepiece pressure demand SCBA certified by NIOSH for a minimum of a 
30-minute service life, or a combination full facepiece pressure demand 
supplied-air respirator with auxiliary self-contained air supply, and 
to implement specific rescue precautions and communication procedures. 
Although OSHA's prior Respiratory Protection standard does not 
explicitly use the term ``IDLH,'' it does require that respirators used 
in ``immediately dangerous'' atmospheres keep inward leakage to a 
minimum and be highly reliable (See paragraph (c) of prior 29 CFR 
1910.134, which incorporates this language from the ANSI Z88.2-1969 
standard by reference).
    Commenters raised a number of issues specifically related to the 
proposed definition of IDLH and to the IDLH concept in general. These 
comments addressed the following points:

 Whether the term IDLH should apply to all delayed effects, 
some delayed effects, or be restricted to immediate effects;
 How OSHA's definition of IDLH differs from those of other 
organizations and how it relates to the definition of IDLH used in 
other OSHA standards;
 How the presence of an IDLH or potential IDLH atmosphere 
affects respirator selection.

The following discussion addresses each of these points in turn.
    The proposed definition of IDLH included the phrase ``delayed 
adverse health effects.'' OSHA has omitted this phrase from the final 
standard to respond to comments received and to remove a source of 
confusion. Many commenters argued that the term IDLH should cover only 
immediate, severe adverse health effects, such as those resulting from 
exposures to hydrogen fluoride or oxides of nitrogen (e.g., Exs. 54-
208, 54-219; 54-316), while others favored taking chronic, delayed 
effects into consideration when making an IDLH decision (See, e.g., 
Exs. 54-202 and 54-437). For example, OCAW stated that ``OSHA's IDLH 
and acute hazard-based framework * * * does not properly emphasize the 
need to consider long-term and cumulative health effects.''
    Most participants, however, argued against including chronic health 
effects in the IDLH definition because it would make the definition too 
broad. These participants feared that including this term would mean 
that exposures typically associated with chronic effects, such as 
cancer, would be designated IDLH (Exs. 54-67; 54-153; 54-175; 54-208; 
54-218; 54-219; 54-232; 54-266; 54-278; 54-307; 54-314; 54-316; 54-
326). Typical of these comments is one from the American Iron and Steel 
Institute: ``The proposed definition, which includes ``delayed health 
effects,'' is so broad that it goes far beyond the accepted IDLH 
concept, and would expand it beyond its intended purpose'' (Ex. 54-
307). Arguing along the same lines, the Exxon Corporation stated that 
``the phrase `delayed health effects' could include chronic toxins like 
asbestos * * *'' (Ex. 54-266).
    Other commenters urged OSHA to narrow the definition of IDLH by 
adding the word ``acute'' before ``adverse'' in the phrase ``delayed 
adverse health effects'' or by making other language changes that would 
achieve the same effect (Exs. 54-67, 54-278, 54-326, 54-208A). For 
example, the American Industrial Hygiene Association (Ex. 54-208A) 
stated that the only atmospheric contaminants with delayed effects that 
should be included in the definition are those, such as the oxides of 
nitrogen, that cause delayed-onset severe adverse health effects (such 
as pulmonary edema). Representatives of Pennzoil suggested that ``* * * 
the phrase `immediate or delayed irreversible debilitating health 
effects', be used'' to achieve the same end (Ex. 54-287).
    These commenters objected to the inclusion of ``delayed health 
effects'' in the proposed definition because the language suggested 
that effects typically associated with long-term exposures, such as 
cancer, would be included. The definition in the final standard 
recognizes that the effects of concern must be the result of an acute 
overexposure but does not specifically limit the length of time between 
that overexposure and the resulting effect.

[[Page 1185]]

Where very serious health effects may arise from a single acute 
exposure, even if such effects become apparent only after a relatively 
long latency period, e.g., hours, days, or even weeks, the atmosphere 
associated with the effect must be designated IDLH. OSHA is confident 
that deleting the word ``delayed'' from the IDLH definition in the 
final rule will reduce confusion but will not affect the level of 
employee protection provided by the standard.
    Many commenters urged OSHA to adopt an IDLH definition developed by 
another organization, agency, or by OSHA itself in other standards. 
Some commenters (Exs. 54-153, 54-214, 54-234, 54-251, 54-266, 54-278, 
54-290, 54-330, 54-361, 54-363, 54-424, 54-439) urged OSHA to adopt the 
ANSI Z88.2-1992 standard's definition of IDLH: ``any atmosphere that 
poses an immediate hazard to life or poses immediate irreversible 
debilitating effects on health'' (clause 3.33). For example, Bell 
Atlantic (Ex. 54-361) suggested that the ANSI definition be used to 
ensure that ``chronic toxins like asbestos would not be considered 
IDLH.'' However, OSHA believes that adopting the definition contained 
in the current ANSI standard could reduce employee protection because 
it states that atmospheres are IDLH only in cases where the adverse 
effects of exposure occur immediately. An example of an atmosphere that 
OSHA believes must be considered IDLH but arguably would not be so 
designated under the ANSI definition is one containing high 
concentrations of cadmium fume, which may result in fatal collapse as 
long as 48-72 hours after an acute overexposure.
    The Exxon Corporation (Ex. 54-266) objected to the phrase ``ability 
to escape'' in OSHA's proposed definition, and suggested that OSHA 
instead adopt the ANSI definition, which does not refer to impairment 
of the ability to escape. OSHA wishes to clarify that the proposed 
terminology, ``interfere with an individual's ability to escape'' was 
not meant to cover a minor or even moderate degree of interference but 
to address interference of a kind sufficiently serious to impair the 
individual's ability to escape from exposure to a dangerous 
concentration of an air contaminant. To address Exxon's concern, the 
final rule's definition has been revised to read ``impair the 
individual's ability to escape.'' OSHA notes that it is imperative for 
employees to be able to escape. There are atmospheres, for example one 
contaminated with a severe eye irritant, that can effectively 
incapacitate an individual in the short term and prevent the individual 
from escaping in time to avoid more serious health consequences. OSHA 
has therefore retained in the IDLH definition language that addresses 
the need to protect workers escaping from dangerous atmospheres.
    One commenter, Monsanto (Ex. 54-219), expressed concern about the 
consistency of IDLH definitions in different OSHA standards. In 
response, OSHA has reviewed the definitions of IDLH used in its 
standards and believes that the final standard's definition is largely 
consistent with those in the two OSHA safety standards that use the 
term: 29 CFR 1910.146, the Permit-Required Confined Space standard 
(``Confined Spaces standard'') and 29 CFR 1910.120, the Hazardous Waste 
Operations and Emergency Response (HAZWOPER) standard.
    Some commenters (Exs. 54-439, 54-330, 54-278) asked which IDLH 
values OSHA endorses or pointed to the limitations of the available 
information on IDLH concentrations. For example, OCAW noted that ``only 
a handful of IDLH limits have been determined. In most worker exposure, 
the IDLH limit is unknown. Even when [an] IDLH limit exists, workers do 
not have access to this information. MSDSs rarely include IDLH 
information'' (Ex. 54-202).
    The final rule does not contain a prescribed list of IDLH values or 
require employers to rely on any particular list. Some commenters (Exs. 
54-278, 54-330, 54-361, 54-424, 54-439) criticized the IDLH values 
listed in the 1994 NIOSH Pocket Guide to Chemical Hazards (Ex. 54-278) 
or recommended that the Emergency Response Planning Guidelines (ERPGs) 
developed under the auspices of the American Industrial Hygiene 
Association be used instead. OSHA is aware that published IDLH values 
are not available for many industrial contaminants and that employers 
must therefore rely on their own knowledge and judgment, and that of 
safety and health professionals, when deciding that a given atmosphere 
has the potential to cause health effects of the kind envisioned by 
OSHA's IDLH definition. During enforcement inspections, OSHA will 
continue to accept any published IDLH value that is based on sound 
scientific evidence; those published by NIOSH and the AIHA would 
clearly meet this test.
    OSHA's final IDLH definition does not separately mention 
``potential'' IDLH atmospheres. Many OSHA enforcement cases have 
involved the failure of employers to provide respirators in situations 
that were not IDLH at the time workers entered the area but became so 
thereafter. OSHA intends employers to interpret the respirator 
selection requirements in paragraph (d)(1) proactively, i.e., where 
employers are uncertain about the adequacy of a given respirator for a 
highly hazardous atmosphere, cannot identify the atmospheric 
concentration of a substance that poses a potentially life-threatening 
or health-impairing risk, or cannot maintain the concentration of such 
a substance below life-threatening or health-impairing levels, the 
employer must consider the atmosphere IDLH and select a respirator 
accordingly. For example, an employer in a chemical plant knows that 
inadvertent releases or spills of highly hazardous chemicals may occur 
at the facility and selects the most protective respirators available 
for employees who must enter a spill area because, in an emergency, 
there is no time to take airborne measurements to determine whether or 
not the concentration is IDLH. OSHA encourages this kind of proactive 
planning because it is protective of employee health.
    Interior structural firefighting. The final respiratory protection 
standard uses the OSHA definition for ``interior structural 
firefighting'' contained in 29 CFR 1910.155, which applies to all 
situations covered by Subpart L--Fire Protection. The definition is as 
follows:

    Interior structural firefighting means the physical activity of 
fire suppression, rescue or both, inside of buildings or enclosed 
structures which are involved in a fire situation beyond the 
incipient stage.

    Loose-fitting facepiece. The final standard now defines this term 
to mean ``a respiratory inlet covering that is designed to form a 
partial seal with the face.'' This definition was not in the proposal, 
and has been added in response to commenters such as the AIHA (Ex. 54-
208), 3M (Ex. 54-218), Monsanto (Ex. 54-219), Martin Marietta Energy 
Systems, Inc. (Ex. 54-410), and ORC (Ex. 54-424), who recommended that 
OSHA adopt several of the ANSI Z88.2-1992 definitions for respirator 
terms. OSHA has adopted only part of the ANSI definition for loose-
fitting facepiece. The phrase in the ANSI definition that states a 
loose-fitting facepiece ``does not cover the neck and shoulders, and 
may or may not offer head protection against impact and penetration'' 
has not been included. This phrase from the ANSI definition was not 
adopted as part of the OSHA definition because adding this phrase would 
not allow users to clearly distinguish between hoods, helmets, and 
loose-fitting respirators. It is important for employers to be able to 
distinguish loose-fitting from tight-

[[Page 1186]]

 fitting respirators in order to correctly apply the fit testing 
requirements.
    Maximum use concentration. OSHA is not defining this term at this 
time because the Agency has reserved the issue of Assigned Protection 
Factors, which is associated with Maximum Use Concentrations, until a 
subsequent phase of this rulemaking.
    Negative pressure respirator (tight fitting). The final standard 
defines this term as ``a respirator in which the air pressure inside 
the facepiece is negative during inhalation with respect to the ambient 
air pressure outside the respirator.'' The proposed definition was 
revised in response to comments (Exs. 54-208, 54-218, 54-219, 54-410, 
and 54-424) that recommended that OSHA adopt the ANSI Z88.2-1992 
standard's definition. In the final rule, OSHA has accepted the ANSI 
definition, with two changes: (1) The word ``facepiece'' has replaced 
the term ``respiratory inlet covering'' to make clear that the 
facepiece is the area of interest with negative pressure respirators; 
and (2) the phrase ``outside the respirator'' has been added after the 
phrase ``ambient air pressure'' to clarify that negative pressure 
exists only when the outside air pressure is higher than the air 
pressure inside the negative pressure facepiece.
    Oxygen-deficient atmosphere. The proposed definition of an ``oxygen 
deficient atmosphere'' was ``an atmosphere with an oxygen content of 
less than 19.5% by volume at altitudes of 8000 feet or below.'' OSHA is 
retaining the 19.5% definition of an oxygen-deficient atmosphere in the 
final rule, but is removing the reference to altitudes. The use of a 
19.5% oxygen level is well established and has even been incorporated 
by Congress into other safety and health legislation (See Federal Mine 
Safety and Health Act, 20 USC 863 (b), discussed in National Mining 
Association v. MSHA, 116 F.3d 520 (D.C. Cir. 1997.) Paragraph d(2)(iii) 
of the final rule requires employers to consider all oxygen-deficient 
atmospheres to be IDLH and to require the use of pressure-demand SCBA 
or a combination full-facepiece pressure-demand SAR with an auxiliary 
self-contained air supply. However, this paragraph also contains an 
exception that would permit employers to use any atmosphere-supplying 
respirator in oxygen-deficient atmospheres where the employer can 
demonstrate that oxygen levels cannot fall below the altitude-adjusted 
concentrations prescribed in Table II of paragraph (d).
    The ANSI Z88.2-1992 standard, NIOSH (Ex.164), and AIHA (Ex. 2098) 
use an altitude-adjusted definition for oxygen deficiency. Although 
there are some small differences, these organizations generally define 
oxygen deficiency as an oxygen level of less than 19.5% at altitudes up 
to 5,000 or 6,000 feet, and less than 20.9% at higher elevations. OSHA 
chose not to adopt this approach to defining oxygen deficiency for 
several reason. First, as was stated in the proposal (59 FR 58905), 
OSHA's concern is that employees not be exposed to environments in 
which the oxygen partial pressure is less than 100 mm Hg; this partial 
pressure of oxygen is generally regarded as an appropriate IDLH level 
(Exs. 164, 208). OSHA believes that using an oxygen concentration of 
19.5 percent as a baseline oxygen level is appropriate because exposure 
to such an atmosphere does not pose a serious health risk at elevations 
below 8,000 feet, i.e., the oxygen partial pressure in such atmospheres 
will remain above 100 mm Hg (Ex.164). Although OSHA realizes that the 
partial pressure of oxygen may be at or above 100 mm Hg even at some 
lower altitudes and lower oxygen concentrations, these lower-altitude, 
lower-concentration situations are generally unstable and can quickly 
deteriorate to life-threatening atmospheres. OSHA has accounted for 
those rare situations where the employer controls the environment to 
maintain a constant altitude-adjusted oxygen level through the 
exception in paragraph (d)(2)(iii) of the final rule. OSHA's definition 
of oxygen deficiency is also consistent with the Compressed Gas 
Association's definition of Grade D breathing air as air containing a 
minimum of 19.5% oxygen. OSHA finds that defining oxygen deficiency as 
an atmosphere with an oxygen content below 19.5% is both protective and 
straightforward, and is consistent with the definition that has been 
used by the Agency in the past.
    Oxygen-deficient IDLH atmosphere. The proposal originally included 
a definition of oxygen-deficient IDLH atmosphere. Because the term has 
not been used in the regulatory text of the final rule, OSHA is 
deleting this term from paragraph (b).
    Physician or other licensed health care professional (PLHCP) is 
defined as ``an individual whose legally permitted scope of practice 
(i.e., license, registration, or certification) allows him or her to 
independently provide, or be delegated the responsibility to provide, 
some or all of the health care services required by paragraph (e) of 
this section.'' This definition has been added because paragraph (e)(2) 
of the final standard requires that all medical evaluation procedures 
be performed by a PLHCP.
    OSHA has long considered the issue of whether, and if so how, to 
specify the qualifications of the particular professionals who are 
permitted to perform the medical evaluations required by its standards. 
The Agency has determined that any professional who is licensed by 
state law to perform the medical evaluation procedures required by the 
standard may perform these procedures under the respiratory protection 
standard. The Agency recognizes that this means that the personnel 
qualified to provide the required medical evaluation may vary from 
state to state, depending on state licensing laws. Under the final 
rule, an employer has the flexibility to retain the services of a 
variety of qualified licensed health care professionals, provided that 
these individuals are licensed to perform a given service. OSHA 
believes that this flexibility will reduce cost and compliance burdens 
for employers and increase convenience for employees. The approach 
taken in this final standard is consistent with the approach OSHA has 
taken in other recent standards (e.g., cadmium, methylene chloride).
    Positive pressure respirator. This term has been redefined in the 
final standard to mean ``a respirator in which the pressure inside the 
respiratory inlet covering is positive with respect to ambient air 
pressure outside the respirator.'' Consistent with the recommendations 
of several commenters (Exs. 54-208, 54-218, 54-219, 54-410, and 54-
424), the final standard's definition adopts the ANSI Z88.2-1992 
definition but adds the phrase ``outside the respirator'' for clarity.
    Powered air-purifying respirator. The final standard defines this 
term as ``an air-purifying respirator that uses a blower to force the 
ambient air through air-purifying elements to the inlet covering.'' 
This revision also reflects commenters' recommendations that OSHA adopt 
ANSI Z88.2-1992 standard definitions (Exs. 54-208, 54-218, 54-219, 54-
410, and 54-424). The term ``ambient atmosphere'' in the ANSI 
definition has been replaced with the term ``ambient air'' for 
simplicity.
    Pressure demand respirator. This type of respirator is defined as 
``a positive pressure atmosphere-supplying respirator that admits 
breathing air to the facepiece when the positive pressure is reduced 
inside the facepiece by inhalation.'' This language has been taken 
verbatim from the ANSI Z88.2-1992 standard's definition, except that

[[Page 1187]]

the term ``breathing air'' has replaced the term ``respirable gas'' for 
clarity.
    Qualitative fit test (QLFT). This definition has been revised to 
read ``a pass/fail fit test to assess the adequacy of respirator fit 
that relies on the individual's response to the test agent.'' OSHA has 
replaced the proposal's QLFT definition with one derived from the ANSI 
Z88.2-1992 standard but has added the phrase ``to assess the adequacy 
of respirator fit'' to emphasize the purpose of QLFT. In addition, the 
OSHA definition uses the phrase ``the individual's response'' instead 
of the ANSI definition's phrase ``subject's sensory response'' for 
clarity.
    Quantitative fit test (QNFT). This definition has been revised and 
simplified to accommodate both current and yet-to-be-developed fit test 
technology. The final standard defines a quantitative fit test (QNFT) 
as ``an assessment of the adequacy of respirator fit by numerically 
measuring the amount of leakage into the respirator.'' Commenters 
generally opposed the proposed definition of QNFT, which made reference 
to challenge agents, because they feared that it might interfere with 
the development of new fit test methods (Exs. 54-5, 54-222, 54-251, 54-
266, 54-275x, 54-350, 54-208, 54-218, 54-219, 54-278, 54-316, 54-424). 
OSHA agrees and has revised the definition accordingly. OSHA believes 
that the definition of QNFT must be usable, enforceable, and 
understandable, and accommodate evolving technology.
    Respiratory inlet covering. The final standard defines this term, 
which is often used in descriptions of respiratory equipment, as ``that 
portion of a respirator that forms the protective barrier between the 
user's respiratory tract and an air-purifying device or breathing air 
source, or both. It may be a facepiece, helmet, hood, suit, or a 
mouthpiece respirator with nose clamp.'' This definition is adapted 
from that in the ANSI Z88.2-1992 standard; the phrase ``that connects 
the wearer's respiratory tract'' in the ANSI definition has been 
modified to read ``that forms the protective barrier between the user's 
respiratory tract'' in the OSHA definition for clarity.
    Self-contained breathing apparatus (SCBA). The proposed definition 
of self-contained breathing apparatus (SCBA) has been revised slightly 
in the final standard to read ``an atmosphere-supplying respirator for 
which the breathing air source is designed to be carried by the user.'' 
This revised definition was adopted from the ANSI Z88.2-1992 standard's 
definition of SCBA.
    Service life. The final standard defines service life as ``the 
period of time that a respirator, filter, or sorbent, or other 
respiratory equipment provides adequate protection to the wearer.'' 
This definition eliminates a reference in the proposal to substances 
``breaking through'' the cartridge or canister, and deletes a statement 
that respirator manufacturers are to determine service life 
concentrations, since this is the employer's responsibility. The new 
definition parallels ANSI's except that it contains additional language 
covering filters, sorbents, and other respiratory equipment. This 
definition is further explained in the discussion of paragraph (d) of 
the Summary and Explanation.
    Supplied-air respirator (SAR) or airline respirator. OSHA has 
elected to retain a definition for supplied-air respirators, since the 
term is used by NIOSH in the 42 CFR part 84 regulations. The final 
standard's definition reads: ``Supplied-air respirator (SAR) or airline 
respirator means an atmosphere-supplying respirator for which the 
source of breathing air is not designed to be carried by the user.'' 
Participants (Exs. 54-208, 54-249) were more familiar with this term 
than with the term ``air-supplied respirator'' recommended as an 
alternative by some commenters (Exs. 54-218, 54-219, 54-363, 54-434). 
The language of this definition is derived from the ANSI Z88.2-1992 
definition for ``airline respirator,'' but also applies to supplied-air 
respirators, a term that NIOSH uses to certify this class of 
respirators. OSHA believes that using both names in the definition will 
reduce confusion for respirator users.
    Tight-fitting facepiece is defined as ``a respiratory inlet 
covering that forms a complete seal with the face.'' This term was not 
defined in the proposal, but numerous commenters requested that OSHA 
add this definition (Exs. 54-222, 54-283, 54-363, 54-410, 54-424, 54-
428, 54-433, 54-455) to the final standard.
    User seal check is defined as ``an action conducted by the 
respirator user to determine if the respirator is properly seated to 
the face.'' Such a check is performed by the user each time the 
respirator is donned or adjusted to ensure that the tight-fitting 
respirator is properly seated on the user's face, i.e., that the proper 
seal has been achieved. Several commenters recommended that OSHA add 
the definition for ``fit check'' from the ANSI Z88.2-1992 standard to 
replace the term ``facepiece seal check'' that was used in Appendix B 
of the proposal (Exs. 54-208, 54-218, 54-219, 54-410, 54-424). The term 
``fit check'' has proven confusing to those respirator users who do not 
realize that a daily fit check is not a substitute for an annual fit 
test. The AIHA (Ex. 54-208) recommended that OSHA add a statement to 
Appendix B to the effect that: ``Fit checks are not substitutes for 
qualitative or quantitative fit tests,'' and OSHA has done so in this 
final standard. Because OSHA believes that the similarity between the 
terms ``fit check'' and ``fit test'' is responsible for this confusion, 
OSHA has used the term ``user seal check'' rather than ``fit check'' in 
the final standard. The definition of ``user seal check'' derives from 
the ANSI Z88.2-1992 standard's definition for ``fit check,'' except 
that the word ``action'' has been substituted for ``test'' to avoid any 
possible confusion among respirator users.

Paragraph (c)--Respiratory Protection Program

    This paragraph of the final standard requires employers to develop 
and implement a written respiratory protection program, with workplace-
specific procedures addressing the major elements of the program, 
whenever respirators are necessary to protect the health of the 
employee. In addition, where an employer requires an employee to wear a 
respirator, i.e., in a situation where the standard does not otherwise 
require such use, a written program must be developed and implemented. 
Employers who provide respirators at the request of their employees or 
who allow their employees to bring their own respirators into the 
workplace must ensure that the respirator used does not present a 
hazard to the health of the employee. However, if the respirator 
voluntarily worn is a filtering facepiece (dust mask), the employer is 
not required to implement a written program. Paragraph (c)(1) also 
requires employers to update the program when changes in the workplace 
or in respirator use make such updating necessary.
    As in the proposed rule, the final standard requires that the 
respiratory protection program be written. OSHA's experience and that 
of the industrial hygiene community have demonstrated that health and 
safety programs can best be effectively implemented and evaluated when 
written. In addition, because workplaces differ substantially, each 
program must be tailored to the specific conditions of the workplace if 
it is to protect employee health, and developing a written program is 
the most efficient way of ensuring that the program reflects the unique 
characteristics of each workplace. Developing and writing down 
worksite-

[[Page 1188]]

 specific procedures requires employers to design their respiratory 
protection programs to address the respiratory hazards in their 
particular workplace, and this process requires employers to think 
about and document all relevant information pertaining to the hazardous 
atmospheres that their employees may encounter under normal operating 
conditions or during reasonably foreseeable emergencies that may occur 
in the workplace. Finally, OSHA's enforcement data indicate that 
compliance with the previous standard has not been optimal, 
particularly in smaller workplaces, and a written program will help 
employers, employees, and compliance officers gauge the adequacy of a 
given program.
    Paragraphs (c)(1)(i) through (c)(1)(ix) identify the elements that 
must be included in the employer's program unless the particular 
element does not apply to the employer's workplace. The previous OSHA 
respiratory protection standard also required employers to develop 
written standard operating procedures that covered the selection, use, 
cleaning, maintenance, inspection, and storage of respirators and the 
training and medical evaluation of respirator users (paragraphs (b)(1), 
(e)(1), and (e)(3), among other provisions of the previous standard). 
In the final standard, the general elements of the written program have 
been expanded, reordered and updated, and the term ``written standard 
operating procedures (SOP)'' used in the previous standard has been 
replaced with the words ``worksite-specific procedures.'' Thus, the 
standard identifies the basic elements of written programs for all 
workplaces, but the employer has the flexibility to tailor these 
general program elements to match the specific workplace conditions and 
processes that occur in that workplace. In the Agency's previous 
respiratory protection standard, the requirement for written standard 
operating procedures tended to lead to the adoption of generic 
procedures. Changing the terminology from ``SOPs'' to ``worksite-
specific procedures'' gives employers the incentive to develop 
procedures that are unique and specific to the employer's workplace, to 
describe the particular respirator selection process used in that 
workplace, and to explain how employees are to use respirators in that 
setting.
    OSHA has also revised the required program elements themselves, for 
several reasons. First, they have been modified to reflect those 
provisions of the final standard that have been added or enhanced to 
reflect advances in respiratory protection technology, such as the 
development of atmosphere-supplying respirators and the widespread use 
of modern methods of fit testing. Second, several of the provisions of 
the previous standard were vague and had caused compliance difficulties 
for employers over the years. OSHA wishes to provide employers with 
clear notice of what elements OSHA considers essential to an effective 
respirator program. Third, OSHA has adopted several changes suggested 
by commenters.
    OSHA also believes that clearer program elements will improve 
employer compliance. According to the Minnesota Department of Labor and 
Industry (Ex. 54-204), for example, many employers have had difficulty 
complying with OSHA's previous standard because they were unsure what 
elements a program was required to include. Several other data sources 
also point to the lack of clarity in OSHA's previous standard; these 
include OSHA's inspection data and compliance experience, comments to 
the record (Ex. 54-219), and studies of workers (Ex. 64-65). As noted 
in the NPRM, data collected on current respirator practices and 
procedures in over 2300 manufacturing plants classified in 15 SIC codes 
were reviewed by the Agency (See Summary of the Preliminary Regulatory 
Impact Analysis, 59 FR 58892). This survey sample was used to produce 
estimates of respirator-related practices for about 123,200 
manufacturing plants with regular and occasional respirator use. Only 
25.5% of these plants were estimated to have written standard operating 
procedures, and only 7.9% had procedures that addressed all eight of 
the program elements required by the previous standard (selection, use, 
cleaning, maintenance, inspection and storage of respirators, and the 
training and medical evaluation of respirator users). More than 80% of 
the very large plants (those with 1000 or more employees) had written 
procedures, while in small plants (those with fewer than 50 employees), 
only about 22% had written procedures. This survey clearly showed that 
improving the clarity of the elements to be addressed in standard 
operating procedures would help employers to develop and implement 
better respiratory protection programs and thus would provide greater 
protection to workers as well.
    Similarly, a study of OSHA citations for violations of the previous 
OSHA respirator standard from 1977 to 1982 showed that 13% of these 
citations were issued because standard operating procedures were either 
inadequate or missing (Rosenthal and Paull; Ex. 33-5). OSHA's latest 
citation data for the respiratory protection standard, for the period 
October 1990 to December 1995, show that the number of citations issued 
for inadequate or missing written respirator programs in general 
industry has increased to 18.4% of all respirator standard-related 
citations. These data indicate that the conclusions reached by 
Rosenthal and Paull are still valid. The citation history for the 
construction industry respiratory protection standard, 29 CFR 1926.103, 
is similar, with citations for inadequate respirator programs 
representing 10.5% of all respirator standard-related citations in that 
industry. OSHA believes that the percentages of respirator standard-
related citations reported in these reviews substantially underestimate 
the real incidence of deficient programs because it is OSHA policy not 
to issue citations for an inadequate program unless an overexposure is 
also documented.
    Paragraphs (c)(1)(i) through (c)(1)(ix) of the final standard 
provide additional detail about each of the required program elements 
but remain performance based to enable employers to adapt them to their 
workplaces. The program elements have been reorganized from those in 
the previous standard so that they track the order of the major 
paragraphs of the standard. OSHA believes that reordering the elements, 
as suggested by one commenter (Ex. 54-204), is logical and should make 
program development easier. OSHA also believes that the additional 
detail and greater clarity provided by the final rule's program 
elements will reduce confusion over the intent of these provisions, 
lead to higher compliance rates, and result in better respiratory 
protection for employees.
    The ANSI Z88.2-1992 standard for respiratory protection also states 
that written procedures covering the complete respirator program must 
be established and implemented (Ex. 81). Thus, like OSHA, ANSI 
recognizes the need for a written respiratory protection program and 
implementing procedures to provide complete and consistent protection 
to employees wearing respirators. Although the ANSI standard does not 
contain detailed instructions on the content of these procedures, it 
does describe, in clause 6, the elements to be included in the program 
to cover routine and emergency use of respirators.
    The program elements in the ANSI Z88.2-1992 standard (i.e., program 
administration, respirator selection, training, respirator fit, 
maintenance, inspection and storage) are similar to those in paragraphs 
(c)(1)(i) through

[[Page 1189]]

(c)(1)(ix) of OSHA's final standard. The specific content of each 
element of the written procedures is left to the employer, who can 
tailor them to match the conditions that occur in his/her worksite. 
Although many of the program elements are common to all respiratory 
protection programs, such as respirator selection, care, use, and 
program evaluation, some elements, such as the one addressing 
specifications for air quality for atmosphere-supplying respirators, 
apply only in workplaces in which those types of respirator are used.
    OSHA received many comments, both on written programs in general 
and on specific program elements. Some commenters (Exs. 54-160, 54-187, 
54-238), questioned the need for a written respirator program with 
worksite-specific procedures. For example, Transtar Railroads (Ex. 54-
160) stated that written procedures do not guarantee an effective 
respiratory protection program and argued that requiring additional 
written program elements would not cause those companies who presently 
disregard OSHA's existing standard to become more conscientious. 
Motorola (Ex. 54-187) urged OSHA to delete the requirement for a 
written program and instead simply to require that employers ensure 
that respirators are properly selected, fitted, used, and maintained as 
necessary to protect employees when respirators are required. However, 
the requirement for a written respirator program was widely supported 
by many other participants in the rulemaking (Exs. 54-204, 54-219, 54-
304, 54-387, 54-389, 54-428, 54-435). For example, the United 
Automobile Workers (Ex. 54-387) agreed that a written respiratory 
protection program that is site-specific and detailed (for example, 
that includes specific procedures for determining when a cartridge or 
filter needs to be changed) should be required. The American Federation 
of Labor and Congress of Industrial Organizations (AFL-CIO) (Ex. 54-
428) strongly supported the requirement for a written respiratory 
program and identified such a program as the fundamental core of the 
standard:

    The AFL-CIO strongly supports the Agency's proposal that 
employers who are required to use respirators or voluntarily use 
respirators in the workplace establish a written respiratory 
protection program. The written program constitutes an employer's 
plan for dealing with worker protection from hazardous airborne 
contaminants that may be present in the workplace, and as such, we 
view these provisions as the fundamental core of the standard. 
Requiring a written program is essential in providing uniformity and 
consistency while supplying the maximum protection for workers who 
use respirators in the workplace. (Ex. 54-428)

    OSHA's expert witness, James Johnson of the Lawrence Livermore 
National Laboratory, testified that respiratory protection programs 
must be written because of their complexity:

    * * * A respirator program involves many decisions. What kind of 
respirator do I use, what kind of concentrations were measured, what 
kind of contaminants were in the workplace
    * * * So all this information is important to provide 
documentation and understanding so that you can make sure the 
program is adequate and you can make changes to it, to improve it 
and to have it be a dynamic operation as the workplace changes * * * 
(Tr. 212)

    Commenting in the same vein, the National Pest Control Association 
(Ex. 54-435), which represents many small businesses, agreed that 
requiring employers to provide a written respiratory program was 
sensible, and the Cambrex Corporation (Ex. 54-389) noted that ``A 
performance approach in defining written program requirements will 
provide needed flexibility to employee protection programs.'' David 
Lee, CIH, CSP (Ex. 54-304), strongly supported the approach OSHA has 
taken in the final rule; he stated that a written respiratory 
protection program should be required in all places where respirators 
are used, regardless of the circumstances, and that the program's 
contents should be specifically tailored to conditions of use at the 
place of employment.
    OSHA agrees with these commenters that it is appropriate to retain 
the previous standard's requirement for a written program, and that the 
program must be flexibly tailored to worksite conditions. OSHA finds 
that comments to the record, and the Agency's own compliance 
experience, strongly suggest that many employers wish to comply but are 
unsure about what is required; for these employers, greater clarity and 
guidance will enhance compliance and enable them to provide their 
employees with needed protection.
    Paragraph (c)(1) of the final rule requires employers to update the 
program as necessary to reflect changes in the workplace. This 
requirement has been revised somewhat from the proposal. The proposed 
standard stated that ``[t]he written program shall reflect current 
workplace conditions and respirator use'' (59 FR 58939). OSHA received 
several comments on this provision (Exs. 54-278, 54-213, 54-249). For 
example, the Dow Chemical Company (Ex. 54-278) urged OSHA to revise 
this language to require that the program reflect only those current 
workplace conditions ``significantly impacting respirator use.'' In the 
final rule, OSHA has moved this provision to paragraph (c)(1) and 
revised it to require that the program be ``updated as necessary to 
reflect those changes in workplace conditions that affect respirator 
use.'' OSHA believes that this change is responsive to Dow's point. As 
now written, when the workplace changes in a way that may affect 
respirator use, such as when new processes are introduced, changes are 
made in the types of chemicals used, or the types of respirators being 
used changes, employers must revise the program as necessary to reflect 
these new conditions.
    One of the major issues raised in the rulemaking dealt with 
situations in which respirator use is not specifically required by 29 
CFR 1910.134 or other OSHA statutory or regulatory requirements, but 
instead is required by employers as a condition of employment or is 
permitted by employers upon the request of employees (i.e., voluntary 
use). The preamble discussion for proposed paragraph (a) stated that 
employers who required employees to use respirators would be covered by 
the standard (59 FR 58895). OSHA also recommended in the NPRM that 
employers who permit voluntary respirator use in their workplaces 
implement the full respiratory protection program. In the final rule, 
paragraph (c)(1) requires that a respiratory protection program be 
developed and implemented ``wherever respirators are required by the 
employer,'' but has greatly reduced the obligations of employers who 
allow their employees to use respirators when such use is not required.
    In the preamble to the proposal, OSHA discussed the reasoning 
behind including employer-required respirator use within the scope of 
the standard (59 FR 58895). OSHA stated that the requirement was 
appropriate both because the use of a respirator could in itself 
present a health hazard to the wearer, and because improper use of a 
respirator in environments where respiratory hazards are present would 
not sufficiently protect employees from those hazards. OSHA finds that 
these are still valid reasons for requiring that a respiratory 
protection program be implemented where employers require respirator 
use. All of the elements of a respiratory protection program apply to 
this situation. Employers must still select respirators that are 
appropriate to the workplace conditions and types of respiratory 
hazards present to ensure that respirators offer adequate protection. 
Improperly selected

[[Page 1190]]

respirators may afford no protection at all (for example, use of a dust 
mask against airborne vapors), may be so uncomfortable as to be 
intolerable to the wearer, or may hinder vision, communication, 
hearing, or movement and thus pose a risk to the wearer's safety or 
health.
    Employees who are required by their employers to wear respirators 
must also be medically evaluated to determine that they are capable of 
tolerating the increased physiological load associated with some 
respirator use. Proper fit testing is necessary to ensure that 
discomfort is minimized and that the respirator selected is offering 
sufficient protection. It is also necessary that respirators required 
by employers be cleaned, disinfected, stored, inspected, and repaired 
according to the procedures contained in the final rule to ensure 
proper respirator functioning and protection of employees from 
dermatitis or exposure to hazardous contaminants that may result from 
using a dirty respirator. Compliance with the provisions of the 
standard dealing with supplied air quality and use is also essential 
where employers require the use of supplied-air respirators. When 
employers require employees to use respirators, OSHA believes it 
necessary that employees be properly trained in their use and care, and 
be informed of the limitations of using respirators. Paragraph (k) of 
the final rule makes clear that employers must implement the employee 
training requirements contained in paragraph (k) if they require their 
employees to use respirators.
    In contrast, not all of these protections are necessary in the 
situation where an employer allows, but does not require, respirator 
use. OSHA has therefore added a new paragraph (c)(2) to the final rule, 
which applies when employers allow employees to use respirators when 
such use is not required by the employer or by the standard. This 
paragraph applies when employers either provide respirators to 
employees who request them or allow employees to use their own 
respirators. In both situations, paragraph (c)(2)(i) states that 
employers must determine that the employees that they allow to use 
respirators are medically able to do so, and that there are no other 
conditions that could cause the respirator use to create a hazard.
    If the employer allows voluntary respirator use, paragraph 
(c)(2)(i) requires that the employer provide the employee with the 
information contained in Appendix D to this standard, entitled 
``Information for Employees Using Respirators When Not Required Under 
the Standard.'' In the rare case where an employee is voluntarily using 
other than a filtering facepiece (dust mask) respirator (paragraph 
(c)(2)(ii)), the employer must implement some of the elements of a 
respiratory protection program, e.g., the medical evaluation component 
of the program and, if the respirator is to be reworn, the cleaning, 
maintenance, and storage components. An exception to this paragraph 
makes clear that, where voluntary respirator use involves only 
filtering facepieces (dust masks), the employer is not required to 
implement a written program.
    Paragraph (c)(2) is necessary because the use of respirators may 
itself present a health hazard to employees who are not medically able 
to wear them, who do not have adequate information to use and care for 
respirators properly, and who do not understand the limitations of 
respirators. Paragraph (c)(2) is intended to allow employers 
flexibility to permit employees to use respirators in situations where 
the employees wish to do so, without imposing the burden of 
implementing an entire respirator program. At the same time, it will 
help ensure that such use does not create an additional hazard and that 
employees are provided with enough information to use and care for 
their respirators properly. This provision does not, of course, 
preclude employers from adopting additional program elements if they 
believe such elements are appropriate.
    The great majority of voluntary use situations involve the use of 
dust masks, i.e., filtering facepieces, which are provided for the 
employee's comfort. For example, some employees who have seasonal 
allergies may request a mask for comfort when working outdoors, or an 
employee may request a dust mask for use while sweeping a dusty floor. 
There are no medical limitations on the use of these respirators, so 
employers who allow their use need only ensure that the masks are not 
dirty or contaminated, that their use does not interfere with 
employees' ability to work safely, and that they provide the employees 
with the information contained in Appendix D, as required by paragraph 
(k) of the final rule.
    In rare cases where the employee requests and the employer allows 
the use of a negative-pressure respirator (tight-fitting), or where the 
employee brings such a respirator into the workplace, the employer must 
implement some provisions of the respirator program described in 
paragraph (c)(1) to ensure that such respirator use will not affect the 
employee's health adversely. The employer can include these elements in 
its existing respiratory protection program, if it is required to 
maintain one. Some medical evaluation is necessary to determine that 
the employee is physically able to use a tight-fitting negative 
pressure respirator. In addition, if the respirators being used 
voluntarily are reused, it is necessary to ensure that they are 
maintained in proper condition to ensure that the employee is not 
exposed to any contaminants that may be present in the facepiece, and 
to prevent skin irritation and dermatitis associated with the use of a 
respirator that has not been cleaned or disinfected. OSHA believes it 
unlikely that voluntary use situations will involve the use of 
supplied-air devices, but such use would also trigger these 
requirements of the standard.
    These requirements are necessary because use of a negative pressure 
(tight-fitting) respirator imposes a significant physiologic burden on 
a respirator user, and it is crucial to determine that the user can 
withstand that burden without suffering adverse health consequences. 
Similarly, reusable tight-fitting negative pressure respirators can 
become contaminated if they are not cleaned, maintained, and stored 
properly. Thus if an employer allows use of this type of respirator, 
the employer must implement the program elements necessary to ensure 
that contamination does not harm the employee.
    The hazards addressed by this requirement are the same ones that 
are already considered under OSHA's longstanding enforcement policy. 
The Agency generally does not issue citations for violations of its 
respirator standards unless there is also evidence of overexposure to a 
hazardous substance, or some other hazard caused by improper or 
inadequate respirator use. (OSHA Field Inspection Reference Manual 
(FIRM), Ch. III. Sec. C.3.c). Other hazards referenced in the FIRM 
include ingestion of harmful substances that may remain on improperly 
cleaned and maintained respirators, or dermatitis caused by the same 
condition. These are precisely the hazards that the requirements of 
paragraph (c)(2) are designed to prevent. They can occur whether 
respirator use is voluntary or required, and OSHA does not believe it 
would be consistent with the OSH Act to allow employees to expose 
themselves to preventable hazards, particularly where there are fairly 
undemanding measures available to prevent that exposure.
    Requiring employers to undertake these minimal obligations when 
they allow voluntary respirator use is

[[Page 1191]]

consistent with the fact that employers control the working conditions 
of employees and are therefore responsible for developing procedures 
designed to protect the health and safety of the employees. Employers 
routinely develop and enforce rules and requirements for employees to 
follow based on considerations of safety. For example, although an 
employer allows employees discretion in the types of clothing that may 
be worn on site, the employer would prohibit the wearing of loose 
clothing in areas where clothing could get caught in machinery, or 
prohibit the use of sleeveless shirts where there is a potential for 
skin contact with hazardous materials. Similarly, if an employer 
determines that improper or inappropriate respirator use presents a 
hazard to the wearer, OSHA finds that the employer must exert control 
over such respirator use and take steps to see that respirators are 
safely used under an appropriate program. It has been OSHA's experience 
that employers will be able to determine whether employees are using 
their own respirators in the workplace, just as they are able to 
determine that employees are adhering to all other procedures and 
requirements established by the employer.
    Concomitantly, OSHA's decision to impose fewer requirements on 
voluntary respirator use than on required use is supported by the 
record. Many comments addressed the issue of how the final standard 
should treat these two types of respirator use. Many commenters (Exs. 
54-96, 54-109, 54-196, 54-222, 54-272, 54-341, 54-424, 145, 176, Tr. 
2127, Tr. 2174 ) supported the inclusion of employer-required 
respirator use, but not of voluntary use, within the full scope of the 
standard. Many of these rulemaking participants believed that voluntary 
respirator use should require a minimal program designed to provide 
information and training to the employee, and that other elements of 
the program should not be made mandatory. Typical of these was the 
post-hearing comment of Organization Resources Counselors, Inc. (ORC):

    OSHA should not require a complete respirator program for the 
voluntary use of respirators by employees, when not required by an 
OSHA standard, or by the employer. Some employees will wish to use 
respirators even though they are not required to protect against 
overexposure to a toxic hazard. In these instances the employer 
should be required only to inform the employee of the safe and 
proper use of such respirators and any associated limitations on the 
particular device chosen (Ex. 145).

In addition, some of these commenters (Exs. 54-341, 176, Tr. 594, Tr. 
2100) suggested that requiring employers to comply with all or most of 
the requirements would discourage employers from permitting voluntary 
respirator use in their workplaces. For example, in its post-hearing 
submission, the North American Insulation Manufacturers Association 
(NAIMA) commented as follows:

    NAIMA agrees with many other hearing participants that employers 
should be required to train voluntary respirator users in the proper 
function and use of respirators * * * OSHA should, however, tailor 
other aspects of the Proposed Rule to ensure that the more onerous 
and unnecessary additional requirements, such as comprehensive 
medical examinations, are not imposed in truly voluntary use 
situations. Applying unnecessary ancillary requirements to voluntary 
use situations would discourage employers from allowing workers such 
use (Ex. 176).

    OSHA believes that the final rule provides for the kind of 
tailoring suggested by NAIMA's comment. Employers who permit the 
voluntary use of tight-fitting negative-pressure respirators must 
utilize the procedures necessary to address the health hazards 
associated with the use of such respirators, but in the vast majority 
of voluntary-use situations where employees are using dust masks 
(filtering facepieces), the standard does not require the employer to 
implement a written respirator program to ensure employee health. Thus, 
the final rule does not require employers providing dust masks 
(filtering facepieces) to their employees to comply with the 
requirements that NAIMA considers ``onerous and unnecessary'' in this 
situation. However, where respirators are used voluntarily by 
employees, and the use of a given type of respirator, e.g., a tight-
fitting negative pressure respirator, is associated with an increased 
health risk, OSHA finds that applying relevant portions of the 
respiratory protection program is essential to ensure worker 
protection.
    Other commenters (Exs. 54-214, 54-218, 54-278, 54-389) believed 
that application of the standard should be limited in situations where 
there was no exposure to a respiratory hazard, regardless of whether 
respirator use is required by employers in this situation or is 
voluntary. In discussing this issue, the 3M Company commented as 
follows:

    1. Any use of respirators or masks in the workplace should 
trigger a requirement for at least a minimal respiratory protection 
program. Regardless of whether use is required or recommended by an 
employer or is self-imposed by an employee, the employer should be 
responsible for the safe use of respirators and masks in the 
workplace.
    2. Where it is documented by an employer that no hazard exists--
such as when used against non-toxic materials, exposures well below 
the permissible exposure limit (PEL) or hazard level, or voluntary 
use against such conditions as discomfort or allergies--the rule 
should only require an abbreviated respiratory protection program * 
* *. (Ex. 54-218)

In a similar argument, the Dow Chemical Company (Ex. 54-278) suggested 
that employers be exempt from the standard's requirements if they 
require employees to use respirators as a precautionary measure where 
exposures are below the PELs.
    OSHA did not adopt this approach in the final rule because the 
Agency believes that, in most cases of employer-required respirator 
use, respirators are being used as protection against actual or 
potential exposure to a respiratory hazard. In these cases, OSHA finds 
that it is necessary and appropriate that the employer implement all 
elements of the respiratory protection program that apply to the 
worksite-specific conditions under which respirators are used. If 
respirators are used as protection against a real or potential risk 
caused by exposure to a respiratory hazard, OSHA believes it essential 
for the employer to provide for proper respirator selection, fit 
testing, medical evaluation, and care and maintenance to ensure that 
the respirator is providing sufficient protection against the hazard 
and that use of the respirator is not imposing an additional health 
risk. OSHA also believes that, by distinguishing between employer-
required and voluntary respirator use in the final rule, it will be 
easier for employers to determine the extent to which the standard will 
apply to their specific workplaces.
    Other rulemaking participants (Exs. 54-208, 177, Tr. 782, Tr. 1722) 
were of the opinion that voluntary respirator use should not be 
distinguished from employer-required use in determining how the 
standard should apply, or reported that some employers already 
implement a program for voluntary use. The AIHA, in support of full 
coverage of the standard for voluntary respirator use, stated in 
written comment:

    The position of AIHA is that all use of respiratory protection 
should be covered by an employer's respiratory protection program. 
That includes both voluntary use as well as required use. Both 
groups should participate in all elements of the respiratory 
protection program. An individual desiring to wear a respirator to 
obtain some level of comfort or to further reduce their exposure to

[[Page 1192]]

a chemical in the workplace should receive the full benefits of an 
established program: training to convey proper knowledge in 
equipment selection, maintenance, and use; medical evaluation to 
confirm that its use will not present a risk to the individual; and 
fit testing to confirm that the equipment fits properly and 
workplace surveillance to confirm that the equipment being utilized 
is suitable for the exposure level. (Ex. 54-208)

At the public hearing, Larry Janssen of the AIHA elaborated that ``* * 
* there should be some kind of a minimum framework to prevent the 
misuse of respirators in those voluntary use situations, that you don't 
do harm by allowing a respirator to be used where it's not really 
needed'' (Tr. 782). Similarly, in a post-hearing comment, the 
Industrial Safety Equipment Association (ISEA) stated that it was 
important to cover voluntary use in the standard since ``* * * 
[r]espirators that are not used properly could present a hazard'' (Ex. 
177). This practice is already being implemented in some workplaces; 
Richard Holmes of Union Carbide, representing the Chemical 
Manufacturers Association (CMA) at the hearings (Tr. 1722), testified 
that ``* * * [w]e treat the voluntary user just like a mandatory user 
so they're in the program just as though they were required to wear the 
respirator and the * * * medical surveillance is all handled the same * 
* * [as is the training].''
    As discussed above, OSHA agrees that some voluntary respirator use 
(e.g., that involving tight-fitting negative-pressure respirators) may 
present a health hazard to employees if the respirator is not properly 
selected, maintained, and used. Therefore, OSHA has revised the final 
rule to ensure that employers who permit voluntary use of such 
respirators in their workplaces implement those portions of the 
standard necessary to protect employees from any health risks 
associated with respirator use. The position taken in the final rule 
also reflects OSHA's long-standing enforcement policy with the previous 
respiratory protection standard, as stated in the FIRM and in several 
letters of interpretation issued by the Agency (See letters dated 10/2/
87 from Thomas J. Shepich, 4/11/91 from Patricia K. Clark, 3/19/91 from 
Patricia K. Clark, 3/4/93 from Roger A. Clark (2 letters), and 3/15/95 
from Ruth McCully). For example, in the letter of March 4, 1993 from 
Roger A. Clark, OSHA stated its policy regarding the application of 29 
CFR 1910.134 to the voluntary use of respirators:

    OSHA's policy is that if the respirator itself could present an 
adverse health condition if a specific requirement of the 
respiratory protection standard is not observed, then the 
requirement applies. Examples may include a dirty respirator that is 
causing dermatitis, a worker's health being jeopardized by wearing a 
respirator due to an inadequately evaluated medical condition, or a 
significant ingestion hazard created by an improperly cleaned 
respirator. This is so regardless of whether the employee purchased 
the respirator or the employer provides it.

    OSHA also has determined that complete training is not required for 
employees using respirators voluntarily. Instead, paragraph (k) of the 
final rule requires employers to provide the information contained in 
Appendix D to ensure that employees are informed of proper respirator 
use and the limitations of respirators.
    Paragraphs (c)(1)(i) through (c)(1)(ix) list the elements of the 
respirator program required by this standard. Paragraph (c)(1)(i) 
requires the program to contain procedures for the selection of 
respirators appropriate to protect employees from the respiratory 
hazards present in the particular workplace. This provision is 
unchanged from the corresponding provision in the proposal and is also 
similar to paragraph (b)(2) of OSHA's previous standard. Paragraph 
(c)(1)(ii) addresses the medical evaluation of employees required to 
wear respirators and is unchanged from the parallel requirement in the 
proposal. The AIHA (Ex. 54-208) recommended that paragraph (c)(1)(ii), 
which requires employers to develop procedures addressing ``medical 
evaluations of employees required to wear respirators,'' be changed to 
specify that these procedures need only cover employees who are 
``authorized by the employer to wear respirators''; the AIHA wanted 
this word change to ensure that employers understood that these 
procedures must cover both voluntary and required use. However, as 
explained above, OSHA has decided to require medical evaluation of 
employees who use respirators voluntarily only when such use may 
present a health hazard to employees, e.g., in the case of tight-
fitting negative pressure respirators. Therefore, OSHA has not included 
the language suggested by the AIHA in the final rule.
    Paragraph (c)(1)(iii) covers the fit test element of the program 
and has been modified since the proposal to respond to comments. The 
proposal would have required the program to contain fit testing 
procedures ``for air-purifying respirators and tight-fitting positive 
pressure respirators.'' The Service Employees International Union (Ex. 
54-455) commented that this provision only needed to address ``tight-
fitting respirators'' because this language adequately describes the 
respiratory equipment to be covered. Since OSHA has revised the fit 
testing requirements in paragraph (f) to cover all tight-fitting 
respirators, the language in paragraph (c)(1)(iii) has been revised 
accordingly.
    Paragraph (c)(1)(iv) states that employers shall include 
``Procedures for proper use of respirators in routine and reasonably 
foreseeable emergency situations.'' In the NPRM, this requirement was 
addressed under paragraph (g)(1), but it has been moved into paragraph 
(c)(1) of the final rule to ensure that employers are aware that 
written workplace-specific procedures must address both routine and 
non-routine respirator usage, including that in reasonably foreseeable 
emergency situations. OSHA received no comments on this provision.
    Paragraph (c)(1)(v) requires the workplace-specific procedures to 
cover ``procedures and schedules for cleaning, disinfecting, storing, 
inspecting, repairing, discarding, and otherwise maintaining 
respirators.'' This provision is unchanged from that proposed. The 
American Iron and Steel Institute (AISI) urged OSHA to remove the word 
``schedules'' from paragraph (c)(1)(iv) and to substitute the word 
``frequencies'' instead. AISI stated that the term ``schedules'' 
connotes a requirement for extensive recordkeeping and paperwork. OSHA 
does not agree. Since OSHA requires the respirator program to be 
written, as required under the prior standard and as proposed and 
supported by comments in this rulemaking, it is OSHA's conclusion that 
including the employer's schedule for cleaning, disinfecting, or 
otherwise maintaining respirators is not unduly burdensome. A schedule 
is needed to inform employees when they are to have their respirators 
fit tested, cleaned, and maintained. Therefore, OSHA is retaining the 
word ``schedule.'' Representatives of the Service Employees 
International Union [(SEIU) Ex. 54-455)] strongly supported the 
requirement for maintenance schedules as proposed under paragraph 
(c)(1)(v) of the NPRM for the same reason.
    Paragraph (c)(1)(vi) is essentially unchanged from the proposal and 
requires ``Procedures to ensure adequate air quality, quantity, and 
flow of breathing air for atmosphere-supplying respirators.'' 
Representatives from SEIU (Ex. 54-455) supported OSHA's addition of 
``quantity and flow'' to paragraph (c)(1)(vi) in the NPRM. Proper air 
quality and quantity are crucial to the use of supplied air respirators 
to protect worker health. The revised provision has been slightly 
modified from the provision in the NPRM that

[[Page 1193]]

read ``* * * ensure proper air quality, quantity, and flow * * *'' for 
atmosphere-supplying respirators. The addition of the words ``* * * for 
breathing air * * *'' is to clarify that under no circumstances should 
air for atmosphere-supplying respirators be of less than Grade D 
breathing air quality.
    Paragraph (c)(1)(vii), as proposed, would have required employers 
to include ``[t]raining of employees in the respiratory and health 
hazards of the hazardous chemicals to which they are potentially 
exposed as required under the Hazard Communication standard (29 CFR 
1910.1200).'' Several commenters questioned the need to cross-reference 
an existing OSHA standard in the respirator standard, and recommended 
that this provision be deleted (Exs. 54-154, 54-271, 54-278, 54-295, 
54-307). OSHA agrees that the cross-reference is unnecessary, and the 
reference to the Hazard Communication standard has been removed from 
the final standard. However, the requirement that employers develop 
procedures that address the ``Training of employees in the respiratory 
hazards to which they are potentially exposed during routine and 
emergency situations'' remains, because there are respiratory hazards, 
such as biological hazards and radioactive particles, that are not 
covered by the Hazard Communication standard.
    Paragraph (c)(1)(viii) requires employers to develop procedures for 
the training of employees in the proper use of respirators, including 
putting on and removing them, the limitations of these devices, and 
maintenance procedures for respirators. OSHA received no comments on 
this provision, which has been revised slightly since the proposal for 
clarity.
    Paragraph (c)(1)(ix) states that the program should include 
``Procedures for regularly evaluating the effectiveness of the 
program.'' This provision is basically the same as in the NPRM except 
that the word ``periodically'' has been deleted to avoid the suggestion 
that OSHA has a fixed interval in mind. This provision notifies 
employers that their written workplace procedures must include routine 
evaluation of the program to ensure that it is effective, up-to-date, 
and includes all necessary provisions. In workplaces where worksite-
specific conditions are relatively stable, such as a manufacturing 
site, program evaluation may be conducted on a fixed schedule. In other 
workplaces where worksite conditions are less stable, employers must 
develop schedules for evaluating the program that make sense in that 
context.
    In a general comment, the United States Enrichment Corporation (Ex. 
54-283) stated that the final rule's requirements for work procedures 
in paragraphs (c)(1)(i) through (c)(1)(ix) implied that OSHA intended 
separate documents to be developed to meet each of the requirements, 
and asked OSHA to clarify this. It has always been OSHA's intention 
that the employer can address the required program elements and the 
development of worksite-specific procedures in a single document, the 
written respiratory protection program. OSHA believes that reorganizing 
the elements of this program to track the order of the standard will 
facilitate the inclusion of all worksite-specific procedures into one 
document.
    In another general comment, Peter Hernandez of the American Iron 
and Steel Institute (AISI) (Ex. 54-307) urged OSHA to revise paragraph 
(c) and other paragraphs of the final rule to remove the term 
``ensure,'' which he interpreted as imposing an impossible burden on 
employers. OSHA disagrees with this interpretation, however. OSHA 
standards use the word ``ensure'' because they impose a mandatory 
requirement to comply on employers and because the OSH Act and 
subsequent case law have made it clear that it is the employer's 
responsibility to compel compliance. The reasoning behind this body of 
case law is that it is the employer, and not the employee, who controls 
the conditions of work at a given workplace. OSHA believes that the 
word ``ensure'' is appropriate because it indicates that the employer 
must manage, lead by example, train, direct, and, if necessary, set up 
a disciplinary system so that employees understand that they must 
follow safe and healthful practices on the job. However, case law also 
makes it clear that employers are not the ``insurers'' of their 
employees' behavior. In other words, if an employer establishes, 
implements, trains employees in, and enforces safe operating 
procedures, and does so in a consistent manner, the employer will not 
be liable for an employee's unforeseeable violation of its safety rule.
    Paragraph (c)(3) of the final rule requires employers to designate 
a person as program administrator and to ensure that this person is 
qualified to perform the responsibilities of this position. The person 
can be qualified either by appropriate training or experience or both. 
The administrator is also the person responsible for evaluating the 
program, as stated in paragraph (c)(3). This requirement is essentially 
unchanged from the proposal, although its language has been clarified. 
The ANSI Z88.2-1992 respiratory protection standard (Ex. 81) also 
contains a description of the responsibilities of the program 
administrator and a requirement that the respirator program be 
``periodically audited to ensure that (a) the program procedures 
reflect the requirements of current applicable regulations and industry 
accepted standards and (b) the program as implemented reflects the 
written procedures'' (See clause 5.3). The ANSI standard recommends 
that the audit be conducted by a knowledgeable person not directly 
associated with the program, rather than by the program administrator. 
OSHA has not adopted the ANSI recommendation that periodic audits be 
performed by knowledgeable outside persons because the OSHA standard 
requires the administrator to be qualified to perform this task; thus, 
an additional requirement for audits to be performed by an outside 
party is unnecessary and may prove unduly burdensome for some 
employers.
    The training requirements and experience level necessary for the 
program administrator were the subject of substantial comment. OSHA 
proposed that the program supervisor be a person ``qualified by 
appropriate training and/or experience'' to be responsible for the 
respirator program. Many commenters supported this performance-based 
requirement (Exs. 54-68, 54-80, 54-91, 54-175, 54-187, 54-208, 54-219, 
54-220, 54-222, 54-252, 54-319, 54-352, 54-361, 54-435, 54-455). For 
example, the Service Employees International Union (Ex. 54-455) 
supported the proposed ``performance-oriented qualifications for the 
designated person (program administrator).'' Allied Signal (Ex. 54-175) 
stated that ``there should be no specific minimum training for program 
administrators. We believe the level of training for the respirator 
program administrator must be adequate to deal with the complexity of 
the program.'' Motorola (Ex. 54-187) commented that ``Training 
requirements for those individuals designated by the employer to 
administer the program should be commensurate with the type of 
respirator program needed at the workplace.''
    Several commenters urged OSHA to add a phrase to this requirement 
in the final rule to require that the level of program supervisor 
training must be adequate to deal with the complexity of the program 
because the level of training appropriate for a workplace with 
extensive respirator use is substantially different from one with 
limited respirator use (Exs. 54-175, 54-

[[Page 1194]]

 187, 54-200, 54-206, 54-214, 54-219, 54-222, 54-245, 54-265, 54-266, 
54-275, 54-361). As Monsanto (Ex. 54-219) stated:

    An employer's respirator usage may be limited to dust 
respirators or may have a wide variety of types covering both air-
purifying and atmosphere-supplying respirators. Program 
administrator training/qualifications would need to cover a wider 
range of topics in the latter case than in the former case.

    However, some commenters, e.g., the Sparks Nevada Fire Department 
(Ex. 54-129), wanted to avoid imposing overly stringent requirements on 
choosing a program administrator, while others, e.g., the Grain 
Elevator and Processing Society (Ex. 54-226), urged OSHA to delete the 
phrase ``qualified by training and/or experience'' on the grounds that 
there are no widely accepted criteria for determining such a program 
administrator's qualifications. A few commenters acknowledged that 
since the program administrator's tasks often vary by type of 
workplace, it would be difficult for OSHA to establish a required 
minimum level of training that would be appropriate for all program 
supervisors in all workplaces. Michael Rehfield, Safety Officer for the 
Westminster, Maryland Fire Department (Ex. 54-68) stated:

    I am in total agreement that the person fulfilling this role and 
the ``qualifications'' should be ``performance oriented''. That 
language should appear in this section. It is imperative that the 
emergency response community be represented by performance oriented 
standards or regulations since the associated tasks are so diverse.

    A working group from the State Universities of New York (Ex. 54-
357) felt that the performance language regarding program supervisors 
was too vague, and suggested that a nonmandatory appendix be added to 
identify the types of qualifications a program supervisor would need. 
The United Automobile, Aerospace & Agricultural Implement Workers of 
America (UAW) (Ex. 54-387) wanted OSHA to define a body of knowledge 
necessary to carry out the duties of a qualified program administrator.
    OSHA discussed these qualifications in the preamble to the NPRM at 
59 FR 58898-58899. That proposal discussion reiterated many of the 
points that are described above: that the level of training appropriate 
for a workplace with limited respirator use would be quite different 
from another with extensive use of different respirator types, and that 
the program administrator can work with a workplace respirator 
committee, or assign responsibility for portions of the program to 
industrial hygienists, safety professionals, or other respirator 
experts while retaining overall responsibility for the program. In 
other words, the level of training of the program administrator must be 
adequate to deal with the complexity of the respirator program.
    The AFL-CIO (Exs. 54-428, 255) urged OSHA to add a new definition 
to paragraph (b) for qualified person as follows:

    Qualified Person: This should be defined as, someone who is 
capable of identifying existing and predictable respiratory hazards 
in the workplace and who maintains a common knowledge of the 
respirator standard. This individual should possess the authority to 
take prompt corrective action to eliminate hazards including the 
measures required in subsection (c). The qualified person shall be 
certified by the manufacturer(s) for their ability to select and 
maintain the type(s) of respirator(s) that is/are used on the job 
site or possess the experience and knowledge needed to properly 
select respirators for the employees and job situation.

    Instead of adopting the AFL-CIO definition for ``qualified 
person,'' OSHA has relied on the type of wording used in the ANSI 
standard, which is more performance oriented. Specifying in detail the 
type and extent of training required for program administrators depends 
upon the type of workplace and is best left to the employer, in OSHA's 
opinion. For example, the level of training that would be appropriate 
for a workplace with limited respirator use would be quite different 
from that required at another workplace with extensive respirator use 
for IDLH atmospheres, highly toxic chemicals, or other complex 
respirator use operations. Therefore, OSHA has adopted a definition of 
training and experience that uses performance language and is similar 
to the ANSI Z88.2-1992 standard's requirement. However, OSHA does 
require employers to ensure that the level of training for the 
respirator program administrator is adequate to deal with the 
complexity of the workplace.
    In keeping with this approach, OSHA has not established any one 
training program, such as the NIOSH respirator course, as the level of 
training program administrators must achieve. OSHA believes that 
NIOSH's course is excellent, and therefore more than sufficient in most 
cases. However, OSHA acknowledges commenters' concerns that a general 
respirator training course covers a broad range of many different 
respirator types and uses, and provides information that is not 
tailored to any one particular workplace (Exs. 54-220, 54-265, 54-342, 
54-435). Typical of these comments is one by the United Parcel Service 
(Ex. 54-220), which stated: ``An attempt to fashion uniform standards 
for all administrators of all respiratory programs could result in 
inadequate training for administrators of particularly sophisticated or 
specialized programs and irrelevant training for administrators of 
relatively simple programs.'' The North American Insulation 
Manufacturers Association agreed, stating (Ex. 54-342) ``A requirement 
that supervisors undergo a rigid minimum training regimen, which would 
require instruction on many issues irrelevant to the supervisor's own 
situation, would be excessive and beyond the rule's intended 
objective.'' For example, extensive training on certain types of 
respirators such as SCBAs would be inappropriate for program 
administrators with simple programs that don't use SCBAs. In other 
cases, respirator program administrators with highly complex respirator 
programs may need an even more comprehensive course than that provided 
by a general respirator training course. Based on the above discussion, 
OSHA has retained a performance-based program approach. OSHA 
anticipates that larger establishments will develop training 
requirements for respirator program administrators that fit the needs 
of a workplace-specific respirator program.
    OSHA has prepared a Small Entity Compliance Guide setting forth how 
a small business owner, manager or an employee of the small business 
can be qualified to be a program administrator. It also sets forth a 
sample respirator program to guide small businesses. If the employees 
of a small business are only exposed to nuisance dusts and relatively 
non-toxic chemicals and use only a few types of relatively simple 
respirators, knowledge of the guide and materials supplied by the 
respirator manufacturer may be sufficient for the small business owner 
or an employee to become qualified as a program administrator. If more 
dangerous chemicals or high exposures are present, or sophisticated 
respirators are used, the program administrator must have more 
knowledge or experience. In these circumstances, it may be necessary 
for the administrator to seek out the expertise needed or to obtain 
appropriate training.
    The need for a specific individual to be in charge of the 
respirator program was discussed by several commenters. One commenter 
argued that requiring that a specific person be selected as program 
administrator requires the equivalent of a full-time person to

[[Page 1195]]

manage the program and conduct periodic reviews of its performance (Ex. 
54-160). Motorola (Ex. 54-187) stated that one overall program 
administrator would be a problem for decentralized workplaces. Motorola 
recommended that OSHA permit a committee or multiple employees to be 
responsible for the respirator program, thus allowing the employer to 
tailor the program to meet the needs of each particular workplace. Dow 
(Ex. 54-278) also supported the use of a committee or team with joint 
responsibility for the respirator program at large sites. Duke Power 
(Ex. 54-326) stated that at large facilities, such as nuclear stations, 
it is often necessary to designate more than one program administrator 
to address radiological and non-radiological use of respirators. The 
Public Service Electric and Gas Company (Ex. 54-196) said it may be 
more effective to have a program administrator for each ``business 
unit'' in a decentralized, diversified company, particularly where each 
unit's respiratory protection needs are different (Ex. 54-196). The 
AFL-CIO (Ex. 54-428) wanted to have one qualified person responsible 
for the program, with a ``site person'' at each work site, who would be 
responsible for the program at that site, but who would report to the 
qualified person. The Department of Defense (Ex. 54-443), specifically 
the Navy, urged OSHA to add language to require that each ``activity'' 
designate a person responsible for the respiratory protection program 
because a single program administrator would be a potential problem for 
a large, multi-tiered employer with activities throughout the world, 
such as the Navy.
    The final standard continues to require that a person qualified by 
training or experience be designated to be responsible for the overall 
management and administration of the program to ensure that the 
integrity of the respiratory protection program is maintained through 
the continuous oversight of one responsible individual. The program 
administrator may serve largely in an oversight and coordination role 
between the various subunits or departments that perform duties in 
support of the respiratory program. Regardless of the number of 
subunits, each employer must ensure that all subunits report to one 
overall program administrator for coordination of the program. The 
program administrator can use the assistance of industrial hygienists, 
safety professionals, or other respirator experts to help run the 
respirator program. The program administrator can work with a committee 
or assign responsibility for portions of the program to other 
personnel, but the overall responsibility for the operation of the 
program must remain with the designated program administrator. This 
approach promotes coordination of all facets of the program. For large 
companies or multiple worksites, the program administrator can delegate 
to a qualified person the responsibility for the day-to-day operation 
of the program at a specific site or for a specific activity. However, 
coordination between different worksites is an important aspect of the 
operation of a good program; therefore, ensuring implementation of the 
overall respirator program remains the duty and responsibility of the 
program administrator. For small and moderate sized employers, OSHA 
believes that the duties of a program administrator will require only a 
small part of one employee's time.
    Paragraph (c)(4) of the final rule requires employers to provide 
respirators at no cost to the employee. This was included in the 
proposal in paragraph (d)(1) and has been moved to paragraph (c) of 
this final standard. This provision reflects OSHA's strong orientation 
that the costs of complying with safety and health requirements must be 
borne by the employer. OSHA has a long-standing policy that employers 
are obligated to provide and pay for necessary personal protective 
equipment (PPE) such as respirators used by employees on the job. A 
compliance memorandum of October 18, 1994, titled ``Employer Obligation 
to Pay for Personal Protective Equipment'' provides detailed guidance 
on this issue. It is available online on the Internet on OSHA's home 
page at http://www.OSHA.gov. The inclusion of this provision is 
consistent with recent OSHA standards, e.g., Cadmium, 29 CFR 
Sec. 1910.1027; 1,3-Butadiene, 29 CFR 1910.1051; and Methylene 
Chloride, 29 CFR 1910.1052.
    OSHA is aware that the Occupational Safety and Health Review 
Commission has not always agreed with the Agency that standards 
requiring an employer to ``provide'' safety or health equipment also 
require the employer to pay for that equipment. See, e.g., Union Tank 
Car Co., OSHRC No. 96-0563 (October 16, 1997). OSHA believes the 
Commission is wrong about this issue. OSHA intends the language ``at no 
cost to the employee'' in paragraph (c)(4) to make the employer's 
obligation to pay for the respiratory protection required by this 
standard crystal clear.
    The requirement that the employer bear the costs of employee 
training and medical evaluations has also been moved to paragraph 
(c)(4) of the final rule, in order to consolidate all similar 
provisions of the standard that clarify that, for these provisions, 
there is no cost to the employee. Section 6(b)(7) of the OSH Act 
requires that employers provide medical exams and evaluations at no 
cost to employees.

Paragraph (d)--Selection of Respirators

Overview
    Paragraph (d) of the final rule contains respirator selection 
criteria and requirements. OSHA has included these provisions in the 
final rule because the record contains many examples of workers using 
respirators that are inappropriate for the type of respiratory hazards 
present (e.g., wearing paper dust masks where the exposure is to a gas 
or vapor contaminant (UAW, Ex. 54-387); using half facepiece 
respirators in acrylonitrile IDLH atmospheres of 20 ppm (International 
Chemical Workers Union (ICWU), Ex. 54-427)). In addition, OSHA's long 
enforcement experience has shown that employers often lack the 
information necessary to make informed choices about respirator 
selection. OSHA stated in the proposal (59 FR 58899) that a major 
deficiency of the previous standard is that it did not contain 
selection criteria; instead, it merely referred employers to the ANSI 
Z88.2-1969 standard.
    No participant in this rulemaking disagreed with OSHA's decision 
that the final standard should include mandatory selection criteria. 
The record does show, however, that there are differences of opinion 
about how restrictive and comprehensive the required criteria should 
be, and how much flexibility should be left to employers in the 
selection process. For example, the Association of American Railroads 
(Ex. 54-286) stated that the details of respirator selection should be 
left to the regulated community and that OSHA should only specify the 
outcome desired, while the Service Employees International Union (SEIU) 
(Ex. 54-455) commented that OSHA should ``strengthen the wording to 
make it clear employers must obtain and account for all of the factors 
listed.'' OSHA believes that those employers who employ on-site 
occupational health professionals generally have the expertise to 
select respirators that are appropriate for their workers. The record 
contains a number of examples of well-thought-out selection programs 
(e.g., Exs. 142, 155, 163). These examples show that the current 
practice of many employers already conforms to the selection 
requirements of paragraph (d). For other employers, however, clearly 
stated

[[Page 1196]]

respirator selection rules and guidance are required.
    OSHA notes that advice on the selection of respirators is available 
from many sources. NIOSH has developed a respirator decision logic, 
widely available and used since 1987, which provides a schematic 
selection guide covering all critical areas of respirator selection 
(Ex. 9). The selection guide for the ANSI Z88.2-1969 respirator 
standard was incorporated by reference into the previous OSHA standard, 
and the 1992 Z88.2 ANSI standard contains updated and comprehensive 
recommendations on respirator selection. OSHA believes that employers 
will find useful information in each of these guides on various 
technical problems that this standard may not cover explicitly. In 
addition, information is provided by respirator manufacturers who 
publish selection guides relating to their models (See, e.g., Mine 
Safety Appliances Company (MSA) Respirator Selection Guide, Ex. 150; 
and ISEA's Respirator Buyers Guide and Safety Video Resource List, 
referenced in Ex. 147). Manufacturers also provide selection advice 
through telephone help lines, sales staff, verbal communications or 
distribution of company product information, and on-site evaluations of 
product use (See, e.g., Tr. at 1438-1439). Chemical manufacturers also 
provide information about respirator selection to help the purchasers 
of their products (See CMA, Tr. 1726-7; Union Carbide Corporation, Ex. 
54-255).
    Because of the variety and detail of selection information 
available, OSHA believes it is necessary in the final rule to specify 
broad performance criteria, in addition to a few specific rules 
relating to highly hazardous operations (i.e., IDLH situations). The 
final rule sets forth general rules for selecting respirators for 
routine operations, prescribes specific kinds of respirators for 
identified highly hazardous atmospheres and emergency situations, and 
specifies when air-purifying respirators can reliably be used. OSHA 
chose not to specify in the regulatory text all the situations and 
respirator-related factors that an employer should consider but instead 
to state performance objectives. Only for workplace situations widely 
accepted as highly hazardous, such as those associated with IDLH 
atmospheres, does the standard require maximally protective 
respirators.
    Because paragraph (d) does not address in detail all the relevant 
factors that may affect employers' selection of particular respirators, 
employers should rely on other information sources to ensure that the 
respirators they select are appropriate for conditions in their 
specific workplaces. Respirator manufacturers are the source of much 
useful information, and the record of this rulemaking indicates that 
much of this information is both helpful and reliable. Indeed, market 
mechanisms work to encourage the dissemination of accurate information. 
OSHA expects that smaller employers will thus generally be able to rely 
on the technical assistance provided by manufacturers on respirator 
selection and that doing so will mean that they will usually be in 
compliance with this standard. For these reasons, paragraph (d) 
concentrates on the minimum selection criteria that the record shows 
must be adhered to by all employers when selecting respirators for 
their employees' use.
    In the following provision-by-provision summary and explanation, 
OSHA explains the changes reflected in the final rule, both from the 
provisions proposed and those in the Agency's previous respiratory 
protection standard (Sec. 1910.134).
Paragraph (d)(1)--General Requirements
    Paragraph (d)(1) prescribes general rules that apply to the 
selection of all respirators. Paragraph (d)(1)(i) requires the employer 
to select and provide an appropriate respirator based on the 
respiratory hazard(s) to which the worker is or will be exposed and on 
the workplace and user factors that have the potential to affect 
respirator performance and reliability. This provision continues a 
requirement from the previous standard: (``respirators shall be 
selected on the basis of hazards to which the worker is exposed'' 
(Sec. 1910.134(b)(2)) and clarifies that the hazard must be viewed in 
the context of the workplace and worker conditions that may reduce or 
impair the effectiveness of a respirator otherwise appropriate for the 
hazard. There is general agreement that taking working conditions into 
account is crucial to proper respirator selection: a respirator that is 
protective under some conditions of wear will fail under others, while 
a respirator that is appropriate for a given hazard may not be workable 
in a particular workplace (e.g., an air supplied respirator in a 
tightly configured space). For example, a worker wearing SCBA who is 
required to perform extremely heavy work may deplete the air supply of 
the respirator well before its calculated service life is reached. This 
means that the employer must evaluate the employee's level of exertion 
in order to determine whether to choose a supplied-air respirator 
rather than a SCBA. The recent ANSI standard also states that the 
purpose of respirator selection is to determine which respirator type 
or class will offer ``adequate protection'' (ANSI Z88.2-1992).
    Final paragraph (d)(1)(i) also requires employers to consider 
workplace and user factors that may affect the respirator's performance 
and reliability when making a respirator selection. Although other 
paragraphs of the standard address the major factors affecting 
respirator performance, i.e., fit, faceseal leakage, and maintenance 
and cleaning, factors specific to the job, user, or worksite often play 
an important role in respirator performance. OSHA noted in the proposal 
(59 FR 58900) that work activities and factors such as temperature and 
humidity ``also affect the stress level associated with wearing a 
respirator as well as the effectiveness of respirator filters and 
cartridges; employees using respirators for longer periods of time 
[under such stressful conditions] may need different types of 
respirators for more comfortable wear.''
    Similarly, where the respirator-wearing employee must communicate 
with other workers, perhaps to warn them about the presence of 
workplace hazards, the respirator must allow the employee to perform 
this vital function. OSHA thus agrees with ANSI that ``it is important 
to ensure that respirator wearers can comfortably communicate when 
necessary, because a worker who is speaking very loudly or yelling may 
cause a facepiece seal leak, and the worker may be tempted to 
temporarily dislodge the device to communicate'' (ANSI Z88.2-1992, 
clause A.13). Therefore, for example, the employer must ensure that 
speaking will not interfere with the fit of the negative-pressure 
elastomeric respirator selected. If the employees are using PAPRs or 
SCBA, amplification devices, including speaking diaphragms and 
microphones, that can be worn with the respirators are available.
    The proposal (59 FR 58900) noted another example in the proposal of 
worksite conditions that could affect respirator selection: ``* * * 
airline respirators should not be used by mobile employees around 
moving machinery unless entanglement of airlines in equipment is easily 
avoided.'' Employers have always been required by OSHA to consider such 
factors as these, because paragraph (a)(2) of the previous respirator 
standard required employers to select respirators that are ``applicable 
and suitable for the purpose intended.''
    Paragraph (d)(1)(i) applies whenever employers provide respirators 
to their

[[Page 1197]]

employees and require their use, whether or not an OSHA standard 
mandates respirator use in the particular environment. The preamble 
discussion relating to paragraph (c)(1) discusses employer-required 
respirator use in more detail and explains OSHA's reasons for reaching 
this conclusion.
    Paragraph (d)(1)(ii) requires the employer to select a NIOSH-
certified respirator and to use the respirator only in ways that comply 
with the conditions of its certification. There was little controversy 
about this requirement, and there is no disagreement that respirators 
must be tested and found to be effective before they can be marketed. 
NIOSH has performed this function in the past and has begun to revise 
its certification requirements to ensure that its procedures continue 
to define the performance capabilities of acceptable respirator models, 
and to identify unacceptable models. The ISEA (Ex. 65-363), the trade 
association that represents most major respirator manufacturers, urged 
OSHA to require that only NIOSH-certified respirators be used to comply 
with this standard, and other commenters agreed (Exs. 54-187, 54-213, 
54-387, 54-428).
    The wording of this provision of the final rule differs slightly 
from that of the proposed provision. The proposal would have required 
that only NIOSH ``approved and certified'' respirators be selected. For 
clarity, the reference to NIOSH-approved respirators has been replaced 
in the final rule by a requirement that respirators be used only in 
accordance with the conditions of their certification. NIOSH approves 
respirators by certifying them; however, some certifications contain 
conditions limiting the situations in which the respirator may be used. 
This is sometimes described as NIOSH ``approval'' of the respirator for 
a particular use.
    Increasingly, however, NIOSH does not certify respirators for 
specific uses. For example, NIOSH does not currently certify 
respirators for use against biological hazards. Where NIOSH has not 
specifically certified any respirator for use against the particular 
contaminant present in the workplace, the employer must select a NIOSH-
certified respirator that has no limitation prohibiting its use against 
that contaminant. The respirator must be appropriate for the 
contaminant's physical form and chemical state and the conditions under 
which it will be used. All respirators must be chosen and used 
according to the limitations of the NIOSH certification, which appears 
on the NIOSH certification label.
    The requirement for NIOSH certification is unconditional in the 
final standard, as it was in the proposal. However, because OSHA stated 
in the proposed preamble that this requirement would apply only when 
such respirators ``exist'' (59 FR 58901), some commenters urged OSHA to 
state in the regulatory text that the requirement for NIOSH 
certification applied only to existing certifications (See, e.g., Ex. 
54-434). For example, the Department of the Army (Ex. 54-443) urged 
OSHA to permit the use of respirators not approved by NIOSH in 
situations where another authority has jurisdiction and the 
documentation to attest to the adequacy of the respirator's 
effectiveness against the contaminant of concern. The Army (Ex. 54-
443D) stated that its employees and contractors may be exposed to 
certain ``military unique contaminants'' for which no NIOSH-approved 
respirator exists but for which military respirators, e.g., gas masks, 
have specifically been developed and tested and are being used by 
civilian and contractor personnel in operations subject to OSHA's 
jurisdiction. The Army urged OSHA to include in the standard ``approval 
authority of the Secretary of the Army for military respirators * * * 
for which no NIOSH approved respirator exists'' (Ex. 54-443D).
    OSHA recognizes that there are unique contaminant situations, such 
as those involving chemical warfare agents, that involve primarily 
military exposure and that may require specialized respiratory 
protection equipment. NIOSH certification for respiratory protection 
specific to such hazards does not exist and is not likely to be 
forthcoming. OSHA also notes, however, that, although the Department of 
the Army argued strongly for OSHA recognition of Army authority to test 
and approve respirators, the Department of the Air Force commented that 
it uses only NIOSH-certified respirators, and requested no exception 
(Ex. 54-443A). OSHA will examine on a case-by-case basis those 
situations involving civilian contractors whose employees wear non-
NIOSH tested respirators that they believe protect employees adequately 
and that have been tested and approved by other Federal agencies for 
use against unique contaminants.
    A similar comment was raised by DOE regarding radioactive hazards 
(Ex. 54-215). DOE stated that, in the nuclear industry, no NIOSH-
certified respirator exists for tritium applications and workers 
therefore must wear non-approved supplied-air suits; this equipment has 
been tested by Los Alamos National Laboratory, and the suits have been 
successfully used for many years. The DOE administers its own job-by-
job approval system for these suits. OSHA's authority to enforce the 
Agency's safety and health standards at gaseous diffusion plants owned 
by DOE and leased to the United States Enrichment Corporation was 
established legislatively in 1992, and OSHA has recently completed a 
memorandum of understanding with DOE on this issue (60 FR 9949, Jan. 
31, 1995). OSHA is currently evaluating an application from one of 
these facilities for a variance relating to these suits. The criteria 
set out in Section 6(d) of the OSH Act will govern this determination. 
OSHA is not determining the acceptability of supplied-air suits as part 
of this rulemaking proceeding, because the Agency believes the variance 
proceeding, which can focus closer attention on the strengths and 
limitations of these suits for the particular use situations, is the 
appropriate forum to decide this issue.
    OSHA notes that NIOSH certification is a minimum qualification. The 
employer must still assess whether the respirator meets all other 
selection criteria in this standard before it can be chosen for a 
particular application. For example, as pointed out by an exchange with 
Richard Duffy of the International Association of Fire Fighters (IAFF), 
NIOSH representatives acknowledged that the employer must evaluate 
whether NIOSH-certified equipment will withstand the specific 
environmental conditions for firefighting because NIOSH flow rate 
requirements do not consider the stresses involved in firefighting, nor 
does NIOSH currently evaluate respirators for their ability to 
withstand those stresses (Tr. 364-365).
    In his testimony at the OSHA hearings, Richard Duffy of the IAFF 
recommended that OSHA require that SCBAs used in firefighting meet the 
requirements of the National Fire Protection Association's NFPA-1981 
Standard on Open Circuit Breathing Apparatus (Tr. 455). This NFPA 
standard establishes more stringent performance criteria for SCBAs used 
in firefighting than those currently used by NIOSH. NIOSH recognizes 
that its current 42 CFR 84 respirator certification standards may not 
be protective enough for respirators used in firefighting. In an 
October 7, 1997 letter to all manufacturers and interested parties, 
NIOSH announced its intent to develop new technical modules to update 
42 CFR 84. One of the proposed technical modules to which NIOSH intends 
to give priority treatment will address SCBAs, including the

[[Page 1198]]

incorporation of NFPA performance requirements for SCBAs. NIOSH also 
intends to propose an Administrative/Quality Assurance module on the 
use of independent testing laboratories in the certification program, 
another issue raised by commenters in this proceeding. OSHA believes 
that NIOSH will resolve any deficiencies in its current respirator 
certification standards through these new 42 CFR 84 rulemaking modules. 
OSHA simply is not equipped to take on the respirator approval and 
certification process currently performed by NIOSH. Therefore, the 
final OSHA respirator standard continues to require the use of NIOSH-
certified respirators and does not incorporate the NFPA performance 
requirements for SCBAs.
    OSHA believes that carving out even limited exceptions to NIOSH 
control of respirator certification authority would confuse the 
regulated community and would not resolve the needs of the vast 
majority of respirator users. Comments by respirator users and worker 
representatives support OSHA's final decision (See, e.g., Exs. 54-265, 
54-118, 54-213, 54-387, 54-455). The final rule, in paragraph (h), also 
requires that when respirator parts are replaced or changed, the 
replacement parts must be NIOSH certified.
    In the proposal (59 FR 58901), OSHA stated that developing an OSHA 
respirator approval mechanism to fill in the gaps in NIOSH 
certification would not be an efficient use of government resources. 
Nonetheless, the Agency asked for comment on this issue. There was no 
consensus among the participants who commented on this point. Some 
commenters supported an OSHA role in approval on a temporary basis, 
while an employer waits for NIOSH approval, or an alternative 
governmental approval process (Exs. 54-213, 54-346, 54-443). Still 
others opposed OSHA's involvement in an approval process (Exs. 54-278, 
54-265, 54-118, 54-213, 54-387, 54-455). The final rule is therefore 
similar to the proposal, which also discussed limited alternatives to 
NIOSH certification and concluded that ``it is inappropriate for OSHA 
to try to correct problems with present NIOSH/MSHA regulations in the 
revised respirator standard'' (59 FR 58891).
    OSHA believes that NIOSH has focused on closing any gaps in its 
certification program. NIOSH's ability and experience in this area are 
unparalleled, and OSHA believes that NIOSH can best resolve any 
concerns through its own proceedings. Further, as stated in the 
proposal, OSHA lacks the resources to perform respirator testing. OSHA 
will, however, continue to evaluate, on a case-by-case basis, whether 
variance or compliance interpretations are appropriate in cases where 
employers claim that there are no NIOSH-certified respirators for use 
in a particular situation.
    Paragraph (d)(1)(iii) of the final rule requires the employer to 
identify and evaluate the respiratory hazard(s) in the workplace. To 
perform this evaluation, the employer must make a ``reasonable 
estimate'' of the employee exposures anticipated to occur as a result 
of those hazards, including those likely to be encountered in 
reasonably foreseeable emergency situations, and must also identify the 
physical state and chemical form of such contaminant(s). Where 
conditions are such that the employer cannot carry out such an 
evaluation, e.g., where exposure monitoring or other means of 
estimation cannot be used, paragraph (d)(1)(iii) requires the employer 
to treat the atmosphere as IDLH. Many of the components of paragraph 
(d)(1)(iii) of the final standard have been required practice since 
1971 because they were included in the selection provisions of the 1969 
ANSI standard incorporated by reference into OSHA's previous 
respiratory protection standard. Paragraph (d)(1)(iii) of the new 
standard makes these provisions clearer by stating them explicitly in 
the regulatory text.
    Identifying and evaluating the hazards a respirator is to provide 
protection against clearly play a pivotal role in respirator selection. 
For example, according to ANSI, ``Respirator selection involves 
reviewing each operation to * * * determine what hazards may be present 
(hazard determination)'' (ANSI Z88.2-1992, clause 7.2.2; See also AISI, 
Tr. 639). Many other commenters emphasized the important role of hazard 
identification in respirator selection (Exs. 54-168, 54-181, 54-186, 
54-208, 54-234, 54-273, 54-307, 54-327, 54-346, 54-426, 54-428). Once 
an employer identifies the nature of the respiratory hazard or hazards 
present, the employer must evaluate the magnitude of the hazard to 
determine the potential exposure of each employee and the extent to 
which respirators of various types can reduce the harm caused by that 
exposure.
    There was extensive comment on the selection process outlined in 
the proposed paragraph dealing with hazard evaluation (Exs. 54-154, 54-
168, 54-181, 54-202, 54-219, 54-245, 54-278, 54-428). Commenters 
representing workers generally supported the detailed approach taken in 
the proposal toward hazard evaluation. For example, the Service 
Employees International Union ``support[ed] the detailed list of 
factors to be considered in respirator selection * * * [which] 
successfully incorporates the important framework from the NIOSH 
decision logic criteria in an easy-to-understand form'' (Ex. 54-428).
    Some commenters, however (Exs. 54-154, 54-168, 54-181, 54-219, 54-
245, 54-278), stated that the scope and depth of the hazard evaluation 
and the items to be covered should be left to the discretion of the 
employer. For example, the Eastman Chemical Company (Ex. 54-245) and 
the Dow Chemical Company (Ex. 54-278) requested that OSHA make the 
requirement ``performance oriented'' and ``flexible''; the Department 
of the Navy, Portsmouth Naval Shipyard (Ex. 54-154), noted that 
detailed analysis for each work situation is not necessary for 
shipbuilding, and that the timing and content of an appropriate 
evaluation vary.
    In response to these comments, OSHA has revised paragraph 
(d)(1)(iii) to be more performance oriented; this provision of the 
final standard no longer specifies precisely how employers are to 
conduct the required evaluation. The proposal (at paragraph (d)(3)) 
would have required employers to ``obtain and evaluate'' information on 
eleven specific factors for each work situation. These proposed factors 
were the nature of the hazard; its physical and chemical properties; 
its adverse health effects; the occupational exposure level; the 
results of workplace sampling; the work operation; the time period of 
respirator wear; the work activities and stresses on the wearer; fit 
test results; warning properties; and the capabilities and limitations 
of respirator types. Although OSHA continues to believe that each of 
these factors is relevant to respirator selection under some 
circumstances, a review of the record has convinced OSHA that each 
factor is not crucial in every respirator selection process and that 
the proposed requirement would have led to needless duplication of 
effort and unnecessarily detailed evaluations.
    The Oil, Chemical and Atomic Workers International Union (OCAW) 
(Ex. 54-202) urged OSHA to require a written hazard assessment each 
time that a respirator was selected. Paragraph (d)(1)(iii) of the final 
rule does not require a written assessment; this was not proposed, and 
OSHA believes that employers should be free to adopt the best approach 
for justifying their respirator selections, based on the hazard 
assessment. The final rule requires the employer to identify and 
evaluate the respiratory hazards present, determine their physical 
state and

[[Page 1199]]

chemical form (e.g., whether they are present in the form of a gas or 
vapor; what their valence state or condition is, where relevant), and 
assess the magnitude of the hazard they present to workers under normal 
conditions of use and in reasonably foreseeable emergency conditions.
    OSHA finds that it is essential for employers to characterize the 
nature and magnitude of employee exposures to respiratory hazards 
before selecting respiratory protection equipment. The language 
contained in paragraph (d)(1)(iii) of the final rule does not specify 
how the employer is to make reasonable estimates of employee exposures 
for the purposes of selecting respirators, nor does the standard 
require the employer to measure worker exposures to airborne hazards. 
OSHA has always considered personal exposure monitoring the ``gold 
standard'' for determining employee exposures because this is the most 
reliable approach for assessing how much and what type of respiratory 
protection is required in a given circumstance. This general view is 
also shared by the industrial hygiene community. All of OSHA's 
comprehensive substance-specific health standards have required 
employee exposure monitoring to determine both the effectiveness of 
existing control measures and the type of respiratory protection 
needed.
    OSHA continues to hold this view with regard to assessing employee 
exposure in connection with this respiratory protection standard. 
However, OSHA recognizes that there are many instances in which it may 
not be possible or necessary to take personal exposure measurements to 
determine whether respiratory protection is needed. Although sampling 
and analytical methods exist for the vast majority of substances for 
which OSHA has a PEL (29 CFR 1910.1000), there are numerous other 
substances for which there are no readily available methods for 
personal sampling. In other cases, the nature of the materials and 
products being used in the workplace, and the way in which they are 
used, make it highly unlikely that an employee working with them would 
be exposed in a manner that would make respiratory protection 
necessary. In these kinds of situations, the final rule permits 
employers to use other approaches for estimating worker exposures to 
respiratory hazards.
    For example, employers may rely on information and data that 
indicate that use or handling of a product or material cannot, under 
worst-case conditions, release concentrations of a respiratory hazard 
above a level that would trigger the need for respirator use or require 
use of a more protective respirator. This approach is similar to that 
used in several OSHA substance-specific health standards, which permit 
employers to use objective data in lieu of exposure monitoring to 
demonstrate that their employees cannot be exposed above an action 
level (See, for example, 29 CFR 1910.1027, Cadmium; 1910.1048, 
Formaldehyde; 1910.1047, Ethylene Oxide; 1910.1028, Benzene). Objective 
data can be obtained from an industry study or from laboratory test 
results conducted by manufacturers of products or materials being used 
in the workplace. To generalize from data in an industry-wide survey to 
conditions in a specific workplace, the survey must have obtained data 
under conditions closely resembling the processes, types of materials, 
control methods, work practices, and environmental conditions in the 
workplace to which it will be generalized, i.e., the employer's 
operation.
    Data from industry-wide surveys by trade associations for use by 
their members, as well as from stewardship programs operated by 
manufacturers for their customers, are often useful in assisting 
employers, particularly small-business owners, to obtain information on 
employee exposures in their workplaces. For example, representatives of 
the North American Insulation Manufacturer's Association (NAIMA) 
testified (Tr. 597) that * * * ``[w]e have conducted numerous surveys 
on end use customers, conducted research with Johns Hopkins University, 
for example to provide estimates of routine exposures and * * * those 
data, when collected appropriately and with organized labor and with 
other industry groups, * * * can assure that the right respirator is 
selected.'' NAIMA stated (Tr. 616, 618), ``it is ultimately the 
employer's responsibility'' to evaluate whether data provided by 
suppliers or others relate to their workplace conditions and 
operations. However, it is clear that such programs can often assist 
employers to estimate workplace exposures reliably enough to make 
correct respirator choices without the need for employee monitoring.
    Another approach that can be used by employers to estimate employee 
exposures involves using mathematical approaches and obtainable 
information. Employers can use data on the physical and chemical 
properties of air contaminants, combined with information on room 
dimensions, air exchange rates, contaminant release rates, and other 
pertinent data, including exposure patterns and work practices, to 
estimate the maximum exposure that could be anticipated in the 
workplace. Methods that utilize this approach are readily available in 
several textbook sources; for example, the ACGIH Industrial Ventilation 
Manual contains calculations that can be applied to certain situations 
to estimate worker exposures. Relying on such an approach to estimate 
exposures requires the use of safety factors to account for uneven 
dispersion of the contaminant in the air and the proximity of the 
worker to the emission source. Usually, this approach works best in 
situations where employees use small amounts of a chemical product 
intermittently, or where contaminant releases are fairly constant and 
predictable. This approach must be used continuously, and the data 
obtained should therefore be interpreted conservatively (i.e., should 
err on the side of worker protection).
    In workplaces involving many complex factors, the use of estimation 
techniques to characterize worker exposure is associated with a high 
degree of uncertainty. In these instances, OSHA recommends that 
employers conduct exposure monitoring instead of relying on estimation 
techniques because they will then be able to have confidence that the 
appropriate respiratory protection device has been selected and that 
they are in compliance with the standard. Furthermore, OSHA believes 
that in workplaces where many complex factors add uncertainty to 
exposure estimates obtained through modeling, employers will find it 
easier and less costly to conduct personal exposure monitoring to 
evaluate the need for respiratory protection.
    Many commenters urged OSHA not to specifically require monitoring 
in the standard because other means of assessing potential exposures 
are available (Exs. 54-153, 54-208, 54-219, 54-237, 54-273, 54-307, 54-
327, 54-443). These participants asked the Agency instead to adopt the 
approach taken in the ANSI standard Z88.2-1992, clause 7.2.2.1(e), 
which allows employers to estimate, as well as measure, exposures in 
the workplace. One commenter questioned the utility of exposure 
monitoring data for respirator selection because exposure sampling 
provides only a ``snapshot'' of hazards on any given day (Ex. 54-178). 
Other commenters disagreed, however. For example, Scott Schneider (Tr. 
1520) of the AFL-CIO stated, ``In most workplaces that I've been in 
there really is very, very little exposure data to know how much a 
person is exposed to * * * exposures are quite variable from

[[Page 1200]]

day to day. And from worker to worker.'' (See comments to same effect 
by OCAW, Ex. 54-202.) Some participants specifically asked OSHA to make 
workplace sampling of airborne concentrations of contaminants explicit 
(Tr. 1009 and Ex. 54-428; Ex. 54-427).
    That some exposure monitoring results may be inadequate begs the 
question of whether adequate monitoring should be conducted. OSHA's 
experience in enforcing permissible exposure limits in the Air 
Contaminant standard, 29 CFR 1910.1000, and for substance-specific 
standards, confirms that, unless operations are highly repetitive, 
conditions are constant, and estimates based on ``historical'' and 
``objective data'' are made by experienced industrial hygiene 
professionals, most employers need exposure monitoring results to 
estimate employee exposure levels reliably. OSHA enforcement experience 
also demonstrates that, where exposures are highly variable, 
fragmentary monitoring results may mislead employees and employers, 
unless they are based on competent sampling strategies. The frequency 
and duration of monitoring, the representativeness of the employees and 
operations sampled, and the skill with which sampling and analysis are 
performed all influence the reliability of monitoring results. In 
making reasonable estimates of employee exposures to satisfy the 
requirements contained in paragraph (d)(1)(iii), OSHA expects employers 
to account for potential variation in exposure and to rely on data or 
information that reflect such variation. This is accomplished by using 
exposure data collected with a strategy that recognizes exposure 
variability, or by using worst-case assumptions and estimation 
techniques to evaluate the highest foreseeable levels to which 
employees may be exposed. The hazard assessment requirements in final 
paragraph (d)(1)(iii) carry over from the requirement of the previous 
standard, which incorporates by reference the ANSI Z88.2-1969 (clause 
6.2) statement that ``[a]ny erring in the selection of respirators 
shall be on the safe side.''
    Paragraph (d)(1)(iii) also requires an employer to consider the 
environment IDLH if employee exposures cannot be estimated reasonably. 
This provision is intended to address those limited situations where 
neither exposure monitoring, professional judgment, nor estimation 
techniques can be relied on to reliably select adequate respiratory 
protection equipment. This provision reflects a similar one in the 1992 
ANSI standard, which requires atmospheres to be considered IDLH if it 
is not possible ``to determine what potentially hazardous contaminants 
may be present * * * or if no exposure limit or guideline is available, 
and estimates of toxicity cannot be made'' (ANSI Z88.2-1992, clause 
7.2.2.2 (b)(c)).
    Several commenters (Exs. 54-381, 54-352, 54-267) objected to OSHA's 
proposed requirement that atmospheres be considered IDLH ``where the 
concentration of the hazardous chemical is unknown'' (59 FR 58939), and 
stated that it would be neither practical nor necessary to wear 
positive pressure respirators in all such situations (Ex. 54-352). One 
commenter believed that requiring the most protective respirators for 
``every unknown hazardous chemical atmosphere'' would result in 95 
percent of the workforce being required to use them (Ex. 54-267). OSHA 
did not intend the absence of workplace-specific exposure measurements 
automatically to trigger selection of the most protective respirator; 
instead, the Agency intends employers to use such equipment when they 
do not have confidence that a less protective respirator is sufficient. 
An example of the kind of situation that should trigger the use of the 
most protective respirator was provided by a representative of CMA, who 
testified (Tr. at 1707) that, when a maintenance person opens a closed 
cycle manufacturing process to work on it for the first time, ``we 
don't know what the air concentration is so we put people in supplied-
air respiratory protection under those circumstances.'' That is, the 
company in this case assumes that exposures will be extremely high and 
selects a respirator accordingly. OSHA believes that the language used 
in paragraph (d)(1)(iii) of the final rule makes OSHA's intent clear, 
i.e., that when reliable data or reasonable estimates of exposure are 
not available, the atmosphere must be considered IDLH.
    Finally, a few participants suggested that exposure estimates 
should only be made by credentialed individuals (See, e.g., Ex. 54-
327). OSHA agrees that persons trained and experienced in evaluating 
the respiratory hazards posed by workplace atmospheres are the most 
competent to evaluate exposure levels, especially in the absence of 
current exposure measurements. ANSI defines an ``occupational health 
professional'' as ``(a)n individual whom, by experience and education, 
is competent at recognizing, evaluating, and controlling health hazards 
in the workplace'' (ANSI Z88.2-1992, clause 3.39). This is the person 
who is responsible for performing expert evaluations under ANSI's 
recommended standard. OSHA believes that this definition has merit, and 
that employers whose workplaces have highly toxic respiratory hazards, 
or many different hazardous chemicals or mixtures, as well as other 
employers with the resources to do so, should utilize such 
professionals wherever possible. However, OSHA is not specifically 
including this requirement in the final rule because reasonable 
estimations can be conducted in many workplaces by persons with the 
qualifications required in the final rule for the respiratory 
protection program administrator.
    Paragraph (d)(1)(iv) requires that the employer choose respirators 
from a sufficient number of respirator models and sizes so that the 
respirator is acceptable to and correctly fits the wearer. The 1992 
ANSI standard includes a similar requirement aimed at achieving 
satisfactory fit and wearer acceptance (Z88.2-1992, clause 9.3.1. and 
9.3.2.). This provision of the final standard revises the corresponding 
proposed provision, which would have required employers to provide for 
fit testing an array of three sizes and two brands of respirators with 
elastomeric facepieces. The dual intent of this provision was to assure 
that wearer acceptability plays a role in respirator selection, and 
that the respirators chosen maintain their fit over the period of use.
    OSHA continues to believe that these goals for respirator selection 
are appropriate. However, OSHA was persuaded by this record that 
specifying the number of sizes, models and brands that an employer must 
provide is unnecessary. Therefore, the final provision deletes the 
specification language for the number of sizes, models and brands that 
must constitute the selection pool. Since this provision of the final 
standard applies to all respirators, the proposal's application only to 
``elastomeric'' facepieces has been dropped.
    Most participants (Exs. 54-1, 54-5, 54-75, 54-80, 54-91, 54-161, 
54-208, 54-214, 54-237, 54-238, 54-246, 54-263, 54-273, 54-280, 54-291, 
54-287, 54-350, 54-363, 54-389) endorsed the inclusion in the final 
rule of a performance-based provision addressing the selection of 
comfortably fitting respirators. Thus, most comment on this issue 
recognized that a sufficient assortment of respirators must be provided 
so that employees will obtain acceptable fits, but that more 
flexibility should be provided in the final rule. Commenters also 
stated that, in some cases, a single manufacturer has a variety of 
respirator models sufficient to

[[Page 1201]]

provide acceptable fit for their employees (Exs. 54-389, 54-150, 54-
161), although others provided only one or two sizes of a particular 
model (Exs. 54-139, 54-38, 54-22, 54-163, 54-196). Some rulemaking 
commenters stated that mandating that respirators from two 
manufacturers be available would be costly and burdensome for small 
employers (Exs. 54-161, 54-295), would not provide any tangible 
improvement in the respirator program (Ex. 54-154), and would 
complicate training and inventory functions (Ex. 54-156).
    In the case of SCBAs, participants pointed out that buying and 
storing two brands for fitting would be extremely costly, would create 
congested storage areas, and would pose the risk that parts could 
inadvertently be interchanged (Exs. 54-208, 54-209, 54-214, 54-250, 54-
300, 54-233, 54-331, 54-348, 54-45, 54-458). Even the AFL-CIO, which 
generally supported the requirement that employers have respirators 
from different manufacturers available, stated that requiring a multi-
manufacturer assortment was not feasible for SCBAs (Ex. 54-428).
    OSHA concludes that providing a wide selection of sizes and models 
of respirators will improve both fit and acceptability, and most 
commenters agreed. In light of the comments, however, OSHA is making 
the final rule's provision more performance-oriented, and is not 
requiring a specific number of types and sizes. As ANSI noted, larger 
employers are more likely to need a larger variety of respirators to 
fit their employee population (Tr. 1426). Concomitantly, this change 
will reduce the burden on smaller employers who will not need to 
maintain such a wide array of respirator choices. OSHA believes 
therefore that employers are in the best position to determine whether 
their employee population is so diverse as to require the availability 
of respirators from more than one manufacturer. OSHA encourages 
employers to offer employees as wide a choice as practical when 
performing fit tests.
    In addition to the general requirement of assuring that employers 
consider employee acceptability, some commenters requested that OSHA 
require employers to offer PAPRs to employees ``who wear respirators 
for long periods of time.'' These commenters stated that PAPRs are 
cooler, more comfortable, and offer less breathing resistance than 
negative pressure respirators (Exs. 54-387, 54-23). OSHA has included 
such provisions in various substance-specific standards based on 
evidence in those records that proper respirator use is likely to be 
increased if more comfortable respirators are available (See, e.g., Ex. 
330 in Docket H-033C, Asbestos in Construction standard, discussed at 
51 FR 22719, June 20, 1986). For example, OSHA stated in the preamble 
to the Lead standard (43 FR at 52933, Nov. 14, 1978) that ``PAPRs 
provide greater protection to individuals, especially those who cannot 
obtain a good face fit on a negative pressure respirator, and will 
provide greater comfort when a respirator needs to be worn for long 
periods of time. OSHA believes employees will have a greater incentive 
to wear respirators if discomfort is minimized.''
    OSHA continues to believe that under some circumstances PAPRs 
provide superior acceptability. These include situations where 
employees wear respirators for full shifts, where employees frequently 
readjust their negative pressure respirators to achieve what they 
consider a more comfortable or tighter fit, and where the air flow 
provided by a PAPR reduces the employee's psychological and 
physiological discomfort. However, where ambient temperatures are 
extremely high or low, PAPRs are often unacceptable because of the 
temperature of the airstream in the facepiece (See preamble to Coke 
Oven standard, 41 FR at 46774).
    OSHA's experience in enforcing standards that contain a provision 
requiring PAPRs to be supplied is that the provision is rarely invoked 
by employees, and even less rarely cited. The Agency continues to 
believe that it is good industrial hygiene practice to provide a 
respirator that the employee considers acceptable. Fit testing 
protocols require that employees have an opportunity to reject 
respirator facepieces that they consider unacceptable (See Appendix A).
    However, this record does not provide a sufficient basis for the 
Agency to require PAPRs upon employee request in all situations where 
the standard applies. For example, Popendorf et al. (Ex. 64-513) 
reported results from a survey of respirator users in indoor swine 
production, poultry production, and grain handling facilities. 
``Acceptability among four classes of respirators (disposable, quarter-
mask, half-mask and powered air-purifying helmets), varied among the 
three user groups. * * * Powered helmets were rated best for breathing 
ease, communication ease, skin comfort and in-mask temperature and 
humidity, while disposables were rated best for weight and 
convenience.'' OSHA emphasizes, however, that if the medical evaluation 
required by this standard finds that an employee's health may be 
impaired by using a negative pressure respirator, the employer must 
provide a PAPR (See paragraph (e)(6)(ii)).
Paragraph (d)(2)--Respirators for IDLH Atmospheres
    Paragraph (d)(2) covers respirators for use in atmospheres that are 
immediately dangerous to life or health (IDLH). The comparable 
provision in the proposal was paragraph (d)(10), which several 
commenters stated was not clearly written (Exs. 54-38, 54-167, 54-213, 
54-280, 54-297, 54-309, 54-455). OSHA has rewritten and reorganized the 
provision so that paragraph (d)(2) of the final rule covers all IDLH 
atmospheres, and paragraph (d)(3) covers all non-IDLH atmospheres.
    The standard requires that the most protective and reliable 
respirators be used for ILDH atmospheres: either a full facepiece 
pressure demand SCBA certified for a minimum service life of thirty 
minutes, or a combination full facepiece pressure demand supplied-air 
respirator with an auxiliary self-contained air supply (paragraph 
(d)(2)(i)). The proposal would have imposed the same requirement, 
except for the addition of the requirement for a minimum service life 
in the final rule.
    OSHA has determined, as have most respirator authorities, that IDLH 
atmospheres require the highest level of respiratory protection and 
reliability. These atmospheres, by definition, are the most dangerous 
environments in which respirators may be used. As OSHA explains in the 
summary and explanation for the definition of ``IDLH,'' the term 
includes atmospheres that pose an immediate threat to life or health, 
would cause irreversible adverse health effects, or would impair an 
employee's ability to escape. In these atmospheres there is no 
tolerance for respirator failure. This record supported OSHA's preamble 
statement that IDLH atmospheres ``require the most protective types of 
respirators for workers'' (59 FR 58896). Commenters and authorities, 
including NIOSH, ANSI, and both labor and management, agree that, for 
these atmospheres, the most highly protective respirators, with escape 
capability, should be required (See the NIOSH Respirator Decision 
Logic, pg. 10; ANSI Z88.2-1992, clause 7.3.2; Ex. 54-38).
    Paragraph (d)(2)(ii) requires employers to select respirators that 
are to be used exclusively for escape from IDLH atmospheres from those 
certified by NIOSH for escape from the atmosphere in which they will be 
used.

[[Page 1202]]

This provision addresses the selection of escape-only respirators from 
IDLH atmospheres involving different substances and situations. For 
example, under current 29 CFR 1910.1050, the standard covering exposure 
to methylenedianiline (MDA), escape respirators may be any full 
facepiece air-purifying respirator equipped with HEPA cartridges, or 
any positive pressure or continuous flow self-contained breathing 
apparatus with full facepiece or hood; for formaldehyde exposure, 
escape respirators may be a full facepiece with chin style, front, or 
back-mounted industrial canister approved against formaldehyde (29 CFR 
1910.1048).
    Paragraph (d)(2)(iii) requires employers to consider all oxygen-
deficient atmospheres to be IDLH atmospheres. An oxygen-deficient 
atmosphere is defined in paragraph (b) of the standard as one that 
contains less than 19.5 percent oxygen. Below this level, employers are 
required to use the same respirators as are required for IDLH 
atmospheres, i.e., a full facepiece pressure-demand supplied-air 
respirator with auxiliary SCBA or pressure-demand SCBA. This paragraph 
contains an exception to permit employers to use any supplied-air 
respirator, provided that the employer demonstrates that oxygen levels 
in the work area can be maintained within the ranges specified in Table 
II of the final rule, i.e., between 19.5 percent and a lower value that 
corresponds to an altitude-adjusted oxygen partial pressure equivalent 
to 16 percent oxygen by volume at sea level. The language of paragraph 
(d)(2)(iii), along with the exception, reflects the same requirement as 
that proposed, but avoids the potential confusion associated with 
having separate definitions and requirements for oxygen-deficient, and 
oxygen-deficient IDLH, atmospheres, as originally proposed. The 
language used in the final rule also reinforces OSHA's belief that all 
atmospheres containing less than 19.5 oxygen must be considered IDLH 
unless the employer has good information that oxygen levels cannot fall 
to dangerously low levels; in atmospheres below this level but falling 
within the ranges showin in Table II, a SAR must be provided.
    In the preamble discussion for paragraph (b), OSHA provided several 
reasons for the selection of the 19.5 percent cutoff to define oxygen 
deficiency. First, OSHA believes that consistency with the Agency's 
confined space standard is essential because most oxygen-deficient 
atmospheres will be associated with work in confined spaces. In the 
preamble to the permit-required confined space standard, 29 CFR 
1910.146(b), OSHA used the term ``asphyxiating atmosphere'' when 
referring to an atmosphere containing less than 19.5 percent oxygen (58 
FR 4466, January 14, 1993). In the confined space standard itself, OSHA 
included ``atmospheric oxygen concentrations [of] less than 19.5 
percent'' within the standard's definition of ``hazardous atmosphere.'' 
Using the same 19.5 percent cutoff point for defining an IDLH oxygen-
deficient atmosphere in this respiratory protection standard will 
reduce the potential for confusion. In addition, OSHA's use of a 19.5 
percent cutoff is consistent with the requirement that Grade D 
breathing air contain a minimum of 19.5 percent oxygen (See paragraph 
(i)).
    OSHA believes that employers will only rarely have occasion to 
avail themselves of the exception in paragraph (d)(2)(iii), which 
allows the use of any supplied-air respirator (SAR) if oxygen levels 
can be maintained within the ranges shown in Table II. Except for 
confined spaces, there were no examples in the record of work 
operations being routinely conducted in well-controlled atmospheres 
where oxygen levels are below 19.5 percent. Most atmospheres with 
oxygen content between 16 and 19.5 percent are not well-controlled, and 
a drop in oxygen content could have severe consequences. OSHA's review 
of enforcement data also confirms that, except for confined spaces, 
such atmospheres are uncommon, although they occasionally occur when 
work is conducted in basements, open pits, and other enclosed spaces. 
If an employer can meet the difficult evidentiary burden of showing 
that the oxygen content can be controlled reliably enough to remain 
within the ranges specified in Table II, the atmosphere is not 
considered IDLH under this standard, and the employer may provide any 
SAR.
    The low end of the ranges of oxygen concentrations in Table II are 
the same as those used to define oxygen-deficient IDLH atmospheres in 
the proposal: 16 percent oxygen by volume for altitudes from sea level 
to 3,000, and 19.5% oxygen content for altitudes above 8,001 feet. For 
altitudes from 3,001 to 8,000 feet, the listed oxygen concentrations 
correspond to an oxygen partial pressure of 100 mm mercury (Hg). OSHA 
explained in the proposal (59 FR at 58906) that these values are 
consistent with those in ANSI's Z88.2-1980 standard and with ANSI's 
definition of ``oxygen deficiency--immediately dangerous to life or 
health'' as a partial pressure of 100 mm Hg at sea level.
    ANSI's more recent 1992 standard permits lower oxygen 
concentrations before classifying an atmosphere as IDLH, provided that 
the employer has determined that the source of the oxygen reduction is 
understood and controlled. OSHA noted in the proposal that IDLH oxygen 
deficiency is now defined by ANSI as an oxygen content at sea level 
that is equivalent to less than 12.5% oxygen (i.e., an atmosphere with 
an oxygen partial pressure of 95 mm Hg or less). However, there is 
general agreement that employees could be seriously and rapidly 
debilitated if their supplied-air respirators should fail in a 12.5% 
oxygen atmosphere. OSHA stated in the proposal that that level 
represents the ``bare minimum safety factor.'' By choosing such a low 
oxygen partial pressure as the ``floor'' for oxygen-deficient IDLH 
atmospheres, the ANSI standard effectively removes any safety margin 
(59 FR 58905). ANSI representatives (Tr. 1289) agreed with OSHA during 
the hearing that OSHA's proposal offered a greater safety buffer than 
the 1992 ANSI standard. In addition, ANSI itself acknowledged in Table 
A-1 of its Z88.2-1992 standard (pg. 22, Ex. 54-50) that an oxygen level 
of 12.5% at sea level would produce effects such as ``Very poor 
judgment and coordination * * * impaired respiration that may cause 
permanent heart damage * * * nausea and vomiting.'' OSHA considers 
these effects unacceptable and intends this standard to prevent their 
occurrence. The ANSI table also states that a 16% oxygen level would 
produce effects such as ``Increased pulse and breathing rates * * * 
impaired thinking and attention * * * reduced coordination,'' and at an 
oxygen level of 14% effects would include ``Abnormal fatigue upon 
exertion * * * emotional upset * * * faulty coordination * * * poor 
judgment.'' All of these effects are potentially incompatible with the 
safe performance of duties.
    The ANSI table shows that the adverse health effects of oxygen 
deficiency become significant at the 16% oxygen level, and that these 
effects increase in severity as the oxygen level decreases. ANSI chose 
the 12.5% level because that level represents the point below which 
significant reductions in blood oxygen levels occur. As ANSI stated in 
clause A.5.2 of the Z88.2-1992 standard ``[t]his rapid rate of change 
then can present an unforgiving situation to an unprotected worker 
where debilitating physiological symptoms can appear suddenly, without 
warning, after only relatively

[[Page 1203]]

small changes in ambient oxygen levels.''
    The ANSI standard anticipates that all atmospheres with reduced 
oxygen levels would be treated as IDLH unless the source of the oxygen 
reduction is understood and controlled (Clause 7.3.1 ANSI Z88.2-1992). 
OSHA found that situations with controlled reduced-oxygen atmospheres 
(below 16% oxygen by volume) are rare and are already treated as an 
IDLH atmosphere by employers. Outside of confined spaces, such as in a 
pit or a basement, a reduced-oxygen atmosphere is rarely stable. 
Reduced-oxygen atmosphere situations may result as a byproduct of 
dynamic processes such as oxygen-consuming operations caused by the 
combustion of fuels or the digestion of organic matter. OSHA considers 
all confined spaces with atmospheric concentrations of less than 19.5% 
oxygen hazardous, and does not permit an oxygen level below 19.5% for 
occupied confined spaces (See 29 CFR 1910.146(b)), because it is 
difficult to ensure that, in a confined space, oxygen levels will not 
drop precipitously with little or no warning. The work being performed 
can itself reduce the oxygen levels, due to displacement of air by 
asphyxiants or through consumption of oxygen by work processes or by 
employees performing the work. Such sources of variability in oxygen 
content, even in workplaces where employers are attempting to stabilize 
the atmospheric oxygen content, can cause oxygen levels to drop to a 
lower level, placing workers at risk. Furthermore, the accurate 
monitoring of oxygen levels can be difficult, since sampling 
instruments test a limited number of areas, and pockets of lower oxygen 
content can exist inside a confined space or in a basement that can 
cause a worker to be overcome. Thus, OSHA has chosen an oxygen level of 
16% by volume as the level at which SCBA or an airline respirator with 
auxiliary air supply must be used because that is the level below which 
severe symptoms from oxygen deprivation first appear, because 
maintenance of oxygen levels below 16% is difficult, and because 
employees who are not protected risk their lives if an employer 
mistakenly believes oxygen content can be controlled.
    OSHA's determination that, at altitudes of up to 3,000 feet, 
atmospheres containing less than 16% oxygen must be considered IDLH was 
based on evidence that NIOSH submitted to the preproposal docket (See 
59 FR at 58905). NIOSH showed that in an oxygen concentration of less 
than 16% at sea level, employees may experience impaired attention, 
thinking and coordination. The American Thoracic Society (Ex. 54-92) 
questioned whether allowing work to be performed in an atmosphere with 
as little as 16% oxygen, with no supplemental oxygen supply, at 
altitudes below 3000 feet is sufficiently protective and suggested that 
mandatory medical examinations might be necessary in such circumstances 
to avoid pulmonary or cardiac disease complications. OSHA believes that 
this comment reflects some of the confusion among rulemaking 
participants concerning the proposed language covering oxygen 
deficiency. OSHA wishes to make clear that, in both the proposed and 
the final rules, employees are not permitted to work in atmospheres 
containing less than 19.5 percent oxygen without the use of a supplied-
air respirator. In the majority of these cases, employers will be 
obligated to provide highly protective respirators that can be used in 
IDLH conditions. In a few cases, employers may be able to justify use 
of any supplied-air respirator. In either case, employees will be 
provided a supplemental source of breathing air when working in oxygen-
deficient atmospheres.
    OSHA has not adopted NIOSH's recommendations that the IDLH 
concentration of oxygen be increased to a concentration above 19.5% for 
work above 8,001 feet. OSHA's experience confirms the record evidence 
that most work at higher altitudes is performed by fully acclimated 
workers (Exs. 54-6, 54-208). These provisions will allow acclimated 
workers to continue to perform their work without oxygen-supplying 
respirators, at any altitude up to 14,000 feet altitude, as long as the 
ambient oxygen content remains above 19.5% and the employee has no 
medical condition that would require the use of supplemental oxygen.
    As noted above, oxygen deficiency frequently occurs in atmospheres 
that are not well controlled, and OSHA's decision to consider all 
oxygen-deficient atmospheres as IDLH except under certain strict 
conditions is appropriate for work conducted in such dangerous 
conditions. The requirement to use the most protective and reliable 
respirators for IDLH atmospheres is proper to protect workers from the 
dire consequences of exposure to these atmospheres.
Paragraph (d)(3)--Respirators for Atmospheres That Are Not IDLH
    Paragraph (d)(3) sets out criteria and requirements for choosing 
respirators for all non-IDLH atmospheres. These provisions supplement 
the general requirements in paragraph (d)(1). This paragraph has been 
reordered from the parallel paragraph of the proposed standard.
    Paragraph (d)(3)(i) requires the employer to provide a respirator 
that is adequate to reduce the exposure of the respirator wearer under 
all conditions of use, including in reasonably foreseeable emergencies. 
Employers must also provide respirators that will ensure compliance 
with all other statutory and regulatory requirements, such as the 
permissible exposure limits (PELs) for substances in 29 CFR 1910.1000, 
substance-specific standards, and other OSHA standards. For example, 29 
CFR 1910.120 (g)(2) of OSHA's Hazardous Waste Operations and Emergency 
Response standard has additional exposure limits that apply to 
hazardous waste sites and emergency response operations. In addition, 
the general duty clause (Sec. 5(a)(1)) of the OSH Act may require 
employers to protect their employees from substances that are not 
regulated but that are known to be hazardous at the exposure levels 
encountered in the workplace. However, as was discussed at length in 
the ``Definitions'' section of this summary and explanation, the final 
standard does not use the term ``hazardous exposure levels,'' in part 
because the proposal was widely misunderstood to require compliance 
with ACGIH's TLVs or NIOSH's RELs in the absence of an OSHA standard. 
Moreover, as also noted above, this rulemaking does not address the 
hierarchy of exposure controls in paragraph (a)(1). Thus, employers may 
not rely on respirators to control exposures when feasible engineering 
controls are available and are sufficient to reduce exposures.
    As explained earlier, OSHA intends to address the issue of assigned 
protection factors (APFs) and their impact on respirator selection in a 
subsequent phase of this rulemaking. OSHA noted in the proposal (59 FR 
58901) that APFs are ``a recognition of the fact that different types 
of equipment provide different degrees of protection, and equipment 
limitations must be considered in selecting respirators.'' A respirator 
with a higher APF will provide more protection than a respirator with a 
lower APF. Considerable information on APFs has developed since OSHA 
adopted its existing standard in 1971. OSHA intends to promulgate APF 
provisions in the future. Accordingly, paragraphs (d)(3)(i) (A) and (B) 
are reserved at this time and will be addressed in the next phase of 
this rulemaking. In the interim, OSHA expects employers to take the 
best available information into account

[[Page 1204]]

in selecting respirators. As it did under the previous standard, OSHA 
itself will continue to refer to the NIOSH APFs in cases where it has 
not made a different determination in a substance-specific standard. In 
addition, where OSHA has specific compliance interpretations for 
certain respirators, e.g., respirators used for abrasive blasting (such 
as for lead), these should be followed.
    Based on the Agency's enforcement experience with the previous 
standard, OSHA does not believe that differences in the APFs set by 
NIOSH and ANSI will have a serious impact on respirator selection, 
because the major differences in NIOSH and ANSI APFs occur with 
respirators having APFs of 25 or greater, and most overexposures 
involve exposures at relatively small multiples of the PELs. An 
analysis of OSHA's Integrated Management Information System (IMIS) data 
showed that only 2 percent of the measurements taken by OSHA exceeded 
the PEL by more than 10 times.
    Paragraph (d)(3)(ii) of the final standard provides that the 
respirators selected must protect employees against the physical state 
and chemical form of the particular contaminant or contaminants present 
in the workplace. For air-purifying respirator selection, the form of 
the contaminant is a critical factor. Different types of air filtration 
respirators are needed for dusts and gases, for example, and, among 
gases, different types are needed for acid gases and for carbon 
monoxide. If the respirator is not equipped with a filter suitable for 
the form of the contaminant to which a worker is exposed, then the 
worker has no protection against that contaminant. No commenter opposed 
this requirement. ANSI's standard acknowledges that this information is 
critical to appropriate respirator selection (ANSI Z 88.2-1992, clause 
4.5.4.(b)).
    Paragraph (d)(3)(iii) covers respirator selection for protection 
against gases and vapors. OSHA's primary intent in this paragraph is to 
ensure that air-purifying respirators are not used in situations where 
a chemical cartridge or canister becomes saturated such that the gas or 
vapor contaminant can ``break through'' the filter's sorbent element 
and enter the respirator and the worker's breathing zone. If this 
happens, even correctly fitting, well-maintained respirators provide no 
protection to their users. This breakthrough problem is avoided 
entirely by the use of atmosphere-supplying respirators. Such 
respirators do not rely on filter sorbents and instead deliver clean 
outside air to the wearer's respirator.
    This paragraph establishes the requirements for selecting 
respirators for protection against gas and vapor contaminants. 
Paragraph (d)(3)(iii)(A) allows the use of atmosphere-supplying 
respirators against any gas or vapor, and paragraph (d)(3)(iii)(B) 
specifies the conditions under which air-purifying respirators may be 
used. These conditions protect users against the gas or vapor 
contaminant breaking through the canister/cartridge filter. Thus, this 
paragraph allows an air-purifying respirator to be used if it is 
equipped with a NIOSH-approved end-of-service life indicator (ESLI) 
(paragraph (d)(3)(iii)(B)(1)) or if the employer enforces a sorbent 
change schedule based on reliable information and data on the service 
life of cartridges and canisters used by the employer (paragraph 
(d)(3)(iii)(B)(2)).
    These provisions differ significantly from those in the proposal. 
In proposed paragraphs (d)(8) and (d)(9), OSHA would have allowed air-
purifying respirator use for gases and vapors with ``adequate warning 
properties,'' such as odor or irritation, and would not have imposed 
additional conditions on their use. A substance would have been 
considered to have adequate warning properties if the threshold for 
detection was no higher than three times the hazardous exposure level. 
For contaminants having poor warning properties, the standard as 
proposed would have required employers to use an ESLI or develop a 
cartridge/canister change schedule that would ensure replacement of the 
sorbent element before 80 percent of its useful service life had 
expired.
    Commenters expressed significant dissatisfaction with the proposed 
provisions, and some asked OSHA to reevaluate them in major respects 
(Exs. 54-414, 54-249, 54-374). Many rulemaking participants urged OSHA 
to rely much more heavily on end-of-service-life indicators (ESLIs) or 
appropriate cartridge or canister change schedules for air-purifying 
respirators, and some suggested that OSHA require NIOSH-certified ESLIs 
on these respirators (Exs. 54-387, 54-443). Other commenters opposed 
limiting the use of air-purifying respirators equipped with ESLIs or 
reliable change out schedules to situations where the odor/irritation 
threshold was less than three times the PEL. However, the Occidental 
Chemical Corporation (Ex. 54-346) stated that adopting this restriction 
would prohibit the use of air-purifying respirators for benzene 
exposures in excess of 3 ppm unnecessarily, and ``counter 10 years of 
effective employee protection that industry has provided.''
    Many other participants criticized the proposal's reliance on 
sensory thresholds such as odor and irritation to indicate when a 
respirator's filtering capacity is exhausted, stating that there is too 
much variation between individuals, that there is no good screening 
mechanism to identify persons with sensory receptor problems, and that 
the proposal would have allowed employees to be overexposed to 
hazardous air contaminants (Exs. 54-151, 54-153, 54-165, 54-202, 54-
206, 54-214, 54-414, 54-280, 54-386, 54-410, 54-427). Still other 
commenters suggested that the kind of respirator required should depend 
on the severity of the harm resulting from overexposure, with exposure 
to more serious hazards requiring supplied-air respirators (Exs. 54-
202, 54-212, 54-347). Finally, some commenters interpreted the proposed 
provision as prohibiting the use of air-purifying respirators against 
particulates ``without adequate warning properties'' (Ex. 54-309). 
This, according to the Associated Builders and Contractors (Ex. 54-
309), would require, for example, a ``pipefitter who is torch cutting 
metal with a galvanized coating to use an air-supplied respirator or 
SCBA--even when working outdoors * * * [and] could add one more item to 
the array of electrical power cords, pneumatic lines, and fall-
protection devices already attached to or trailing many construction 
workers.''
    ORC testified (Tr. 2164-65) that in general, the experience of most 
of its member companies is that most toxic substances do not have 
appropriate sensory warning properties. Indeed, in the preamble to its 
proposed Glycol Ethers standard, OSHA noted that reported values for 
the odor threshold of any substance vary widely, both because of 
differences between individuals' ability to perceive a particular odor 
and because of the methodology employed in conducting the odor 
threshold determination (58 FR 15526).
    NIOSH's ``Guide to Industrial Respiratory Protection--Appendix C'' 
reports that on average, 95% of a population will have a personal odor 
threshold that lies within the range from about one-sixteenth to 
sixteen times the reported mean odor threshold for a substance. As 
stated by Amoore and Hautala(1983):

[t]he interpretation of these data * * * will depend markedly on the 
individual circumstances. The threshold data * * * are based on 
averages for samples of the population, presumably in good health. 
Individuals can differ quite markedly from the population average in 
their smell sensitivity, due to any of a variety of innate,

[[Page 1205]]

chronic, or acute physiological conditions * * * Continuing exposure 
to an odor usually results in a gradual diminution or even 
disappearance of the smell sensation. This phenomenon is known as 
olfactory adaption or smell fatigue. If the adaption has not been 
too severe or too prolonged, sensitivity can often be restored by 
stepping aside for a few moments to an uncontaminated atmosphere, if 
available. Unfortunately, workers chronically exposed to a strong 
odor can develop a desensitization which persists up to two weeks or 
more after their departure from the contaminated atmosphere * * * 
Hydrogen sulfide and perhaps other dangerous gases can very quickly 
lose their characteristic odor at high concentrations * * * Certain 
commercial diffusible odor masking or suppressing agents may reduce 
the perceptibility of odors, without removing the chemical source.

    Other commenters agreed that odor threshold levels are so variable 
that it is ``virtually impossible'' to set general rules for uniform 
application (Moldex-Metric, Ex. 54-153; See also Phillips Petroleum, 
Ex. 54-165 and Ex. 54-151). OSHA notes that NIOSH, in its 1987 
Respirator Decision Logic (Ex. 9 at pg. 3) stated that ``[w]hen warning 
properties must be relied on as part of a respiratory protection 
program, the employer should accurately, validly, and reliably screen 
each prospective wearer for the ability to detect the warning 
properties of the hazardous substance(s) at exposure levels that are 
less than the exposure limits for the substance(s).''
    In light of this evidence, OSHA has reconsidered the conditions 
under which air-purifying respirators may be used. The final standard 
requires the use of ESLIs where they are available and appropriate for 
the employer's workplace, whether or not warning properties exist for a 
contaminant. If there is no ESLI available, the employer is required to 
develop a cartridge/canister change schedule based on available 
information and data that describe the service life of the sorbent 
elements against the contaminant present in the employer's workplace 
and that will ensure that sorbent elements are replaced before they are 
exhausted. Reliance on odor thresholds and other warning properties is 
no longer explicitly permitted in the final rule as the sole basis for 
determining that an air-purifying respirator will afford adequate 
protection against exposure to gas and vapor contaminants.
    To date, only five contaminant-specific ESLIs have been granted the 
NIOSH approval necessary to allow them to be used. To the extent that 
NIOSH certified end-of-service life indicators are available, OSHA 
finds that there are considerable benefits to their use. As a 
representative of the Mine Safety Appliances Company (MSA) testified 
(Tr. 821), ``ESLIs * * * simplify administration of the respirator 
program. The idea of trying to administer control on the change out 
schedule for these cartridges leads to human error or could lead to 
human error. Where the end-of-service-life indicator is a more active 
indicator for the actual respirator user that his cartridge needs 
replacement, it takes the guesswork out of the respirator program and 
change out schedule.''
    NIOSH has established rigorous testing criteria for end-of-service 
life indicators. An applicant must supply NIOSH with data 
``demonstrating that the ESLI is a reliable indicator of sorbent 
depletion (equal to or less than 90% of service life). These shall 
include a flow-temperature study at low and high temperatures, 
humidities, and contaminant concentrations which are representative of 
actual workplace conditions where a given respirator will be used * * 
*. Additional data concerning desorption of impregnating agents used in 
the indicator, on the effects of industrial interferences commonly 
found, on reaction products, and which predict the storage life of the 
indicator'' are also required (NIOSH 1987, Ex. 9 at 45-46). Other 
criteria cover the durability of an ESLI, and whether it interferes 
with respirator performance or otherwise constitutes a health or safety 
hazard to the wearer.
    OSHA finds that these rigorous testing requirements will ensure 
that employers who can rely on ESLIs can be confident that their 
employees are adequately protected while using air-purifying 
respirators against gas and vapor contaminants, and is therefore 
requiring their use in the final rule. One commenter pointed out that 
the use of cartridges with moisture-dependent end-of-service life 
indicators will allow dangerously high exposures in dry atmospheres 
(Ex. 54-455). However, the final rule requires the use of cartridges 
and canisters equipped with an ESLI only if its use is appropriate for 
the conditions of the employer's workplace. Thus, employers would not 
be required to rely on an ESLI if the employer could demonstrate that 
its use presents a hazard to employees.
    There was much agreement in the record that it would not be 
possible or feasible to require replacement of cartridges and canisters 
before 80 percent of the useful service life of the sorbent element had 
expired, primarily due to the lack of data available to employers to 
make this determination (Exs. 54-6, 54-48, 54-165, 54-178, 54-181, 54-
226, 54-231, 54-289, 54-374). To implement this requirement as it was 
proposed, the employer would need quantitative information that 
describes how long a cartridge or canister would last when challenged 
with a specific concentration of a gas or vapor. Such studies are 
called ``breakthrough studies'' and require the use of elaborate 
instrumentation and rigid test protocols. Several published 
breakthrough studies of a few dozen commonly used industrial chemicals 
are available in the literature (See, for example, Exs. 21-5, 21-7, 21-
8, 21-10, 38-13, 38-14, 38-15). OSHA recently used breakthrough data to 
develop a general cartridge and canister change schedule for air-
purifying respirators used against 1,3-butadiene (61 FR 56817). Under 
Section 5 of the Toxic Substances Control Act (TSCA), EPA's Office of 
Pollution Prevention and Toxics (OPPT) requires manufacturers and 
importers of new chemicals to conduct breakthrough studies and develop 
cartridge/canister change schedules based on this service life testing.
    As described above, however, comments to the record indicate that 
breakthrough test data are not likely to be available for many 
hazardous gases or vapors encountered in American workplaces. For 
example, one commenter agreed that, although there is a need to protect 
employees against contaminant breakthrough, it disagreed with relying 
on employer-devised schedules because there has not been enough 
breakthrough testing (Laidlaw Environmental Services, Ex. 54-178). The 
American Electric Power Service Corporation asked OSHA to provide 
needed guidance on how to assess the useful life of gas and vapor 
cartridges under widely varying conditions (Ex. 54-181).
    The record shows clearly that respirator manufacturers, chemical 
manufacturers, and even NIOSH must provide more information about how 
long respirator cartridges and canisters can be expected to provide 
protection for employees, as well as additional tools to assess whether 
the cartridges are still functioning. NIOSH's certification process 
does not require respirator manufacturers to provide information on the 
maximum or expected life span for gas and vapor cartridges. Nor do 
chemical manufacturers written specifications routinely include this 
information. The certification process tests only for minimum service 
life, which for most cartridges is 25 to 50 minutes, and for most 
canisters is 12 minutes (42 CFR part 84, Tables 6, 11). Also, as stated 
by Cohen and Garrison of the University of Michigan (Ex. 64-

[[Page 1206]]

 207, at 486), ``(c)urrent certification by NIOSH involves testing 
respirator cartridges containing activated carbon against carbon 
tetrachloride in the presence of water vapor. Testing cartridges with 
carbon tetrachloride cannot predict how other organic vapors will be 
adsorbed.''
    Alternatives to OSHA's proposal that were suggested by rulemaking 
participants included adopting the ANSI requirement to develop and 
implement a cartridge change schedule based on cartridge service data 
(which would require the use of breakthrough test data) and information 
on expected exposure and respirator use patterns (Ex. 54-273), or 
following manufacturers' recommendations for cartridge and canister use 
(Ex. 54-6). Therefore, in the final rule, OSHA is not retaining the 
proposed requirement for employers to ensure that chemical cartridges 
and canisters be replaced before 80 percent of their useful life. 
Instead, OSHA is requiring that employers develop cartridge/canister 
change schedules based on available data or information that can be 
relied upon to ensure that cartridges and canisters are changed before 
the end of their useful service life. Such information may include 
either information based on breakthrough test data or reliable use 
recommendations from the employer's respirator and/or chemical 
suppliers.
    Unlike the proposal, the requirement in the final rule would not 
require the employer to search for and analyze breakthrough test data, 
but instead permits the employer to obtain information from other 
sources who have the expertise and knowledge to be able to assist the 
employer to develop change schedules. OSHA has revised the final rule 
from the proposal in this manner to recognize that there may be 
instances in which specific breakthrough test data are not available 
for a particular contaminant, but manufacturers and suppliers may 
nevertheless still be able to provide guidance to an employer to 
develop an adequate change schedule. If the employer is unable to 
obtain such data, information, or recommendations to support the use of 
air-purifying respirators against the gases or vapors encountered in 
the employer's workplace, the final rule requires the employer to rely 
on atmosphere-supplied respirators because the employer can have no 
assurance that air-purifying respirators will provide adequate 
protection.
    Ideally, change schedules should be based on tests of cartridge/
canister breakthrough that were conducted under worst-case conditions 
of contaminant concentration, humidity, temperature and air flow rate 
through the filter element. One such protocol is described in the EPA 
Interim Recommendations for Determining Organic Vapor Cartridge Service 
Life for NIOSH Approved Respirators (dated May 1, 1991), as revised in 
May 1994. This protocol requires breakthrough testing at three 
different concentrations at 80 and 20 percent relative humidity. 
Additional testing is required if it is determined that the substance 
may be used in workplaces where there are elevated temperatures, or 
where breakthrough is evident at lower humidity. The protocol also 
requires manufacturers to develop change schedules that incorporate a 
safety factor of 60 percent of the measured service life.
    OSHA emphasizes that a conservative approach is recommended when 
evaluating service life testing data. Temperature, humidity, air flow 
through the filter, the work rate, and the presence of other potential 
interfering chemicals in the workplace all can have a serious effect on 
the service life of an air-purifying cartridge or canister. High 
temperature and humidity directly impact the performance of the 
activated carbon in air-purifying filters. OSHA believes that, in 
establishing a schedule for filter replacement, it is important to base 
the schedule on worst-case conditions found in the workplace, since 
this will provide the greatest margin for safety in using air-purifying 
respirators with gases and vapors. Thus, to the extent that change 
schedules are based on test data that were not obtained under similar 
worst-case conditions, OSHA recommends that employers provide an 
additional margin of safety to ensure that breakthrough is not likely 
to occur during respirator use. OSHA encourages respirator and chemical 
manufacturers to perform their own tests to provide appropriate 
breakthrough test data to employers, particularly to small companies 
with limited resources, for those situations where the data are not 
already publicly available.
    If breakthrough data are not available, the employer may seek other 
information on which to base a reliable cartridge/canister change 
schedule. OSHA believes that the most readily available alternative is 
for employers to rely on recommendations of their respirator and/or 
chemical suppliers. To be reliable, such recommendations should 
consider workplace-specific factors that are likely to affect 
cartridge/canister service life, such as concentrations of contaminants 
in the workplace air, patterns of respirator use (i.e., whether use is 
intermittent or continuous throughout the shift), and environmental 
factors including temperature and humidity. Such recommendations must 
be viewed by the employer in light of the employer's own past 
experience with respirator use. For example, reports by employees that 
they can detect the odor of vapors while respirators are being used 
suggest that cartridges or canisters should be changed more frequently.
    Another potential approach involves the use of mathematical models 
that have been developed to describe the physical and chemical 
interactions between the contaminant and sorbent material. Theoretical 
modeling has been conducted to determine the effect of contaminant 
concentration on breakthrough time and other similar relationships. It 
is generally agreed, however, that the relationships between 
contaminant concentrations, exposure durations, breathing rates, and 
breakthrough times are complex and heavily dependent upon assumptions 
concerning several factors, including environmental conditions (See 
references 1-8 in Ex. 64-331). As a result, predictive models are 
probably not likely to present an acceptable alternative for most 
employers, and their use would require that a considerable margin of 
safety be incorporated into any change schedule developed from such 
estimation techniques.
    Research is also underway to develop a field method for evaluating 
the service lives of organic vapor cartridges using a small carbon-
filled tube to sample air from the work environment. The principal 
investigator for this research stated in 1991 that ``(a) field 
evaluation of the method is currently underway. It is expected to be 
the final step in evaluating and validating the method for predicting 
the service lives of organic vapor respirator cartridges in workplace 
environments' (Ex. 64-208 at 42). Although OSHA cannot at this time 
evaluate the utility of this method because results of the field 
testing of this device have not been reported, the development of such 
tools to assist employers to better estimate cartridge/canister service 
times is encouraged, and their use would be permitted under the 
standard providing that the reliability of such a method had been 
appropriately demonstrated.
    Representatives of CMA testified in favor of requiring the employer 
to provide some written documentation for determining service life or a 
change out schedule (Tr. 1736-1737). OSHA agrees that it is important 
for the employer to

[[Page 1207]]

document the basis for establishing the change schedule and has 
included in paragraph (d)(3)(iii)(B)(2) a requirement for the employer 
to do so as part of his or her written respiratory protection program. 
The written respirator program is the proper place for employers to 
document change schedules, since the written program is the place where 
employers give specific directions on workplace-related operations and 
procedures for their employees to follow. The written program also 
documents the exposure measurements or reasonable estimates that were 
made, which form the basis of the calculations used to make the filter 
change schedules. Developing a filter change schedule involves a number 
of decisions. The employer must evaluate the hazardous exposure level, 
the performance capacity of the filters being used, and the duration of 
employee use of the respirator, which impact on the service life 
calculations. OSHA believes that including the basis for the change 
schedule in the written program will cause employers to better evaluate 
the quality and reliability of the underlying information, and will 
prompt the employer to obtain additional information, ask additional 
questions of their suppliers, or seek competent professional help to 
develop a change schedule that will ensure adequate performance of 
cartridges and canisters used in the employer's workplace.
    OSHA proposed in paragraph (d)(3)(ii) that, as part of the required 
selection evaluation, the employer evaluate the physical properties of 
the relevant contaminant and, in the preamble, listed ``the particle 
size for dusts'' as a factor affecting respirator selection (59 FR 
58900). ANSI recommended in its 1992 standard particle size/filter 
selection criteria as follows: if the contaminant is an aerosol, with 
an unknown particle size or a size less than 2 m, use a high 
efficiency filter; if the contaminant is a fume, use a filter approved 
for fumes or a high efficiency filter; and if the contaminant is an 
aerosol, with a particle size greater than 2 m, use any filter 
type (ANSI Z88.2-1992, clause 7.2.2.2.j, k, and l).
    NIOSH agreed with ANSI's recommendations insofar as particulate 
filtering respirators certified under former 30 CFR 11 are concerned. 
However, NIOSH expressed particular concern about very small particles: 
``Laboratory research beginning in the early 1970s, and continuing into 
the 1990s, demonstrated that some, but not all, members of the Dust 
Mist (DM) and Dust Fume Mist (DFM) filter classes allow significant 
penetration of submicron-sized particles. Additionally submicron 
particulates present special medical concerns because they can diffuse 
throughout the respiratory system * * *'' In NIOSH's new 42 CFR part 
84, classes of particulate filters now certified as filter series N, R, 
and P may be used against any size particulate in the workplace (Ex. 
54-437).
    Based on this evidence, OSHA has determined that where employees 
are exposed to submicron particles of a respiratory hazard, OSHA will 
enforce paragraph (d)(3)(iv) as limiting the use of DM and DFM filters 
certified under former 30 CFR 11 to employers who can demonstrate that 
exposure in their workplace is limited to particulates that have a mass 
median aerodynamic diameter of 2 m or larger. OSHA notes that 
employers have alternative choices to using HEPA filters where the 
sizes of particles are unknown or are less than 2 m. The new 
filter media certified by NIOSH under new 42 CFR part 84 as series N, R 
and P, may be used for any size particulate; however, where another 
OSHA standard requires the use of HEPA-filtered respirators, the 
employer may only use HEPA filters defined under 30 CFR 11 or N100, 
R100, or P100 filters defined under 42 CFR part 84.

Paragraph (e)--Medical Evaluation

    Medical evaluation to determine whether an employee is able to use 
a given respirator is an important element of an effective respiratory 
protection program and is necessary to prevent injuries, illnesses, and 
even, in rare cases, death from the physiological burden imposed by 
respirator use. The previous standard stated, at 29 CFR 
1910.134(b)(10), that employees should not be assigned to tasks 
requiring the use of respirators unless it has been determined that 
they are physically able to perform the work while using the 
respiratory equipment. That standard also provided that ``the local 
physician shall determine what health and physical conditions are 
pertinent,'' but listed no specific medical or workplace conditions to 
consider when making such a determination. The previous standard also 
stated that regular reviews of the medical status of respirator users 
should be undertaken, and suggested that a once yearly evaluation would 
be appropriate. Employers are thus aware of the need for medical 
evaluations of respirator users and have been conducting such 
evaluations as part of their respiratory protection programs for years.
    OSHA believes that, to ensure employee protection, medical 
evaluations for respirator use must be conducted before initial 
respirator use, and that such evaluations must consist of effective 
procedures and methods. Accordingly, the final standard's medical 
evaluation requirements for respirator use identify who is to be 
evaluated, and address the frequency and content of these evaluations. 
It authorizes licensed health care professionals, both physicians and 
nonphysicians, to evaluate employees for respirator use to the extent 
authorized by the scope of their state licensure, and to conduct 
follow-up medical evaluations based on specific indicators of need.
    In the proposal, OSHA described three alternative approaches to 
medical evaluation for respirator users. The first proposed alternative 
in the regulatory text would have required employers annually to obtain 
a physician's written opinion for every employee using a respirator for 
more than five hours in any work week. The physician's opinion was to 
inform the employer whether or not a medical examination of the 
employee was necessary and, if so, was to specify the content of the 
medical examination.
    The second proposed alternative required a mandatory medical 
history and examination, using questions and procedures similar to 
those contained in the ANSI standard on physical qualifications for 
respirator use, ANSI Z88.6-1984 (Ex. 38-4). This alternative would have 
applied only to employees using a respirator for more than five hours 
during any work week. Medical evaluation was to be performed annually 
and whenever an employee experienced breathing difficulty while being 
fitted for, or using, a respirator. The medical evaluation was to be 
conducted by a physician or a health care professional supervised by a 
physician, who, in arriving at a decision regarding the employee's 
medical ability for respirator use, was to consider a number of 
respirator and workplace conditions (e.g., type of respirator used, 
duration and frequency of respirator use, substances to which the 
employee is exposed, work effort and type of work, need for protective 
clothing, and special environmental conditions (e.g., heat, confined 
spaces)) that could affect the health and safety of respirator users. 
The resulting medical opinion, which was to be written by a physician, 
was to recommend any medical limitation on respirator use, and was to 
be provided to both the employer and employee. This proposed 
alternative contained an exemption for employees who had received a 
comparable medical history and examination within the previous year for 
the same respirator and conditions of respirator use. OSHA proposed a 
nonmandatory Appendix C

[[Page 1208]]

with this alternative that specified the elements of the medical 
evaluation.
    The third proposed alternative would have required that a medical 
questionnaire be administered to every respirator user, regardless of 
the duration of respirator use. The medical questionnaires could be 
administered by health professionals or other personnel who had been 
trained in medical administration by a physician. If the answers to the 
medical questionnaire showed that a medical examination was needed, the 
employee had to be provided such an examination (see 59 FR 58911). 
Medical examinations were to be mandatory for employees who would be 
required to use SCBAs when assigned to emergency or rescue operations. 
Medical examinations were to be conducted by physicians or physician-
supervised health care professionals. The medical opinion was to be 
written by a physician; consider the same respirator and workplace 
conditions specified for the second alternative; specify any medical 
limitations on respirator use; and be provided to both the employer and 
employee.
    In addition to proposing three medical evaluation alternatives, the 
proposal requested comments on medical removal protection, including 
the need to provide alternative respirators or job assignments to 
employees found to be medically unable to use the required respirator.
Overview of the Final Rule's Provisions
    The provisions of paragraph (e) in the final Respiratory Protection 
standard are based on an extensive review of the comments received on 
the proposal, especially comments regarding the three proposed medical 
evaluation alternatives. Final paragraph (e)(1) specifies that every 
employee must be medically evaluated prior to fit testing and initial 
use of a respirator. Paragraph (e)(2) states that employers must select 
a physician or other licensed health care professional (PLHCP) to 
conduct the medical evaluation, which must consist either of the 
administration of a medical questionnaire or an initial medical 
examination. Mandatory Appendix C contains the medical questionnaire to 
be administered to employees if the medical questionnaire approach is 
taken.
    Paragraph (e)(3) requires the employer to provide a follow-up 
medical examination to an employee who answers ``yes'' to any question 
among questions 1 through 8 in Section 2, Part A of the medical 
questionnaire in Appendix C. The follow-up medical examination is to 
consist of any tests, consultations, or diagnostic procedures that the 
PLHCP deems necessary.
    Paragraph (e)(4) specifies that the medical questionnaire and 
examinations shall be administered confidentially and at a time and 
place, during working hours, that is convenient to the employee, and 
that the employee understands the content of the questionnaire.
    Paragraph (e)(5) requires the employer to provide the PLHCP with 
specific information needed to make an informed decision about whether 
the employee is able to use a respirator. The information includes 
descriptions of the respirator to be used and workplace conditions that 
may impose physiological burdens on respirator users, or that may 
interact with an existing medical condition to increase the risk that 
respirator use will adversely affect the employee's health.
    Final paragraph (e)(6) requires the employer to obtain a written 
recommendation from the PLHCP on whether or not the employee is 
medically able to use a respirator. The recommendation must identify 
any limitations on the employee's use of the respirator, as well as the 
need for follow-up medical evaluations to assist the PLHCP in 
determining the effects of respirator use on the employee's health. The 
employee must receive a copy of the PLHCP's written recommendation. The 
last provision of paragraph (e)(6) requires that a powered air-
purifying respirator (PAPR) be provided to an employee when information 
from the medical evaluation shows that the employee can use a PAPR but 
not a negative pressure respirator. If the PLHCP determines at a 
subsequent time that the employee is able to use a negative pressure 
respirator, the employer is no longer required to provide a PAPR to 
that employee.
    Paragraph (e)(7) specifies circumstances that require the employer 
to provide additional medical evaluations to respirator users. Medical 
reevaluations must be provided under the following conditions: when the 
employee reports signs or symptoms that are relevant to the employee's 
ability to use a respirator; when a PLHCP, supervisor, or respirator 
program administrator informs the employer that an employee needs to be 
reevaluated; when information from the respirator program, including 
observations made during fit testing or program evaluation, indicates a 
need for employee reevaluation; or if a change in workplace conditions 
occurs that may result in a substantial increase in the physiological 
burden that respirator use places on the employee. The following 
paragraphs describe the comments received in connection with each 
medical evaluation requirement, and discuss OSHA's reasons for 
including each requirement in the final rule.
Introduction
    OSHA is including an introduction to the regulatory text that 
provides a brief rationale for requiring employers to implement a 
medical evaluation program as part of their overall respiratory 
protection program. The introduction is provided for informational 
purposes, and does not impose regulatory obligations on employers.
    The purpose of a medical evaluation program is to ensure that any 
employee required to use a respirator can tolerate the physiological 
burden associated with such use, including the burden imposed by the 
respirator itself (e.g., its weight and breathing resistance during 
both normal operation and under conditions of filter, canister, or 
cartridge overload); musculoskeletal stress (e.g., when the respirator 
to be worn is an SCBA); limitations on auditory, visual, and odor 
sensations; and isolation from the workplace environment (Exs. 113, 22-
1, 64-427). Certain job and workplace conditions in which a respirator 
is used can also impose a physiological load on the user; factors to be 
considered include the duration and frequency of respirator use, the 
level of physical work effort, the use of protective clothing, and the 
presence of temperature extremes or high humidity. Job- and workplace-
related stressors may interact with respirator characteristics to 
increase the physiological stress experienced by employees (Exs. 113, 
64-363). For example, being required to wear protective clothing while 
performing work that imposes a heavy workload can be highly stressful.
    Specific medical conditions can compromise an employee's ability to 
tolerate the physiological burdens imposed by respirator use, thereby 
placing the employee at increased risk of illness, injury, and even 
death (Exs. 64-363, 64-427). These medical conditions include 
cardiovascular and respiratory diseases (e.g., a history of high blood 
pressure, angina, heart attack, cardiac arrhythmias, stroke, asthma, 
chronic bronchitis, emphysema), reduced pulmonary function caused by 
other factors (e.g., smoking or prior exposure to respiratory hazards), 
neurological or musculoskeletal disorders (e.g., ringing in the ears, 
epilepsy, lower back pain), and impaired sensory function (e.g., a 
perforated ear drum, reduced olfactory

[[Page 1209]]

function). Psychological conditions, such as claustrophobia, can also 
impair the effective use of respirators by employees and may also 
cause, independent of physiological burdens, significant elevations in 
heart rate, blood pressure, and respiratory rate that can jeopardize 
the health of employees who are at high risk for cardiopulmonary 
disease (Ex. 22-14). One commenter (Ex. 54-429) emphasized the 
importance of evaluating claustrophobia and severe anxiety, noting that 
these conditions are often detected during respirator training.
    The introduction states that the medical evaluation requirements in 
paragraph (e) of the final rule are minimal requirements that OSHA 
believes are necessary to protect the health of respirator users.
Paragraph (e)(1)--General
    This paragraph requires that employees required to wear a 
respirator, or those voluntarily wearing a negative pressure air 
purifying respirator, be medically evaluated, and that a determination 
be made that they are able to use the respirators selected by the 
employer. A medical evaluation must be performed on every employee 
required to use a respirator, regardless of the duration and frequency 
of respirator use. In addition, as discussed above in connection with 
paragraph (c)(2), employers must provide a medical evaluation to any 
employee who elects to use a respirator that may place a physiological 
burden on the user, e.g., a negative pressure air-purifying respirator. 
By medically evaluating employees prior to respirator use, employers 
will avoid exposing employees to the physiological stresses associated 
with such use. Paragraph (e)(1) is similar to a provision in the 
American National Standards Institute (ANSI) consensus standard Z88.2-
1992 (``American National Standard for Respiratory Protection) that 
states: ``any medical conditions [of an employee] that would preclude 
the use of respirators shall be determined.''
    Commenters (Exs. 54-21, 54-307, 54-361, 54-419, 54-420, 54-421, 54-
441) generally agreed that medical evaluation should precede initial 
respirator use, i.e., should take place before fit testing and first 
time use of the respirator in the workplace. For example, the 
International Brotherhood of Electrical Workers (Ex. 54-441) stated, 
``The physical fitness of respirator users must be known prior to them 
donning a respirator, not after they become injured.'' Three other 
commenters (Exs. 54-419, 54-420, 54-421) agreed, without elaboration, 
that medical evaluations should be performed before respirator use. One 
commenter (Ex. 54-21) recommended that employees receive medical 
evaluations after fit testing but before actual use so that 
difficulties with respirator use during fit testing could be reported 
to the PLHCP, and two other commenters (Exs. 54-307, 54-361) also 
suggested that the medical evaluation be conducted prior to fit 
testing.
    OSHA believes that the initial medical evaluation must be conducted 
prior to fit testing to identify those employees who have medical 
conditions that contraindicate even the limited amount of respirator 
use associated with fit testing. If medical problems are observed 
during fit testing, the employee must be medically reevaluated (see 
final paragraph (e)(7)).
    Final paragraph (e)(1) requires the medical evaluation of employees 
who use respirators, regardless of duration of use. This final 
requirement differs from proposed alternatives 1 and 2, which would 
have exempted from medical evaluation those employees who used a 
respirator for five or fewer hours during any work week. The 
overwhelming majority of commenters stated that the exemption should be 
eliminated entirely or be limited only to those employees who are 
exposed to minimal physiological stresses or workplace hazards. These 
comments can be grouped, and are summarized, as follows:
    (1) If the five-hours-per-week threshold were used, employers would 
avoid the proposed medical evaluation requirement by rotating employees 
who use respirators into jobs not requiring respirators just short of 
the five-hour limit (Exs. 54-5, 54-165, 54-178, 54-419);
    (2) Employees who use respirators frequently for periods of less 
than five hours per work week, or who use respirators for more than 
five hours per work week but do so infrequently, are still at risk of 
the adverse health effects potentially associated with respirator use 
and, therefore, they should also be medically evaluated (Exs. 54-163, 
54-178, 54-308, 54-345);
    (3) The five-hour exemption should not apply to respirator use that 
is known to be physiologically burdensome (e.g., use of SCBAs by 
emergency responders) or to use under the job or working conditions 
(including hazardous exposures) that impose a significant physiological 
burden on employees (Exs. 54-5, 54-68, 54-92, 54-107, 54-137, 54-153, 
54-158, 54-159, 54-187, 54-194, 54-195, 54-206, 54-208, 54-213, 54-224, 
54-247, 54-264, 54-265, 54-275, 54-283, 54-290, 54-327, 54-342, 54-348, 
54-363, 54-395, 54-415, 54-427, 54-429, 54-453);
    (4) The five-hour exemption would be too difficult for OSHA to 
enforce or could not be administered effectively and efficiently by 
employers (Exs. 54-70, 54-136, 54-167, 54-196, 54-244, 54-250, 54-267, 
54-327, 54-348, 54-443);
    (5) The health of employees with preexisting medical problems would 
be endangered because these problems may go undetected until the five-
hour limit is reached (and, in some cases, may never be detected if 
employees ``self-select'' into jobs with little respirator use because 
of their medical problems) (Exs. 54-92, 54-159, 54-247, 54-415, 54-441, 
54-455); and
    (6) The five-hour exemption is not appropriate because every 
employee who uses a respirator should have a medical evaluation (Exs. 
54-6, 54-46, 54-79, 54-196, 54-202, 54-208, 54-214, 54-218, 54-233, 54-
272, 54-275, 54-287, 54-289, 54-295, 54-357, 54-394, 54-420, 54-424, 
54-430, 54-434, 54-453), or the exemption is arbitrary, has no 
scientific basis, or would increase an employer's risk of liability 
(Exs. 54-188, 54-434).
    Several commenters recommended that medical evaluation not be 
required for SCBA users (Exs. 54-68, 54-320, 54-331, 54-353); that 
medical evaluations for emergency responders be contingent on 
respirator use exceeding five hours per year (Ex. 54-429); or that 
emergency responders be exempted from medical evaluation requirements 
that are unique to employees who use airline respirators or SCBAs (Ex. 
54-420).
    Some commenters recommended adopting the five hours per week 
exemption (Exs. 54-14, 54-80, 54-91, 54-182, 54-220, 54-223, 54-224, 
54-252, 54-283, 54-319) to achieve cost savings and improve the 
efficiency of the respiratory protection program. Two commenters (Exs. 
54-177, 54-402) stated that the five-hour limit represented the point 
at which the effects of job-related physical stress should be medically 
evaluated. Although generally endorsing the provision, several 
commenters (Exs. 54-168, 54-206, 54-209, 54-295, 54-357, 54-366) found 
the phrase ``during any work week'' to be vague, confusing, or in need 
of being defined.
    Several commenters wanted the five hours per week limit revised 
upwards. One commenter (Ex. 54-300) recommended that the limit be 
raised to 10 hours per week, while another commenter (Ex. 54-249) 
endorsed a limit of 30 days per year. A third commenter (Ex. 54-116) 
stated that the limit could be increased, without

[[Page 1210]]

danger, to 10 hours per week for firefighters who use SCBAs, but 
presented no data to support this position, while three other 
commenters (Exs. 54-209, 54-254, 54-454) stated that a 10 or 15-hour 
per week limit could be tolerated without stress by most employees who 
use respirators. One commenter (Ex. 54-435) believed that the exemption 
should be broadened to cover seasonal employees because medical 
evaluations are too difficult to administer to these employees. Another 
commenter (Ex. 54-263) opposed any requirement for the medical 
evaluation of employees who use respirators.
    One commenter recommended that medical evaluations not be required 
for employees who use disposable half-mask or dust mask respirators, 
regardless of workplace exposure conditions (Ex. 54-329). A number of 
commenters suggested eliminating medical evaluations if employers 
choose to provide respirators to their employees (i.e., if they are not 
required by OSHA to provide such respirators) (Exs. 54-69, 54-91, 54-
265, 54-287, 54-295, 54-320, 54-327, 54-339, 54-346, 54-421); two of 
these commenters (Exs. 54-69, 54-339) expressed the concern that 
employers may stop offering respirators to their employees if medical 
evaluation is required in these cases.
    The final standard, as noted above, provides an exception from the 
requirement that employees who use dust masks on a voluntary-use basis, 
as defined in paragraph (c), must be medically evaluated. OSHA based 
the decision to require medical evaluation for all employees required 
to use respirators, and for those employees voluntarily using negative 
pressure respirators, on a number of scientific studies, discussed 
below, which demonstrated that adverse health effects can result, in 
some cases, even from short duration use of respirators. Several 
experimental studies in the record show that even healthy individuals 
using what is generally believed to be a ``low risk'' respirator for 
short periods can experience adverse physiological and psychomotor 
effects. In one experiment (Ex. 64-388), 12 individuals using low 
resistance, disposable half-mask respirators under heavy workloads 
(using a treadmill apparatus) for only five minutes experienced 
statistically significant elevations in heart and respiratory rates, 
systolic and diastolic blood pressure, and body temperatures compared 
with these measures in the same individuals under control (i.e., no 
respirator use) conditions. Some of these effects were observed while 
the study participants were working at light and moderate workloads. 
For two of these individuals, the study's author classified blood 
pressure changes at heavy workload levels as ``clinically important.'' 
These results suggest that in an individual with cardiac insufficiency, 
such physiological stress could cause fatal arrhythmia.
    In another study (Ex. 64-444), 15 individuals used a full facepiece 
respirator while performing light, moderate, and heavy workloads on a 
bicycle ergometer for 15 minutes. Immediately following the 15 minute 
exercise period, the ability of the individuals to maintain their 
equilibrium (i.e., postural stability) was assessed using a special 
platform designed for this purpose. Under every workload condition, 
respirator use resulted in significantly increased heart rates and 
impaired equilibrium compared to conditions when the individuals did 
not use respirators.
    A third study (Ex. 64-490) involved 12 individuals, each of whom 
exercised for 30 minutes on a bicycle ergometer at a light-to-moderate 
workload while using one of three types of respirators, i.e., 
disposable half-mask, negative pressure half-mask, and full facepiece 
airline respirators. After taking a 10 minute rest, the study 
participants repeated the procedure until each respirator type had been 
tested. Compared to the control condition in which the subjects 
exercised without respirators, the individuals were found to consume 
more oxygen while exercising with the negative pressure half-mask and 
full facepiece airline respirators, and to have higher systolic and 
diastolic blood pressures while using the full facepiece airline 
respirator. Under the test conditions of this study, therefore, 
negative pressure half-mask and full facepiece airline respirators 
imposed significant physiological stress on the respirator users.
    Louhevaara (Ex. 164, Attachment D), after reviewing the available 
research literature on respirator physiology, concluded that the major 
physiological effects of negative pressure respirators and supplied-air 
respirators, as well as SCBAs, are ``alterations in breathing patterns, 
hypoventilation, retention of carbon dioxide, and [an] increase in the 
work of breathing,'' and that these effects are worse under conditions 
of increased filter resistance, poor respirator maintenance, and heavy 
physical work. Sulotto et al. (Ex. 164, Attachment D) found that 
negative pressure respirators resulted in higher breathing resistances 
as physical workload on a bicycle ergometer increased, leading to 
substantially reduced breathing frequency, ventilation rate, oxygen 
uptake, and carbon dioxide production.
    One study (Ex. 164, Attachment D, Beckett) that reviewed the 
scientific literature on the medical effects of respirator-imposed 
breathing resistance among healthy young men noted that ``[t]hese and 
other studies indicate no clinically significant impairment of normal 
respiratory function at submaximal workloads with the loads imposed by 
currently approved, properly maintained, negative pressure respiratory 
protective devices.'' This reviewer stated further, however, that 
``[r]elatively less is known about the use of respirators by those with 
abnormal physiology (for example, obstructive or restrictive pulmonary 
diseases) and about the use of respirators whose resistance 
characteristics are altered by excessively long use, such that 
inspiratory resistance is increased by the deposition of matter within 
the filter or absorptive elements of the canister.''
    The Agency finds that these studies demonstrate the potential for 
adverse health effects resulting from respirator use, even for healthy 
employees using respirators designed for low breathing resistance and 
used for short durations. The Agency believes, therefore, that 
respirator use would impose a substantial risk of material impairment 
to the health of employees who have preexisting respiratory and 
cardiovascular impairments. As the earlier discussion of final 
paragraph (e)(1) indicates, the record contains overwhelming support 
for requiring medical evaluation of respirator users; many employers 
who provided comments to the record have established medical evaluation 
programs for all employees who use respirators (see, e.g., comments by 
Organization Resources Counselors, Inc., Ex. 54-424). Consequently, 
OSHA finds, consistent with the results of these studies and the entire 
record, that the use of any respirator requires a prior medical 
evaluation to determine fitness.
    Other considerations that have caused OSHA to make this decision 
are the potential impairment of health that may occur among employees 
with preexisting medical problems if these problems are not detected 
before respirator use; the need to identify medical problems that can 
arise even from short term use of respirators of the types known to 
impose severe physical stress on employees (e.g., SCBAs); and the 
administrative difficulties and inefficiencies that employers would 
experience if OSHA adopted a provision that required medical 
evaluations only of some respirator users, i.e., those using certain 
types of respirators or those

[[Page 1211]]

using them for a specified number of hours per week.
    OSHA specifically disagrees with those commenters who stated that 
no medical evaluations are needed for employees who only occasionally 
use SCBAs. SCBAs create the highest cardiovascular stress of any type 
of respirator because of their weight, and they are often used in high 
physical stress situations, such as fires and other emergencies. This 
combination of stressors makes medical evaluation necessary to avoid 
myocardial infarction in susceptible individuals; at least 40 million 
people in the United States have some form of heart disease (Levy, in 
54 FR 2541).
    One commenter (Ex. 54-284) recommended that the required medical 
evaluations should be discontinued after an employee stops using 
respirators. OSHA agrees with this recommendation, and has revised 
final paragraph (e)(1) accordingly.
Paragraph (e)(2)--Medical Evaluation Procedures
    Paragraph (e)(2)(i). This final paragraph requires the employer to 
identify a physician or other licensed health care professional (PLHCP) 
to perform medical evaluations using a medical questionnaire or medical 
examination. Two major issues were raised in the rulemaking record: (1) 
What must be done to evaluate employees, and (2) who must perform the 
evaluation. Proposed paragraphs (e)(1) and (e)(3) would have required 
physician involvement in the medical evaluation process, with 
nonphysician health care professionals permitted to review the 
employee's medical status only under the supervision of a licensed 
physician. The final rule allows the evaluation to be performed either 
by a physician or other licensed health care professional (e.g., nurse 
practitioners, physician assistants, occupational health nurses), 
provided that their license permits them to perform such evaluations.
    Many commenters, representing labor, management, occupational 
nurses, nurse practitioners, and physician assistants, recommended that 
OSHA permit the use of nonphysician health care professionals (usually 
nurse practitioners, physician assistants, occupational health nurses, 
or registered nurses) to take medical histories, conduct physical 
examinations (including pulmonary function tests), and administer and 
review employee responses to medical questionnaires, provided that they 
do so under the supervision of a licensed physician (Exs.54-6, 54-7, 
54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187, 54-205, 
54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304, 54-357, 
54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443, 54-
453). Some commenters stated that nonphysician health care 
professionals are competent to conduct medical assessments, while 
physician supervision or involvement would guarantee that quality 
control was maintained over the assessment process (Exs. 54-273, 54-
363, 54-381, 54-443, 54-453). Two of these commenters (Exs. 54-278, 54-
430) noted that any health care professional could review medical 
questionnaires without physician supervision, but that physicians 
should conduct or supervise any medical examinations conducted on the 
basis of answers to the medical questionnaires.
    Many other commenters, representing labor, management, and 
physicians, preferred that only physicians be involved in medical 
evaluation programs (Exs. 54-14, 54-46, 54-70, 54-101, 54-107, 54-150, 
54-151, 54-165, 54-175, 54-180, 54-186, 54-189, 54-199, 54-217, 54-219, 
54-220, 54-249, 54-271, 54-295, 54-313, 54-352, 54-455). This 
preference was usually based on the prior or current practices of these 
commenters. For example, the American College of Occupational and 
Environmental Medicine (ACOEM) (Ex. 54-453) stated that the health 
status of employees in a respiratory protection program should be 
reviewed by physicians with specific training and experience in 
occupational medicine because these medical specialists have knowledge 
of the physical demands of respirator use needed to make valid 
decisions regarding an employee's medical ability for the program. A 
similar recommendation was made by the Service Employees International 
Union (Ex. 54-455).
    Some commenters recommended that the employee's medical ability to 
use a respirator be evaluated solely by nonphysician health care 
professionals (Exs. 54-16, 54-19, 54-25, 54-32, 54-79, 54-159, 54-184, 
54-213, 54-222, 54-226, 54-253, 54-265, 54-272, 54-278, 54-397). Most 
of these commenters cited their favorable experiences with nonphysician 
health care professionals, and pointed to the cost savings of using 
nonphysicians (Exs. 54-19, 54-79, 54-184, 54-226, 54-253). Several of 
these commenters provided additional justifications. For example, one 
commenter (Ex. 54-184) stated that ``physician assistants, by 
education, training, and state regulation, are well qualified and 
legally able to perform all aspects of a medical evaluation,'' and 
argued that the scope of practice with regard to medical evaluations 
should remain the prerogative of state licensing boards.
    Another commenter (Ex. 54-213) noted that ``many physicians are not 
familiar with occupational health risks as they relate to respiratory 
exposures, types of respiratory protection available, and work 
requirements.'' This commenter stated further that ``nurse[s] or other 
qualified health care professional[s], operating within their licensed 
scope of practice, [have] clinical expertise and knowledge of the work 
environment and can best evaluate the physical requirements placed on 
the user of respiratory protective equipment'' and that ``[u]se of 
qualified health care professionals other than physicians is cost-
beneficial to employers, particularly [in] small business settings'' 
(Ex. 54-213).
    The American Thoracic Society (Ex. 54-92), which recommended the 
use of medical questionnaires rather than medical examinations, stated 
that ``there is no demonstration that [physician-based] examinations 
actually predict who will develop difficulties with respirator use'' 
because ``[v]ery few physicians have in-depth knowledge of respiratory 
protection and workplace hazards sufficient to render a fully reasoned 
view.''
    None of the commenters, including those who used nonphysician 
health care professionals to conduct medical evaluations as part of 
their respiratory protection programs, cited any data or experience 
showing that the type of PLHCP qualification and licensure, or the 
manner in which PLHCPs are involved in the medical evaluation process, 
had compromised the medical evaluation process or had resulted in 
faulty medical evaluations.
    After reviewing the entire record, OSHA decided to allow any PLHCP 
to evaluate an employee's medical ability to use a respirator, 
providing that the PLHCP is authorized to do so by his or her state 
license, certification, or registration. Although OSHA agrees that 
physicians with training and experience in occupational medicine are 
highly qualified to conduct medical evaluations for respirator use, an 
insufficient number (slightly more than 2,000 nationally) of these 
specialists are available for this purpose (personal communication, 
American Board of Medical Specialties, to Vanessa Holland, M.D., 5/29/
97). In addition, in circumstances where questions arise as to the 
employee's physical condition and capability, OSHA believes that the 
PLHCP can be relied on to consult with an appropriate specialist or 
physician.

[[Page 1212]]

    After a review of the licensing provisions of the 50 states and 
Puerto Rico, OSHA concludes that state licensing laws often require 
some physician involvement in conducting the medical evaluations 
required by the final standard. For example, the majority of states 
require that nurse practitioners perform their medical functions under 
a formal written agreement with a physician. Only six states (i.e., 
Montana, New Mexico, North Dakota, Oregon, Vermont, and Washington) and 
Puerto Rico allow licensed nurse practitioners to function 
independently of physician supervision. Even these jurisdictions, 
however, require licensed nurse practitioners to refer patients to a 
physician for further evaluation and treatment when a medical problem 
beyond the nurse practitioner's level of expertise arises. OSHA 
believes that the states are best suited to judge the medical 
competencies of those PLHCPs who practice within their jurisdictions, 
and to regulate the scope of practice of these individuals.
    To summarize, the final rule allows any PLHCP to administer the 
medical questionnaire or to conduct the medical examination if doing so 
is within the scope of the PLHCP's license. The basis for this decision 
includes the following:
    (1) The record (Exs. 54-19, 54-79, 54-92, 54-184, 54-253) generally 
supports the position that properly qualified PLHCPs, regardless of the 
type of health care specialization, are competent to assess the medical 
ability of employees to use respirators using accepted medical 
questionnaires or medical examinations;
    (2) Evidence in the record that employers who operate respiratory 
protection programs have successfully used PLHCPS, including 
nonphysicians, to conduct medical evaluations and to make medical 
ability recommendations, shows that nonphysicians have done so safely 
and efficaciously (Exs. 54-213, 54-240, 54-389);
    (3) Providing employers with ready access, at reasonable cost, to 
the basic medical assessment skills required to perform at least the 
initial phases of employee medical evaluation for respirator use 
contributes to the efficient and effective allocation health care 
resources; and
    (4) The lack of record support for a requirement allowing medical 
evaluations to be performed only by physicians. The record (Exs. 54-6, 
54-7, 54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187, 
54-205, 54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304, 
54-357, 54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443, 
54-453) indicates that medical evaluations performed independently by 
nonphysician health care professionals, as defined by this section, are 
effective for at least the initial phases of an employer's medical 
evaluation program (i.e., evaluating the medical questionnaire or 
conducting an initial medical examination), and protect employee health 
as well as medical evaluations conducted only by physicians or with 
physician oversight. Employers are free, however, to select any PLHCP 
they wish to satisfy this requirement, provided that the PLHCP is 
qualified by license to do so. In some cases, the medical condition of 
the employee or the conditions of respirator use may warrant physician 
involvement, and OSHA is confident that LHCPs faced with such 
situations will seek such medical advice.
    Paragraph (e)(2)(ii). Paragraph (e)(2)(i) requires employers to 
identify a PLHCP to perform the medical evaluations required by the 
final rule. It also specifies that employers may choose to use the 
medical questionnaire in Appendix C to conduct the initial medical 
evaluation or provide a medical examination that obtains the same 
information as the medical questionnaire. Employers are free to provide 
respirator users with a medical examination in lieu of the medical 
questionnaire if they choose to do so, but they are not required by the 
standard to administer a medical examination unless the employee gives 
a positive response to any question among questions 1 through 8 in 
Section 2, Part A of Appendix C (see paragraph (e)(3)).
    The approach taken in the final rule thus resembles the third 
alternative proposed by OSHA in the NPRM: reliance on a medical 
questionnaire (with medical examination follow-up if positive responses 
are given to selected questions on the medical questionnaire). Those 
commenters (Exs. 54-3, 54-14, 54-46, 54-67, 54-107, 54-151, 54-168, 54-
175, 54-180, 54-218, 54-220, 54-224, 54-226, 54-227, 54-240, 54-244, 
54-264, 54-292, 54-294, 54-295, 54-324, 54-326, 54-327, 54-339, 54-346, 
54-352, 54-366, 54-370, 54-210, 54-432, 54-434, 54-443, 54-445, 54-453) 
who preferred the other alternatives (i.e., medical history and medical 
examination for all respirator users, or medical examination and 
written opinion) supported their views with a variety of opinions.
    A number of the commenters who recommended the medical history and 
examination alternative (Exs. 54-153, 54-165, 54-218, 54-226, 54-227, 
54-263, 54-264, 54-294, 54-326, 54-327, 54-363, 54-443) favored this 
approach only in those cases when employees would be using SCBAs, while 
others (Exs. 54-16, 54-220) stated that medical questionnaires should 
be used only for employees who use dust masks, and that other 
respirator users should receive a medical history and examination 
regardless of the duration of respirator use. Another commenter (Ex. 
54-101) recommended that medical questionnaires be administered to 
employees who use dust masks for fewer than five hours per week, while 
other employees should receive a medical history and examination. One 
commenter favored medical questionnaires only for respirator users who 
perform ``isolated operations,'' while recommending that respirator use 
in other employment settings require a medical history and/or 
examination (Ex. 54-46). Another commenter stated that employees using 
respirators under workplace exposure conditions exceeding an OSHA PEL 
should receive a medical history and examination, while respirator 
users exposed to other workplace atmospheres should only be required to 
complete a medical questionnaire (Ex. 54-339).
    Those commenters (Exs. 54-7, 54-16, 54-21, 54-25, 54-32, 54-69, 54-
91, 54-92, 54-101, 54-134, 54-142, 54-153, 54-154, 54-157, 54-158, 54-
165, 54-170, 54-171, 54-172, 54-173, 54-176, 54-187, 54-190, 54-192, 
54-154, 54-197, 54-205, 54-206, 54-208, 54-209, 54-213, 54-14, 54-219, 
54-222, 54-223, 54-234, 54-239, 54-241, 54-242, 54-245, 54-251, 54-252, 
54-253, 54-254, 54-262, 54-263, 54-265, 54-267, 54-269, 54-272, 54-273, 
54-275, 54-278, 54-284, 54-286, 54-289, 54-296, 54-304, 54-309, 54-319, 
54-320, 54-325, 54-330, 54-332, 54-334, 54-342, 54-350, 54-357, 54-361, 
54-363, 54-381, 54-389, 54-396, 54-401, 54-421, 54-424, 54-426, 54-428, 
54-429, 54-430, 54-441, 54-453, 54-455) recommending medical 
questionnaires (proposed alternative 3) objected to the medical 
examination and written opinion approaches because, in their view, 
medical examinations and opinions are difficult to obtain, have poor 
predictive value, and are expensive, especially for workplaces that 
have high employee turnover. Regarding costs, the American Iron and 
Steel Institute (Ex. 175) stated that the medical opinion required by 
alternative 1 would cost their industry $195 per employee, including 
$150 for the medical examination and opinion, and $45 in lost work time 
for the employee.
    The record does not demonstrate that any of the three alternatives 
were

[[Page 1213]]

superior in detecting medical conditions that could potentially limit 
employee use of respirators. Testimony at the hearing by the United 
Steel Workers of America (USWA) (Tr. 1059 and following) in support of 
alternative 2 (medical history and examination) provided information on 
the ability of different medical assessment procedures to detect 
disqualifying medical conditions. This information showed that, among 
126 employees, 16 were disqualified for respirator use because of 
various medical conditions. Medical histories identified six of the 
employees with these conditions, while a medical examination conducted 
by a physician identified the remaining 10 employees. The USWA 
attributed the reduced effectiveness of the medical histories in this 
instance to the lack of awareness among employees of the medical 
conditions that could potentially limit such use.
    The United Steel Worker's testimony (Tr. 1059 and following) also 
described a study in which physician-administered medical examinations 
were found to be about 95 percent accurate and medical questionnaires 
were found to be 60 to 70 percent accurate in identifying specific 
medical problems. The final rule is designed to overcome this problem 
to some extent by requiring that employees be trained to recognize the 
medical signs and symptoms associated with the physiological burden 
imposed by respirator use; see paragraph (k)(1)(vi).
    A number of commenters supported the medical questionnaire option 
on the grounds that this approach is more efficient and effective. The 
United States Air Force (Ex. 54-443G) stated, ``After working under the 
provisions of [proposed] alternative 2 for several years and comparing 
the Air Force's occupational health and cost savings by reducing 
unnecessary medical evaluations and freeing physician time under 
[proposed] alternative 3, the Air Force supports [proposed] alternative 
3.'' Similarly, the CITGO Petroleum Corporation (Ex. 54-251) endorsed 
medical questionnaires as more cost-effective than medical 
examinations. CITGO administered medical examinations to a sample of 
1634 employees in 1994 to detect respiratory disorders, a major medical 
concern for respiratory protection programs, and identified only one 
abnormal case that was confirmed after referral for follow-up medical 
examination.
    An additional study involving validation of medical questionnaires 
was described by Organization Resources Counselors, Inc. (ORC) (Ex. 54-
424). One of ORC's member companies, a large, diversified manufacturing 
organization, recently reviewed approximately 700 records of employee 
respirator medical examinations to determine the effectiveness of using 
a medical questionnaire as a screening tool. This company currently 
gives all respirator users a full medical examination in addition to 
having them fill out a medical questionnaire. The records review 
revealed that, out of 700 examinations, only 10 (less than 2%) required 
medical limitations on respirator use. These limitations were due to 
claustrophobia, asthma, and heavy smoking. All of these limitations 
would have been identified, in the company's view, by a medical 
questionnaire. The employees identified through the medical 
questionnaire could then have been given a complete medical 
examination. By using the medical questionnaire as a screening tool, 
this company believes it could have eliminated unnecessary examinations 
for 98% of its worker population.
    A private physician and three management groups (Exs. 54-32, 54-
424, 55-29, 155) submitted medical questionnaires to the record and 
expressed satisfaction with these medical questionnaires, in terms of 
both the medical conditions that were detected and the administrative 
efficiency of the process; these commenters, however, recommended that 
physicians be involved in reviewing the medical questionnaires. Several 
commenters (Exs. 54-70, 54-159, 54-215) endorsed the medical evaluation 
procedures specified in the American National Standard Institute's 
(ANSI) consensus standard Z88.6-1984, titled ``American National 
Standard for Respiratory Protection--Respirator Use--Physical 
Qualifications for Personnel.'' This ANSI standard recommends that a 
medical history questionnaire be administered to employees who are 
enrolled in respiratory protection programs, and that a physician 
review each employee's responses to the medical questionnaire to 
determine if additional medical examinations are required.
    OSHA concludes that information in the record supports the use of 
medical questionnaires for detecting medical conditions that may 
disqualify employees from, or limit employee participation in, 
respiratory protection programs. OSHA believes that the ORC study (Ex. 
54-424) provides support for the conclusion that medical questionnaires 
are an efficient and effective means of screening employees for 
subsequent medical examination. OSHA also believes that the training 
required by paragraph (k)(1) of the final rule, which requires that 
employees understand the limitations of respirator use and recognize 
the signs and symptoms of medical problems associated with respirator 
use, will increase employee awareness and overcome the problems that 
the USWA (Tr. 1059 and following) noted in its testimony. A number of 
commenters (Exs. 54-107, 54-151, 54-153, 54-165, 54-190, 54-218, 54-
251, 54-253, 54-272, 54-339, 54-361, 54-401) stated that medical 
questionnaires had several advantages over the other alternatives, 
including simplicity and efficiency of use, completeness and accuracy 
of the medical information obtained, and adaptability (i.e., easily 
revised to accommodate new or different medical problems, different 
employee groups, and changing job, workplace, and respirator 
conditions). An additional advantage of medical questionnaires is lower 
cost, most notably in terms of development, administration, and 
analysis.
    Employers are free to use medical examinations instead of medical 
questionnaires, but are not required by the standard to do so (see 
paragraph (e)(2) of the final standard). OSHA also recognizes that 
medical examinations are necessary in some cases, e.g., where the 
employee's responses to the medical questionnaire indicate the presence 
of a medical condition that could increase the risk of adverse health 
effects if a respirator is used. Examples of such cases are employees 
who report a history of smoking, pulmonary or cardiovascular symptoms 
or problems, eye irritation, nose, throat, or skin problems, vision or 
hearing problems (for employees who use full facepiece respirators), 
and musculoskeletal problems (for employees who use SCBAs). In 
addition, certain workplace conditions or job requirements, such as 
SCBA use, being an emergency responder or a member of a HAZMAT team, 
working in an IDLH atmosphere, wearing heavy protective clothing, or 
performing heavy physical work, may warrant a medical examination. In 
the future, however, OSHA may, on a case-by-case basis, require medical 
examinations to detect respirator-related conditions in its substance-
specific standards, depending on the particular circumstances and 
physiological effects of the toxic substance being regulated.
    The medical questionnaire in Appendix C of the final standard is 
based on the medical history questionnaire contained in ANSI Z88.6-
1984, as well as medical questionnaires submitted to the record by 
commenters

[[Page 1214]]

(Exs. 54-32, 54-424, 55-29). The medical questionnaire is designed to 
identify general medical conditions that place employees who use 
respirators at risk of serious medical consequences, and includes 
questions addressing these conditions. These medical conditions include 
seizures, diabetes, respiratory disorders and chronic lung disease, and 
cardiovascular problems. As the discussion of the Introduction and 
paragraphs (e)(1) and (5) in this Summary and Explanation demonstrate, 
these conditions have been found to increase the risk of material 
impairment among employees who use respirators. A question asking about 
fear of tight or enclosed spaces was included in the medical 
questionnaire because claustrophobia and anxiety associated with such 
spaces were mentioned by a commenter as the most frequent medical 
problem detected during respirator training (Ex. 54-429); additionally, 
research submitted to the record (Ex. 164, Attachment D, Morgan) 
indicates that more than 10 per cent of ``normal'' young men experience 
dizziness, claustrophobia, or anxiety attacks while exercising during 
respirator use.
    Questions 10 through 15 of the medical questionnaire in Appendix C 
must be answered only by employees who use a full facepiece respirator 
or SCBA. These questions ask about hearing and vision impairments, as 
well as back and other musculoskeletal problems. Employees who use full 
facepiece respirators, for example, must be asked about eye and hearing 
problems because the configuration of these respirators (e.g., helmets, 
hoods) can add to the limitations associated with existing visual and 
auditory impairments, resulting in an elevated risk of injury to 
employees with such impairments, as well as to other employees who may 
rely on the impaired employee to warn them of emergencies (Ex. 164, 
Attachment D, Beckett). The heavy weight and range-of-motion 
limitations of SCBAs may prevent employees who have existing problems 
in the lower back or upper or lower extremities from using these 
respirators.
    A physician (Ex. 54-16) commented that an employee's medical 
history should be considered by the PLHCP in making a recommendation 
about the employee's ability to use respirators. This commenter 
specified a number of prior medical conditions, including those 
involving cardiovascular and respiratory health, psychological 
variables, neurological and sensory organ status, endocrine function, 
and the use of medications that would be useful to PLHCPs in arriving 
at a medical ability recommendation. OSHA believes that these 
variables, especially cardiovascular and respiratory fitness, are 
important determinants of respiratory fitness, and, therefore, included 
items specific to these medical conditions in the medical 
questionnaire. OSHA concludes that the employee's answers to the 
medical questionnaire will provide an adequate medical history for the 
PLHCP.
    Two commenters (Exs. 54-222, 54-251) requested that OSHA define 
medical evaluation procedures and provided sample definitions. OSHA 
believes that the regulatory text of the final rule, which has been 
clarified and simplified since the proposal, provides clear guidance 
and that these definitions are, therefore, not necessary. As used in 
the final rule, ``medical evaluation'' means the use of subjective 
(e.g., medical questionnaires) or objective methods (e.g., medical 
examinations), as well as other available medical, occupational, and 
respirator information, to make a determination or recommendation about 
an employee's medical ability to use respirators; ``medical 
examination'' means the use of objective methods (i.e., manipulative, 
physiological, biochemical, or psychological devices, techniques, or 
procedures) to directly assess the employee's physical and mental 
status for the purpose of making a recommendation regarding the 
employee's medical ability to use the respirator.
Paragraph (e)(3)--Follow-up Medical Examination
    Paragraph (e)(3) addresses follow-up medical examinations and 
states that the employer must provide such examinations to any employee 
who gives a positive response to any question among questions 1 through 
8 in Section 2, part A in Appendix C. The PLHCP is free to include any 
medical tests, consultations, or diagnostic procedures that he or she 
determines to be necessary to assist him or her in making a final 
determination of the employee's ability to use a respirator. OSHA 
expects that the number of cases where PLHCPs will have to provide 
follow-up examinations will be small, because it is generally possible 
to recommend against respirator use, or determine the limitations to 
place on an employee's use of respirators, on the basis of responses to 
the medical questionnaire. However, where difficult medical issues are 
involved, such as the need to make a differential diagnosis or to 
assess an employee's ability to handle the physical stress imposed by 
an extra-hazardous job, a medical examination and involvement of a 
physician may be needed. Many commenters (Exs. 54-92, 54-101, 54-134, 
54-171, 54-223, 54-278, 54-304, 54-363, 54-389) endorsed this 
requirement. Two commenters (Exs. 54-151, 54-189) stated that medical 
examinations should not be limited to answers on the medical 
questionnaire that indicate a need for medical examinations. A few 
commenters (Exs. 54-153, 54-176, 54-218) recommended that a mandatory 
medical examination requirement based on the employee's responses to 
the medical questionnaire is wasteful and unnecessary.
    OSHA agrees that PLHCPs should be permitted to obtain any medical 
information they believe would be useful in arriving at a final medical 
recommendation, and they should not be limited to investigating 
problems associated only with answers on the medical questionnaire. 
Information from medical examinations may also be needed to validate an 
answer that a PLHCP believes is incorrect. Also, as recommended by ORC 
(Ex. 54-424), a PLHCP should be free to investigate through medical 
examination any medical conditions related to respirator use that may 
not have been addressed by the medical questionnaire or may not have 
been obtained from other sources.
Paragraph (e)(4)--Administration of the Medical Questionnaire and 
Examinations
    Paragraph (e)(4)(i). This paragraph sets out the procedures 
employers must follow when administering the medical questionnaire or 
examinations required by paragraph (e)(2). Paragraph (e)(4)(i) requires 
employers to administer the required medical questionnaire or 
examinations in a manner that protects the confidentiality of the 
employee being evaluated. In addition, the evaluation must be 
administered during normal work hours or at a time and place convenient 
to the employee, and in a manner that ensures that the employee 
understands the questions on the medical questionnaire. Although this 
requirement was not specifically proposed, it is consistent with OSHA 
policy and with Section 6(b)(7) of the Act. OSHA has included similar 
requirements in a number of substance-specific health standards (see, 
e.g., the Cadmium standard, 29 CFR 1910.1027, the Lead standard, 29 CFR 
1910.1025, and the Benzene standard, 29 CFR 1910.1043). If an employee 
must travel off-site for medical evaluation, travel arrangements must 
be made, and costs incurred paid or reimbursed, by the employer.
    The final standard differs from the proposal in that it does not 
specify who

[[Page 1215]]

must supervise the administration of the medical questionnaire. 
Alternative 3 in the proposal would have required that the medical 
questionnaires be administered by ``a health professional or a person 
trained in administering the questionnaire by a physician.'' (See 59 FR 
58911.) Commenters (Exs. 54-25, 54-69, 54-153, 54-165, 54-190, 54-218, 
54-251, 54-253, 54-272, 54-339, 54-361, 54-401) recommended that 
persons performing this function have various qualifications, e.g., be 
a trained designee of the employer, a safety or health professional, a 
physician, or a nonphysician health care professional operating under 
the supervision of a physician. Some commenters (Exs. 54-25, 54-101, 
54-214, 54-389, 54-421) recommended that a PLHCP be present during 
administration of the medical questionnaire to ensure the accuracy and 
validity of the employee's answers. Others (Exs. 54-69, 54-361) stated 
that the medical questionnaire should be designed so as to be easily 
comprehended by the employee and simple to administer, thereby 
requiring only minimal involvement by an employer. OSHA agrees with 
those commenters (Exs. 54-69, 54-361) who urged that the medical 
questionnaire be easy to understand, and has developed the medical 
questionnaire in Appendix C accordingly. OSHA does not believe that 
oversight is necessary because the standard requires that the medical 
questionnaire be understandable to the employee and that the employee 
be given an opportunity to ask questions of the PLHCP administering the 
questionnaire.
    Although the OSHA medical questionnaire is designed to be easily 
comprehended by employees, paragraph (e)(4)(i) of the final standard 
specifically requires that employers ensure that employees understand 
the medical questionnaire. For employees who are not able to complete 
the medical questionnaire because of reading difficulty, or who speak a 
foreign language, OSHA requires that the employer take action to ensure 
that the employee understands the questions on the medical 
questionnaire. Language and comprehension deficits could invalidate the 
answers of such employees and result in inaccurate determinations. 
Under these circumstances, the PLHCP may assist the employee in 
completing the medical questionnaire (perhaps with the aid of an 
employer-supplied interpreter). The employer also may have the medical 
questionnaire translated into the employee's language or administer a 
physical examination that meets the requirements of paragraph (e)(2) of 
the final standard. In fulfilling this requirement, OSHA is not 
requiring employers to hire professional interpreters. Instead, 
employers may use an English-speaking employee who can translate the 
medical questionnaire into the questionnaire taker's native language, 
or other nonprofessional translators who can perform the same function 
(for example, a friend or family member of the test taker).
    Paragraph (e)(4)(ii). This paragraph requires the employer to 
permit the employee to discuss the medical questionnaire results with a 
PLHCP. Employees who are uncertain of the significance of the questions 
asked will thus be able to obtain clarification. One commenter, Dr. 
Ross H. Ronish, Site Medical Director for the Hanford Environmental 
Health Foundation (Ex. 54-151), agreed that the opportunity for 
discussion between the PLHCP and the employee would improve the 
usefulness of the medical questionnaire. The standard does not require 
the employer to follow a specific procedure in providing employees with 
the opportunity to discuss the medical questionnaire with a PLHCP. 
Employers must, however, at least inform employees that a PLHCP is 
available to discuss the medical questionnaire with them and notify the 
employees how to contact the PLHCP. For example, the employer could 
post the PLHCP's name and telephone number in a conspicuous location, 
or include this information on a separate sheet with the medical 
questionnaire.
Paragraph (e)(5)--Supplemental Information for the PLHCP
    Paragraph (e)(5)(i). The first requirement in this paragraph 
requires employers to provide the PLHCP with specific information for 
use in making a recommendation regarding the employee's ability to use 
a respirator. OSHA had proposed a similar requirement, stating that 
``[i]n advance of the medical examination the employer shall provide 
the examining professional with [supplemental] information * * *'' OSHA 
received four comments (Exs. 54-181, 54-234, 54-330, 54-445) on this 
proposed requirement. These commenters stated that only supplemental 
information requested by the PLHCP should be provided because PLHCPs 
can best determine what information they need to make medical-ability 
recommendations; additionally, limiting the requirement to information 
requested by the PLHCP would lower the associated paperwork burden. The 
Boeing Company (Ex. 54-445), for example, stated, ``The employer should 
not be required to provide additional information unless requested to 
do so by the examining physician.'' Another commenter (Ex. 54-434) 
stated that the proposed supplemental information might not be 
meaningful to every PLHCP.
    OSHA believes that the supplemental information specified is 
important to the PLHCP in making a recommendation regarding the 
employee's medical ability to use the respirator. However, as indicated 
in paragraph (e)(5)(ii) of the final standard, this information need 
only be provided once to the PLHCP unless the information differs from 
what was provided to the PLHCP previously, or a new PLHCP is conducting 
the medical evaluation.
    With few exceptions, the supplemental information that must be 
provided by the employer to the PLHCP is the same information listed in 
the proposed regulatory language for alternative 3 (59 FR 58911, 
paragraphs (e)(vi) (A) to (G)). Three commenters (Exs. 54-160, 54-191, 
54-287) endorsed the entire list of supplemental information items in 
the proposal. Most of the commenters who took exception to the proposed 
list disagreed with the item requiring that information be provided to 
the PLHCP on the substances to which the employee will be exposed 
(i.e., paragraph (e)(vi)(B) of proposed alternative 3); two commenters 
(Exs. 54-352, 54-453), however, believed it was important to specify 
these substances so that the PLHCP would be aware of the hazards in the 
workplace. One commenter (Ex. 54-339) stated that information on 
substance exposure would be useful to the program administrator for fit 
testing, but was not needed by the PLHCP. Another commenter (Ex. 54-
208) stated that information about these substances was unnecessary 
because OSHA intended to propose a separate rule for medical 
surveillance, and one commenter (Ex. 54-273) wanted this item to be 
deleted and replaced by an item informing the PLHCP about the 
employee's use of impervious clothing because such clothing, if worn, 
may impose serious heat stress on the employee.
    The record also contains an article by Dr. William S. Beckett 
advising occupational health professionals on medical evaluations for 
respirator use (Ex. 164, Attachment D). The article addressed the need 
to provide these professionals with exposure information: ``An 
employer's inability to provide this basic information [regarding 
employee exposure levels] on which a respirator choice has been

[[Page 1216]]

made should throw the adequacy of the respiratory protection program 
into serious doubt.'' Dr. Beckett explained that such information was 
necessary because preexisting lung impairments make some employees 
``more sensitive to the effects of some occupational agents and [these 
employees] may thus suffer further impairment at exposure 
concentrations that would not affect a normal worker.'' In explaining 
these effects, Dr. Beckett stated that employees who have become 
``sensitized immunologically to a workplace substance may not be able 
to attain protection factors using usual respirator precautions even 
though the same respirator might be adequate for individuals not 
sensitized to the substance.'' Dr. Beckett noted that ``the worker 
sensitized to toluene di-isocyanate (TDI) * * * will experience 
alterations in pulmonary function at an air concentration of 0.001 ppm 
TDI while normal individuals will not experience symptoms at 20 times 
this concentration.''
    In response to these comments, OSHA has modified the proposed 
requirement specifically requiring employers to inform PLHCPs of the 
substances to which employees may be exposed. Under paragraph 
(e)(5)(iii) of the final rule, employers must provide the PLHCP with a 
copy of the written respiratory protection program. As required by 
paragraph (c)(1)(i) of the final rule, the written program must specify 
the procedures for selecting respirators for use in the workplace; 
accordingly, these procedures must describe the workplace exposure 
conditions that require respirator use. OSHA believes these 
descriptions will provide the necessary information, while imposing 
little additional burden on employers.
    These requirement are necessary, the Agency concludes, because 
employees can have medical conditions that predispose them to respond 
adversely to the workplace substances to which they are exposed, and 
the resulting effects can impair an employee's ability to use some 
types of respirators. Consequently, providing PLHCPs with information 
about the workplace substances to which employees are exposed will 
assist the PLHCPs in determining if these substances may interact with 
preexisting medical conditions to impair an employee's ability to use 
the respirator. In addition, the Agency believes that knowledge about 
the substances to which employees are exposed will provide an indirect 
means of determining the effectiveness of the overall respiratory 
protection program. If employees experience signs and symptoms 
typically associated with exposure to the workplace substances 
documented in the written respiratory protection program, the PLHCP can 
alert the employer to these effects, and corrective action can be 
taken.
    In response to the commenter who urged OSHA to include information 
on impervious clothing, OSHA notes that the final standard requires 
employers to provide information on other protective clothing and 
equipment to be worn by the employee. This item will provide 
information on impervious clothing, and, therefore, addresses the 
commenter's concerns regarding the heat stress imposed on employees by 
such clothing.
    One commenter (Ex. 54-214) stated that descriptions of the type of 
work performed and physical work effort should be dropped from the 
list, while another commenter (Ex. 54-445) believed that information 
about the type of respirator would not be useful to the PLHCP. As noted 
in the discussion of final paragraph (e)(1) in this Summary and 
Explanation, cardiovascular and respiratory fitness are important 
variables in determining the ability of an employee to use a 
respirator. The physical work effort required by the employee's job, in 
combination with the characteristics of the respirator (e.g., weight, 
breathing resistance, interference with range of motion), are variables 
that must be considered by a PLHCP in making a recommendation regarding 
the employee's fitness to use the respirator.
    A study conducted by NIOSH (Ex. 64-469) found that tolerance to 
work conditions, heart rate, and skin temperature were affected by 
three variables: the type of personal protective clothing worn, the 
weight of the respirator, and the level of physical work effort. In the 
NIOSH study, nine healthy young men who had prior experience with 
respirators and personal protective clothing (most of them were 
firefighters), exercised on a treadmill at low and high physical 
workloads under each of the following conditions: wearing light work 
clothing and using a low-resistance disposable half-mask respirator (LT 
condition); wearing light work clothing and using an SCBA (SCBA 
condition); wearing firefighter turnout gear and using an SCBA (FF 
condition); and wearing chemical protective clothing and using an SCBA 
(CBC condition). While exercising at low physical workloads under the 
LT, SCBA, FF, and CBC conditions, the study participants tolerated 
these work conditions for 167, 130, 26, and 73 minutes, respectively; 
at high physical workloads, the four protective clothing conditions 
were tolerated for 91, 23, 4, and 13 minutes. Heart rates and skin 
temperatures rose as tolerance diminished. At the high workload level, 
testing under the SCBA, FF, and CBC conditions had to be terminated 
early because the heart rates of the study participants reached 
critically high levels (i.e., 90% of the predicted maximal heart rate). 
At low physical workloads, heart rate rose progressively under the SCBA 
conditions (about 15 beats per minute) compared to the LT condition, 
then remained steady. Under high physical workloads, heart rates rose 
sharply and never reached a steady level until after the testing was 
terminated.
    The authors of the NIOSH study noted that the work tolerance, heart 
rate, and skin temperature effects found in the study would be more 
severe among individuals who were not as healthy or experienced as the 
study participants. They attributed these effects both to the weight of 
the respirator and to the poor evaporative cooling properties of the 
personal protective clothing (i.e., the capacity to remove body heat 
under the humid conditions generated inside the protective clothing as 
a result of physical work). Based on these findings, the authors 
concluded that ``[the study participants] wearing protective clothing 
and respirators during exercise exhibited a significant degree of 
cardiorespiratory and thermoregulatory stress * * *''
    The conclusion reached by the NIOSH study is supported by other 
researchers who have tested the physiological effects of personal 
protective clothing combined with SCBA use among healthy men performing 
exercise or simulated work tasks under light to moderate levels of 
physical exertion. (See Ex. 164, Attachment D, Smolander et al. (1984), 
and Smolander et al. (1985).) These researchers found that personal 
protective clothing substantially increased oxygen consumption and 
carbon dioxide production, and recommended careful evaluation of the 
cardiovascular health and heat tolerance of workers who must wear 
personal protective clothing.
    In another study (Ex. 64-445), healthy young men (average age: 29 
years), older men (average age: 47 years), and women (average age: 29 
years) used air-purifying respirators while performing the following 
simulated, low physical workload, mining task: lifting a shovel 
weighing 3.1 lbs. (6.8 kg.) from the floor to the top of a table (a 
distance of 3 feet (90 cm)), releasing the shovel's grip, then lifting 
the shovel from the table back to the floor and releasing the grip 
again. The task was performed at a rate

[[Page 1217]]

of 10 cycles per minute for 20 minutes at temperatures of 73 deg. F 
(23 deg. C) and 104 deg. F (40 deg. C). The study participants wore 
appropriate mining clothing (i.e., pants, heavy shirt, gloves, leather 
apron, and safety helmet) while performing the task. The results showed 
that respirator use and heat combined to raise the heart rate 
substantially more than either variable alone, and that this effect was 
especially pronounced for the women.
    This study, and the NIOSH study described earlier, demonstrated 
that information regarding such physiological stressors as physical 
work effort, respirator type and weight, personal protective clothing, 
and temperature and humidity conditions must be provided to PLHCPs who 
are responsible for medically evaluating employees for respirator use. 
The studies found that these stressors, especially respirator weight, 
impose physiological burdens that result in substantial impairment to 
functional capacity, even among healthy respirator users. OSHA 
believes, therefore, that information on respirator type and weight, 
personal protective clothing, and temperature and humidity must be 
provided to, and be considered by, PLHCPs to ensure that only employees 
who can endure these stressors without adverse medical consequences are 
recommended for the respiratory protection program; consequently, these 
items were included in paragraph (e)(5)(i) of the final standard.
    The United Steelworkers (Tr. 1057) stated that ``[PLHCPs should be] 
mandated to have knowledge of the workplace, and possibly to have 
visited it at some point in time.'' OSHA agrees that familiarity with 
the workplace is important, and believes that many employers will make 
such visits a requirement. OSHA believes, however, that making such 
visits a requirement is unnecessary because the information required to 
be given to the PLHCP by the standard will be sufficient for the PLHCP 
to make a valid recommendation regarding the employee's ability to use 
the respirator.
    Other revisions made to the proposed paragraph include a 
requirement that the weight of the respirator be provided to the PLHCP, 
principally to inform the PLHCP of the physical stress that a heavy 
respirator may impose on an employee's cardiovascular and respiratory 
systems. This revision was made in response to the number of commenters 
(Exs. 54-153, 54-165, 54-218, 54-226, 54-227, 54-263, 54-264, 54-294, 
54-326, 54-327, 54-363, 54-443) who recommended that employees using 
SCBAs and other heavy respirators be administered medical examinations, 
largely because of the additional workload associated with using these 
respirators. A physician (Tr. 398) testified that SCBAs in particular 
increased an employee's workload by 20 percent. The studies just 
discussed also demonstrate that respirator weight plays a significant 
role in the increased burden that a respirator places on the user. In 
addition, scientific evidence obtained by Louhevaara et al. (Ex. 164, 
Attachment D) demonstrates that use of SCBAs by experienced 
firefighters performing light to moderate exercise on a treadmill 
substantially reduces tidal volume and increases heart rate, oxygen 
consumption, and ventilation rate. These physiological effects led 
Kilbom (Ex. 164, Attachment D) to recommend that no firefighter over 
the age of 50 be assigned tasks that require SCBA use.
    In the NPRM, OSHA asked whether information on the duration and 
frequency of respirator use should be provided to the PLHCP. No 
comments were received on this subject. The research studies described 
earlier in this Summary and Explanation show that duration and 
frequency of respirator use interact with other respirator use 
conditions (e.g., respirator weight, protective clothing, temperature 
and humidity) in imposing pulmonary and cardiovascular stress on 
respirator users. OSHA believes that information about the duration and 
frequency of respirator use will be important to PLHCPs in making 
medical ability recommendations, and concludes that this information 
must be included in the information required to be provided to the 
PLHCP.
    Paragraph (e)(5)(ii). As noted above, OSHA received recommendations 
from several commenters (Exs. 54-181, 54-234, 54-330, 54-445) to reduce 
the amount of information required to be submitted to the PLHCP. In 
responding to this recommendation, OSHA first reduced the number of 
items required. Second, OSHA revised the requirement so that employers 
only need to provide the supplemental information once to the PLHCP, 
unless the information differs from the information provided to the 
PLHCP previously or a new PLHCP is conducting the medical evaluations. 
Under the revised provision, therefore, the employer must ensure that: 
the PLHCP retains the supplemental information that is provided by the 
employer; the supplemental information is updated appropriately and in 
a timely fashion; and a new PLHCP is provided with the required 
supplemental information. The requirement to provide the new PLHCP with 
the appropriate information does not mean that the new PLHCP must 
medically reevaluate employees, only that the new PLHCP obtains the 
information required under this paragraph. The employer can meet this 
requirement by either providing the relevant documents to the new PLHCP 
or ensuring that the documents are transferred from the former PLHCP to 
the new PLHCP.
    Paragraph (e)(5)(iii). OSHA believes that the requirement for 
employers to provide a copy of the final standard and a copy of the 
written respiratory program to the PLHCP, although not included in the 
proposed standard, is needed to assure that PLHCPs have a thorough 
understanding of their duties and responsibilities in the medical 
evaluation process, thereby enhancing their ability to make a sound 
medical recommendation on an employee's ability to use the respirator. 
The written program is site-specific, and will inform the PLHCP of the 
working conditions the employee will encounter during respirator use. 
This information is critical if the PLHCP is to make a thorough and 
accurate evaluation of the employee's ability to use the assigned 
respirator. The PLHCP's ability to conduct appropriate medical 
evaluation will also be aided by knowledge of the standard, which sets 
forth the requirements of the medical evaluation program, as well as 
other requirements that affect the employee's respirator use. 
Consequently, this requirement will help ensure that medical 
evaluations conducted by PLHCPs are thorough and accurate; 
recommendations regarding an employee's medical ability to use the 
respirator are valid; employees are informed of these recommendations; 
and the privacy and confidentiality of employees are maintained. OSHA 
believes that this requirement is necessary to ensure that the 
objectives and other requirements of final paragraph (e) are fulfilled.
    As noted in the previous discussion of paragraph (e)(5)(ii), this 
information must be provided to the PLHCP only once for all employees 
who are involved in the employer's respiratory protection program. This 
information does not have to be provided again to the same PLHCP unless 
the standard or the employer's respiratory protection program is 
substantially revised. For example, the information does not have to be 
provided again when only minor revisions have been made to either the 
standard or the respiratory protection program. When the employer hires 
a different PLHCP to conduct medical evaluations, the employer must 
ensure that the new PLHCP has this information, by either providing the 
new PLHCP with the appropriate documents or ensuring that the

[[Page 1218]]

documents are transferred from the former PLHCP to the new PLHCP.
Paragraph (e)(6)--Medical Determination
    Paragraph (e)(1) of the NPRM proposed that the employer be 
responsible for making the final determination regarding the employee's 
ability to use the respirator. The proposed regulatory language 
required the physician (now a PLHCP) to deliver a medical opinion 
regarding the employee's medical ability to use the respirator, 
including any recommended limitations on this use, to the employer. 
OSHA proposed, consistent with its substance-specific standards, to 
make the employer responsible for the final determination regarding an 
employee's ability to use the respirator. This determination was to be 
based on all of the information available to the employer, including 
the physician's opinion and recommendations. The final standard follows 
this approach, although the final rule's requirements have been revised 
to reflect the record.
    Paragraph (e)(6)(i). This provision states that the ``employer 
shall obtain a written recommendation regarding the employee's ability 
to use the respirator from the PLHCP * * * `` Because the PLHCP's 
recommendation is an important element in the employer's determination 
as to whether it is hazardous for an employee to use a respirator, the 
recommendation needs to be clear and in writing.
    Final paragraph (e)(6)(i) requires that the PLHCP's recommendation 
be restricted to the three elements listed in paragraphs (e)(6)(i)(A) 
through (C) (i.e., ``[t]he recommendation shall provide only the 
following information'') [emphasis added]. This requirement is similar 
to the proposed regulatory language for paragraph (e)(1) and paragraph 
(e)(1)(v) of proposed alternative 3. The purpose of this limitation is 
to protect employee privacy with regard to medical conditions not 
relevant to respirator use.
    Several commenters (Exs. 54-92, 54-455) supported the need for 
privacy but recommended further that the basis of the PLHCP's medical 
recommendation not be disclosed to employers because such information 
could be used by an employer to remove an employee from the workforce. 
The AFL-CIO (Ex. 54-428) stated that ``[medical] reports to employers 
should contain only a statement of approval or disapproval for 
employees who are tested.'' The Brotherhood of Maintenance of Way 
Employees (BMWE) (Ex. 122) supported limiting the medical information 
provided to the employer to whether or not the employee can perform the 
required work while using the respirator, and whether or not 
restrictions need to be applied to the employee's respirator use. The 
BMWE stated further that no information should be provided on the 
specific medical conditions detected during the medical evaluation.
    OSHA believes that protection of employee privacy and 
confidentiality is important to obtain accurate and candid responses 
from employees about their medical conditions. OSHA has retained this 
requirement in the final standard and believes that, as worded, it 
strikes the proper balance between the need to provide sufficient 
information to the employer to make a decision on respirator use and 
the need to protect employee privacy.
    Paragraph (e)(6)(i)(A) in the final standard also specifies the 
information the PLHCP is to include in the recommendation to the 
employer: ``Any limitations on respirator use related to the medical 
condition of the employee, or relating to the workplace conditions in 
which the respirator will be used, including whether or not the 
employee is medically eligible to use the respirator.'' OSHA's 
experience in enforcing standards with similarly worded provisions 
indicates that this language is appropriate; also, OSHA believes a 
statement regarding the employee's medical ability to use the 
respirator will assist both the employer and employee in determining 
the final medical disposition of the employee.
    Paragraph (e)(6)(i)(B) of the final standard specifies that the 
PLHCP must state whether there is a need for follow-up medical 
evaluations. This provision was added to the final standard for several 
reasons. First, the initial medical evaluation may indicate that there 
is a possibility that the employee's health may change in a way which 
would reduce the employee's ability to use a respirator. In these 
circumstances, the PLHCP is required to specify appropriate follow-up 
medical evaluations. Second, the final standard does not provide for 
periodic (such as annual) evaluations, as most other OSHA health 
standards do. It is therefore important that the PLHCP specify whether 
an employee requires follow-up medical evaluation so that the 
employee's ability to use a respirator can be carefully monitored by 
the PLHCP. This requirement will ensure that employees are using 
respirators that will not adversely affect their health.
    Paragraph (e)(6)(i)(C) requires that the employee be provided with 
a copy of the PLHCP's written recommendation. No comments were received 
by the Agency on this proposed requirement. OSHA believes that a copy 
of the PLHCP's written recommendation will provide employees with 
information necessary to ensure that they are using respirators that 
will not adversely affect their health.
    The employer may either transmit the PLHCP's written recommendation 
to the employee or arrange for the PLHCP to do so. The employer shall 
allow the employee, consistent with paragraph (e)(4)(ii) of the final 
standard, to discuss the recommendation with the PLHCP. During the 
discussion, the PLHCP may inform the employee of the basis of the 
recommendation, as well as other medical conditions that are indicated 
by the results of the medical evaluation but that are not directly 
related to the employee's medical ability to use the respirator. OSHA 
believes that the additional information provided to the employee by 
the PLHCP should be determined by the legal, professional, and ethical 
standards that govern the PLHCP's practice and, therefore, should not 
be regulated by the final standard.
    Paragraph (e)(6)(ii). If the PLHCP's medical evaluation finds that 
use of a negative pressure respirator would place the employee at 
increased risk of adverse health effects, but that the employee is able 
to use a powered air-purifying respirator (PAPR), this paragraph 
requires employers to provide the employee with a PAPR. The rationale 
for this provision was discussed in the proposal (59 FR 58906). 
Negative pressure respirators can result in sufficient cardiovascular 
and respiratory stress to make employees medically unable to use this 
class of respirators. The use of PAPRs involves lower cardiovascular 
and respiratory stress, and PAPRs can often be tolerated by employees 
when negative pressure respirators cannot. Consequently, OSHA believes 
that this requirement is consistent with the requirements of paragraph 
(a)(2) of the final standard, which states that ``employers [must] 
provide the respirators which are applicable and suitable for the 
purpose intended.''
    Several commenters endorsed this provision (Exs. 54-101, 54-363, 
54-455). ISEA (Ex. 54-363) recommended that ``employers ensure that all 
alternative types [of respirators] be considered and made available'' 
to employees found to be medically unable to use the respirator 
selected initially by the employer. The proposal was consistent with 
this recommendation in requiring that alternative respirators be 
selected from among existing positive pressure respirators, including 
supplied-air respirators. OSHA has

[[Page 1219]]

determined, however, that supplied-air respirators should not be listed 
as alternative respirators in the final standard because, as noted 
earlier in this Summary and Explanation, these respirators impose many 
of the same pulmonary and cardiovascular burdens on employees as 
negative pressure respirators. The Brotherhood of Maintenance and Way 
Employees (BMWE) (Ex. 126) found that PAPRs would be an effective 
substitute for negative pressure respirators, and endorsed issuing 
PAPRs to employees who were found to be medically unable to use 
negative pressure respirators. In making this endorsement, the BMWE 
estimated that less than 1 percent of its membership would require such 
an upgrade. Consequently, OSHA removed the requirement for supplied-air 
respirators from the final standard, and now requires only that 
employers provide PAPRs to employees who are medically unable to use 
negative pressure respirators but who are able to use PAPRs. In 
addition, paragraph (e)(6)(ii) of the final standard specifies that if 
a subsequent medical evaluation finds that the employee is able to use 
a negative pressure respirator, then the employer is no longer required 
to provide that employee with a PAPR.
Paragraph (e)(7)--Additional Medical Evaluations
    Paragraph (e)(7) of the standard requires the employer to provide 
additional medical evaluations whenever there is any indication that a 
reevaluation is appropriate. At a minimum, this would occur: if the 
employee reports any signs or symptoms that are related to the ability 
to use a respirator; if the PLHCP, program administrator or supervisor 
determines that a reevaluation is necessary; if information from the 
respiratory protection program indicates a need for reevaluation; or if 
a change in workplace conditions could affect the physiological burden 
placed on the employee. This is a significant change from the proposal, 
which in alternatives 2 and 3 would have required reevaluation on an 
annual basis of employees subject to medical evaluation. Although this 
would not necessarily have required a medical examination, proposed 
paragraph (e)(3) and alternative 3 would have required a written 
medical opinion. The provision in the final standard is similar to the 
requirement in several of OSHA's substance-specific standards that 
employees be medically reevaluated if they experience breathing 
difficulties during fit testing or under other respirator use 
conditions (see, e.g., the Cadmium standard at 29 CFR 
1910.1027(l)(6)(iii)).
    OSHA also made a specific request for comments on the 
appropriateness of requiring medical evaluations at the age-related 
intervals used by ANSI or NIOSH. ANSI and NIOSH recommend that older 
employees should be screened more frequently than younger employees 
because of the heightened risk of cardiovascular and respiratory 
disease associated with age. The ANSI Z88.6-1984 consensus standard 
recommends medical evaluations at the following age intervals: every 
five years below age 35, every two years for employees aged 35 to 45, 
and annually thereafter. NIOSH's Respirator Decision Logic (Ex. 9) 
calls for medical evaluations at similar intervals, except that 
employees over 45 years old should be evaluated every one to two years. 
One commenter (Ex. 54-394) stated that age-based medical evaluations 
are important because the American workforce is aging.
    The proposed requirement that medical reevaluation be conducted 
annually resulted in numerous comments, most of which recommended that 
the requirement be revised. Eight commenters (Exs. 54-219, 54-224, 54-
253, 54-264, 54-348, 54-421, 54-441, 54-455) endorsed the proposed 
requirement without revision. Three commenters (Exs. 54-70, 54-326, 54-
357) stated that cost concerns and the administrative burden should 
limit annual medical evaluations to employees who use SCBAs. Other 
commenters (Exs. 54-70, 54-185, 54-206, 54-326, 54-357, 54-429) 
recommended that annual medical evaluations be administered to 
employees who use non-SCBA respirators only if such use is on a daily 
basis, for more than 50 per cent of the work week, or at least five 
hours per work week. A few commenters (Exs. 54-220, 54-244, 54-327, 54-
424, 54-429) recommended annual medical evaluations if the evaluations 
consisted entirely of a medical questionnaire.
    The Boeing Company (Ex. 54-445) was one of the commenters 
recommending that OSHA reconsider the requirement for annual medical 
examinations. Boeing stated:

    [Our] experience with annual review has been that approximately 
1-2% of [our] employees reviewed per year are restricted from 
respirator use. Very rarely to never are these restrictions due to a 
medical condition that would make respirator use dangerous for an 
employee. Rather, the restrictions are related to other aspects of 
an employee's job or to administrative reasons, such as failure to 
undergo the review or employee preference.

    The American Iron and Steel Institute (AISI) (Ex. 175) also 
provided limited evidence that regular (e.g., annual) medical 
examinations are ineffective. AISI cited an industry study in which 
2,195 medical examinations were administered to 1,816 employees 
subsequent to their initial medical examination; the elapsed interval, 
however, was unspecified. The medical reevaluations found only two 
employees who had unknown (to the employees) medical conditions; one of 
the employees had claustrophobia, and the other employee had reduced 
pulmonary function and an abnormal chest x-ray. AISI recommended that 
the frequency of medical reevaluation be ``determined by a licensed 
medical provider or to verify a suspected functional disability that 
might affect the ability to wear a respirator.''
    The statements and recommendations made by commenters who believed 
that the requirement should be revised or eliminated are summarized as 
follows:
    (1) An annual interval is arbitrary or unnecessary (Exs. 54-234, 
54-263, 54-267);
    (2) A biannual interval should be used (Exs. 54-191, 54-278, 54-
326);
    (3) The intervals should be age-based, using either the ANSI or 
NIOSH age intervals (Exs. 54-66, 54-172, 54-215, 54-245, 54-250, 54-
273, 54-318, 54-374, 54-381, 54-388, 54-426, 54-441, 54-450, 54-451, 
54-452, 54-453), the age intervals recommended by the National Fire 
Protection Association (NFPA) under NFPA standard 1582 (Ex. 54-155), or 
unspecified age intervals (Exs. 54-67, 54-218, 54-240, 54-271, 54-326, 
54-327, 54-342, 54-346, 54-361, 54-363, 54-429, 54-445, 54-454);
    (4) Medical reevaluation should be conducted only at the request of 
the PLHCP (Exs. 54-70, 54-150, 54-180, 54-217, 54-224, 54-313, 54-348, 
54-350, 54-361, 54-432, 54-448, 54-449, 54-450, 54-451, 54-452), 
employers (Ex. 54-251), employees (Ex. 54-157), or employees trained to 
recognize respirator-induced medical effects (Exs. 54-181, 54-219, 54-
242);
    (5) Medical reevaluation should be event-driven, with the events 
specified as a combination of age, physical condition or medical 
symptoms (including breathing difficulty), job conditions, respirator 
type, frequency of respirator use, medical history, or type of exposure 
(Exs. 54-79, 54-187, 54-189, 54-217, 54-218, 54-219, 54-220, 54-242, 
54-253, 54-265, 54-275, 54-278, 54-318, 54-319, 54-342, 54-357, 54-381, 
54-395, 54-439), or when job conditions or the type of respirator used 
by the employee increase the risk of

[[Page 1220]]

adverse effects on the employee's health (Exs. 54-151, 54-153).
    Several commenters (Exs. 54-38, 54-191, 54-388) stated that medical 
reevaluation should not be conducted when employees experience 
breathing difficulties during respirator use because these effects 
usually occur as a result of canister or filter overloading rather than 
an employee's medical condition.
    The commenters who endorsed the proposed requirement for an annual 
medical evaluation stated that annual medical evaluations would 
identify or prevent medical problems that may arise as a result of less 
frequent or event-driven medical evaluations. After carefully reviewing 
the entire record, OSHA decided to revise the proposed requirement and 
to make medical reevaluation contingent on specific events that may 
occur during respirator use, regardless of the duration of respirator 
use. OSHA also has determined that a rigid approach to medical 
reevaluation based on age may ignore serious medical conditions among 
younger employees that could be aggravated by continued respirator use. 
As noted by Dr. Ross H. Ronish, Site Medical Director for the Hanford 
Environmental Health Foundation (Ex. 54-151), ``[m]edical conditions 
which can affect the ability of an individual to use various types of 
respirator occur even in young people.''
    This approach is appropriate because medical problems requiring 
evaluation by a PLHCP can occur after any period of respirator use and 
in workers of any age, and the requirement for medical reevaluation 
must be sufficiently flexible to accommodate this variability. In 
addition, the employee, supervisor, and program administrator are in a 
position to note conditions, such as breathing difficulty, which would 
trigger the need for a medical reevaluation.
    The events described in paragraph (e)(7) of the final standard 
include significant medical, occupational, and respirator use 
conditions that warrant medical reevaluation because these conditions 
are known to impose additional physiological stress on employees, or 
are recognized indicators of medical problems associated with 
respirator use. This paragraph, therefore, will provide for flexible 
and prompt detection of medical problems among employees who use 
respirators.
    The specific events OSHA has listed in paragraphs (e)(7)(i), (ii), 
(iii) and (iv) that trigger medical reevaluation are based on OSHA's 
experience with substance-specific standards and the record of this 
rulemaking. OSHA believes that these events cover most situations in 
which employees are at risk of experiencing adverse health effects 
because of respirator use and in which the employee's underlying 
medical conditions or workplace conditions have changed sufficiently to 
make the initial medical evaluation obsolete. As noted earlier in the 
discussion of this paragraph, these variables were considered by many 
commenters to be important in determining the frequency with which 
employees should be medically reevaluated.
Medical Removal Protection
    The proposed rule did not include a provision for medical removal 
protection (MRP). Such a provision requires employers to provide 
employees who are unable to use respirators with alternative jobs at no 
loss of pay and other benefits. In the notice of proposed rulemaking 
(59 FR 58912), the Agency noted that MRP provisions had been included 
in some earlier substance-specific standards, but stated that 
insufficient information had been provided in response to the ANPR to 
include in the proposed rule an MRP provision that would be applicable 
to all workplaces in which respirators are used. To enable it to 
evaluate whether an MRP provision might be appropriate for this generic 
respirator standard, OSHA asked for comments and information about 
cases in which employees were found to be unable to use respirators in 
their jobs. The Agency specifically requested information about the 
frequency of cases in which employees were found to be unable to use 
respirators and the details of such cases, including how the 
determination of an employee's inability to use a respirator affected 
the worker's job responsibilities.
    Numerous comments were received on this issue. Most of the 
commenters who addressed the issue (Exs. 54-92, 54-206, 54-220, 54-240, 
54-250, 54-267, 54-273, 54-286, 54-295, 54-342, 54-381, 54-435, 54-443) 
suggested that a provision requiring employers to provide alternative 
jobs as a consequence of medical removal be excluded from the final 
standard, although some (Exs. 54-213, 54-387, 54-427, 54-428, 54-455) 
endorsed such a provision. The commenters who opposed the provision 
argued that: employees already receive adequate protection against 
medically related job displacement and unemployment through existing 
federal, state, and local law (e.g., the Americans with Disabilities 
Act and the Rehabilitation Act of 1973); the requirement exceeded 
OSHA's statutory authority; and OSHA failed to justify the provision 
adequately in the proposal. Commenters who favored MRP believed that 
such a provision was needed for medical evaluation to be effective. 
They stated that employees will refuse necessary medical evaluation if 
they believe their jobs might be placed in jeopardy. The Brotherhood of 
Maintenance of Way Employees (BMWE) (Ex. 126) endorsed MRP, claiming 
that in most cases such protection is feasible on both a temporary and 
permanent basis for the railroad industry; infeasible or inconvenient 
cases could be resolved, according to this commenter, under their 
collective bargaining agreement. The BMWE also recommended that 
employees who have been determined by employers to be unable to use 
respirators be allowed to seek a second medical opinion (i.e., to have 
multiple physician review) ``unencumbered by ulterior motives on the 
part of the employer.''
    As noted above, OSHA has included MRP in some of its existing 
substance-specific standards for employees who are unable to use 
respirators. In the Cotton Dust standard, for example, OSHA provided 
that if a physician determines that an employee is unable to use any 
type of respirator, the employee must be given the opportunity to 
transfer to an available position in which respirator use is not 
required, with no loss of wages or benefits (50 FR 51154-56). OSHA 
specifically found, based on the evidence in the Cotton Dust rulemaking 
record, that some employees would be reluctant to reveal information 
necessary for proper health care if the employee feared that the 
information might result in transfer to lower paying jobs. Similar MRP 
provisions for employees unable to use respirators have been included 
in OSHA's Asbestos and Cadmium standards. However, MRP provisions for 
workers unable to use respirators have not been included in most of 
OSHA's substance-specific standards, even though all such standards 
require that employees who use respirators undergo medical evaluation 
to determine their ability to do so (e.g., the 1,3-Butadiene, 
Formaldehyde, Ethylene Oxide, Acrylonitrile, Benzene, and Lead 
standards).
    OSHA believes that a number of provisions of the final standard 
will effectively avoid any disincentive on the part of employees to 
cooperate with medical evaluation. Paragraph (e)(1) requires the 
employer to provide medical evaluation to an employee before the 
employee uses a respirator in the workplace. Therefore, employees

[[Page 1221]]

cannot refuse to undergo medical evaluation and continue in a job that 
requires respirator use. All employees who use SCBAs, the type of 
respirator that imposes the greatest physiological burden on the user, 
must receive medical examinations, and the PLHCP who conducts the 
examination has discretion to determine the tests, consultations, and 
diagnostic procedures to be included in the examination. Given this 
discretion on the part of the PLHCP, and the PLHCP's awareness of the 
considerable physiological burden that SCBA use places on the user, 
OSHA believes that the PLHCP will be able to evaluate the employee's 
ability to use an SCBA even if the employee is reluctant to cooperate 
fully with the examination.
    Moreover, paragraph (e)(7) requires the employer to medically 
reevaluate an employee when a PLHCP, supervisor, or program 
administrator observes that the employee is having a medical problem 
during respirator use and they inform the employer of their 
observation. Many of the jobs in which SCBA use is required are 
strenuous, and any undue physiological burden the respirator places on 
an employee will often be readily observable by the employer, PLHCP, 
supervisors, or program administrator. Paragraph (e)(7), therefore, 
will help ensure that an employee who is medically unable to use a 
respirator, whether a SCBA or another type of respirator, cannot avoid 
medical evaluation by refusing to cooperate.
    The final standard also encourages cooperation in medical 
evaluation by employees who are assigned to use negative pressure 
respirators. Some employees will be unable to use negative pressure 
respirators because of breathing resistance caused by medical 
conditions such as asthma and bronchitis. The final standard provides 
these employees with a strong incentive to cooperate with medical 
evaluation by requiring the employer to provide them with a powered 
air-purifying respirator (PAPR) when the PLHCP who conducts the 
evaluation determines that the employees cannot use a negative pressure 
respirator but can use a PAPR. OSHA believes that many workers who are 
medically unable to use a negative pressure respirator will be able to 
use a PAPR, which offers considerably less breathing resistance than a 
negative pressure respirator. Therefore, those employees who are 
concerned about their medical ability to use a respirator will have a 
strong incentive to cooperate fully with the medical evaluation because 
they are likely to be provided with a less physiologically burdensome 
respirator that will enable them to continue in their jobs.

Paragraph (f)--Fit Testing

Introduction
    The final rule requires that, before an employee is required to use 
any respirator with a negative or positive pressure tight-fitting 
facepiece, the employee must be fit tested with the same make, model, 
style and size of respirator that will be used. The ANSI Z88.2-1992 
respiratory protection standard also recommends such testing before 
respirator use. Employers who allow employees to voluntarily use 
respirators need not provide fit testing for those employees, although 
OSHA encourages them to do so.
    It is axiomatic that respirators must fit properly to provide 
protection. If a tight seal is not maintained between the facepiece and 
the employee's face, contaminated air will be drawn into the facepiece 
and be breathed by the employee. The fit testing requirement of 
paragraph (f) seeks to protect the employee against breathing 
contaminated ambient air and is one of the core provisions of the 
respirator program required by this standard.
    In the years since OSHA adopted the previous respirator standard, a 
number of new fit testing protocols have been developed and tested 
(Exs. 2, 8, 24-2, 24-12, 24-20, 46, 49). During the same period 
manufacturers have developed multiple sizes and models of respirator 
facepieces in order to provide better fits for the variety of facial 
sizes and shapes found among respirator users. Incorporation of these 
advances into the standard is particularly important because facepiece 
leakage is a major source of in-mask contamination.
    Studies show that lack of fit testing results in reduced 
protection. In a health hazard evaluation (HHE) conducted by NIOSH at a 
medical center (Ex. 64-56), NIOSH found that workers using disposable 
respirators were not getting adequate protection because the 
respirators had not been fit tested. Other HHEs conducted by NIOSH show 
that workers who used respirators where there was no fit testing 
suffered adverse health effects resulting from overexposure to airborne 
contaminants (See HETAs 81-283-1224 and 83-075-1559).
    Based on the record evidence, OSHA concludes that poorly fitting 
facepieces expose workers to contaminants and that the use of an 
effective fit testing protocol is the best way of determining which 
respirator facepiece is most appropriate for each employee. Indeed, the 
need to include fit testing requirements in the standard, and to 
specify the proper method of accomplishing such testing, were among the 
major reasons OSHA proposed to revise the existing respirator standard.
    Fit testing may be either qualitative or quantitative. Qualitative 
fit testing (QLFT) involves the introduction of a gas, vapor, or 
aerosol test agent into an area around the head of the respirator user. 
If the respirator user can detect the presence of the test agent 
through subjective means, such as odor, taste, or irritation, the 
respirator fit is inadequate. In a quantitative respirator fit test 
(QNFT), the adequacy of respirator fit is assessed by measuring the 
amount of leakage into the respirator, either by generating a test 
aerosol as a test atmosphere, using ambient aerosol as the test agent, 
or using controlled negative pressure to measure the volumetric leak 
rate. Appropriate instrumentation is required to quantify respirator 
fit in QNFT.
    OSHA's prior respirator standard required training that provided 
opportunities for each user to have the respirator ``fitted properly'' 
and to wear it in a test atmosphere. However, it did not specify the 
test protocols to be used. The previous standard also required that 
employees be trained to check the fit each time the respirator is put 
on, although without specifying how the fit check was to be performed 
or the types of fit checks that were acceptable. OSHA's own compliance 
experience, and the experience gained from respirator research over the 
past 25 years, demonstrates that the existing standard's limited fit 
testing requirements do not provide employers with adequate guidance to 
perform appropriate fit testing.
    The substance-specific standards that have been issued over the 
past 20 years show the evolution of OSHA's recognition of the need for 
fit testing guidance. The early standards, such as the 1978 
Acrylonitrile standard (29 CFR 1910.1045) and the 1978 Lead standard 
(29 CFR 1910.1025), required quantitative fit tests but did not provide 
specific protocols. Subsequently, in 1982, the lead standard was 
amended to allow qualitative fit testing for half mask negative 
pressure respirators, provided that one of three specified protocols 
was followed (47 FR 51110). These specified qualitative fit testing 
(QLFT) protocols use isoamyl acetate, irritant smoke, or saccharin as 
the test agents. They have been used in all subsequent standards (e.g., 
Cadmium, Sec. 1910.1027; 1-3 Butadiene, Sec. 1910.1051; Methylene 
Chloride, Sec. 1910.1052) with fit testing requirements.

[[Page 1222]]

    One of the major changes from requirements in the previous standard 
made by this final standard is its requirement that fit testing be 
conducted according to specific protocols and at specific intervals or 
on the occurrence of defined triggering events. Paragraphs (f)(1) and 
(f)(2) of the standard require employers to ensure that each employee 
using a tight-fitting facepiece respirator passes an appropriate fit 
test before using such a respirator for the first time and whenever a 
different respirator facepiece is used, as well as at least annually 
thereafter. Paragraph (f)(3) requires the employer to provide an 
additional fit test whenever the employee reports, or the employer, 
PLHCP, supervisor, or program administrator observes, changes in the 
employee's physical condition that could affect respirator fit. 
Examples of conditions causing such changes could be the wearing of new 
dentures, cosmetic surgery, or major weight loss or gain. Paragraph 
(f)(4) specifies that if an employee who has passed a fit test 
subsequently notifies the employer, program administrator, supervisor, 
or PLHCP that the fit of the respirator is unacceptable, the employee 
must be given a reasonable opportunity to select a different respirator 
facepiece and to be retested. Paragraph (f)(5) requires that the fit 
test be administered according to one of the protocols included in 
mandatory Appendix A.
    Paragraph (f)(6) limits qualitative fit testing to situations where 
the user of a negative pressure air-purifying respirator must achieve a 
minimum fit factor of 100 or less. Paragraph (f)(7) explains that a 
quantitative fit test has been passed when the fit factor, as 
determined through an OSHA accepted protocol, is at least 100 for 
tight-fitting half masks or 500 for tight-fitting full facepiece 
respirators.
    Paragraph (f)(8) requires that all QLFT or QNFT fit testing of 
tight-fitting atmosphere-supplying respirators and tight-fitting 
powered air-purifying respirators be performed with respirators in the 
negative pressure mode, even if they are to be used in positive 
pressure mode in the workplace, and contains additional requirements 
for measuring fit testing results. It also requires that all facepieces 
modified to perform a fit test be restored to their NIOSH-approved 
configuration before being used in the workplace.
    Detailed discussions of each of the paragraphs related to fit 
testing follow.
Fit Testing--Paragraph (f)(1)
    Paragraph (f)(1) of the final standard requires that all tight-
fitting respirators be fit tested in accordance with the requirements 
of the final standard. The ANSI Z88.2-1992 standard has a similar fit 
testing requirement, as did proposed paragraph (f)(3). The need to fit 
test ``negative pressure'' respirators was widely supported (Exs. 54-5, 
54-38, 54-67, 54-153, 54-158, 54-167, 54-172, 54-173, 54-185, 54-208, 
54-219, 54-263, 54-273, 54-278, 54-313, 54-330, 54-424). No comments 
opposing this requirement were received.
    However, the record contains comments both supporting and opposing 
the need to require the same type and frequency of fit testing for 
``positive pressure'' respirators, which are defined in the final 
standard as respirators ``in which the pressure inside the respiratory 
inlet covering exceeds the ambient air pressure outside the 
respirator.'' A number of commenters stated that positive pressure 
atmosphere-supplying respirator users should not be required to pass a 
fit test (Exs. 54-271, 54-280, 54-290, 54-297, 54-314, 54-324, 54-330, 
54-339, 54-346, 54-350, 54-352, 54-361, 54-424). These commenters 
believed that fit testing of such respirators was not needed because 
the positive pressure inside the facepiece would prevent contaminated 
ambient air from leaking from the outside atmosphere to the area inside 
the facepiece.
    For example, the Southern California Edison Company (Ex. 54-316) 
stated that there was no need to fit test tight-fitting positive 
pressure respirators because ``[t]he chances of these type of 
respirators becoming negative pressure under normal use conditions are 
very slim and generally occur only when there has been a restriction or 
failure of the air supply system.'' The Alabama Power Company (Ex. 54-
217) similarly stated that there was no need to fit test tight-fitting 
supplied air respirators (SARs) or powered air-purifying respirators 
(PAPRs) because the chance was slight that a negative pressure 
condition would occur during normal use. The Reynolds Metals Company 
(Ex. 54-222) stated that, with positive pressure respirators, gross 
leaks were unlikely to occur if the user was trained. Beaumont & 
Associates (Ex. 54-246) stated that a well trained user of pressure 
demand or continuous flow respirators would quickly be aware of any 
gross leakage. Eric Jaycock, CIH, (Ex. 54-419) questioned whether 
requiring the fit testing of positive pressure respirators would cause 
employers to choose other, less protective, respirators. The County of 
Rockland Fire Training Center (Ex. 54-155) stated that positive 
pressure SCBAs may, theoretically, leak around the seal, but that, in 
its experience, this was unlikely to happen in normal working 
situations. It recommended that positive pressure SCBAs be exempted 
from the fit test requirement if the user passes a negative pressure 
fit check upon donning to ensure an effective seal.
    Other evidence in the record, however, demonstrates that, even with 
positive pressure respirators, facepiece leakage can occur when the 
high inhalation rates associated with increased workloads cause the 
facepiece pressure to become negative in relation to the outside 
atmosphere. An evaluation of the performance of powered air-purifying 
respirators equipped with tight-fitting half masks by the Lawrence 
Livermore National Laboratory (Ex. 64-94) demonstrated what its authors 
called the ``Myth of Positive Pressure.'' The study found that, at the 
NIOSH-required flow rate of 4 cubic feet/minute (cfm), a half mask PAPR 
tested at an 80% work rate had a negative facepiece pressure during 
inhalation for all subjects. The authors concluded that the respirator 
protection that the device can provide is dependent in large part on 
the tightness of the seal to the face of the wearer.
    Dahlback and Novak (Ex. 24-22) also found negative pressure inside 
the facepieces of pressure-demand respirators when workers engaged in 
heavy work and had inhalation peak flow rates of 300 liters a minute. 
Workers in this study who had not been fit tested developed negative 
pressure inside their masks much more frequently than those who had 
been fit tested.
    Some commenters (Exs. 54-214, 54-217, 54-222, 54-232, 54-234, 54-
245, 54-251, 54-278, 54-330, 54-424) stated that any negative pressure 
due to leaks on inhalation can be countered by the increased air flow 
of a positive pressure respirator. While increased air flow can reduce 
the number of negative pressure episodes (Ex. 64-94), OSHA does not 
believe that the realities of respirator usage allow exclusive reliance 
on this mechanism to substitute for fit testing. Moreover, the air 
pressure that positive pressure respirators provide inside the 
facepiece is intended to overcome the momentary leakage that may occur 
even with a properly fitting facepiece. This positive airflow alone is 
not an adequate substitute for a properly fitting facepiece, and cannot 
be relied upon to overcome the leakage that can occur into poorly 
fitting facepieces.

[[Page 1223]]

    Requiring fit tests for positive pressure respirators is also 
necessary because the consequences of facepiece leakage into positive 
pressure respirators can be extremely serious. Positive pressure 
respirators are usually worn in more hazardous situations than those in 
which negative pressure respirators are worn. For example, only 
positive pressure respirators can be worn in IDLH atmospheres. By 
definition, there is little tolerance for facepiece leakage in such 
atmospheres. Positive pressure respirators also are used when the 
concentration of the toxic substance is many times greater than the 
permissible exposure limit. Even where positive pressure respirators 
are worn in lower risk situations, they are often selected because the 
hazardous gas or vapor in the atmosphere lacks adequate sensory warning 
properties, clearly a factor calling for the minimum amount of 
facepiece leakage. Employees also may believe that they can afford to 
use less care in using a respirator that appears to be highly 
protective; they may ignore seal checks and strap tensioning because 
they are relying on air flow to overcome any leaks. Fit testing 
demonstrates to employees that positive pressure respirators can leak, 
and offers an opportunity for the employee to see, via quantification, 
what actions (e.g., bending at the waist, jerking the head, talking) 
relating to fit will decrease protection.
    Similarly, although a negative or positive pressure user seal check 
is important to ensure proper donning and adjustment of the respirator 
each time it is put on, it is not a substitute for the selection of an 
adequately fitting respirator through fit testing. Most respirator fit 
testing is preceded by a user seal check, but experience with 
respirator fit testing has shown that some individuals who pass this 
user seal check with what they think is an adequately fitting facepiece 
subsequently fail their fit test due to poor respirator fit. As John 
Hale of Respirator Support Services (Ex. 54-5) stated, ``Yes, there is 
some information to be obtained about gross facepiece-to-face leakage 
by performing these checks. But, there are no performance criteria, 
there is no known correlation between the result of this check and 
respirator fit or performance * * * .''
    A number of experts and consensus organizations supported the 
proposal's requirement for fit testing of all tight-fitting 
respirators. The Washington State Department of Labor and Industries 
(Ex. 54-173), the Aluminum Company of America (Ex. 54-317) and the 
United Auto Workers (Ex. 54-387) endorsed fit testing for positive 
pressure respirators because these respirators do not always maintain 
positive pressure due to overbreathing or physical exertion. The 
Industrial Safety Equipment Association (ISEA)(Ex. 54-363) supported 
OSHA's proposal for fit testing of all tight-fitting respirators, 
stating that it was consistent with the ANSI Z88.2-1992 standard's 
requirements. Fit testing for all tight-fitting respirators is found in 
clause 9.1.2 of the ANSI Z88.2-1992 respirator standard (Ex. 81), which 
requires that positive pressure respirators with tight-fitting 
facepieces be qualitatively or quantitatively fit tested in the 
negative pressure mode. The National Fire Protection Association (NFPA) 
standards 1500 and 1404 also require that firefighters using SCBAs pass 
a fit test (Tr. 479). The American Industrial Hygiene Association (Ex. 
54-208) also supported the fit testing of all tight-fitting 
respirators. Moreover, workplace protection factor studies conducted by 
respirator manufacturers, NIOSH, national laboratories and others 
always fit test subjects to reduce the effect of facepiece leakage that 
is unrelated to design and construction (See, e.g., Exs. 64-14, 64-36, 
64-94).
    This record has convinced OSHA that it is necessary to require the 
fit testing of both positive and negative pressure tight-fitting 
respirators. Even positive pressure respirators do not always maintain 
positive pressure inside the facepiece, particularly when facepiece fit 
is poor, strenuous work is being performed, and overbreathing of the 
respirator occurs (Exs. 64-94, 64-101). Leakage must be minimized so 
that users consistently achieve the high levels of protection they 
need. Most workplace use of positive pressure atmosphere-supplying 
respirators occurs in high hazard atmospheres (e.g., emergencies, 
spills, IDLH conditions, very high exposures, abrasive blasting), where 
a high degree of certainty is required that the respirator is maximally 
effective. Positive pressure respirators, like negative pressure 
respirators, come in a variety of sizes and models, each with its own 
unique fit characteristics. The only reliable way to choose an 
adequately fitting facepiece for an individual user from among the 
different sizes available is by fit testing. The problem of leakage due 
to poor facepiece fit can be minimized by choosing good fitting 
facepieces through fit testing for positive pressure respirator users. 
OSHA concludes that the requirement to fit test tight-fitting positive 
pressure respirators is appropriate to reduce leakage into facepieces, 
and to improve the protection that all kinds of tight-fitting 
respirators provide in the workplace.
Frequency of Fit Testing--Paragraph (f)(2)
    Final paragraph (f)(2), like the proposal, requires that fit 
testing be performed prior to an employee's initial use of a respirator 
in the workplace; whenever a different model, size, make, or style of 
respirator facepiece is used; and at least annually thereafter. Only 
the requirement to conduct fit testing annually was disputed in the 
rulemaking. Commenters generally agreed that some additional fit 
testing beyond an initial test was necessary, but opinions varied 
widely on the appropriate intervals at which such tests should be 
performed. A few participants, including the UAW (Ex. 54-387), urged 
that fit testing be required every six months, since changes in weight, 
facial hair and scarring, dental work, and cosmetic surgery may alter 
respirator fit. The UAW also stated that visual observation was not a 
reliable way to identify the presence of these changes.
    A number of commenters suggested that longer intervals, generally 
two to three years, would be appropriate. For example, Allied Signal 
(Ex. 54-175) recommended ``periodic'' or ``every two-years'' as the fit 
testing interval. Public Service Electric and Gas Co. (Ex. 54-196) 
stated that a ``two year time frame strikes a good balance between 
safety concerns and practicality.'' The Texas Chemical Council (Ex. 54-
232) stated that, in its members' experience, ``* * * virtually no 
individuals fail fit tests a year after initial testing for a given 
chemical exposure using the same manufacturer's respirator.'' The Exxon 
Company (Ex. 183), in response to questions asked at the June hearings, 
reported that of the 230 employees at their Baton Rouge refinery given 
an annual QNFT in 1995, a year after their initial respirator selection 
in 1994, less than one percent (two employees) changed their respirator 
size because of failing the annual QNFT. Exxon stated that few 
employees change the size of their respirator from year to year, and 
that ``the data suggest that annual quantitative fit-testing should not 
be necessary and such testing may be done on a less frequent basis than 
once per year.'' The Peco Energy Company (Ex. 54-292) stated that its 
experience showed that a three year interval is sufficient to ensure a 
proper fit, provided that mandatory refitting is conducted if there are 
changes in the respirator user's physical condition. The Eastman 
Chemical Co. (Ex. 54-245) recommended that the time limit be not

[[Page 1224]]

less than two years. The International Paper Co. (Ex. 54-290) stated 
that ``bi-annual (sic) [every two years] fit-testing with proper 
training should be adequate'' and that proper training would require 
that employees report to the employer facial feature changes that have 
occurred or failure to get an adequate seal during the positive/
negative pressure seal check.
    Other participants believed that fit testing beyond initial fit 
testing should be required only when an employee switches to a 
different respirator, or when a significant change occurs in an 
employee's physical condition that may interfere with obtaining an 
adequate facepiece seal (Exs. 54-177, 54-187, 54-190, 54-193, 54-197, 
54-214, 54-286, 54-297, 54-396, 54-397, 54-435, 54-323, 54-422, Ex. 
123). The American Iron and Steel Institute (Ex. 54-307, Ex. 175) 
stated that annual fit testing was unnecessary, and that the steel 
industry experience shows that once a wearer has been fit tested and 
has an acceptable fit, subsequent fit tests demonstrate consistent fit 
factors. Mallinckrodt Chemical (Ex. 54-289) questioned the need for 
annual fit testing for those employees who may use a respirator 
infrequently, such as once or twice a year.
    However, a large number of rulemaking participants supported OSHA's 
proposal to require the testing of respirator fit on an annual basis 
(Exs. 54-5, 54-6, 54-20, 54-153, 54-167, 54-172, 54-179, 54-219, 54-
273, 54-289, 54-293, 54-309, 54-348, 54-363, 54-410, 54-428, 54-455, 
Ex. 177; Tr. 1573, 1610, 1653, 1674). The comments of these 
participants and other evidence in the rulemaking record convince OSHA 
that the annual testing requirement is appropriate to protect employee 
health.
    Annual retesting of respirator fit detects those respirator users 
whose respirators no longer fit them properly. The Lord Corporation, 
which already performs annual fit tests, reported that of its 154 
employees who wear respirators, one to three (2 percent or less) are 
identified each year as needing changes in model or size of mask (Ex. 
54-156). Hoffman-LaRoche only performs fit tests at two-year intervals, 
and it reported a much higher incidence of fit test failures. Sixteen 
of the 233 people tested in a recent two year cycle of fit testing 
(6.86%) needed a change in their assigned respirators (Ex. 54-106).
    The Lord experience (Ex. 54-156) indicates that annual retesting of 
facepiece fit detects poorly fitting facepieces, while the Hoffman-
LaRoche evidence demonstrates that waiting two years for retesting can 
result in the discovery that quite a high percentage of workers have 
been relying on poorly fitting respirators. Extending the retest 
interval to more than one year would allow those individuals with poor 
fits that could have been detected by annual fit testing to wear their 
respirator for a second year before the poor fit is detected.
    This evidence also supports OSHA's view that triggering the 
requirement to retest only by certain events, such as a change in the 
worker's condition, and not including a required retest interval, would 
allow poor fits to continue. Changes in a worker's physical condition, 
such as significant weight gain or loss, new dentures or other 
conditions, can cause alterations in facial structure and thus 
respirator fit. Physiological changes that affect facepiece fit can 
occur gradually over time and are easily overlooked by observers, and 
by the users themselves. Individuals with poorly fitting respirators 
were often detected only through fit testing, and not by other methods 
such as observation of changes in facepiece fit, failure to pass a user 
seal check, or an employee reporting problems with the fit of the 
respirator. Retesting facepiece fit solely on the basis of physical 
changes in individual respirator users would not be a reliable 
substitute for fit testing on an annual basis. These changes in an 
individual's physical condition do, however, indicate the need for 
retesting that individual's facepiece, and paragraph (f)(3) requires 
additional fit testing whenever any of these changes is detected.
    Moreover, fit testing not only determines whether a facepiece seal 
is adequate; it also provides an opportunity to check that fit is 
acceptable, permits the employee to reduce unnecessary discomfort and 
irritation by selecting a more comfortable respirator, and reinforces 
respirator training by providing users with a hands-on review of the 
proper methods of donning and wearing the respirator. Therefore, as 
well as providing the opportunity to detect poorly fitting respirator 
facepieces, the annual fit testing requirement complements OSHA's 
requirement for, and may partially fulfill, annual training under final 
paragraphs (k)(1), (k)(3) and (k)(5). For the reasons presented above, 
and based on a thorough review of the record, OSHA has included an 
annual fit test requirement in the final rule.
Refitting Due to Facial Changes--Paragraph (f)(3)
    Paragraph (f)(7) in the proposal addressed the need to refit 
respirators when changes in the employee's physical condition occur. 
The proposal identified facial scarring, cosmetic surgery, or an 
obvious change in body weight as conditions requiring refitting. Some 
commenters (Exs. 54-280, 54-428, 54-455) suggested that dental work 
affecting facial shape should also trigger refitting. The International 
Chemical Workers Union (ICWU) suggested that a change of five percent 
in body weight or twenty pounds should be regarded as an obvious change 
in body weight that requires refitting (Ex. 54-427). One commenter 
opposed requiring the employer to determine whether an employee's 
physical change should trigger refitting, stating that the 
responsibility for reporting physical changes should rest with the 
employee (Ex. 54-357).
    The language of the proposed paragraph has been revised in the 
final rule to provide greater clarity and to account for these 
comments. Because weight loss or gain affects the facial configuration 
of different individuals differently, OSHA does not believe it possible 
to stipulate a given weight change ``trigger'' for requiring a new fit 
test. The final standard thus retains the proposed language regarding 
an obvious change in body weight. In response to the comments that 
dental work can affect facial shape and respirator fit, the language in 
final paragraph (f)(3) has been revised to add dental changes as 
another item that can trigger a new fit test requirement. The provision 
has been modified to trigger retests based on employee reports of 
facial changes, in addition to changes observed by the employer, 
supervisor, program administrator, or PLHCP that may affect facepiece 
fit. Employer observations of potential problems with fit, along with 
self-reported problems with facepiece fit or changes in facial 
configuration, would trigger a respirator fit retest under final 
paragraph (f)(3).
    Paragraph (f)(3) requires employers to conduct an additional fit 
test whenever an employee reports changes, or there are observations of 
changes, in the employee's physical condition that could affect 
respirator fit. This provision addresses the rare situation in which an 
employee's facial features change to the extent that a respirator that 
once fit properly may no longer fit. The conditions listed in the 
standard that may cause such changes in facial features--facial 
scarring, dental changes, cosmetic surgery, or an obvious change in 
body weight--will generally be observable by the employer. If the 
employee reports facial changes that are not readily observable, the 
employer may require verification of

[[Page 1225]]

the changes before offering an additional fit test.
Retesting for Unacceptability--Paragraph (f)(4)
    Paragraph (f)(4) of the final standard requires retesting whenever 
the respirator becomes ``unacceptable'' to the employee. An employee 
who notifies the employer, the program administrator, supervisor, or 
the PLHCP that the fit of the respirator is unacceptable must be given 
a reasonable opportunity to be retested and to select a different 
respirator facepiece. This requirement was derived from paragraph 
(f)(8) in the proposal, which required refitting within the first two 
weeks of respirator use for masks that become ``unacceptably 
uncomfortable.''
    Although some commenters wanted to delete this provision on the 
grounds that a properly fitted and trained worker should have no reason 
to exchange the respirator (Exs. 54-6, 54-20, 54-156, 54-209, 54-215), 
others urged that the employee be allowed to request a refit at any 
time a respirator becomes unacceptable. These commenters saw no reason 
to limit this period to two weeks (Exs. 54-154, 54-165). The utility of 
the two week period was specifically questioned for situations where 
respirators are not routinely used for long periods of time (Ex. 54-
66), or are used only occasionally (Ex. 54-220). Exxon (Ex. 54-266) 
stated that the two week provision was too restrictive, and that 
employees should be allowed to select another respirator or facepiece 
as necessary . Dow (Ex. 54-278) also suggested dropping the two week 
limitation. The American Petroleum Institute (Ex. 54-330) recommended 
revised performance language for this provision. The Occidental 
Chemical Company (Ex. 54-346) saw no reason to specify a two week 
period, and stated that employees should be permitted to select a new 
respirator facepiece at any time because of unacceptable discomfort.
    In the final rule, OSHA has deleted the two week limitation on the 
time in which an employee may have a respirator retested. In addition, 
the term ``unacceptable'' has been substituted for the term 
``uncomfortable,'' which was used in the proposal and was objected to 
by several commenters (Exs. 54-154, 54-266, 54-278, 54-330). A 
respirator may be unacceptable if it causes irritation or pain to an 
employee or if, because of discomfort, the employee is unable to wear 
the respirator for the time required.
Fit Testing Protocols--Paragraph (f)(5)
    Paragraph (f)(5) in the final standard, which is substantively the 
same as proposed paragraph (f)(3), requires that the employer use an 
OSHA-accepted QLFT or QNFT protocol for fit testing. These protocols 
are described in mandatory Appendix A. Appendix A also describes the 
methods OSHA will use to determine whether to approve additional fit 
test methods. The provisions in proposed paragraphs (f)(3), (f)(4), and 
(f)(5) that referenced alternative fit test procedures therefore have 
been removed from the final rule.
    For qualitative fit testing (QLFT), Part I of Appendix A contains 
the OSHA-accepted qualitative fit testing protocols for the isoamyl 
acetate QLFT protocol; the saccharin QLFT protocol; and the irritant 
smoke QLFT protocol, which were first adopted in the Lead standard (29 
CFR 1910.1025). In addition, Appendix A contains an OSHA-accepted 
protocol for the BitrexTM (Denatonium benzoate) QLFT method, 
which was submitted to the rulemaking record and commented on during 
this rulemaking.
    Appendix A also lists three protocols for the QNFT methods that are 
OSHA-accepted. The first is the traditional generated aerosol QNFT 
method in which a test atmosphere (corn oil, DEHS, or salt) is 
generated inside a test enclosure and the concentration inside and 
outside the mask is measured. The second method is the ambient aerosol 
QNFT method, commonly called the PortacountTM method, which 
uses a condensation nuclei counter to measure the ambient aerosol 
concentrations inside and outside the mask. The third method that has 
been added is the controlled negative pressure (CNP) QNFT method 
(Dynatech Nevada FitTester 3000TM), which was the subject of 
comments during this rulemaking. These OSHA-accepted QLFT and QNFT 
methods are described further in the discussion of Appendix A that 
follows.
    The only fit test method that generated any controversy during the 
rulemaking proceeding was the irritant smoke QLFT protocol. OSHA is 
continuing to accept the irritant smoke QLFT protocol for use under 
this standard because the method is valuable when used properly and is 
often used by small employers because it is relatively inexpensive. 
Moreover, it is also the only QLFT method where facepiece leakage 
elicits an involuntary response, which can eliminate the possibility 
that a wearer could pretend to pass the fit test in order to be 
eligible for a job requiring respirator use.
    Nevertheless, OSHA is aware that high levels of irritant smoke can 
be produced during a fit test and that these concentrations can be 
dangerous. Employees exposed to excessive concentrations of irritant 
smoke have suffered severe reactions (Ex. 54-437; Tr. 390). For this 
reason, it is particularly important that employers using the irritant 
smoke protocol ensure that test operators are well trained in this 
method and comply with all the steps in the OSHA protocol. To ensure 
that any leakage will be as minimal as possible, the test must not be 
performed until the employee has passed a user seal check. In 
performing the sensitivity check necessary to determine that the 
particular user is sensitive to irritant smoke, it is extremely 
important to assure that the employee is exposed to the least amount of 
irritant smoke necessary to trigger a response. Appendix A is a 
mandatory appendix, and failure to comply completely with its protocols 
will constitute a violation of this standard.
QLFT Limits--Paragraph (f)(6)
    Paragraph (f)(6) of the final standard limits qualitative fit 
testing to situations where the user of a negative pressure air-
purifying respirators must achieve a minimum fit factor of 100 or less. 
A similar limitation was contained in the proposal (paragraph 
(f)(6)(i)(A)). This limitation is based on the fact that the existing 
evidence only validates the use of qualitative fit testing to identify 
users who pass the QLFT with a respirator that achieves a minimum fit 
factor of 100. Dividing the fit factor of 100 by a standard safety 
factor of 10 means that a negative pressure air-purifying respirator 
fit tested by QLFT cannot be relied upon to reduce exposures by more 
than a protection factor of 10. The safety factor of 10 is used because 
protection factors in the workplace tend to be much lower than the fit 
factors achieved during fit testing; the use of a safety factor is a 
standard practice supported by most experts to offset this limitation. 
For example, the ANSI Z88.2-1992 standard states, in clause 9.1.1, ``If 
a quantitative fit test is used, a fit factor that is at least 10 times 
greater than the assigned protection factor (table 1) of a negative-
pressure respirator shall be obtained before that respirator is 
assigned to an individual. If a qualitative test is used, only 
validated protocols are acceptable. The test shall be designed to 
assess fit factors 10 times greater than the assigned protection 
factor.''
    The only objection to this limitation was expressed by a few 
commenters (Exs. 54-153, 54-178) who noted that in

[[Page 1226]]

the future, new QLFT protocols may be developed allowing the 
measurement of higher fit factors. If new methods are developed that 
permit QLFT use for higher fit factors, OSHA will, as part of the 
acceptance process for these new methods, adjust this requirement 
appropriately.
QNFT Minimum Fit Factors--Paragraph (f)(7)
    Paragraph (f)(7) of the final standard lists the minimum fit 
factors required to be achieved during quantitative fit testing. These 
minimum fit factors were listed in paragraphs (f)(6)(i)(B) and 
(f)(6)(ii)(B) of the proposal. Half masks are required to achieve a 
minimum fit factor of 100 during QNFT, and full facepiece respirators 
must achieve a minimum fit factor of 500. Paragraph (f)(7) in the final 
standard consolidates the minimum QNFT fit factors for half mask and 
full facepiece respirators into one provision. The safety factor of ten 
used for full facepiece respirators is the same as that for half masks.
    The minimum fit factors in the final standard for QNFT are the same 
as those that were proposed, and are identical to the minimum fit 
factors required in OSHA substance-specific standards that require QNFT 
(See e.g., Asbestos, 29 CFR 1910.1001; Cadmium, 29 CFR 1910.1027; 
Benzene, 29 CFR 1910.1028; Formaldehyde, 29 CFR 1910.1048; 1,3-
Butadiene, 29 CFR 1910.1051).
    Most participants who commented on the issue agreed with these 
minimum fit factors. A few participants argued for higher minimum fit 
factors (Exs. 67, 54-405). For example, Robert da Roza, citing his 
study on the reproducibility of QNFT (Ex. 24-9), stated in his 
testimony at the OSHA hearings on minimum fit factors that ``What I 
feel confident in is that you do need something higher than a ten. It 
may be as high as 800. I'm suggesting that some statistician look at 
this a little more rigorously and come up with some better number.'' 
(Tr. 102)
    TSI, Inc. (Ex. 54-405), in discussing the pass/fail levels for 
QNFT, recommended the following:

    The proposed requirement that a successful QNFT achieve a fit 
factor of at least 100 for a half mask and 500 for a full-face mask 
should be raised. The proposed values allow employers to accept what 
in reality is a very poor fit compared to what can be achieved with 
proper employee training * * * We feel that a fit factor of at least 
1000 for half masks and at least 2000 for full face respirators is 
justifiable and readily achievable with minimal extra effort by the 
employer.

    However, empirical data or statistical analyses that supported the 
need to increase the minimum fit factors proposed were not presented. 
Although fit factors substantially higher than the minimum values are 
frequently achieved, OSHA's experience enforcing the substance-specific 
standards that have similar requirements to the minimum fit factors 
contained in the final respiratory protection standard shows that these 
factors are adequate to distinguish well fitting respirators from those 
that fit poorly, which is the purpose of fit testing. Accordingly, OSHA 
is retaining the proposed fit factors in the final standard.
Testing Positive Pressure Respirators--Paragraph (f)(8)
    Paragraph (f)(6)(iii)(B) in the proposal required that fit testing 
of positive pressure respirators be conducted without any of the air-
supplying equipment or attachments that produce a positive pressure 
inside the facepiece during respirator use. Thus, the proposal required 
positive pressure respirators to be tested under negative pressure. 
Final paragraph (f)(8) similarly requires that positive pressure tight-
fitting respirators be fit tested in the negative pressure mode. Fit 
testing seeks to measure the tightness of the facepiece seal. If the 
air pressure inside the facepiece is higher than that outside, the 
pressure differential reduces the amount of ambient air leaking into 
the facepiece, and the measurements obtained during the fit test do not 
represent the tightness of the seal between the face and the facepiece. 
Many tight-fitting respirator facepieces are available in both air-
purifying models and atmosphere-supplying units. For these, fit testing 
can be performed using an identical negative pressure air-purifying 
respirator facepiece, with the same sealing surfaces, as a surrogate 
for the atmosphere-supplying facepiece the employee will actually be 
using. Where an identical negative pressure facepiece is unavailable, 
the employer may convert the facepiece of the employee's unit to allow 
for qualitative or quantitative fit testing. Many SCBA manufacturers 
(e.g., MSA, Interspiro and Survivair) sell fit testing adaptors for 
this purpose that allow for fit testing of their SCBA facepieces.
    Final paragraphs (f)(8)(i) and (f)(8)(ii) describe the specific 
ways in which these alternatives apply for performing QLFT and QNFT 
measurements, respectively. If the respirator facepiece has been 
modified for fit testing, final paragraph (f)(8)(iii) requires that the 
modifications must be completely removed and the respirator restored to 
its NIOSH-approved configuration before it is used in the workplace. 
These requirements replace the similar provisions in proposed paragraph 
(f)(6), and should clearly inform employers of the requirements for fit 
testing tight-fitting atmosphere-supplying or powered air-purifying 
respirators. These provisions are designed so that the testing reflects 
the conditions of respirator use as accurately as possible. There were 
no significant objections to this provision in the record.
Proposed Paragraph (f)(9)--Interim Use of QLFT
    The final standard deletes proposed paragraph (f)(9), which would 
have allowed an employer initially to perform a qualitative fit test to 
fit the respirator user where an assigned protection factor greater 
than 10 is required if the employer had an outside party conduct 
quantitative fit testing within 30 days. OSHA proposed this provision 
to address those few instances when contractors were not available to 
test employees who had been hired after the annual fit testing for a 
given establishment had been conducted. There was considerable 
opposition to this provision. John Hale of Respirator Support Services 
(Ex. 54-5) recommended that this provision be eliminated because the 
provision could be abused. The Exxon Company (Ex. 54-266) also 
recommended that the provision be deleted, suggesting that full 
facepiece respirators fit tested using a QLFT be limited to use in 
atmospheres containing 10 times the exposure limit of a hazardous 
substance until an adequate QNFT is performed. Other commenters stated 
that retaining the provision could result in overexposure of the 
employee to workplace contaminants (Exs. 54-280, 54-303, 54-408). The 
Los Alamos National Laboratory (Ex. 54-420) criticized the provision on 
the basis that it is the employer's responsibility to provide 
appropriate fit testing prior to assigning employees to work where 
respirators are required. The U.S. Army (Ex. 54-443D) stated that if 
employers have a functioning respirator program and know of the 
requirement for annual testing, then they should be able to schedule 
fit testing appropriately, with no need for an extra 30 days.
    Some participants who supported the proposed requirement stated 
that QNFT has not been shown to be a better predictor of workplace 
protection than QLFT, and recommended that QNFT be an optional, rather 
than a required method, when fit factors greater than 10 are needed. 
Moldex Metric Inc. (Ex. 54-153) recommended that the provision be 
broadened to allow the employer some

[[Page 1227]]

latitude in selecting which fit testing methods must be used. Bayer 
Corporation (Ex. 54-210) recommended the period be extended to 90 days, 
and that the provision be broadened to include repair and/or 
calibration of fit testing instruments; other participants also 
recommended a 60 or 90 day period (Exs. 54-222, 54-278, 54-330, 54-361, 
54-424, Ex. 54-430).
    OSHA has concluded that the rulemaking record demonstrates that 
proposed paragraph (f)(9) is unnecessary. Contractors who perform QNFT 
services are located throughout the country, and an employer can 
arrange a schedule to ensure that fit testing will be available when 
required. QNFT instruments are also available for rent and can be used 
by employers themselves after appropriate training if no contractor is 
available. Several different types of reasonably priced QNFT 
instruments are manufactured, and OSHA believes many employers can 
readily purchase one to perform their own QNFT. The instruments are 
highly portable and can be readily shipped to where they are needed. As 
the Army points out (Ex. 54-433D), an employer with a respirator 
program that requires annual fit testing can readily schedule fit 
testing appropriately.
    In addition, the comments OSHA received urging that the provision 
be expanded increase OSHA's concern that leaving the option in the 
standard could expose employees unnecessarily to excessive 
concentrations of hazardous substances. The QNFT exemption as proposed 
was intended to be narrow in scope and to apply only when contractors 
were not readily available to test new employees who were hired after 
the annual fit testing session. The reasons advanced for extending this 
QNFT exemption were not convincing. OSHA believes that there are other 
ways to address the concerns raised by commenters in support of this 
QNFT exemption. For example, employers can schedule QNFT instrument 
calibration during times when fit testing is not scheduled and can 
obtain a substitute QNFT instrument when their own unit needs repair. 
OSHA concludes that this provision is not appropriately included in the 
final standard.
Appendix A--Mandatory Fit Test Protocols
    Appendix A contains the fit test protocols that employers must 
follow in performing qualitative and quantitative fit testing for 
tight-fitting respirators. The Appendix also contains procedures OSHA 
will use to evaluate ``new'' fit testing methods. Proposed Appendix A 
addressed the same subjects. Employers who have in the past performed 
fit tests pursuant to a substance-specific standard must now follow the 
protocols for OSHA-accepted fit tests that are set out in Appendix A. 
OSHA has removed the fit testing protocols in the substance-specific 
standards to eliminate duplication and consolidate all fit testing 
protocols in Appendix A.
    Appendix A has been reorganized from its proposed format to improve 
clarity and usefulness. The provisions dealing with administering OSHA-
accepted fit testing protocols have been moved to part I.
    Section A of part I contains general provisions and test exercises 
that apply to both QLFT and QNFT.
    Section B contains the OSHA-accepted QLFT protocols for isoamyl 
acetate, saccharin, Bitrex, and irritant smoke fit tests.
    Section C contains the OSHA-accepted QNFT protocols for generated 
aerosol, ambient aerosol (CNC), and controlled negative pressure (CNP) 
fit tests.
    Part II addresses the methodology OSHA will use to evaluate new fit 
test methods and technology.
    Appendix A provides general instructions for performing fit testing 
which have been simplified and clarified by combining the common 
elements for both QLFT and QNFT and presenting them in Section A of 
Part I. This includes directions for such procedures as selecting a 
respirator for fit testing and performing the required test exercises. 
By combining common elements and eliminating the duplication of fit 
test protocols in the substance-specific standards, OSHA has reduced 
the number of pages in its regulations dedicated to fit testing. The 
purpose of the OSHA fit testing protocols is to tell fit test operators 
how to perform fit testing to ensure that an adequately fitting 
facepiece is selected. The protocols reflect the fit test elements 
(i.e., equipment and basic procedures) that were performed during the 
validation testing that initially led to their acceptance by OSHA. The 
protocols do not contain specific instructions on operating any 
particular fit test instrument because each instrument has specific 
manufacturer's operating instructions that must be followed to obtain 
valid results.
    The fit testing procedures and specific requirements in the QLFT 
and QNFT protocols in Sections B and C of part I reflect both the 
experience that has been gained in performing fit testing and the 
validation testing that was done initially in order for each method to 
be accepted by OSHA. The OSHA-accepted methods were evaluated by 
comparing their performance with that of another accepted fit test to 
demonstrate that each new method would reliably identify adequately 
fitting facepieces. The OSHA-accepted protocols reflect the specific 
procedures and equipment that were used in validation testing, and they 
must be followed to ensure minimum reproducibility. These elements in 
the OSHA protocols are not written in performance-oriented language, 
since any significant variation from the required protocols would 
invalidate the reliability testing that was performed initially to gain 
OSHA acceptance and would add uncertainty to the validity of fit test 
results.
Fit Testing Procedures--General Requirements
    The general requirements for fit testing contained in Appendix A, 
part I.A apply to all OSHA-accepted fit test methods, both QLFT and 
QNFT. These provisions contain general requirements and instructions 
for both the person being fit tested, and the person conducting the fit 
testing. The provisions have been modified slightly from the proposal.
    Provision A.1 requires that the test subject be afforded a 
selection of respirators of various sizes and models from which to pick 
the most acceptable. The revised language of this provision reflects 
the substitution of the term ``acceptable'' for ``comfortable'' in 
paragraph (d)(1)(iv). Provision A.2 is identical to that proposed. The 
test operator shows the person being fit tested how to don the 
respirator properly. This instruction may complement the training 
required by paragraph (k) of this standard. Provisions A.3 to A.7 
contain instructions for selecting the most acceptable respirator for 
fit testing.
    Provision A.8 requires the subject to perform a ``user seal check'' 
before the fit test is performed. The language in this provision has 
been modified to reflect the use of the new definition for ``user seal 
check.'' Provision A.9 restates that fit testing shall not be conducted 
if there is any hair growth between the skin and sealing surface of the 
respirator. If the test subject exhibits breathing difficulty during 
fit testing, provision A.10 requires that he or she be referred to a 
PLHCP. Minor revisions to this provision reflect changes made to 
paragraph (e) of the standard on medical evaluation. Provision A.11 
requires retesting whenever the employee finds the fit unacceptable. 
Provision A.12 of Appendix A, Part II of the proposal regarding fit 
testing records has been moved to paragraph (m) of the final

[[Page 1228]]

standard to consolidate all recordkeeping provisions.
    Provisions A.12 through A.14 of this final standard describe the 
specific exercises to be performed under all qualitative and 
quantitative fit tests protocols. The exercises are mostly the same; 
however, the grimace exercise is not performed for QLFT protocols. In 
addition, a separate test regimen is prescribed in Section C for the 
CNP quantitative fit test. Except for minor modifications, the 
exercises are identical to those in the proposal and to those in OSHA's 
substance-specific health standards. Participant comments focussed on a 
few issues: the number and duration of fit test exercises (Exs. 54-158, 
54-187, 54-206, 54-218, 54-219, 54-261, 54-271, 54-273, 54-350, 54-325, 
155), and the need for the grimace, bending over/jogging-in-place, and 
talking exercises (54-153, 54-173, 54-175, 54-179, 54-208, 54-218, 54-
219, 54-261, 54-273, 54-317, 54-363, 54-408, 54-420, 54-424). These 
comments are addressed below.
    Provision A.14 requires the employee being fit-tested to perform 
eight exercises. Seven of the exercises must be performed for one 
minute, while the grimace exercise lasts for only 15 seconds. The test 
exercises and exercise sequence are: normal breathing; deep breathing; 
turning the head side to side; moving the head up and down; talking; 
grimacing; bending over (or jogging in place if the test unit is not 
large enough for the test subject to bend at the waist); and normal 
breathing.
    Some participants complained that the number and length of the 
exercises required to be performed were excessive. For example, the 3M 
Company stated that OSHA has made numerous changes to accepted 
protocols without verifying the effect of the changes on test 
performance (Ex. 54-218). According to 3M, OSHA arbitrarily altered the 
fit tests by requiring the test exercises to be performed for one 
minute, rather than 30 seconds, and by including the grimace and the 
bending over/jogging-in-place exercises, and that this alteration 
violates the original validation of the fit test protocols. In fact, 
the protocols in this standard are virtually identical to those in 
other OSHA health standards that have been promulgated over the past 
fifteen years. The isoamyl acetate (IAA) QLFT test that was evaluated 
and adopted in the lead standard in 1982 has six exercises. Five of the 
exercises must be performed for one minute, and the talking exercise is 
performed for ``several'' minutes. Thus, the total test time for the 
six exercises is seven to eight minutes, compared to the seven minutes 
and 15 seconds that completion of the exercises in this standard will 
take. Since the length of the two test protocols is similar, OSHA 
concludes that the IAA concentration at the end of the fit test under 
this standard would be the same as if the fit test was performed under 
the IAA QLFT protocol contained in the lead standard.
    The grimace exercise drew a number of comments. The test is 
intended to simulate the type of normal facial movements that could 
break a respirator seal. It was developed in the asbestos standard in 
1986 and has been incorporated into subsequent OSHA standards. 
Participants questioned the need for the grimace exercise, particularly 
with QLFT, where a break in the facepiece seal could cause sensory 
fatigue (Exs. 54-153, 54-208, 54-218, 54-219, 54-263, 54-273, 54-363, 
54-408, 54-424). Several commenters (Exs. 54-173, 54-179, 54-261, 54-
317) stated that the grimace exercise cannot be described so that its 
effects are standardized and reproducible. DuPont (Ex. 54-350) 
recommended that the standard incorporate only six exercises, deleting 
both the grimace and bending/jogging exercises. DuPont stated that if 
the grimace remained in the fit test protocol, it should be performed 
last, with the results excluded from the calculations. Allied Signal 
(Ex. 54-175) also recommended that the grimace exercise be deleted; 
however, if retained, it should be performed at the completion of the 
other test exercises. In contrast, the Los Alamos National Laboratory 
(Ex. 54-420), which originated fit testing protocols, stated that their 
researchers included the grimace exercise as part of the test exercises 
for full facepieces in the early 1970s. Los Alamos stated that an 
exercise that simulates a worker's normal facial movements should not 
be excluded from the test exercises, and recommended that it be 
retained.
    These comments have persuaded OSHA to delete the grimace exercise 
as one of the required fit testing exercises for QLFT, but to retain it 
for QNFT. A break in the facepiece seal during a QLFT could cause 
sensory fatigue that would invalidate the results of the grimace test 
and any remaining fit test exercises. Performing the exercise as the 
final element of the qualitative fit test would not address this 
concern because one purpose of the test is to determine whether the 
respirator reseals after the seal has been broken, and performing the 
grimace test after all the others have been completed will not allow a 
determination of whether the respirator has resealed effectively after 
the test.
    The concern about sensory fatigue does not exist with quantitative 
fit tests, however, and OSHA believes the grimace exercise is a 
valuable aspect of these tests. Because the exercise stresses the 
facepiece seal, it allows the test to determine whether the facepiece 
reseats itself during subsequent exercises. The results from the 
grimace exercise are not to be used in calculating the fit factor for 
QNFT (provision C(2)(h)(1)), since breaking of the seal would 
necessarily produce a low fit factor for the grimace exercise. However, 
if the respirator facepiece fails to reseat itself, the fit factors 
measured for the subsequent exercises would reflect this failure, 
causing the employee to fail the fit test. Therefore the grimace 
exercise has been retained as one of the required QNFT fit testing 
exercises.
    The Air Conditioning Contractors of America (Ex. 54-248) questioned 
the need to require employees to read from a text, such as the Rainbow 
Passage. Members of the association stated that their technicians had 
their own methods of determining fit. As stated above, however, OSHA 
believes that standardized fit testing protocols provide important 
safety benefits to employees. To the extent that employers develop 
other valid fit test methods, Part II of Appendix A provides a 
procedure through which they can seek OSHA approval of those fit test 
protocols. The talking exercise requirement is also not onerous. To 
perform this exercise, the employee must either read from a prepared 
text such as the Rainbow Passage, count backward from 100, or recite a 
memorized poem or song. These alternatives provide employers and 
employees with some flexibility when performing this exercise.
Qualitative Fit Test (QLFT) Protocols--Appendix A, Paragraph B
    B.1. General. Provision B.1.(a) of Part I of Appendix A on 
qualitative fit test protocols contains two general provisions relating 
to QLFT. The provisions are substantively the same as in the proposal. 
The term ``assure'' has been replaced by ``ensure,'' reflecting a 
change that has been made throughout the regulatory text.
    Provision B.1.(a) requires the employer to ensure that the person 
administering QLFT be able to perform tests correctly, to recognize 
invalid tests, and to ensure that the test equipment is in proper 
working order. This applies regardless of whether the tester works 
directly for the employer or for an outside contractor. When QLFT is 
performed by the employer's own personnel, the testers must be properly

[[Page 1229]]

trained in the performance of the particular QLFT protocol that will be 
used. If outside contractors are used to provide fit testing support, 
the employer must ensure that the test operators performing the fit 
testing protocols are trained, and can competently administer the QLFT 
according to the OSHA protocols. This provision is performance 
oriented, since it lists the abilities the test operator needs, but 
does not describe a specific training program. The type of QLFT 
operator training needed is specific to the QLFT method selected, and 
new methods may be developed in the future that require additional 
training.
    The second provision, B.1.(b), requires that the QLFT equipment be 
kept clean and well maintained so it operates within its designed 
parameters. For example, the nebulizers used for the saccharin and 
Bitrex QLFT protocols can clog when not properly cleaned and 
maintained, resulting in invalid tests. The test operator must maintain 
the equipment used for fit testing to ensure proper performance. The 
requirement is again performance oriented, since the QLFT equipment 
used will vary with the type of QLFT selected.
    There are four qualitative fit test protocols approved in this 
Appendix. The isoamyl acetate (IAA) test determines whether a 
respirator is protecting a user by questioning whether the user can 
smell the distinctive odor of IAA. Both the saccharin and Bitrex tests 
involve substances with distinctive tastes, which should not be 
detected through an effective respirator. The irritant smoke test 
involves a substance that elicits an involuntary irritation response in 
those exposed to it.
    B.2--Isoamyl acetate protocol. The IAA test protocol included in 
the final standard evolved out of the IAA protocol OSHA originally 
adopted for the lead standard (29 CFR 1910.1025). It requires that an 
employee first be tested to determine if the employee can detect the 
odor of IAA, often called banana oil because it gives off a distinctive 
banana-like smell. The fit test is only to be conducted on employees 
who can detect this odor. An employee passes the fit test with a 
particular respirator if he/she cannot detect the IAA odor while 
wearing the respirator. The primary drawback of the test is the strong 
ability of IAA to induce ``odor fatigue,'' so that an individual 
quickly loses the ability to detect the odor if exposed to it for any 
period of time. Odor sensitivity is the key to the IAA fit test, and 
any decrease in the employee's odor sensitivity due to background 
levels of IAA could invalidate IAA fit testing. For this reason several 
provisions of the protocol are intended to minimize the possibility of 
background exposure to IAA that could impair the test subject's ability 
to detect the odor in the fit test.
    IAA vapor easily penetrates a particulate filter, and the IAA 
protocol therefore cannot be used to fit test particulate respirators 
unless the respirator is equipped with an organic vapor filter. The 
protocol requires that separate rooms be used for the odor screening 
and fit tests, and that the rooms be ventilated sufficiently to ensure 
that there is no detectable odor of IAA prior to a test being 
conducted. In prior standards, OSHA has required that separate 
ventilation systems, in addition to separate rooms, be used for these 
functions (e.g., Lead [47 FR 51114]). OSHA proposed to do the same in 
this standard. However, OSHA has been convinced by the comment of Mobil 
Oil Corporation (Ex. 54-234) that this elaborate precaution against 
odor fatigue and general background contamination is burdensome and 
unnecessary. OSHA agrees with Mobil that the ventilation simply needs 
to be adequate to prevent IAA odor from becoming evident in the rooms 
where odor sensitivity testing and respirator selection and donning 
take place, and that the need to have separate ventilation systems for 
IAA fit testing will make it unnecessarily difficult to find an 
acceptable building in which to perform fit testing. OSHA is therefore 
removing the requirements that the odor threshold screening test and 
fit test rooms not be connected to the same ventilation system. 
Instead, the ventilation requirement is stated in performance language 
in the final standard: the testing rooms must be sufficiently 
ventilated to prevent the odor of IAA from becoming evident to the 
employee to be tested. OSHA believes that this performance-based 
language will be sufficient to alert employers to the requirement to 
prevent olfactory fatigue among workers being fit tested by preventing 
a buildup of IAA in the general room air.
    The proposed IAA protocol required that the test atmosphere be 
generated by wetting a paper towel or other absorbent material with 
0.75 cc of pure IAA and suspending the towel from a hook at the tip 
center of the test chamber. Two commenters stated that the standard 
should also allow the test atmosphere to be generated by the use of 
commercially prepared test swabs or IAA ampules as long as these 
methods generate the required airborne concentrations of IAA (Mobil Oil 
(Ex. 54-234); Bath Iron Works (Ex. 54-340)).
    OSHA agrees that alternative methods of generating the IAA test 
atmosphere should be permitted as long as those methods have been shown 
to reproducibly generate the minimum concentration of IAA needed for a 
successful fit test. The National Bureau of Standards (Ex. 64-182), in 
its report on fit testing of half mask respirators using the IAA 
protocol in the OSHA lead standard, found that the minimum IAA 
concentration inside the test chamber was 100 ppm during fit testing. 
Accordingly, the IAA protocol in Appendix A of the final standard has 
been modified to permit the use of test swabs or ampules as long as 
these have been shown to generate a test atmosphere concentration 
comparable to that generated by the towel-saturation method in the 
proposed standard. An employer who wishes to use test swabs or ampules 
would need to demonstrate that the swabs or ampules generate an 
acceptable test atmosphere. For this purpose, the employer may rely on 
data obtained from the manufacturer of the swabs or ampules as long as 
the employer uses the products in a way that reproduces the 
concentrations obtained by the manufacturer under the manufacturer's 
test conditions.
    OSHA has also added a provision recommended by the American 
Industrial Hygiene Association (Ex. 54-208) to reduce the possibility 
of test area contamination from used paper towels. AIHA recommended 
that B.2.(b)(10) be revised to ensure that the used towels are stored 
in self-sealing bags to prevent test area contamination. OSHA adopted 
the language changes the AIHA proposed; the final standard requires 
that used IAA towels be removed from the test chamber to avoid test 
area contamination.
    AIHA (Ex. 54-208) also recommended that OSHA remove the language in 
B.2.(b)(2) of the IAA fit test protocol requiring that organic vapor 
cartridges be changed at least weekly. AIHA stated that a fit test 
operator who is competent to implement an adequate QLFT program will be 
able to determine an adequate cartridge change schedule. OSHA agrees, 
and has removed the language requiring weekly filter changes, because 
weekly changes may overstate or understate appropriate frequencies. 
However, the program administrator or the fit test operator must 
replace the cartridges as appropriate to ensure their proper function.
    After the close of the NPRM comment period and the hearings, during 
the post-hearing comment period, the ISEA (Ex. 54-363B) submitted a 
report on fit testing for full facepiece respirators

[[Page 1230]]

using an IAA QLFT protocol for which the test concentration of IAA was 
raised to 10 times the concentration used in the OSHA-accepted IAA 
protocol. ISEA reported that the pass/fail cutoff for the modified IAA 
QLFT was a required fit factor of 1000, and that this increased IAA 
concentration fit test could therefore be used to test full facepiece 
respirators for use where ambient exposures were 100 times the PEL. 
ISEA stated that the validation data that it submitted for this new IAA 
fit test meet the validation requirements of the September 17, 1989 
ANSI Z88.10 draft standard entitled ``Respirator Fit Test Methods.'' 
OSHA notes, however, that all draft provisions of the draft ANSI fit 
testing standard are still subject to change until published as part of 
the final ANSI Z88.10 standard. Further, ISEA did not indicate that the 
test met the validation criteria proposed by OSHA. In addition, no 
comments were received from the regulated community on this modified 
IAA protocol. Since the proposed, ISEA-modified, IAA qualitative fit 
test was submitted as a post-hearing comment, an opportunity did not 
exist for the regulated community to comment on it as part of this 
rulemaking record. The revised IAA fit test, therefore, has not 
received the review and public comment to which the other new fit tests 
(i.e., Portacount, CNP, Bitrex) were subjected during this rulemaking. 
Accordingly, OSHA is not adding the modified IAA fit test for full 
facepieces to the final standard's fit test protocols. This Appendix 
establishes procedures for OSHA acceptance of new fit test protocols, 
and a proponent of the modified IAA fit test may submit it for review 
under those procedures.
    B.3 and B.4--Saccharin Solution and BitrexTM (Denatonium 
benzoate) Solution Aerosol Protocols. The protocols for the saccharin 
and Bitrex solution aerosol fit test methods are similar. Both involve 
test agents that a test subject will taste if his or her respirator is 
not functioning effectively. Saccharin is a sugar substitute with a 
sweet taste, and Bitrex is a bitter taste-aversion agent. In both 
cases, the subjects are first tested to ascertain that they are in fact 
able to taste the test agent being used, and then are tested with a 
respirator. During the fit test the subjects are instructed to breathe 
with their mouths slightly open and their tongues extended. If they can 
taste the test agent during the fit test, the test has failed.
    The proposal included the saccharin protocol but not the Bitrex 
protocol, which was not validated until after the proposal was issued. 
The saccharin protocol was identical to that contained in the Lead 
standard (29 CFR 1910.1025, Appendix D II; 29 CFR 1910.1027 (Cadmium); 
29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048 (Formaldehyde); 29 CFR 
1910.1050 (Methylenedianaline); 29 CFR 1910.1051 (1-3 Butadiene)). 
Several commenters (Exs. 54-208, 54-218, 54-219, 54-363) recommended 
minor revisions to the language of the protocol to correct specific 
problems, and to clarify the procedures. In response to these comments, 
the formula for preparing the threshold check solution has been revised 
to remove an error in dilution contained in the lead standard protocol. 
OSHA has also changed the requirement that employees being tested open 
their mouths wide to a requirement that they open their mouths 
slightly, since opening the mouth wide could distort normal facepiece 
fit and invalidate the test results. Opening the mouth slightly is 
sufficient to allow the employee to detect leakage of the test agent 
into the respirator when testing for facepiece seal leakage.
    The final standard also does not restrict employers to using a 
DeVilbiss Model 40 nebulizer but also allows them to use an equivalent 
test nebulizer. Allowing the use of alternative nebulizers that can 
produce an acceptable test atmosphere is a change from the lead 
standard protocol, which allowed only the use of the DeVilbiss 
nebulizer. Finally, the protocol now states clearly that, to elicit a 
taste response, a minimum of ten nebulizer squeezes is required during 
the threshold screening. This matches the minimum number of squeezes of 
the fit test nebulizer required by the protocol.
    NIOSH (Ex. 54-437) was the only participant to object to the 
saccharin aerosol protocol. NIOSH is concerned that saccharin is a 
potential carcinogen, and it believes that Bitrex is an acceptable 
alternative test agent. Although saccharin is suspected of being a 
carcinogen when ingested in large quantities over long periods of time, 
it is not a substance that OSHA has regulated, and even NIOSH does not 
have a Recommended Exposure Limit for it. A test subject would be 
exposed to saccharin only for a brief time during the pre-test 
sensitivity check, and again either upon failing the test or during the 
post-test sensitivity check. Either exposure would likely occur only 
once a year. These exposures would be very low, at or near the 
threshold of detectability, and it is extremely unlikely that they pose 
a significant risk to the health of employees or that they would exceed 
any realistic exposure limit that may be established.
    Moreover, although the Bitrex fit test protocol is an acceptable 
alternative for situations in which the saccharin protocol is used, 
Bitrex is not as widely available as saccharin, and the test is not as 
widely accepted. The Bitrex QLFT protocol was developed by 3M (Ex. 54-
218). The test protocol is essentially the same as that for the 
saccharin QLFT, with changes made in preparing the threshold check 
solution and the fit test solution to account for the non-linear taste 
sensitivity of Bitrex. A recent paper by Mullins, Danisch, and Johnston 
(Ex. 178) in the November 1995 AIHA journal describes the development 
of the Bitrex QLFT method. Validation testing consisted of 150 paired 
qualitative and quantitative fit tests, with test volunteers using half 
mask respirators. The Bitrex fit test was evaluated against the 
saccharin fit test and found to have a test sensitivity of 0.98 and a 
predictive value for passing of 0.98 at a fit factor of 100. The 
overall test results were identical for the Bitrex and saccharin fit 
test methods.
    Only one rulemaking participant objected to the possibility that 
OSHA would approve the Bitrex test. Robert daRoza of the Lawrence 
Livermore Laboratory (personal communication with John Steelnack, OSHA, 
6/4/97) stated that this method has not been adequately tested by 
multiple facilities, and that the ratio of the concentrations specified 
does not follow the same logic used in the saccharin method. Until the 
method is validated by multiple facilities and the logic of the 
specified concentrations determined, Mr. daRoza believes that the test 
should not be incorporated into the final standard.
    In contrast, NIOSH has recommended Bitrex as an acceptable 
alternative test agent for saccharin (Ex. 54-437). OSHA has reviewed 
the validation studies (Ex. 178) in depth, and believes that they 
establish the Bitrex protocol as an appropriate fit test method. 
Therefore, OSHA is approving this protocol.
Irritant Smoke (Stannic Chloride) Protocol
    The irritant smoke protocol (also called irritant fume) uses 
stannic chloride smoke tubes to produce a smoke containing hydrochloric 
acid. Exposure to this test agent causes irritation resulting in 
coughing. Because the response to irritant smoke is involuntary, the 
irritant smoke fit test is the only QLFT method that does not rely on 
the subjective response of the employee being tested (Exs. 54-325, 54-
424). The protocol contains a number of provisions intended to minimize 
employee exposure to the irritant

[[Page 1231]]

smoke, which can be harmful to some individuals at high exposure 
levels.
    Irritant smoke is the oldest method of fit testing still in use. It 
was developed at the Los Alamos National Laboratory more than fifty 
years ago (Ex. 25-4). OSHA has approved the protocol in all of its 
health standards that allow QLFT (See 29 CFR 1910.1025 (Lead); 29 CFR 
1910.1027 (Cadmium); 29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048 
(Formaldehyde)).
    The irritant smoke protocol also has the drawback, however, that 
excessive exposure to irritant smoke can cause severe irritation and, 
in some cases, permanent harm. For this reason, NIOSH (Ex. 54-437) 
recommended against the continued use of irritant smoke for qualitative 
fit testing. NIOSH has conducted the only study known to OSHA that 
assessed the concentrations of hydrogen chloride produced from irritant 
smoke tubes. When smoke tubes were attached to an aspirator bulb, NIOSH 
measured concentrations of hydrochloric acid that ranged from 100 ppm 
(measured at a distance of six inches from the end of the smoke tube) 
to 11,900 ppm (measured at a distance of two inches). The use of a low-
flow pump produced hydrogen chloride concentrations ranging from 1500 
ppm to more than 2000 ppm within 10 seconds of turning on the pump. 
NIOSH did not measure the amount of irritant smoke inside any 
respirator facepieces (Tr. 411). The OSHA PEL for hydrogen chloride is 
a ceiling limit of 5 ppm, which may not be exceeded at any time (29 CFR 
1910.1000(a)). NIOSH has established an IDLH value of 50 ppm and notes 
that a concentration of 309 ppm has been reported as the level of 
hydrogen chloride causing a severe toxic endpoint in laboratory 
animals. NIOSH also cited a recommendation by a National Academy of 
Sciences committee to limit emergency exposure to 20 ppm (Ex. 54-437R 
at p. 6).
    NIOSH performed these measurements after evaluating irritant smoke 
testing at the request of the Anchorage Alaska Fire Department (Ex. 54-
437R) because four firefighters had reported experiencing either skin 
or eye irritation during irritant smoke fit testing inside a test 
enclosure. NIOSH additionally described a telephone report it had 
received of vocal chord damage caused by exposure to hydrochloric acid 
during an irritant smoke fit test. OSHA notes, however, that this fit 
test was performed inside a test enclosure and that the test subject 
failed four consecutive fit tests using this challenge agent (Tr. 411).
    TSI, Inc. (Ex. 54-303), the manufacturer of the Portacount QNFT 
system, also recommended that the irritant smoke QLFT protocol be 
deleted from the final standard. Like NIOSH, TSI was concerned that 
employees being fit tested may be exposed to hydrochloric acid in 
excess of the PEL and, sometimes, in excess of the IDLH level. TSI also 
stated that the proposed protocol did not contain a threshold test to 
measure the employee's sensitivity to irritant smoke, and does not 
provide a means for generating a stable test-agent concentration. The 
3M Company (Ex. 137), citing the NIOSH recommendation that irritant 
smoke not be used for fit testing, also recommended against its use. In 
addition, 3M stated that ``the irritant smoke test has not yet been 
completely validated. Neither the level of smoke necessary to evoke a 
response nor the challenge concentration during the fit test have been 
measured and shown to be reproducible.''
    In contrast, OSHA received comments urging that it continue to 
approve the irritant smoke protocol. The Organization Resources 
Counselors, Inc. (ORC) (Ex. 54-424) noted that the irritant smoke 
protocol is generally considered to be one of the easiest, cheapest, 
quickest, and most effective QLFT methods available, although ORC 
recognized that precautions must be taken to minimize exposures. For 
example, ORC pointed out that irritant smoke fit testing should not be 
performed in a small chamber, such as an inverted plastic bag or hood, 
since this could allow the accumulation of high concentrations of 
hydrogen chloride. SEIU (Ex. 54-455) supported the use of irritant 
smoke QLFT because of the benefits of its involuntary response. The 
SEIU stated:

    SEIU objects to the use of non-irritant challenge agents 
(isoamly acetate and saccharine). We have found that many of our 
members are pressured to complete fit tests quickly and get back to 
work, and hence will not acknowledge when a respirator has leaked 
during a fit test. The reaction to an irritant fume is very 
difficult to disguise.

    Willson Safety Products (Ex. 54-86) also supported the use of the 
irritant smaoke fit test, citing ``the thousands of businesses who now 
use the irritant smoke fit test procedure with a 50 ml squeeze bulb. 
They find the irritant fume protocol the least complicated and most 
easily performed of the QLFT protocols.''
    All of the comments urging OSHA not to approve the irritant smoke 
protocol were based on the possibility that the test could expose 
employees to high levels of hydrogen chloride. The irritant smoke 
protocol in Appendix A has been carefully designed to minimize such 
exposures. The initial and post fit-test sensitivity checks must be 
performed with ``a small amount'' of ``a weak concentration'' of 
irritant smoke, with care being taken to use ``only the minimum amount 
of smoke necessary to elicit a response.'' (See provisions I.B.5(a)(4); 
and 5(b)(3)). Test subjects are to be instructed to close their eyes to 
prevent eye irritation during the test. The test must be performed in a 
well-ventilated area to prevent any build-up of irritant smoke in the 
general atmosphere (provision I.B.5(a)(5)). Unlike other QLFT methods, 
the irritant smoke test may not be performed inside a test enclosure or 
hood (provision I.B.5(a)(3)).
    Persons being fit tested must pass a user seal check before the fit 
testing begins (See provision I.A.8). The irritant smoke fit test 
starts with a small amount of the irritant smoke being produced from a 
smoke tube, and the person being tested wafting a small portion of the 
smoke toward his or her breathing zone to determine if any gross 
facepiece leakage occurs. Only after determining that the initial fit 
is adequate does the operator direct smoke at the facepiece seal area, 
starting at least 12 inches away from the head and working around the 
seal area and gradually approaching the test subject's face. Because 
the test is performed in an open area, the person being tested can step 
back into clean air any time irritant smoke is detected within the 
mask. This limits the maximum exposure to as little as one breath of 
irritant smoke.
    Following this protocol would have avoided both of the adverse 
reaction incidents NIOSH described. In the Anchorage case, positive 
pressure SCBAs were fit tested by placing the users inside a test 
enclosure and pumping it full of irritant smoke. The users were 
apparently not warned to close their eyes during the fit test. The use 
of a test enclosure is expressly prohibited in the OSHA protocol, as is 
exposing test subjects to more than the minimum amount of smoke 
necessary to elicit a response. And test subjects must be instructed to 
close their eyes during testing. The test subject in the second 
incident who suffered damage to her vocal cords was also tested inside 
a test enclosure; in addition, she failed four consecutive fit tests 
involving this agent. Repeated testing of a subject who fails the test 
not once, but four consecutive times, inside a test enclosure filled 
with irritant smoke is prohibited by the OSHA protocol. Following the 
OSHA-accepted protocol would have reduced to substantially lower levels 
the exposures received by these employees.

[[Page 1232]]

    In approving this fit test protocol, OSHA is not discounting the 
evidence that irritant smoke can cause adverse reactions in test 
subjects. All of the cases OSHA is aware of, however, involve tests 
that were not done in a way that OSHA considers acceptable, and 
consequently exposed the test subjects to excessive concentrations of 
irritant smoke. OSHA emphasizes the critical importance of following 
its approved protocol, including all of the safeguards against 
excessive exposure, when this test is used. Indeed, paragraph (f)(5) 
requires that employers follow these protocols and failure to do so 
constitutes a violation of the standard.
    Participants also made a number of suggestions about specific 
aspects of the protocol. The proposed irritant smoke protocol, which 
was derived from protocols promulgated in other standards (29 CFR 
1910.1025 and subsequent health standards), required the use of a low-
flow air pump set to deliver 200 milliliters of irritant smoke per 
minute. Several participants commented that an aspirator bulb should be 
acceptable for generating an irritant smoke test agent, and that 
further justification was needed for requiring a low-flow air pump 
(Exs. 54-38, 54-86, 54-135, 54-309, 54-316, 54-324, 54-363, 54-424). 
The Coastal Corporation (Ex. 54-272) said that requiring only the low-
flow air pump would impose an unnecessary financial burden, and 
recommended that OSHA allow for alternative methods, such as an orifice 
adapter on a compressed air system, for delivering a uniform stream of 
irritant smoke. The ISEA (Ex. 54-363) stated that its members were not 
aware of a commercially available low-flow air pump, and also 
recommended that an aspirator bulb, which it said was now used by many 
fit test operators, be allowed instead.
    In response to these comments, the requirement that only a low-flow 
pump may be used to generate the irritant smoke has been changed in the 
final standard. In addition to the low-flow pump, an aspirator squeeze 
bulb may be used to generate the irritant smoke for fit testing. 
However, care must be taken by the fit test operator to ensure that the 
aspirator bulb produces irritant smoke at the required flow rate of 200 
ml/minute. Since aspirator bulbs vary in size, the person performing 
the fit test must know the volume of the aspirator bulb being used to 
push air through the smoke tube. The number of bulb squeezes per minute 
will vary depending on bulb volume. For example, a large 50 ml bulb 
would need four squeezes per minute to produce the required volume of 
irritant smoke, while a smaller 25 ml bulb would need eight squeezes 
per minute. The squeezes should be uniform, and evenly spaced out 
through each minute to maintain a relatively constant flow of irritant 
smoke. The use of an aspirator bulb to deliver the test agent at a 
stable, constant rate requires some skill on the part of the test 
operator, since each squeeze can be different, and care must be taken 
by the fit test operator to produce a steady stream of irritant smoke. 
An aspirator bulb can produce a large amount of irritant smoke during a 
single squeeze. However, the squeeze bulb method when properly 
performed can be an effective fit test for determining facepiece fit. 
Willson Safety Products (Exs. 54-86) submitted a March 4, 1991 letter 
of interpretation it had received from Thomas Shepich of the OSHA 
Directorate of Technical Support regarding the use of a squeeze bulb 
for performing the irritant smoke QLFT under the asbestos, lead, 
benzene and formaldehyde standards. Mr. Shepich stated:

    In your letter you indicated that a majority of your customers 
use a 50 ml rubber squeeze bulb that is capable of delivering a flow 
of 200 ml of air per minute if used correctly. You also express 
concern over the need to spend $500.00 or more to use a mechanical 
pump since the rubber squeeze bulb can adequately meet the intent of 
the OSHA standard.
    The QLFT method is a pass/fail test. Since a rubber squeeze bulb 
generated challenge agent can be as effective as a mechanically 
aspirated one, the intent of the standards has been met. The 
training of individuals administering QLFT by the rubber squeeze 
bulb method must include techniques on the proper number of 
compressions per minute necessary to generate an appropriate air 
flow.

    A few other modifications to the protocol have also been made. As 
the ISEA (Ex. 54-363) recommended, the term ``irritating properties'' 
has been substituted for ``characteristic odor'' in the irritant smoke 
protocol in Appendix A, since the term better describes what the 
employee experiences. Based on ORC recommendations (Ex. 54-424), the 
reference to the MSA smoke tube has been removed, and language has been 
added requiring that the end of the smoke tube be covered with a short 
length of tubing to prevent injury from any jagged glass where the tube 
has been opened. As the AIHA (Ex. 54-298) recommended, the description 
``involuntary cough'' has been added to the description of the response 
to irritant smoke. A clear statement that no form of test enclosure or 
hood is to be used with irritant smoke has been added, as supported by 
ORC (Ex. 54-424), and in response to the problems described by NIOSH 
and TSI (Exs. 54-303; 54-437R).
Quantitative Fit Test (QNFT)
    Appendix A includes three quantitative fit test protocols, the 
generated aerosol protocol, the Portacount TM protocol that 
uses ambient aerosol as the test agent and a condensation nuclei 
counter (CNC) as the test instrumentation, and the controlled negative 
pressure (CNP) protocol (i.e., the Dynatech FitTester 3000 
TM). Only the generated aerosol protocol was included in the 
proposal. Each QNFT method is described in a separate section of 
Appendix A.
    Part I of section C contains general requirements for QNFT. The 
employer is to ensure that the individuals who perform the QNFT, 
whether employees or contractors, are able to calibrate equipment and 
perform tests properly, recognize invalid tests, calculate fit factors 
properly and ensure that test equipment is in proper working order. The 
employer is also responsible for ensuring that the QNFT equipment is 
cleaned, maintained, and calibrated according to the manufacturer's 
instructions so that it will operate as designed.
    Respirators used for QNFT must be in proper working condition. 
Respirators are to be rejected if leakage is detected from exhalation 
valves that fail to reseat adequately, near the probe or hose 
connections, or if the respirator is missing gaskets. The requirement 
in paragraphs (h)(1)(iv) and (h)(3)(i)(A) that all respirators used in 
non-emergency situations be inspected for defects before each use and 
cleaned after each use also apply to fit testing. The test operator 
must inspect the test respirator for: cracking, holes, or tears in the 
rubber body of the facepiece; cracks or tears in valve material and in 
the inhalation and exhalation valve assemblies; foreign material 
between the valve and valve seats; proper installation of the valve 
body in the facepiece; and warped or wrinkled valves. Respirators with 
any of these defects cannot be used for fit testing.
    A user seal check must be conducted prior to starting QNFT to 
ensure that the respirator facepiece is properly adjusted. The use of 
an abbreviated, or screening, QLFT before QNFT fit testing to identify 
poorly fitting respirators is optional.
Paragraph 2--Generated Aerosol QNFT
    The procedures for conducting the generated aerosol quantitative 
fit test are widely recognized and accepted by the industrial hygiene 
community. The test is performed inside a test unit such as

[[Page 1233]]

a hood, portable booth, or chamber. An aerosol of a test agent is 
generated inside the enclosure. A stable ambient test agent 
concentration must be achieved prior to beginning the test exercise 
regimen. The test unit must be large enough to permit the employee 
being tested to freely perform the QNFT exercise regimen without 
disturbing the test agent concentration, and the unit must effectively 
contain the test agent in a uniform concentration.
    During the test, the respirators are fitted with filters, such as 
high efficiency HEPA, or P100 filters, that offer 99.97% efficiency 
against 0.3 micron aerosols as defined by NIOSH in 30 CFR part 11 or 42 
CFR part 84. Therefore, virtually any measurable leakage should be the 
result of leaks between the respirator sealing surface and the 
respirator user's face. If test agents other than particulates are 
used, the sorbent/filters must offer a similar degree of collection 
efficiency against the test agent. The concentration of the test agent 
is measured both inside and outside the respirator. Commonly used 
detection methods include forward light-scattering photometry or flame 
photometry.
    Three methods were proposed for using the results of these 
measurements to calculate fit factors: the average peak penetration 
method; the maximum peak penetration method; and the use of an 
integrator to calculate the area under the individual peak for each 
exercise (59 FR 58919). OSHA proposed that the fit factor derived from 
QNFT using test agents be calculated by dividing the average test agent 
concentration inside the chamber (i.e., the ambient concentration) by 
the average test agent concentration inside the respirator for each 
test exercise (excluding the grimace exercise). The average ambient 
concentration is derived from the measurement of the test agent 
concentration in the test chamber (i.e., outside the respirator) at the 
beginning and end of the test. TSI, Inc. (Ex. 54-8) stated that while 
the language proposed for determining the average test chamber 
concentration was correct, better accuracy could be obtained by 
averaging the chamber concentration before and after each exercise, and 
by allowing for continuous chamber concentration measurements. OSHA 
agrees that the standard should allow for these other methods of 
measuring average test chamber concentration, and has adopted the 
revised language submitted by TSI.
    In the proposal, the average test agent concentration inside the 
respirator was to be determined from the aerosol penetration during 
each test exercise using one of three approved methods for calculating 
the overall fit factor. TSI, Inc. (Ex. 54-8) noted that the intuitive, 
but algebraically incorrect, method of computing the arithmetic average 
of the fit factors for all exercises (i.e., for instruments that report 
their exercise results as fit factors instead of peak penetrations) 
would result in an overestimation of the overall fit factor. This 
commenter suggested that OSHA adopt the equation from the draft ANSI 
Z88.10 fit testing standard that correctly states how to perform the 
fit factor calculation for instruments that report results as exercise 
fit factors instead of peak penetration values. OSHA agrees and has 
added this equation to Appendix A in the final standard.
    The test aerosol penetration measured for the grimace exercise is 
not to be used in calculating the average test agent concentration 
inside the respirator (See provision I.C.2(b)(8)(i)). The purpose of 
the grimace exercise is to determine whether the respirator being fit 
tested will reseat itself on the face after the respirator seal is 
stressed during the exercise. With a properly fitting respirator, the 
test instrumentation should record a rise in test agent concentration 
inside the mask during the grimace exercise, and a drop in test agent 
concentration when the respirator reseats itself. If the respirator 
fails to reseat itself following the grimace exercise, the subsequent 
normal breathing exercise will show excessive leakage into the mask and 
result in a failed fit test. Since even a properly fitting respirator 
may show increased test agent penetration during part of the grimace 
exercise, the penetration value measured during the grimace exercise is 
not to be used in calculating the overall fit factor.
    A clear association is required between an event taking place 
during testing and the record of the event. This requirement is 
critical for the proper calculation of aerosol penetration for specific 
test exercises. Short duration leaks (displayed as peaks on the 
recording instrument) can occur during, and as a result of, each fit 
test exercise, and these leaks indicate poor respirator fit. These 
penetration peaks are used to determine the fit factor. An inability to 
measure these penetration peaks could result in the fit factor being 
overestimated, since averaging all the test exercise penetration peaks 
may obscure the high penetration levels that occur during a test 
exercise. An inability to clearly associate the exercise event with the 
recording makes correct calculation of the fit factor impossible.
    Several factors can affect the time interval between an exercise 
event occurring during QNFT and the recording of the event, such as the 
diameter of the sampling line, sampling rate, and the length of the 
sampling line. Response time will increase with an increase in the 
length and/or diameter of the sampling line. Therefore, the length and 
inside diameter of the sampling line should be as small as possible. 
The line used for sampling the test chamber test agent concentration, 
and the line used for testing the test agent concentration inside the 
respirator, must have the same length and inside diameter so that 
aerosol loss caused by aerosol deposition in each sample line is 
equivalent for the two lines.
    To minimize both contamination of the general room atmosphere and 
test operator exposure to the test agent, the generated aerosol 
protocol requires that air exhausted from the test unit must pass 
through a high-efficiency filter (or sorbent).
    Since the relative humidity in the test chamber may affect the 
particle size of sodium chloride aerosols, the protocol further 
requires that the relative humidity of the test unit be kept below 50 
percent. This requirement is consistent with manufacturer's 
instructions for sodium chloride units.
    Prior to beginning the generated aerosol QNFT, a stable test agent 
concentration must be achieved inside the test unit. The concentration 
inside small test booths or waist-length hoods may be diluted 
significantly when the employee enters the booth. Normally, the test 
agent concentration will stabilize within two to five minutes.
    Adjustments to the respirator must not be made during the QNFT. Any 
facepiece fit adjustments must be made by the employee before starting 
the exercise regimen. This requirement will prevent manipulation of the 
respirator during fit testing to achieve higher fit factors. The fit 
test is to be terminated whenever any single peak penetration exceeds 
two percent for half masks and quarter facepiece respirators, and one 
percent for full facepiece respirators. Such leaks correspond to fit 
factors below 100 for half masks and 500 for full facepiece 
respirators, and indicate an unacceptable respirator fit. In such 
cases, the respirator may be refitted or adjusted, and the employee 
retested. If a subsequent QNFT test performed after the respirator has 
been refitted or adjusted is terminated because of excessive 
penetration, then the respirator fit for that individual must be 
considered unacceptable, and a different respirator must be selected 
and tested.
    OSHA had proposed that an employee successfully complete three 
separate fit

[[Page 1234]]

tests with the same respirator using a QNFT protocol. The proposed 
requirement was derived from the fit testing protocols in OSHA's 
substance-specific standards, e.g., the Benzene standard (29 CFR 
1910.1028). This proposed provision received more than 150 comments. 
Many commenters stated that only a single QNFT was needed, and that the 
additional tests would only increase the cost of fit testing without a 
corresponding improvement in attaining a successful fit (Exs. 54-11, 
54-26, 54-35, 54-37, 54-41, 54-44, 54-63, 54-83, 54-114, 54-124, 54-
139, 54-208, 54-289, 54-316, 54-359, 54-363). Some said that requiring 
three tests for QNFT would discourage employers from adopting QNFT (Ex. 
54-164), or would force employers to use the less protective QLFT, 
which requires only one fit test (Exs. 54-316, 54-359, 54-363, 54-434). 
One commenter stated that three fit tests for QNFT would only be needed 
if OSHA allows higher APFs based on the results (Ex. 54-84). (OSHA 
notes that the concept of increasing the APF based on repeated fit 
testing, originally contained in the ANSI Z88.2-1980 respirator 
standard, was subsequently removed from the Z88.2-1992 revision of that 
standard (Ex. 54-443)). The Bath Iron Works (Ex. 54-340) stated that 
the variation between separate fit tests is significant, and 
recommended that this problem could be resolved by increasing the 
safety factor beyond 10. Other commenters suggested that increasing the 
fit factor required for passing a single QNFT was an alternative to 
requiring three fit tests (Exs. 54-139, 54-154, 54-173, 54-340).
    The final standard does not include the requirement to perform 
three successful QNFTs because performing three tests has not been 
shown in this record to better detect poor respirator fit. Increasing 
the safety factor of 10, thereby raising the minimum fit factor 
required to pass a QNFT, also has not been adopted by OSHA because 
experience indicates a safety factor of ten is sufficient. While many 
employers have, on their own, decided to require higher fit factors 
during fit testing, data in the record do not support the suggestion 
that increasing the safety factor beyond 10 is appropriate. Using a 
safety factor of 10 is current practice in fit testing, and is used to 
account for the variability in fit testing procedures, as well as other 
variables (e.g., differences in respirator fit between the workplace 
and during fit testing).
    The results of the fit test must be at or above the minimum fit 
factor required for that class of tight-fitting air-purifying 
respirator. The required fit factors are established by applying a 
safety factor of 10 to the APFs for that class of respirator. For 
example, quarter and half mask air-purifying respirators with an APF of 
10 must achieve at least a fit factor of 100, and full facepiece air-
purifying respirators with an APF of 50 require a minimum fit factor of 
500.
Paragraph 3--Condensation Nuclei Counter (CNC) QNFT
    A protocol for the ambient aerosol condensation nuclei counter 
(CNC) quantitative fit testing protocol (i.e., TSI, Inc. Portacount 
TM) has been added to the final standard as an accepted QNFT 
method. Many commenters pointed to the need for a CNC QNFT protocol. 
Commenters, (Exs. 54-216, 54-326, 54-359) noted that the Portacount is 
the most commonly used method, and that sufficient data have been 
developed over the past several years to validate its effectiveness. 
The use of the Portacount has been allowed by OSHA under a compliance 
interpretation published in 1988. Commenters urged that the ambient 
aerosol CNC method be included in the list of accepted QNFT methods in 
the final standard (Exs. 54-216, 54-326, 54-359). OSHA agrees with 
these comments. The written instructions for performing the fit test in 
Appendix A are essentially the same as the instructions provided by the 
manufacturer.
Paragraph 4--Controlled Negative Pressure (CNP) QNFT
    The protocol for the controlled negative pressure (CNP) 
quantitative fit test method (Dynatech Nevada FitTester 3000 
TM) has also been added to the list of accepted QNFT 
methods. This fit test method involves the use of a fit test instrument 
to generate a controlled negative pressure inside the facepiece of the 
respirator to measure the resulting leak rate.
    This fit test protocol is the same protocol allowed by OSHA under a 
compliance interpretation letter issued in 1994 and based on various 
studies on the performance of the CNP method conducted by its 
developer, Dr. Cliff Crutchfield (Exs. 71, 54-436). These studies 
reported results that were validated by comparing them to results from 
the existing aerosol fit test systems. The data showed that the fit 
factors measured with CNP are always lower than the fit factors 
measured with an aerosol QNFT. OSHA had reviewed these studies before 
issuing its compliance letter. OSHA believes that the CNP method, based 
on Dr. Crutchfield's validation data, constitutes adequate support for 
the method's reliability in rejecting bad fits. Although no body of 
data is available that describes employer experience using the CNP 
method in the workplace, OSHA is confident that the extensive 
validation data showing consistently conservative results using CNP 
means that this method will identify bad fits at least at the same rate 
as other accepted fit test protocols.
    Several commenters urged OSHA to provide a protocol for the CNP 
method and to list it as approved (See, e.g., Exs. 54-167, 54-216). In 
addition, NIOSH in its comments and testimony stated that ``NIOSH 
recommends that OSHA recognize * * * the following fit test procedures 
as acceptable * * * Quantitative fit tests using controlled negative 
pressure and appropriate instrumentation to measure the volumetric leak 
rate of a facepiece to quantify the respirator fit'' (Tr. 359, Ex. 54-
437). NIOSH further stated in its comment (Ex. 54-437) that ``[o]nly 
the controlled negative pressure fit test system, which has been 
excluded in the OSHA proposal, has been subjected to limited 
validation'' (Decker and Crutchfield, 1993). The State of Washington 
Department of Labor and Industries (Ex. 54-173) requested that OSHA 
provide performance criteria so that methods such as ``Dynatech test 
equipment'' described as ``proven'' and ``accepted'' may more easily be 
used.
    Penelec/Genco reported favorable experience using the CNP method 
(Ex. 54-167). As stated in its comment:

    Penelec/Genco recently quantitatively fit tested approximately 
1500 employees on both half and full face respirator facepieces 
using the Dynatech/Nevada FitTester 3000. For the past 10 years we 
have performed fit tests using particle counting equipment. We are 
most pleased with the results provided by the FitTester 3000 * * * 
We believe that the science is sound, the equipment is reliable, and 
the results are valid. When used as part of a complete respiratory 
protection program, we believe controlled negative pressure fit 
testing is an effective way of matching each person with the best-
fitting, most comfortable facepiece respirator.
    All the peer-reviewed studies consistently show that controlled 
negative pressure equipment and protocols always produce more 
conservative fit test results than particle counting equipment and 
protocols. Our experience totally supports this.
    We find the Dynatech/Nevada FitTester 3000 to be durable, 
reliable and easy to use. Results are always reproducible, with 
minimum variation. Employee acceptance is excellent, especially 
because they get a direct perception of fit (leaks or lack of) which 
corresponds well to the machine's fit results.
    Using the FitTester 3000 we are able to select more comfortable, 
better fitting respirators for our employees. We believe that 
certain respirator brands are far superior to others in terms of fit 
and comfort. As a result, we have switched brands. Our

[[Page 1235]]

employees are far more satisfied with the fit and comfort of their 
new respirators * * * (Ex. 54-167)

    TSI, Inc. (Exs. 54-229, 54-302) stated that OSHA should reject the 
CNP method as a valid QNFT, since employees who are tested using this 
method must hold their breath and remain motionless during the 
measurement, i.e., they cannot perform the required exercises 
simultaneously with the measurement. According to TSI (Ex. 171), 
dynamic exercises are necessary to simulate the face seal stresses 
imposed by workplace conditions. Dr. Crutchfield, in his post-hearing 
submission (Ex. 134), responded to statements made by Jeff Weed of TSI 
at the hearing and in TSI's submissions to the record regarding the CNP 
fit test method. He discussed the ability of aerosol-based fit test 
methods to measure transient leaks, stated that leakage occurs with 
inhalation, and that the CNP method measured more respirator leakage 
than aerosol-based systems, and further, that CNP fit factors ``tend to 
align more closely with workplace protection factors than do aerosol-
based fit factors.'' Dr. Crutchfield stressed the importance of being 
able to effectively measure fundamental leakage into the respirator, 
stating that ``most dynamic exercises do not seem to have a 
statistically significant effect on measured fit factors.''
    OSHA recognizes the need to perform fit testing exercises to stress 
the facepiece seal, and has included a full range of exercises in the 
CNP protocol in Appendix A. They differ from the exercises for the CNC 
method, since test results are not taken while the test exercise is 
being performed, but are taken after the exercise is completed. 
However, since the CNP method cannot distinguish changes in facepiece 
volume that are related to movement during an exercise from leakage 
into the facepiece caused by poor respirator fit, the CNP protocol 
requires that the employee remain motionless during the short sampling 
period that is required after each exercise. OSHA believes that any 
changes in fundamental fit caused by the test exercises should, 
consequently, be measured by the CNP method during the 10-second 
sampling period following each exercise, and that this does not affect 
the test's ability to detect poor fits when the seal is stressed.
    In addition to the OSHA-accepted CNP fit test protocol, Dr. 
Crutchfield (Tr. 254) testified about a new fit test protocol for the 
CNP method. This new protocol is substantially different from the OSHA-
accepted protocol, which requires the performance of test exercises 
followed by CNP measurements. The new protocol was also described in 
detail in a letter from Senator John McCain of Arizona on behalf of Dr. 
Crutchfield (Ex. 54-460). The new protocol submitted after the close of 
the post-hearing comment period is described as consisting of three 
exercises and two redonnings. The first exercise measured ``fundamental 
respirator fit'' with the head facing forward. The second exercise was 
a bending exercise, with the respirator parallel to the floor. The 
third exercise consisted of vigorously shaking the head from side-to-
side for three seconds, followed by a ``fundamental fit'' measurement. 
The respirator user then is required to remove and redon the respirator 
twice, with ``fundamental fit'' measured after each redonning. This 
protocol results in five CNP measurements, from which a harmonic mean 
fit factor is calculated and used to make a pass-fail determination for 
the fit test.
    The information on the new protocol was not submitted to the 
rulemaking docket in time to allow an opportunity for public comment. 
OSHA, therefore, cannot include it in this final standard. Appendix A, 
Part II establishes procedures by which OSHA will approve new fit 
testing protocols after allowing opportunity for public comment. A 
proponent of the revised CNP fit test protocol may submit it for 
approval in accordance with Appendix A, Part II.
    Proposed part (II)(A)(12) of Appendix A required that the employer 
maintain a record of the qualitative or quantitative fit test 
administered to an employee. This requirement has been moved to 
paragraph (m)(2) in the final standard to consolidate the standard's 
recordkeeping requirements. The fit test record must include the date 
and type of fit test performed, employee information, and type of 
respirator. When a QNFT is administered, a record of the test (e.g., 
strip charts, computer integration) must be retained. The fit test 
records are to be maintained until the next fit test is administered. A 
record is necessary for OSHA to determine compliance by verifying that: 
the employee has been fit tested, both prior to starting respirator use 
and at least annually thereafter; the tested employee passed the 
qualitative fit test or achieved a sufficiently high fit factor to pass 
the quantitative fit test for the required assigned protection factor; 
the quantitative fit test was correctly performed, and the fit factor 
calculated properly; and the model and size of the respirator used 
during fit testing are the same as the model and size of the respirator 
used by the employee in the workplace.
New Fit Test Protocols
    Paragraph (f)(3) of the proposed rule stated that OSHA would 
evaluate new fit test protocols under criteria specified in Section I 
of Appendix A and would initiate rulemaking under section 6(b)(7) of 
the OSH Act if the proponent of a new fit test method submitted the 
method and validation testing data to OSHA for evaluation. The section 
listed detailed criteria OSHA would apply in determining whether to 
approve the new protocol.
    Some commenters recommended alternative approaches for approving 
new fit test protocols. Mobil Oil (54-234) and the American Petroleum 
Institute (Ex. 54-330) suggested that NIOSH should be the reviewer of 
alternative fit test methods. Exxon (Ex. 54-266) questioned the role 
OSHA would have in the approval of new fit test protocols, stating that 
NIOSH or other agencies or laboratories could better review new fit 
test methods. The American Association of Occupational Health Nurses 
(Ex. 54-213) supported the use of other new fit test methods, provided 
that they have been demonstrated to be statistically equivalent to the 
existing OSHA-accepted methods, but stated that the administrative 
rulemaking procedure OSHA had proposed would result in delays and 
paperwork that would discourage the development of new methods. The 
Composites Fabricators Association (Ex. 54-295) also stated that 
subjecting new fit test methods to rulemaking would discourage an 
employer from developing or adopting any fit test method not already 
approved by OSHA. The Society of the Plastics Industry (Ex. 54-310) 
stated that rulemaking on new methods was unnecessary, and that OSHA 
should publish criteria for fit tests and allow employers to adopt new 
methods without cumbersome rulemaking. The National Association of 
Manufacturers (Ex. 54-313) proposed that publication of a new fit test 
method in a peer-reviewed journal should be prima facie evidence that 
the method had been validated.
    OSHA cannot accept the suggestion by some commenters that it should 
accept new fit test protocols without following the OSH Act's 
rulemaking procedures. Appendix A was adopted under the OSH Act's 
rulemaking procedures and, under section 6(b) of the Act, can only be 
modified through the same rulemaking procedures. Modifications to 
Appendix A to add new fit test protocols would therefore

[[Page 1236]]

have to undergo the same type of rulemaking scrutiny, including the 
opportunity for public comment, that the approved protocols have 
received.
    In response to comments received, OSHA has modified Appendix A from 
the version contained in the proposal. These changes streamline the 
process of approving new fit test protocols by assuring that any new 
method proposed is supported by data of high quality. As modified, 
Appendix A also takes a more performance-oriented approach to the 
approval process than did the proposal. Rather than listing the 
detailed criteria a new fit test protocol must satisfy, final Appendix 
A requires that a proposed new protocol be supported either by test 
results obtained by an independent government research laboratory or by 
publication in a peer-reviewed industrial hygiene journal.
    Both of these options will assure that any new fit test protocol 
proposed will have a sound scientific basis before being submitted to 
OSHA. Government research laboratories such as Los Alamos National 
Laboratory and Lawrence Livermore National Laboratory have considerable 
expertise in reviewing new fit test protocols to determine whether they 
are safe, accurate, and statistically valid. A favorable recommendation 
by such a laboratory, along with the supporting data gathered by the 
laboratory, will provide a solid basis on which OSHA can base its 
evaluation. Moreover, because the laboratory's report and 
recommendation will be in the public record when the OSHA rulemaking 
proceeding begins, the public will have the opportunity to examine the 
data supporting the proposed new method and to provide any additional 
data either in support of or in opposition to the proposed method.
    An application for a new test protocol that has been published in a 
peer-reviewed industrial hygiene journal will similarly provide a sound 
basis for rulemaking on the new method. Like review by a national 
research laboratory, the peer-review process assures that the data 
supporting the method has been scrutinized and found acceptable by a 
neutral party with expertise in evaluating fit test methods. The 
published article would be available to the public when the rulemaking 
commences, and interested members of the public would therefore be 
apprised of all relevant aspects of the proposed method and would be 
well-positioned to comment on the method.
    OSHA believes that the final rule's approach will streamline the 
process of accepting new fit test protocols and avoid discouraging the 
development of new methods. A rulemaking on a new protocol would thus 
only begin after the protocol's proponent has established a solid basis 
for seeking the Agency's approval. At the time the rulemaking begins, 
interested members of the public would know the scientific basis on 
which approval is sought and would be able to afford OSHA the benefit 
of their views. The rulemaking process should therefore be able to 
proceed more quickly than if OSHA were to evaluate data that had not 
previously been scrutinized by an expert body and were to base the 
approval process on the detailed criteria contained in Appendix A of 
the proposed rule. And because the rulemaking process can be expected 
to proceed expeditiously once a qualifying application has been 
submitted, parties interested in developing new protocols should not be 
discouraged from doing so.
    New fit test methods are to undergo notice and comment rulemaking. 
This decision reflects OSHA's long experience in evaluating fit test 
methods, which includes, in this rulemaking, such fit test methods as 
the ``condensation nuclei counter'' (CNC) method and the ``controlled 
negative pressure'' (CNP) method and, in past rulemakings, the 
``saccharin QLFT'' method and the ``isoamyl acetate QLFT'' method. In 
the past 20 years there have only been a few new methods, but each has 
required the evaluation of supporting data, and each new method has 
generated wide public interest and comment. New fit test methods, 
particularly those that involve new scientific principles and new 
techniques for evaluating respirator performance, require full 
consideration and public discussion of the issues by the regulated 
community, competitive interests, respirator experts, and labor groups. 
The notice and comment rulemaking process will ensure that OSHA 
receives the necessary public input, as well as data required for open 
evaluation, and that all interested parties have a chance to comment 
publicly on any new method. Publishing a new fit test method in the 
Federal Register should: elicit public comment and debate over the 
merits of the method; notify the regulated community of the possible 
availability of a new method; and solicit any additional information 
that would be relevant for consideration before OSHA makes its final 
decision. OSHA does not intend the rulemaking process to be cumbersome 
or involved, but such a process will ensure that all information and 
comments are available to the public, and that any known problems with 
the new method are addressed before final acceptance.
    Adopting an approach that allows for the acceptance of new fit test 
methods is a fundamental change to this standard. Fit test methods 
directly impact a worker's health, since fit tests are designed to 
identify poorly fitting respirators. Without the careful evaluation 
that a new fit test method will receive during the rulemaking process, 
OSHA cannot be sure that a flawed fit test method would not be 
developed and marketed to respirator users. If used to select 
respirators, a flawed method would lead to unnecessary worker exposure 
to hazardous substances, since poorly fitting respirators would not be 
detected by the method. Determining the reliability of new fit test 
methods requires more evaluation, for example, than do new respirator 
cleaning methods or new user seal check methods, which can be developed 
by the respirator manufacturer (See Appendix B). New cleaning methods 
and user seal checks need not undergo rulemaking to become accepted 
methods. The more rigorous evaluation through notice and comment is 
required only for new fit testing methods, where OSHA experience has 
shown the need for a public review of performance.
    Moldex (Ex. 54-153) Mobil Oil (Ex. 54-234), Exxon (Ex. 54-266), and 
the American Petroleum Institute (Ex. 54-330), recommended that OSHA 
allow interested parties other than employers to submit new fit test 
methods for OSHA acceptance. In the past, OSHA has allowed other 
interested parties, such as the developers of new fit test equipment, 
to submit new test protocols and methods for OSHA approval, and will 
continue to do so. To make this explicit, the final rule states that a 
proposed new protocol may be submitted by any person.

Paragraph (g)--Use of Respirators

    The final rule requires employers to establish and implement 
procedures for the proper use of respirators. Paragraph (g)(1) contains 
specific requirements for ensuring an adequate facepiece seal each time 
a respirator is used. Paragraph (g)(2) requires employers to reevaluate 
respirator effectiveness when there are changes in environmental or 
user conditions, as well as requiring that employees leave the 
respirator use area if they detect any signs that respirator 
effectiveness has been compromised or to perform any adjustments. 
Paragraphs (g)(3) and (g)(4) address procedures for the use of 
respirators in IDLH atmospheres and in interior structural fire 
fighting, respectively.

[[Page 1237]]

    Paragraph (g) of the proposal addressed the same issues in the 
context of requiring employers to develop and implement written 
standard operating procedures. As suggested by a number of commenters, 
OSHA has deleted the requirement for written procedures in light of the 
fact that paragraph (c) already requires a written respiratory 
protection program (Exs. 54-38, 54-163, 54-226, 54-428). In addition, 
OSHA has moved to paragraph (d), governing respirator selection, the 
proposed paragraph (g) requirement that employers ensure that SCBAs are 
certified for a minimum service life of 30 minutes if they are to be 
used in IDLH atmospheres, for emergency entry, or for fire fighting. 
Final paragraph (g) thus contains only those requirements necessary for 
the appropriate use of respirators in non-IDLH, IDLH, and interior 
structural fire fighting atmospheres.
Paragraph (g)(1)--Facepiece Seal Protection
    Paragraphs (g)(1)(i) and (g)(1)(ii) are intended to ensure that 
facial hair, other conditions potentially interfering with the 
facepiece seal or valve function, and eyewear or other personal 
protective equipment does not interfere with the effective functioning 
of the respirator. Paragraph (g)(1)(iii) requires employees to perform 
a user seal check each time they put on a respirator for use in the 
workplace.
    Paragraph (g)(1)(i)(A) prohibits an employer from allowing 
respirators with tight-fitting facepieces to be worn by employees who 
have ``facial hair that comes between the sealing surface of the 
facepiece and the face or that interferes with valve function.'' 
Paragraph (g)(1)(i)(B) prohibits tight-fitting facepieces to be worn by 
employees who have any condition that interferes with the face-to-
facepiece seal or with valve function. The prior standard prohibited 
the wearing of respirators ``when conditions prevent a good face seal. 
Such conditions may be a growth of beard [or] sideburns * * *.'' The 
proposed requirement would similarly have prohibited employers from 
allowing tight-fitting respirator facepieces to be worn by employees 
``with conditions that prevent such fits.'' ``Facial hair that 
interferes with the facepiece seal'' was listed as one example of such 
a condition. The final rule thus clarifies the language of the NPRM.
    OSHA's final standard affords employers more flexibility than the 
ANSI Z88.2-1992 standard, Section 7.5.1, which prohibits the use of any 
respirator equipped with a facepiece, whether tight or loose-fitting, 
if the user has facial hair that comes between the sealing surface of 
the facepiece and the face. Although some commenters recommended that 
OSHA adopt the language of the ANSI standard (Exs. 54-218, 54-219), 
OSHA has determined that it is only necessary to apply the facial hair 
prohibition to tight-fitting respirators.
    The rulemaking record (Exs. 15-11, 15-26, 15-28, 15-27A, 15-30, 15-
33, 15-35, 15-36, 15-41, 15-52, 15-58, 15-62, 15-73, 15-77) also 
contains strong evidence that facial hair can interfere with tight-
fitting facepiece seals. According to the study by Hyatt and Pritchard, 
discussed further below, facial hair includes stubble (Ex. 23-5). A 
number of studies and comments that were submitted to the record (Exs. 
23-5, 36-49, 36-31, 36-45, 36-47, 54-443D, 54-408) addressed the effect 
of facial hair on respirator performance. McGee and Oestenstad (Ex. 23-
2) tested eight volunteers on a closed-circuit, pressure-demand, self-
contained breathing apparatus. The volunteers were clean-shaven at the 
beginning of the study. They underwent quantitative fit tests at two-
week intervals over an eight-week beard growth period. Beard growth had 
a profound, negative effect on the observed fit factors. Most of the 
volunteers started with fit factors of 20,000 when first fit tested; 
after eight weeks, these same workers achieved fit factors ranging only 
from 14 to 1067.
    In another study, E.C. Hyatt, J.A. Pritchard and others (Ex. 23-5) 
investigated the effect of facial hair on the performance of half-mask 
and full-facepiece respirators. Quantitative fit tests were performed 
on test volunteers with varying amounts of facial hair, including 
stubble, sideburns, and beards. The results showed that facial hair can 
have a range of effects on respirator performance, depending on factors 
such as the degree to which the hair interferes with the sealing 
surface of the respirator, the physical characteristics of the hair, 
the type of respirator, and facial characteristics. In general, the 
presence of beards and wide sideburns had a detrimental effect on the 
performance of the respirators. The authors concluded that:
     Individuals with excessive facial hair, including stubble 
and wide sideburns, that interfere with the seal cannot expect to 
obtain as high a degree of respirator performance as clean shaven 
individuals.
     The degree of interference depends on many factors (e.g., 
the length, texture, and density of facial hair) and the extent to 
which those factors interfere with the respirator's sealing surface.
     Short of testing a bearded worker for fit daily, the only 
prudent approaches are to require that facial hair not interfere with 
the respirator seal surface (e.g., shave where the seal touches the 
face) or to prohibit the employee from working in areas requiring 
respiratory protection.
    Other fit testing studies also show that non-bearded workers have 
significantly higher fit factors than bearded workers. Skretvedt and 
Loschiavo (Ex. 23-3) tested both half-mask and full facepiece 
respirators on 370 male employees who were fit tested both 
qualitatively and quantitatively; 67 of the employees had full beards. 
The bearded workers consistently failed qualitative fit testing. 
Bearded employees using half-masks had a median fit factor of 12, while 
clean-shaven employees had a median fit factor of 2950. For full 
facepiece respirators, bearded workers had a median fit factor of 30 
and clean-shaven employees had a fit factor of greater than 10,000.
    Only one study found no significant difference in respirator 
performance for employees with or without beards. Fergin (Ex. 23-1) 
studied workplace protection factors, but not fit factors, for three 
different types of disposable respirators used by carbon setters during 
carbon setting and ore bucket filling operations. The study, which 
involved a total of 75 samples collected from 38 non-bearded and 22 
bearded workers, compared ambient concentrations with ``in-mask'' 
concentrations. Beard types were classified as light, medium, heavy, 
fine, soft, coarse, and curly. Results showed no clear relationship 
between type of beard and respirator protection factor. The authors 
recommended that, ``* * * where acceptable protection factors can be 
demonstrated for subjects with facial hair, the no-beard rule should be 
waived.''
    OSHA does not find this study a persuasive basis for changing its 
position on facial hair. The fact that an acceptable protection factor 
can be obtained for a bearded respirator wearer in a workplace 
protection factor study does not mean that the worker can achieve the 
same protection level each time the respirator is used. First, 
protection factor studies are designed to minimize program defects and 
are often conducted under very tight supervision, which is generally 
not typical of conditions in real workplaces. Second, beards grow and 
change daily, resulting in variability of protection from one day to 
the next.
    Fergin based his conclusion that respirator performance is similar 
for

[[Page 1238]]

bearded and non-bearded workers on a statistical comparison of 
geometric means, calculated separately for each type of respirator for 
bearded and non-bearded workers. OSHA is more concerned about the wide 
range of values than the geometric mean values. The protection factors 
observed by Fergin varied greatly and ranged from 1-1041 (no beards) 
and 4-332 (beards) for a 3M-9910 respirator; 12-36 (no beards) and 7-30 
(beards) for a 3M-8706 respirator; and 5-1006 (no beards) and 42-391 
(beards) for a 3M-9906 respirator. OSHA notes that the protection 
factors of 5 and lower that Fergin achieved for both bearded and clean-
shaven workers are below the NIOSH recommended protection factors for 
disposable respirators of the types tested by Fergin (NIOSH Respirator 
Decision Logic, 1987, Ex. 9).
    There are several other weaknesses in this study that undermine its 
use as a counterweight to so much other evidence and expert opinion. 
The study did not account for particle size or the differences between 
protection factors obtained when the respirators were used in high as 
compared to low ambient concentrations. Moreover, two of the three 
respirators involved lacked adjustable face straps, which makes any 
sort of tightening impossible. Finally, the author himself cautioned 
that facial hair can significantly impair respirator seal effectiveness 
in atmospheres that are highly toxic or IDLH.
    In fact, most rulemaking participants (Exs. 3, 13, 15-50, 23-2, 23-
3, 23-5) agreed that facial hair can be a problem for respirator users, 
although they suggested different approaches to address this issue. A 
few commenters recommended that OSHA simply prohibit the use of 
respirators by bearded workers, based on the ANSI rationale that beards 
interfere with the functioning of all respirators (Exs. 54-443, 54-
408). In general, these commenters were opposed to any requirement in 
the standard that would have required employers to provide bearded 
workers with loose-fitting respirators to accommodate their beards. 
Other commenters stated that OSHA should require employers to provide 
loose-fitting respirators (e.g., supplied-air hoods, helmets, or suits) 
for use by employees with beards (Exs. 15-14, 15-31, 15-34, 15-46, 15-
47, 15-48, 15-54, 15-55, 15-79, 15-81, 54-427, 54-387, 54-363). For 
example, NIOSH recommended that, when the situation permits, employers 
should be allowed to accommodate bearded workers by providing 
respirators that will not be affected by facial hair (Ex. 54-437). 
Daniel Shipp of the Industrial Safety Equipment Association (ISEA) also 
stated that, in situations where employers do not intend to enforce 
policies against facial hair, the ISEA would recommend that employers 
provide respirators that do not rely on a tight facepiece fit (Ex. 54-
363).
    Richard Uhlar and Michael Sprinker of the International Chemical 
Workers Union (ICWU) stated that there should be some provision in the 
standard to notify employees that respirators other than tight-fitting 
respirators can be used by bearded workers (Ex. 54-427). This comment 
is in basic agreement with NIOSH's recommendation that there should be 
some provision in the standard to notify employees that other 
respirators that can be worn with beards exist (Ex. 54-437).
    In contrast, other commenters (Exs. 54-408, 54-443) recommended 
that OSHA prohibit the wearing of beards by employees who use 
respirators on the grounds that employers should not have to supply 
loose-fitting respirators because an employee is unwilling to shave off 
his beard. More specifically, George Thomas of Duquesne Light Company 
(Ex. 54-408) stated that his company does not support a requirement 
that employers should provide workers with loose-fitting respirators 
when employees have facial hair. According to Mike Rush of the 
Association of American Railroads, requiring employers to provide 
respirators other than tight-fitting air-purifying respirators would be 
cost-prohibitive, because PAPRs cost 50 times as much as half masks 
(Ex. 54-286). A. Gayle Jordan of Norfolk Southern Corporation quoted 
the cost of a PAPR as $700 (Ex. 54-267).
    This standard does not interfere directly with employer policies 
regarding facial hair. Instead, it requires employers to take the 
presence or absence of facial hair into consideration in developing 
policies for a given workplace; different policies may affect the range 
of choices available. However, OSHA notes that several respiratory 
protection alternatives, such as loose-fitting hoods or helmets, are 
available to accommodate facial hair.
    Some commenters focused on the specific language in the proposal. 
One commenter said that the term ``any hair growth'' should be 
substituted for ``facial hair'' (Ex. 54-69). Another urged OSHA to 
specify what acceptable facial hair growth was (Ex. 54-138). OSHA 
believes that the term ``facial hair'' is appropriate because the 
record shows that any facial hair, including beard stubble, can 
interfere with facepiece seal (Exs. 23-5, 54-69). By prohibiting hair 
that ``comes between the sealing surface of the facepiece and the 
face,'' as well as hair that ``interferes with valve function,'' OSHA 
believes it is being as precise as possible. OSHA believes that the 
second phrase is necessary because employees with large beards may 
shave the skin area where the facepiece of the respirator seals to the 
face but the fullness or length of the beard could still block the 
valve or cause the valve to malfunction.
    In a standard that will apply as broadly as this one will, it is 
not possible for OSHA to specify every condition under which respirator 
use may be affected by an employee's facial hair. Workplace situations 
are variable, as is hair growth. OSHA has instead written the standard 
in performance-oriented terms, stressing the importance of the face-to-
facepiece seal and conditions that might interfere with that seal. The 
thrust of the entire standard is on making sure that the fit and the 
performance of the respirator are not compromised. Employers, 
therefore, must ensure that respirators fit and perform properly.
    Paragraph (g)(1)(i)(B) prohibits an employer from allowing 
respirators with tight-fitting facepieces to be worn by employees who 
have any condition that interferes with the face-to-facepiece seal or 
valve function. Examples of these conditions include, but are not 
limited to, missing dentures, the presence of facial scars, the wearing 
of jewelry, or the use of headgear that projects under the facepiece 
seal. As with the facial hair requirements, the intent of this 
provision is to prevent an employee from wearing a respirator if there 
is any factor that could prevent an adequate facepiece-to-face seal. 
Therefore, conditions such as missing dentures or facial scars will not 
prevent an employee from using a respirator where it can be 
demonstrated that those conditions do not prevent an adequate seal.
    Paragraph (g)(1)(ii) requires employers to ensure that corrective 
glasses or goggles or other personal protective equipment is worn in a 
manner that does not interfere with the seal of the facepiece to the 
face of the user. The proposal contained a similar provision that 
addressed only eyewear. The prior standard contained a similar 
provision, but also prohibited the use of contact lenses with 
respirators. Final paragraph (g)(1)(ii) is consistent with the 1992 
ANSI standard, which allows the use of corrective lenses, spectacles, 
and face protection devices, providing that these items do not 
interfere with the seal of the respirator; ANSI also allows the use of 
contact lenses where the wearer has successfully worn such lenses 
before

[[Page 1239]]

and practices wearing them with the respirator.
    Most comments supported the proposed provision (Exs. 54-68, 54-266, 
54-286, 54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219, 
54-222, 54-346, 54-402, 54-408, 54-267, 54-286, 54-361, 54-232, 54-234, 
54-244, 54-245, 54-263, 54-265). Some commenters, however, addressed 
specific pieces of corrective eyewear. For example, Barbara Price of 
the Phillips Petroleum Company recommended, based on the company's 
experience with successful quantitative fit testing of employees while 
wearing sports goggles, that prescription sports goggles be permitted 
with full facepiece respirators (Ex. 54-165). Darrell Mattheis of the 
Organization Resources Counselors (ORC) also supported the use of 
prescription sports goggles, such as the mask-adaptable goggles (MAG-1) 
by Criss Optical, with a full facepiece respirator, based on ORC 
companies' successful quantitative fit testing experience (Ex. 54-424).
    Again, the standard is written in performance terms so that any 
particular piece of equipment may be used as long as it does not 
interfere with the facepiece seal. This has consistently been OSHA's 
position under the prior standard as well. For example, in a compliance 
interpretation letter dated April 7, 1987, OSHA addressed the use of 
eyeglass inserts or spectacle kits inside full facepiece respirators. 
OSHA stated that eyeglass inserts or spectacle kits are acceptable if 
the devices: (1) Do not interfere with the facepiece seal; (2) do not 
cause any distortion of vision; and (3) do not cause any physical harm 
to the wearer during use (Ex. 64-519).
    OSHA again addressed the appropriateness of using the MAG-1 goggles 
with full facepiece respirators and SCBAs in a September 20, 1995, 
letter to the Excelsior Fire Department. By 1995, OSHA had the benefit 
of four quantitative fit testing studies of MAG-1 goggles, two funded 
by the goggle manufacturer and the other two funded by OSHA itself. The 
letter to Excelsior stated that since the MAG-1 straps project under 
the facepiece, use of the MAG-1 could in some cases violate paragraph 
(e)(5)(i) of the previous standard. The letter concluded that obtaining 
a fit with these goggles is quite complex because the respirator user 
may be able in some cases to control the factors determining whether a 
seal can be obtained. (For a full discussion, see letter, 9/20/95, Ex. 
64-520, Docket H-049a.) In a post hearing comment submitted by the 
Exxon Company, Steve Killiany commented about Criss Optical Mag 
Spectacles with thin rubber straps (Ex. 183). Mr. Killiany stated that 
the spectacles can safely be worn with full facepiece respirators as 
long as users are fit tested with the spectacles in place during fit 
tests. In its program, Exxon prohibits eyeglasses with temple pieces 
for users of full facepiece respirators. Exxon also prohibits hard 
contact lenses, but users are allowed to wear soft contact lenses.
    The NPRM contained a lengthy explanation of OSHA's proposal not to 
include a prohibition against the use of contact lenses with 
respirators in the final rule (59 FR 58921, 11/15/94). Although a few 
participants requested that OSHA retain the prohibition, or at least 
prohibit contact lenses in certain situations (Exs. 54-334, 54-387, 54-
437), most of the commenters agreed with OSHA's conclusion that contact 
lenses can be used safely with respirators (Exs. 54-68, 54-266, 54-286, 
54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219, 54-222, 
54-232, 54-234, 54-244, 54-245, 54-263, 54-265, 54-346, 54-402, 54-408, 
54-267, 54-286, 54-361). For example, NIOSH specifically recommended 
that OSHA allow respirator users to wear contact lenses (Ex. 54-437). 
Larry DeCook, President of the American Optometric Association, stated 
that the Association was not aware of any reports of injury because of 
the use of contact lenses with respirators (Ex. 54-235). Similarly, a 
study by the Lawrence Livermore National Laboratory showed that far 
fewer firefighters who wore contact lenses with their SCBAs had 
problems that necessitated the removal of their facepieces than did 
firefighters wearing glasses (Ex. 38-9). Finally, OSHA's review of the 
record identified no evidence that the use of contact lenses with 
respirators increases safety hazards.
    OSHA notes that employers of employees who wear corrective eyewear 
must be sure that the respirator selected does not interfere with the 
eyewear, make it uncomfortable, or force the employee to remove the 
eyewear altogether. Employers should use the respirator selection 
process to make accommodations to ensure that their respirator-wearing 
employees can see properly when wearing these devices.
    In this final rule, OSHA has also expanded the requirements of 
paragraph (g)(1)(ii) to cover personal protective equipment other than 
goggles and glasses. Other forms of personal protective equipment are 
required by OSHA under specific circumstances (See, e.g., Subpart I--
Personal Protective Equipment, and Section 1910.133--Eye and face 
protection). Like eyewear, this equipment may interfere with the fit of 
respiratory protection equipment. The generic phrase ``other personal 
protective equipment'' applies to faceshields, protective clothing, and 
helmets, as well as to any other form of personal protective equipment 
that an employee may wear that could interfere with safe respirator 
use.
    Paragraph (g)(1)(iii) requires employers to ensure that their 
employees perform user seal checks each time they put on a tight-
fitting respirator, using the ``user seal check'' procedures in 
Appendix B-1 or equally effective procedures recommended by the 
respirator manufacturer. The proposal would also have given employers 
the option of using either the Appendix B-1 procedures or those 
recommended by the manufacturer, which is also the approach recommended 
by the ANSI standard. Although the prior standard also required a fit 
check each time the worker used a respirator, it mandated that the 
manufacturer's instructions be followed when performing the check.
    OSHA's prior respirator standard referred to respirators being 
``fit * * * checked.'' The NPRM used the phrase ``facepiece seal 
check,'' and this has been changed in the final standard to ``user seal 
check.'' The three phrases are synonymous, and all three were used 
interchangeably by rulemaking participants (e.g., Exs. 54-218, 54-219, 
who recommended that the term ``fit check'' be used to be consistent 
with the ANSI Z88.2-1992 definition). Other commenters (Exs. 54-5, 54-
408) used the term ``seal check'' or ``facepiece seal check.'' The 
final standard uses the term ``user seal check'' because OSHA believes 
that this phrase best describes the actual procedure to be performed by 
the respirator wearer. Also, commenters stated that the similarity 
between the terms ``fit check'' and ``fit test'' might lead to 
confusion, causing employers erroneously to conclude either that 
complete fit testing must be done each time an employee puts on a 
respirator or that the fit check can be substituted for a fit test.
    In general, commenters (Exs. 54-221, 54-185, 54-321, 54-427, 54-
414, 64-521) agreed with OSHA that user seal checks are necessary. 
Although these checks are not as objective a measure of facepiece 
leakage as a fit test, they do provide a quick and easy means of 
determining that a respirator is seated properly. If a user seal check 
cannot be performed on a tight-fitting respirator, the final rule 
prohibits that respirator from being used. Appendix B-1, which derives 
from the 1992 ANSI standard, contains procedures for user seal checking 
of negative pressure and

[[Page 1240]]

positive pressure devices. It states that a check is to be performed 
every time the respirator is donned or adjusted to ensure proper 
seating of the respirator to the face.
    Participants expressed diverse views on whether the negative/
positive fit check procedures in Appendix B-1 should be the exclusive 
means of compliance with this requirement or whether procedures 
recommended by respirator manufacturers should also be allowed. John 
Hale of Respirator Support Services stated that the only way to perform 
a fit check is to use the negative/positive fit check methods in 
Appendix B-1 (Ex. 54-5). George Notarianni of Logan Associates also 
recommended that reference to manufacturers' procedures for fit 
checking be deleted, because he was unaware of any effective fit check 
methods other than those described in Appendix B (Ex. 54-152). Richard 
Miller of the E.D. Bullard Company, however, stated that the manner in 
which fit checks are conducted should be left up to the manufacturer 
(Ex. 54-221).
    The positive/negative user seal checks described in Appendix B-1 
cannot be performed on all tight-fitting respirators. William Lambert 
of the Mine Safety Appliances Company (MSA) (Ex. 54-414) stated that 
respirators for which negative or positive pressure tests cannot be 
performed should not be used. He also recommended that OSHA work 
cooperatively with NIOSH to develop a testing protocol that would 
preclude approval of respirators that cannot be easily checked using a 
positive/negative fit check.
    The rulemaking record, however, contains evidence that effective 
user seal checks can be performed in several ways. OSHA reviewed a 
study by Myers (1995) in which the authors described several ANSI fit 
check methods, an AIHA/ACGIH negative/positive pressure check, and 
manufacturer-recommended check methods (See Myers et al., 
``Effectiveness of Fit Check Methods on Half Mask Respirators,'' in 
Applied Occupational Environmental Hygiene, Vol. 10(11), November 1995) 
(Ex. 64-521). In addition, the authors briefly explained that 
manufacturers of disposable, filtering facepieces recommended covering 
the mask with both hands, exhaling, and checking for air flow between 
the face and the sealing surface of the respirator. Since it was not 
the intent of the authors to evaluate different fit check methods, they 
did not present any comparison data; however, they did conclude that 
employing the manufacturer's recommended fit check procedure will help 
detect and prevent poor respirator donning practices. OSHA is also 
aware that some manufacturers make a fit check cup that can be used to 
perform a user seal check even with valveless respirators. The final 
rule thus allows for the use of the methods in Appendix B-1 as well as 
manufacturers' recommended procedures for user seal checks where these 
are equivalently effective. This means that respirator manufacturers' 
recommended procedures may be used for user seal checking if the 
employer demonstrates that the manufacturer's procedures are as 
effective as those in Appendix B-1. The intent of the ``equally 
effective'' phrase is to ensure that the procedures used have been 
demonstrated to be effective in identifying respirators that fit poorly 
when donned or adjusted. OSHA believes that the use of performance 
language will provide incentives to respirator manufacturers to develop 
new user seal check methods and to develop respirators for which user 
seal checks can be performed.
    There are also respirators for which no user seal checks can be 
conducted. A number of rulemaking participants argued that the 
inability to seal check a respirator should disqualify these 
respirators from use (See, e.g., Exs. 54-152, 54-408, 54-427, 54-321). 
For example, William Lambert of MSA (Ex. 54-414) pointed out that, 
since respirators are not put on and taken off the same way each time, 
the seal check is essential to verify that the user has correctly 
donned the respirator.
    OSHA agrees with those commenters who stated that OSHA should not 
allow the use of respirators that cannot be fit checked. Without the 
ability to perform user seal checks, employees may be overexposed to 
respiratory hazards as a result of the respirator leakage caused by 
multiple redonnings and adjustments. OSHA believes that user seal 
checks are important in assuring that respirators are functioning 
properly. If no method exists to check how well a respirator performs 
during multiple redonnings under actual workplace conditions, OSHA does 
not consider the respirator acceptable for use.
    Richard Olson of the Dow Chemical Company raised another issue 
about paragraph (g)(1)(iii). He stated that use of the word ``ensure'' 
was inappropriate in this instance, because employers cannot ``ensure'' 
that user seal checks are performed:

    This is impossible for the employer to do in all cases because 
the employer is not there. Supervision is not at the work site at 
all times, sometimes the employee is the only person in the 
facility. The employee can be trained to do this however the 
employer can not personally be there to observe and ensure every 
time the employee wears a respirator (Ex. 54-278).

    OSHA has stated consistently, in connection with the use of the 
word ``ensure'' in other standards, that it is not OSHA's intent that 
each employee be continually monitored. Further, OSHA case law has held 
that employers are required by the use of the word ``ensure'' to take 
actions that will result in appropriate employee behavior. These 
actions consist of: rules with sanctions, training employees in 
behaviors required, and exercising diligence in monitoring the safety 
behavior of their employees. The past enforcement history of the use of 
the word ``ensure'' in other OSHA standards, including the respirator 
provisions in substance specific standards, shows that employers who 
demonstrate this level of responsibility are in compliance with 
provisions that use the term ``ensure.''
Paragraph (g)(2)--Continuing Respirator Effectiveness
    Paragraph (g)(2) contains three sub-paragraphs. Paragraph (g)(2)(i) 
requires employers to be aware of conditions in work areas where 
employees are using respirators. Paragraph (g)(2)(ii) requires 
employers to ensure that their employees leave the respirator use area 
to perform any activity that involves removing or adjusting a 
respirator facepiece or if there is any indication that a respirator 
may not be fully effective. Paragraph (g)(2)(iii) requires employers to 
replace, repair, or discard respirators if there is any indication that 
they are not functioning properly.
    The prior standard did not contain any of these provisions; 
however, OSHA proposed them after including similar requirements in a 
number of OSHA substance-specific health standards. OSHA believes that 
these provisions are important because the effectiveness of even the 
best respirator program is diminished if employers do not have 
procedures in place to ensure that respirators continue to provide 
appropriate protection.
    Final paragraph (g)(2)(i), which states, ``Appropriate surveillance 
shall be maintained of work area conditions, and degree of employee 
exposure or stress,'' reiterates paragraph (b)(8) of the prior 
standard. This means that employers are required to evaluate workplace 
conditions routinely so that they can provide additional respiratory 
protection or different respiratory protection, when necessary. By 
observing respirator use under actual workplace conditions, employers 
can

[[Page 1241]]

note problems such as changes in the fit of a respirator due to 
protective equipment or conditions leading to skin irritation. The 
employer can then make adjustments to ensure that employees continue to 
receive appropriate respiratory protection.
    Paragraph (g)(2)(ii) requires employers to ensure that employees 
are allowed to leave the respirator use area in several circumstances. 
The intent of this requirement is to ensure that employees leave the 
area when necessary. The final standard stipulates that, in these 
cases, employees are to leave the ``respirator use'' area, not the work 
area or workplace. This language is intended to give employers the 
flexibility to establish safe areas in their workplaces that will 
minimize interruptions in work flow and production while ensuring that 
the area where respirators are removed is free of respiratory hazards 
or contamination.
    Paragraph (g)(2)(ii)(A) requires employers to ensure that their 
employees leave the respirator use area to wash their faces and 
respirator facepieces as necessary to prevent eye or skin irritation; 
such irritation occurs frequently with the wearing of tight-fitting 
respirators. Many of OSHA's substance specific-standards, such as the 
cadmium (29 CFR 1910.1027) and arsenic (29 CFR 1910.1018) standards, as 
well as the ANSI Z88.2-1992 standard, contain provisions allowing 
employees to leave the respirator use area to wash their faces and 
respirator facepieces to prevent the skin irritation that is often 
associated with the use of respirators. Paragraph (g)(2)(ii) is thus 
consistent with these requirements of the Agency's substance-specific 
standards, as well as with the ANSI Z88.2-1992 standard.
    A number of participants (Exs. 54-6, 36-47, 54-362) questioned the 
need for this provision, however. For example, Christopher Seniuk of 
Lovell Safety Management Company stated that allowing employees to 
leave the area to wash their faces is counterproductive because 
allowing frequent breaks increases the chance of contamination while 
putting on and removing the respirator (Ex. 54-6). Richard Boggs of ORC 
(Ex. 36-47) also recommended that this requirement be dropped, on the 
grounds that the frequency with which employees leave their work areas 
is a ``labor relations'' issue. Kevin Hayes of ABB Ceno Fuel Operations 
(Ex. 54-362) expressed a similar concern; he suggested that employees 
be allowed to leave the work area periodically, rather than on an ``as 
necessary'' basis, and asked that OSHA quantify the extent of skin 
irritation that needed to be present for employees to leave the area 
for washing and cleaning. Mr. Hayes was concerned that disgruntled 
employees could use this requirement to ``establish a revolving door 
from the work area.''
    Dr. Franklin Mirer, director of safety and health for the United 
Auto Workers, supported this provision, however; he stated that 
allowing employees to leave the area to wash would lead to fewer 
hygiene problems (Ex. 54-387). OSHA agrees with Dr. Mirer: if employees 
are allowed to wash their faces and respirators, the amount of 
contamination will be reduced, employees' hands and respirators will be 
cleaner, and employees will be donning cleaner respirators. OSHA 
believes that, to protect employee health, employees must be able to 
wash their faces and facepieces as often as necessary. The skin 
irritation caused by dirty respirators can interfere with effective 
respirator use (Ex. 64-65). Clearly, any skin irritation that causes 
the wearer to move the respirator in a way that breaks the facepiece-
to-face seal is sufficient to warrant an employee leaving the 
respirator use area to wash. Whenever eye or skin problems interfere 
with respirator performance, the wearer should be able to leave the use 
area.
    Paragraphs (g)(2)(ii)(B) and (C) require the employer to ensure 
that employees leave the respirator use area if they detect vapor or 
gas breakthrough, changes in breathing resistance, or leakage of the 
facepiece, and to replace the respirator or the filter, cartridge, or 
canister elements when these have been exhausted. These requirements 
are consistent with the NIOSH Respirator Decision Logic (Ex. 9, page 
8), which states that workers who suspect respirator failure should be 
instructed to leave the contaminated area immediately to assess and 
correct the problem. In addition, employees may need to leave the 
respirator use area to change the cartridge or canister when the end-
of-service-life indicator (ESLI) or change schedule demands a change in 
canister or cartridge. (See the Summary and Explanation for paragraphs 
(c) and (d).) The requirements in paragraph (g)(2)(ii)(B) are essential 
to ensure the continuing effectiveness of the protection provided to 
the wearer by the respirator. If, for example, the wearer can detect 
the odor or taste of a vapor or gas, the cartridge or canister is 
clearly no longer providing protection. Similarly, if a filter element 
is so loaded with particulates that it increases the work-of-breathing, 
it clearly must be changed to continue to be effective. The leakage of 
air through the facepiece also requires immediate attention, because it 
is a sign that the facepiece-to-face seal has been broken and that the 
wearer is breathing contaminated air.
    Paragraph (g)(2)(ii)(C) requires employers to ensure that 
respirator wearers leave the use area when the filter element, 
cartridge, or canister must be changed in order for it to continue to 
provide the necessary protection. In the proposal, the term ``filter 
elements'' was used instead of the more specific language ``cartridge'' 
and ``canister,'' and the proposed language generated several comments 
requesting the Agency to clarify this terminology (See, e.g., Ex. 54-
173). A representative from Monsanto Company suggested that OSHA should 
change the language from ``filter'' to ``cartridge'' or ``canister'' 
(Ex. 54-219) because filters apply only to particulates, not vapors and 
gases. Larry Zobel, Medical Director of 3M, made a similar comment (Ex. 
54-218). OSHA has amended the language in final paragraph (g)(2)(ii)(C) 
to make it more precise, and the final rule uses the terms 
``cartridge,'' ``canister,'' and ``filter'' as these specifically 
apply.
    Paragraph (g)(2)(iii) requires the employer to replace, repair, or 
discard a respirator that is not functioning properly. This requirement 
applies in addition to the provisions in paragraphs (d) and (h) of this 
section that address the routine replacement of respirators and 
respirator parts. The language of this paragraph has been changed from 
the proposal to emphasize that a malfunctioning or otherwise defective 
respirator must be replaced or repaired before the user returns to the 
work area.
    Rulemaking participants agreed that respirators should not be used 
if they are defective in any way (See, e.g., Ex. 54-362, Kevin Hayes of 
ABB Combustion Engineering Nuclear Operations). However, one commenter, 
Peter Hernandez of the American Iron and Steel Institute, objected to 
the proposal's requirement that defective respirators be repaired 
``immediately.'' Mr. Hernandez stated that it is necessary immediately 
to replace, but not immediately to repair or discard, a defective 
respirator (Ex. 54-307). OSHA agrees that employers can delay repairing 
or discarding respirators so long as the affected employees have been 
issued proper replacement respirators. This was the intent of paragraph 
(g)(8) in the NPRM, and this point has been clarified in the final 
regulation by placing the word ``replace'' first and deleting the word 
``immediately.'' The intent of final paragraph (g)(2)(iii) is to ensure 
that employees receive the necessary protection whenever they are in a 
respirator use area. This paragraph

[[Page 1242]]

means that employers must ensure that employees in the respirator use 
area are wearing respirators that are in good working order.
    The proposed rule would have required disposables to be discarded 
at the end of the task or workshift, whichever came first (See 
paragraph (g)(9) of the NPRM). A number of commenters (See, e.g., Exs. 
54-309, 54-307, 54-442) discussed the use of, and the criteria for 
discarding, disposable respirators. OSHA has deleted specific 
references to the term ``disposable'' in the final rule and has instead 
required, in paragraph (g)(2)(iii), that employers replace, repair, or 
discard respirators if employees detect vapor or gas breakthrough, a 
change in breathing resistance, or leakage of the facepiece, or 
identify any other respirator defect, before allowing the employee to 
return to the work area. This requirement thus focuses on the need for 
respirators to function properly to provide protection to employees 
rather than on a time schedule for discarding particular respirators.
    Some commenters stated that disposable respirators should be 
allowed to be used until the physical integrity of the respirator is 
compromised, which may take longer than one work shift (Exs. 54-190, 
54-193, 54-197, 54-205, 54-214, 54-222, 54-241, 54-253, 54-268, 54-271, 
54-307, 54-357, 54-171). For example, Peter Hernandez, representing the 
American Iron and Steel Institute, stated that employees may perform 20 
different tasks in a work day (Ex. 54-307). The implication of Mr. 
Hernandez' comment is that workers who perform short duration tasks 
would have been required by the proposed requirement to use many 
disposable respirators in the course of such a day, which would be 
unnecessarily expensive. Suey Howe, representing the Associated 
Builders and Contractors, recommended that employees be allowed to keep 
their disposable respirators in clean containers on days when the same 
task may be performed intermittently (Ex. 54-309). Homer Cole of 
Reynolds Metals Company stated that some workplace situations exist 
where the environment is clean enough for disposable respirators to be 
reused (Ex. 54-222). Randy Sheppard, Battalion Chief of Palm Beach 
County Fire-Rescue (Ex. 54-442), stated that disposing of HEPA 
disposable respirators after each use would be extremely costly for 
large fire departments that respond to many emergency calls. He noted 
that these respirators should be discarded, however, when they are no 
longer in their original working condition, whether this condition 
results from contamination, structural defects, or wear. In a post 
hearing comment submitted by the North American Insulation 
Manufacturers Association (NAIMA), Kenneth Mentzer, Executive Vice 
President, and others stated that OSHA should make it clear that NIOSH-
approved disposable respirators may be used when they provide adequate 
protection factors for the exposures encountered. The authors of this 
submission also stated that NIOSH-approved disposable respirators 
provide protection and have some advantages over reusable respirators 
(Ex. 176).
    Richard Niemeier of NIOSH (Ex. 54-437) recommended that dust-mist 
and dust-mist-fume disposable respirators not be reused, on the grounds 
that many of these models degrade in oil mist and humid environments. 
He also recommended that only filters approved under 42 CFR Part 84 be 
considered for use beyond one shift.
    OSHA has considered all of these comments in revising the language 
in final paragraph (g)(2)(iii) to reflect a more performance-oriented 
approach to the replacement, repair, or discarding of respirators. 
Nonetheless, employers still have the responsibility, in paragraph 
(a)(2), to ensure that respirators are suitable for each use to which 
they are put. [See also discussion in NPRM, 59 FR 58922.]
Paragraphs (g)(3) and (g)(4)--Procedures for IDLH Atmospheres and 
Interior Structural Fire Fighting
    Paragraphs (g)(3) and (g)(4) of the final rule contain requirements 
for respirator use in IDLH atmospheres. Paragraph (g)(3) addresses all 
IDLH atmospheres, and paragraph (g)(4) contains three additional 
requirements applicable only to the extra-hazardous environments 
encountered during interior structural fire fighting. These two 
paragraphs, which deal with requirements for standby personnel outside 
the IDLH atmosphere and communication between those standby personnel 
and the respirator users inside the atmosphere, are intended to ensure 
that adequate rescue capability exists in case of respirator failure or 
some other emergency inside the IDLH environment.
    Paragraphs (g)(3) (i), (ii), and (iii) require that at least one 
employee who is trained and equipped to provide effective emergency 
rescue be located outside the IDLH respirator use area, and that this 
employee maintain communication with the respirator user(s) inside the 
area. Paragraphs (g)(3) (iv) and (v) require, respectively, that the 
employer or authorized designee be notified before the standby 
personnel undertake rescue activity and that the employer or designee 
then provide appropriate assistance for the particular situation. 
Paragraph (g)(3)(vi) addresses emergency equipment needed by the 
standby personnel so that they can perform their duties effectively.
    The prior standard, Sec. 1910.134(e), did not distinguish between 
types of IDLH atmospheres. Instead, it distinguished between IDLH and 
potentially IDLH atmospheres. It stated that only one standby person 
was necessary when a respirator failure ``could'' cause its wearer to 
be overcome, but that standby ``men'' (plural) with suitable rescue 
equipment were required when employees must enter known IDLH 
atmospheres wearing SCBA. Under this provision, at least two standby 
personnel were required for known IDLH atmospheres (See, e.g., May 1, 
1995 memo from James Stanley, Deputy Assistant Secretary, to Regional 
Administrators and state-plan designees). In IDLH atmospheres where 
airline respirators are used, the prior standard required that users be 
equipped with safety harnesses and safety lines to lift or remove them 
from the hazardous atmosphere and that ``a standby man or men,'' 
equipped with suitable SCBA, be available for emergency rescue.
    The proposal would have required that, for all IDLH atmospheres, at 
least one standby person, able to provide emergency assistance, be 
located outside any IDLH atmosphere, and that this person must maintain 
communication with the employee(s) in the IDLH atmosphere.
    The need for standby personnel when workers use respirators in IDLH 
atmospheres is clear. The margin for error in IDLH atmospheres is 
slight or nonexistent because an equipment malfunction or employee 
mistake can, without warning, expose the employee to an atmosphere 
incapable of supporting human life. Such exposure may disable the 
employee from exiting the atmosphere without help and require an 
immediate rescue if the employee's life is to be saved. Accordingly, 
the standard requires that, whenever employees work in an IDLH 
atmosphere, at least one standby person must remain outside the 
atmosphere in communication with the employee(s) inside the atmosphere. 
It also requires that the standby personnel be trained and equipped to 
provide effective emergency assistance.
    A number of reports from OSHA's investigative files demonstrate the 
types of failures that can give rise to the need for immediate rescues 
of workers in

[[Page 1243]]

IDLH atmospheres. These cases illustrate that the absence of properly 
equipped standby personnel greatly increases the risk to the employees 
who enter the IDLH atmosphere. For example, a fire in a cold-rolling 
mill triggered a carbon dioxide fire extinguishing system and created 
an oxygen deficient atmosphere in the mill's basement. Two security 
guards descended a stairway into the basement to reset the system. 
Although the employees had been provided SCBAs, they left those 
respiratory devices in their vehicle and took only a single self-
rescuer with them. The workers collapsed upon reaching the bottom of 
the stairway. No standby personnel were present and, as a result, the 
workers were not discovered until 30 minutes had elapsed. Attempts to 
revive them failed. This case illustrates that the suddenness with 
which workers can be disabled in an IDLH atmosphere can prevent the 
workers from leaving the atmosphere under their own power and 
underlines the need for employers to provide standby personnel whenever 
workers enter such atmospheres. If a properly trained and equipped 
standby person had been present, that person could have notified the 
employer that help was needed when the two workers collapsed and could 
have initiated rescue efforts immediately.
    In another case, two mechanics entered a corn starch reactor to 
perform routine maintenance and repair. Employee No. 1 detected the 
odor of propylene oxide and then observed the chemical running out of 
an open vent. Employee No. 1 managed to escape, but employee No. 2 was 
overcome and died. A standby person equipped with proper rescue 
equipment would have been able to provide immediate, effective 
assistance once employee No. 2 was overcome and might have saved that 
employee's life.
    Some cases from OSHA's investigative files involve fatalities that 
occurred when standby personnel were present but were unable to prevent 
the fatalities from occurring. These cases illustrate both the types of 
failures that can give rise to the need for immediate rescue efforts in 
IDLH atmospheres and the importance of standby personnel being trained 
and equipped to provide effective rescue capability.
    In one case, an employee (No. 1) was working in a confined space 
while wearing an SCBA. A standby person (No. 2) advised employee No. 1 
that the respirator's air supply was low and that he should leave the 
confined space. However, employee No. 1 collapsed and died before he 
could exit. Employee No. 2 had no equipment with which to extricate 
employee No. 1 from the confined space. This example illustrates, 
first, that even an employee who is properly equipped when entering an 
IDLH atmosphere may need to be rescued as a result of human error and/
or equipment failure. It also illustrates the need for the standby 
person to be equipped to be able to provide effective emergency rescue.
    In yet another case, an employee (No. 1) was sandblasting inside a 
rail car wearing an airline respirator with an abrasive blasting hood. 
A standby person (No. 2) was stationed outside the car. During the 
operation, employee No. 1 swallowed a dental appliance and lost 
consciousness. Employee No. 2 had not maintained constant communication 
with employee No. 1 and only discovered that employee No. 1 had been 
overcome too late to save his life. This case shows that the demanding 
work often required by a worker constrained by respiratory equipment in 
an IDLH atmosphere may lead to accidents that can disable the worker 
and require immediate rescue efforts. It also illustrates that the need 
for emergency assistance can arise at any time and without warning, and 
that standby personnel must therefore maintain constant communication 
with the worker(s) inside the IDLH atmosphere.
    Standby personnel must also be adequately trained and equipped to 
protect themselves against the IDLH atmosphere if an emergency arises. 
In a recent case, two employees (Nos. 1 and 2) were installing a blind 
flange in a pipeline used to transfer hydrogen sulfide. As the flange 
was opened, the hydrogen sulfide alarm sounded. Employee No. 1 tried to 
remove his full-facepiece respirator, was overcome, and died. Employee 
No. 2 had previously loosened the straps on his respirator to test for 
the smell of hydrogen sulfide and was also overcome. A standby person 
(No. 3) equipped with an SCBA was on the ground outside the area and 
attempted an immediate rescue. Unfortunately, his respirator caught on 
an obstruction and tore as he attempted to enter the atmosphere and he, 
along with employee No. 2, was overcome and required hospitalization. 
The case is another example of the type of human and equipment failures 
that can endanger employees who must work in IDLH atmospheres. Although 
the rescue effort in this case faltered, the presence of a standby 
person equipped with an SCBA increased the chance that the employees in 
the IDLH atmosphere could have been rescued before they were killed or 
seriously injured, and the availability of appropriate respiratory 
equipment reduced the risk to the standby person who attempted the 
rescue. It illustrates the benefit of having standby personnel who can 
undertake immediate rescue efforts and the need for such personnel to 
be trained and equipped properly for their own protection as well as 
the protection of the workers in the IDLH atmosphere.
    The proposed provision would have required only a single standby 
person in most IDLH situations. However, firefighter representatives 
urged OSHA (Ex. 75, Tr. 468-469) to retain the prior standard's 
requirement for two standby personnel and to expand the provision to 
cover all IDLH atmospheres. OSHA has determined, however, that outside 
of the fire fighting and emergency response situations, which are 
discussed in connection with paragraph (g)(4), environments containing 
IDLH atmospheres are frequently well-enough characterized and 
controlled that a single standby person is adequate. In most fixed 
workplaces, the atmosphere is known, i.e., has been well characterized 
either through analysis of monitoring results or through a process 
hazard analysis. For example, employers in chemical plants have 
conducted comprehensive process hazard analyses as required by OSHA's 
Process Safety Management standard, 29 CFR 1910.119, to determine which 
of their process units pose potential IDLH hazards. In such situations, 
effective communication systems and rescue capabilities have been 
established. In addition, in many industrial IDLH situations, only one 
respirator user is exposed to the IDLH atmosphere at a time, which 
means that a single standby person can easily monitor that employee's 
status. Even in situations where more than one respirator user is 
inside an IDLH atmosphere, a single standby person can often provide 
adequate communication and support. For example, in a small pump room 
or shed, even though two or three employees may be inside an IDLH 
atmosphere performing routine maintenance activities such as changing 
pump seals, one standby person can observe and communicate with all of 
them. In this type of situation, one standby person is adequate and 
appropriate.
    In other cases, however, more than one standby person may be 
needed; paragraph (g)(3)(i) of the final standard therefore states the 
requirement for standby personnel in performance language: ``one 
employee or, when needed, more than one employee * * * [shall be] 
located outside the IDLH atmosphere.'' For example, to clean and paint 
the inside of a multi-level, multi-

[[Page 1244]]

 portal water tower, a process that often generates a deadly atmosphere 
as a result of cleaning solution and paint solvent vapors, employees 
often enter the tower through different portals to work on different 
levels. In such a situation, there will be a need for good 
communications at each entry portal, and more than one standby person 
would be needed to maintain adequate communication and accessibility.
    Several commenters (Exs. 54-6, 54-38, and 54-266) requested 
clarification of the proposed requirements that employers ensure that 
communication is maintained between the employee(s) in the IDLH 
atmosphere and the standby personnel located outside the IDLH 
environment. For example, Exxon (Ex. 54-266) requested that OSHA make 
clear that, in addition to voice communication, visual contact and hand 
signals may be used. In response, paragraph (g)(3)(ii) of the final 
rule clarifies that visual, voice, or signal line communication must be 
maintained between the employee(s) in the IDLH atmosphere and the 
employee(s) located outside the IDLH atmosphere.
    Under final paragraph (g)(3)(iv), employers must ensure that before 
entering an IDLH environment to provide emergency rescue, standby 
personnel notify the employer, or a designee authorized by the employer 
to provide necessary assistance, that they are about to enter the IDLH 
area. The employer will have determined, in advance, as part of the 
written respirator program's worksite-specific procedures, the 
procedures standby personnel will follow and whom they must notify in 
rescue situations. The employer's emergency response team may provide 
the necessary support, or other arrangements may have been made with 
local firefighting and emergency rescue personnel. The language used 
requires that the employer be notified, which provides the employer 
great flexibility in determining who will respond to such emergency 
rescue situations.
    Paragraph (g)(3)(iv) responds to concerns expressed by several 
participants (Exs. 54-6, 54-266, 54-307, 54-330) about the obligation 
of standby personnel to provide effective emergency rescue. A number of 
comments emphasized that standby personnel should not attempt any 
rescue activities without making sure that their own whereabouts are 
known and monitored. According to Exxon (Ex. 54 266), ``the ``stand-
by'' person should be able to summon effective emergency assistance and 
only then provide the assistance.'' Christopher Seniuk of Lovell Safety 
Management Company also stated that a standby employee should have a 
telephone or radio to summon help and should not be expected to enter 
an IDLH environment for rescue until additional help arrives (Ex. 54-
6). The American Iron and Steel Institute (Ex. 54-307) agreed, stating 
that the standby person should be in communication with the employee(s) 
in the IDLH atmosphere and be ``able to assist in providing or 
obtaining effective emergency assistance.'' The American Petroleum 
Institute (Ex. 54-330) also stated that when the employee wears a 
respirator in an IDLH atmosphere, the employer must ensure that 
adequate provisions have been made for rescue.
    OSHA agrees that standby personnel should contact the employer or 
employer's designee before undertaking any rescue activities in an IDLH 
atmosphere. Accordingly, final paragraph (g)(3)(iv) includes an 
employer or designee notification requirement. Although this 
requirement was not contained in the NPRM, a similar requirement has 
been included in other OSHA standards, e.g., the Permit Required 
Confined Spaces standard, 29 CFR 1910.146, and the Hazardous Waste 
Operations and Emergency Response standard, 29 CFR 1910.120. By 
including this requirement, OSHA is pointing to the need for the 
employer or authorized designee to take responsibility for ensuring 
that rescue operations are carried out appropriately, that rescuers are 
provided with proper respiratory equipment, and that employees are 
adequately prepared to facilitate rescue attempts.
    On the other hand, the notification provision is not intended to 
suggest that standby employees should wait indefinitely for their 
employer or designee to respond to notification before entering the 
IDLH atmosphere when employees inside are in danger of succumbing and 
standby personnel are appropriately trained and equipped to provide 
assistance. OSHA is aware that this practice is followed in fire 
fighting situations (See paragraph 6-4.4, NFPA 1500 standard, 1997.) In 
the majority of cases, however, rescuers should not enter the IDLH 
environment until receiving some response to the notification that 
rescue is necessary, i.e., the employer or designee should know that 
the rescuers are entering, and emergency response units should be on 
their way to the incident. OSHA believes that these requirements are 
consistent with current industry practice (Exs. 54-266, 54-307, 54-6) 
and with other OSHA standards (e.g., the permit-required confined 
spaces standard).
    This practice is consistent with OSHA's interpretations of other 
standards. (See letter of interpretation of the Hazardous Waste and 
Emergency Response Standard 29 CFR 1910.120 regarding the number of 
standby personnel present when there is a potential emergency); ``* * * 
process operators who have (1) informed the incident command * * * of 
the emergency * * * (2) [have] adequate PPE (3) [have] adequate 
training * * * and (4) employed the buddy system, may take limited 
action * * * once the emergency response team arrives, these employees 
would be restricted to the action that their training level allows * * 
* this has been OSHA's long standing policy for operators responding to 
emergencies * * *'' McCully to Olson; July 11, 1996.
    Failure to follow such practices can result in employee death. For 
example, recently, one employee (No. 1) was working inside a reactor 
vessel, attempting to obtain a sample of catalyst. He was wearing a 
supplied air respirator with an escape bottle. The standby 
``attendant'' informed the employee inside that it was time to exit to 
change the air supply cylinder; witnesses said the inside employee (No. 
1) did not appear to hear this instruction. When the air supply became 
critical, other workers outside ``yelled'' to the inside employee to 
hurry outside; by then, the inside employee was moving slowly and then 
fell. The attendant tried to check the air pressure while another 
employee, a bystander welder (No. 2), entered the vessel without a 
breathing apparatus and tried to help the inside employee (No. 1). The 
welder also fell down. Other bystanders were partially overcome by the 
nitrogen coming out of the vessel. The air hose on the respirator on 
the inside employee (No. 1) was disconnected. Neither the first 
employee inside (No. 1) nor the welder (No. 2) was wearing a harness or 
lifeline. The inside employee later died. [OSHA citation text abstracts 
for unscheduled investigations of accidents involving fatalities (one 
or more) and catastrophic injuries during calendar years 1994 and 
1995].
    Once the employer or designee has been notified, paragraph 
(g)(3)(v) requires the employer or designee to provide the necessary 
assistance appropriate to the situation. Such assistance does not 
always require that additional standby personnel enter the hazardous 
atmosphere; in some cases, the appropriate assistance could be, for 
example, the provision of emergency medical treatment. If standby 
employees do need to enter the hazardous environment to perform rescue

[[Page 1245]]

operations, however, the employer must ensure that those rescuers are 
fully protected.
    Final paragraphs (g)(3)(vi) (A), (B), and (C) require that standby 
personnel have appropriate equipment to minimize the danger to these 
personnel during rescue efforts. They stipulate that standby employees 
be equipped with pressure demand or other positive pressure SCBA, or a 
pressure demand or other positive pressure supplied-air respirator with 
auxiliary SCBA, according to final paragraph (g)(3)(vi)(A). This 
requirement was contained in paragraph (g)(2)(i) of the proposal, and 
was not objected to by any participants. It is also consistent with 
requirements in clause 7.3.2 of ANSI Z88.2--1992.
    The requirements that address appropriate retrieval equipment and 
means of rescue in paragraphs (g)(3)(vi)(B)-(C) are written in 
performance-based language. Established rescue procedures are well 
known, and retrieval equipment is readily available. OSHA therefore 
believes that it is necessary merely to state that this equipment must 
be used unless its use would increase the overall risk associated with 
entry into or rescue from the IDLH environment. OSHA acknowledged in 
the Permit-Required Confined Space standard, 58 FR 4530, that 
situations exist in which retrieval lines (harnesses, wristlets, 
anklets) may pose an entanglement problem, especially in areas in which 
air lines or electrical cords are present in the work areas in which 
the IDLH atmosphere occurs. Most of the time, however, rescue with 
retrieval equipment is effective, and much safer for the rescuers (Ex. 
54-428).
    Paragraph (g)(4) applies only to respirator use in the ultra-
hazardous context of interior structural fire fighting; the 
requirements in this paragraph apply in addition to those in paragraph 
(g)(3). OSHA has included this provision in its standard in response to 
the record evidence about the extreme hazards of this activity. 
Paragraph (g)(4)(i) requires that workers engaged in interior 
structural fire fighting work in a buddy system: at least two workers 
must enter the building together, so that they can monitor each other's 
whereabouts as well as the work environment. In addition, for interior 
structural firefighting, paragraph (g)(4)(ii) retains the requirement 
that there be at least two standby personnel outside the IDLH 
respirator use area, i.e., outside the fire area. Paragraph (g)(4)(iii) 
requires that all personnel engaged in interior structural fire 
fighting use SCBA respirators. Finally, the notes to paragraph (g)(4) 
clarify that these requirements are not intended to interfere with 
necessary rescue operations, and the extent to which the standby 
personnel can perform other functions.
    Paragraph (g)(4) of this Federal standard applies to private sector 
workers engaged in firefighting through industrial fire brigades, 
private incorporated fire companies, Federal employees through Section 
19 of the OSH Act, and other firefighters. It should be noted that 
Federal OSHA's jurisdiction does not extend to employees of state and 
local governments; therefore, public sector firefighters are covered 
only in the 25 states which operate their own OSHA-approved 
occupational safety and health state programs and are required to 
extend the provisions of their state standards to these workers. These 
states and territories are: Alaska, Arizona, California, Connecticut, 
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada, 
New Mexico, New York, North Carolina, Oregon, Puerto Rico, South 
Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands, 
Washington, and Wyoming . Eighteen (18) of these states under certain 
circumstances also consider ``volunteers'' to be employees and thus may 
provide protection to private or public sector volunteer firefighters, 
subject to specific interpretation of state law. State and local 
government employees, including firefighters, in States which do not 
operate OSHA-approved state plans, are not covered by these 
requirements, unless voluntarily adopted for local applicability.
    Although the proposed rule did not distinguish between interior 
structural fire fighting and other IDLH situations, OSHA decided to 
include separate requirements for the former activity in the final 
standard in response to evidence in the record that safeguards that may 
be adequate for well-controlled and well-characterized IDLH situations 
are not adequate in the uncontrolled and unpredictable situation 
presented by a burning building. The firefighting community already 
recognizes that one person alone cannot be sent safely into a structure 
to fight a fire that is beyond the incipient stage. The final rule's 
staffing requirements for fire fighting are consistent with OSHA's 
current enforcement practice for employers subject to federal OSHA 
enforcement, and assure that firefighters will not be subject to any 
diminution in protection as a result of the more flexible requirements 
for IDLH respirator use included in other paragraphs of the final rule.
    OSHA has previously recognized that emergency situations analogous 
to interior structural fire fighting require additional safeguards for 
employees involved in emergency response activities. For example, the 
Hazardous Waste Operations and Emergency Response (HAZWOPER) standard, 
at 29 CFR 1910.120(q), requires the use of a ``buddy system'' in 
responding to IDLH atmospheres. This means that employees involved in 
such operations are to be organized into workgroups in such a manner 
that each employee of the work group is designated to be observed 
continuously by at least one other employee in the work group. 
Paragraph (q)(3)(v) of Sec. 1910.120 requires operations in hazardous 
areas to be performed using the buddy system in groups of two or more; 
paragraph (q)(3)(vi) of that standard specifies that back-up personnel 
shall stand by with equipment ready to provide assistance or rescue. 
OSHA has made clear that these provisions require more than one standby 
person to be present.
    The final standard is also consistent with relevant National Fire 
Protection Association (NFPA) standards. The NFPA is recognized 
internationally as a clearinghouse for information on fire prevention, 
fire fighting procedures, and fire protection. A number of NFPA 
standards require firefighters using SCBA to operate in a buddy system. 
NFPA 1404, ``Fire Department Self-Contained Breathing Apparatus 
Program,'' states, in paragraph 3-1.6, that members using SCBA are to 
operate in teams of two or more, must be able to communicate with each 
other through visual, audible, physical, safety guide rope, electronic, 
or other means to coordinate their activities, and are to remain in 
close proximity to each other to provide emergency assistance.
    The NFPA 600 standard addressing industrial fire brigades requires 
in paragraph 5.3.5 that firefighters using SCBA ``operate in teams of 
two or more who are in communication with each other * * * and are in 
close proximity to each other to provide assistance in case of an 
emergency.'' Although this standard, which applies only to industrial 
fire brigades where firefighters are working in fixed locations that 
are well characterized and have established communications and rescue 
systems, requires only one standby person outside the fire area, 
another standard, NFPA 1500, ``Standard on Fire Department Occupational 
Safety and Health Programs,'' which addresses fire department safety 
and health programs

[[Page 1246]]

in the general sense, requires at least two standby personnel. This 
provision first appeared in 1992, as a Tentative Interim Amendment to 
NFPA 1500 requiring, in paragraph 6-4.1.1, that ``[a]t least four 
members shall be assembled before initiating interior fire fighting 
operations at a working structural fire.'' In 1997, NFPA finalized the 
Amendment. Paragraph 6-4 of the current NFPA 1500 standard, ``Members 
Operating at Emergency Incidents,'' addresses the number of persons 
required to be present, and requires at least four individuals, 
consisting of two persons in the hazard area and two individuals 
outside the hazard area, for assistance or rescue (paragraph 6-4.4). 
One standby member is permitted to perform other duties, but those 
other duties are not allowed to interfere with the member's ability to 
provide assistance or rescue to the firefighters working at the 
incident (paragraph 6-4.2).
    In addition, a 1994 CDC/NIOSH Alert, titled ``Request for 
Assistance in Preventing Injuries and Death of Firefighters,'' also 
recommends the use of a buddy system whenever firefighters wear SCBAs. 
The recommendation states:

    Two firefighters should work together and remain in contact with 
each other at all times. Two additional firefighters should form a 
rescue team that is stationed outside the hazardous area. The rescue 
team should be trained and equipped to begin a rescue immediately if 
any of the firefighters in the hazardous area require assistance.

Similarly, in testimony on H.R. 1783 before the Subcommittee on 
Economic and Educational Opportunities, House of Representatives, 104th 
Congress (July 11, 1995, Chairman: Cass Ballenger), Harold A. 
Schaitberger, Executive Assistant to the General President of the 
International Association of Fire Fighters (IAFF), stated that ``* * * 
our organization understood from the outset that the regulation [29 CFR 
1910.134(e)] required firefighters wearing self-contained breathing 
apparatus and involved in interior structural fire operations to 
operate in a `buddy system,' with two firefighters entering a burning 
building and two firefighters stationed outside the endangered area for 
assistance or rescue, and for accountability purposes * * * The two-in/
two-out rule has been the industry standard in the fire service for 
over 25 years.''
    The record in this rulemaking provides strong support for including 
this requirement in the final standard. Richard Duffy, Director of 
Occupational Health and Safety for the International Association of 
Fire Fighters (IAFF), argued strongly for provisions similar to those 
in the HAZWOPER standard for SCBA users working in IDLH situations. In 
his written testimony (Ex. 75), Mr. Duffy stated that the proposed 
requirements in paragraph (g)(2)(ii), which would not have required the 
buddy system or that two standby personnel be available outside the 
IDLH atmosphere, would place workers using respiratory protection in 
IDLH situations at considerable risk.
    The IAFF recommended that a minimum of 4 individuals be present any 
time employees are using SCBA in an IDLH atmosphere: two individuals to 
work as a team inside the IDLH atmosphere and two identically trained 
and equipped employees to remain outside to account for, and be 
available to assist or rescue, the team members working inside the IDLH 
atmosphere (Tr. 468-469). The inside employees would use a buddy system 
and maintain direct voice or visual contact or be tethered with a 
signal line (Tr. 468-469).
    According to Mr. Duffy, these changes were necessary:

to save workers'--specifically firefighters'--lives. Since 1970 * * 
* 1,416 members of [IAFF] have died in the line of duty. Prohibiting 
employers from allowing employees to work alone while working in 
IDLH, potentially IDLH or unknown atmospheres * * * would have saved 
many of these firefighters' lives * * * [I]f there was a team in 
place that accounted for employees while they were working in IDLH * 
* * many more firefighters would have been saved and [be] alive 
today (Ex. 75).

Mr. Duffy described several incidents in which firefighters had been 
injured or killed because of inadequate safety practices, and 
particularly the failure to have specific individuals assigned to keep 
track of employees in IDLH atmospheres. For example, he referred to a 
recent occurrence (Tr. 470) in which three firefighters died inside an 
IDLH atmosphere. In this incident, although many firefighters were on 
the scene, no one could account for the three firefighters who had been 
overcome by the IDLH atmosphere. Their bodies were later discovered 
inside the burned building. It appears that more stringent precautions, 
such as a buddy system and standby personnel specifically assigned to 
keep track of the firefighters' condition, could have prevented these 
deaths.
    In addition, the Oklahoma Department of Labor submitted comments 
stating that it supports a two-in/two-out rule, especially for 
firefighters. Specifically, it stated that ``Although we are not a 
state plan state, we operate a fully functional OSHA safety and health 
program in the public sector * * * it would be unfortunate if the new 
respiratory protection standard's interpretation of the `buddy system' 
* * * confused this issue (two-out for firefighters) [Ex. 187].'' 
However, some firefighter services and organizations urged OSHA to 
abandon its existing requirement for at least two standby personnel. 
For example, Truckee Meadows Fire Protection District in Nevada (Ex. 
384) stated that:

there are circumstances where a three person * * * company can 
safely and efficiently respond and aggressively attack a fire. 
Similarly, there are occasions where additional personnel and 
resources may be required before initiating an attack * * * the 
emphasis must be practically placed upon assessment of the risk at 
the time of arrival and throughout the incident to determine the 
resources and precautions needed. The overriding concern should be * 
* * safe egress or recovery of personnel should conditions change, 
regardless of the standby crew assembled.

A similar opinion was expressed by the fire chief of Sparks, Nevada 
(Ex. 54-129).
    Even a comment from the County of Rockland Fire Training Center, 
Pomona, New York (Ex. 54-155) recommending removing the requirement for 
standby personnel from the final rule, noted that ``in operations 
during a fire or emergency, it is a standard practice to utilize the 
team approach.'' The comment went on to state, however, that ``removing 
the restriction of having persons outside the IDLH * * * and allowing 
the incident commander the flexibility of moving personnel around as he 
or she sees fit at any given situation * * * would actually enhance the 
safety of our forces operating at the scene of a fire or emergency.'' 
As discussed below, OSHA believes that the requirements in the final 
standard allow enough flexibility to maximize safety.
    OSHA concludes that, for interior structural fire fighting, a buddy 
system for workers inside the IDLH atmosphere and at least two standby 
personnel outside that atmosphere are necessary. In fact, as noted 
above, OSHA has previously explained that under the prior standard and 
the OSH Act's general duty clause, there must be more than one person 
present outside and at least two firefighters inside when conducting an 
interior attack on an interior structural fire. Accordingly, special 
provisions have been included in this revised respiratory protection 
standard to clarify that firefighters may not enter an IDLH atmosphere 
alone during interior structural firefighting, and that two standby 
personnel are

[[Page 1247]]

required for all interior structural fire fighting.
    As discussed above, however, OSHA does not believe that similar 
practices are necessary in better controlled and characterized IDLH 
situations, such as those potentially arising in industrial 
environments. In those cases, where standby personnel can more easily 
track the precise movements of the respirator users and communication 
mechanisms are in place, OSHA believes that one standby person will 
often be sufficient, although paragraph (g)(3)(i) clearly recognizes 
that some nonfirefighting IDLH situations will require multiple standby 
personnel.
    These additional requirements are necessary because fire fighting 
ranks among the most hazardous of all occupations, and interior 
structural fire fighting is one of the most dangerous fire fighting 
jobs (See, e.g., Jankovic et al. 1991). As the International 
Association of Fire Chiefs (Ex. 54-328) pointed out, ``[t]he fire 
fighter is usually operating in a hostile environment where normal 
systems, facilities, processes and equipment to ensure safety have 
already failed.'' A very basic difference between firefighters--
particularly those involved in fighting interior structural fires--and 
employees in other occupations is that the work site is always new and 
unknown. Firefighters do not report to a fixed location or work in a 
familiar environment. Heat stress also affects firefighters differently 
than other workers. Petrochemical workers and those in other high heat-
stress occupations, such as highway workers, can deal with issues such 
as heat stress through other options, including acclimatization periods 
for new employees, scheduling high exertion work at night, and allowing 
frequent breaks (Smith 1996). Firefighters do not have these options.
    Fire fighting is also extremely stressful mentally because of the 
sense of personal danger and urgency inherent in search and rescue 
operations. A firefighter regularly steps into situations that others 
are fleeing, accepting a level of personal risk that would be 
unacceptable to workers in most other occupations. Psychological stress 
is caused by the firefighter's need to focus on the protection of lives 
and property, as well as the need to maximize his or her own personal 
safety and that of his/her coworkers. Tenants and others in the process 
of being rescued have also been known to panic and attack firefighters 
to obtain air from the firefighter's respirator in an attempt to save 
their own lives (1994 NIOSH Alert).
    Fire fighting is a high-risk occupation with a very narrow window 
of survivability for those who lose their orientation or become 
disabled on the job. The terrible toll among firefighters is recorded 
in many different national data bases. For example, for the period 
1980-1989, the NIOSH National Traumatic Occupational Fatalities (NTOF) 
Surveillance System reported 278 deaths among firefighters caused just 
by work-related traumatic injuries; NIOSH recognizes that this number 
is an underestimate because of the collection and reporting methods 
used by NTOF, which limit the kinds of events recorded. Data collected 
by the IAFF for the period 1970-1994 report 1,369 firefighter deaths, 
and data collected by the NFPA for the period 1990-1992 indicate that 
280 firefighters died in this 2-year period alone (1994 NIOSH Alert). 
OSHA believes that the requirements of this respirator standard may 
prevent a significant number of these deaths and injuries. For example, 
in a recent incident, a team of two firefighters was operating inside a 
structural fire. Rapidly deteriorating conditions occurred in which 
there was dense smoke. Confusion ensued and the team lost contact, 
resulting in one firefighter death. (Incident number 2; OSHA 
Investigations of Firefighter Fatalities; 10/1/91-3/17/97; IMIS) In 
this situation, the need for additional accountability and monitoring 
of firefighters during interior structural fire fighting is clear. 
Multiple standby personnel and two-person teams inside an IDLH 
atmosphere are therefore necessary to check for signs of heat stress, 
other illnesses, disorientation, malfunctioning of respiratory and 
other protective equipment, and to assist in exit or rescue when needed 
(Smith, 1996).
    OSHA emphasizes that the requirement for standby personnel does not 
preclude the incident commander from relying on his/her professional 
judgment to make assignments during a fire emergency. Although the 
standard requires at least two standby persons during the attack on an 
interior fire, there are obviously situations where more than two 
persons will be required both inside and outside the interior 
structure, a decision ultimately to be made by the incident commander. 
In addition, as is the case under the previous respiratory protection 
standard, one of the standby personnel may have other duties and may 
even serve as the incident commander. According to OSHA's letter to 
Chief Ewell, IFC, Oakland, CA, (J. Dear; 2/27/96), ``* * * one of the 
two individuals outside the hazard area may be assigned more than one 
role, such as incident commander in charge of the emergency or the 
safety officer. However, the assignment of standby personnel of other 
roles such as the incident commander, safety officer, or operator of 
fire apparatus will not be permitted if by abandoning their critical 
task(s) to assist in, or if necessary, perform a rescue clearly 
jeopardizes the safety and health of any firefighter working at the 
incident.'' OSHA has included specific guidance regarding other duties 
of standby personnel under paragraph (g)(4). These duties are 
consistent with OSHA's past enforcement policy and NFPA recommendations 
(NFPA 1500, 1977 Edition; Section 6-4.4.2).
    It is important to have at least two standby people available so 
that in the event of an emergency in which both members of the interior 
team need rescue or other assistance, adequate personnel are available 
for rescue. As Harold A. Schaitberger testified, ``* * * The two-in/
two-out rule has been the industry standard in the fire service for 
over 25 years. It is also based on common sense. If there are two 
firefighters inside a burning building when a roof caves in, at least 
two firefighters are required to assist and/or rescue them (Testimony 
on H.R. 1783 before the Subcommittee on Economic and Educational 
Opportunities, House of Representatives, 104th Congress (July 11, 1995, 
Chairman: Cass Ballenger).'' Whenever possible, the use of the buddy 
system should also be maintained during rescue operations.
    Moreover, the ``two-in/two-out'' requirement does not take effect 
until firefighters begin to perform interior structural fire fighting. 
While the fire is in the incipient stage, the incident commander or 
other person in charge may conduct an investigation or ``size up'' the 
situation to determine whether the fire has progressed beyond the 
incipient stage. During this investigative phase, the standard does not 
require two-member teams inside and outside the structure. Similarly, 
nothing in this rule is meant to preclude firefighters from performing 
rescue activities before an entire team has assembled. If there are 
fewer than four team members available, and an individual inside the 
burning structure must be rescued immediately, this rule does not 
prevent the rescue from occurring, as the Note to the regulatory text 
makes clear. However, once firefighters begin the interior attack on an 
interior structural fire, the atmosphere is assumed to be IDLH and 
paragraph (g)(4) applies.
    OSHA's requirement in no way is intended to establish staffing

[[Page 1248]]

requirements with regard to, for example, the number of persons on a 
fire truck or the size of a fire company. Rather, the 2 in / 2 out 
provision specifies only the number of firefighters who must be present 
before the interior attack on an interior structural fire is initiated. 
Firefighters may be assembled from multiple companies, or arrive at the 
scene at various times. All that is intended is that an interior attack 
should not be undertaken until sufficient staff are assembled to allow 
for both buddy and standby teams.
    These requirements are consistent with OSHA's past enforcement 
policy. OSHA has relied on the NFPA recommendations as a basis for 
determining an appropriate standard of care in fire fighting situations 
under the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1). In 
its interpretative memoranda addressing requirements that are 
applicable to firefighters, OSHA noted that occupational exposure to 
fire is a well-recognized hazard, and that firefighters using SCBA in 
hazardous atmospheres should be operating in a buddy system of two or 
more personnel. The Agency explained that even under OSHA's previous 
respiratory protection standard, a minimum of four personnel should be 
used, with two members inside the hazardous area and two members 
outside the hazardous area who are available to enter the area to 
provide emergency assistance or rescue if needed. One memorandum also 
pointed out that there was no prohibition against the outside standby 
personnel having other duties, such as functioning as incident 
commander or safety officer, as long as it would not jeopardize the 
safety and health of any firefighter working at the incident if the 
standby personnel left those duties to perform emergency assistance and 
rescue operations.
    OSHA notes that the requirements of paragraph (g)(4) apply in 
addition to the requirements of OSHA's specific fire protection 
standards, subpart L of 29 CFR 1910. OSHA intends to begin negotiated 
rulemaking on those fire protection standards in the near future.
Paragraph (h)--Maintenance and Care of Respirators
    This final standard for respiratory protection, in paragraph (h), 
addresses the elements of respirator maintenance and care that OSHA 
believes are essential to the proper functioning of respirators for the 
continuing protection of employees. As OSHA stated in the preamble to 
the NPRM (59 FR 58923), ``a lax attitude toward this part of the 
respiratory protection program will negate successful selection and fit 
because the devices will not deliver the assumed protection unless they 
are kept in good working order.'' The maintenance and care provisions, 
which are divided into cleaning and disinfecting, storage, inspection, 
and repair, are essentially unchanged (with the exception of the 
cleaning and disinfecting provisions) from paragraph (f) of OSHA's 
prior respiratory protection standard. Some rearrangement and 
consolidation of the regulatory text and minor language changes have 
been made to this paragraph to simplify and clarify the requirements as 
a result of comments and concerns that were raised in response to the 
proposed rule.
    Paragraph (h)(1) of the final standard requires that employers 
provide each respirator wearer with a respirator that is clean, 
sanitary, and in good working order. It further requires that employers 
use the procedures for cleaning and disinfecting respirators described 
in mandatory Appendix B-2 or, alternatively, procedures recommended by 
the respirator manufacturer, provided such procedures are as effective 
as those in Appendix B-2. The prior respiratory protection standard 
required that employers clean and disinfect respirators in accordance 
with the maintenance and care provision of paragraph (f), but offered 
no specific guidance on how to perform these procedures. Mandatory 
Appendix B-2 presents a method employers may use to comply with the 
cleaning and disinfecting requirements of final paragraph (h)(1). The 
procedures listed in Appendix B-2 were compiled from several sources, 
including publications of the American Industrial Hygiene Association, 
ANSI Z88.2-1992 (clause A.4, Annex A), and NIOSH. Other methods may be 
used, including those recommended by the respirator manufacturer, as 
long as they are equivalent in effectiveness to the method in Appendix 
B-2. Equivalent effectiveness simply means that the procedures used 
must accomplish the objectives set forth in Appendix B-2, i.e., must 
ensure that the respirator is properly cleaned and disinfected in a 
manner that prevents damage to the respirator and does not cause harm 
to the user.
    Several commenters (Exs. 54-267, 54-300, 54-307) supported the 
cleaning and disinfecting provisions in general and the inclusion of 
manufacturers' instructions in particular. The American Iron and Steel 
Institute (AISI), for example, suggested the following language: 
``Respirators must be cleaned and maintained in a sanitary condition. 
The cleaning procedures recommended by the respirator manufacturer or 
in Appendix B, or a recognized standard-setting organization should be 
followed'' (Ex. 54-307).
    The need for appropriate cleaning and disinfecting procedures was 
also supported during the hearings. For example, James Johnson of 
Lawrence Livermore National Laboratories testified:

    [P]rocedures and schedules for cleaning, disinfecting, storing, 
inspecting, repairing, or otherwise maintaining respirators * * * 
are elements of the respiratory protection program which are 
important and are addressed in the rule * * *. I did some personal 
evaluation on the disinfecting procedures recommended by several 
U.S. respirator manufacturers. I found that they vary significantly. 
If you look in Appendix B of the proposed rule, the hypochlorite or 
bleach recommendation and the other disinfectants outlined there are 
certainly what is typically recommended and used (Tr. 184).

    The Appendix B-2 procedures can be used both with manual and semi-
automated cleaning methods, such as those using specially adapted 
domestic dishwashers and washing machines. As with most effective 
cleaning procedures, Appendix B-2 divides the cleaning process into 
disassembly of components, cleaning and disinfecting, rinsing, drying, 
reassembly and testing. Recommended temperatures for washing and 
rinsing are given in Appendix B-2, as are instructions for preparing 
effective disinfectants.
    OSHA has made minor changes to the contents of Appendix B-2 in the 
final standard. For example, the cleaning procedures listed in the 
final rule are more consistent with the procedures suggested in Clause 
A.4, Annex A of the ANSI Z88.2-1992 standard than those proposed, 
particularly with regard to the temperatures recommended to prevent 
damage to the respirator. Additionally, automated cleaning, which is 
now being used by many larger companies, is allowed as long as 
effective cleaning and disinfecting solutions are used and recommended 
temperatures, which are designed to prevent damage to respirator 
components, are not exceeded.
    Commenters (Exs. 54-91, 54-187, 54-330, 54-389, 54-309, Tr. 695) 
generally supported the need for a respirator maintenance program but 
took differing approaches to the provisions proposed in paragraph 
(h)(1) (i)-(iii) dealing with the frequency of cleaning and 
disinfecting respirators. One commenter (Ex. 54-187) agreed with the 
provisions as proposed. Others (Exs. 54-208, 54-67, 54-91, 54-408) 
recommended a more performance-oriented approach.

[[Page 1249]]

For example, Darell Bevis of Bevis Associates International objected to 
the proposed requirement that respirators that are issued for the 
exclusive use of an employee be cleaned and disinfected daily by 
stating:

    [D]iffering workplace conditions will require that cleaning and 
disinfection may be required more frequently or even less frequently 
than daily. A requirement for daily cleaning when unnecessary 
results in considerable additional respirator program costs with no 
benefit. A more realistic and still enforceable requirement would be 
routinely used respirators issued for the exclusive use of an 
employee shall be cleaned and disinfected as frequently as necessary 
to ensure that the user has a clean, sanitary, properly functioning 
respirator at all times (Tr. 695).

    Other commenters (Exs. 54-67, 54-91, 54-234, 54-271, 54-278, 54-
286, 54-289, 54-293, 54-334, 54-350, 54-374, 54-424, 54-435, Ex. 163) 
also objected to cleaning and disinfecting respirators at the end of 
each day's use if the respirator is issued for the exclusive use of a 
single employee. These comments were in general agreement with the 
American Industrial Hygiene Association's statement:

    The performance-oriented language of the existing standard is 
more reasonable [than the proposed language]. Cleaning and 
disinfecting of individually assigned respirators should be done 
``as needed'' to assure proper respirator performance and to 
preclude skin irritation or toxicity hazards from accumulation of 
materials. Disinfecting an individually issued respirator is 
probably not necessary at all unless the ``contaminant'' is 
biological in nature (Ex. 54-208).

    Several other commenters (See, e.g., Exs. 54-330, 54-389, 309) were 
in favor of cleaning individually assigned respirators at the end of 
each day's use, but recommended disinfecting or sanitizing only after 
longer periods or when necessary. Michael Laford, Manager of Industrial 
Hygiene and Safety at Cambrex, commented as follows:

    It is important to clean all personal protective equipment, 
preferably after each use as needed, and not just once a day. 
However, is the additional requirement for daily disinfection * * * 
where respirators are individually assigned, supported with valid 
studies or data? In the absence of data that supports a real benefit 
of this requirement, the language should revert to ``periodic'' 
disinfecting of respirators (Ex. 54-389).

    The need for flexibility with respect to maintaining clean and 
sanitary respirators was also discussed during the hearings. For 
example, in response to a question asked by a member of the OSHA panel 
regarding how often a respirator mask should be cleaned, James Centner, 
Safety and Health Specialist with the United Steel Workers of America 
(USWA), replied that it depended on the length of time the respirator 
is worn and the workplace conditions. He stated, ``If you're working in 
a smelter where it's hot and dirty and dusty, workers probably need to 
take that respirator off about every 30 minutes and do a good, thorough 
job of washing the grit and dirt off their face and . . . do a quick 
maintenance clean-up job on the sealing surface of the respirator so it 
maintains an adequate fit'' (Tr. 1068). Darell Bevis of Bevis 
Associates International (Tr. 747-748) responded similarly when asked 
this question; he contrasted dusty workplaces, such as fossil fuel 
power generation plants where respirators become filthy with hazardous 
particulates, to workplaces involving exposure only to gases and vapors 
where respirators may remain clean for long periods.
    OSHA agrees with these commenters that the necessary frequency for 
cleaning a respirator can range from several times a day to less than 
daily. Therefore, OSHA has restated paragraph (h)(1)(i) in performance-
based language, which will provide employers with flexibility in 
maintaining clean and sanitary respirators when the respirator is used 
exclusively by a single employee. Final paragraph (h)(1)(i) now reads 
as follows: ``Respirators issued for the exclusive use of an employee 
shall be cleaned and disinfected as often as necessary to be maintained 
in a sanitary condition.'' Final paragraph (h)(1)(i) is complemented by 
the respirator use provision in final paragraph (g)(2)(ii)(A), which 
requires that employers ensure that workers leave the respirator use 
area to wash their faces as necessary to prevent eye or skin 
irritation. OSHA believes that compliance with final paragraphs 
(h)(1)(i) and (g)(2)(ii)(A), as well as the training provisions in 
paragraph (k) regarding maintenance of the respirator, will provide 
effective employee protection against hazardous substances that 
accumulate on the respirator, interfere with facepiece seal, and cause 
irritation of the user's skin.
    Proposed paragraphs (h)(1)(ii)-(iii) specified that respirators 
used by more than one employee or respirators issued for emergency use 
be cleaned and disinfected after each use and were the subject of a 
number of comments (See, e.g., Exs. 54-67, 54-234, 54-361, 54-408, 54-
424 and Tr. 695). For example, the Service Employees International 
Union (Ex. 54-455) suggested that OSHA replace the phrase ``after each 
use'' with ``before they are worn by another user.'' OSHA agrees with 
this suggestion as it applies to the shared use of respirators in non-
emergency situations, and has revised final paragraph (h)(1)(ii) to 
require cleaning and disinfecting of respirators prior to their use by 
other individuals. OSHA believes that this modification provides 
flexibility in those areas where respirators are assigned to more than 
one employee. This requirement is also consistent with the parallel 
provision of ANSI Z88.2-1992. However, if the respirator is to be used 
in an emergency situation, it should be in a clean and sanitary 
condition and immediately ready for use at all times. Emergency 
personnel cannot waste time cleaning and sanitizing the respirator 
prior to responding to an emergency. Thus, if the respirator is one 
that is maintained for emergency use, the final standard in paragraph 
(h)(1)(iii) retains the requirement to clean and disinfect the 
respirator after each use.
    Final paragraph (h)(1)(iv) requires the cleaning and disinfecting 
of respirators used in fit testing and training exercises. This 
provision was added in response to a recommendation made by the Public 
Service Company of Colorado (Ex. 54-179) that respirators be cleaned 
and disinfected after each fit test. Additionally, representatives of 
Electronic and Information Technologies (Ex. 54-161) pointed out that, 
although the proposal addressed cleaning and disinfecting procedures 
for respirators worn during routine and emergency use, it did not 
specify how respirators should be cleaned/disinfected during fit 
testing or training activities. Since these conditions involve shared 
use, OSHA has emphasized in final paragraph (h)(1)(iv) the need to 
properly clean and disinfect or sanitize respirators used for training 
and fit testing after each use.
    OSHA noted in the proposal that it was not stating who should do 
the cleaning and disinfecting, only that it be done (59 FR 58924). 
However, as with all other provisions of the standard, the employer is 
responsible for satisfying the cleaning and disinfecting requirements. 
The final standard requires that the employer ensure that cleaning is 
done properly, and that only properly cleaned and disinfected 
respirators are used. The employer is allowed to choose the cleaning 
and disinfecting program that best meets the requirements of the 
standard and the particular circumstances of the workplace. Richard 
Uhlar, an industrial hygienist for the International Chemical Workers 
Union (ICWU), commented that workers should be given paid time to 
clean, disinfect, and inspect respirators; otherwise, in the view of

[[Page 1250]]

this commenter, respirators will not be taken care of properly (Ex. 54-
427). OSHA notes that if the employer elects to have employees clean 
their own respirators, the employer must provide the cleaning and 
disinfecting equipment, supplies, and facilities, as well as time for 
the job to be done.
    Commenting on a preproposal draft of the standard, the United 
Steelworkers of America (USWA) (Ex. 36-46) recommended that OSHA 
require the employer to clean and repair respirators. The USWA stated 
that programs in which employers require employees to return their 
respirators at the end of each shift to a central facility for 
inspection, cleaning, and repairs by trained personnel are more 
effective than programs in which employees are responsible for cleaning 
their own respirators. OSHA agrees that such a centralized cleaning and 
repair operation can ensure that properly cleaned and disinfected 
respirators are available for use, but this approach is not the only 
way to fulfill this requirement. For example, central facilities may be 
inappropriate in workplaces where respirator use is infrequent, or 
where the number of respirators in use is small.
    Final paragraph (h)(2), which establishes storage requirements for 
respirators, does not differ substantively from the corresponding 
requirements in the proposal. However, some of the proposed provisions 
have been consolidated to simplify understanding and interpretation of 
the requirements. Final paragraph (h)(2)(i) sets forth the storage 
requirements for all respirators, while final paragraph (h)(2)(ii) 
addresses additional requirements for the storage of emergency 
respirators. Specifically, final paragraph (h)(2)(i) requires that all 
respirators be stored in a manner that protects them from damage, 
contamination, harmful environmental conditions and damaging chemicals, 
and prevents deformation of the facepiece and exhalation valve. 
Respirators maintained for emergency use also must be stored in 
accordance with the requirements of final paragraph (h)(2)(i) and, in 
addition, must be kept accessible to the work area, be stored in 
compartments or covers that are clearly marked as containing emergency 
respirators, and be stored in accordance with any applicable 
manufacturer's instructions (paragraph (h)(2)(ii)).
    There was general support in the record for the performance 
approach that OSHA took in the proposal with regard to storage 
requirements. For example, the Industrial Safety Equipment Association 
(ISEA) commented: ``[B]ecause the degree of severity of an 
environmental condition that would cause deterioration would be related 
to the tolerance of the particular equipment in question and would thus 
vary from model to model, there is no need to specify conditions of 
storage in more detail'' (Ex. 54-363). The comment submitted by the 
Mobil Oil Corporation (Ex. 54-234) agreed with OSHA's proposed approach 
on respirator storage, but went further to state that ``[t]o place 
storage requirements in specific language may actually contradict 
specific recommendations of the manufacturer.'' Other commenters also 
supported OSHA's provisions as proposed (See Exs. 54-172, 54-250, 54-
273, 54-408, 54-424, and 54-455).
    There were, however, some suggested changes that commenters 
believed would clarify final paragraph (h)(2). One commenter (Ex. 54-
32) suggested that, in addition to requirements for accessibility and 
maintenance of emergency respirators, there should be a requirement for 
specific `` awareness training'' to remind employees of the location of 
such respirators. OSHA agrees that such knowledge is vital. The 
training specified in paragraph (k), especially the provisions on how 
to use a respirator in emergency situations (final paragraph 
(k)(1)(iii)) and procedures for the maintenance and storage of 
respirators (final paragraph (k)(1)(v)), are designed to do this. In 
addition, paragraph (k) requires that employers retrain employees where 
it appears necessary to do so to ensure safe respirator use.
    Two commenters recommended that employees, rather than employers, 
be held responsible for cleaning, sanitizing, and storing their 
respirators. The Grain Elevator and Processing Society (Ex. 54-226) 
recommended that, for most operations, the maintenance and care of 
respirators should be the responsibility of the employee once the 
employee has been trained. In another comment specific to the storage 
provision, the American Petroleum Institute (Ex. 54-330) pointed out 
that employers generally do not store respirators; instead, respirator 
storage is the responsibility of the employee. In response, OSHA notes 
that section 5(a)(2) of the OSH Act and case law interpreting that 
provision have specifically placed the burden of complying with safety 
and health standards on the employer because the employer controls 
conditions in the workplace. The employer is, therefore, responsible 
for the results of actions taken by others at the direction of the 
employer. For example, although an employee may physically store a 
respirator, a contractor may perform a fit test, or a physician may 
examine an employee at the employer's direction, the employer is 
ultimately responsible for ensuring that these actions are taken to 
comply with the standard.
    Proposed paragraph (h)(2)(ii) would have required that compartments 
be built to protect respirators that are stored in locations where 
weathering, contamination, or deterioration could occur. The 
Westminster, Maryland Fire Department (Ex. 54-68) raised the following 
concern about this proposed provision:

    This requirement may be appropriate for manufacturing but is not 
practical given the operations of the fire service. * * * As OSHA is 
aware the fire service maintains its breathing apparatus in a ready 
posture on the apparatus. To require the apparatus to be placed in a 
compartment would eliminate the precious time saved by donning the 
apparatus enroute to the emergency. This operation has been the 
backbone of our efficiency at rescue and suppression operations.

Similar concerns were raised by the National Volunteer Fire Council 
(Tr. 499) and the Connecticut Fire Chiefs' Association, Inc. (Ex. 180). 
In response to these concerns, OSHA has crafted language that the 
Agency believes fulfills the purpose of this provision and maintains 
the efficiency of emergency response workers such as firefighters. 
Instead of requiring emergency respirators to be stored only in 
compartments, final paragraph (h)(2)(ii)(B) permits them alternatively 
to be stored in covers that are clearly marked as containing emergency 
respirators. Walk-out brackets with covers that are mounted on a wall 
or to a stable surface (e.g., on a fire truck) may be used so long as 
the respirator is covered to prevent damage when not in use. Because a 
cover can be removed in seconds, OSHA believes that this change 
addresses the needs of firefighters and other emergency responders. It 
is important that the walk-out brackets are mounted within the vehicle. 
For example, they can be mounted directly to the fire truck to enable 
firefighters to rapidly don the respiratory equipment when needed. 
However, any means of storage used must be secure. If walk-out brackets 
are not mounted, there is a danger that the unsecured respirators could 
become damaged as a result of vehicle motion.
    Final paragraph (h)(3) requires regular inspections to ensure the 
continued reliability of respiratory equipment. The frequency of 
inspection and the procedures to be followed depend on whether the 
respirator is intended for non-emergency, emergency, or escape-only 
use.

[[Page 1251]]

    Final paragraph (h)(3)(i)(A) requires respirators for use in non-
emergency situations to be inspected before each use and during 
cleaning. For respirators designated for use in an emergency situation, 
final paragraph (h)(3)(i)(B) requires that they be inspected at least 
monthly and in accordance with the manufacturer's instruction. In 
addition, emergency respirators must be examined to ensure that they 
are working properly before and after each use. Examining respirator 
performance before and after each use is not intended to be as 
extensive and thorough a process as respirator inspection. A basic 
examination conducted prior to each use will provide assurance to the 
wearer that the respirator which he/she is about to don in an emergency 
situation will work properly, e.g., that the cylinders on the SCBA are 
charged, that air is available and flowing. This examination can be 
done fairly quickly, and OSHA believes that this added measure of 
employee protection is both necessary and appropriate.
    Respirators used for escape only are to be inspected prior to being 
carried into the workplace (paragraph (h)(3)(i)(C)). The Dow Chemical 
Company (Ex. 54-278) addressed the inspection of emergency escape 
respirators, stating, ``Emergency escape respirators such as mouthbit 
respirators, usually stored in the box or bag they come in, do not need 
to be inspected monthly.'' OSHA agrees with this statement. Mouthbit or 
other emergency escape respirators are carried by an individual worker 
into the workplace for personal use in an emergency, and must be 
inspected for proper condition prior to being carried into the 
workplace. Additional monthly inspections of emergency escape 
respirators that are stored for future use are unnecessary, since they 
will be inspected prior to being carried into the workplace. Final 
paragraph (h)(3)(i)(C) therefore specifies that ``escape-only'' 
respirators need only be inspected before being carried into the 
workplace.
    Although no commenters were opposed to the inspection requirements, 
some participants raised the issues that are discussed below with 
respect to inspection frequency and procedures. When respirators are 
inspected, the final rule (paragraph (h)(3)(ii)(A)) requires that the 
inspection include an examination to ensure that respirators are 
working properly, including an examination of the tightness of 
connections and the condition of the various components. Two comments 
were made with respect to respirator inspection procedures. John Clarke 
of Electronic and Information Technologies (Ex. 54-162) stated that 
checking for proper function (examination to ensure that respirators 
work properly) presents a dilemma if use is to include sanitizing the 
facepiece. He pointed out that SCBAs reserved for use by multiple 
persons presents a special problem. Likewise, John O'Green of American 
Electric Power (Ex. 54-181) asked that ``functional check'' be better 
defined and clarified. He stated that requiring the actual activation 
of the respirator, including the flow of air to the facepiece, could be 
time consuming for all the emergency respirators in their facilities. 
OSHA does not intend that the respirator be physically placed on the 
employee to examine the respirator to ensure that it is working 
properly. Visual inspection can detect factors that would interfere 
with proper performance, e.g., distortion in shape (often the result of 
improper storage), missing or loose components, blockage, and improper 
connections. Alarms can also be examined without actually putting the 
respirator on the employee. In addition, examining elastomer parts for 
pliability and signs of deterioration, as required by final paragraph 
(h)(3)(ii)(B), can be performed without wearing the respirator.
    Under paragraph (h)(3)(iii) of the final rule, SCBAs must be 
inspected monthly. The employer must ensure that the cylinders are 
fully charged. Recharging is required when the pressure falls below 90 
percent of the manufacturer's recommended pressure level. The 
Westminster, Maryland Fire Department (Ex. 54-68) strongly recommended 
that the apparatus be inspected at the beginning of each shift or 
workday rather than monthly. OSHA notes that the final rule specifies 
only the minimum requirements for an effective respiratory protection 
program. Employers, however, are encouraged to exceed these minimum 
criteria if, by doing so, employee protection and operating efficiency 
are enhanced.
    The final provision for recharging air and oxygen cylinders for 
SCBAs in paragraph (h)(3)(iii) is unchanged from proposed paragraph 
(h)(3)(i)(C). Although no commenters disagreed with this provision as 
proposed, a few commenters (Exs. 54-6, 54-220) asked OSHA to clarify 
the requirement that SCBA equipment be maintained in a fully charged 
state and recharged when the pressure falls to 90% or less of the 
manufacturer's recommended pressure level. By way of example, OSHA 
notes that if the manufacturer states that the cylinder is fully 
charged at 100 psi, the cylinder must be recharged when the pressure 
falls to 90 psi (i.e., 90% of the fully charged level). The 90 percent 
level was selected to ensure that sufficient air remains in the 
cylinder to allow emergency responders to perform their required duties 
in a contaminated or oxygen-deficient atmosphere and still have 
sufficient air available to escape from these conditions. The 90 
percent level, and the requirement that cylinders be recharged once the 
pressure falls below 90 percent, was also recommended by the American 
Industrial Hygiene Association (Ex. 54-208).
    In two separate submissions to the record (Exs. 54-121 and 54-135), 
Consolidated Engineering Services asked what type of training is 
required for employees who inspect respirators used for emergency 
response. OSHA notes that, under final paragraph (k), the specifics of 
an appropriate training program are left to the discretion of the 
employer. Regarding respirators for emergency use, final paragraph 
(k)(1)(iii) requires that employees be trained in how to use the 
respirator effectively in emergency situations, while final paragraph 
(k)(1)(iv) requires training on how to inspect the respirator. As these 
paragraphs make clear, OSHA requires the employer to develop 
appropriate training programs for employees who inspect emergency 
respirators.
    As part of the inspection process for respirators that are 
maintained for use in emergencies, paragraph (h)(3)(iv) of the final 
standard requires certification of the inspection. Documentation of 
certification includes the date of inspection, the name or signature of 
the inspector, the findings of the inspection, any required remedial 
action, and a serial number or other means of identifying the inspected 
respirator. This information must be tagged to the respirator or its 
storage compartment, or otherwise stored in the form of inspection 
reports (i.e., paper or electronic), and be maintained until replaced 
following a subsequent certification.
    This requirement was included in the proposal, and several comments 
addressed it. Dow Chemical (Ex. 54-278) stated that it supports the 
proposed requirement. The American Petroleum Institute (Ex. 54-330) 
recommended that OSHA require ``identification of the person that made 
the inspection'' in lieu of a signature. However, OSHA believes that 
the inspector's name or signature is a clear and precise 
identification, and therefore has retained this requirement in the 
final rule as proposed.
    The final provision of paragraph (h) deals with respirator repairs 
and adjustments. Final paragraph (h)(4) provides that respirators that 
fail

[[Page 1252]]

inspections, or are otherwise defective, are to be removed from service 
and discarded, repaired, or adjusted according to the specified 
procedures. In addition, the employer shall ensure that repairs or 
adjustments to respirators are made only by persons appropriately 
trained to do so, and that they use only the respirator manufacturer's 
NIOSH-approved parts that are designed for the particular respirator. 
The repairs also must be made in accordance with the manufacturer's 
recommendations and specifications. Because components such as reducing 
and admission valves, regulators, and alarms are complex and essential 
to the safe functioning of the respirator, they are required to be 
adjusted and repaired only by the manufacturer or a technician trained 
by the manufacturer.
    Several comments were submitted to the record regarding this 
particular provision. Consolidated Engineering Services (Exs. 54-121 
and 54-135) and the Florida Department of Labor and Employment Security 
(Ex. 54-79) asked what type of training is required for employees who 
repair and adjust respirators. Motorola (Ex. 54-187) also addressed 
this point, but added that specialized training for most respirator 
repair work was not necessary, and that the training program required 
by the standard should provide employees with sufficient expertise to 
perform the necessary repair work, or at least to recognize when repair 
is beyond their ability. Another commenter (Ex. 54-293) asserted that, 
depending on the manufacturer's recommendation, a trained person may or 
may not be necessary to make repairs; for example, no training is 
required to replace a broken respirator strap.
    In response to these concerns, OSHA does not believe that it is 
necessary or appropriate to specify in detail in the final rule the 
type of training that is required to qualify a person to repair and 
adjust respirators. However, because of the important health-related 
functions of respirators, the person making the repair needs to be 
properly trained. OSHA expects that such repair will often be performed 
by the manufacturer, particularly if special expertise is required. 
Where this is not the case, the employer must ensure that the employee 
or person repairing the respirator has the skills necessary to conduct 
the appropriate repair and adjustment functions. The use of the term 
``appropriately trained'' refers to an individual who has received 
training from the respirator manufacturer or otherwise has demonstrated 
that he/she has the skills to return the respirator to its original 
state of effectiveness.
    The AFL-CIO (Ex. 54-428) and Service Employees International Union 
(SEIU) (Ex. 54-455) recommended that OSHA require employers to tag as 
``out of service'' those respirators that fail inspections. OSHA agrees 
that some means must be available for ensuring that only properly 
functioning respirators are introduced into the workplace. However, 
OSHA believes that the decision on how to handle respirators that fail 
inspection is most appropriately addressed in the employer's respirator 
protection program, as required under final paragraph (c). 
Specifically, final paragraph (c)(1)(v) would allow such procedures to 
be tailored to satisfy the needs of a particular workplace.
    The SEIU (Ex. 54-455) recommended that OSHA require employers to 
keep an adequate supply of cartridges and other routine replacement 
parts in stock and readily accessible to employees so that they can 
replace needed parts. OSHA does not believe it is necessary to specify 
that employers must maintain an adequate number of spare parts. Final 
paragraph (h)(4) requires that defective respirators be removed from 
service unless they are repaired or adjusted, and an employer who does 
not keep on hand sufficient parts to allow respirators to be repaired 
will need to remove those respirators from service until suitable 
repairs can be made. Thus, an employer who does not maintain an 
adequate inventory of parts will either need to keep extra respirators 
on hand or cease operations that require respirator use until parts can 
be obtained or installed.
Paragraph (i)--Breathing Air Quality and Use
    This paragraph of the respiratory protection standard requires that 
breathing air for atmosphere-supplying respirators be of high purity, 
meet quality levels for content, and not exceed certain contaminant 
levels and moisture requirements. The paragraph sets performance 
standards for the operation and maintenance of breathing air 
compressors and cylinders, establishes methods for ensuring breathing 
air quality, and sets requirements for the quality of purchased 
breathing air.
    Paragraph (i)(1) of the final standard applies to atmosphere-
supplying respirators that are being used to protect employees, and 
requires that breathing air supplied to these respirators be of high 
purity. This same requirement for breathing air quality was included in 
proposed paragraph (i)(1). Both the prior and final rules refer to a 
number of standard references that establish parameters for breathing 
air quality. For example, under (i)(1)(i), the final rule requires the 
employer to ensure that oxygen used for breathing purposes meets the 
requirements of the United States Pharmacopoeia (USP) for medical or 
breathing oxygen. This provision is the same as the requirement in 
OSHA's prior respiratory protection standard at paragraph (d)(1). The 
ANSI Z88.2-1992 respirator standard, in Clause 10.5.1, also requires 
that air be of high purity and that oxygen meet the USP requirements. 
Inclusion of this requirement in the final rule was strongly supported 
by the AFL-CIO (Ex. 54-428), which stated that the employer must ensure 
that ``compressed air, compressed oxygen, liquid air, and liquid oxygen 
used for respiration is of high purity and in accordance with the 
specifications listed in [proposed paragraph] (i)(1).''
    Under paragraph (i)(1)(ii) of the final standard, breathing air 
must meet at least the requirements for Type I--Grade D breathing air, 
as described in the ANSI/CGA G-7.1-1989 standard, which is the latest 
revision of that reference standard and the one currently used by OSHA 
when determining breathing air quality. Final paragraph (i)(1)(ii) 
identifies the specifications for the contents of Grade D breathing 
air: oxygen content (volume/volume) of 19.5 to 23.5 percent; 
hydrocarbon (condensed) concentration of five milligrams or less per 
cubic meter of air; carbon monoxide level of 10 ppm or less; carbon 
dioxide level of 1,000 ppm or less; and a lack of noticeable odor.
    The OSHA respiratory protection standard adopted in 1971 referenced 
the then-current CGA G-7.1-1966 breathing air quality standard. In 
1973, and again in 1989, the CGA, in conjunction with ANSI, revised the 
G-7.1 standard. The Grade D specification was changed as part of the 
1989 ANSI revision, at which time the carbon monoxide level was reduced 
from 20 ppm to 10 ppm. The OSHA Directorate of Compliance Programs 
subsequently issued letters of interpretation in 1991 and 1992 that 
required employers to use the updated Grade D specifications for 
breathing air quality.
    The proposal requested comments on whether acceptable respirator 
breathing air quality should continue to meet the specifications for 
Grade D breathing air described in the ANSI/CGA G 7.1-1989 standard. 
Commenters supported inclusion of a requirement for use of the 1989 
Grade D breathing air values in the final rule (Exs. 54-141, 54-189, 
54-267, 54-286, 54-408, 54-443). For example, the Tennessee Valley 
Authority (Ex. 54-189) and Norfolk Southern (Ex. 54-267)

[[Page 1253]]

supported the Grade D breathing air requirement, stating that, in their 
experience, the Grade D air they have been using is fully adequate and 
safe, and that OSHA should not adopt more stringent requirements across 
the board.
    Modern Safety Techniques, Inc. (Ex. 54-141) supported maintaining 
the Grade D breathing air quality requirement but recommended that the 
OSHA rule not specify the year of the ANSI/CGA standard, because, for 
example, employers were confused when the CGA revised the ANSI/CGA G-
7.1 standard in 1989 and the OSHA standard referred to an earlier 
version of that standard. However, the regulations governing the 
incorporation of documents by reference (1 CFR 51) require that the 
revision date of incorporated references be specified when they are 
included in any new or revised standard. Where incorporated references 
are used in final paragraph (i), therefore, the latest revision dates 
for these references have been used.
    The Los Alamos National Laboratory (LANL) (Ex. 36-52) recommended 
that Grade E air rather than Grade D air be used since most air that 
passes the Grade D requirements will also pass Grade E requirements. 
The Grade E specifications narrow the range of permitted oxygen content 
from 19.5-23.5 percent to 20 to 22 percent oxygen and lower the 
allowable carbon dioxide level from 1000 ppm to 500 ppm. LANL gave no 
specific safety or health reason for OSHA to adopt this more stringent 
recommendation. The Service Employees International Union (Ex. 54-455), 
however, points out that Grade E air of reliable quality may be 
difficult for employers to obtain. In addition, OSHA is not aware of 
any problems that have occurred as a result of breathing Grade D air, 
and believes that the Grade D specifications will fully protect 
employees who use atmosphere-supplying respirators. Therefore, OSHA is 
not convinced a higher grade of air is required, and the final rule 
specifies Grade D air.
    OSHA has been informed that NIOSH has been working with the 
National Aeronautics and Space Administration (NASA) on a new ``liquid 
air SCBA'' that may be submitted for NIOSH certification in the future. 
In its revision of the 42 CFR 84 respirator certification standard, 
NIOSH incorporated the CGA Commodity Specification for Air in the CGA's 
G-7.1-1966 standard to maintain the quality verification category for 
Type II liquid compressed air, which had been removed from the updated 
ANSI/CGA G-7.1-1989 standard. NIOSH included this specification because 
a liquid compressed air quality category is needed for future 
evaluations of atmosphere-supplying respirators that use liquefied 
compressed air. NIOSH continues to recommend the use of the ANSI/CGA G-
7.1-1989 standard for breathing air quality for currently issued 
respirator certifications.
    Under paragraph (i)(2) of the final standard, employers are 
prohibited from using compressed oxygen in atmosphere-supplying 
respirators, including open-circuit SCBAs, that have previously used 
compressed air. This prohibition was proposed in the NPRM, and is 
intended to prevent the fires and explosions that could result if high 
pressure oxygen comes into contact with oil or grease that has been 
introduced to the respirator or the air lines during compressed air 
operations. Comments to the record (Exs. 10, 54-165, 54-208, 54-218) 
support this provision. Additionally, the prohibition is consistent 
with Clause 10.5.2 of the ANSI Z88.2-1992 standard.
    Proposed paragraph (i)(3) would have prohibited the use of oxygen 
with supplied air respirators. This provision was intended to avoid the 
possibility of fires and explosions that can result when oxygen is used 
in high concentrations. However, some respiratory equipment is 
specifically designed to avoid fire and explosion hazards when used 
with oxygen in concentrations greater than 23.5%. Therefore, paragraph 
(i)(3) of the final standard specifies that oxygen in concentrations 
greater than 23.5% is to be used only with equipment designed 
specifically for oxygen service or distribution. Several commenters 
pointed out the need to specify a maximum oxygen concentration (Exs. 
54-165, 54-208, 54-218, 54-219). Clause 10.5.2 of the ANSI Z88.2-1992 
standard (Ex. 81) also states, ``Oxygen concentrations greater than 
23.5% shall be used only in equipment designed for oxygen service or 
distribution.'' OSHA agrees with the recommendations made by the AIHA 
(Ex. 54-208), 3M (Ex. 54-218), and Monsanto (Ex. 54-219) that the final 
rule adopt the maximum oxygen concentration language from the ANSI 
standard, and the final rule reflects this recommendation.
    Final paragraph (i)(4) requires that breathing air for respirators 
provided from cylinders or air compressors meet certain minimum 
standards. Under final paragraph (i)(4)(i), cylinders must be tested 
and maintained as prescribed in the Shipping Container Specification 
Regulations of the Department of Transportation (DOT) (49 CFR parts 173 
and 178); these DOT regulations are also required for NIOSH respirator 
certification. The DOT regulations in parts 173 and 178 cover the 
construction, maintenance, and testing of these compressed air 
cylinders, and are necessary to prevent the explosions that can result 
if high pressure breathing air cylinders rupture. The proposal 
referenced only 49 CFR part 178, but the AIHA (Ex. 54-208) recommended 
that the DOT requirements found in 49 CFR part 173 also be specified in 
the final rule because they apply to breathing air cylinders. Final 
paragraph (i)(4)(i) therefore includes a reference to part 173 in 
addition to part 178.
    Paragraph (i)(4)(ii) of the final standard includes a provision 
requiring employers to ensure that cylinders of purchased breathing air 
are accompanied by a certificate from the supplier stating that the air 
meets the requirements for Type 1-Grade D breathing air contained in 
paragraph (i)(1)(ii) of the final standard. Employers must obtain a 
certificate of analysis of purchased breathing air from the supplier to 
ensure that its content and quality meet the requirements for Grade D 
breathing air. This will allow the employer to have assurance that the 
purchased breathing air being used by employees is safe. The proposal 
did not include a requirement for the certification of the quality of 
purchased breathing air. There was, however, support in the record 
(Exs. 54-234, 54-266, 54-273, 54-330, 54-408) for adding this 
requirement. For example, the American Petroleum Institute (Ex. 54-330) 
and Duquesne Light Company (Ex. 54-408) recommended that additional 
guidance, similar to that in ANSI Z88.2-1992, be provided to ensure the 
quality of purchased breathing air. Exxon (Ex. 54-266) stated that OSHA 
should not allow the direct blending of compressed nitrogen and oxygen 
gases by the employer to produce Grade D air, citing the ``extreme 
consequences of having too little oxygen in a cylinder.'' Exxon further 
recommended that 100% of the cylinders be tested for oxygen content for 
all nitrogen/oxygen mixed cylinders (Ex. 54-266). The requirement that 
the employer obtain a certificate of analysis of purchased breathing 
air means that every cylinder will have been analyzed for oxygen 
content by the supplier and, therefore, the situation feared by Exxon 
will not arise.
    Final paragraph (i)(4)(iii) requires that the moisture content of 
compressed air in air cylinders not exceed a dew point of -50 deg. F 
(-45.6 deg. C) at one atmosphere of pressure. This requirement will 
prevent respirator valves from freezing, which can occur when excess 
moisture accumulates on the valves. This provision has been revised 
from the proposed requirement to be consistent

[[Page 1254]]

with the latest versions of the standard references for moisture 
content of compressed breathing air, the ANSI Z88.2-1992 and ANSI/CGA 
G-7.1-1989 standards. Consistency between the required value and the 
standard references will avoid confusion in measuring moisture content 
and, consequently, will enhance employee protection. This dew point 
value, as the AIHA (Ex. 54-208) recommended, has been taken from the 
ANSI/CGA G-7.1-1989 specifications for Grade D air and replaces the 27 
ml/m3 value for moisture content specified in the proposal.
    Final paragraph (i)(5)(i) requires that compressors that supply 
breathing air are to be constructed and situated so that contaminated 
air cannot enter the air supply system. This provision from the prior 
standard is retained and also reflects the intent of the proposed 
requirement. The purity of the air entering the compressor intake is a 
major factor in the purity of air delivered to the respirator user. The 
location of the intake is most important, and must be in an 
uncontaminated area where exhaust gases from nearby vehicles, the 
internal combustion motor that is powering the compressor itself (if 
applicable), or other exhaust gases being ventilated from the plant 
will not be picked up by the compressor air intake. Contaminated air or 
exhaust gases from internal combustion engines that are taken into the 
compressor are major hazards to the purity of breathing air from 
compressors, and these hazards occur with all compressors, not just 
oil-lubricated ones. Respirator users have died or been injured when 
the air intake was not properly located to avoid contaminants. Final 
paragraph (i)(5)(i), therefore, requires that air intakes for all 
compressors be located in a way that avoids entry of any contaminated 
air into the compressor.
    Support for this requirement can be found in the Distler air 
compressor study (Ex. 32-1). This study recommended that engine exhaust 
gases should be piped upward or downwind from the compressor air 
intake, particularly where exhaust gases are not reliably dispersed, 
such as in partially enclosed spaces or in turbulent wind areas. The 
compressor exhaust piping used in the Distler study had to be 
repositioned several times to find a location where the exhaust gases 
would not be picked up by the compressor air intake. All of these 
findings reinforce the importance of locating the compressor's air 
intake in an area that ensures that only high-quality air can be taken 
in. No comments were received on the proposed requirement for the 
location of compressor air intakes.
    Final paragraph (i)(5)(ii) has been slightly modified from proposed 
requirement (i)(4)(ii) to require that the moisture content of 
compressed air be minimized so that the dew point at one atmosphere of 
pressure is 10 degrees Fahrenheit (5.56 degrees Celsius) below the 
ambient temperature to prevent water freezing in valves and connections 
of the air supply system. Such freezing can block air lines, fittings, 
and pressure regulators. This final requirement is similar to the 
parallel provision of the previous standard, which required that 
breathing air meet the requirements of CGA G-7.1-1966. Two commenters 
(Exs. 54-208, 54-218) pointed out that the proposal specified a dew 
point of 10 degrees Celsius instead of the 10 degrees Fahrenheit 
specified in the ANSI/CGA G-7.1-1989 standard. The value in final 
paragraph (i)(5)(ii) has been revised to match the 10 deg. F provision 
in the G-7.1-1989 standard for Grade D air, with an equivalent value of 
5.56 deg. C added to comply with a Federal government requirement (P.L. 
100-418 and E.O. 12770) that scientific and technical measures are 
expressed as metric units.
    Paragraph (d)(2)(ii) of the prior standard required air compressors 
to have a receiver of sufficient capacity to permit the respirator user 
to escape from a hazardous atmosphere in the event of compressor 
failure. However, under paragraph (d)(2) of the final standard, the 
only respirators that can now be used in IDLH atmospheres are either 
SCBAs or supplied-air respirators with an auxiliary self-contained air 
supply for escape. Consequently, a requirement for an air receiver to 
permit escape from IDLH atmospheres is no longer needed in the final 
rule. Also, the prior respiratory protection standard, in paragraph 
(d)(2)(ii), required compressors to have alarms to indicate compressor 
failure and overheating; this requirement was part of the same 
provision that specified that a receiver for escape from a contaminated 
atmosphere in the event of compressor failure be available. This alarm 
requirement was deleted from the proposal and is not part of the final 
standard. An alarm to indicate compressor failure or overheating is 
unnecessary in non-IDLH atmospheres since, as OSHA stated in the 
proposal, the respirator user can readily exit the hazardous area if 
the respirator fails.
    The deletion from the final standard of the prior standard's 
requirement for compressors to be equipped with receivers if they were 
to be used in hazardous atmospheres will clarify an enforcement issue 
that has arisen in connection with ambient air movers. Ambient air 
movers have been developed to provide air to supplied-air respirators. 
These units are small electric compressors that are not oil-lubricated 
and have no air receiver. Such compressors are used in non-IDLH 
atmospheres. The use of ambient air movers has been allowed under an 
existing OSHA compliance directive even though such devices do not have 
the air receiver required for air compressors by the prior respiratory 
protection standard. However, the final standard removes the air 
receiver requirement for compressors, and ambient air movers will 
therefore be treated like any other air compressor used in non-IDLH 
atmospheres.
    Under final paragraph (i)(5)(iii), compressors must be equipped 
with suitable in-line air-purifying sorbent beds and filters to further 
assure breathing air purity. The Associated Builders and Contractors, 
Inc. (Ex. 54-309) recommended that the corresponding provision in the 
proposal be revised to add the requirement that employers change air-
purifying sorbent bed and filters in accordance with the manufacturer's 
instructions. Also, clause 10.5.4.2 of the ANSI Z88.2-1992 standard 
recommends that maintenance and replacement or refurbishment of the 
air-purifying and filter media be performed periodically by trained 
personnel and in accordance with the manufacturer's recommendations and 
instructions. OSHA agrees with the Associated Builders and Contractors 
that sorbent beds and filters must be maintained properly, and has 
added language to paragraph (i)(5)(iii) that is similar to that in ANSI 
Z88.2-1992, and requires sorbent beds and filters to be maintained and 
replaced or refurbished periodically in accordance with the 
manufacturer's recommendations. The Associated Builders and Contractors 
also recommended that sorbent bed and filter changes be documented, 
that such documentation be retained for one year, and that it be made 
available to OSHA on request. However, OSHA is not generally requiring 
that records of respirator maintenance performed under this standard be 
kept and does not believe such a requirement is necessary here. 
Instead, OSHA is requiring in paragraph (i)(5)(iv) that a tag 
containing the most recent date of sorbent bed replacement or 
refurbishing, along with the signature of the person performing the 
change, be kept at the compressor. This tagging requirement is also 
consistent with OSHA's efforts, as required by the Paperwork Reduction

[[Page 1255]]

Act of 1995, to reduce paperwork to the extent consistent with employee 
safety and health.
    Paragraphs (I)(6) and (i)(7) address the control of carbon monoxide 
levels in breathing air. Paragraph (i)(6) requires that, for 
compressors that are not oil lubricated, the CO levels in the breathing 
air may not exceed 10ppm. Paragraph (i)(7) requires monitoring of CO 
levels for oil lubricated compressors. OSHA stated in the NPRM that one 
method to prevent contaminated air from reaching the breathing air 
supply was to require carbon monoxide filters with continuous alarms 
for all breathing air compressors. The agency requested comments on the 
use of carbon monoxide alarms, high-temperature alarms, and shutoff 
devices in the workplace (59 FR 58926). A number of comments were 
received that addressed the issue of carbon monoxide monitors and 
alarms.
    Modern Safety Techniques, Inc. (MST) (Ex. 54-141) noted that in 
many workplaces it may be impossible or cost prohibitive to relocate 
the air intake to an area that would reduce the likelihood of carbon 
monoxide entering the system. In these cases, MST recommended 
continuous monitoring as the only method that would ensure breathing 
air quality. MST stated that the use of a carbon monoxide alarm or 
measuring device is necessary to tell whether carbon monoxide purifiers 
(e.g., Hopcalite filters) are functioning properly. MST stated, 
``Unless continuous monitoring is being conducted on the breathing air 
supply, ``frequent'' monitoring, or proper placement of the breathing 
air supply, only assures that the requirements are met at that 
particular instance in time.'' [Emphasis in original.] Eugene Satrun, 
an industrial hygienist who runs a respirator program in Illinois (Ex. 
54-261), supported the need for continuous carbon monoxide monitors, 
noting that automatic compressors can be operated with a vehicle 
running nearby and may consequently pull significant levels of carbon 
monoxide into the intake.
    Several commenters were opposed to OSHA adopting a requirement for 
continuous carbon monoxide monitoring and alarms (Exs. 54-234, 54-250, 
54-408). They stated that the requirements for sorbent bed filtration, 
proper air inlet location, and Grade D air quality, confirmed by 
periodic sampling, would be sufficient to control the carbon monoxide 
hazard. Kodak (Ex. 54-265) stated that it has assessed the purity of 
compressed air for breathing use over a period of 18 years at its 
plants, collecting and analyzing more than 1200 samples, and that no 
incidents of carbon monoxide production involving oil-lubricated 
compressors have been reported. Carbon monoxide production, Kodak 
stated, is best prevented by adequate procedures, awareness, and 
certification. Kodak did not provide specific procedures for 
determining air system compliance, nor further clarification of what is 
meant by awareness or certification. The Duquesne Light Company (Ex. 
54-408) stated that continuous monitoring was unnecessary, and that 
requiring filtration or purification of the air supply, proper location 
of the air intake, and Grade D air purity should be sufficient to 
ensure a safe breathing air supply. Meridian Oil (Ex. 54-206) opposed 
continuous monitors because these devices can generate false alarms.
    Other commenters proposed alternatives to continuous monitoring. 
Niagara Mohawk Power (Ex. 54-177), in comments opposing carbon monoxide 
alarms, stated that carbon monoxide filters with color-change 
indicators are an appropriate method to monitor carbon monoxide. 
Monsanto (Ex. 54-219) stated that OSHA should not require all 
compressors to have carbon monoxide filters and alarms. Monsanto stated 
that high-temperature alarms or automatic compressor shut downs would 
only be needed when there was a reasonable possibility of carbon 
monoxide production in the compressor due to equipment problems. TU 
Electric (Ex. 54-250) stated that carbon monoxide filters or continuous 
monitoring alarms should not be required for all breathing air 
compressors, but that regular testing of breathing air prior to use, 
and testing in specific locations on a regular basis during compressor 
use, should be required. This commenter also recommended against a 
requirement for carbon monoxide filters or monitors for oil-free 
compressors.
    Other commenters (Exs. 54-206, 54-234, 54-250) supported testing 
ambient air near the intake on a regular basis, but did not recommend a 
testing frequency. General guidance for periodic sampling of air 
quality for compressors is specified in Clause 10.5.4.3 and Table 4 of 
the ANSI Z88.2-1992 standard. The ANSI procedure was recommended by 
several commenters (Exs. 54-234, 54-250, 54-263, 54-273, 54-363). ANSI 
Z88.2-1992 recommends acceptance testing prior to initial use and 
representative sampling at distribution supply points on a periodic 
basis to ensure ``a continued high-quality air supply.'' Norfolk 
Southern (Ex. 54-267) stated that OSHA should not require the use of 
carbon monoxide filters with compressor-supplied air, and that the 
employer should have the option of using a carbon monoxide detector. 
This commenter stated also that installing a carbon monoxide filter is 
not reasonable for those systems that already have a carbon monoxide 
detector and high-temperature alarm. St. Lawrence Gas (Ex. 54-402) 
commented that carbon monoxide alarms should not be required and noted 
that it has found the use of carbon monoxide-to-carbon dioxide 
converters (with color-change indicators) sufficient for detecting the 
presence of carbon monoxide. ORC (Ex. 54-424) stated that carbon 
monoxide alarms or high-temperature alarms are not needed for all 
compressors. ORC recommended that adequate procedures, awareness, and 
certification for installation are the best means to ensure that 
contaminated air does not enter the compressor. This language is 
similar to that used by Kodak (Ex. 54-265), and, like Kodak, ORC (Ex. 
54-424) did not provide any elaboration of the phrase ``adequate 
procedures, awareness, and certification for installation.''
    A carbon monoxide monitor with an alarm can be used to continuously 
measure the breathing air and warn respirator users when carbon 
monoxide levels exceed the 10 ppm limit set for Grade D breathing air. 
However, these alarms need to be properly maintained to function 
effectively. MST (Ex. 54-141) stated that the electrochemical type of 
sensors used today are specific for carbon monoxide, are relatively 
stable during temperature and humidity changes, and are accurate enough 
to meet the CGA G-7.1-1989 requirements. These sensors have replaced 
the older metal oxide sensors that had problems with false alarms. 
However, the electrochemical sensors must be calibrated periodically 
(usually on a monthly basis) to perform accurately. The Service 
Employees International Union (Ex. 54-455) also recommended that the 
final standard address regular replacement of alarm sensors and filter 
media.
    Carbon monoxide filters with color-change indicators are used to 
convert carbon monoxide in breathing air to carbon dioxide, which is 
less likely to pose a hazard to the respirator user. The source of the 
carbon monoxide can be from contamination of the intake air or from 
carbon monoxide generated by the compressor. However, the color change 
in the indicator results from moisture in the breathing air that is 
trapped in the filter element. The color-change indicator, therefore, 
does not indicate the presence of carbon monoxide, but instead signals 
only the presence of moisture, which can render the sorbent filters 
ineffective. Consequently, the

[[Page 1256]]

color-change indicator cannot be used directly to detect carbon 
monoxide. In addition, these carbon monoxide filters, like carbon 
monoxide alarms, need periodic maintenance to ensure their continued 
effectiveness.
    In summary, strong arguments favor a requirement for continuous 
carbon monoxide monitoring of compressor-generated breathing air. This 
is the case because preventing carbon monoxide contamination by 
locating the air intake for compressors in an area that is free of 
carbon monoxide contamination is difficult in many cases and impossible 
in others. Automatic compressors with poorly located air intakes may 
operate when a running vehicle is in the immediate area, thereby 
contaminating the air supply with carbon monoxide from the vehicle's 
exhaust. In addition, older compressors, which may still be operational 
after hundreds, if not thousands of operating hours, may allow 
increased oil blow-by due to piston ring and cylinder wear, which 
increases the possibility of carbon monoxide contamination.
    The most convincing evidence against a requirement for continuous 
carbon monoxide monitoring comes from the 18-year collection of 
sampling results taken by Kodak (Ex. 54-265). OSHA notes, however, that 
Kodak's results are likely to be due to the company's careful 
observance of operating procedures, such as procedures ensuring the 
proper location of air intakes and regular and thorough maintenance and 
repair of all compressors. OSHA notes that Clause 10.5.4.3 of the ANSI 
Z88.2-1992 standard calls for periodic, rather than continuous, 
sampling of breathing air from the air supply.
    The arguments for and against carbon monoxide alarms are less well 
defined than the case for carbon monoxide monitoring devices. Several 
commenters specifically recommended the use of carbon monoxide alarms 
whenever compressed air is being used as breathing air (Exs. 54-337, 
54-428, 54-455). The AFL-CIO (Ex. 54-428) recommended the use of carbon 
monoxide alarms or monitors on all air supply systems that service 
respirators with Grade D breathing air. Both of these recommendations 
would assure an air supply uncontaminated by carbon monoxide. The 
proponents of carbon monoxide alarms (Exs. 54-141, 54-261, 54-337, 54-
428, 54-455) state that they are needed to alert personnel that 
equipment is malfunctioning; the Exxon Company (Ex. 54-266) stated that 
gasoline- and diesel-powered compressors should be required to have 
carbon monoxide alarms to detect exhaust gases that enter the air 
supply, as well as compressor failure and high-temperature alarms; 
other commenters (Exs. 54-337, 54-428) would require the use of carbon 
monoxide alarms to prevent accidental carbon monoxide contamination 
whenever compressed air is being used as breathing air.
    The opponents (Exs. 54-177, 54-206, 54-219, 54-234, 54-250, 54-265, 
54-402) of carbon monoxide alarms cite the availability of alternate 
equipment and procedures that they claim are as effective as alarms in 
protecting the purity of breathing air. Examples of these alternatives 
are filters with color-change indicators, carbon monoxide-to-carbon 
dioxide converters, oil-free compressors, proper air intake placement, 
certification of air compressor systems, and periodic monitoring (Exs. 
54-177, 54-206, 54-219, 54-250, 54-265, 54-330, 54-402, 54-408, 54-
424).
    OSHA believes that it is essential for the employer to ensure that 
excessive carbon monoxide is not in the compressed breathing air 
supplied to respirators. Final paragraphs (i)(6) and (i)(7), therefore, 
require that the employer prevent carbon monoxide levels in the 
breathing air from exceeding 10 ppm. For compressors that are not oil-
lubricated, this requirement can be met by several different methods, 
including the use of continuous carbon monoxide alarms, carbon monoxide 
filters, proper air intake location in an area free of contaminants, 
frequent monitoring of air quality, or the use of high-temperature 
alarms and automatic shutoff devices, as appropriate. No single method 
will be appropriate in all situations, and several methods may need to 
be combined, e.g., the use of carbon monoxide alarms with carbon 
monoxide filters where conditions are such that a reliable carbon 
monoxide-free area for compressor air intakes cannot be found. As the 
comments to the record show, there was no agreement on the most 
appropriate method for ensuring that carbon monoxide would not 
contaminate the breathing air coming from compressors. OSHA has decided 
that a performance-based requirement ensuring that carbon monoxide does 
not contaminate breathing air will give employers flexibility in 
selecting the method(s) most appropriate for conditions in their 
workplace.
    Oil-lubricated compressors can produce carbon monoxide if the oil 
enters the combustion chamber and is ignited. This can be a 
particularly severe problem in older compressors whose piston rings and 
cylinders are worn. Final paragraph (i)(7) requires that such 
compressors have a high-temperature or carbon monoxide alarm, or both. 
If only a high-temperature alarm is used, the air from the oil-
lubricated compressor must be monitored at intervals sufficient to 
prevent carbon monoxide in the breathing air from exceeding 10 ppm. The 
latter requirement ensures that carbon monoxide that enters a poorly 
located compressor air intake, as well as carbon monoxide generated by 
the compressor itself, is detected.
    Final paragraph (i)(7) is similar to a provision in the previous 
standard. In the NPRM, OSHA proposed to delete the requirement from the 
previous respirator standard that oil-lubricated compressors be 
equipped with carbon monoxide alarms and high-temperature shutoff 
devices. However, a number of commenters (Exs. 54-144, 54-219, 54-266) 
stated that precautions against excessive carbon monoxide were needed 
when oil-lubricated compressors were used. Modern Safety Techniques 
(Ex. 54-144) stated that oil-lubricated compressors used by industry to 
supply breathing air often have hundreds of hours of use, allowing 
greater oil blow-by and therefore greater potential for carbon monoxide 
production, was reported in the Distler study. That study found that 
properly functioning air compressors are unlikely to reach temperatures 
at which carbon monoxide production occurs. Exxon (Ex. 54-266) 
encouraged OSHA to include a requirement for in-line carbon monoxide 
alarms for diesel- or gasoline-powered compressors, since its 
experience indicates that the use of these compressors increases the 
risk of carbon monoxide contamination from the compressor's exhaust. 
Monsanto (Ex. 54-219) stated that high-temperature alarms or automatic 
compressor shutoffs would be needed when there was a reasonable 
possibility of carbon monoxide production in the compressor due to 
equipment problems. The Service Employees International Union (Ex. 54-
455) argued that the requirements specifying Grade D breathing air 
purity and location of the compressor air intake in an uncontaminated 
atmosphere were not sufficient to ensure that carbon monoxide is not 
entrained in the system.
    An incident of carbon monoxide production by an oil-lubricated 
compressor was described in a MSHA Accident Investigation Report issued 
in January 1985 (Ex. 38-12). An oil-cooled, diesel-powered, two-stage, 
rotary air compressor overheated during a sandblasting operation at a 
limestone quarry. The air compressor thermo-bypass valve, which should 
have directed the oil through a cooling

[[Page 1257]]

radiator once the oil had reached a temperature of 185 deg.F, failed, 
which allowed the temperature of the cooling oil to rise above its 
flashpoint of 420 deg.F. The oil ignited, producing carbon monoxide. 
The compressor was equipped with a high-temperature shutoff switch set 
for 235 deg.F, but it had been disconnected for at least 30 days prior 
to the incident. The compressor was not equipped with a carbon monoxide 
filter or alarm. The sandblaster collapsed from carbon monoxide 
poisoning. Monsanto (Ex. 54-219) stated that this incident resulted 
from a failure to follow the provision in the previous standard 
requiring that oil-lubricated compressors have a functional high-
temperature or carbon monoxide alarm, or both. OSHA believes that this 
incident, as well as the comments described above, supports carrying 
the previous standard's requirement forward in the final rule.
    Final paragraph (i)(8) requires that air line couplings be 
incompatible with outlets for non-respirable worksite air or other gas 
systems to prevent the inadvertent provision of nonrespirable gases to 
airline respirators. Breathing air couplings, therefore, are to be made 
incompatible with outlets from nonrespirable plant air and other gas 
systems. This requirement is similar to the provision in paragraph 
(d)(3) of the previous respiratory protection standard and proposed 
paragraph (i)(5) of the NPRM. Martin Marietta (Ex. 54-410) stated that 
there have been documented cases in which cross-connections have 
introduced hazardous contaminants into breathing air lines. To avoid 
this problem, Martin Marietta recommended that OSHA add a provision to 
the final standard that prohibits connecting breathing air lines to any 
nonrespirable gas source or process. Consistent with this 
recommendation, OSHA has added a sentence to paragraph (i)(8) requiring 
that no asphyxiating substance be introduced into breathing air lines. 
This requirement will cover not only the contamination of the breathing 
air system from cross-connections, but will also cover other potential 
contaminating conditions, e.g., using nitrogen to blow out worksite air 
lines where the worksite air source is also used for breathing air.
    The final standard also requires that the employer prevent utility 
oxygen, i.e., oxygen supplied to meet other manufacturing needs, from 
entering the respirator air supply system. As discussed above, the 
standard permits oxygen to be used in respirators designed for oxygen 
service. The final standard prohibits the introduction of utility 
oxygen into breathing air systems that supply respirators that are not 
designed for oxygen service; this provision is needed to prevent the 
fires and explosions that could result if high-pressure oxygen comes 
into contact with oil or grease that has been introduced to the 
respirator or the air lines during compressed air operations.
    Final rule paragraph (i)(9) requires employers to use breathing gas 
containers marked in accordance with the NIOSH respirator certification 
standard at 42 CFR part 84. This requirement differs from proposed 
paragraph (i)(6), which listed several additional standards for 
breathing gas containers. These additional standards have been 
incorporated into 42 CFR part 84, making reference to them in the final 
rule unnecessary.
Paragraph (j)--Identification of Filters, Cartridges, and Canisters
    The final rule provides that the employer only use filter 
cartridges and canisters that are labeled and color coded with the 
NIOSH approval label and that the label not be removed or made 
illegible. This is similar to the parallel requirement in the proposal, 
which was supported by commenters (Exs. 54-361, 54-428, 54-455). OSHA 
has modified the proposed language in certain respects to add 
compliance flexibility while retaining the original objective, i.e., 
assurance that these elements meet NIOSH's stringent requirements. 
These comments and modifications are discussed below.
    OSHA proposed to eliminate from the previous respiratory protection 
standard the language in paragraphs (g)(1) to (g)(6), which described 
labeling requirements, and Table I-1, which listed color codes assigned 
to canisters and cartridges. These requirements were adopted from the 
original national consensus standard (i.e., ANSI K13.1, ``Standard for 
Identification of Air-Purifying Respirator Canisters and Cartridges'') 
adopted by OSHA in 1971. In place of these requirements, proposed 
paragraph (j)(1) would have required employers to ensure that all 
filters, cartridges, and canisters bear a NIOSH approval label before 
being placed into service.
    Proposed paragraph (j)(2) specified that the label not be removed, 
obscured, or defaced while the filter, cartridge, or canister was in 
service to ensure that the label provided information to the employee 
about the protection being afforded by the respirator. In the final 
standard, OSHA has combined proposed paragraphs (j)(1) and (j)(2) into 
a single paragraph (j). The changes from the previous standard 
recognize that employers who use respirators should be able to rely on 
labeling and color coding by respirator manufacturers for assurance 
that the respirators meet NIOSH requirements.
    This position is consistent with that taken by many commenters, who 
noted that the labeling and color coding of filters are the 
responsibility of the respirator manufacturer (Exs. 54-208, 54-218, 54-
219, 54-278, 54-289) and are required by NIOSH for certification. OSHA 
agrees that color coding and the attachment of NIOSH approval labels to 
respirators are the responsibility of the manufacturer. However, it is 
still the employer's responsibility to use only components bearing a 
NIOSH approval label, and to ensure that the NIOSH approval labels are 
not removed from the filters, cartridges, and canisters that are used 
in the workplace and remain legible.
    The NIOSH label serves several purposes. It ensures selection of 
appropriate filters for the contaminants encountered in the workplace 
and permits the employee using the respirator to check and confirm that 
the respirator has the appropriate filters before the respirator is 
used. David Lee, a CIH, CSP, and respirator consultant (Ex. 54-304), 
commented that, once a filter selection is made and the respirator is 
donned, the label becomes meaningless. However, the employee is not the 
only one who uses the color coding and label. Color coding and labeling 
also allow fellow employees, supervisors, and the respirator program 
administrator to readily determine that the appropriate filters are 
being used by the employee. Cartridges that are appropriate for one 
operation may be inappropriate for another, and color coding and 
labeling allow respirator users with inappropriate filters to be 
identified in the workplace and potential respiratory hazards to be 
avoided.
    Proposed paragraph (j)(2) required that the NIOSH approval label 
not be ``removed, obscured or defaced'' while respirators are being 
used. 3M (Ex. 54-218) and Monsanto (Ex. 54-219) urged OSHA to add the 
word ``intentionally'' before ``removed, obscured or defaced,'' since 
they believe that an employer would be in violation of this provision 
if, for example, a label is covered with paint overspray during use. 
Monsanto also stated that some OSHA substance-specific standards 
require that cartridges be dated by the employee to indicate when they 
were first put into service and that some employers could use this 
dating method to control cartridge use even when not required by OSHA. 
Accordingly, Monsanto urged OSHA to add the phrase ``except if it is to 
record

[[Page 1258]]

initial use information'' to paragraph (j)(2) to clarify that adding a 
date to the NIOSH label is allowed and will not be regarded as defacing 
the label. David Lee (Ex. 54-304) was concerned that dirt, dust, and 
debris can easily obscure the label once the respirator is in use and 
that employees would be required by the proposed provision to leave the 
area to clean the label to make it legible. Dow (Ex. 54-278) stated 
that, because of the small size of the label on some cartridges, the 
employer cannot date the cartridges without obscuring some of the 
information on the label. To resolve this problem, Dow suggested that 
the words ``pertinent information'' be added before ``obscured.''
    OSHA has not added the term ``intentional'' to final paragraph (j) 
because it would be difficult, if not impossible, to determine if the 
removal or obscuring of a NIOSH label was accidental or intentional. 
Also, the final provision does not include an exemption for documenting 
the initial use date on cartridge and canister labels, since OSHA 
already permits this practice. OSHA's experience indicates that the 
initial use date can easily be added to a filter, cartridge, or 
canister without obscuring the label, and this procedure has not proven 
to be a problem in the substance-specific standards that require such 
dating. The term ``pertinent information'' has not been included in 
final paragraph (j) because OSHA believes that all of the information 
on the NIOSH approval label is pertinent. The degree of cleanliness 
required of the label while the respirator is in service should not be 
an issue because the label only needs to be legible and reasonably 
clean to provide the required information. Any dust, dirt, paint 
overspray, or other substance that completely obscures the label would 
also affect respirator cleanliness and the service life of the filter, 
resulting in replacement of the filter with new filters that have 
unobscured labels, as required by paragraph (g).
    In summary, final paragraph (j) combines into a single provision 
the proposed requirements that employers ensure that the manufacturer's 
NIOSH approval label is on the cartridge, filter, or canister, and that 
employers maintain the labels in legible condition while the cartridge, 
filter, or canister is in service. As with the proposed paragraphs, 
this provision is a performance-based requirement that permits 
employers to adopt whatever procedures are appropriate to ensure that 
the label remains on the filter and is not removed, defaced, or 
obscured during respirator use.
Paragraph (k)--Training and Information
    Paragraphs (k)(1)-(3) of the final standard require employers to 
provide effective training for employees required by the employer to 
wear respirators. Employees must be trained sufficiently to be able to 
demonstrate a knowledge of why the respirator is necessary; how 
improper fit, usage, or maintenance can compromise the protective 
effect of the respirator; the limitations and capabilities of the 
selected respirator; how to deal with emergency situations involving 
the use of respirators or with respirator malfunction; how to inspect, 
don and remove, and check the seal of the respirator; procedures for 
maintenance and storage of the respirator; the medical symptoms and 
signs that may limit or prevent the effective use of respirators; and 
the general requirements of this standard.
    Paragraph (k)(4) allows for the ``portability'' of previous 
respirator training, and paragraph (k)(5) specifies the requirement for 
at least annual retraining. Also, as discussed earlier under the 
Summary and Explanation for paragraph (c), Respiratory Protection 
Program, final paragraph (k)(6) requires employers to provide the basic 
advisory information presented in Appendix D of this section to 
employees who voluntarily use respirators in their workplace.
    The final standard requires that training be understandable and be 
given to the employee prior to using a respirator in the workplace, and 
annually thereafter. Additionally, if the employer has reason to 
believe that any employee who has already been trained does not have 
sufficient understanding and skill to use the respirator, the employer 
must retrain the employee in those areas in which his or her knowledge 
or skill is deficient. Retraining is also required when changes in the 
workplace or in the type of respirator used render previous training 
obsolete.
    Section 1910.134(e)(5) of the previous standard required training 
in the selection, use, and maintenance of respirators and required 
respirator wearers to be provided an opportunity to handle the 
respirator, have it fitted properly, test its facepiece seal, and wear 
it in normal air for a familiarity period. The final training paragraph 
retains many of these provisions. However, the format of the final 
training provisions is different, and specific provisions for annual 
training and retraining are included in the final standard. Although 
the previous standard's requirement for a familiarity period has not 
specifically been retained, the final standard requires the respirator 
wearer to be trained sufficiently to demonstrate the ability to use the 
respirator properly, which may or may not necessitate wearing the 
respirator in normal air ``for a long familiarity period.''
    The record shows widespread agreement that employee training is a 
critical part of a successful respiratory protection program and is 
essential for correct respirator use (Exs. 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, 54-5, 
54-68, 54-91, 54-92, 54-165, 54-172, 54-208, 54-219, 54-278, 54-361, 
54-387, 54-428, 54-455, Tr. 186, 387, 595, 1011, 1063, 1083, 1103, 
1226).
    For example, James Johnson of the Lawrence Livermore National 
Laboratory testified:

    The training element of the respiratory protection program is 
one of the most important elements to assure the respirator is 
properly used and is performing as intended * * *. This is the only 
time that the worker has a chance to interact with a trained 
professional who can properly instruct that person on the correct 
use of the respirator, the employee can see what is right, what 
doesn't work, and can understand this item that is given to him to 
wear throughout a year to help protect his health * * * (Tr. 186)
    Dan Faulkner of the United Steelworkers of America concurred, 
commenting that: Training must be seen as a critical component of 
respiratory protection. This is an area that is grossly ignored 
under the current regulation * * *. The very first step in the 
education process must be to empower workers to identify the 
hazardous substances involved and at what levels they are exposed. 
In order for the workers to have confidence that his/her respirator 
is providing the necessary protection from the hostile work 
environment they must have a thorough knowledge of this entire 
process. Once this is understood, the worker can make an informed 
decision on what type of respirator to wear. (Tr. 1062)

ASARCO, Inc. (ASARCO) agrees about the importance of training and 
reports that its company Respiratory Protection Program Manual states: 
``For the safe use of any respirator, it is essential that the user be 
properly instructed in the respirator's purpose, selection, fitting, 
use, and limitations' (Ex. 163).
    OSHA agrees with the many commenters who urged OSHA to mandate a 
program that is performance oriented and can be presented informally 
(Exs. 15-13, 15-18, 15-22, 15-30, 15-41, 15-47, 15-62, 15-73, 15-75, 
54-213, 54-265, 54-275, 54-455). The final standard does not specify 
how the training is to be performed nor the format to be used by the 
employer. As suggested by commenters (Ex. 15-53, Tr. 837, Tr. 1087), 
the employer can use

[[Page 1259]]

whatever training method is effective for the particular worksite, 
provided that the method addresses the required topics. Employers can 
use prepared materials such as audio-visual and slide presentations, 
formal classroom instruction, informal discussions during safety 
meetings, training programs developed or conducted by unions or outside 
sources such as respirator manufacturers, or a combination of these 
methods.
    As in the proposal, several categories of training information must 
be addressed in the final rule. The final provisions have been 
simplified since the proposal, but the information to be covered is 
essentially the same as that proposed.
    Paragraph (k)(1) requires the employer to ensure that before the 
employee uses the respirator in the workplace, the employee 
demonstrates that he/she has learned the information communicated under 
the training program. The employer can comply with this provision by 
reviewing with the employee, either in writing or orally, the 
informational part of the training program and by reviewing the 
employee's hands-on use of respirators.
    OSHA's personal protective equipment standard (Sec. 1910.132(f)(2)) 
also requires that employees demonstrate effectiveness in using PPE 
before workplace use. When that standard was adopted in 1994, OSHA 
stated that ``in order for training to be successful, clear and 
measurable objectives must be set, and employees must demonstrate that 
the training objectives have been reached by showing that they 
understand the information provided and that they can use the PPE 
properly'' (59 FR 16339). This reasoning applies equally to respiratory 
protection. In the NPRM for the respiratory protection standard 
(proposed paragraph (k)(1)(iii)), OSHA proposed a similar requirement, 
which stated that the training itself was to include ``sufficient 
practice to enable the employee to become * * * effective in performing 
tasks [relating to inspection, donning and removal, checking the fit 
and seals, and in wearing the respirator.]''
    The final standard's requirement that employees ``demonstrate'' 
competence in using respiratory equipment is supported by the 
recommendation of commenters that the PPE standard's similar 
requirement replace the less direct provision in the respiratory 
protection proposal (Exs. 54-213, 54-319). OSHA's enforcement of the 
PPE standard has reinforced the Agency's belief that training 
effectiveness must be evaluated by demonstrating how well employees use 
equipment on-the-job. OSHA believes that adopting a provision in the 
respirator standard that is worded similarly to the corresponding 
requirement in the PPE standard will promote compliance with both 
standards and uniformity of interpretations and enforcement actions. 
Moreover, measuring the adequacy of training by evaluating the 
employee's knowledge gained from the training is consistent with the 
performance orientation of the final standard and with the absence of 
specific hourly training requirements in the final standard.
    The first category of information to be included in the training 
program, specified in final paragraph (k)(1)(i), is a discussion of why 
the use of the respirator is necessary. Proposed paragraph (k)(1)(i) 
specifically set forth that this discussion was to include information 
on the nature, extent, and effects of the respiratory hazards to which 
the employee may be exposed while using the respirator. The language of 
final paragraph (k)(1)(i) has been simplified; OSHA believes that 
training in why the respirator is necessary will include information on 
the nature, extent, and effects of the respiratory hazards. For 
example, such training would address the identification of the 
hazardous chemicals involved, the extent of employee exposures to those 
chemicals, and the potential health effects of such exposure. Much of 
this information will be available on the Material Safety Data Sheets 
that chemical manufacturers provide to employers under the Hazard 
Communication standard (29 CFR 1910.1200). Employee training on the 
health effects of hazardous chemicals is also required under the Hazard 
Communication standard, and the same training could help satisfy this 
respirator training requirement. Many commenters agreed that hazard 
information is an essential element of training (Exs. 15-10, 15-14, 15-
18, 15-19, 15-27A, 15-41, 15-46, 15-53, 15-62, 15-73, 54-5, 54-68, 54-
91, 54-165, 54-172, 54-208, 54-278, 54-361, 54-428, 54-455).
    Information regarding the consequences of improper fit, usage or 
maintenance on respirator effectiveness must also be provided to 
employees under final paragraph (k)(1)(i). Improper attention to any of 
these program elements would obviously defeat the effectiveness of the 
respirator. Employees must understand that proper fit, usage and 
maintenance of respirators is critical to ensure that they can perform 
their protective function.
    Under final paragraph (k)(1)(ii), employers are to explain the 
limitations and capabilities of the respirator selected for employee 
use. A discussion of the limitations and capabilities of the respirator 
must address how the respirator operates. This training would include, 
for example, an explanation of how the respirator provides protection 
by either filtering the air, absorbing the vapor or gas, or providing 
clean air from an uncontaminated source. Where appropriate, it also 
should include limitations on the use of the equipment, such as 
prohibitions against using an air-purifying respirator in IDLH 
atmospheres and an explanation of why such a respirator should not be 
used in such situations.
    Paragraph (k)(1)(iii) requires that employees be provided with 
information on respirator use in emergency situations, including those 
in which the respirator malfunctions. This training requirement was 
included in proposed paragraph (k)(1)(v). Respirators malfunction on 
occasion, work routines change, and emergency situations occur that 
require a different respirator. The training program must discuss these 
possibilities and the procedures the employer has established to deal 
with them. Commenters concurred that comprehensive training is 
necessary where respirators are to be used in IDLH situations, 
including oxygen-deficient atmospheres, such as those that occur in 
firefighting, rescue operations and confined area entry (Exs. 15-18, 
15-19, 15-26, 15-31, 15-33, 15-37, 15-41, 15-48, 15-50, 15-54, 15-55, 
15-56, 15-59, 15-70).
    The employee should be able to thoroughly understand the operation 
of the respirator as a result of this training and demonstrate the 
ability to properly use the respirator selected. Numerous commenters 
supported the elements in the training program provided for under final 
paragraphs (k)(1) (ii) and (iii) (Exs. 61-3, 15-14, 15-18, 15-27A, 15-
41, 15-46, 15-53, 15-62, 15-73, 54-5, 54-68, 54-91, 54-172, 54-208, 54-
361, 54-428, 54-455). For example, Michael P. Rehfeld, Safety Officer, 
Westminster Fire Department, stated that:

    In section (k) of the NPRM dealing with training, I strongly 
believe OSHA should put the strongest emphasis. It has been my 
experience that the stronger the employer training program the less 
likely that an employee would become injured or dies from a 
respiratory protection failure. OSHA has historically put a strong 
emphasis on training (1910.120, 1910.1200, 1910.138, 1910.146). The 
same emphasis should appear in this rule (Ex. 54-68).


[[Page 1260]]


    Final paragraph (k)(1)(iv) requires the employer to provide 
specific instruction on how respirators are inspected, donned, removed, 
positive/negative pressure checked, and worn. Although the employer is 
required to ensure that respirator inspections are performed, employees 
using the equipment may frequently be responsible for inspecting the 
respirators assigned to them. In this case it is necessary that 
respirator users have this process explained and demonstrated to them 
so that they are capable of recognizing any problems that may diminish 
the protective capability of the respirator. The training must include 
the steps employees are to follow if they discover any problems during 
inspection, such as to whom problems should be reported and where 
replacement equipment can be obtained if needed. If, however, the 
employer routinely has extensive inspections done by separate 
personnel, individual respirator wearers are not required to be trained 
in how to perform full inspections. Training only in those parts of the 
inspection process that may be their responsibility would be 
sufficient.
    The training under this paragraph must also include the procedures 
for donning and removing the respirator, checking the fit and seals, 
and using the respirator. Respirator fit in the workplace must be as 
close as possible to the fit obtained during fit testing; therefore, 
employees must know how to follow procedures that will improve fit in 
the workplace. The fit testing procedures can also help in training 
employees. For example, employers can use quantitative fit testing 
procedures to demonstrate to employees the dramatic improvement in 
measured fit when the respirator is adjusted properly (See the 
discussion above of paragraph (f) and Ex. 15-44, Tr. 1083).
    Final paragraph (k)(1)(iv) requires training in how to check the 
respirator seal. Appendix B-1 describes methods for checking the seal 
of positive and negative pressure facepieces. Employees must be trained 
in the methods set forth in Appendix B-1 or in alternative methods that 
are equally effective. The training requirements set forth in paragraph 
(k)(1)(iv) were widely supported in the record (Exs. 15-10, 15-14, 15-
22, 15-27A, 15-41, 15-46, 15-50, 15-62, 15-73, 54-5, 54-68, 54-91, 54-
165, 54-172, 54-208, 54-219, 54-278, 54-361, 54-428, 54-455).
    Final paragraph (k)(1)(v), like proposed paragraph (k)(1)(iv), 
requires the employer to explain the procedures for maintenance and 
storage of respirators. The extent of training required under this 
provision may vary according to workplace conditions. In some cases, 
where employees are responsible for performing some or all respirator 
maintenance and for storing respirators while not in use, detailed 
training in maintenance and storage procedures may be necessary. In 
other facilities where specific personnel or central repair facilities 
are assigned to perform these activities, employees may need only to be 
informed of the maintenance and storage procedures without having to 
learn significant technical maintenance information. The importance of 
providing some knowledge to all employees regarding maintenance and 
storage of respirators was recognized by a number of commenters. Those 
commenters stated that employees must be able to identify respirator 
deficiencies that can result from improper maintenance and storage of 
respirators so that they will not use improperly functioning 
respirators (Exs. 61-3, 61-8, 15-10, 15-14, 15-27A, 15-41, 15-46, 15-
50, 15-62, Tr. 1063).
    Final paragraph (k)(1)(vi) requires that employees be instructed in 
ways to recognize the medical signs and symptoms that may limit or 
prevent the effective use of respirators. This provision was not 
included in the proposed standard. However, the Agency agrees with the 
AFL-CIO (Ex. 54-428) that employee knowledge of this information is 
important to ensure implementation of a successful respirator program. 
An employee's knowledge of the medical problems that may preclude the 
employee from using some types of respirators or from wearing a 
respirator under certain workplace conditions helps assure that the 
employee receives the protection intended by the standard. Examples of 
medical conditions and signs and symptoms that may affect an employee's 
ability to use a respirator are provided in mandatory Appendix C of the 
final standard. Training in these signs and symptoms need not be 
medically sophisticated or burdensome. Employees must be provided only 
with medical information sufficient for them to recognize the signs or 
symptoms of medical conditions (e.g., shortness of breath, dizziness) 
that may affect their use of respirators. This information will also 
enable employees to understand the purpose of the medical assessment 
procedures required under paragraph (e) of the final standard, will 
improve the ability of employees to recognize and report medical signs 
and symptoms, and will give them the knowledge they need to initiate 
the follow-up medical evaluations required under paragraph (e) of this 
section, if necessary.
    Final paragraph (k)(1)(vii) requires the employer to inform 
employees of the general requirements of this section. OSHA agrees with 
Organization Resources Counselors (Ex. 54-424) that ``general 
requirements'' better describes the substantive purpose of this 
provision than did the word ``contents,'' which was used in proposed 
paragraph (k)(1)(vi). OSHA believes it is necessary to ensure that 
employees know, in general, the employer's obligations under the 
standard with respect to employee protection. This discussion need not 
focus on the details of the standard's provisions but could, for 
example, simply inform employees that employers are obligated to 
develop a written program, properly select respirators, evaluate 
respirator use, correct deficiencies in respirator use, conduct medical 
evaluations, provide for the maintenance, storage, and cleaning of 
respirators, and retain and provide access to specific records.
    Proposed paragraph (k)(1)(vi) would have required that employees be 
provided with information on the written respiratory protection 
program, as well as the location and availability of the written 
program and the standard. These elements are omitted from final 
paragraph (k)(1)(vii) because they are addressed in other provisions of 
the final standard. For example, employee access to the standard and 
written program is required under final paragraph (m)(4), and employee 
knowledge about the written respirator program will be imparted to 
employees under the training required by final paragraph (k)(1), which 
specifies the elements to be included in the written respirator 
program.
    All of the training elements are important. They are presented in 
performance language to give the employer flexibility to adapt the 
training to specific workplace conditions and to the respirators used. 
Unless the training information is presented in a way that employees 
can understand, the training will not be effective. Therefore, final 
paragraph (k)(2) requires that training be conducted in a way that is 
understandable to employees. Employers should develop training programs 
based upon their employees' educational level and language background. 
This will ensure that all employees will receive training that will 
enable them to maximize the effectiveness of the respirators they use. 
Inclusion of a provision addressing training comprehension was 
supported in the record (Tr. 166) and is consistent with similar 
requirements in other recent OSHA rulemakings (Cadmium, 29 CFR 
1910.1027; Bloodborne

[[Page 1261]]

pathogens, 29 CFR 1910.1030; Formaldehyde, 29 CFR 1910.1048).
    Final paragraph (k)(3) requires the employer to provide training 
before the employee uses a respirator in the workplace. This provision 
was included under proposed paragraph (k)(2) and was widely supported 
by rulemaking participants (Tr. 1011, Tr. 1986; Exs. 54-91, 54-165, 54-
196, 54-234, 54-267, 54-278, 54-298, 54-319, 54-334, 54-361, 54-387, 
54-428, 54-455). No comments opposing this requirement were received.
    Final paragraph (k)(4) provides that an employer who can 
demonstrate that a new employee has received training within the last 
12 months that addressed the elements specified in paragraph (k)(1)(i) 
through (vii) is not required to repeat such training provided that, as 
required by paragraph (k)(1), the employee can demonstrate knowledge of 
the element(s). Employers availing themselves of this provision must, 
however, provide subsequent training no later than 12 months from the 
date of the previous training, as required by final paragraph (k)(4).
    An employee who has been trained in the use of respirators who 
moves to another job that involves the use of respirators may not need 
to take all of the initial training prescribed in paragraph (k)(4). 
Prior training in the topics required by the standard may remain 
relevant in the new work setting. Thus, OSHA is permitting limited 
``portability'' of training, as noted in the standard. Training in the 
elements listed in paragraph (k)(1) that has been provided in the past 
12 months by a previous employer may be taken into account by the new 
employer when evaluating the training needs of that new employee.
    The employer must demonstrate that the employee has received the 
prior training and retained the necessary knowledge before the prior 
training can be accepted as meeting the requirements of paragraph (k). 
Discussions with the employee and with the previous employer may be 
used to determine whether the previous training has been sufficient to 
enable the employee to wear, use, and care for the respirator 
successfully. If the employer cannot demonstrate that the new employee 
has been trained in the required elements of the program, and 
understands these elements, the new employer is obligated to train the 
employee. In cases where training in some elements is lacking or 
inadequate, the employer is required by paragraph (k)(4) to provide 
training in those elements.
    Final paragraph (k)(5) requires retraining annually and when 
certain situations occur. The requirement for annual training was 
strongly supported by management, labor, and other rulemaking 
participants as being necessary to ensure the continuing effectiveness 
of the respirator program (Exs. 15-10, 15-18, 15-19, 15-20, 15-37, 15-
44, 15-47, 15-48, 15-50, 15-54, 15-55, 15-71, 54-91, 54-157, 54-165, 
54-173, 54-208, 54-222, 54-245, 54-265, 54-292, 54-319, 54-332, 54-361, 
54-363, 54-387, 54-424, 54-427, 54-428, 54-442, 54-455, 122, 166; Tr. 
187, 443, 547, 614, 1011, 1022, 1226, 1768). For example, the Railway 
Labor Executive Association testified:

    The training requirements as proposed should be mandated on an 
annual basis . . . Such a training schedule will assure continuous 
familiarization with the equipment and will serve to negate the 
inevitable effects of complacency on the part of both the employer 
and the employee. (Tr. 443)

    Exxon stated that ``Annual training is good so the employee will 
feel comfortable with the respirator they will be using in the future'' 
(Tr. 547). James Johnson of Lawrence Livermore National Laboratory 
testified that annual training is ``. . . necessary to ensure a 
reasonable amount of recall and performance . . . `` (Tr. 187). Eastman 
Chemical Company (Ex. 54-245) commented that ``Eastman supports [the] 
annual training requirement . . . our Company believes this is 
necessary to adequately train employees.'' ASARCO and U.S. Steel 
require that their employees who wear respirators undergo annual 
training, and ASARCO states in its Respiratory Protection Manual that:

    All respirator wearing employees shall be given annual training 
on routine respirator use. . . . Applicable individuals will also be 
thoroughly instructed and trained annually in the use of respiratory 
protection and necessary procedures for non-routine or emergency 
situations. (Ex. 163)

    The Respirator Protection Program training manual for U.S. Steel, 
submitted by AISI, requires that: ``Each respirator wearer should be 
retrained at least annually. Where necessary, more frequent training 
should be performed. The required use of respirators should be 
specified in routine training aids such as Safe Job Procedures.'' (Ex. 
142)
    A number of commenters recommended that training should be required 
less frequently than annually (Exs. 15-41, 54-316, 54-324) or should be 
required only in response to a change in the respirator program (Exs. 
54-168, 54-172, 54-178, 54-187, 54-213, 54-234, 54-267, 54-273, 54-275, 
54-278, 54-297, 54-307, 54-316, 54-324, 54-334, 54-352, 54-389, 54-408, 
54-434). Other commenters recommended more frequent (than annual) 
training for employees required to use SCBAs, or for employees who may 
be required to use respirators in emergency situations (Exs. 54-210, 
54-290, 54-363, 54-410, 54-424).
    OSHA believes that annual training is necessary and appropriate to 
ensure that employees know about the respiratory protection program and 
that they cooperate and actively participate in the program. Further, 
as specifically noted by several witnesses at the hearing, annual 
training is necessary so that employees will be confident when using 
respirators (Tr. 547, Tr. 595). Annual training will also eliminate 
complacency on the part of both the employer and employees with respect 
to respirator use (Tr. 443), and annual training will ensure a 
reasonable amount of recall and performance on the part of the 
respirator user (Tr. 187). In addition, periodic training provides an 
opportunity for the employee to interact with trained professionals who 
can provide instruction and understanding in the correct use of the 
respirator (Tr. 186), which will serve to overcome employee resistance 
to proper respirator use (Tr. 1021). OSHA also believes that employee 
interaction with respirator instructors on at least an annual basis 
will reinforce employee knowledge about the correct use of respirators 
and other pertinent elements of the respiratory protection program.
    Commenters requesting that training be required less frequently 
than annually provided no substantive data demonstrating that training 
every two years, for example, would be sufficient for respirator users 
to retain information critical to the successful use of respirators on 
a continuing basis (Exs. 54-316, 54-324). Less frequent periodic 
training would tend to diminish employee attention to proper respirator 
use and may result in a long period of poor respirator practice before 
problems are identified and corrected. OSHA notes that both the ANSI 
Z88.2-1980 and Z88.2-1992 respiratory protection standards provide for 
annual retraining. Further, annual periodic training of workers with 
respect to the use of respirators is required in other OSHA standards 
(i.e., 29 CFR 1910.1001, Asbestos; 29 CFR 1910.1017, Vinyl chloride; 29 
CFR 1910.1018, Arsenic; 29 CFR 1910.1025, Lead; 29 CFR 1910.1029, Coke 
oven emissions; 29 CFR 1910.1043, Cotton dust; 29 CFR 1910.1044, 
Dibromochloropropane (DBCP); 29 CFR 1910.1045, Acrylonitrile; 29 CFR 
1910.1047, Ethylene oxide; and 29 CFR 1910.1048, Formaldehyde). In 
addition, OSHA's

[[Page 1262]]

compliance experience has demonstrated that inadequate respirator 
training is a common problem (Ex. 33-5), and is often associated with 
respirator program deficiencies that could lead to employee exposures 
to workplace contaminants. Adherence to annual training will minimize 
respirator misuse. Thus, the Agency's experience under other 
rulemakings, as well as its compliance experience with the previous 
respiratory protection standard, serve, in part, as the basis for 
concluding that annual training for respirator users under this final 
standard is reasonable and appropriate.
    As noted above, a number of commenters argued that training should 
be required only to inform employees about changes in the respirator 
program. This view suggests that regular, periodic training in the use 
of respirators is not necessary to ensure the success of a respirator 
program. However, as discussed above, evidence provided by management, 
labor, and other participants in this and other rulemaking records 
demonstrates the importance of reinforcing an employee's knowledge with 
respect to the use of respirators on a regular basis to ensure the 
successful use of respirators. Accordingly, the final standard in 
paragraph (k)(5) includes the requirement for annual training for 
respirator users. This provision ensures the successful implementation 
of the respiratory protection program by keeping employees thoroughly 
and accurately informed on a regular basis regarding the current status 
of the program.
    Several commenters recommended that training be provided more 
frequently than annually to users of SCBAs and to employees who are 
required to use respirators during emergency situations (Exs. 54-210, 
54-290, 54-363, 54-410, 54-424). OSHA agrees that retraining more 
frequently than annually may be appropriate for some users of SCBAs and 
emergency responders. This concern is addressed in final paragraph 
(k)(5), which contemplates such additional training in circumstances in 
which the employer has reason to believe that a previously trained 
employee does not have the understanding and skill required to use the 
respirator properly on a continuing basis. Although this provision is 
performance oriented, it requires that more frequent (than annual) 
periodic training be provided if necessary (e.g., because of the 
complexity of the respirator or exposure conditions). If respirator 
users must be trained more frequently than annually to retain the 
knowledge necessary to ensure proper use of the respirator, then the 
employer must provide the additional training.
    Final paragraphs (k)(5)(i)-(iii) require additional training when 
changes in the workplace (process change, increase in exposure, new 
hazards) or in the type of respirator used by the employee render 
previous training obsolete, when the employee has not retained the 
requisite understanding or skill to use the respirator properly, or 
when any other situation arises in which retraining appears necessary. 
These provisions recognize circumstances that require supplemental 
training in addition to full annual training. For example, retraining 
with respect to the nature of the hazard may be necessary because of an 
increase in the workplace level of a hazardous substance. Retraining 
would also be required when an employee does not sufficiently 
understand any program element (Ex. 54-387). OSHA believes that the 
regulatory burden imposed on employers by final paragraph (k)(5) will 
be minimal because this paragraph only requires element-specific 
retraining on an as-needed basis to supplement annual training.
    Final paragraph (k)(6) provides very basic protection for employees 
who use respirators voluntarily. As discussed, in connection with 
paragraph (c)(2), such employees are only covered by those provisions 
of this standard that are necessary to ensure that respirator use does 
not present a health hazard to these employees. Respirator use can 
create health and safety problems. For example, an employee who has 
chronic obstructive lung disease and who is given a negative pressure 
air-purifying respirator to wear may be at risk of hypertension, 
overexertion, and dizziness. Employees who voluntarily use some types 
of respirators (e.g., air-purifying respirators) are potentially 
exposed to the hazards associated with respirator use. Consequently, in 
paragraph (k)(6), OSHA requires employers to provide employees who 
voluntarily use some types of respirators (e.g., air purifying 
respirators) with the informational material in Appendix D so that the 
employee will be familiar with basic respirator use procedures.
Paragraph (l)--Program Evaluation
    Paragraph (l) requires employers to perform evaluations to 
determine whether the respiratory protection program is functioning 
effectively. Problems with protection, irritation, breathing 
resistance, comfort, and other respirator-related factors occasionally 
arise in most respiratory protection programs. Although it is not 
possible to eliminate all problems associated with respirator use, the 
employer must eliminate as many problems as possible to improve 
respiratory protection and encourage employee acceptance and safe use 
of respirators. Eliminating problems is accomplished most effectively 
when the respiratory protection program is evaluated thoroughly and 
revised as necessary. Although the previous respiratory protection 
standard requires that the employer perform regular checks of the 
effectiveness of the respiratory protection program, it provided little 
guidance regarding how these evaluations are to be done. The final 
rule, like the proposal, describes the required program evaluation with 
greater specificity than OSHA's previous respiratory protection 
standard did.
    Final paragraph (c) of the respirator standard requires the 
employer to establish a written respiratory protection program. The 
program must include procedures for evaluating the effectiveness of the 
respirator program and must designate a program administrator who is to 
monitor conditions in the workplace on a regular basis to ensure that 
the provisions of the written respiratory protection program are being 
properly implemented. Final paragraph (l) specifies certain steps the 
employer must take as part of his/her regular evaluation of the 
respiratory protection program.
    Paragraph (l) requires the employer to consult employees who use 
respirators to ascertain whether they perceive any problems with the 
equipment and to obtain their views on program effectiveness. This 
assessment must evaluate such factors as difficulty breathing or 
fatigue during respirator use, whether the respirator interferes with 
hearing and vision, communication, or job performance or restricts 
movement, whether the respirator causes discomfort, and whether the 
employee has confidence in the respirator's effectiveness. The employer 
must correct any problems that are revealed by the evaluation.
    The record supports the need to review and evaluate workplace 
respirator use to ensure the continuous effectiveness of the respirator 
program (Exs. 54-91, 54-153, 54-181, 54-213, 54-219, 54-234, 54-244, 
54-252, 54-263, 54-265, 54-54-286, 54-297, 54-330, 54-352, 54-387, 54-
424, 54-428, 54-455, Tr. 387, 1012, 1714, 1733, 1998). Based on the 
record, however, the final program evaluation provisions were modified, 
as discussed below, from those proposed.
    Final paragraph (l)(1) requires the employer to conduct regular 
evaluations of the workplace to ensure that the

[[Page 1263]]

provisions of the written program are being properly implemented for 
all employees required to use respirators, and to ensure the continued 
effectiveness of the program. Proposed paragraph (l)(1) required the 
employer to review the written respiratory protection program at least 
annually and to conduct frequent random inspections of the workplace to 
ensure that the provisions of the program are being properly 
implemented for all employees. The review of the written program was to 
include an assessment of each written program element specified under 
proposed paragraph (c)(1) of the standard.
    The final standard under paragraph (l) has deleted the proposed 
provisions for annual written program review of each element and 
``frequent random'' workplace evaluations in favor of more performance-
oriented requirements. Although a number of commenters supported annual 
written program review (Exs. 54-91, 54-153, 54-181, 54-213, 54-244, 54-
265, 54-361, 54-387, 54-424, 54-428), others asserted that program 
review was necessary but should only be required on an as-needed, 
rather than annual, basis as necessitated by workplace or user 
conditions or characteristics (Exs. 54-177, 54-234, 54-263, 54-286, 54-
297, 54-330, 54-352, 54-402, Tr. 1733). The Chemical Manufacturers 
Association (CMA) (Ex. 54-263), for example, stated:

    For simple programs such as a single air purifying respirator in 
use with a single contaminant, assessments might be necessary once 
every 3-5 years. For programs with numerous hazards that change 
repeatedly such as batch processes, reviews may be needed more 
frequently.

    The CMA (Ex. 54-263) and Mobil Corporation (Ex. 54-234) support 
adoption of the ANSI Z88.2 (1992) recommendation that reads ``The 
program shall be periodically audited to ensure that it is implemented 
and reflects the written procedures.'' Consumer Power (Ex. 54-297) 
argued that program review and revision should be required ``as 
necessary to reflect changes in respirator used, training, fit test 
methods, and storage or maintenance of the respirator in use at the 
facility.''
    OSHA agrees with commenters that a more performance-oriented 
approach with respect to written program review is appropriate in lieu 
of an annual requirement. The Agency believes that the final standard 
will ensure the maintenance of an up-to-date written respirator program 
without imposing an arbitrary review schedule. Final paragraph (c)(1) 
states, in part, that the program shall be updated as necessary to 
reflect changes in workplace conditions and respirator use. This 
provision requires employers to review the written program and to 
revise, as necessary, the written program elements specified in 
paragraph (c)(1) when workplace conditions affecting the use of 
respirators change.
    Accordingly, the final standard does not contain the proposed 
requirement for an annual written program review but instead requires 
program review and revision as necessary based on workplace changes. 
Evaluation frequency to ensure the continued effectiveness of the 
program is to be based on program complexity and on factors such as the 
nature and extent of workplace hazards, types of respirators in use, 
variability of workplace processes and operations, number of respirator 
users, and worker experience in the use of respirators. In other words, 
the employer must audit respirator use in the workplace with sufficient 
frequency to ensure that continuous, successful implementation of all 
written respirator program elements prescribed under paragraph (c) is 
being achieved.
    As noted previously, the proposed requirement for ``frequent 
random'' workplace evaluations has been deleted in favor of a 
requirement for evaluations conducted on an as-necessary basis. OSHA 
agrees with commenters' assertions that the meaning of the term 
``frequent random'' was unclear (Exs. 54-181, 54-334), especially with 
respect to conditions of infrequent or brief respirator use (Exs. 54-
166, 54-177). In such instances, the commenters indicated that 
evaluations would have to be scheduled based on when respirators are 
used. The Agency believes that the final standard's evaluation 
procedures incorporate a flexible and reasonable approach that will 
meet the needs of different workplaces while ensuring continued, 
effective implementation of the respirator program. OSHA emphasizes 
that the change in language in the final standard is not intended to 
deemphasize the importance of conducting evaluations.
    Final paragraph (l)(2) requires the employer to consult regularly 
with employees who wear respirators to obtain their views on the 
effectiveness of the program and to correct any problems that are 
identified. This assessment must determine if the respirators are 
properly fitted. It must also evaluate whether employees are able to 
wear the respirators without interfering with effective workplace 
performance, whether respirators are correctly selected for the hazards 
encountered, whether respirators are being worn when necessary, and 
whether respirators are being maintained properly. Many commenters 
(Exs. 54-91, 54-153, 54-181, 54-213, 54-265, 54-361, 54-387, 54-424, 
54-488) supported the proposed requirement for the employer 
periodically to consult with employees.
    This requirement is essentially unchanged from the proposed 
provision. Some commenters (Exs. 54-187, 54-278) argued that the 
employer's obligations to consult with employees should be limited to 
those employees required by OSHA to wear respirators. However, as 
explained in detail in the Summary and Explanation for paragraphs (a) 
and (c), OSHA believes that all employees who are required to wear 
respirators should be covered by the program, regardless of whether 
their respirator use is required by OSHA or their employer.
    Thus, final paragraph (l)(2) requires the employer to consult with 
employees who wear respirators when auditing the effectiveness of the 
respirator program. As discussed above in connection with paragraph 
(c), OSHA has consistently required employers who provide their 
employees with respirators to ensure that those respirators do not pose 
a health hazard (e.g., do not increase the work-of-breathing in a way 
that threatens health, do not impair vision or hearing). In general, 
assessments conducted to comply with paragraph (l) will involve a 
technical evaluation of whether respirators are being used properly. If 
respirators are not being used properly, the employer is required to 
correct any problems found during the assessment. The areas to be 
reevaluated include whether the respirator program is providing 
employees with properly fitting respirators and whether the appropriate 
respirators are being selected, used, and maintained properly.
    Proposed paragraph (l)(2)(i), which would have required the 
employer to assess whether the program was ``preventing the occurrence 
of illness,'' has been deleted from the final rule. Commenters noted 
that the individual performing the program evaluation under this 
paragraph is not likely to be a health care professional with 
sufficient expertise to identify illnesses caused by improper 
respirator use, other than skin/eye irritation, which can readily be 
observed by the program administrator, supervisor, employer, or 
employee. Commenters argued that medical determinations and evaluations 
are part of the review of an employee's medical status required by 
paragraph (e) of this section (Exs. 54-187, 54-237). OSHA agrees and, 
accordingly, has

[[Page 1264]]

omitted this proposed requirement from final paragraph (l)(2). However, 
identification of respirator-related medical conditions, such as skin 
irritation, would properly be part of the program evaluation. Employees 
identified during the evaluation as having skin irritation can either 
be referred to the PLHCP or be advised by the program administrator 
about the need to leave the respirator use area as necessary to wash 
the face and facepiece, as permitted by paragraph (g). It should be 
noted that final paragraph (e)(7)(iii) requires medical evaluation if 
observations made during the program evaluation indicate that such 
evaluation is necessary.
Paragraph (m)--Recordkeeping
    The final standard requires the employer to establish and retain 
written information regarding medical evaluations, fit testing, and the 
respirator program. The final provisions addressing these records 
differ in some respects from the proposed requirements. In the proposed 
rule, paragraph (c) contained recordkeeping provisions for the written 
respiratory program, paragraph (m) required retention of medical 
evaluation records, and fit testing records were required to be 
maintained under Appendix A. In the final rule, however, all 
recordkeeping requirements have been consolidated in paragraph (m), in 
response to those commenters who suggested that placing all 
recordkeeping provisions in one paragraph will improve understanding of 
the rule's recordkeeping obligations (Exs. 54-267, 54-286).
    Paragraph (m)(1) of the final standard requires the employer to 
retain a medical evaluation record for each employee subject to medical 
evaluation under final paragraph (e). Such records are to be kept and 
made available as required by 29 CFR 1910.1020, OSHA's Access to 
Employee Exposure and Medical Records rule. The record is to include 
the result of the medical questionnaire and, if applicable, a copy of 
the PLHCP's written opinion and recommendations, including the results 
of relevant medical examinations and tests. It is standard medical 
practice to make and retain written records of medical examinations and 
evaluations. Retention of such records will enable PLHCPs in subsequent 
evaluations to determine whether the employee's health has 
deteriorated, and will enable employees to obtain copies for their 
personal physician or other licensed health care professional to review 
as necessary.
    Although the format of final paragraph (m)(1) has been simplified 
from that of the proposed rule, the substance of the medical evaluation 
records to be retained is similar. Several proposed paragraphs referred 
specifically to provisions in 29 CFR 1910.1020 that address the 
maintenance, availability, and transfer of the medical evaluation 
records. As recommended by several commenters, however, only one 
reference to 29 CFR 1910.1020 is needed for this purpose, and the final 
respiratory protection rule has been revised accordingly (Exs. 54-220, 
54-350, 54-362, 54-455, Tr. 1054).
    Final paragraph (m)(2) addresses the retention of respirator fit-
testing records. The provisions of this paragraph remain basically 
unchanged from the requirements of Appendix A, section II. 12 of the 
proposal. The records specified in final paragraphs (m)(2)(i)(A)--(E) 
consist of the name or identification of the person tested; the type of 
fit test performed (QLFT, QNFT--irritant smoke, saccharin, etc.); the 
make, model, and size of the respirator fitted; the date of the fit 
test; pass/fail results if a QLFT is used; or the fit factor and strip 
chart recording or other record of the test results if quantitative fit 
testing was performed.
    Under final paragraph (m)(2)(ii), the fit test record must be 
maintained until the next fit test is administered. If the employee's 
use of a respirator is discontinued (e.g., because of a change of 
duties or successful implementation of engineering controls), fit test 
records need not be retained for the employee. Fit test records must be 
maintained to determine whether annual fit testing has been done, and 
whether the employee who was tested passed the QLFT or passed the QNFT 
with a fit factor that was appropriate for the type of respirator being 
used. OSHA agrees with commenters (Exs. 36-6, 36-17, 36-34, 36-46, 54-
165, 54-210) who stated that fit testing records must be maintained to 
ensure that all respirator users have received a fit test, the 
respirator selected by fit testing is being used, and retesting is 
being performed annually.
    Some commenters argued that the employer should only be required to 
certify that fit testing has been completed, and that retaining the 
other proposed information would provide little additional benefit 
(Exs. 54-222, 54-310). OSHA disagrees with this position. The Agency 
believes it is essential that fit test records identify the respirator 
and employee being fit tested. As noted in the preceding paragraph, 
other commenters stated that the information in this record would be 
the only means of determining whether the appropriate respirator was 
being used by the employee. OSHA believes that the effectiveness of the 
respiratory protection program will be substantially improved if these 
records are kept. Similar recordkeeping requirements are found in many 
OSHA standards: 29 CFR 1910.1027, Cadmium; 29 CFR 1910.1028, Benzene; 
29 CFR 1910.1048, Formaldehyde; 29 CFR 1910.1050, Methylenedianiline.
    Final paragraph (m)(3) specifically requires employers to maintain 
a written copy of the current respiratory protection program prescribed 
by final paragraph (c). As discussed under paragraph (c), a written 
program is necessary to assure the appropriate use of respirators and 
the on-going effectiveness of the program.
    Final paragraph (m)(4) provides that written materials required to 
be maintained under final paragraph (m) must be made available, upon 
request, to employees and to the Assistant Secretary for examination 
and copying. This final paragraph replaces, but is consistent with, the 
record availability requirement of proposed paragraph (m)(2). Employee 
access to these records is necessary to ensure that employees can 
assess and verify information describing their exposure to respiratory 
hazards in the workplace and the effectiveness of the respirator 
program in protecting them from those hazards. Access to these records 
by the Assistant Secretary or his or her designees is necessary to 
allow OSHA to monitor compliance with the standard and its 
effectiveness.
    The access provisions in final paragraph (m)(4) are consistent with 
provisions found in other OSHA standards: 29 CFR 1910.1001, Asbestos; 
29 CFR 1910.1027, Cadmium; 29 CFR 1910.1028, Benzene; 29 CFR 1910.1047, 
Ethylene Oxide; 29 CFR 1910.1048, Formaldehyde; and 20 CFR 1910.1050, 
Methylenedianiline.
Paragraph (n)--Dates
    The final Respiratory Protection standard will become effective on 
April 8, 1998. For most requirements of the standard, however, 
compliance need not be achieved until the start-up dates specified in 
paragraph (n) of the final rule. Unless a different start-up date is 
specified for a particular requirement, compliance must be achieved by 
the effective date.
    The proposal would have required compliance with all provisions of 
the standard 90 days after publication of the final standard in the 
Federal Register. The Air Conditioning Contractors of America (Ex. 54-
248) stated that a 90-day compliance period should be

[[Page 1265]]

sufficient if OSHA plans to disseminate information to employers in a 
``user-friendly'' format, but that additional time would be required if 
industry organizations had to analyze and distribute information on the 
final standard by themselves. Several commenters recommended a 6-12 
month effective date for implementing the final standard (Exs. 54-248, 
54-271, 54-283, 54-293, 54-309). The U.S. Enrichment Corporation (Ex. 
54-283) wanted the standard phased in over a 12-month period to allow 
additional time for the employer to obtain respiratory protection 
equipment from manufacturers and to perform fit testing. The American 
Subcontractors Association (Ex. 54-293) stated that small contractors 
rely on their organization and others for education and training 
regarding new standards, and that a 90-day period is too short a period 
for transition to a new program. They specifically mentioned training, 
updating written programs, changing written standard operating 
procedures (SOPs), and medical examinations as provisions in the 
standard that may be difficult to comply with in a short time period. 
The Associated Building Contractors (Ex. 54-309) also wanted the final 
standard to be phased in over 12 months to allow for revising written 
SOPs and programs, training, and medical evaluation of respirator 
users. Exxon (Ex. 54-266) and the American Petroleum Institute (Ex. 54-
330) stated that employers could not fit test every employee within the 
specified 90-day effective date and recommended that employees be fit 
tested within one year of the effective date of the standard.
    Based on many of these comments, OSHA concludes that additional 
time is required for employers to comply with certain provisions of the 
final standard. The Agency has therefore included extended start-up 
dates for some of the program elements. OSHA does intend, however, to 
disseminate information on this standard in a ``user friendly'' format.
    Within 150 days of the effective date of the standard, employers 
must determine whether respirator use is required under paragraph (a). 
This period will afford employers sufficient time to become familiar 
with the final standard and to evaluate whether respirator use is 
required in their workplaces.
    Employers must comply with all the remaining requirements of the 
respirator standard no later than 180 days after the effective date of 
the standard. OSHA concludes that with the start-up dates provided, all 
employers will have adequate time to comply. Paragraph (n)(3) states 
that if there is an administrative or judicial delay of the standard, 
the respiratory protection provisions of the previous standards (i.e., 
29 CFR 1910.134 and 29 CFR 1926.103) will remain in effect and will be 
enforced until the issues have been resolved. Many employers already 
have an established respiratory protection program that includes 
specific program elements (e.g., fit testing, annual training, medical 
evaluations of respirator users, and program evaluation) that comply 
with the requirements of the Agency's prior respirator standards. 
Program elements that were implemented to meet the prior respirator 
standards' requirements may also meet the requirements of this final 
respiratory protection standard. Paragraph (n)(4) states that if, in 
the 12 month period preceding the effective date of the revised 
standard, the employer has conducted annual respirator training, fit 
testing, respirator program evaluation, or medical evaluations, the 
employer may use the results of these activities to comply with the 
corresponding provisions of this section, provided that these 
activities were conducted in a manner that meets the requirements of 
the revised standard. For example, if the employer has an existing fit 
testing program in place on the effective date of the final standard, 
the employer may continue that fit testing program if it meets the fit 
testing requirements of the final standard. In such cases, employees 
would be retested within one year of their last fit test date. 
Employers, therefore, can incorporate annual fit testing, training, and 
program evaluation into their existing respiratory protection programs 
if the appropriate program elements comply with the provisions of the 
final standard. This approach should help reduce the impact of the 
final rule on employers with effective existing respirator programs.
Paragraph (o)--Appendices
    The final paragraph of the standard identifies four appendices that 
supplement the requirements specified in the regulatory text. 
Appendices A (Fit Testing Procedures), B-1 (User Seal Check 
Procedures), B-2 (Cleaning Procedures), and C (Medical Questionnaire) 
are mandatory, and contain requirements for performing fit testing, 
user seal checks, cleaning, and medical evaluations that supplement the 
regulatory requirements in paragraphs (e), (f), (g), and (h) of the 
final standard.
    Appendix D (Information for Employees Using Respirators When Not 
Required Under The Standard) is nonmandatory.
    The four appendices are discussed in detail under the Summary and 
Explanation sections of the corresponding paragraphs of the final 
standard: Appendix A in paragraph (f), ``Fit Testing''; Appendix B-1 in 
paragraph (g), ``Use of respirators''; Appendix B-2 in paragraph (h), 
``Maintenance and care of respirators''; Appendix C in paragraph (e), 
``Medical evaluation''; Appendix D in paragraph (c), ``Written 
program'' and paragraph (a), ``Permissible practice.''
Paragraph (p)--Revisions to Specific OSHA Standards
    A number of OSHA standards regulating exposure to toxic substance 
and harmful physical agents incorporate certain provisions of 29 CFR 
1910.134. OSHA proposed to revise these provisions to simplify 
compliance for employers by consolidating many of the Agency's 
respirator requirements, removing inconsistencies, and deleting 
duplicative requirements. The purpose of revising the respirator-
related provisions of OSHA's existing standards was to conform these 
standards, to the extent possible, to each other and to revised 29 CFR 
1910.134 in general. These standards will be improved by this process, 
because they will now refer to the revised respiratory protection 
standard, which is based on current respirator use and technology. For 
example, revising the respirator-approval references in these standards 
from MSHA/NIOSH, Bureau of Mines, and ANSI Z88.2-1969 to the recently 
published NIOSH regulation at 42 CFR Part 84 updates these respiratory 
protection provisions. The Agency concludes, therefore, that updating 
these standards is consistent with the proposed goal of bringing 
uniformity to OSHA's respiratory protection requirements. OSHA believes 
that regulatory consistency will improve compliance with the 
respiratory protection provisions, reduce the compliance burden on the 
regulated community, and, consequently, enhance the protection provided 
to employees who use respirators. OSHA's review of the rulemaking 
record shows that no commenters objected to updating the provisions of 
these standards to conform with the requirements of revised 29 CFR 
1910.134.
    The Agency also notes that revised 29 CFR 1910.134 is intended to 
serve as a ``building block'' standard with respect to future standards 
that may contain respiratory protection requirements. To the extent 
possible, therefore, future standards that regulate respirator use in

[[Page 1266]]

controlling employee exposure to toxic substances and harmful physical 
agents will refer to provisions of the final respiratory protection 
standard at 29 CFR 1910.134 instead of containing their own respirator 
requirements. (However, these standards will continue to have any 
respirator requirements, e.g., canister/cartridge change schedules, 
that are specific to the substance or agent being regulated.)
    In developing the final revision, OSHA also revised the wording 
and/or location of some paragraphs to improve the comprehensibility and 
uniformity of the requirements; however, the substantive requirements 
of the standards addressing respirators have not been revised. 
Additionally, the tables in the substance-specific standards specifying 
parameters for respirator selection have not been republished because 
these tables will remain unchanged and, thus, will continue to be part 
of the substance-specific standards until resolution of the reserved 
portions of this final standard.
    OSHA found that the existing substance-specific standards were 
especially in need of revision. Except for a limited number of 
respirator provisions unique to each substance-specific standard, the 
remaining regulatory text on respirators now reads virtually the same 
for each of these standards. For example, all provisions addressing 
respirator use, selection, and fit testing were deleted from the 
substance-specific standards, making these standards consistent with 
the final respiratory protection standard with respect to these 
requirements. The Agency believes that revisions to 29 CFR 1910.134 are 
sufficiently comprehensive to allow deletion of those provisions in the 
substance-specific standards that duplicated provisions of revised 29 
CFR 1910.134. A provision was retained only when it addressed 
conditions (for example, medical evaluation) that were unique and/or 
integral to the substance-specific standard. The Agency concludes, 
therefore, that deletion of duplicative provisions from the substance-
specific standards will reduce confusion among members of the regulated 
community and decrease the burden of compliance. It will thereby 
enhance compliance with the respiratory protection requirements and, 
consequently, improve the protection afforded to employees who use 
respirators to control exposure to the toxic substances and harmful 
physical agents regulated by these standards. The proposed revisions to 
the substance-specific standards were widely supported by rulemaking 
participants (Exs. 54-187, 54-208, 54-219, 54-220, 54-233, 54-234, 54-
261, 54-263, 54-266, 54-267, 54-273, 54-283, 54-289, 54-327, 54-333, 
54-363, 54-424.)
    In general, for the substance-specific standards, the incorporated 
provisions of revised 29 CFR 1910.134 cover the following requirements: 
definitions (paragraph (b)); respiratory protection program (paragraph 
(c)); selection of respirators (paragraph (d)); fit testing (paragraph 
(f)); use of respirators (paragraph (g)); maintenance and care of 
respirators (paragraph (h)); breathing air quality and use (paragraph 
(i)); identification of filters, cartridges, and canisters (paragraph 
(j)); training and information (paragraph (k)); program evaluation 
(paragraph (l)); and recordkeeping (paragraph (m)). Each of these 
requirements was addressed by paragraphs (b), (c), (d), (e), and (f) of 
the prior respiratory protection standard.
    OSHA did not propose to conform the respirator provisions of its 
Cadmium, Benzene, Formaldehyde, 1,3-Butadiene, and Methylene chloride 
standards with the corresponding requirements of revised 29 CFR 
1910.134. Rulemaking participants recommended that the respirator 
provisions of the existing Cadmium, Benzene, and Formaldehyde standards 
be revised to conform with those provisions of 29 CFR 1910.134 to 
improve regulatory consistency and uniformity (Exs. 54-194, 54-195, 54-
208, 54-218, 54-275, 54-294, 54-337, 54-350, 54-387, 54-434). In view 
of these comments, the Agency assumes that a consensus exists among the 
regulated community to bring these standards (as well as the 1,3-
Butadiene and Methylene chloride standards, which were issued after the 
close of the comment period for the respirator rulemaking) into 
conformity with the revised respiratory protection standard. 
Accordingly, these standards have been revised in the same manner as 
the other substance-specific standards for which OSHA proposed 
revisions.
    In revising the fit-testing provisions (paragraph (f)) of the 
substance-specific standards, the frequency of respirator fit testing 
was revised from semiannually to annually for the Asbestos (29 CFR 
1910.1001 and 1926.1101), Arsenic (29 CFR 1910.1018), Lead (29 CFR 
1910.1025 and 1926.62) and Acrylonitrile (29 CFR 1910.1045) standards. 
The Agency believes that this revision will not diminish the 
effectiveness of respiratory protection provided by these standards. 
OSHA's experience in recent rulemakings (Cadmium, 1992; 
Methylenedianiline, 1992; Formaldehyde, 1992; Methylene chloride, 1997) 
has led the Agency to conclude that annual respirator fit testing, 
which is provided for in the recent standards, protects employees 
appropriately, and that semi-annual fit testing is not necessary for 
employee protection. The basis for adopting a semiannual fit-testing 
requirement is not discussed in the preambles to any of the standards 
that contain that requirement. For example, there is no discussion in 
the preambles of those standards that semiannual fit testing was 
adopted because of the toxic properties of the regulated substances or 
the particular characteristics of the respirators to be used.
    Recent rulemakings, including proposed revisions to the respiratory 
protection standard, have provided the Agency with much more scientific 
and experiential information on fit testing than was available when the 
affected standards were adopted. A number of commenters in the current 
rulemaking asserted that provisions for semiannual fit testing in the 
existing Asbestos, Arsenic, Lead, and Acrylonitrile standards should be 
revised to conform to the annual fit testing requirements of the 
recently-adopted standards (Exs. 54-5, 54-179, 54-186, 54-208, 54-218, 
54-219, 54-222, 54-242, 54-289, 54-326, 54-330, 54-348, 54-410, 54-424, 
54-439, 54-443.) The Agency, therefore, concludes that it is reasonable 
and appropriate, for the purpose of regulatory consistency and 
uniformity, to require only annual respirator fit testing in its 
substance-specific standards.
    While the proposal did not incorporate revised paragraph (m) 
(recordkeeping) into the existing substance-specific standards, OSHA 
incorporated this paragraph in the final rulemaking in the belief that 
such action: (1) Will make recordkeeping requirements consistent and 
uniform for employers who use respirators to control employee exposures 
to the airborne contaminants regulated by the substance-specific 
standards; (2) will reduce the regulatory burden on employers because 
they are currently required under 29 CFR 1910.1020 to maintain exposure 
and medical records; and, (3) it is a prevailing business and 
industrial-hygiene practice to retain fit-testing records to 
demonstrate that protection was provided to exposed employees.
    For the 13 carcinogens addressed by existing 29 CFR 1910.1003 (the 
``13 Carcinogens standard''), the provision requiring employers to 
ensure that employees use respirators ``in accordance with 29 CFR 
1910.134'' was amended to require compliance with paragraphs (b), (c), 
(d) (except (d)(1) (iii), (iv), and (d)(3)), and (e)-(m) of the

[[Page 1267]]

final standard. While the proposal did not incorporate revised 
paragraph (e) (medical evaluation) into the 13 Carcinogens standard, 
OSHA did so in the final rulemaking because such incorporation is 
consistent with the requirements of existing 29 CFR 1910.134, conforms 
to accepted industry practice, and improves comprehension of, and 
compliance with, the respiratory protection requirements of the 13 
Carcinogens standard.
    Unlike 29 CFR 1910.1003, each of the existing substance-specific 
OSHA standards includes unique medical-evaluation requirements for 
employees who use respirators. OSHA believes that the medical-
evaluation requirements for respirator use established under its 
existing substance-specific standards provide a high degree of medical 
protection to employees who are required to use respirators to control 
their exposures to the airborne substances regulated by the substance-
specific standards. In addition, the medical-evaluation requirements 
for respirator use in the substance-specific standards are part of a 
comprehensive, integrated medical-surveillance program designed to 
evaluate employees for conditions and risks associated with exposure to 
the regulated substances; consequently, OSHA believes that any revision 
to the frequency or content of medical evaluations for respirator use 
would unnecessarily disrupt ongoing medical-surveillance programs and, 
therefore, jeopardize the health of employees who must use respirators 
to prevent exposure to hazardous workplace substances.
    Paragraph (d)(1)(iii) of the revised respiratory protection 
standard, which requires employers to estimate exposure levels in 
selecting appropriate respirators, has not been incorporated into 
OSHA's substance-specific standards in the final rulemaking. The 
existing substance-specific standards, except the 13 Carcinogens 
standard, already include exposure assessment provisions that are more 
specific than the general exposure-assessment requirement in the final 
respiratory protection standard. With respect to the 13 Carcinogens 
standard, no PELs or other exposure criteria are specified in that 
standard that would be relevant to respirator selection. In the 13 
Carcinogens standard, exposure estimates for the substances regulated 
by the standard are not necessary for respirator selection because 
appropriate respirators have been identified for specific work 
activities that occur during employee exposure to each of the 13 
carcinogenic substances.
    OSHA excepted substance-specific standards that already contain 
requirements for cartridge- and canister-change schedules (Vinyl 
chloride, Benzene, Acrylonitrile, Formaldehyde, and 1,3-Butadiene) from 
paragraphs (d)(3)(iii)(B) (1) and (2) of the revised respiratory 
protection standard, which also addresses change schedules, to preclude 
regulatory conflict. The Agency finds that information obtained during 
the rulemakings for these substance-specific standards resulted in the 
development of change schedules that were especially tailored to the 
chemistry of the specific substance, documented the exposure conditions 
requiring these schedules, and determined the types of respirators 
required for employee protection. Consequently, the Agency concludes 
that the change schedules adopted during these rulemakings must not be 
replaced by the generic change-schedule requirements of revised 29 CFR 
1910.134.
    As proposed, the Agency also removed a number of appendices from 
the substance-specific standards that addressed fit-testing 
requirements, replacing them with references to Appendix A of revised 
29 CFR 1910.134. In this regard, the Agency proposed to update Section 
IV of Appendix B of 29 CFR 1910.1025 (the Lead standard) by citing 
Appendix A of 29 CFR 1910.134 as the reference for fit-testing 
procedures; the proposed revision has been made in the final 
rulemaking. While not proposed, the Agency revised the same information 
in Appendix B of 29 CFR 1926.62 (the Lead standard for Construction), 
removed the sixth paragraph from Section IV of Appendix B of 29 CFR 
1910.1025 and 1926.62 as being outdated, and revised references for 
respirator approval in Section IV of Appendix B of 29 CFR 1910.1025, 
Section IV of Appendix A to 29 CFR 1910.1045 (the Acrylonitrile 
standard), Section IV of Appendix A to 29 CFR 1910.1047 (the Ethylene 
Oxide standard), Section III of Appendix A to 29 CFR 1910.1050 (the 4, 
4'-Methylenedianiline standard), and Section IV of Appendix B to 29 CFR 
1926.62, Lead in Construction. The Agency believes that these revisions 
will conform the affected standards with the provisions of the revised 
respiratory protection standard; the resulting consistency will, 
therefore, reduce confusion and ease compliance.
    The following provisions, addressing fit-testing, respirator 
selection, and respirator use, have been deleted from OSHA's substance-
specific standards because they duplicate requirements specified in 
revised 29 CFR 1910.134:
(1) Fit Testing
    This requirement is specified in paragraph (f) of the revised 
respiratory protection standard, allowing for the removal of the 
following paragraphs:

(a) 29 CFR 1910.1001 Asbestos.
    (g)(4) and Appendix C
(b) 29 CFR 1910.1018 Inorganic arsenic.
    (h)(3) (i), (ii), and (iii)
(c) 29 CFR 1910.1025 Lead.
    (f)(3) (i) and (ii), and Appendix D; Section IV of Appendix B 
revised in part
(d) 29 CFR 1910.1027 Cadmium.
    (g)(4) and Appendix C
(e) 29 CFR 1910.1028 Benzene.
    (g)(5) and Appendix E
(f) 29 CFR 1910.1045 Acrylonitrile.
    (h)(3)(iii)
(g) 1910.1048 Formaldehyde.
    (g)(3)(ii) and Appendix E
(h) 29 CFR 1910.1050 Methylenedianiline.
    (h)(5) and Appendix E
(i) 29 CFR 1910.1051 1,3-Butadiene.
    (h)(5) and Appendix E
(j) 29 CFR 1910.1052 Methylene chloride.
    (g)(7)
(k) 29 CFR 1926.60 Methylenedianiline. (i)(5) and Appendix E
(l) 29 CFR 1926.62 Lead.
    (f)(3) (i) and (ii), and Appendix D; Section IV of Appendix B 
revised in part
(m) 29 CFR 1926.1101 Asbestos.
    (h)(4) and Appendix C
(n) 29 CFR 1926.1127 Cadmium.
    (g)(4) and Appendix C
(2) Respirator-Approval Requirements that Reference MSHA or NIOSH 30 
CFR Part 11
    The requirement to select respirators approved by NIOSH in 42 CFR 
part 84 is specified in paragraph (d)(1)(ii) of the revised respiratory 
protection standard. This requirement updates the existing respirator-
approval requirement in the substance-specific standards to select 
respirators approved by MSHA or NIOSH under 30 CFR part 11, allowing 
for removal of the following paragraphs:

(a) 29 CFR 1910.1001 Asbestos.
    (g)(2)(i) [part]
(b) 29 CFR 1910.1017 Vinyl chloride.
    (g)(2)
(c) 29 CFR 1910.1018 Inorganic arsenic.
    (h)(2)(iii)
(d) 29 CFR 1910.1025 Lead.
    (f)(2)(iii); Section IV of Appendix B revised in part
(e) 29 CFR 1910.1027 Cadmium.
    (g)(2)(i) [part]
(f) 29 CFR 1910.1028 Benzene

[[Page 1268]]

    (g)(2)(ii)
(g) 29 CFR 1910.1029 Coke oven emissions.
    (g)(2)(iii)
(h) 29 CFR 1910.1044 1,2-Dibromo-3-chloropropane.
    (h)(2)(ii)
(i) 29 CFR 1910.1045 Acrylonitrile.
    (h)(2)(ii); Section IV of Appendix A revised in part
(j) 29 CFR 1910.1047 Ethylene oxide.
    (g)(2)(ii); Section IV of Appendix A revised in part
(k) 29 CFR 1910.1048  Formaldehyde.
    (g)(2)(i) [part]
(l) 29 CFR 1910.1050  Methylenedianiline.
    (h)(2)(ii); Section III of Appendix A revised in part
(m) 29 CFR 1910.1051  1,3-Butadiene.
    (h)(2)(ii) [part]
(n) 29 CFR 1910.1052  Methylene chloride.
    (g)(3) [part]
(o) 29 CFR 1926.60  Methylenedianiline.
    (i)(2)(ii)
(p) 29 CFR 1926.62  Lead.
    (f)(2)(iii); Section IV of Appendix B revised in part
(q) 29 CFR 1926.1101  Asbestos.
    (h)(2)(ii)
(r) 29 CFR 1926.1127  Cadmium.
    (g)(2)(i) [part]
(3) Respirator Use
    Paragraph (g) of the revised respiratory protection standard 
addresses, in part, facepiece seal protection (paragraph (g)(1)), and 
employees leaving the work area to wash their faces and respirator 
facepieces (paragraph (g)(2)(ii)(A)) and to change filter elements 
(paragraph (g)(2)(ii) (B) and (C)), allowing removal of the following 
paragraphs:

(a) 29 CFR 1910.1001  Asbestos.
    (g)(3) (ii) and (iii)
(b) 29 CFR 1910.1018  Inorganic arsenic.
    (h)(4) (ii) and (iii)
(c) 29 CFR 1910.1025  Lead.
    (f)(4) (ii) and (iii)
(d) 29 CFR 1910.1027  Cadmium.
    (g)(3) (ii) and (iii)
(e) 29 CFR 1910.1028  Benzene.
    (g)(4)(iii)
(f) 29 CFR 1910.1029  Coke oven emissions.
    (g)(4)
(g) 29 CFR 1910.1043  Cotton dust.
    (f)(4)
(h) 29 CFR 1910.1044  1,2-Dibromo-3-chloropropane.
    (h)(3)(ii)
(i) 29 CFR 1910.1045  Acrylonitrile.
    (h)(3)(iv)
(j) 29 CFR 1910.1048  Formaldehyde.
    (g)(3)(v)
(k) 29 CFR 1910.1050  Methylenedianiline.
    (h)(4)(ii)
(l) 29 CFR 1910.1051  1,3-Butadiene.
    (h)(4)(v)
(m) 29 CFR 1910.1052  Methylene chloride.
    (g)(5)
(n) 29 CFR 1926.60  Methylenedianiline. (i)(4)(ii)
(o) 29 CFR 1926.62  Lead.
    (f)(4) (ii) and (iii)
(p) 1926.1101  Asbestos.
    (h)(3) (ii) and (iii)
(q) 29 CFR 19126.1127  Cadmium.
    (g)(3) (ii) and (iii)

    The full text, after deletions and revisions, of the paragraphs 
dealing with respirators that remain in each of OSHA's existing 
substance specific standards has been published in Section XI of this 
preamble.
    The provisions of the respiratory protection standard found in 29 
CFR part 1926 (Construction), specifically 29 CFR 1926.103, are now 
identical to the new 29 CFR 1910.134. Following its policy of not 
repeating identical health provisions in order to reduce paperwork 
burden and to avoid regulatory confusion, OSHA is deleting the 
duplicate text in 29 CFR 1926.103 and cross-referencing the text in 29 
CFR 1910.134. To implement this action, the title of this section 
remains, but a Note is added to read: ``Note: The requirements 
applicable to construction work under this section are identical to 
those set forth at 29 CFR 1910.134 of this chapter.'' For the 
convenience of the Construction industry, OSHA makes available an 
indexed manual that includes the full text of all regulations 
applicable to construction, including OSHA's respirator requirements.
    OSHA is also revising or removing a number of provisions in 
addition to safety and health standards, other than the substance-
specific standards, that duplicate provisions now found in the revised 
respiratory protection standard. These standards and their revisions 
include:
    (1) 29 CFR 1910.94 Ventilation.
    (a)(1)(i)--Removed the phrase ``continuous flow'' from the 
definition of abrasive-blasting respirator consistent with the proposed 
requirement to select respirators in accordance with 29 CFR 1910.134.
    (a)(5)(i)--Revised the reference from ``30 CFR part 11'' to ``42 
CFR Part 84.''
    (a)(5)(iii)--Provided the reference ``42 CFR Part 84.''
    (a)(5)(iv)--Revised the reference from ``Sec. 1910.134 (a) and 
(b)'' to ``Sec. 1910.134.''
    (a)(6)--Revised the air-requirement reference for abrasive-blasting 
respirators from ``ANSI Z9.2-1960'' to ``29 CFR 1910.134(i).''
    (c)(6)(iii)(a)--Revised the reference from ``MSHA/NIOSH/ANSI Z-
88.2-1969'' to ``NIOSH under 42 CFR Part 84.''
    (d)(9)(vi)--Revised the reference from ``MSHA/NIOSH'' to ``NIOSH 
under 42 CFR Part 84.''
    (2) 29 CFR 1910.111 Storage and handling of anhydrous ammonia.
    (a)(2)(x)--Revised the reference from ``MSHA'' to ``the National 
Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part 
84.''
    (b)(10)(ii)--Revised the reference from ``Bureau of Mines'' to 
``NIOSH under 42 CFR Part 84.''
    (3) 29 CFR 1910.156  Fire brigades.
    (f)(1)(i) and (v)--Revised the reference from ``MSHA/NIOSH'' to 
``NIOSH under 42 CFR Part 84.''
    (4) 29 CFR 1910.252  General requirements.
    (c)(4)(ii) and (iii), (c)(7)(iii), (c)(9)(i), and (c)(10)--Revised 
the references from ``MSHA/NIOSH'' to ``National Institute for 
Occupational Safety and Health (NIOSH) under 42 CFR Part 84'' and 
``NIOSH under 42 CFR Part 84.''
    (5) 29 CFR 1910.261  Pulp, paper, and paperboard mills.
    (b)(2) and (g)(10--Revised the reference from ``ANSI Z88.2-1969'' 
to ``29 CFR 1910.134.''
    (h)(2)(iii) and (iv)--Revised the reference from ``ANSI Z-88.2-1969 
and K-13.1-1967'' to ``29 CFR 1910.134.''
    (6) 29 CFR 1926.57  Ventilation.
    (f)(1)(ii)--Removed the phrase ``continuous flow'' from the 
definition of abrasive-blasting respirator consistent with the proposed 
requirement to select respirators in accordance with 29 CFR 1910.134.
    (f)(5)(i)--Revised the reference from ``30 CFR Part 11'' to ``42 
CFR Part 84.''
    (f)(5)(iii)--Provided the reference ``42 CFR Part 84.''
    (f)(6)--Revised the air-requirement reference for abrasive-blasting 
respirators from ``ANSI Z9.2-1960'' to ``29 CFR 1910.134(i).''
    (h)(6)(iii)(A)--Revised the reference from ``MSHA/NIOSH/ANSI Z-
88.2-1969'' to ``NIOSH under 42 CFR Part 84.''
    (i)(9)(vi)--Revised the reference from ``MSHA/NIOSH'' to ``NIOSH 
under 42 CFR Part 84.''
    (7) 29 CFR 1926.103  Respiratory protection.
    Removed paragraphs (a) through (i) and replaced them with a note to 
read as follows:

    Note: The requirements applicable to construction work under 
this section are identical to those set forth at Sec. 1910.134 of 
this chapter.


[[Page 1269]]


    (8) 29 CFR 1926.800  Underground construction.
    (g)(2)--Revised the reference from ``MSHA/NIOSH'' to ``the National 
Institute for Occupational Safety and Health under 42 CFR Part 84,'' 
and from ``Sec. 1926.103 (b) and (c)'' to ``29 CFR 1926.103.''
Appendices
    The four appendices are discussed in detail under the Summary and 
Explanation sections for the following paragraphs of the final 
standard: Appendix A in paragraph (f), ``Fit Testing''; Appendix B-1 in 
paragraph (g), ``Use of respirators''; Appendix B-2 in paragraph (h), 
``Maintenance and care of respirators'; Appendix C in paragraph (e), 
``Medical evaluation''; Appendix D in paragraphs (c), ``Written 
program'' and paragraph (a), ``Permissible practice.''

VIII. Authority and Signature

    This document was prepared under the direction of Charles N. 
Jeffress, Assistant Secretary of Labor for Occupational Safety and 
Health, U.S. Department of Labor, 200 Constitution Avenue, NW., 
Washington, DC 20210.
    Pursuant to sections 4, 6(b), 8(c), and 8(g) of the Occupational 
Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Sec. 107 of 
the Contract Work Hours and Safety Standards Act (the Construction 
Safety Act) (40 U.S.C. 333); Sec. 41, the Longshore and Harbor Worker's 
Compensation Act (33 U.S.C. 941); Secretary of Labor's Order Nos. 12-71 
(36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR 
9033), or 6-96 (62 FR 111), as applicable; and 29 CFR part 1911; 29 CFR 
parts 1910 and 1926 are amended as set forth below.

List of Subjects in 29 CFR Parts 1910 and 1926

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

    Signed at Washington, DC, this 15th day of December, 1997.
Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health.

IX. Amended Standards

    Part 1910 of Title 29 of the Code of Federal Regulations is hearby 
amended as follows:

PART 1910--[AMENDED]

Subpart G--[Amended]

    1. The authority citation for Subpart G of Part 1910 is revised to 
read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
part 1911.

    2. Section 1910.94 is amended by revising paragraphs (a)(1)(ii), 
(a)(5)(i), (a)(5)(iii) introductory text, (a)(5)(iv), (a)(6), 
(c)(6)(iii)(a), and (d)(9)(vi) as follows:


Sec. 1910.94  Ventilation.

    (a) * * *
    (1) * * *
    (ii) Abrasive-blasting respirator. A respirator constructed so that 
it covers the wearer's head, neck, and shoulders to protect the wearer 
from rebounding abrasive.
* * * * *
    (5) Personal protective equipment. (i) Employers must use only 
respirators approved by the National Institute for Occupational Safety 
and Health (NIOSH) under 42 CFR part 84 to protect employees from dusts 
produced during abrasive-blasting operations.
* * * * *
    (iii) Properly fitted particulate-filter respirators, commonly 
referred to as dust-filter respirators, may be used for short, 
intermittent, or occasional dust exposures such as cleanup, dumping of 
dust collectors, or unloading shipments of sand at a receiving point 
when it is not feasible to control the dust by enclosure, exhaust 
ventilation, or other means. The respirators used must be approved by 
NIOSH under 42 CFR part 84 for protection against the specific type of 
dust encountered.
* * * * *
    (iv) For employees who use respirators required by this section, 
the employer must implement a respiratory protection program in 
accordance with 29 CFR 1910.134.
* * * * *
    (6) Air supply and air compressors. Air for abrasive-blasting 
respirators must be free of harmful quantities of dusts, mists, or 
noxious gases, and must meet the requirements for supplied-air quality 
and use specified in 29 CFR 1910.134(i).
* * * * *
    (c) * * *
    (6) * * *
    (iii) (a) When an operator is in a booth downstream from the object 
being sprayed, an air-supplied respirator or other type of respirator 
must be used by employees that has been approved by NIOSH under 42 CFR 
part 84 for the material being sprayed.
* * * * *
    (d) * * *
    (9) * * *
    (vi) During the emergencies specified in paragraph (d)(11)(v) of 
this section, if employees must be in areas where the concentrations of 
air contaminants are greater than the limits set by paragraph 
(d)(2)(iii) of this section or the oxygen concentration is less than 
19.5 percent, they must use respirators that reduce their exposure to a 
level below these limits or that provide adequate oxygen. Such 
respirators must also be provided in marked, quickly-accessible storage 
compartments built for this purpose when the possibility exists that 
hazardous concentrations of air contaminants could be released 
accidentally. The respirators must be approved by the NIOSH under 42 
CFR part 84, selected by a competent industrial hygienist or other 
technically-qualified source, and used in accordance with 29 CFR 
1910.134.
* * * * *

Subpart H--[Amended]

    3. The authority citation for subpart H of part 1910 is revised to 
read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
part 1911.

    4. Section 1910.111 is amended by revising paragraphs (a)(2)(x) and 
(b)(10)(ii) as follows:


Sec. 1910.111  Storage and handling of anhydrous ammonia.

    (a) * * *
    (2) * * *
    (x) Gas masks.  Gas masks must be approved by the National 
Institute for Occupational Safety and Health (NIOSH) under 42 CFR part 
84 for use with anhydrous ammonia.
* * * * *
    (b) * * *
    (10) * * *
    (ii) Stationary storage installations must have at least two 
suitable gas masks in readily-accessible locations. Full-face masks 
with ammonia canisters that have been approved by NIOSH under 42 CFR 
part 84 are suitable for emergency action involving most anhydrous 
ammonia leaks, particularly leaks that occur outdoors. For respiratory 
protection in concentrated ammonia atmospheres, a self-contained 
breathing apparatus is required.
* * * * *

[[Page 1270]]

Subpart I--[Amended]

    5. The authority citation for Subpart I of Part 1910 is revised to 
read as follows:

    Authority: Sections 4, 6, and 8, Occupational Safety and Health 
Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order 
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 
(55 FR 9033), or 6-96 (62 FR 111), as applicable.
    Sections 1910.132, 1910.134, and 1910.138 also issued under 29 
CFR part 1911.
    Sections 1910.133, 1910.135, and 1910.136 also issued under 29 
CFR part 1911 and 5 U.S.C. 553.

    6. Section 1910.134 is redesignated as Sec. 1910.139 in subpart I 
and amended by revising its title and adding introductory text to read 
as follows:


Sec. 1910.139  Respiratory protection for M. tuberculosis.

    This section applies only to respiratory protection against M. 
tuberculosis and applies in lieu of Sec. 1910.134.
* * * * *
    7. A new section 1910.134 is added to read as follows:


Sec. 1910.134  Respiratory protection.

    This section applies to General Industry (part 1910), Shipyards 
(part 1915), Marine Terminals (part 1917), Longshoring (part 1918), and 
Construction (part 1926).
    (a) Permissible practice. (1) In the control of those occupational 
diseases caused by breathing air contaminated with harmful dusts, fogs, 
fumes, mists, gases, smokes, sprays, or vapors, the primary objective 
shall be to prevent atmospheric contamination. This shall be 
accomplished as far as feasible by accepted engineering control 
measures (for example, enclosure or confinement of the operation, 
general and local ventilation, and substitution of less toxic 
materials). When effective engineering controls are not feasible, or 
while they are being instituted, appropriate respirators shall be used 
pursuant to this section.
    (2) Respirators shall be provided by the employer when such 
equipment is necessary to protect the health of the employee. The 
employer shall provide the respirators which are applicable and 
suitable for the purpose intended. The employer shall be responsible 
for the establishment and maintenance of a respiratory protection 
program which shall include the requirements outlined in paragraph (c) 
of this section.
    (b) Definitions. The following definitions are important terms used 
in the respiratory protection standard in this section.
    Air-purifying respirator means a respirator with an air-purifying 
filter, cartridge, or canister that removes specific air contaminants 
by passing ambient air through the air-purifying element.
    Assigned protection factor (APF) [Reserved]
    Atmosphere-supplying respirator means a respirator that supplies 
the respirator user with breathing air from a source independent of the 
ambient atmosphere, and includes supplied-air respirators (SARs) and 
self-contained breathing apparatus (SCBA) units.
    Canister or cartridge means a container with a filter, sorbent, or 
catalyst, or combination of these items, which removes specific 
contaminants from the air passed through the container.
    Demand respirator means an atmosphere-supplying respirator that 
admits breathing air to the facepiece only when a negative pressure is 
created inside the facepiece by inhalation.
    Emergency situation means any occurrence such as, but not limited 
to, equipment failure, rupture of containers, or failure of control 
equipment that may or does result in an uncontrolled significant 
release of an airborne contaminant.
    Employee exposure means exposure to a concentration of an airborne 
contaminant that would occur if the employee were not using respiratory 
protection.
    End-of-service-life indicator (ESLI) means a system that warns the 
respirator user of the approach of the end of adequate respiratory 
protection, for example, that the sorbent is approaching saturation or 
is no longer effective.
    Escape-only respirator means a respirator intended to be used only 
for emergency exit.
    Filter or air purifying element means a component used in 
respirators to remove solid or liquid aerosols from the inspired air.
    Filtering facepiece (dust mask) means a negative pressure 
particulate respirator with a filter as an integral part of the 
facepiece or with the entire facepiece composed of the filtering 
medium.
    Fit factor means a quantitative estimate of the fit of a particular 
respirator to a specific individual, and typically estimates the ratio 
of the concentration of a substance in ambient air to its concentration 
inside the respirator when worn.
    Fit test means the use of a protocol to qualitatively or 
quantitatively evaluate the fit of a respirator on an individual. (See 
also Qualitative fit test QLFT and Quantitative fit test QNFT.)
    Helmet means a rigid respiratory inlet covering that also provides 
head protection against impact and penetration.
    High efficiency particulate air (HEPA) filter means a filter that 
is at least 99.97% efficient in removing monodisperse particles of 0.3 
micrometers in diameter. The equivalent NIOSH 42 CFR 84 particulate 
filters are the N100, R100, and P100 filters.
    Hood means a respiratory inlet covering that completely covers the 
head and neck and may also cover portions of the shoulders and torso.
    Immediately dangerous to life or health (IDLH) means an atmosphere 
that poses an immediate threat to life, would cause irreversible 
adverse health effects, or would impair an individual's ability to 
escape from a dangerous atmosphere.
    Interior structural firefighting means the physical activity of 
fire suppression, rescue or both, inside of buildings or enclosed 
structures which are involved in a fire situation beyond the incipient 
stage. (See 29 CFR 1910.155)
    Loose-fitting facepiece means a respiratory inlet covering that is 
designed to form a partial seal with the face.
    Maximum use concentration (MUC) [Reserved].
    Negative pressure respirator (tight fitting) means a respirator in 
which the air pressure inside the facepiece is negative during 
inhalation with respect to the ambient air pressure outside the 
respirator.
    Oxygen deficient atmosphere means an atmosphere with an oxygen 
content below 19.5% by volume.
    Physician or other licensed health care professional (PLHCP) means 
an individual whose legally permitted scope of practice (i.e., license, 
registration, or certification) allows him or her to independently 
provide, or be delegated the responsibility to provide, some or all of 
the health care services required by paragraph (e) of this section.
    Positive pressure respirator means a respirator in which the 
pressure inside the respiratory inlet covering exceeds the ambient air 
pressure outside the respirator.
    Powered air-purifying respirator (PAPR) means an air-purifying 
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
    Pressure demand respirator means a positive pressure atmosphere-
supplying respirator that admits breathing air to the facepiece when 
the positive pressure

[[Page 1271]]

is reduced inside the facepiece by inhalation.
    Qualitative fit test (QLFT) means a pass/fail fit test to assess 
the adequacy of respirator fit that relies on the individual's response 
to the test agent.
    Quantitative fit test (QNFT) means an assessment of the adequacy of 
respirator fit by numerically measuring the amount of leakage into the 
respirator.
    Respiratory inlet covering means that portion of a respirator that 
forms the protective barrier between the user's respiratory tract and 
an air-purifying device or breathing air source, or both. It may be a 
facepiece, helmet, hood, suit, or a mouthpiece respirator with nose 
clamp.
    Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the breathing air source is designed to 
be carried by the user.
    Service life means the period of time that a respirator, filter or 
sorbent, or other respiratory equipment provides adequate protection to 
the wearer.
    Supplied-air respirator (SAR) or airline respirator means an 
atmosphere-supplying respirator for which the source of breathing air 
is not designed to be carried by the user.
    This section means this respiratory protection standard.
    Tight-fitting facepiece means a respiratory inlet covering that 
forms a complete seal with the face.
    User seal check means an action conducted by the respirator user to 
determine if the respirator is properly seated to the face.
    (c) Respiratory protection program. This paragraph requires the 
employer to develop and implement a written respiratory protection 
program with required worksite-specific procedures and elements for 
required respirator use. The program must be administered by a suitably 
trained program administrator. In addition, certain program elements 
may be required for voluntary use to prevent potential hazards 
associated with the use of the respirator. The Small Entity Compliance 
Guide contains criteria for the selection of a program administrator 
and a sample program that meets the requirements of this paragraph. 
Copies of the Small Entity Compliance Guide will be available on or 
about April 8, 1998 from the Occupational Safety and Health 
Administration's Office of Publications, Room N 3101, 200 Constitution 
Avenue, NW, Washington, DC, 20210 (202-219-4667).
    (1) In any workplace where respirators are necessary to protect the 
health of the employee or whenever respirators are required by the 
employer, the employer shall establish and implement a written 
respiratory protection program with worksite-specific procedures. The 
program shall be updated as necessary to reflect those changes in 
workplace conditions that affect respirator use. The employer shall 
include in the program the following provisions of this section, as 
applicable:
    (i) Procedures for selecting respirators for use in the workplace;
    (ii) Medical evaluations of employees required to use respirators;
    (iii) Fit testing procedures for tight-fitting respirators;
    (iv) Procedures for proper use of respirators in routine and 
reasonably foreseeable emergency situations;
    (v) Procedures and schedules for cleaning, disinfecting, storing, 
inspecting, repairing, discarding, and otherwise maintaining 
respirators;
    (vi) Procedures to ensure adequate air quality, quantity, and flow 
of breathing air for atmosphere-supplying respirators;
    (vii) Training of employees in the respiratory hazards to which 
they are potentially exposed during routine and emergency situations;
    (viii) Training of employees in the proper use of respirators, 
including putting on and removing them, any limitations on their use, 
and their maintenance; and
    (ix) Procedures for regularly evaluating the effectiveness of the 
program.
    (2) Where respirator use is not required:
    (i) An employer may provide respirators at the request of employees 
or permit employees to use their own respirators, if the employer 
determines that such respirator use will not in itself create a hazard. 
If the employer determines that any voluntary respirator use is 
permissible, the employer shall provide the respirator users with the 
information contained in Appendix D to this section (``Information for 
Employees Using Respirators When Not Required Under the Standard''); 
and
    (ii) In addition, the employer must establish and implement those 
elements of a written respiratory protection program necessary to 
ensure that any employee using a respirator voluntarily is medically 
able to use that respirator, and that the respirator is cleaned, 
stored, and maintained so that its use does not present a health hazard 
to the user. Exception: Employers are not required to include in a 
written respiratory protection program those employees whose only use 
of respirators involves the voluntary use of filtering facepieces (dust 
masks).
    (3) The employer shall designate a program administrator who is 
qualified by appropriate training or experience that is commensurate 
with the complexity of the program to administer or oversee the 
respiratory protection program and conduct the required evaluations of 
program effectiveness.
    (4) The employer shall provide respirators, training, and medical 
evaluations at no cost to the employee.
    (d) Selection of respirators. This paragraph requires the employer 
to evaluate respiratory hazard(s) in the workplace, identify relevant 
workplace and user factors, and base respirator selection on these 
factors. The paragraph also specifies appropriately protective 
respirators for use in IDLH atmospheres, and limits the selection and 
use of air-purifying respirators.
    (1) General requirements. (i) The employer shall select and provide 
an appropriate respirator based on the respiratory hazard(s) to which 
the worker is exposed and workplace and user factors that affect 
respirator performance and reliability.
    (ii) The employer shall select a NIOSH-certified respirator. The 
respirator shall be used in compliance with the conditions of its 
certification.
    (iii) The employer shall identify and evaluate the respiratory 
hazard(s) in the workplace; this evaluation shall include a reasonable 
estimate of employee exposures to respiratory hazard(s) and an 
identification of the contaminant's chemical state and physical form. 
Where the employer cannot identify or reasonably estimate the employee 
exposure, the employer shall consider the atmosphere to be IDLH.
    (iv) The employer shall select respirators from a sufficient number 
of respirator models and sizes so that the respirator is acceptable to, 
and correctly fits, the user.
    (2) Respirators for IDLH atmospheres. (i) The employer shall 
provide the following respirators for employee use in IDLH atmospheres:
    (A) A full facepiece pressure demand SCBA certified by NIOSH for a 
minimum service life of thirty minutes, or
    (B) A combination full facepiece pressure demand supplied-air 
respirator (SAR) with auxiliary self-contained air supply.
    (ii) Respirators provided only for escape from IDLH atmospheres 
shall be NIOSH-certified for escape from the atmosphere in which they 
will be used.
    (iii) All oxygen-deficient atmospheres shall be considered IDLH. 
Exception: If the employer demonstrates that, under all foreseeable 
conditions, the oxygen concentration can be maintained within

[[Page 1272]]

the ranges specified in Table II of this section (i.e., for the 
altitudes set out in the table), then any atmosphere-supplying 
respirator may be used.
    (3) Respirators for atmospheres that are not IDLH. (i) The employer 
shall provide a respirator that is adequate to protect the health of 
the employee and ensure compliance with all other OSHA statutory and 
regulatory requirements, under routine and reasonably foreseeable 
emergency situations.
    (A) Assigned Protection Factors (APFs) [Reserved]
    (B) Maximum Use Concentration (MUC) [Reserved]
    (ii) The respirator selected shall be appropriate for the chemical 
state and physical form of the contaminant.
    (iii) For protection against gases and vapors, the employer shall 
provide:
    (A) An atmosphere-supplying respirator, or
    (B) An air-purifying respirator, provided that:
    (1) The respirator is equipped with an end-of-service-life 
indicator (ESLI) certified by NIOSH for the contaminant; or
    (2) If there is no ESLI appropriate for conditions in the 
employer's workplace, the employer implements a change schedule for 
canisters and cartridges that is based on objective information or data 
that will ensure that canisters and cartridges are changed before the 
end of their service life. The employer shall describe in the 
respirator program the information and data relied upon and the basis 
for the canister and cartridge change schedule and the basis for 
reliance on the data.
    (iv) For protection against particulates, the employer shall 
provide:
    (A) An atmosphere-supplying respirator; or
    (B) An air-purifying respirator equipped with a filter certified by 
NIOSH under 30 CFR part 11 as a high efficiency particulate air (HEPA) 
filter, or an air-purifying respirator equipped with a filter certified 
for particulates by NIOSH under 42 CFR part 84; or
    (C) For contaminants consisting primarily of particles with mass 
median aerodynamic diameters (MMAD) of at least 2 micrometers, an air-
purifying respirator equipped with any filter certified for 
particulates by NIOSH.

            Table I.--Assigned Protection Factors [Reserved]            
                                                                        
                                                                        
                                                                        
                                                                        
                                                                        
                                                                        


                                Table II                                
------------------------------------------------------------------------
                                                                Oxygen  
                                                              deficient 
                                                             Atmospheres
                                                              (% 02) for
                                                              which the 
                       Altitude (ft.)                          employer 
                                                             may rely on
                                                             atmosphere-
                                                              supplying 
                                                             respirators
------------------------------------------------------------------------
Less than 3,001............................................    16.0-19.5
3,001-4,000................................................    16.4-19.5
4,001-5,000................................................    17.1-19.5
5,001-6,000................................................    17.8-19.5
6,001-7,000................................................    18.5-19.5
7,001-8,000\1\.............................................  19.3-19.5. 
------------------------------------------------------------------------
\1\ Above 8,000 feet the exception does not apply. Oxygen-enriched      
  breathing air must be supplied above 14,000 feet.                     

    (e) Medical evaluation. Using a respirator may place a 
physiological burden on employees that varies with the type of 
respirator worn, the job and workplace conditions in which the 
respirator is used, and the medical status of the employee. 
Accordingly, this paragraph specifies the minimum requirements for 
medical evaluation that employers must implement to determine the 
employee's ability to use a respirator.
    (1) General. The employer shall provide a medical evaluation to 
determine the employee's ability to use a respirator, before the 
employee is fit tested or required to use the respirator in the 
workplace. The employer may discontinue an employee's medical 
evaluations when the employee is no longer required to use a 
respirator.
    (2) Medical evaluation procedures. (i) The employer shall identify 
a physician or other licensed health care professional (PLHCP) to 
perform medical evaluations using a medical questionnaire or an initial 
medical examination that obtains the same information as the medical 
questionnaire.
    (ii) The medical evaluation shall obtain the information requested 
by the questionnaire in Sections 1 and 2, Part A of Appendix C of this 
section.
    (3) Follow-up medical examination. (i) The employer shall ensure 
that a follow-up medical examination is provided for an employee who 
gives a positive response to any question among questions 1 through 8 
in Section 2, Part A of Appendix C or whose initial medical examination 
demonstrates the need for a follow-up medical examination.
    (ii) The follow-up medical examination shall include any medical 
tests, consultations, or diagnostic procedures that the PLHCP deems 
necessary to make a final determination.
    (4) Administration of the medical questionnaire and examinations. 
(i) The medical questionnaire and examinations shall be administered 
confidentially during the employee's normal working hours or at a time 
and place convenient to the employee. The medical questionnaire shall 
be administered in a manner that ensures that the employee understands 
its content.
    (ii) The employer shall provide the employee with an opportunity to 
discuss the questionnaire and examination results with the PLHCP.
    (5) Supplemental information for the PLHCP. (i) The following 
information must be provided to the PLHCP before the PLHCP makes a 
recommendation concerning an employee's ability to use a respirator:
    (A) The type and weight of the respirator to be used by the 
employee;
    (B) The duration and frequency of respirator use (including use for 
rescue and escape);
    (C) The expected physical work effort;
    (D) Additional protective clothing and equipment to be worn; and
    (E) Temperature and humidity extremes that may be encountered.
    (ii) Any supplemental information provided previously to the PLHCP 
regarding an employee need not be provided for a subsequent medical 
evaluation if the information and the PLHCP remain the same.
    (iii) The employer shall provide the PLHCP with a copy of the 
written respiratory protection program and a copy of this section.

    Note to Paragraph (e)(5)(iii): When the employer replaces a 
PLHCP, the employer must ensure that the new PLHCP obtains this 
information, either by providing the documents directly to the PLHCP 
or having the documents transferred from the former PLHCP to the new 
PLHCP. However, OSHA does not expect employers to have employees 
medically reevaluated solely because a new PLHCP has been selected.

    (6) Medical determination. In determining the employee's ability to 
use a respirator, the employer shall:
    (i) Obtain a written recommendation regarding the employee's 
ability to use the respirator from the PLHCP. The recommendation shall 
provide only the following information:
    (A) Any limitations on respirator use related to the medical 
condition of the employee, or relating to the workplace conditions in 
which the respirator will be used, including whether or not the 
employee is medically able to use the respirator;
    (B) The need, if any, for follow-up medical evaluations; and
    (C) A statement that the PLHCP has provided the employee with a 
copy of the PLHCP's written recommendation.

[[Page 1273]]

    (ii) If the respirator is a negative pressure respirator and the 
PLHCP finds a medical condition that may place the employee's health at 
increased risk if the respirator is used, the employer shall provide a 
PAPR if the PLHCP's medical evaluation finds that the employee can use 
such a respirator; if a subsequent medical evaluation finds that the 
employee is medically able to use a negative pressure respirator, then 
the employer is no longer required to provide a PAPR.
    (7) Additional medical evaluations. At a minimum, the employer 
shall provide additional medical evaluations that comply with the 
requirements of this section if:
    (i) An employee reports medical signs or symptoms that are related 
to ability to use a respirator;
    (ii) A PLHCP, supervisor, or the respirator program administrator 
informs the employer that an employee needs to be reevaluated;
    (iii) Information from the respiratory protection program, 
including observations made during fit testing and program evaluation, 
indicates a need for employee reevaluation; or
    (iv) A change occurs in workplace conditions (e.g., physical work 
effort, protective clothing, temperature) that may result in a 
substantial increase in the physiological burden placed on an employee.
    (f) Fit testing. This paragraph requires that, before an employee 
may be required to use any respirator with a negative or positive 
pressure tight-fitting facepiece, the employee must be fit tested with 
the same make, model, style, and size of respirator that will be used. 
This paragraph specifies the kinds of fit tests allowed, the procedures 
for conducting them, and how the results of the fit tests must be used.
    (1) The employer shall ensure that employees using a tight-fitting 
facepiece respirator pass an appropriate qualitative fit test (QLFT) or 
quantitative fit test (QNFT) as stated in this paragraph.
    (2) The employer shall ensure that an employee using a tight-
fitting facepiece respirator is fit tested prior to initial use of the 
respirator, whenever a different respirator facepiece (size, style, 
model or make) is used, and at least annually thereafter.
    (3) The employer shall conduct an additional fit test whenever the 
employee reports, or the employer, PLHCP, supervisor, or program 
administrator makes visual observations of, changes in the employee's 
physical condition that could affect respirator fit. Such conditions 
include, but are not limited to, facial scarring, dental changes, 
cosmetic surgery, or an obvious change in body weight.
    (4) If after passing a QLFT or QNFT, the employee subsequently 
notifies the employer, program administrator, supervisor, or PLHCP that 
the fit of the respirator is unacceptable, the employee shall be given 
a reasonable opportunity to select a different respirator facepiece and 
to be retested.
    (5) The fit test shall be administered using an OSHA-accepted QLFT 
or QNFT protocol. The OSHA-accepted QLFT and QNFT protocols and 
procedures are contained in Appendix A of this section.
    (6) QLFT may only be used to fit test negative pressure air-
purifying respirators that must achieve a fit factor of 100 or less.
    (7) If the fit factor, as determined through an OSHA-accepted QNFT 
protocol, is equal to or greater than 100 for tight-fitting half 
facepieces, or equal to or greater than 500 for tight-fitting full 
facepieces, the QNFT has been passed with that respirator.
    (8) Fit testing of tight-fitting atmosphere-supplying respirators 
and tight-fitting powered air-purifying respirators shall be 
accomplished by performing quantitative or qualitative fit testing in 
the negative pressure mode, regardless of the mode of operation 
(negative or positive pressure) that is used for respiratory 
protection.
    (i) Qualitative fit testing of these respirators shall be 
accomplished by temporarily converting the respirator user's actual 
facepiece into a negative pressure respirator with appropriate filters, 
or by using an identical negative pressure air-purifying respirator 
facepiece with the same sealing surfaces as a surrogate for the 
atmosphere-supplying or powered air-purifying respirator facepiece.
    (ii) Quantitative fit testing of these respirators shall be 
accomplished by modifying the facepiece to allow sampling inside the 
facepiece in the breathing zone of the user, midway between the nose 
and mouth. This requirement shall be accomplished by installing a 
permanent sampling probe onto a surrogate facepiece, or by using a 
sampling adapter designed to temporarily provide a means of sampling 
air from inside the facepiece.
    (iii) Any modifications to the respirator facepiece for fit testing 
shall be completely removed, and the facepiece restored to NIOSH-
approved configuration, before that facepiece can be used in the 
workplace.
    (g) Use of respirators. This paragraph requires employers to 
establish and implement procedures for the proper use of respirators. 
These requirements include prohibiting conditions that may result in 
facepiece seal leakage, preventing employees from removing respirators 
in hazardous environments, taking actions to ensure continued effective 
respirator operation throughout the work shift, and establishing 
procedures for the use of respirators in IDLH atmospheres or in 
interior structural firefighting situations.
    (1) Facepiece seal protection. (i) The employer shall not permit 
respirators with tight-fitting facepieces to be worn by employees who 
have:
    (A) Facial hair that comes between the sealing surface of the 
facepiece and the face or that interferes with valve function; or
    (B) Any condition that interferes with the face-to-facepiece seal 
or valve function.
    (ii) If an employee wears corrective glasses or goggles or other 
personal protective equipment, the employer shall ensure that such 
equipment is worn in a manner that does not interfere with the seal of 
the facepiece to the face of the user.
    (iii) For all tight-fitting respirators, the employer shall ensure 
that employees perform a user seal check each time they put on the 
respirator using the procedures in Appendix B-1 or procedures 
recommended by the respirator manufacturer that the employer 
demonstrates are as effective as those in Appendix B-1 of this section.
    (2) Continuing respirator effectiveness. (i) Appropriate 
surveillance shall be maintained of work area conditions and degree of 
employee exposure or stress. When there is a change in work area 
conditions or degree of employee exposure or stress that may affect 
respirator effectiveness, the employer shall reevaluate the continued 
effectiveness of the respirator.
    (ii) The employer shall ensure that employees leave the respirator 
use area:
    (A) To wash their faces and respirator facepieces as necessary to 
prevent eye or skin irritation associated with respirator use; or
    (B) If they detect vapor or gas breakthrough, changes in breathing 
resistance, or leakage of the facepiece; or
    (C) To replace the respirator or the filter, cartridge, or canister 
elements.
    (iii) If the employee detects vapor or gas breakthrough, changes in 
breathing resistance, or leakage of the facepiece, the employer must 
replace or repair the respirator before allowing the employee to return 
to the work area.
    (3) Procedures for IDLH atmospheres. For all IDLH atmospheres, the 
employer shall ensure that:

[[Page 1274]]

    (i) One employee or, when needed, more than one employee is located 
outside the IDLH atmosphere;
    (ii) Visual, voice, or signal line communication is maintained 
between the employee(s) in the IDLH atmosphere and the employee(s) 
located outside the IDLH atmosphere;
    (iii) The employee(s) located outside the IDLH atmosphere are 
trained and equipped to provide effective emergency rescue;
    (iv) The employer or designee is notified before the employee(s) 
located outside the IDLH atmosphere enter the IDLH atmosphere to 
provide emergency rescue;
    (v) The employer or designee authorized to do so by the employer, 
once notified, provides necessary assistance appropriate to the 
situation;
    (vi) Employee(s) located outside the IDLH atmospheres are equipped 
with:
    (A) Pressure demand or other positive pressure SCBAs, or a pressure 
demand or other positive pressure supplied-air respirator with 
auxiliary SCBA; and either
    (B) Appropriate retrieval equipment for removing the employee(s) 
who enter(s) these hazardous atmospheres where retrieval equipment 
would contribute to the rescue of the employee(s) and would not 
increase the overall risk resulting from entry; or
    (C) Equivalent means for rescue where retrieval equipment is not 
required under paragraph (g)(3)(vi)(B).
    (4) Procedures for interior structural firefighting. In addition to 
the requirements set forth under paragraph (g)(3), in interior 
structural fires, the employer shall ensure that:
    (i) At least two employees enter the IDLH atmosphere and remain in 
visual or voice contact with one another at all times;
    (ii) At least two employees are located outside the IDLH 
atmosphere; and
    (iii) All employees engaged in interior structural firefighting use 
SCBAs.

    Note 1 to paragraph (g): One of the two individuals located 
outside the IDLH atmosphere may be assigned to an additional role, 
such as incident commander in charge of the emergency or safety 
officer, so long as this individual is able to perform assistance or 
rescue activities without jeopardizing the safety or health of any 
firefighter working at the incident.
    Note 2 to paragraph (g): Nothing in this section is meant to 
preclude firefighters from performing emergency rescue activities 
before an entire team has assembled.

    (h) Maintenance and care of respirators. This paragraph requires 
the employer to provide for the cleaning and disinfecting, storage, 
inspection, and repair of respirators used by employees.
    (1) Cleaning and disinfecting. The employer shall provide each 
respirator user with a respirator that is clean, sanitary, and in good 
working order. The employer shall ensure that respirators are cleaned 
and disinfected using the procedures in Appendix B-2 of this section, 
or procedures recommended by the respirator manufacturer, provided that 
such procedures are of equivalent effectiveness. The respirators shall 
be cleaned and disinfected at the following intervals:
    (i) Respirators issued for the exclusive use of an employee shall 
be cleaned and disinfected as often as necessary to be maintained in a 
sanitary condition;
    (ii) Respirators issued to more than one employee shall be cleaned 
and disinfected before being worn by different individuals;
    (iii) Respirators maintained for emergency use shall be cleaned and 
disinfected after each use; and
    (iv) Respirators used in fit testing and training shall be cleaned 
and disinfected after each use.
    (2) Storage. The employer shall ensure that respirators are stored 
as follows:
    (i) All respirators shall be stored to protect them from damage, 
contamination, dust, sunlight, extreme temperatures, excessive 
moisture, and damaging chemicals, and they shall be packed or stored to 
prevent deformation of the facepiece and exhalation valve.
    (ii) In addition to the requirements of paragraph (h)(2)(i) of this 
section, emergency respirators shall be:
    (A) Kept accessible to the work area;
    (B) Stored in compartments or in covers that are clearly marked as 
containing emergency respirators; and
    (C) Stored in accordance with any applicable manufacturer 
instructions.
    (3) Inspection. (i) The employer shall ensure that respirators are 
inspected as follows:
    (A) All respirators used in routine situations shall be inspected 
before each use and during cleaning;
    (B) All respirators maintained for use in emergency situations 
shall be inspected at least monthly and in accordance with the 
manufacturer's recommendations, and shall be checked for proper 
function before and after each use; and
    (C) Emergency escape-only respirators shall be inspected before 
being carried into the workplace for use.
    (ii) The employer shall ensure that respirator inspections include 
the following:
    (A) A check of respirator function, tightness of connections, and 
the condition of the various parts including, but not limited to, the 
facepiece, head straps, valves, connecting tube, and cartridges, 
canisters or filters; and
    (B) A check of elastomeric parts for pliability and signs of 
deterioration.
    (iii) In addition to the requirements of paragraphs (h)(3)(i) and 
(ii) of this section, self-contained breathing apparatus shall be 
inspected monthly. Air and oxygen cylinders shall be maintained in a 
fully charged state and shall be recharged when the pressure falls to 
90% of the manufacturer's recommended pressure level. The employer 
shall determine that the regulator and warning devices function 
properly.
    (iv) For respirators maintained for emergency use, the employer 
shall:
    (A) Certify the respirator by documenting the date the inspection 
was performed, the name (or signature) of the person who made the 
inspection, the findings, required remedial action, and a serial number 
or other means of identifying the inspected respirator; and
    (B) Provide this information on a tag or label that is attached to 
the storage compartment for the respirator, is kept with the 
respirator, or is included in inspection reports stored as paper or 
electronic files. This information shall be maintained until replaced 
following a subsequent certification.
    (4) Repairs. The employer shall ensure that respirators that fail 
an inspection or are otherwise found to be defective are removed from 
service, and are discarded or repaired or adjusted in accordance with 
the following procedures:
    (i) Repairs or adjustments to respirators are to be made only by 
persons appropriately trained to perform such operations and shall use 
only the respirator manufacturer's NIOSH-approved parts designed for 
the respirator;
    (ii) Repairs shall be made according to the manufacturer's 
recommendations and specifications for the type and extent of repairs 
to be performed; and
    (iii) Reducing and admission valves, regulators, and alarms shall 
be adjusted or repaired only by the manufacturer or a technician 
trained by the manufacturer.
    (i) Breathing air quality and use. This paragraph requires the 
employer to provide employees using atmosphere-supplying respirators 
(supplied-air and SCBA) with breathing gases of high purity.
    (1) The employer shall ensure that compressed air, compressed 
oxygen, liquid air, and liquid oxygen used for respiration accords with 
the following specifications:

[[Page 1275]]

    (i) Compressed and liquid oxygen shall meet the United States 
Pharmacopoeia requirements for medical or breathing oxygen; and
    (ii) Compressed breathing air shall meet at least the requirements 
for Type 1-Grade D breathing air described in ANSI/Compressed Gas 
Association Commodity Specification for Air, G-7.1-1989, to include:
    (A) Oxygen content (v/v) of 19.5-23.5%;
    (B) Hydrocarbon (condensed) content of 5 milligrams per cubic meter 
of air or less;
    (C) Carbon monoxide (CO) content of 10 ppm or less;
    (D) Carbon dioxide content of 1,000 ppm or less; and
    (E) Lack of noticeable odor.
    (2) The employer shall ensure that compressed oxygen is not used in 
atmosphere-supplying respirators that have previously used compressed 
air.
    (3) The employer shall ensure that oxygen concentrations greater 
than  23.5% are used only in equipment designed for oxygen service or 
distribution.
    (4) The employer shall ensure that cylinders used to supply 
breathing air to respirators meet the following requirements:
    (i) Cylinders are tested and maintained as prescribed in the 
Shipping Container Specification Regulations of the Department of 
Transportation (49 CFR part 173 and part 178);
    (ii) Cylinders of purchased breathing air have a certificate of 
analysis from the supplier that the breathing air meets the 
requirements for Type 1--Grade D breathing air; and
    (iii) The moisture content in the cylinder does not exceed a dew 
point of -50  deg.F (-45.6  deg.C) at 1 atmosphere pressure.
    (5) The employer shall ensure that compressors used to supply 
breathing air to respirators are constructed and situated so as to:
    (i) Prevent entry of contaminated air into the air-supply system;
    (ii) Minimize moisture content so that the dew point at 1 
atmosphere pressure is 10 degrees F (5.56  deg.C) below the ambient 
temperature;
    (iii) Have suitable in-line air-purifying sorbent beds and filters 
to further ensure breathing air quality. Sorbent beds and filters shall 
be maintained and replaced or refurbished periodically following the 
manufacturer's instructions.
    (iv) Have a tag containing the most recent change date and the 
signature of the person authorized by the employer to perform the 
change. The tag shall be maintained at the compressor.
    (6) For compressors that are not oil-lubricated, the employer shall 
ensure that carbon monoxide levels in the breathing air do not exceed 
10 ppm.
    (7) For oil-lubricated compressors, the employer shall use a high-
temperature or carbon monoxide alarm, or both, to monitor carbon 
monoxide levels. If only high-temperature alarms are used, the air 
supply shall be monitored at intervals sufficient to prevent carbon 
monoxide in the breathing air from exceeding 10 ppm.
    (8) The employer shall ensure that breathing air couplings are 
incompatible with outlets for nonrespirable worksite air or other gas 
systems. No asphyxiating substance shall be introduced into breathing 
air lines.
    (9) The employer shall use breathing gas containers marked in 
accordance with the NIOSH respirator certification standard, 42 CFR 
part 84.
    (j) Identification of filters, cartridges, and canisters. The 
employer shall ensure that all filters, cartridges and canisters used 
in the workplace are labeled and color coded with the NIOSH approval 
label and that the label is not removed and remains legible.
    (k) Training and information. This paragraph requires the employer 
to provide effective training to employees who are required to use 
respirators. The training must be comprehensive, understandable, and 
recur annually, and more often if necessary. This paragraph also 
requires the employer to provide the basic information on respirators 
in Appendix D of this section to employees who wear respirators when 
not required by this section or by the employer to do so.
    (1) The employer shall ensure that each employee can demonstrate 
knowledge of at least the following:
    (i) Why the respirator is necessary and how improper fit, usage, or 
maintenance can compromise the protective effect of the respirator;
    (ii) What the limitations and capabilities of the respirator are;
    (iii) How to use the respirator effectively in emergency 
situations, including situations in which the respirator malfunctions;
    (iv) How to inspect, put on and remove, use, and check the seals of 
the respirator;
    (v) What the procedures are for maintenance and storage of the 
respirator;
    (vi) How to recognize medical signs and symptoms that may limit or 
prevent the effective use of respirators; and
    (vii) The general requirements of this section.
    (2) The training shall be conducted in a manner that is 
understandable to the employee.
    (3) The employer shall provide the training prior to requiring the 
employee to use a respirator in the workplace.
    (4) An employer who is able to demonstrate that a new employee has 
received training within the last 12 months that addresses the elements 
specified in paragraph (k)(1)(i) through (vii) is not required to 
repeat such training provided that, as required by paragraph (k)(1), 
the employee can demonstrate knowledge of those element(s). Previous 
training not repeated initially by the employer must be provided no 
later than 12 months from the date of the previous training.
    (5) Retraining shall be administered annually, and when the 
following situations occur:
    (i) Changes in the workplace or the type of respirator render 
previous training obsolete;
    (ii) Inadequacies in the employee's knowledge or use of the 
respirator indicate that the employee has not retained the requisite 
understanding or skill; or
    (iii) Any other situation arises in which retraining appears 
necessary to ensure safe respirator use.
    (6) The basic advisory information on respirators, as presented in 
Appendix D of this section, shall be provided by the employer in any 
written or oral format, to employees who wear respirators when such use 
is not required by this section or by the employer.
    (l) Program evaluation. This section requires the employer to 
conduct evaluations of the workplace to ensure that the written 
respiratory protection program is being properly implemented, and to 
consult employees to ensure that they are using the respirators 
properly.
    (1) The employer shall conduct evaluations of the workplace as 
necessary to ensure that the provisions of the current written program 
are being effectively implemented and that it continues to be 
effective.
    (2) The employer shall regularly consult employees required to use 
respirators to assess the employees' views on program effectiveness and 
to identify any problems. Any problems that are identified during this 
assessment shall be corrected. Factors to be assessed include, but are 
not limited to:
    (i) Respirator fit (including the ability to use the respirator 
without interfering with effective workplace performance);
    (ii) Appropriate respirator selection for the hazards to which the 
employee is exposed;

[[Page 1276]]

    (iii) Proper respirator use under the workplace conditions the 
employee encounters; and
    (iv) Proper respirator maintenance.
    (m) Recordkeeping. This section requires the employer to establish 
and retain written information regarding medical evaluations, fit 
testing, and the respirator program. This information will facilitate 
employee involvement in the respirator program, assist the employer in 
auditing the adequacy of the program, and provide a record for 
compliance determinations by OSHA.
    (1) Medical evaluation. Records of medical evaluations required by 
this section must be retained and made available in accordance with 29 
CFR 1910.1020.
    (2) Fit testing. (i) The employer shall establish a record of the 
qualitative and quantitative fit tests administered to an employee 
including:
    (A) The name or identification of the employee tested;
    (B) Type of fit test performed;
    (C) Specific make, model, style, and size of respirator tested;
    (D) Date of test; and
    (E) The pass/fail results for QLFTs or the fit factor and strip 
chart recording or other recording of the test results for QNFTs.
    (ii) Fit test records shall be retained for respirator users until 
the next fit test is administered.
    (3) A written copy of the current respirator program shall be 
retained by the employer.
    (4) Written materials required to be retained under this paragraph 
shall be made available upon request to affected employees and to the 
Assistant Secretary or designee for examination and copying.
    (n) Dates. (1) Effective date. This section is effective April 8, 
1998. The obligations imposed by this section commence on the effective 
date unless otherwise noted in this paragraph. Compliance with 
obligations that do not commence on the effective date shall occur no 
later than the applicable start-up date.
    (2) Compliance dates. All obligations of this section commence on 
the effective date except as follows:
    (i) The determination that respirator use is required (paragraph 
(a)) shall be completed no later than September 8, 1998.
    (ii) Compliance with provisions of this section for all other 
provisions shall be completed no later than October 5, 1998.
    (3) The provisions of 29 CFR 1910.134 and 29 CFR 1926.103, 
contained in the 29 CFR parts 1900 to 1910.99 and the 29 CFR part 1926 
editions, revised as of July 1, 1997, are in effect and enforceable 
until April 8, 1998, or during any administrative or judicial stay of 
the provisions of this section.
    (4) Existing Respiratory Protection Programs. If, in the 12 month 
period preceding April 8, 1998, the employer has conducted annual 
respirator training, fit testing, respirator program evaluation, or 
medical evaluations, the employer may use the results of those 
activities to comply with the corresponding provisions of this section, 
providing that these activities were conducted in a manner that meets 
the requirements of this section.
    (o) Appendices. (1) Compliance with Appendix A, Appendix B-1, 
Appendix B-2, and Appendix C of this section is mandatory.
    (2) Appendix D of this section is non-mandatory and is not intended 
to create any additional obligations not otherwise imposed or to 
detract from any existing obligations.

Appendix A to Sec. 1910.134: Fit Testing Procedures (Mandatory)

Part I. OSHA-Accepted Fit Test Protocols

A. Fit Testing Procedures--General Requirements

    The employer shall conduct fit testing using the following 
procedures. The requirements in this appendix apply to all OSHA-
accepted fit test methods, both QLFT and QNFT.
    1. The test subject shall be allowed to pick the most acceptable 
respirator from a sufficient number of respirator models and sizes 
so that the respirator is acceptable to, and correctly fits, the 
user.
    2. Prior to the selection process, the test subject shall be 
shown how to put on a respirator, how it should be positioned on the 
face, how to set strap tension and how to determine an acceptable 
fit. A mirror shall be available to assist the subject in evaluating 
the fit and positioning of the respirator. This instruction may not 
constitute the subject's formal training on respirator use, because 
it is only a review.
    3. The test subject shall be informed that he/she is being asked 
to select the respirator that provides the most acceptable fit. Each 
respirator represents a different size and shape, and if fitted and 
used properly, will provide adequate protection.
    4. The test subject shall be instructed to hold each chosen 
facepiece up to the face and eliminate those that obviously do not 
give an acceptable fit.
    5. The more acceptable facepieces are noted in case the one 
selected proves unacceptable; the most comfortable mask is donned 
and worn at least five minutes to assess comfort. Assistance in 
assessing comfort can be given by discussing the points in the 
following item A.6. If the test subject is not familiar with using a 
particular respirator, the test subject shall be directed to don the 
mask several times and to adjust the straps each time to become 
adept at setting proper tension on the straps.
    6. Assessment of comfort shall include a review of the following 
points with the test subject and allowing the test subject adequate 
time to determine the comfort of the respirator:
    (a) Position of the mask on the nose
    (b) Room for eye protection
    (c) Room to talk
    (d) Position of mask on face and cheeks
    7. The following criteria shall be used to help determine the 
adequacy of the respirator fit:
    (a) Chin properly placed;
    (b) Adequate strap tension, not overly tightened;
    (c) Fit across nose bridge;
    (d) Respirator of proper size to span distance from nose to 
chin;
    (e) Tendency of respirator to slip;
    (f) Self-observation in mirror to evaluate fit and respirator 
position.
    8. The test subject shall conduct a user seal check, either the 
negative and positive pressure seal checks described in Appendix B-1 
of this section or those recommended by the respirator manufacturer 
which provide equivalent protection to the procedures in Appendix B-
1. Before conducting the negative and positive pressure checks, the 
subject shall be told to seat the mask on the face by moving the 
head from side-to-side and up and down slowly while taking in a few 
slow deep breaths. Another facepiece shall be selected and retested 
if the test subject fails the user seal check tests.
    9. The test shall not be conducted if there is any hair growth 
between the skin and the facepiece sealing surface, such as stubble 
beard growth, beard, mustache or sideburns which cross the 
respirator sealing surface. Any type of apparel which interferes 
with a satisfactory fit shall be altered or removed.
    10. If a test subject exhibits difficulty in breathing during 
the tests, she or he shall be referred to a physician or other 
licensed health care professional, as appropriate, to determine 
whether the test subject can wear a respirator while performing her 
or his duties.
    11. If the employee finds the fit of the respirator 
unacceptable, the test subject shall be given the opportunity to 
select a different respirator and to be retested.
    12. Exercise regimen. Prior to the commencement of the fit test, 
the test subject shall be given a description of the fit test and 
the test subject's responsibilities during the test procedure. The 
description of the process shall include a description of the test 
exercises that the subject will be performing. The respirator to be 
tested shall be worn for at least 5 minutes before the start of the 
fit test.
    13. The fit test shall be performed while the test subject is 
wearing any applicable safety equipment that may be worn during 
actual respirator use which could interfere with respirator fit.
    14. Test Exercises. (a) The following test exercises are to be 
performed for all fit testing methods prescribed in this appendix, 
except for the CNP method. A separate fit testing exercise regimen 
is contained in the CNP protocol. The test subject shall perform 
exercises, in the test environment, in the following manner:

[[Page 1277]]

    (1) Normal breathing. In a normal standing position, without 
talking, the subject shall breathe normally.
    (2) Deep breathing. In a normal standing position, the subject 
shall breathe slowly and deeply, taking caution so as not to 
hyperventilate.
    (3) Turning head side to side. Standing in place, the subject 
shall slowly turn his/her head from side to side between the extreme 
positions on each side. The head shall be held at each extreme 
momentarily so the subject can inhale at each side.
    (4) Moving head up and down. Standing in place, the subject 
shall slowly move his/her head up and down. The subject shall be 
instructed to inhale in the up position (i.e., when looking toward 
the ceiling).
    (5) Talking. The subject shall talk out loud slowly and loud 
enough so as to be heard clearly by the test conductor. The subject 
can read from a prepared text such as the Rainbow Passage, count 
backward from 100, or recite a memorized poem or song.

Rainbow Passage

    When the sunlight strikes raindrops in the air, they act like a 
prism and form a rainbow. The rainbow is a division of white light 
into many beautiful colors. These take the shape of a long round 
arch, with its path high above, and its two ends apparently beyond 
the horizon. There is, according to legend, a boiling pot of gold at 
one end. People look, but no one ever finds it. When a man looks for 
something beyond reach, his friends say he is looking for the pot of 
gold at the end of the rainbow.
    (6) Grimace. The test subject shall grimace by smiling or 
frowning. (This applies only to QNFT testing; it is not performed 
for QLFT)
    (7) Bending over. The test subject shall bend at the waist as if 
he/she were to touch his/her toes. Jogging in place shall be 
substituted for this exercise in those test environments such as 
shroud type QNFT or QLFT units that do not permit bending over at 
the waist.
    (8) Normal breathing. Same as exercise (1).
    (b) Each test exercise shall be performed for one minute except 
for the grimace exercise which shall be performed for 15 seconds. 
The test subject shall be questioned by the test conductor regarding 
the comfort of the respirator upon completion of the protocol. If it 
has become unacceptable, another model of respirator shall be tried. 
The respirator shall not be adjusted once the fit test exercises 
begin. Any adjustment voids the test, and the fit test must be 
repeated.

B. Qualitative Fit Test (QLFT) Protocols

1. General

    (a) The employer shall ensure that persons administering QLFT 
are able to prepare test solutions, calibrate equipment and perform 
tests properly, recognize invalid tests, and ensure that test 
equipment is in proper working order.
    (b) The employer shall ensure that QLFT equipment is kept clean 
and well maintained so as to operate within the parameters for which 
it was designed.

2. Isoamyl Acetate Protocol

    Note: This protocol is not appropriate to use for the fit 
testing of particulate respirators. If used to fit test particulate 
respirators, the respirator must be equipped with an organic vapor 
filter.

(a) Odor Threshold Screening

    Odor threshold screening, performed without wearing a 
respirator, is intended to determine if the individual tested can 
detect the odor of isoamyl acetate at low levels.
    (1) Three 1 liter glass jars with metal lids are required.
    (2) Odor-free water (e.g., distilled or spring water) at 
approximately 25 deg. C (77 deg. F) shall be used for the solutions.
    (3) The isoamyl acetate (IAA) (also known at isopentyl acetate) 
stock solution is prepared by adding 1 ml of pure IAA to 800 ml of 
odor-free water in a 1 liter jar, closing the lid and shaking for 30 
seconds. A new solution shall be prepared at least weekly.
    (4) The screening test shall be conducted in a room separate 
from the room used for actual fit testing. The two rooms shall be 
well-ventilated to prevent the odor of IAA from becoming evident in 
the general room air where testing takes place.
    (5) The odor test solution is prepared in a second jar by 
placing 0.4 ml of the stock solution into 500 ml of odor-free water 
using a clean dropper or pipette. The solution shall be shaken for 
30 seconds and allowed to stand for two to three minutes so that the 
IAA concentration above the liquid may reach equilibrium. This 
solution shall be used for only one day.
    (6) A test blank shall be prepared in a third jar by adding 500 
cc of odor-free water.
    (7) The odor test and test blank jar lids shall be labeled 
(e.g., 1 and 2) for jar identification. Labels shall be placed on 
the lids so that they can be peeled off periodically and switched to 
maintain the integrity of the test.
    (8) The following instruction shall be typed on a card and 
placed on the table in front of the two test jars (i.e., 1 and 2): 
``The purpose of this test is to determine if you can smell banana 
oil at a low concentration. The two bottles in front of you contain 
water. One of these bottles also contains a small amount of banana 
oil. Be sure the covers are on tight, then shake each bottle for two 
seconds. Unscrew the lid of each bottle, one at a time, and sniff at 
the mouth of the bottle. Indicate to the test conductor which bottle 
contains banana oil.''
    (9) The mixtures used in the IAA odor detection test shall be 
prepared in an area separate from where the test is performed, in 
order to prevent olfactory fatigue in the subject.
    (10) If the test subject is unable to correctly identify the jar 
containing the odor test solution, the IAA qualitative fit test 
shall not be performed.
    (11) If the test subject correctly identifies the jar containing 
the odor test solution, the test subject may proceed to respirator 
selection and fit testing.

(b) Isoamyl Acetate Fit Test

    (1) The fit test chamber shall be a clear 55-gallon drum liner 
suspended inverted over a 2-foot diameter frame so that the top of 
the chamber is about 6 inches above the test subject's head. If no 
drum liner is available, a similar chamber shall be constructed 
using plastic sheeting. The inside top center of the chamber shall 
have a small hook attached.
    (2) Each respirator used for the fitting and fit testing shall 
be equipped with organic vapor cartridges or offer protection 
against organic vapors.
    (3) After selecting, donning, and properly adjusting a 
respirator, the test subject shall wear it to the fit testing room. 
This room shall be separate from the room used for odor threshold 
screening and respirator selection, and shall be well-ventilated, as 
by an exhaust fan or lab hood, to prevent general room 
contamination.
    (4) A copy of the test exercises and any prepared text from 
which the subject is to read shall be taped to the inside of the 
test chamber.
    (5) Upon entering the test chamber, the test subject shall be 
given a 6-inch by 5-inch piece of paper towel, or other porous, 
absorbent, single-ply material, folded in half and wetted with 0.75 
ml of pure IAA. The test subject shall hang the wet towel on the 
hook at the top of the chamber. An IAA test swab or ampule may be 
substituted for the IAA wetted paper towel provided it has been 
demonstrated that the alternative IAA source will generate an IAA 
test atmosphere with a concentration equivalent to that generated by 
the paper towel method.
    (6) Allow two minutes for the IAA test concentration to 
stabilize before starting the fit test exercises. This would be an 
appropriate time to talk with the test subject; to explain the fit 
test, the importance of his/her cooperation, and the purpose for the 
test exercises; or to demonstrate some of the exercises.
    (7) If at any time during the test, the subject detects the 
banana-like odor of IAA, the test is failed. The subject shall 
quickly exit from the test chamber and leave the test area to avoid 
olfactory fatigue.
    (8) If the test is failed, the subject shall return to the 
selection room and remove the respirator. The test subject shall 
repeat the odor sensitivity test, select and put on another 
respirator, return to the test area and again begin the fit test 
procedure described in (b) (1) through (7) above. The process 
continues until a respirator that fits well has been found. Should 
the odor sensitivity test be failed, the subject shall wait at least 
5 minutes before retesting. Odor sensitivity will usually have 
returned by this time.
    (9) If the subject passes the test, the efficiency of the test 
procedure shall be demonstrated by having the subject break the 
respirator face seal and take a breath before exiting the chamber.
    (10) When the test subject leaves the chamber, the subject shall 
remove the saturated towel and return it to the person conducting 
the test, so that there is no significant IAA concentration buildup 
in the chamber during subsequent tests. The used towels shall be 
kept in a self-sealing plastic bag to keep the test area from being 
contaminated.

3. Saccharin Solution Aerosol Protocol

    The entire screening and testing procedure shall be explained to 
the test subject prior to the conduct of the screening test.
    (a) Taste threshold screening. The saccharin taste threshold 
screening,

[[Page 1278]]

performed without wearing a respirator, is intended to determine 
whether the individual being tested can detect the taste of 
saccharin.
    (1) During threshold screening as well as during fit testing, 
subjects shall wear an enclosure about the head and shoulders that 
is approximately 12 inches in diameter by 14 inches tall with at 
least the front portion clear and that allows free movements of the 
head when a respirator is worn. An enclosure substantially similar 
to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is 
adequate.
    (2) The test enclosure shall have a \3/4\-inch (1.9 cm) hole in 
front of the test subject's nose and mouth area to accommodate the 
nebulizer nozzle.
    (3) The test subject shall don the test enclosure. Throughout 
the threshold screening test, the test subject shall breathe through 
his/her slightly open mouth with tongue extended. The subject is 
instructed to report when he/she detects a sweet taste.
    (4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer 
or equivalent, the test conductor shall spray the threshold check 
solution into the enclosure. The nozzle is directed away from the 
nose and mouth of the person. This nebulizer shall be clearly marked 
to distinguish it from the fit test solution nebulizer.
    (5) The threshold check solution is prepared by dissolving 0.83 
gram of sodium saccharin USP in 100 ml of warm water. It can be 
prepared by putting 1 ml of the fit test solution (see (b)(5) below) 
in 100 ml of distilled water.
    (6) To produce the aerosol, the nebulizer bulb is firmly 
squeezed so that it collapses completely, then released and allowed 
to fully expand.
    (7) Ten squeezes are repeated rapidly and then the test subject 
is asked whether the saccharin can be tasted. If the test subject 
reports tasting the sweet taste during the ten squeezes, the 
screening test is completed. The taste threshold is noted as ten 
regardless of the number of squeezes actually completed.
    (8) If the first response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
saccharin is tasted. If the test subject reports tasting the sweet 
taste during the second ten squeezes, the screening test is 
completed. The taste threshold is noted as twenty regardless of the 
number of squeezes actually completed.
    (9) If the second response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
saccharin is tasted. If the test subject reports tasting the sweet 
taste during the third set of ten squeezes, the screening test is 
completed. The taste threshold is noted as thirty regardless of the 
number of squeezes actually completed.
    (10) The test conductor will take note of the number of squeezes 
required to solicit a taste response.
    (11) If the saccharin is not tasted after 30 squeezes (step 10), 
the test subject is unable to taste saccharin and may not perform 
the saccharin fit test.

    Note to paragraph 3. (a): If the test subject eats or drinks 
something sweet before the screening test, he/she may be unable to 
taste the weak saccharin solution.

    (12) If a taste response is elicited, the test subject shall be 
asked to take note of the taste for reference in the fit test.
    (13) Correct use of the nebulizer means that approximately 1 ml 
of liquid is used at a time in the nebulizer body.
    (14) The nebulizer shall be thoroughly rinsed in water, shaken 
dry, and refilled at least each morning and afternoon or at least 
every four hours.
    (b) Saccharin solution aerosol fit test procedure.
    (1) The test subject may not eat, drink (except plain water), 
smoke, or chew gum for 15 minutes before the test.
    (2) The fit test uses the same enclosure described in 3. (a) 
above.
    (3) The test subject shall don the enclosure while wearing the 
respirator selected in section I. A. of this appendix. The 
respirator shall be properly adjusted and equipped with a 
particulate filter(s).
    (4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer 
or equivalent is used to spray the fit test solution into the 
enclosure. This nebulizer shall be clearly marked to distinguish it 
from the screening test solution nebulizer.
    (5) The fit test solution is prepared by adding 83 grams of 
sodium saccharin to 100 ml of warm water.
    (6) As before, the test subject shall breathe through the 
slightly open mouth with tongue extended, and report if he/she 
tastes the sweet taste of saccharin.
    (7) The nebulizer is inserted into the hole in the front of the 
enclosure and an initial concentration of saccharin fit test 
solution is sprayed into the enclosure using the same number of 
squeezes (either 10, 20 or 30 squeezes) based on the number of 
squeezes required to elicit a taste response as noted during the 
screening test. A minimum of 10 squeezes is required.
    (8) After generating the aerosol, the test subject shall be 
instructed to perform the exercises in section I. A. 14. of this 
appendix.
    (9) Every 30 seconds the aerosol concentration shall be 
replenished using one half the original number of squeezes used 
initially (e.g., 5, 10 or 15).
    (10) The test subject shall indicate to the test conductor if at 
any time during the fit test the taste of saccharin is detected. If 
the test subject does not report tasting the saccharin, the test is 
passed.
    (11) If the taste of saccharin is detected, the fit is deemed 
unsatisfactory and the test is failed. A different respirator shall 
be tried and the entire test procedure is repeated (taste threshold 
screening and fit testing).
    (12) Since the nebulizer has a tendency to clog during use, the 
test operator must make periodic checks of the nebulizer to ensure 
that it is not clogged. If clogging is found at the end of the test 
session, the test is invalid.

4. BitrexTM (Denatonium Benzoate) Solution Aerosol 
Qualitative Fit Test Protocol

    The BitrexTM (Denatonium benzoate) solution aerosol 
QLFT protocol uses the published saccharin test protocol because 
that protocol is widely accepted. Bitrex is routinely used as a 
taste aversion agent in household liquids which children should not 
be drinking and is endorsed by the American Medical Association, the 
National Safety Council, and the American Association of Poison 
Control Centers. The entire screening and testing procedure shall be 
explained to the test subject prior to the conduct of the screening 
test.
    (a) Taste Threshold Screening.
    The Bitrex taste threshold screening, performed without wearing 
a respirator, is intended to determine whether the individual being 
tested can detect the taste of Bitrex.
    (1) During threshold screening as well as during fit testing, 
subjects shall wear an enclosure about the head and shoulders that 
is approximately 12 inches (30.5 cm) in diameter by 14 inches (35.6 
cm) tall. The front portion of the enclosure shall be clear from the 
respirator and allow free movement of the head when a respirator is 
worn. An enclosure substantially similar to the 3M hood assembly, 
parts #14 and #15 combined, is adequate.
    (2) The test enclosure shall have a \3/4\ inch (1.9 cm) hole in 
front of the test subject's nose and mouth area to accommodate the 
nebulizer nozzle.
    (3) The test subject shall don the test enclosure. Throughout 
the threshold screening test, the test subject shall breathe through 
his or her slightly open mouth with tongue extended. The subject is 
instructed to report when he/she detects a bitter taste.
    (4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer 
or equivalent, the test conductor shall spray the Threshold Check 
Solution into the enclosure. This Nebulizer shall be clearly marked 
to distinguish it from the fit test solution nebulizer.
    (5) The Threshold Check Solution is prepared by adding 13.5 
milligrams of Bitrex to 100 ml of 5% salt (NaCl) solution in 
distilled water.
    (6) To produce the aerosol, the nebulizer bulb is firmly 
squeezed so that the bulb collapses completely, and is then released 
and allowed to fully expand.
    (7) An initial ten squeezes are repeated rapidly and then the 
test subject is asked whether the Bitrex can be tasted. If the test 
subject reports tasting the bitter taste during the ten squeezes, 
the screening test is completed. The taste threshold is noted as ten 
regardless of the number of squeezes actually completed.
    (8) If the first response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
Bitrex is tasted. If the test subject reports tasting the bitter 
taste during the second ten squeezes, the screening test is 
completed. The taste threshold is noted as twenty regardless of the 
number of squeezes actually completed.
    (9) If the second response is negative, ten more squeezes are 
repeated rapidly and the test subject is again asked whether the 
Bitrex is tasted. If the test subject reports tasting the bitter 
taste during the third set of ten squeezes, the screening test is 
completed. The taste threshold is noted as thirty regardless of the 
number of squeezes actually completed.
    (10) The test conductor will take note of the number of squeezes 
required to solicit a taste response.

[[Page 1279]]

    (11) If the Bitrex is not tasted after 30 squeezes (step 10), 
the test subject is unable to taste Bitrex and may not perform the 
Bitrex fit test.
    (12) If a taste response is elicited, the test subject shall be 
asked to take note of the taste for reference in the fit test.
    (13) Correct use of the nebulizer means that approximately 1 ml 
of liquid is used at a time in the nebulizer body.
    (14) The nebulizer shall be thoroughly rinsed in water, shaken 
to dry, and refilled at least each morning and afternoon or at least 
every four hours.
    (b) Bitrex Solution Aerosol Fit Test Procedure.
    (1) The test subject may not eat, drink (except plain water), 
smoke, or chew gum for 15 minutes before the test.
    (2) The fit test uses the same enclosure as that described in 4. 
(a) above.
    (3) The test subject shall don the enclosure while wearing the 
respirator selected according to section I. A. of this appendix. The 
respirator shall be properly adjusted and equipped with any type 
particulate filter(s).
    (4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer 
or equivalent is used to spray the fit test solution into the 
enclosure. This nebulizer shall be clearly marked to distinguish it 
from the screening test solution nebulizer.
    (5) The fit test solution is prepared by adding 337.5 mg of 
Bitrex to 200 ml of a 5% salt (NaCl) solution in warm water.
    (6) As before, the test subject shall breathe through his or her 
slightly open mouth with tongue extended, and be instructed to 
report if he/she tastes the bitter taste of Bitrex..
    (7) The nebulizer is inserted into the hole in the front of the 
enclosure and an initial concentration of the fit test solution is 
sprayed into the enclosure using the same number of squeezes (either 
10, 20 or 30 squeezes) based on the number of squeezes required to 
elicit a taste response as noted during the screening test.
    (8) After generating the aerosol, the test subject shall be 
instructed to perform the exercises in section I. A. 14. of this 
appendix.
    (9) Every 30 seconds the aerosol concentration shall be 
replenished using one half the number of squeezes used initially 
(e.g., 5, 10 or 15).
    (10) The test subject shall indicate to the test conductor if at 
any time during the fit test the taste of Bitrex is detected. If the 
test subject does not report tasting the Bitrex, the test is passed.
    (11) If the taste of Bitrex is detected, the fit is deemed 
unsatisfactory and the test is failed. A different respirator shall 
be tried and the entire test procedure is repeated (taste threshold 
screening and fit testing).

5. Irritant Smoke (Stannic Chloride) Protocol

    This qualitative fit test uses a person's response to the 
irritating chemicals released in the ``smoke'' produced by a stannic 
chloride ventilation smoke tube to detect leakage into the 
respirator.

(a) General Requirements and Precautions

    (1) The respirator to be tested shall be equipped with high 
efficiency particulate air (HEPA) or P100 series filter(s).
    (2) Only stannic chloride smoke tubes shall be used for this 
protocol.
    (3) No form of test enclosure or hood for the test subject shall 
be used.
    (4) The smoke can be irritating to the eyes, lungs, and nasal 
passages. The test conductor shall take precautions to minimize the 
test subject's exposure to irritant smoke. Sensitivity varies, and 
certain individuals may respond to a greater degree to irritant 
smoke. Care shall be taken when performing the sensitivity screening 
checks that determine whether the test subject can detect irritant 
smoke to use only the minimum amount of smoke necessary to elicit a 
response from the test subject.
    (5) The fit test shall be performed in an area with adequate 
ventilation to prevent exposure of the person conducting the fit 
test or the build-up of irritant smoke in the general atmosphere.

(b) Sensitivity Screening Check

    The person to be tested must demonstrate his or her ability to 
detect a weak concentration of the irritant smoke.
    (1) The test operator shall break both ends of a ventilation 
smoke tube containing stannic chloride, and attach one end of the 
smoke tube to a low flow air pump set to deliver 200 milliliters per 
minute, or an aspirator squeeze bulb. The test operator shall cover 
the other end of the smoke tube with a short piece of tubing to 
prevent potential injury from the jagged end of the smoke tube.
    (2) The test operator shall advise the test subject that the 
smoke can be irritating to the eyes, lungs, and nasal passages and 
instruct the subject to keep his/her eyes closed while the test is 
performed.
    (3) The test subject shall be allowed to smell a weak 
concentration of the irritant smoke before the respirator is donned 
to become familiar with its irritating properties and to determine 
if he/she can detect the irritating properties of the smoke. The 
test operator shall carefully direct a small amount of the irritant 
smoke in the test subject's direction to determine that he/she can 
detect it.

(c) Irritant Smoke Fit Test Procedure

    (1) The person being fit tested shall don the respirator without 
assistance, and perform the required user seal check(s).
    (2) The test subject shall be instructed to keep his/her eyes 
closed.
    (3) The test operator shall direct the stream of irritant smoke 
from the smoke tube toward the faceseal area of the test subject, 
using the low flow pump or the squeeze bulb. The test operator shall 
begin at least 12 inches from the facepiece and move the smoke 
stream around the whole perimeter of the mask. The operator shall 
gradually make two more passes around the perimeter of the mask, 
moving to within six inches of the respirator.
    (4) If the person being tested has not had an involuntary 
response and/or detected the irritant smoke, proceed with the test 
exercises.
    (5) The exercises identified in section I.A. 14. of this 
appendix shall be performed by the test subject while the respirator 
seal is being continually challenged by the smoke, directed around 
the perimeter of the respirator at a distance of six inches.
    (6) If the person being fit tested reports detecting the 
irritant smoke at any time, the test is failed. The person being 
retested must repeat the entire sensitivity check and fit test 
procedure.
    (7) Each test subject passing the irritant smoke test without 
evidence of a response (involuntary cough, irritation) shall be 
given a second sensitivity screening check, with the smoke from the 
same smoke tube used during the fit test, once the respirator has 
been removed, to determine whether he/she still reacts to the smoke. 
Failure to evoke a response shall void the fit test.
    (8) If a response is produced during this second sensitivity 
check, then the fit test is passed.

C. Quantitative Fit Test (QNFT) Protocols

    The following quantitative fit testing procedures have been 
demonstrated to be acceptable: Quantitative fit testing using a non-
hazardous test aerosol (such as corn oil, polyethylene glycol 400 
[PEG 400], di-2-ethyl hexyl sebacate [DEHS], or sodium chloride) 
generated in a test chamber, and employing instrumentation to 
quantify the fit of the respirator; Quantitative fit testing using 
ambient aerosol as the test agent and appropriate instrumentation 
(condensation nuclei counter) to quantify the respirator fit; 
Quantitative fit testing using controlled negative pressure and 
appropriate instrumentation to measure the volumetric leak rate of a 
facepiece to quantify the respirator fit.

1. General

    (a) The employer shall ensure that persons administering QNFT 
are able to calibrate equipment and perform tests properly, 
recognize invalid tests, calculate fit factors properly and ensure 
that test equipment is in proper working order.
    (b) The employer shall ensure that QNFT equipment is kept clean, 
and is maintained and calibrated according to the manufacturer's 
instructions so as to operate at the parameters for which it was 
designed.

2. Generated Aerosol Quantitative Fit Testing Protocol

    (a) Apparatus.
    (1) Instrumentation. Aerosol generation, dilution, and 
measurement systems using particulates (corn oil, polyethylene 
glycol 400 [PEG 400], di-2-ethyl hexyl sebacate [DEHS] or sodium 
chloride) as test aerosols shall be used for quantitative fit 
testing.
    (2) Test chamber. The test chamber shall be large enough to 
permit all test subjects to perform freely all required exercises 
without disturbing the test agent concentration or the measurement 
apparatus. The test chamber shall be equipped and constructed so 
that the test agent is effectively isolated from the ambient air, 
yet uniform in concentration throughout the chamber.
    (3) When testing air-purifying respirators, the normal filter or 
cartridge element shall be replaced with a high efficiency 
particulate air (HEPA) or P100 series filter supplied by the same 
manufacturer.
    (4) The sampling instrument shall be selected so that a computer 
record or strip chart record may be made of the test showing the 
rise and fall of the test agent concentration with each inspiration 
and expiration at fit factors of at least 2,000.

[[Page 1280]]

Integrators or computers that integrate the amount of test agent 
penetration leakage into the respirator for each exercise may be 
used provided a record of the readings is made.
    (5) The combination of substitute air-purifying elements, test 
agent and test agent concentration shall be such that the test 
subject is not exposed in excess of an established exposure limit 
for the test agent at any time during the testing process, based 
upon the length of the exposure and the exposure limit duration.
    (6) The sampling port on the test specimen respirator shall be 
placed and constructed so that no leakage occurs around the port 
(e.g., where the respirator is probed), a free air flow is allowed 
into the sampling line at all times, and there is no interference 
with the fit or performance of the respirator. The in-mask sampling 
device (probe) shall be designed and used so that the air sample is 
drawn from the breathing zone of the test subject, midway between 
the nose and mouth and with the probe extending into the facepiece 
cavity at least 1/4 inch.
    (7) The test setup shall permit the person administering the 
test to observe the test subject inside the chamber during the test.
    (8) The equipment generating the test atmosphere shall maintain 
the concentration of test agent constant to within a 10 percent 
variation for the duration of the test.
    (9) The time lag (interval between an event and the recording of 
the event on the strip chart or computer or integrator) shall be 
kept to a minimum. There shall be a clear association between the 
occurrence of an event and its being recorded.
    (10) The sampling line tubing for the test chamber atmosphere 
and for the respirator sampling port shall be of equal diameter and 
of the same material. The length of the two lines shall be equal.
    (11) The exhaust flow from the test chamber shall pass through 
an appropriate filter (i.e., high efficiency particulate or P100 
series filter) before release.
    (12) When sodium chloride aerosol is used, the relative humidity 
inside the test chamber shall not exceed 50 percent.
    (13) The limitations of instrument detection shall be taken into 
account when determining the fit factor.
    (14) Test respirators shall be maintained in proper working 
order and be inspected regularly for deficiencies such as cracks or 
missing valves and gaskets.
    (b) Procedural Requirements.
    (1) When performing the initial user seal check using a positive 
or negative pressure check, the sampling line shall be crimped 
closed in order to avoid air pressure leakage during either of these 
pressure checks.
    (2) The use of an abbreviated screening QLFT test is optional. 
Such a test may be utilized in order to quickly identify poor 
fitting respirators that passed the positive and/or negative 
pressure test and reduce the amount of QNFT time. The use of the CNC 
QNFT instrument in the count mode is another optional method to 
obtain a quick estimate of fit and eliminate poor fitting 
respirators before going on to perform a full QNFT.
    (3) A reasonably stable test agent concentration shall be 
measured in the test chamber prior to testing. For canopy or shower 
curtain types of test units, the determination of the test agent's 
stability may be established after the test subject has entered the 
test environment.
    (4) Immediately after the subject enters the test chamber, the 
test agent concentration inside the respirator shall be measured to 
ensure that the peak penetration does not exceed 5 percent for a 
half mask or 1 percent for a full facepiece respirator.
    (5) A stable test agent concentration shall be obtained prior to 
the actual start of testing.
    (6) Respirator restraining straps shall not be over-tightened 
for testing. The straps shall be adjusted by the wearer without 
assistance from other persons to give a reasonably comfortable fit 
typical of normal use. The respirator shall not be adjusted once the 
fit test exercises begin.
    (7) The test shall be terminated whenever any single peak 
penetration exceeds 5 percent for half masks and 1 percent for full 
facepiece respirators. The test subject shall be refitted and 
retested.
    (8) Calculation of fit factors.
    (i) The fit factor shall be determined for the quantitative fit 
test by taking the ratio of the average chamber concentration to the 
concentration measured inside the respirator for each test exercise 
except the grimace exercise.
    (ii) The average test chamber concentration shall be calculated 
as the arithmetic average of the concentration measured before and 
after each test (i.e., 7 exercises) or the arithmetic average of the 
concentration measured before and after each exercise or the true 
average measured continuously during the respirator sample.
    (iii) The concentration of the challenge agent inside the 
respirator shall be determined by one of the following methods:
    (A) Average peak penetration method means the method of 
determining test agent penetration into the respirator utilizing a 
strip chart recorder, integrator, or computer. The agent penetration 
is determined by an average of the peak heights on the graph or by 
computer integration, for each exercise except the grimace exercise. 
Integrators or computers that calculate the actual test agent 
penetration into the respirator for each exercise will also be 
considered to meet the requirements of the average peak penetration 
method.
    (B) Maximum peak penetration method means the method of 
determining test agent penetration in the respirator as determined 
by strip chart recordings of the test. The highest peak penetration 
for a given exercise is taken to be representative of average 
penetration into the respirator for that exercise.
    (C) Integration by calculation of the area under the individual 
peak for each exercise except the grimace exercise. This includes 
computerized integration.
    (D) The calculation of the overall fit factor using individual 
exercise fit factors involves first converting the exercise fit 
factors to penetration values, determining the average, and then 
converting that result back to a fit factor. This procedure is 
described in the following equation:
[GRAPHIC] [TIFF OMITTED] TR08JA98.006

Where ff1, ff2, ff3, etc. are the 
fit factors for exercises 1, 2, 3, etc.

    (9) The test subject shall not be permitted to wear a half mask 
or quarter facepiece respirator unless a minimum fit factor of 100 
is obtained, or a full facepiece respirator unless a minimum fit 
factor of 500 is obtained.
    (10) Filters used for quantitative fit testing shall be replaced 
whenever increased breathing resistance is encountered, or when the 
test agent has altered the integrity of the filter media.
    3. Ambient aerosol condensation nuclei counter (CNC) 
quantitative fit testing protocol.
    The ambient aerosol condensation nuclei counter (CNC) 
quantitative fit testing (Portacount TM ) protocol 
quantitatively fit tests respirators with the use of a probe. The 
probed respirator is only used for quantitative fit tests. A probed 
respirator has a special sampling device, installed on the 
respirator, that allows the probe to sample the air from inside the 
mask. A probed respirator is required for each make, style, model, 
and size that the employer uses and can be obtained from the 
respirator manufacturer or distributor. The CNC instrument 
manufacturer, TSI Inc., also provides probe attachments (TSI 
sampling adapters) that permit fit testing in an employee's own 
respirator. A minimum fit factor pass level of at least 100 is 
necessary for a half-mask respirator and a minimum fit factor pass 
level of at least 500 is required for a full facepiece negative 
pressure respirator. The entire screening and testing procedure 
shall be explained to the test subject prior to the conduct of the 
screening test.
    (a) Portacount Fit Test Requirements.
    (1) Check the respirator to make sure the respirator is fitted 
with a high-efficiency filter and that the sampling probe and line 
are properly attached to the facepiece.
    (2) Instruct the person to be tested to don the respirator for 
five minutes before the fit test starts. This purges the ambient 
particles trapped inside the respirator and permits the wearer to 
make certain the respirator is comfortable. This individual shall 
already have been trained on how to wear the respirator properly.

[[Page 1281]]

    (3) Check the following conditions for the adequacy of the 
respirator fit: Chin properly placed; Adequate strap tension, not 
overly tightened; Fit across nose bridge; Respirator of proper size 
to span distance from nose to chin; Tendency of the respirator to 
slip; Self-observation in a mirror to evaluate fit and respirator 
position.
    (4) Have the person wearing the respirator do a user seal check. 
If leakage is detected, determine the cause. If leakage is from a 
poorly fitting facepiece, try another size of the same model 
respirator, or another model of respirator.
    (5) Follow the manufacturer's instructions for operating the 
Portacount and proceed with the test.
    (6) The test subject shall be instructed to perform the 
exercises in section I. A. 14. of this appendix.
    (7) After the test exercises, the test subject shall be 
questioned by the test conductor regarding the comfort of the 
respirator upon completion of the protocol. If it has become 
unacceptable, another model of respirator shall be tried.
    (b) Portacount Test Instrument.
    (1) The Portacount will automatically stop and calculate the 
overall fit factor for the entire set of exercises. The overall fit 
factor is what counts. The Pass or Fail message will indicate 
whether or not the test was successful. If the test was a Pass, the 
fit test is over.
    (2) Since the pass or fail criterion of the Portacount is user 
programmable, the test operator shall ensure that the pass or fail 
criterion meet the requirements for minimum respirator performance 
in this Appendix.
    (3) A record of the test needs to be kept on file, assuming the 
fit test was successful. The record must contain the test subject's 
name; overall fit factor; make, model, style, and size of respirator 
used; and date tested.
    4. Controlled negative pressure (CNP) quantitative fit testing 
protocol.
    The CNP protocol provides an alternative to aerosol fit test 
methods. The CNP fit test method technology is based on exhausting 
air from a temporarily sealed respirator facepiece to generate and 
then maintain a constant negative pressure inside the facepiece. The 
rate of air exhaust is controlled so that a constant negative 
pressure is maintained in the respirator during the fit test. The 
level of pressure is selected to replicate the mean inspiratory 
pressure that causes leakage into the respirator under normal use 
conditions. With pressure held constant, air flow out of the 
respirator is equal to air flow into the respirator. Therefore, 
measurement of the exhaust stream that is required to hold the 
pressure in the temporarily sealed respirator constant yields a 
direct measure of leakage air flow into the respirator. The CNP fit 
test method measures leak rates through the facepiece as a method 
for determining the facepiece fit for negative pressure respirators. 
The CNP instrument manufacturer Dynatech Nevada also provides 
attachments (sampling manifolds) that replace the filter cartridges 
to permit fit testing in an employee's own respirator. To perform 
the test, the test subject closes his or her mouth and holds his/her 
breath, after which an air pump removes air from the respirator 
facepiece at a pre-selected constant pressure. The facepiece fit is 
expressed as the leak rate through the facepiece, expressed as 
milliliters per minute. The quality and validity of the CNP fit 
tests are determined by the degree to which the in-mask pressure 
tracks the test pressure during the system measurement time of 
approximately five seconds. Instantaneous feedback in the form of a 
real-time pressure trace of the in-mask pressure is provided and 
used to determine test validity and quality. A minimum fit factor 
pass level of 100 is necessary for a half-mask respirator and a 
minimum fit factor of at least 500 is required for a full facepiece 
respirator. The entire screening and testing procedure shall be 
explained to the test subject prior to the conduct of the screening 
test.
    (a) CNP Fit Test Requirements.
    (1) The instrument shall have a non-adjustable test pressure of 
15.0 mm water pressure.
    (2) The CNP system defaults selected for test pressure shall be 
set at--1.5 mm of water (-0.58 inches of water) and the modeled 
inspiratory flow rate shall be 53.8 liters per minute for performing 
fit tests.

(Note: CNP systems have built-in capability to conduct fit testing 
that is specific to unique work rate, mask, and gender situations 
that might apply in a specific workplace. Use of system default 
values, which were selected to represent respirator wear with medium 
cartridge resistance at a low-moderate work rate, will allow inter-
test comparison of the respirator fit.)

    (3) The individual who conducts the CNP fit testing shall be 
thoroughly trained to perform the test.
    (4) The respirator filter or cartridge needs to be replaced with 
the CNP test manifold. The inhalation valve downstream from the 
manifold either needs to be temporarily removed or propped open.
    (5) The test subject shall be trained to hold his or her breath 
for at least 20 seconds.
    (6) The test subject shall don the test respirator without any 
assistance from the individual who conducts the CNP fit test.
    (7) The QNFT protocol shall be followed according to section I. 
C. 1. of this appendix with an exception for the CNP test exercises.
    (b) CNP Test Exercises.
    (1) Normal breathing. In a normal standing position, without 
talking, the subject shall breathe normally for 1 minute. After the 
normal breathing exercise, the subject needs to hold head straight 
ahead and hold his or her breath for 10 seconds during the test 
measurement.
    (2) Deep breathing. In a normal standing position, the subject 
shall breathe slowly and deeply for 1 minute, being careful not to 
hyperventilate. After the deep breathing exercise, the subject shall 
hold his or her head straight ahead and hold his or her breath for 
10 seconds during test measurement.
    (3) Turning head side to side. Standing in place, the subject 
shall slowly turn his or her head from side to side between the 
extreme positions on each side for 1 minute. The head shall be held 
at each extreme momentarily so the subject can inhale at each side. 
After the turning head side to side exercise, the subject needs to 
hold head full left and hold his or her breath for 10 seconds during 
test measurement. Next, the subject needs to hold head full right 
and hold his or her breath for 10 seconds during test measurement.
    (4) Moving head up and down. Standing in place, the subject 
shall slowly move his or her head up and down for 1 minute. The 
subject shall be instructed to inhale in the up position (i.e., when 
looking toward the ceiling). After the moving head up and down 
exercise, the subject shall hold his or her head full up and hold 
his or her breath for 10 seconds during test measurement. Next, the 
subject shall hold his or her head full down and hold his or her 
breath for 10 seconds during test measurement.
    (5) Talking. The subject shall talk out loud slowly and loud 
enough so as to be heard clearly by the test conductor. The subject 
can read from a prepared text such as the Rainbow Passage, count 
backward from 100, or recite a memorized poem or song for 1 minute. 
After the talking exercise, the subject shall hold his or her head 
straight ahead and hold his or her breath for 10 seconds during the 
test measurement.
    (6) Grimace. The test subject shall grimace by smiling or 
frowning for 15 seconds.
    (7) Bending Over. The test subject shall bend at the waist as if 
he or she were to touch his or her toes for 1 minute. Jogging in 
place shall be substituted for this exercise in those test 
environments such as shroud-type QNFT units that prohibit bending at 
the waist. After the bending over exercise, the subject shall hold 
his or her head straight ahead and hold his or her breath for 10 
seconds during the test measurement.
    (8) Normal Breathing. The test subject shall remove and re-don 
the respirator within a one-minute period. Then, in a normal 
standing position, without talking, the subject shall breathe 
normally for 1 minute. After the normal breathing exercise, the 
subject shall hold his or her head straight ahead and hold his or 
her breath for 10 seconds during the test measurement. After the 
test exercises, the test subject shall be questioned by the test 
conductor regarding the comfort of the respirator upon completion of 
the protocol. If it has become unacceptable, another model of a 
respirator shall be tried.
    (c) CNP Test Instrument.
    (1) The test instrument shall have an effective audio warning 
device when the test subject fails to hold his or her breath during 
the test. The test shall be terminated whenever the test subject 
failed to hold his or her breath. The test subject may be refitted 
and retested.
    (2) A record of the test shall be kept on file, assuming the fit 
test was successful. The record must contain the test subject's 
name; overall fit factor; make, model, style and size of respirator 
used; and date tested.

Part II. New Fit Test Protocols

    A. Any person may submit to OSHA an application for approval of 
a new fit test protocol. If the application meets the following 
criteria, OSHA will initiate a rulemaking proceeding under section 
6(b)(7) of the OSH Act to determine whether to list

[[Page 1282]]

the new protocol as an approved protocol in this Appendix A.
    B. The application must include a detailed description of the 
proposed new fit test protocol. This application must be supported 
by either:
    1. A test report prepared by an independent government research 
laboratory (e.g., Lawrence Livermore National Laboratory, Los Alamos 
National Laboratory, the National Institute for Standards and 
Technology) stating that the laboratory has tested the protocol and 
had found it to be accurate and reliable; or
    2. An article that has been published in a peer-reviewed 
industrial hygiene journal describing the protocol and explaining 
how test data support the protocol's accuracy and reliability.
    C. If OSHA determines that additional information is required 
before the Agency commences a rulemaking proceeding under this 
section, OSHA will so notify the applicant and afford the applicant 
the opportunity to submit the supplemental information. Initiation 
of a rulemaking proceeding will be deferred until OSHA has received 
and evaluated the supplemental information.

Appendix B-1 to Sec. 1910.134: User Seal Check Procedures (Mandatory)

    The individual who uses a tight-fitting respirator is to perform 
a user seal check to ensure that an adequate seal is achieved each 
time the respirator is put on. Either the positive and negative 
pressure checks listed in this appendix, or the respirator 
manufacturer's recommended user seal check method shall be used. 
User seal checks are not substitutes for qualitative or quantitative 
fit tests.

I. Facepiece Positive and/or Negative Pressure Checks

    A. Positive pressure check. Close off the exhalation valve and 
exhale gently into the facepiece. The face fit is considered 
satisfactory if a slight positive pressure can be built up inside 
the facepiece without any evidence of outward leakage of air at the 
seal. For most respirators this method of leak testing requires the 
wearer to first remove the exhalation valve cover before closing off 
the exhalation valve and then carefully replacing it after the test.
    B. Negative pressure check. Close off the inlet opening of the 
canister or cartridge(s) by covering with the palm of the hand(s) or 
by replacing the filter seal(s), inhale gently so that the facepiece 
collapses slightly, and hold the breath for ten seconds. The design 
of the inlet opening of some cartridges cannot be effectively 
covered with the palm of the hand. The test can be performed by 
covering the inlet opening of the cartridge with a thin latex or 
nitrile glove. If the facepiece remains in its slightly collapsed 
condition and no inward leakage of air is detected, the tightness of 
the respirator is considered satisfactory.

II. Manufacturer's Recommended User Seal Check Procedures

    The respirator manufacturer's recommended procedures for 
performing a user seal check may be used instead of the positive 
and/or negative pressure check procedures provided that the employer 
demonstrates that the manufacturer's procedures are equally 
effective.

Appendix B-2 to Sec. 1910.134: Respirator Cleaning Procedures 
(Mandatory)

    These procedures are provided for employer use when cleaning 
respirators. They are general in nature, and the employer as an 
alternative may use the cleaning recommendations provided by the 
manufacturer of the respirators used by their employees, provided 
such procedures are as effective as those listed here in Appendix B-
2. Equivalent effectiveness simply means that the procedures used 
must accomplish the objectives set forth in Appendix B-2, i.e., must 
ensure that the respirator is properly cleaned and disinfected in a 
manner that prevents damage to the respirator and does not cause 
harm to the user.

I. Procedures for Cleaning Respirators

    A. Remove filters, cartridges, or canisters. Disassemble 
facepieces by removing speaking diaphragms, demand and pressure-
demand valve assemblies, hoses, or any components recommended by the 
manufacturer. Discard or repair any defective parts.
    B. Wash components in warm (43 deg. C [110 deg. F] maximum) 
water with a mild detergent or with a cleaner recommended by the 
manufacturer. A stiff bristle (not wire) brush may be used to 
facilitate the removal of dirt.
    C. Rinse components thoroughly in clean, warm (43 deg. C 
[110 deg. F] maximum), preferably running water. Drain.
    D. When the cleaner used does not contain a disinfecting agent, 
respirator components should be immersed for two minutes in one of 
the following:
    1. Hypochlorite solution (50 ppm of chlorine) made by adding 
approximately one milliliter of laundry bleach to one liter of water 
at 43 deg. C (110 deg. F); or,
    2. Aqueous solution of iodine (50 ppm iodine) made by adding 
approximately 0.8 milliliters of tincture of iodine (6-8 grams 
ammonium and/or potassium iodide/100 cc of 45% alcohol) to one liter 
of water at 43 deg. C (110 deg. F); or,
    3. Other commercially available cleansers of equivalent 
disinfectant quality when used as directed, if their use is 
recommended or approved by the respirator manufacturer.
    E. Rinse components thoroughly in clean, warm (43 deg. C 
[110 deg. F] maximum), preferably running water. Drain. The 
importance of thorough rinsing cannot be overemphasized. Detergents 
or disinfectants that dry on facepieces may result in dermatitis. In 
addition, some disinfectants may cause deterioration of rubber or 
corrosion of metal parts if not completely removed.
    F. Components should be hand-dried with a clean lint-free cloth 
or air-dried.
    G. Reassemble facepiece, replacing filters, cartridges, and 
canisters where necessary.
    H. Test the respirator to ensure that all components work 
properly.

Appendix C to Sec. 1910.134: OSHA Respirator Medical Evaluation 
Questionnaire (Mandatory)

    To the employer: Answers to questions in Section 1, and to 
question 9 in Section 2 of Part A, do not require a medical 
examination.
    To the employee:

Can you read (circle one): Yes/No

    Your employer must allow you to answer this questionnaire during 
normal working hours, or at a time and place that is convenient to 
you. To maintain your confidentiality, your employer or supervisor 
must not look at or review your answers, and your employer must tell 
you how to deliver or send this questionnaire to the health care 
professional who will review it.
    Part A. Section 1. (Mandatory) The following information must be 
provided by every employee who has been selected to use any type of 
respirator (please print).

1. Today's date:-------------------------------------------------------

2. Your name:----------------------------------------------------------

3. Your age (to nearest year):-----------------------------------------

4. Sex (circle one): Male/Female

5. Your height: __________ ft. __________ in.

6. Your weight: ____________ lbs.

7. Your job title:-----------------------------------------------------
8. A phone number where you can be reached by the health care 
professional who reviews this questionnaire (include the Area Code): 
____________________

9. The best time to phone you at this number: ________________
10. Has your employer told you how to contact the health care 
professional who will review this questionnaire (circle one): Yes/No
11. Check the type of respirator you will use (you can check more 
than one category):

    a. ______ N, R, or P disposable respirator (filter-mask, non-
cartridge type only).
    b. ______ Other type (for example, half- or full-facepiece type, 
powered-air purifying, supplied-air, self-contained breathing 
apparatus).

12. Have you worn a respirator (circle one): Yes/No

  If ``yes,'' what type(s):--------------------------------------------

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

    Part A. Section 2. (Mandatory) Questions 1 through 9 below must 
be answered by every employee who has been selected to use any type 
of respirator (please circle ``yes'' or ``no'').

1. Do you currently smoke tobacco, or have you smoked tobacco in the 
last month: Yes/No
2. Have you ever had any of the following conditions?
    a. Seizures (fits): Yes/No
    b. Diabetes (sugar disease): Yes/No
    c. Allergic reactions that interfere with your breathing: Yes/No
    d. Claustrophobia (fear of closed-in places): Yes/No
    e. Trouble smelling odors: Yes/No
3. Have you ever had any of the following pulmonary or lung 
problems?
    a. Asbestosis: Yes/No
    b. Asthma: Yes/No

[[Page 1283]]

    c. Chronic bronchitis: Yes/No
    d. Emphysema: Yes/No
    e. Pneumonia: Yes/No
    f. Tuberculosis: Yes/No
    g. Silicosis: Yes/No
    h. Pneumothorax (collapsed lung): Yes/No
    i. Lung cancer: Yes/No
    j. Broken ribs: Yes/No
    k. Any chest injuries or surgeries: Yes/No
    l. Any other lung problem that you've been told about: Yes/No
4. Do you currently have any of the following symptoms of pulmonary 
or lung illness?
    a. Shortness of breath: Yes/No
    b. Shortness of breath when walking fast on level ground or 
walking up a slight hill or incline: Yes/No
    c. Shortness of breath when walking with other people at an 
ordinary pace on level ground: Yes/No
    d. Have to stop for breath when walking at your own pace on 
level ground: Yes/No
    e. Shortness of breath when washing or dressing yourself: Yes/No
    f. Shortness of breath that interferes with your job: Yes/No
    g. Coughing that produces phlegm (thick sputum): Yes/No
    h. Coughing that wakes you early in the morning: Yes/No
    i. Coughing that occurs mostly when you are lying down: Yes/No
    j. Coughing up blood in the last month: Yes/No
    k. Wheezing: Yes/No
    l. Wheezing that interferes with your job: Yes/No
    m. Chest pain when you breathe deeply: Yes/No
    n. Any other symptoms that you think may be related to lung 
problems: Yes/No
5. Have you ever had any of the following cardiovascular or heart 
problems?
    a. Heart attack: Yes/No
    b. Stroke: Yes/No
    c. Angina: Yes/No
    d. Heart failure: Yes/No
    e. Swelling in your legs or feet (not caused by walking): Yes/No
    f. Heart arrhythmia (heart beating irregularly): Yes/No
    g. High blood pressure: Yes/No
    h. Any other heart problem that you've been told about: Yes/No
6. Have you ever had any of the following cardiovascular or heart 
symptoms?
    a. Frequent pain or tightness in your chest: Yes/No
    b. Pain or tightness in your chest during physical activity: 
Yes/No
    c. Pain or tightness in your chest that interferes with your 
job: Yes/No
    d. In the past two years, have you noticed your heart skipping 
or missing a beat: Yes/No
    e. Heartburn or indigestion that is not related to eating: Yes/
No
    f. Any other symptoms that you think may be related to heart or 
circulation problems: Yes/No
7. Do you currently take medication for any of the following 
problems?
    a. Breathing or lung problems: Yes/No
    b. Heart trouble: Yes/No
    c. Blood pressure: Yes/No
    d. Seizures (fits): Yes/No
8. If you've used a respirator, have you ever had any of the 
following problems? (If you've never used a respirator, check the 
following space and go to question 9:)
    a. Eye irritation: Yes/No
    b. Skin allergies or rashes: Yes/No
    c. Anxiety: Yes/No
    d. General weakness or fatigue: Yes/No
    e. Any other problem that interferes with your use of a 
respirator: Yes/No
9. Would you like to talk to the health care professional who will 
review this questionnaire about your answers to this questionnaire: 
Yes/No

    Questions 10 to 15 below must be answered by every employee who 
has been selected to use either a full-facepiece respirator or a 
self-contained breathing apparatus (SCBA). For employees who have 
been selected to use other types of respirators, answering these 
questions is voluntary.

10. Have you ever lost vision in either eye (temporarily or 
permanently): Yes/No
11. Do you currently have any of the following vision problems?
    a. Wear contact lenses: Yes/No
    b. Wear glasses: Yes/No
    c. Color blind: Yes/No
    e. Any other eye or vision problem: Yes/No
12. Have you ever had an injury to your ears, including a broken ear 
drum: Yes/No
13. Do you currently have any of the following hearing problems?
    a. Difficulty hearing: Yes/No
    b. Wear a hearing aid: Yes/No
    c. Any other hearing or ear problem: Yes/No
14. Have you ever had a back injury: Yes/No
15. Do you currently have any of the following musculoskeletal 
problems?
    a. Weakness in any of your arms, hands, legs, or feet: Yes/No
    b. Back pain: Yes/No
    c. Difficulty fully moving your arms and legs: Yes/No
    d. Pain or stiffness when you lean forward or backward at the 
waist: Yes/No
    e. Difficulty fully moving your head up or down: Yes/No
    f. Difficulty fully moving your head side to side: Yes/No
    g. Difficulty bending at your knees: Yes/No
    h. Difficulty squatting to the ground: Yes/No
    i. Climbing a flight of stairs or a ladder carrying more than 25 
lbs: Yes/No
    j. Any other muscle or skeletal problem that interferes with 
using a respirator: Yes/No

    Part B  Any of the following questions, and other questions not 
listed, may be added to the questionnaire at the discretion of the 
health care professional who will review the questionnaire.

1. In your present job, are you working at high altitudes (over 
5,000 feet) or in a place that has lower than normal amounts of 
oxygen: Yes/No
    If ``yes,'' do you have feelings of dizziness, shortness of 
breath, pounding in your chest, or other symptoms when you're 
working under these conditions: Yes/No
2. At work or at home, have you ever been exposed to hazardous 
solvents, hazardous airborne chemicals (e.g., gases, fumes, or 
dust), or have you come into skin contact with hazardous chemicals: 
Yes/No

  If ``yes,'' name the chemicals if you know them:---------------------

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

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

3. Have you ever worked with any of the materials, or under any of 
the conditions, listed below:
    a. Asbestos: Yes/No
    b. Silica (e.g., in sandblasting): Yes/No
    c. Tungsten/cobalt (e.g., grinding or welding this material): 
Yes/No
    d. Beryllium: Yes/No
    e. Aluminum: Yes/No
    f. Coal (for example, mining): Yes/No
    g. Iron: Yes/No
    h. Tin: Yes/No
    i. Dusty environments: Yes/No
    j. Any other hazardous exposures: Yes/No

  If ``yes,'' describe these exposures:--------------------------------

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

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

4. List any second jobs or side businesses you have:-------------------

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

5. List your previous occupations:-------------------------------------

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

6. List your current and previous hobbies:-----------------------------

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

7. Have you been in the military services? Yes/No
    If ``yes,'' were you exposed to biological or chemical agents 
(either in training or combat): Yes/No
8. Have you ever worked on a HAZMAT team? Yes/No
9. Other than medications for breathing and lung problems, heart 
trouble, blood pressure, and seizures mentioned earlier in this 
questionnaire, are you taking any other medications for any reason 
(including over-the-counter medications): Yes/No

  If ``yes,'' name the medications if you know them:-------------------

10. Will you be using any of the following items with your 
respirator(s)?
    a. HEPA Filters: Yes/No
    b. Canisters (for example, gas masks): Yes/No
    c. Cartridges: Yes/No
11. How often are you expected to use the respirator(s) (circle 
``yes'' or ``no'' for all answers that apply to you)?:
    a. Escape only (no rescue): Yes/No
    b. Emergency rescue only: Yes/No
    c. Less than 5 hours per week: Yes/No
    d. Less than 2 hours per day: Yes/No
    e. 2 to 4 hours per day: Yes/No

[[Page 1284]]

    f. Over 4 hours per day: Yes/No
12. During the period you are using the respirator(s), is your work 
effort:
    a. Light (less than 200 kcal per hour): Yes/No

If ``yes,'' how long does this period last during the average 
shift:____________hrs.____________mins.

    Examples of a light work effort are sitting while writing, 
typing, drafting, or performing light assembly work; or standing 
while operating a drill press (1-3 lbs.) or controlling machines.

    b. Moderate (200 to 350 kcal per hour): Yes/No

    If ``yes,'' how long does this period last during the average 
shift:____________hrs.____________mins.

    Examples of moderate work effort are sitting while nailing or 
filing; driving a truck or bus in urban traffic; standing while 
drilling, nailing, performing assembly work, or transferring a 
moderate load (about 35 lbs.) at trunk level; walking on a level 
surface about 2 mph or down a 5-degree grade about 3 mph; or pushing 
a wheelbarrow with a heavy load (about 100 lbs.) on a level surface.

    c. Heavy (above 350 kcal per hour): Yes/No

    If ``yes,'' how long does this period last during the average 
shift:____________hrs.____________mins.

    Examples of heavy work are lifting a heavy load (about 50 lbs.) 
from the floor to your waist or shoulder; working on a loading dock; 
shoveling; standing while bricklaying or chipping castings; walking 
up an 8-degree grade about 2 mph; climbing stairs with a heavy load 
(about 50 lbs.).

13. Will you be wearing protective clothing and/or equipment (other 
than the respirator) when you're using your respirator: Yes/No
  If ``yes,'' describe this protective clothing and/or equipment:------

----------------------------------------------------------------------
14. Will you be working under hot conditions (temperature exceeding 
77 deg. F): Yes/No
15. Will you be working under humid conditions: Yes/No
16. Describe the work you'll be doing while you're using your 
respirator(s):

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

----------------------------------------------------------------------
17. Describe any special or hazardous conditions you might encounter 
when you're using your respirator(s) (for example, confined spaces, 
life-threatening gases):

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

----------------------------------------------------------------------
18. Provide the following information, if you know it, for each 
toxic substance that you'll be exposed to when you're using your 
respirator(s):

  Name of the first toxic substance:-----------------------------------

  Estimated maximum exposure level per shift:--------------------------

  Duration of exposure per shift---------------------------------------

  Name of the second toxic substance:----------------------------------

  Estimated maximum exposure level per shift:--------------------------

  Duration of exposure per shift:--------------------------------------

  Name of the third toxic substance:-----------------------------------

  Estimated maximum exposure level per shift:--------------------------

  Duration of exposure per shift:--------------------------------------

    The name of any other toxic substances that you'll be exposed to 
while using your respirator:

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

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

----------------------------------------------------------------------
19. Describe any special responsibilities you'll have while using 
your respirator(s) that may affect the safety and well-being of 
others (for example, rescue, security):

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

Appendix D to Sec. 1910.134 (Non-Mandatory) Information for Employees 
Using Respirators When Not Required Under the Standard

    Respirators are an effective method of protection against 
designated hazards when properly selected and worn. Respirator use 
is encouraged, even when exposures are below the exposure limit, to 
provide an additional level of comfort and protection for workers. 
However, if a respirator is used improperly or not kept clean, the 
respirator itself can become a hazard to the worker. Sometimes, 
workers may wear respirators to avoid exposures to hazards, even if 
the amount of hazardous substance does not exceed the limits set by 
OSHA standards. If your employer provides respirators for your 
voluntary use, of if you provide your own respirator, you need to 
take certain precautions to be sure that the respirator itself does 
not present a hazard.
    You should do the following:
    1. Read and heed all instructions provided by the manufacturer 
on use, maintenance, cleaning and care, and warnings regarding the 
respirators limitations.
    2. Choose respirators certified for use to protect against the 
contaminant of concern. NIOSH, the National Institute for 
Occupational Safety and Health of the U.S. Department of Health and 
Human Services, certifies respirators. A label or statement of 
certification should appear on the respirator or respirator 
packaging. It will tell you what the respirator is designed for and 
how much it will protect you.
    3. Do not wear your respirator into atmospheres containing 
contaminants for which your respirator is not designed to protect 
against. For example, a respirator designed to filter dust particles 
will not protect you against gases, vapors, or very small solid 
particles of fumes or smoke.
    4. Keep track of your respirator so that you do not mistakenly 
use someone else's respirator.

Subpart L--[Amended]

    8. The authority citation for Subpart L of Part 1910 is revised to 
read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable.

    9. Section 1910.156 is amended by revising paragraphs (f)(1)(i) and 
(f)(1)(v) as follows:


Sec. 1910.156  Fire brigades.

* * * * *
    (f) Respiratory protection. (1) General. (i) The employer must 
ensure that respirators are provided to, and used by, fire brigade 
members, and that the respirators meet the requirements of 29 CFR 
1910.134 and this paragraph.
* * * * *
    (v) Self-contained breathing apparatuses must have a minimum 
service-life rating of 30 minutes in accordance with the methods and 
requirements specified by NIOSH under 42 CFR part 84, except for escape 
self-contained breathing apparatus (ESCBAs) used only for emergency 
escape purposes.
* * * * *

Subpart Q--[Amended]

    10. The authority citation for Subpart Q of Part 1910 is revised to 
read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
part 1911.

    11. Section 1910.252 is amended by revising paragraphs (c)(4)(ii), 
(c)(4)(iii), (c)(7)(iii), (c)(9)(i), and (c)(10) as follows:


Sec. 1910.252  General requirements.

* * * * *
    (c) *  *  *
    (4) *  *  *
    (ii) Airline respirators. In circumstances for which it is 
impossible to provide such ventilation, airline respirators or hose 
masks approved for this purpose by the National Institute for 
Occupational Safety and Health (NIOSH) under 42 CFR part 84 must be 
used.
    (iii) Self-contained units. In areas immediately hazardous to life, 
a full-facepiece, pressure-demand, self-contained breathing apparatus 
or a combination full-facepiece, pressure-demand supplied-air 
respirator with an auxiliary, self-contained air supply approved by 
NIOSH under 42 CFR part 84 must be used.
* * * * *
    (7) * * *
    (iii) Local ventilation. In confined spaces or indoors, welding or 
cutting operations involving metals containing lead, other than as an 
impurity, or

[[Page 1285]]

metals coated with lead-bearing materials, including paint, must be 
done using local exhaust ventilation or airline respirators. Such 
operations, when done outdoors, must be done using respirators approved 
for this purpose by NIOSH under 42 CFR part 84. In all cases, workers 
in the immediate vicinity of the cutting operation must be protected by 
local exhaust ventilation or airline respirators.
* * * * *
    (9) * * *
    (i) General. In confined spaces or indoors, welding or cutting 
operations involving cadmium-bearing or cadmium-coated base metals must 
be done using local exhaust ventilation or airline respirators unless 
atmospheric tests under the most adverse conditions show that employee 
exposure is within the acceptable concentrations specified by 29 CFR 
1910.1000. Such operations, when done outdoors, must be done using 
respirators, such as fume respirators, approved for this purpose by 
NIOSH under 42 CFR part 84.
* * * * *
    (10) Mercury. In confined spaces or indoors, welding or cutting 
operations involving metals coated with mercury-bearing materials, 
including paint, must be done using local exhaust ventilation or 
airline respirators unless atmospheric tests under the most adverse 
conditions show that employee exposure is within the acceptable 
concentrations specified by 29 CFR 1910.1000. Such operations, when 
done outdoors, must be done using respirators approved for this purpose 
by NIOSH under 42 CFR part 84.
* * * * *

Subpart R--[Amended]

    12. The authority citation for Subpart R of Part 1910 is revised as 
follows:

    Authority: Sections 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
part 11.
    Sections 1910.261, 1910.262, 1910.265 through 1910.269, 
1910.274, and 1910.275 also issued under 29 CFR part 1911.

    13. Section 1910.261 is amended by revising paragraphs (b)(2), 
(g)(10), (h)(2)(iii), and (h)(2)(iv) as follows:


Sec. 1910.261  Pulp, paper, and paperboard mills.

* * * * *
    (b) * * *
    (2) Personal protective clothing and equipment. Foot protection, 
shin guards, hard hats, noise-attenuation devices, and other personal 
protective clothing and equipment must be worn when the extent of the 
hazard warrants their use. Such equipment must be worn when 
specifically required by other paragraphs of this section, and must be 
maintained in accordance with applicable American National Standards 
Institute standards. Respirators, goggles, protective masks, rubber 
gloves, rubber boots, and other such equipment must be cleaned and 
disinfected before being used by another employee. Required eye, head, 
and ear protection must conform to American National Standards 
Institute standards Z24.22-1957, Z87.1-1968, and Z89.1-1969. 
Respiratory protection must conform to the requirements of 29 CFR 
1910.134.
* * * * *
    (g) * * *
    (10) Gas masks (digester building). Gas masks must be available, 
and they must furnish adequate protection against sulfurous acid and 
chlorine gases and be inspected and repaired in accordance with 29 CFR 
1910.134.
* * * * *
    (h) * * *
    (2) * * *
    (iii) Gas masks must be provided for emergency use in accordance 
with 29 CFR 1910.134.
    (iv) For emergency and rescue operations, the employer must provide 
employees with self-contained breathing apparatuses or supplied-air 
respirators, and ensure that employees use these respirators, in 
accordance with the requirements of 29 CFR 1910.134.
* * * * *

Subpart Z--[Amended]

    14. The general authority citation for Subpart Z of 29 CFR Part 
1910 is revised to read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act (29 U.S.C. 653, 655, and 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
Part 1911.
* * * * *
    15. Section 1910.1001 is amended by removing Appendix C and 
revising paragraph (g), to read as follows:


Sec. 1910.1001  Asbestos.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities, 
for which engineering and work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the TWA and/or excursion limit.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) The employer must provide a tight-fitting, powered, air-
purifying respirator instead of any negative-pressure respirator 
specified in Table 1 of this section when an employee chooses to use 
this type of respirator and the respirator provides adequate protection 
to the employee.
    (iii) No employee must be assigned to tasks requiring the use of 
respirators if, based on their most recent medical examination, the 
examining physician determines that the employee will be unable to 
function normally using a respirator, or that the safety or health of 
the employee or other employees will be impaired by the use of a 
respirator. Such employees must be assigned to another job or given the 
opportunity to transfer to a different position, the duties of which 
they can perform. If such a transfer position is available, the 
position must be with the same employer, in the same geographical area, 
and with the same seniority, status, and rate of pay the employee had 
just prior to such transfer.
    (3) Respirator selection. The employer must select and provide the 
appropriate respirator from Table 1 of this section.

          Table 1.--Respiratory Protection for Asbestos Fibers          
------------------------------------------------------------------------
  Airborne concentration of                                             
asbestos or conditions of use             Required respirator           
------------------------------------------------------------------------
Not in excess of 1 f/cc (10 X  Half-mask air purifying respirator other 
 PEL).                          than a disposable respirator, equipped  
                                with high efficiency filters.           

[[Page 1286]]

                                                                        
Not in excess of 5 f/cc (50 X  Full facepiece air-purifying respirator  
 PEL).                          equipped with high efficiency filters.  
Not in excess of 10 f/cc (100  Any powered air-purifying respirator     
 X PEL).                        equipped with high efficiency filters or
                                any supplied air respirator operated in 
                                continuous flow mode.                   
Not in excess of 100 f/cc      Full facepiece supplied air respirator   
 (1,000 X PEL).                 operated in pressure demand mode.       
Greater than 100 f/cc (1,000   Full facepiece supplied air respirator   
 X PEL) or unknown              operated in pressure demand mode,       
 concentration.                 equipped with an auxiliary positive     
                                pressure self-contained breathing       
                                apparatus.                              
------------------------------------------------------------------------
Note: a. Respirators assigned for high environmental concentrations may 
  be used at lower concentrations, or when required respirator use is   
  independent of concentration.                                         
b. A high efficiency filter means a filter that is at least 99.97       
  percent efficient against mono-dispersed particles of 0.3 micrometers 
  in diameter or larger.                                                

* * * * *
    16. Section 1910.1003 is amended by revising paragraphs (c)(4)(iv) 
and (d)(1) as follows:


Sec. 1910.1003 13  Carcinogens (4-Nitrobiphenyl, etc.).

* * * * *
    (c) * * *
    (4) * * *
    (iv) Employees engaged in handling operations involving the 
carcinogens addressed by this section must be provided with, and 
required to wear and use, a half-face filter-type respirator for dusts, 
mists, and fumes. A respirator affording higher levels of protection 
than this respirator may be substituted.
* * * * *
    (d) * * *
    (1) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b), (c), (d) 
(except (d)(1)(iii) and (iv), and (d)(3)), and (e) through (m).
* * * * *
    17. Section 1910.1017 is amended by revising paragraph (g) to read 
as follows:


Sec. 1910.1017  Vinyl chloride.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii), and (d)(3)(iii)(B)(1) and (2)), and (f) through 
(m).
    (3) Respirator selection. (i) Respirators must be selected from the 
following table:

------------------------------------------------------------------------
 Atmospheric concentration of                                           
        vinyl chloride                     Required apparatus           
------------------------------------------------------------------------
(i) Unknown, or above 3,600 p/ Open-circuit, self-contained breathing   
 m.                             apparatus, pressure demand type, with   
                                full facepiece.                         
(ii) Not over 3,600 p/m......  (A) Combination type C supplied air      
                                respirator, pressure demand type, with  
                                full or half facepiece, and auxiliary   
                                self-contained air supply; or           
(iii) Not over 1,000 p/m.....  (B) Combination type, supplied air       
                                respirator continuous flow type, with   
                                full or half facepiece, and auxiliary   
                                self-contained air supply. Type C,      
                                supplied air respirator, continuous flow
                                type, with full or half facepiece,      
                                helmet or hood.                         
(iv) Not over 100 p/m........  (A) Combination type C supplied air      
                                respirator demand type, with full       
                                facepiece, and auxiliary self-contained 
                                air supply; or                          
                               (B) Open-circuit self-contained breathing
                                apparatus with full facepiece, in demand
                                mode; or                                
                               Type (C) supplied air respirator, demand 
                                type, with full facepiece.              
(v) Not over 25 p/m..........  (A) A powered air-purifying respirator   
                                with hood, helmet, full or half         
                                facepiece, and a canister which provides
                                a service life of at least 4 hours for  
                                concentrations of vinyl chloride up to  
                                25 p/m, or                              
                               (B) Gas mask, front- or back-mounted     
                                canister which provides a service life  
                                of at least 4 hours for concentrations  
                                of vinyl chloride up to 25 p/m.         
(vi) Not over 10 p/m.........  (A) Combination type C supplied-air      
                                respirator, demand type, with half      
                                facepiece, and auxiliary self-contained 
                                air supply; or                          
                               (B) Type C supplied-air respirator,      
                                demand type, with half facepiece; or    
                               (C) Any chemical cartridge respirator    
                                with an organic vapor cartridge which   
                                provides a service life of at least 1   
                                hour for concentrations of vinyl        
                                chloride up to 10 p/m.                  
------------------------------------------------------------------------

    (ii) When air-purifying respirators are used:
    (A) Air-purifying canisters or cartridges must be replaced prior to 
the expiration of their service life or the end of the shift in which 
they are first used, whichever occurs first.
    (B) A continuous-monitoring and alarm system must be provided when 
concentrations of vinyl chloride could reasonably exceed the allowable 
concentrations for the devices in use. Such a system must be used to 
alert employees when vinyl chloride concentrations exceed the allowable 
concentrations for the devices in use.
    (iii) Respirators specified for higher concentrations may be used 
for lower concentrations.
* * * * *
    18. Section 1910.1018 is amended by revising paragraph (h) to read 
as follows:


Sec. 1910.1018  Inorganic arsenic.

* * * * *
    (h) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
or work-practice controls.
    (ii) Work operations, such as maintenance and repair activities, 
for which the employer establishes that

[[Page 1287]]

engineering and work-practice controls are not feasible.
    (iii) Work operations for which engineering and work-practice 
controls are not yet sufficient to reduce employee exposures to or 
below the permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) If an employee exhibits breathing difficulty during fit 
testing or respirator use, they must be examined by a physician trained 
in pulmonary medicine to determine whether they can use a respirator 
while performing the required duty.
    (3) Respirator selection. (i) The employer must use Table I of this 
section to select the appropriate respirator or combination of 
respirators for inorganic arsenic compounds without significant vapor 
pressure, and Table II of this section to select the appropriate 
respirator or combination of respirators for inorganic arsenic 
compounds that have significant vapor pressure.
    (ii) When employee exposures exceed the permissible exposure limit 
for inorganic arsenic and also exceed the relevant limit for other 
gases (for example, sulfur dioxide), an air-purifying respirator 
provided to the employee as specified by this section must have a 
combination high-efficiency filter with an appropriate gas sorbent. 
(See footnote in Table 1 of this section.)
    (iii) Employees required to use respirators may choose, and the 
employer must provide, a powered air-purifying respirator if it will 
provide proper protection. In addition, the employer must provide a 
combination dust and acid-gas respirator to employees who are exposed 
to gases over the relevant exposure limits.

   Table I.--Respiratory Protection for Inorganic Arsenic Particulate   
            Except for Those With Significant Vapor Pressure            
------------------------------------------------------------------------
  Concentration of inorganic                                            
 arsenic (as As) or condition             Required respirator           
            of use                                                      
------------------------------------------------------------------------
(i) Unknown or greater or      (A) Any full facepiece self-contained    
 lesser than 20,000 g/m(3) (20 mg/m(3)) or       pressure mode.                          
 firefighting.                                                          
(ii) Not greater than 20,000   (A) Supplied air respirator with full    
 g/m(3) (20 mg/m(3)).  facepiece, hood, or helmet or suit and  
                                operated in positive pressure mode.     
(iii) Not greater than 10,000  (A) Powered air-purifying respirators in 
 g/m(3) (10 mg/m(3)).  all inlet face coverings with high      
                                efficiency filters \1\.                 
                               (B)Half-mask supplied air respirators    
                                operated in positive pressure mode.     
(iv) Not greater than 500      (A) Full facepiece air-purifying         
 g/m(3).               respirator equipped with high-efficiency
                                filter \1\.                             
                               (B) Any full facepiece supplied air      
                                respirator.                             
                               (C) Any full facepiece self-contained    
                                breathing apparatus.                    
(v) Not greater than 100       (A) Half-mask air-purifying respirator   
 g/m(3).               equipped with high-efficiency filter    
                                \1\.                                    
                               (B) Any half-mask supplied air           
                                respirator.                             
------------------------------------------------------------------------
\1\ High-efficiency filter-99.97 pct efficiency against 0.3 micrometer  
  monodisperse diethyl-hexyl phthalate (DOP) particles.                 


   Table II.--Respiratory Protection for Inorganic Arsenicals (Such as  
  Arsenic Trichloride \2\ and Arsenic Phosphide) With Significant Vapor 
                                Pressure                                
------------------------------------------------------------------------
  Concentration of inorganic                                            
 arsenic (as As) or condition             Required respirator           
            of use                                                      
------------------------------------------------------------------------
(i) Unknown or greater or      (A) Any full facepiece self-contained    
 lesser than 20,000 g/m(3) (20 mg/m(3)) or       pressure mode.                          
 firefighting.                                                          
(ii) Not greater than 20,000   (A) Supplied air respirator with full    
 g/m(3) (20 mg/m(3)).  facepiece, hood, or helmet or suit and  
                                operated in positive pressure mode.     
(iii) Not greater than 10,000  (A) Half-mask \2\ supplied air respirator
 g/m(3) (10 mg/m(3)).  operated in positive pressure mode.     
(iv) Not greater than 500      (A) Front or back mounted gas mask       
 g/m(3).               equipped with high-efficiency filter \1\
                                and acid gas canister.                  
                               (B) Any full facepiece supplied air      
                                respirator.                             
                               (C) Any full facepiece self-contained    
                                breathing apparatus.                    
(v) Not greater than 100       (A) Half-mask air-purifying respirator   
 g/m(3).               equipped with high efficiency filter \1\
                                and acid gas cartridge.                 
                               (B) Any half-mask supplied air           
                                respirator.                             
------------------------------------------------------------------------
\1\ High-efficiency filter-99.97 pct efficiency against 0.3 micrometer  
  monodisperse diethyl-hexyl phthalate (DOP) particles.                 
\2\ Half-mask respirators shall not be used for protection against      
  arsenic trichloride, as it is rapidly absorbed through the skin.      

* * * * *
    19. Section 1910.1025 is amended by revising paragraph (f); 
revising the second and fourth paragraphs of Section IV to Appendix B; 
removing the sixth paragraph of Section IV to Appendix B; and removing 
Appendix D, as follows:


Sec. 1910.1025  Lead.

* * * * *
    (f) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement engineering or work-
practice controls, except that no employer can require an employee to 
use a respirator longer than 4.4 hours per day.
    (ii) Work operations for which engineering and work-practice 
controls are not sufficient to reduce employee exposures to or below 
the permissible exposure limit.
    (iii) Periods when an employee requests a respirator.

[[Page 1288]]

    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) If an employee has breathing difficulty during fit testing or 
respirator use, the employer must provide the employee with a medical 
examination in accordance with paragraph (j)(3)(i)(C) of this section 
to determine whether or not the employee can use a respirator while 
performing the required duty.

           Table II.--Respiratory Protection for Lead Aerosols          
------------------------------------------------------------------------
  Airborne concentration of                                             
   lead or condition of use               Required respirator           
------------------------------------------------------------------------
Not in excess of 0.5 mg/m\3\   Half-mask, air-purifying respirator      
 (10X PEL).                     equipped with high efficiency           
                                filters.\2\ \3\                         
Not in excess of 2.5 mg/m\3\   Full facepiece, air-purifying respirator 
 (50X PEL).                     with high efficiency filters.\3\        
Not in excess of 50 mg/m\3\    (1) Any powered, air-purifying respirator
 (1000X PEL).                   with high efficiency filters\3\; or (2) 
                                Half-mask supplied-air respirator       
                                operated in positive-pressure mode.\2\  
Not in excess of 100 mg/m\3\   Supplied-air respirators with full       
 (2000XPEL).                    facepiece, hood, helmet, or suit,       
                                operated in positive pressure mode.     
Greater than 100 mg/m\3\,      Full facepiece, self-contained breathing 
 unknown concentration or       apparatus operated in positive-pressure 
 fire fighting.                 mode.                                   
------------------------------------------------------------------------
\1\ Respirators specified for high concentrations can be used at lower  
  concentrations of lead.                                               
\2\ Full facepiece is required if the lead aerosols cause eye or skin   
  irritation at the use concentrations.                                 
\3\ A high efficiency particulate filter means 99.97 percent efficient  
  against 0.3 micron size particles.                                    

    (3) Respirator selection. (i) The employer must select the 
appropriate respirator or combination of respirators from Table II of 
this section.
    (ii) The employer must provide a powered air-purifying respirator 
instead of the respirator specified in Table II of this section when an 
employee chooses to use this type of respirator and such a respirator 
provides adequate protection to the employee.
* * * * *

Appendix B to Sec. 1910.1025--Employee Standard Summary

* * * * *

IV. Respiratory Protection--Paragraph (f)

* * * * *
    Your employer is required to select respirators from the seven 
types listed in Table II of the Respiratory Protection section of 
the standard (Sec. 1910.1025(f)). Any respirator chosen must be 
approved by the National Institute for Occupational Safety and 
Health (NIOSH) under the provisions of 42 CFR part 84. This 
respirator selection table will enable your employer to choose a 
type of respirator that will give you a proper amount of protection 
based on your airborne lead exposure. Your employer may select a 
type of respirator that provides greater protection than that 
required by the standard; that is, one recommended for a higher 
concentration of lead than is present in your workplace. For 
example, a powered air-purifying respirator (PAPR) is much more 
protective than a typical negative pressure respirator, and may also 
be more comfortable to wear. A PAPR has a filter, cartridge, or 
canister to clean the air, and a power source that continuously 
blows filtered air into your breathing zone. Your employer might 
make a PAPR available to you to ease the burden of having to wear a 
respirator for long periods of time. The standard provides that you 
can obtain a PAPR upon request.
* * * * *
    Your employer must ensure that your respirator facepiece fits 
properly. Proper fit of a respirator facepiece is critical to your 
protection from airborne lead. Obtaining a proper fit on each 
employee may require your employer to make available several 
different types of respirator masks. To ensure that your respirator 
fits properly and that facepiece leakage is minimal, your employer 
must give you either a qualitative or quantitative fit test as 
specified in Appendix A of the Respiratory Protection standard 
located at 29 CFR 1910.134.
* * * * *
    20. Section 1910.1027 is amended by removing and reserving Appendix 
C and revising paragraph (g) to read as follows:


Sec. 1910.1027  Cadmium.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls when employee exposure levels exceed the 
PEL.
    (ii) Maintenance and repair activities, and brief or intermittent 
operations, for which employee exposures exceed the PEL and engineering 
and work-practice controls are not feasible or are not required.
    (iii) Activities in regulated areas specified in paragraph (e) of 
this section.
    (iv) Work operations for which the employer has implemented all 
feasible engineering and work-practice controls and such controls are 
not sufficient to reduce employee exposures to or below the PEL.
    (v) Work operations for which an employee is exposed to cadmium at 
or above the action level, and the employee requests a respirator.
    (vi) Work operations for which an employee is exposed to cadmium 
above the PEL and engineering controls are not required by paragraph 
(f)(1)(ii) of this section.
    (vii) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) No employees must use a respirator if, based on their most 
recent medical examination, the examining physician determines that 
they will be unable to continue to function normally while using a 
respirator. If the physician determines that the employee must be 
limited in, or removed from, their current job because of their 
inability to use a respirator, the limitation or removal must be in 
accordance with paragraphs (l) (11) and (12) of this section.
    (iii) If an employee has breathing difficulty during fit testing or 
respirator use, the employer must provide the employee with a medical 
examination in accordance with paragraph (l)(6)(ii) of this section to 
determine if the employee can use a respirator while performing the 
required duties.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table 2 of this section.

[[Page 1289]]



              Table 2.--Respiratory Protection for Cadmium              
------------------------------------------------------------------------
  Airborne concentration or                                             
      condition of use a               Required respirator type b       
------------------------------------------------------------------------
10 X or less.................  A half mask, air-purifying equipped with 
                                a HEPA c filter.d                       
25 X or less.................  A powered air-purifying respirator       
                                (``PAPR'') with a loose-fitting hood or 
                                helmet equipped with a HEPA filter, or a
                                supplied-air respirator with a loose-   
                                fitting hood or helmet facepiece        
                                operated in the continuous flow mode.   
50 X or less.................  A full facepiece air-purifying respirator
                                equipped with a HEPA filter, or a       
                                powered air-purifying respirator with a 
                                tight-fitting half mask equipped with a 
                                HEPA filter, or a supplied-air          
                                respirator with a tight-fitting half    
                                mask operated in the continuous flow    
                                mode.                                   
250 X or less................  A powered air-purifying respirator with a
                                tight fitting full facepiece equipped   
                                with a HEPA filter, or a supplied-air   
                                respirator with a tight-fitting full    
                                facepiece operated in the continuous    
                                flow mode.                              
1000 X or less...............  A supplied air respirator with half mask 
                                or full facepiece operated in the       
                                pressure demand or other positive       
                                pressure mode.                          
>1000 X or unknown             A self-contained breathing apparatus with
 concentrations.                a full facepiece operated in the        
                                pressure demand or other positive       
                                pressure mode, or a supplied-air        
                                respirator with a full facepiece        
                                operated in the pressure demand or other
                                positive pressure mode and equipped with
                                an auxiliary escape type self-contained 
                                breathing apparatus operated in the     
                                pressure demand mode.                   
Fire fighting................  A self-contained breathing apparatus with
                                full facepiece operated in the pressure 
                                demand or other positive pressure mode. 
------------------------------------------------------------------------
a Concentrations expressed as multiple of the PEL.                      
b Respirators assigned for higher environmental concentrations may be   
  used at lower exposure levels. Quantitative fit testing is required   
  for all tight-fitting air purifying respirators where airborne        
  concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3) 
  = 50 ug/m(3)). A full facepiece respirator is required when eye       
  irritation is experienced.                                            
c HEPA means High-efficiency Particulate Air.                           
d Fit testing, qualitative or quantitative, is required.                
 SOURCE: Respiratory Decision Logic, NIOSH, 1987.                       

    (ii) The employer must provide an employee with a powered air-
purifying respirator instead of a negative-pressure respirator when an 
employee who is entitled to a respirator chooses to use this type of 
respirator and such a respirator provides adequate protection to the 
employee.
* * * * *
    21. Section 1910.1028 is amended by removing Appendix E and 
revising paragraph (g) to read as follows:


Sec. 1910.1028  Benzene.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations for which the employer establishes that 
compliance with either the TWA or STEL through the use of engineering 
and work-practice controls is not feasible; for example, some 
maintenance and repair activities, vessel cleaning, or other operations 
for which engineering and work-practice controls are infeasible because 
exposures are intermittent and limited in duration.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient, or are not required under 
paragraph (f)(1)(iii) of this section, to reduce employee exposure to 
or below the PELs.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f) 
through (m).
    (ii) For air-purifying respirators, the employer must replace the 
air-purifying element at the expiration of its service life or at the 
beginning of each shift in which such elements are used, whichever 
comes first.
    (iii) If NIOSH approves an air-purifying element with an end-of-
service-life indicator for benzene, such an element may be used until 
the indicator shows no further useful life.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table 1 of this section.
    (ii) Any employee who cannot use a negative-pressure respirator 
must be allowed to use a respirator with less breathing resistance, 
such as a powered air-purifying respirator or supplied-air respirator.

              Table 1.--Respiratory Protection for Benzene              
------------------------------------------------------------------------
  Airborne concentration of                                             
 benzene or condition of use                Respirator type             
------------------------------------------------------------------------
(a) Less than or equal to 10   (1) Half-mask air-purifying respirator   
 ppm.                           with organic vapor cartridge.           
(b) Less than or equal to 50   (1) Full facepiece respirator with       
 ppm.                           organic vapor cartridges.               
                               (1) Full facepiece gas mask with chin    
                                style canister.1                        
(c) Less than or equal to 100  (1) Full facepiece powered air-purifying 
 ppm.                           respirator with organic vapor canister.1
(d) Less than or equal to      (1) Supplied air respirator with full    
 1,000 ppm.                     facepiece in positive-pressure mode.    
(e) Greater than 1,000 ppm or  (1) Self-contained breathing apparatus   
 unknown concentration.         with full facepiece in positive pressure
                                mode.                                   
                               (2) Full facepiece positive-pressure     
                                supplied-air respirator with auxiliary  
                                self-contained air supply.              
(f) Escape...................  (1) Any organic vapor gas mask; or       
                               (2) Any self-contained breathing         
                                apparatus with full facepiece.          

[[Page 1290]]

                                                                        
(g) Firefighting.............  (1) Full facepiece self-contained        
                                breathing apparatus in positive pressure
                                mode.                                   
------------------------------------------------------------------------
\1\ Canisters must have a minimum service life of four (4) hours when   
  tested at 150 ppm benzene, at a flow rate of 64 LPM, 25 deg. C, and   
  85% relative humidity for non-powered air purifying respirators. The  
  flow rate shall be 115 LPM and 170 LPM respectively for tight fitting 
  and loose fitting powered air-purifying respirators.                  

* * * * *
    22. Section 1910.1029 is amended by revising paragraph (g) to read 
as follows:


Sec. 1910.1029  Coke oven emissions.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Compliance with the permissible exposure limit may not be achieved by 
the use of respirators except during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activity, for 
which engineering and work-practice controls are technologically not 
feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii)), and (f) through (m).
    (3) Respirator selection. The employer must select appropriate 
respirators or combination of respirators from Table I of this section.

        TABLE I.--Respiratory Protection for Coke Oven Emissions        
------------------------------------------------------------------------
  Airborne concentration of                                             
     coke oven emissions                  Required respirator           
------------------------------------------------------------------------
(a) Any concentration........  (1) A Type C supplied air respirator     
                                operated in pressure demand or other    
                                positive pressure or continuous flow    
                                mode; or                                
                               (2) A powered air-purifying particulate  
                                filter respirator for dust and mist or  
                               (3) A powered air-purifying particulate  
                                filter respirator or combination        
                                chemical cartridge and particulate      
                                filter respirator for coke oven         
                                emissions.                              
(b) Concentrations not         (1) Any particulate filter respirator for
 greater than 1500 ug/m \3\.    dust and mist except single-use         
                                respirator; or                          
                               (2) Any particulate filter respirator or 
                                combination chemical cartridge and      
                                particulate filter respirator for coke  
                                oven emissions; or                      
                               (3) Any respirator listed in paragraph   
                                (g)(3)(a) of this section.              
------------------------------------------------------------------------

* * * * *
    23. Section 1910.1043 is amended by revising paragraph (f) to read 
as follows:


Sec. 1910.1043  Cotton dust.

* * * * *
    (f) Respiratory protection. (1) General. For employees who are 
required to use respirators by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Maintenance and repair activities for which engineering and 
work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the permissible exposure limits.
    (iv) Work operations specified under paragraph (g)(1) of this 
section.
    (v) Periods for which an employee requests a respirator.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) Whenever a physician determines that an employee who works in 
an area in which the cotton-dust concentration exceeds the PEL is 
unable to use a respirator, including a powered air-purifying 
respirator, the employee must be given the opportunity to transfer to 
an available position, or to a position that becomes available later, 
that has a cotton-dust concentration at or below the PEL. The employer 
must ensure that such employees retain their current wage rate or other 
benefits as a result of the transfer.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table I of this section.

                                 Table I                                
------------------------------------------------------------------------
  Cotton dust concentration               Required respirator           
------------------------------------------------------------------------
Not greater than:                                                       
    (a) 5  x  the applicable   A disposable respirator with a           
     permissible exposure       particulate filter.                     
     limit (PEL).                                                       
    (b) 10  x  the applicable  A quarter or half-mask respirator, other 
     PEL.                       than a disposable respirator, equipped  
                                with particulate filters.               
    (c) 100  x  the            A full facepiece respirator equipped with
     applicable PEL.            high-efficiency particulate filters.    
    (d) Greater than 100  x    A powered air-purifying respirator       
     the applicable PEL.        equipped with high-efficiency           
                                particulate filters.                    
------------------------------------------------------------------------
Notes:                                                                  
 1. A disposable respirator means the filter element is an inseparable  
  part of the respirator.                                               
 2. Any respirators permitted at higher environmental concentrations can
  be used at lower concentrations.                                      

[[Page 1291]]

                                                                        
 3. Self-contained breathing apparatus are not required respirators but 
  are permitted respirators.                                            
 4. Supplied air respirators are not required but are permitted under   
  the following conditions: Cotton dust concentration not greater than  
  10X the PEL--Any supplied air respirator; not greater than 100X the   
  PEL--Any supplied air respirator with full facepiece, helmet or hood; 
  greater than 100X the PEL--A supplied air respirator operated in      
  positive pressure mode.                                               

    (ii) Whenever respirators are required by this section for cotton-
dust concentrations that do not exceed the applicable permissible 
exposure limit by a multiple of 100 (100 X), the employer must, when 
requested by an employee, provide a powered air-purifying respirator 
with a high-efficiency particulate filter instead of the respirator 
specified in paragraphs (a), (b), or (c) of Table I of this section.
* * * * *
    24. Section 1910.1044 is amended by revising paragraph (h) to read 
as follows:


Sec. 1910.1044  1,2-Dibromo-3-chloropropane.

* * * * *
    (h) Respiratory protection. (1) General. For employees who are 
required to use respirators by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Maintenance and repair activities for which engineering and 
work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the permissible exposure limit.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii)), and (f) through (m).
    (3) Respirator selection. The employer must select the appropriate 
respirator from Table 1 of this section.

                Table 1.--Respiratory Protection for DBCP               
------------------------------------------------------------------------
  Airborne concentration of                                             
   DBCP or condition of use                 Respirator type             
------------------------------------------------------------------------
(a) Less than or equal to 10   (1) Any supplied-air respirator; or (2)  
 ppb.                           any self-contained breathing apparatus. 
(b) Less than or equal to 50   (1) Any supplied-air respirator with full
 ppb.                           facepiece, helmet, or hood; or (2) any  
                                self-contained breathing apparatus with 
                                full facepiece.                         
(c) Less than or equal to      (1) A Type C supplied-air respirator     
 1,000 ppb.                     operated in pressure-demand or other    
                                positive pressure or continuous flow    
                                mode.                                   
(d) Less than or equal to      (1) A Type C supplied-air respirator with
 2,000 ppb.                     full facepiece operated in pressure-    
                                demand or other positive pressure mode, 
                                or with full facepiece, helmet, or hood 
                                operated in continuous flow mode.       
(e) Greater than 2,000 ppb or  (1) A combination respirator which       
 entry and escape from          includes a Type C supplied-air          
 unknown concentrations.        respirator with full facepiece operated 
                                in pressure-demand or other positive    
                                pressure or continuous flow mode and an 
                                auxiliary self-contained breathing      
                                apparatus operated in pressure-demand or
                                positive pressure mode; or (2) a self-  
                                contained breathing apparatus with full 
                                facepiece operated in pressure-demand or
                                other positive pressure mode.           
(f) Firefighting.............  (1) A self-contained breathing apparatus 
                                with full facepiece operated in pressure-
                                demand or other positive pressure mode. 
------------------------------------------------------------------------

* * * * *
    25. Section 1910.1045 is amended by revising paragraph (h) and the 
first paragraph of Section IV to Appendix A to read as follows:


Sec. 1910.1045  Acrylonitrile.

* * * * *
    (h) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities or 
reactor cleaning, for which the employer establishes that engineering 
and work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the permissible exposure limits.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f) 
through (m).
    (ii) If air-purifying respirators (chemical-cartridge or chemical-
canister types) are used:
    (A) The air-purifying canister or cartridge must be replaced prior 
to the expiration of its service life or at the completion of each 
shift, whichever occurs first.
    (B) A label must be attached to the cartridge or canister to 
indicate the date and time at which it is first installed on the 
respirator.
    (3) Respirator selection. The employer must select the appropriate 
respirator from Table I of this section.

         Table I.--Respiratory Protection for Acrylonitrile (AN)        
------------------------------------------------------------------------
    Concentration of AN or                                              
       condition of use                     Respirator type             
------------------------------------------------------------------------
(a) Less than or equal to 20   (1) Chemical cartridge respirator with   
 ppm.                           organic vapor cartridge(s) and half-mask
                                facepiece; or                           
                               (2) Supplied air respirator with half-   
                                mask facepiece.                         
(b) Less than or equal to 100  (1) Full facepiece respirator with (A)   
 ppm or maximum use             organic vapor cartridges, (B) organic   
 concentration (MUC) of         vapor gas mask chin-style, or (C)       
 cartridges or canisters,       organic vapor gas mask canister, front- 
 whichever is lower.            or back-mounted;                        

[[Page 1292]]

                                                                        
                               (2) Supplied air respirator with full    
                                facepiece; or                           
                               (3) Self-contained breathing apparatus   
                                with full facepiece.                    
(c) Less than or equal to      (1) Supplied air respirator operated in  
 4,000 ppm.                     the positive pressure mode with full    
                                facepiece, helmet, suit, or hood.       
(d) Greater than 4,000 ppm or  (1) Supplied air and auxiliary self-     
 unknown concentration.         contained breathing apparatus with full 
                                facepiece in positive pressure mode; or 
                               (2) Self-contained breathing apparatus   
                                with full facepiece in positive pressure
                                mode.                                   
(e) Firefighting.............  Self-contained breathing apparatus with  
                                full facepiece in positive pressure     
                                mode.                                   
(f) Escape...................  (1) Any organic vapor respirator, or     
                               (2) Any self-contained breathing         
                                apparatus.                              
------------------------------------------------------------------------

* * * * *

Appendix A to Sec. 1910.1045--Substance Safety Data Sheet for 
Acrylonitrile

* * * * *

IV. Respirators and Protective Clothing

    A. Respirators. You may be required to wear a respirator for 
nonroutine activities, in emergencies, while your employer is in the 
process of reducing acrylonitrile exposures through engineering 
controls, and in areas where engineering controls are not feasible. 
If respirators are worn, they must have a label issued by the 
National Institute for Occupational Safety and Health under the 
provisions of 42 CFR part 84 stating that the respirators have been 
approved for use with organic vapors. For effective protection, 
respirators must fit your face and head snugly. Respirators must not 
be loosened or removed in work situations where their use is 
required.
* * * * *
    26. Section 1910.1047 is amended by removing table 1 following 
paragraph (h)(2) and revising paragraph (g) and the first paragraph of 
Section IV to Appendix A to read as follows:


Sec. 1910.1047  Ethylene oxide.

* * * * *
    (g) Respiratory protection and personal protective equipment. (1) 
General. For employees who use respirators required by this section, 
the employer must provide respirators that comply with the requirements 
of this paragraph. Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities and 
vessel cleaning, for which engineering and work-practice controls are 
not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the TWA.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii)), and (f) through (m).
    (3) Respirator selection. The employer must select the appropriate 
respirator from Table 1 of this section.

 Table 1.--Minimum Requirements for Respiratory Protection for Airborne 
                                   EtO                                  
------------------------------------------------------------------------
     Condition of use or                                                
concentration of airborne EtO         Minimum required respirator       
            (ppm)                                                       
------------------------------------------------------------------------
Equal to or less than 50.....  (a) Full facepiece respirator with EtO   
                                approved canister, front-or back-       
                                mounted.                                
Equal to or less than 2,000..  (a) Positive-pressure supplied air       
                                respirator, equipped with full          
                                facepiece, hood, or helmet, or          
                               (b) Continuous-flow supplied air         
                                respirator (positive pressure) equipped 
                                with hood, helmet or suit.              
Concentration above 2,000 or   (a) Positive-pressure self-contained     
 unknown concentration (such    breathing apparatus (SCBA), equipped    
 as in emergencies).            with full facepiece, or                 
                               (b) Positive-pressure full facepiece     
                                supplied air respirator equipped with an
                                auxiliary positive-pressure self-       
                                contained breathing apparatus.          
Firefighting.................  (a) Positive pressure self-contained     
                                breathing apparatus equipped with full  
                                facepiece.                              
Escape.......................  (a) Any respirator described above.      
------------------------------------------------------------------------
Note. Respirators approved for use in higher concentrations are         
  permitted to be used in lower concentrations.                         

    (4) Protective clothing and equipment. When employees could have 
eye or skin contact with EtO or EtO solutions, the employer must select 
and provide, at no cost to the employee, appropriate protective 
clothing or other equipment in accordance with 29 CFR 1910.132 and 
1910.133 to protect any area of the employee's body that may come in 
contact with the EtO or EtO solution, and must ensure that the employee 
wears the protective clothing and equipment provided.
* * * * *

Appendix A to Sec. 1910.1047--Substance Safety Data Sheet for Ethylene 
Oxide (Non-mandatory)

* * * * *

IV. Respirators and Protective Clothing

    A. Respirators. You may be required to wear a respirator for 
nonroutine activities, in emergencies, while your employer is in the 
process of reducing EtO exposures through engineering controls, and 
in areas where engineering controls are not feasible. As of the 
effective date of this standard, only air-supplied, positive-
pressure, full-facepiece respirators are approved for protection 
against EtO. If air-purifying respirators are worn in the future, 
they must have a label issued by the National Institute for 
Occupational Safety and Health under the provisions of 42 CFR part 
84 stating that the respirators have been approved for use with 
ethylene oxide. For effective protection, respirators must fit your 
face and head snugly. Respirators must not be loosened or removed in 
work situations where their use is required.
* * * * *
    27. Section 1910.1048 is amended by removing Appendix E and 
revising paragraph (g) to read as follows:

[[Page 1293]]

Sec. 1910.1048  Formaldehyde.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities or 
vessel cleaning, for which the employer establishes that engineering 
and work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the PELs.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f) 
through (m).
    (ii) If air-purifying chemical-cartridge respirators are used, the 
employer must:
    (A) Replace the cartridge after three (3) hours of use or at the 
end of the workshift, whichever occurs first, unless the cartridge 
contains a NIOSH-approved end-of-service-life indicator (ESLI) to show 
when breakthrough occurs.
    (B) Unless the canister contains a NIOSH-approved ESLI to show when 
breakthrough occurs, replace canisters used in atmospheres up to 7.5 
ppm (10xPEL) every four (4) hours and industrial-sized canisters used 
in atmospheres up to 75 ppm (100xPEL) every two (2) hours, or at the 
end of the workshift, whichever occurs first.
    (3) Respirator selection. (i) The employer must select appropriate 
respirators from Table 1 in this section.

    Table 1.--Minimum Requirements for Respiratory Protection Against   
                              Formaldehyde                              
------------------------------------------------------------------------
     Condition of use or                                                
  formaldehyde concentration        Minimum respirator required \1\     
            (ppm)                                                       
------------------------------------------------------------------------
Up to 7.5 ppm. (10 x PEL)....  Full facepiece with cartridges or        
                                canisters specifically approved for     
                                protection against formaldehyde.\2\     
Up to 75 ppm. (100 x PEL)....  Full-face mask with chin style or chest  
                                or back mounted type, with industrial   
                                size canister specifically approved for 
                                protection against formaldehyde. Type C 
                                supplied air respirator, demand type, or
                                continuous flow type, with full         
                                facepiece, hood, or helmet.             
Above 75 ppm or unknown.       Self-contained breathing apparatus (SCBA)
 (emergencies). (100 x PEL).    with positive pressure full facepiece.  
                                Combination supplied-air, full facepiece
                                positive pressure respirator with       
                                auxiliary self-contained air supply.    
Firefighting.................  SCBA with positive pressure in full face-
                                piece.                                  
Escape.......................  SCBA in demand or pressure demand mode.  
                                Full-face mask with chin style or front 
                                or back mounted type industrial size    
                                canister specifically approved for      
                                protection against formaldehyde.        
------------------------------------------------------------------------
\1\ Respirators specified for use at higher concentrations may be used  
  at lower concentrations.                                              
\2\ A half-mask respirator with cartridges specifically approved for    
  protection against formaldehyde can be substituted for the full       
  facepiece respirator providing that effective gas-proof goggles are   
  provided and used in combination with the half-mask respirator.       

    (ii) The employer must provide a powered air-purifying respirator 
adequate to protect against formaldehyde exposure to any employee who 
has difficulty using a negative-pressure respirator.
* * * * *
    28. Section 1910.1050 is amended by revising paragraph (h) and the 
first paragraph of Section III to Appendix A to read as follows:


Sec. 1910.1050  Methylenedianiline.

* * * * *
    (h) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations for which the employer establishes that 
engineering and work-practice controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the PEL.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii)), and (f) through (m).
    (3) Respirator selection. (i) The employer must select, and ensure 
that employees use, the appropriate respirator from Table 1 in this 
section.

                Table 1.--Respiratory Protection for MDA                
------------------------------------------------------------------------
Airborne concentration of MDA                                           
     or condition of use                    Respirator type             
------------------------------------------------------------------------
a. Less than or equal to 10    (1) Half-Mask Respirator with HEPA \1\   
 x  PEL.                        Cartridge.\2\                           
b. Less than or equal to 50    (1) Full facepiece Respirator with HEPA  
 x  PEL.                        \1\ Cartridge or Canister.\2\           
c. Less than or equal to 1000  (1) Full facepiece powered air-purifying 
  x  PEL.                       respirator with HEPA \1\ cartridges.\2\ 
d. Greater than 1000  x  PEL   (1) Self-contained breathing apparatus   
 or unknown concentrations.     with full facepiece in positive pressure
                                mode.                                   
                               (2) Full facepiece positive pressure     
                                demand supplied-air respirator with     
                                auxiliary self-contained air supply.    
e. Escape....................  (1) Any full facepiece air-purifying     
                                respirator with HEPA \1\ cartridges; \2\
                               (2) Any positive pressure or continuous  
                                flow self-contained breathing apparatus 
                                with full facepiece or hood.            
f. Firefighting..............  (1) Full facepiece self-contained        
                                breathing apparatus in positive pressure
                                demand mode.                            
------------------------------------------------------------------------
Note: Respirators assigned for higher environmental concentrations may  
  be used at lower concentrations.                                      

[[Page 1294]]

                                                                        
\1\ High Efficiency Particulate in Air filter (HEPA) means a filter that
  is at least 99.97 percent efficient against mono-dispersed particles  
  of 0.3 micrometers or larger.                                         
\2\ Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA
  in liquid form or a process requiring heat is used.                   

    (ii) Any employee who cannot use a negative-pressure respirator 
must be given the option of using a positive-pressure respirator, or a 
supplied-air respirator operated in the continuous-flow or pressure-
demand mode.
* * * * *

Appendix A to Sec. 1910.1050--Substance Safety Data Sheet for 4,4'-
Methylenedianiline

* * * * *

III. Protective Clothing and Equipment

    A. Respirators. Respirators are required for those operations in 
which engineering controls or work-practice controls are not 
adequate or feasible to reduce exposure to the permissible limit. If 
respirators are worn, they must have a label issued by the National 
Institute for Occupational Safety and Health under the provisions of 
42 CFR part 84 stating that the respirators have been approved for 
this purpose, and cartridges and canisters must be replaced in 
accordance with the requirements of 29 CFR 1910.134. If you 
experience difficulty breathing while wearing a respirator, you can 
request a positive-pressure respirator from your employer. You must 
be thoroughly trained to use the assigned respirator, and the 
training must be provided by your employer.
* * * * *
    29. Section 1910.1051 is amended by removing and reserving Appendix 
E and revising paragraph (h) to read as follows:


Sec. 1910.1051  1,3-Butadiene.

* * * * *
    (h) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Non-routine work operations that are performed infrequently 
and for which employee exposures are limited in duration.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposures 
to or below the PELs.
    (iv) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii), (d)(3)(iii)(B)(1), and (2)), and (f) 
through (m).
    (ii) If air-purifying respirators are used, the employer must 
replace the air-purifying filter elements according to the replacement 
schedule set for the class of respirators listed in Table 1 of this 
section, and at the beginning of each work shift.
    (iii) Instead of using the replacement schedule listed in Table 1 
of this section, the employer may replace cartridges or canisters at 
90% of their expiration service life, provided the employer:
    (A) Demonstrates that employees will be adequately protected by 
this procedure.
    (B) Uses BD breakthrough data for this purpose that have been 
derived from tests conducted under worst-case conditions of humidity, 
temperature, and air-flow rate through the filter element, and the 
employer also describes the data supporting the cartridge-or canister-
change schedule, as well as the basis for using the data in the 
employer's respirator program.
    (iv) A label must be attached to each filter element to indicate 
the date and time it is first installed on the respirator.
    (v) If NIOSH approves an end-of-service-life indicator (ESLI) for 
an air-purifying filter element, the element may be used until the ESLI 
shows no further useful service life or until the element is replaced 
at the beginning of the next work shift, whichever occurs first.
    (vi) Regardless of the air-purifying element used, if an employee 
detects the odor of BD, the employer must replace the air-purifying 
element immediately.
    (3) Respirator selection. (i) The employer must select appropriate 
respirators from Table 1 of this section.

 Table 1.--Minimum Requirements for Respiratory Protection for Airborne 
                                   BD                                   
------------------------------------------------------------------------
 Concentration of airborne BD                                           
  (ppm) or condition of use           Minimum required respirator       
------------------------------------------------------------------------
Less than or equal to 5 ppm    (a) Air-purifying half mask or full      
 (5 times PEL).                 facepiece respirator equipped with      
                                approved BD or organic vapor cartridges 
                                or canisters. Cartridges or canisters   
                                shall be replaced every 4 hours.        
Less than or equal to 10 ppm   (a) Air-purifying half mask or full      
 (10 times PEL).                facepiece respirator equipped with      
                                approved BD or organic vapor cartridges 
                                or canisters. Cartridges or canisters   
                                shall be replaced every 3 hours.        
Less than or equal to 25 ppm   (a) Air-purifying full facepiece         
 (25 times PEL).                respirator equipped with approved BD or 
                                organic vapor cartridges or canisters.  
                                Cartridges or canisters shall be        
                                replaced every 2 hours.                 
                               (b) Any powered air-purifying respirator 
                                equipped with approved BD or organic    
                                vapor cartridges. PAPR cartridges shall 
                                be replaced every 2 hours.              
                               (c) Continuous flow supplied air         
                                respirator equipped with a hood or      
                                helmet.                                 
Less than or equal to 50 ppm   (a) Air-purifying full facepiece         
 (50 times PEL).                respirator equipped with approved BD or 
                                organic vapor cartridges or canisters.  
                                Cartridges or canisters shall be        
                                replaced every (1) hour.                
                               (b) Powered air-purifying respirator     
                                equipped with a tight-fitting facepiece 
                                and an approved BD or organic vapor     
                                cartridges. PAPR cartridges shall be    
                                replaced every (1) hour.                
Less than or equal to 1,000    (a) Supplied air respirator equipped with
 ppm (1,000 times PEL).         a half mask of full facepiece and       
                                operated in a pressure demand or other  
                                positive pressure mode.                 
Greater than 1000 ppm unknown  (a) Self-contained breathing apparatus   
 concentration, or              equipped with a full facepiece and      
 firefighting.                  operated in a pressure demand or other  
                                positive pressure mode.                 
                               (b) Any supplied air respirator equipped 
                                with a full facepiece and operated in a 
                                pressure demand or other positive       
                                pressure mode in combination with an    
                                auxiliary self-contained breathing      
                                apparatus operated in a pressure demand 
                                or other positive pressure mode.        
Escape from IDLH conditions..  (a) Any positive pressure self-contained 
                                breathing apparatus with an appropriate 
                                service life.                           

[[Page 1295]]

                                                                        
                               (b) A air-purifying full facepiece       
                                respirator equipped with a front or back
                                mounted BD or organic vapor canister.   
------------------------------------------------------------------------
Notes: Respirators approved for use in higher concentrations are        
  permitted to be used in lower concentrations. Full facepiece is       
  required when eye irritation is anticipated.                          

    (ii) Air-purifying respirators must have filter elements approved 
by NIOSH for organic vapors or BD.
    (iii) When an employee whose job requires the use of a respirator 
cannot use a negative-pressure respirator, the employer must provide 
the employee with a respirator that has less breathing resistance than 
the negative-pressure respirator, such as a powered air-purifying 
respirator or supplied-air respirator, when the employee is able to use 
it and if it provides the employee adequate protection.
* * * * *
    30. Section 1910.1052 is amended by revising paragraph (g) to read 
as follows:


Sec. 1910.1052  Methylene chloride.

* * * * *
    (g) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods when an employee's exposure to MC exceeds the 8-hour 
TWA, PEL, or STEL (for example, when an employee is using MC in a 
regulated area).
    (ii) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (iii) A few work operations, such as some maintenance operations 
and repair activities, for which the employer demonstrates that 
engineering and work-practice controls are infeasible.
    (iv) Work operations for which feasible engineering and work-
practice controls are not sufficient to reduce employee exposures to or 
below the PELs.
    (v) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (m) (except (d)(1)(iii)).
    (ii) Employers who provide employees with gas masks with organic-
vapor canisters for the purpose of emergency escape must replace the 
canisters after any emergency use and before the gas masks are returned 
to service.
    (3) Respirator selection. The employer must select appropriate 
atmosphere-supplying respirators from Table 2 of this section.

 Table 2.--Minimum Requirements for Respiratory Protection for Airborne 
                           Methylene Chloride                           
------------------------------------------------------------------------
 Methylene chloride airborne                                            
    concentration (ppm) or          Minimum respirator required \1\     
       condition of use                                                 
------------------------------------------------------------------------
Up to 625 ppm (25 X PEL).....  (1) Continuous flow supplied-air         
                                respirator, hood or helmet.             
Up to 1250 ppm (50 X 8-TWA     (1) Full facepiece supplied-air          
 PEL).                          respirator operated in negative pressure
                                (demand) mode.                          
                               (2) Full facepiece self-contained        
                                breathing apparatus (SCBA) operated in  
                                negative pressure (demand) mode.        
Up to 5000 ppm (200 X 8-TWA    (1) Continuous flow supplied-air         
 PEL).                          respirator, full facepiece.             
                               (2) Pressure demand supplied-air         
                                respirator, full facepiece.             
                               (3) Positive pressure full facepiece     
                                SCBA.                                   
Unknown concentration, or      (1) Positive pressure full facepiece     
 above 5000 ppm (Greater than   SCBA.                                   
 200 X 8-TWA PEL).                                                      
                               (2) Full facepiece pressure demand       
                                supplied-air respirator with an         
                                auxiliary self-contained air supply.    
Fire fighting................  Positive pressure full facepiece SCBA.   
Emergency escape.............  (1) Any continuous flow or pressure      
                                demand SCBA.                            
                               (2) Gas mask with organic vapor canister.
------------------------------------------------------------------------
\1\ Respirators assigned for higher airborne concentrations may be used 
  at lower concentrations.                                              

    (4) Medical evaluation. Before having an employee use a supplied-
air respirator in the negative-pressure mode, or a gas mask with an 
organic-vapor canister for emergency escape, the employer must:
    (i) Have a physician or other licensed health-care professional 
(PLHCP) evaluate the employee's ability to use such respiratory 
protection.
    (ii) Ensure that the PLHCP provides their findings in a written 
opinion to the employee and the employer.
* * * * *

PART 1926--[AMENDED]

Subpart D--[Amended]

    31. The authority citation for Subpart D of Part 1926 is revised to 
read as follows:

    Authority: Sec. 107, Contract Work Hours and Safety Standards 
Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8 of 
the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 
657); Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR 
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111), 
as applicable; and 29 CFR Part 11.
    Secs. 1926.58, 1926.59, 1926.60, and 1926.65 of 29 CFR, also 
issued under 5 U.S.C. 553, and 29 CFR Part 1911.
    Sec. 1926.62 of 29 CFR, also issued under sec. 1031 of the 
Housing and Community Development Act of 1992 (42 U.S.C. 4853).
    Sec. 1926.65 of 29 CFR, also issued under sec. 126 of the 
Superfund Amendments and Reauthorization Act of 1986, as amended (29 
U.S.C. 655 note), and 5 U.S.C. 553.

    32. Section 1926.57 is amended by revising paragraphs (f)(1)(ii), 
(f)(5)(i) and (iii), (f)(6), (h)(6)(iii)(A), and (i)(9)(vi) to read as 
follows:


Sec. 1926.57  Ventilation.

* * * * *

[[Page 1296]]

    (f) * * *
    (1) * * *
    (ii) Abrasive-blasting respirator. A respirator constructed so that 
it covers the wearer's head, neck, and shoulders to protect the wearer 
from rebounding abrasive.
* * * * *
    (5) Personal protective equipment. (i) Employers must use only 
respirators approved by NIOSH under 42 CFR part 84 for protecting 
employees from dusts produced during abrasive-blasting operations.
* * * * *
    (iii) Properly fitted particulate-filter respirators, commonly 
referred to as dust-filter respirators, may be used for short, 
intermittent, or occasional dust exposures such as cleanup, dumping of 
dust collectors, or unloading shipments of sand at a receiving point 
when it is not feasible to control the dust by enclosure, exhaust 
ventilation, or other means. The respirators used must be approved by 
NIOSH under 42 CFR part 84 for protection against the specific type of 
dust encountered.
* * * * *
    (6) Air supply and air compressors. Air for abrasive-blasting 
respirators must be free of harmful quantities of dusts, mists, or 
noxious gases, and must meet the requirements for supplied-air quality 
and use specified in 29 CFR 1910.134(i).
* * * * *
    (h) * * *
    (6) * * *
    (iii)(A) When an operator is in a booth downstream of the object 
being sprayed, an air-supplied respirator or other type of respirator 
approved by NIOSH under 42 CFR Part 84 for the material being sprayed 
should be used by the operator.
* * * * *
    (i) * * *
    (9) * * *
    (vi) When, during the emergencies specified in paragraph (i)(11)(v) 
of this section, employees must be in areas where concentrations of air 
contaminants are greater than the limits set by paragraph (i)(2)(iii) 
of this section or oxygen concentrations are less than 19.5 percent, 
they must use respirators that reduce their exposure to a level below 
these limits or that provide adequate oxygen. Such respirators must 
also be provided in marked, quickly-accessible storage compartments 
built for this purpose when the possibility exists of accidental 
release of hazardous concentrations of air contaminants. Respirators 
must be approved by NIOSH under 42 CFR part 84, selected by a competent 
industrial hygienist or other technically-qualified source, and used in 
accordance with 29 CFR 1926.103.
* * * * *
    33. Section 1926.60 is amended by removing Appendix E and revising 
paragraph (i) to read as follows:


Sec. 1926.60  Methylenedianiline.

* * * * *
    (i) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls.
    (ii) Work operations, such as maintenance and repair activities and 
spray-application processes, for which engineering and work-practice 
controls are not feasible.
    (iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to 
or below the PELs.
    (iv) Emergencies.
    (2) Respirator program. The employer must implement a respiratory 
protection program in accordance with 29 CFR 1910.134 (b) through (d) 
(except (d)(1)(iii), and (f) through (m).
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table 1 of this section.

                Table 1.--Respiratory Protection for MDA                
------------------------------------------------------------------------
Airborne concentration of MDA                                           
     or condition of use                    Respirator type             
------------------------------------------------------------------------
a. Less than or equal to 10    (1) Half-Mask Respirator with HEPA\1\    
 x  PEL.                        Cartridge.\2\                           
b. Less than or equal to 50    (1) Full facepiece Respirator with       
 x  PEL.                        HEPA\1\ Cartridge or Canister.\2\       
c. Less than or equal to 1000  (1) Full facepiece powered air-purifying 
  x  PEL.                       respirator with HEPA\1\ cartridge.\2\   
d. Greater than 1000  x  PEL   (1) Self-contained breathing apparatus   
 or unknown concentration.      with full facepiece in positive pressure
                                mode.                                   
                               (2) Full facepiece positive pressure     
                                demand supplied-air respirator with     
                                auxiliary self-contained air supply.    
e. Escape....................  (1) Any full facepiece air-purifying     
                                respirator with HEPA\1\ cartridges.\2\  
                               (2) Any positive pressure or continuous  
                                flow self-contained breathing apparatus 
                                with full facepiece or hood.            
f. Firefighting..............  (1) Full facepiece self-contained        
                                breathing apparatus in positive pressure
                                demand mode.                            
------------------------------------------------------------------------
Note: Respirators assigned for higher environmental concentrations may  
  be used at lower concentrations.                                      
\1\ High Efficiency Particulate in Air filter (HEPA) means a filter that
  is at least 99.97 percent efficient against mono-dispersed particles  
  of 0.3 micrometers or larger.                                         
\2\ Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA
  in liquid form or a process requiring heat is used.                   

    (ii) An employee who cannot use a negative-pressure respirator must 
be given the option of using a positive-pressure respirator, or a 
supplied-air respirator operated in the continuous-flow or pressure-
demand mode.
* * * * *
    34. Section 1926.62 is amended by revising paragraph (f); revising 
the second and fourth paragraphs of Section IV to Appendix B; removing 
the sixth paragraph of Section IV to Appendix B; and removing Appendix 
D, as follows:


Sec. 1926.62   Lead.

* * * * *
    (f) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods when an employee's exposure to lead exceeds the PEL.
    (ii) Work operations for which engineering and work-practice 
controls are not sufficient to reduce employee exposures to or below 
the PEL.
    (iii) Periods when an employee requests a respirator.
    (iv) Periods when respirators are required to provide interim 
protection of employees while they perform the

[[Page 1297]]

operations specified in paragraph (d)(2) of this section.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) If an employee has breathing difficulty during fit testing or 
respirator use, the employer must provide the employee with a medical 
examination in accordance with paragraph (j)(3)(i)(B) of this section 
to determine whether or not the employee can use a respirator while 
performing the required duty.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator or combination of respirators from Table I of 
this section.
    (ii) The employer must provide a powered air-purifying respirator 
when an employee chooses to use such a respirator and it will provide 
adequate protection to the employee.

           Table 1.--Respiratory Protection for Lead Aerosols           
------------------------------------------------------------------------
  Airborne concentration of                                             
   lead or condition of use              Required respirator 1          
------------------------------------------------------------------------
Not in excess of 500 ug/m3...  \1/2\ mask air purifying respirator with 
                                high efficiency filters.2 3             
                               \1/2\ mask supplied air respirator       
                                operated in demand (negative pressure)  
                                mode.                                   
Not in excess of 1,250 ug/m3.  Loose fitting hood or helmet powered air 
                                purifying respirator with high          
                                efficiency filters.3                    
                               Hood or helmet supplied air respirator   
                                operated in a continuous-flow mode--    
                                e.g., type CE abrasive blasting         
                                respirators operated in a continuous-   
                                flow mode.                              
Not in excess of 2,500 ug/m3.  Full facepiece air purifying respirator  
                                with high efficiency filters.3          
                               Tight fitting powered air purifying      
                                respirator with high efficiency         
                                filters.3                               
                               Full facepiece supplied air respirator   
                                operated in demand mode.                
                               \1/2\ mask or full facepiece supplied air
                                respirator operated in a continuous-flow
                                mode.                                   
                               Full facepiece self-contained breathing  
                                apparatus (SCBA) operated in demand     
                                mode.                                   
Not in excess of 50,000 ug/m3  \1/2\ mask supplied air respirator       
                                operated in pressure demand or other    
                                positive-pressure mode.                 
Not in excess of 100,000 ug/   Full facepiece supplied air respirator   
 m3.                            operated in pressure demand or other    
                                positive-pressure mode--e.g., type CE   
                                abrasive blasting respirators operated  
                                in a positive-pressure mode.            
Greater than 100,000 ug/m3     Full facepiece SCBA operated in pressure 
 unknown concentration, or      demand or other positive-pressure mode. 
 fire fighting.                                                         
------------------------------------------------------------------------
\1\ Respirators specified for higher concentrations can be used at lower
  concentrations of lead.                                               
\2\ Full facepiece is required if the lead aerosols cause eye or skin   
  irritation at the use concentrations.                                 
\3\ A high efficiency particulate filter (HEPA) means a filter that is a
  99.97 percent efficient against particles of 0.3 micron size or       
  larger.                                                               

* * * * *

Appendix B to Sec. 1926.62--Employee Standard Summary

* * * * *

IV. Respiratory Protection--Paragraph (f)

* * * * *
    Your employer is required to select respirators from the types 
listed in Table I of the Respiratory Protection section of the standard 
(Sec. 1926.62 (f)). Any respirator chosen must be approved by the 
National Institute for Occupational Safety and Health (NIOSH) under the 
provisions of 42 CFR part 84. This respirator selection table will 
enable your employer to choose a type of respirator that will give you 
a proper amount of protection based on your airborne lead exposure. 
Your employer may select a type of respirator that provides greater 
protection than that required by the standard; that is, one recommended 
for a higher concentration of lead than is present in your workplace. 
For example, a powered air-purifying respirator (PAPR) is much more 
protective than a typical negative pressure respirator, and may also be 
more comfortable to wear. A PAPR has a filter, cartridge, or canister 
to clean the air, and a power source that continuously blows filtered 
air into your breathing zone. Your employer might make a PAPR available 
to you to ease the burden of having to wear a respirator for long 
periods of time. The standard provides that you can obtain a PAPR upon 
request.
* * * * *
    Your employer must ensure that your respirator facepiece fits 
properly. Proper fit of a respirator facepiece is critical to your 
protection from airborne lead. Obtaining a proper fit on each 
employee may require your employer to make available several 
different types of respirator masks. To ensure that your respirator 
fits properly and that facepiece leakage is minimal, your employer 
must give you either a qualitative or quantitative fit test as 
specified in Appendix A of the Respiratory Protection standard 
located at 29 CFR 1910.134.
* * * * *

Subpart E--[Amended]

    35. The authority citation for Subpart E of Part 1926 is revised to 
read as follows:

    Authority: Sec. 107, Contract Work Hours and Safety Standards 
Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8 of 
the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655, 
657); Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR 
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111), 
as applicable; and 29 CFR part 11.

    36. Section 1926.103 is revised to read as follows:


Sec. 1926.103  Respiratory protection.

    Note: The requirements applicable to construction work under 
this section are identical to those set forth at 29 CFR 1910.134 of 
this chapter.

Subpart S--[Amended]

    37. The authority citation for Subpart S of Part 1926 is revised to 
read as follows:

    Authority: Sec. 107, Contract Work Hours and Safety Standards 
Act (40 U.S.C. 333); secs. 4, 6, and 8 of the Occupational Safety 
and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of 
Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 
35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable.

    38. Section 1926.800 is amended by revising paragraph (g)(2) as 
follows:


Sec. 1926.800  Underground construction.

* * * * *
    (g) * * *
    (2) Self-rescuers. The employer must provide self-rescuers approved 
by the National Institute for Occupational Safety and Health under 42 
CFR part 84. The respirators must be immediately available to all 
employees at work stations in underground areas where employees might 
be trapped by smoke or gas. The selection, issuance, use, and care of 
respirators must be in accordance with 29 CFR 1926.103.
* * * * *

[[Page 1298]]

Subpart Z--[Amended]

    39. The authority citation for Subpart Z of Part 1926 is revised to 
read as follows:

    Authority: Secs. 4, 6, and 8 of the Occupational Safety and 
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's 
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR 
part 11.
    Section 1926.1102 of 29 CFR not issued under 29 U.S.C. 655 or 29 
CFR part 1911; also issued under 5 U.S.C. 553.

    40. Section 1926.1101 is amended by removing and reserving Appendix 
C and revising paragraph (h) to read as follows:


Sec. 1926.1101  Asbestos.

* * * * *
    (h) Respiratory protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Class I asbestos work.
    (ii) Class II asbestos work when ACM is not removed in a 
substantially intact state.
    (iii) Class II and III asbestos work that is not performed using 
wet methods, except for removal of ACM from sloped roofs when a 
negative-exposure assessment has been conducted and ACM is removed in 
an intact state.
    (iv) Class II and III asbestos work for which a negative-exposure 
assessment has not been conducted.
    (v) Class III asbestos work when TSI or surfacing ACM or PACM is 
being disturbed.
    (vi) Class IV asbestos work performed within regulated areas where 
employees who are performing other work are required to use 
respirators.
    (vii) Work operations covered by this section for which employees 
are exposed above the TWA or excursion limit.
    (viii) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) No employee shall be assigned to asbestos work that requires 
respirator use if, based on their most recent medical examination, the 
examining physician determines that the employee will be unable to 
function normally while using a respirator, or that the safety or 
health of the employee or other employees will be impaired by the 
employee's respirator use. Such employees must be assigned to another 
job or given the opportunity to transfer to a different position that 
they can perform. If such a transfer position is available, it must be 
with the same employer, in the same geographical area, and with the 
same seniority, status, rate of pay, and other job benefits the 
employee had just prior to such transfer.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table 1 of this section.

          Table 1.--Respiratory Protection for Asbestos Fibers          
------------------------------------------------------------------------
  Airborne concentrations of                                            
asbestos or conditions of use             Required respirator           
------------------------------------------------------------------------
Not in excess of 1 f/cc (10 X  Half-mask air purifying respirator other 
 PEL), or otherwise as          than a disposable respirator, equipped  
 required independent of        with high efficiency filters.           
 exposure pursuant to                                                   
 paragraph (h)(2)(iv) of this                                           
 section.                                                               
Not in excess of 5 f/cc (50 X  Full facepiece air-purifying respirator  
 PEL).                          equipped with high efficiency filters.  
Not in excess of 10 f/cc (100  Any powered air-purifying respirator     
 X PEL).                        equipped with high efficiency filter or 
                                any supplied air respirator operated in 
                                continuous flow mode.                   
Not in excess of 100 f/cc      Full facepiece supplied air respirator   
 (1,000 X PEL) or unknown       operated in pressure demand mode.       
 concentration.                                                         
Greater than 100 f/cc (1,000   Full facepiece supplied air respirator   
 X PEL) or unknown              operated in pressure demand mode,       
 concentration.                 equipped with an auxiliary positive     
                                pressure self-contained breathing       
                                apparatus.                              
------------------------------------------------------------------------
Note: a. Respirators assigned for high environmental concentrations may 
  be used at lower concentrations, or when required respirator use is   
  independent of concentration.                                         
b. A high efficiency filter means a filter that is at least 99.97       
  percent efficient against mono-dispersed particles of 0.3 micrometers 
  in diameters in diameter or larger.                                   

    (ii) The employer must provide an employee with a tight-fitting, 
powered air-purifying respirator instead of a negative-pressure 
respirator from Table 1 when the employee chooses to use this type of 
respirator and such a respirator will provide adequate protection to 
the employee.
    (iii) The employer must provide a half-mask air-purifying 
respirator, other than a disposable respirator, that is equipped with 
high-efficiency filters when the employee performs:
    (A) Class II and III asbestos work and a negative-exposure 
assessment has not been conducted by the employer.
    (B) Class III asbestos work when TSI or surfacing ACM or PACM is 
being disturbed.
    (iv) The employer must provide employees with a full-facepiece 
supplied-air respirator operated in the pressure-demand mode and 
equipped with an auxiliary, positive-pressure self-contained breathing 
apparatus when the employees are in a regulated area where Class I work 
is being performed and the employer has not conducted a negative-
exposure assessment.
* * * * *
    41. Section 1926.1127 is amended by removing and reserving Appendix 
C and revising paragraph (g) to read as follows:


Sec. 1926.1127  Cadmium.

* * * * *
    (g) Respirator protection. (1) General. For employees who use 
respirators required by this section, the employer must provide 
respirators that comply with the requirements of this paragraph. 
Respirators must be used during:
    (i) Periods necessary to install or implement feasible engineering 
and work-practice controls when employee exposures exceed the PEL.
    (ii) Maintenance and repair activities, and brief or intermittent 
work operations, for which employee exposures exceed the PEL and 
engineering and work-practice controls are not feasible or are not 
required.
    (iii) Work operations in the regulated areas specified in paragraph 
(e) of this section.
    (iv) Work operations for which the employer has implemented all 
feasible engineering and work-practice controls, and such controls are 
not sufficient to reduce employee exposures to or below the PEL.

[[Page 1299]]

    (v) Work operations for which an employee, who is exposed to 
cadmium at or above the action level, requests a respirator.
    (vi) Work operations for which engineering controls are not 
required by paragraph (f)(1)(ii) of this section to reduce employee 
exposures that exceed the PEL.
    (vii) Emergencies.
    (2) Respirator program. (i) The employer must implement a 
respiratory protection program in accordance with 29 CFR 1910.134 (b) 
through (d) (except (d)(1)(iii)), and (f) through (m).
    (ii) If an employee exhibits breathing difficulty during fit 
testing or respirator use, the employer must provide the employee with 
a medical examination in accordance with paragraph (l)(6)(ii) of this 
section to determine if the employee can use a respirator while 
performing the required duties.
    (iii) No employee must use a respirator when, based on their most 
recent medical examination, the examining physician determines that the 
employee will be unable to continue to function normally while using a 
respirator. If the physician determines the employee must be limited 
in, or removed from, their current job because of the employee's 
inability to use a respirator, the job limitation or removal must be 
conducted in accordance with paragraphs (l) (11) and (12) of this 
section.
    (3) Respirator selection. (i) The employer must select the 
appropriate respirator from Table 1 of this section.

              Table 1.--Respiratory Protection for Cadmium              
------------------------------------------------------------------------
                                                     Required respirator
   Airborne concentration or condition of use a            type b       
------------------------------------------------------------------------
10 X or less......................................  A half mask, air-   
                                                     purifying equipped 
                                                     with a HEPA c      
                                                     filter.d           
25 X or less......................................  A powered air-      
                                                     purifying          
                                                     respirator         
                                                     (``PAPR'') with a  
                                                     loose-fitting hood 
                                                     or helmet equipped 
                                                     with a HEPA filter,
                                                     or a supplied-air  
                                                     respirator with a  
                                                     loose-fitting hood 
                                                     or helmet facepiece
                                                     operated in the    
                                                     continuous flow    
                                                     mode.              
50 X or less......................................  A full facepiece air-
                                                     purifying          
                                                     respirator equipped
                                                     with a HEPA filter,
                                                     or a powered air-  
                                                     purifying          
                                                     respirator with a  
                                                     tight-fitting half 
                                                     mask equipped with 
                                                     a HEPA filter, or a
                                                     supplied-air       
                                                     respirator with a  
                                                     tight-fitting half 
                                                     mask operated in   
                                                     the continuous flow
                                                     mode.              
250 X or less.....................................  A powered air-      
                                                     purifying          
                                                     respirator with a  
                                                     tight fitting full 
                                                     facepiece equipped 
                                                     with a HEPA filter,
                                                     or a supplied-air  
                                                     respirator with a  
                                                     tight-fitting full 
                                                     facepiece operated 
                                                     in the continuous  
                                                     flow mode.         
1000 X or less....................................  A supplied air      
                                                     respirator with    
                                                     half mask or full  
                                                     facepiece operated 
                                                     in the pressure    
                                                     demand or other    
                                                     positive pressure  
                                                     mode.              
>1000 X or unknown concentrations.................  A self-contained    
                                                     breathing apparatus
                                                     with a full        
                                                     facepiece operated 
                                                     in the pressure    
                                                     demand or other    
                                                     positive pressure  
                                                     mode, or a supplied-
                                                     air respirator with
                                                     a full facepiece   
                                                     operated in the    
                                                     pressure demand or 
                                                     other positive     
                                                     pressure mode and  
                                                     equipped with an   
                                                     auxiliary escape   
                                                     type self-contained
                                                     breathing apparatus
                                                     operated in the    
                                                     pressure demand    
                                                     mode.              
Firefighting......................................  A self-contained    
                                                     breathing apparatus
                                                     with full facepiece
                                                     operated in the    
                                                     pressure demand or 
                                                     other positive     
                                                     pressure mode.     
------------------------------------------------------------------------
a Concentrations expressed as multiple of the PEL.                      
b Respirators assigned for higher environmental concentrations may be   
  used at lower exposure levels. Quantitative fit testing is required   
  for all tight-fitting air purifying respirators where airborne        
  concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3) 
  = 50 ug/m(3)). A full facepiece respirator is required when eye       
  irritation is experienced.                                            
c HEPA means High-efficiency Particulate Air.                           
d Fit testing, qualitative or quantitative, is required.                
SOURCE: Respiratory Decision Logic, NIOSH, 1987.                        

    (ii) The employer must provide a powered air-purifying respirator 
instead of a negative-pressure respirator when an employee entitled to 
a respirator chooses to use this type of respirator and such a 
respirator will provide adequate protection to the employee.
* * * * *
    Note: The following table will not appear in the Code of Federal 
Regulations.

          Redesignation Table for Actions on Specific Standards         
------------------------------------------------------------------------
                Old section                          New section        
------------------------------------------------------------------------
1910.94:                                                                
  (a)(1)(ii)..............................  Revised.                    
  (a)(5)(i)...............................  Revised.                    
  (a)(5)(iii).............................  Revised.                    
  (a)(5)(iv)..............................  Revised.                    
  (a)(6)..................................  Revised.                    
  (c)(6)(iii)(a)..........................  Revised.                    
  (d)(9)(vi)..............................  Revised.                    
1910.111:                                                               
  (a)(2)(x)...............................  Revised.                    
  (b)(10)(ii).............................  Revised.                    
1910.156:                                                               
  (f)(1)(i)...............................  Revised.                    
  (f)(1)(v)...............................  Revised.                    
1910.252:                                                               
  (c)(4)(ii)..............................  Revised.                    
  (c)(4)(iii).............................  Revised.                    
  (c)(7)(iii).............................  Revised.                    
  (c)(9)(i)...............................  Revised.                    
  (c)(10).................................  Revised.                    
1910.261:                                                               
  (b)(2)..................................  Revised.                    
  (g)(10).................................  Revised.                    
  (h)(2)(iii).............................  Revised.                    
  (h)(2)(iv)..............................  Revised.                    
1910.1001:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (g)(3).            
  (g)(2)(ii)..............................  Revised; (g)(2)(ii).        
  (g)(3)(i)...............................  Revised; (g)(2)(i).         
  (g)(3)(ii)..............................  Removed.                    
  (g)(3)(iii).............................  Removed.                    
  (g)(3)(iv)..............................  Revised; (g)(2)(iii).       
  (g)(4)..................................  Removed.                    
  Appendix C..............................  Removed.                    
1910.1003:                                                              
  (c)(4)(iv)..............................  Revised.                    
  (d)(1) [Reserved].......................  Revised.                    
1910.1017:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)..................................  Removed.                    
  (g)(3)..................................  Revised; (g)(2).            
  (g)(4)..................................  Revised; (g)(3)(i).         
  (g)(5)..................................  Removed.                    
  (g)(6) (i) and (ii).....................  Revised; (g)(3)(ii).        
  (g)(7)..................................  Revised; (g)(3)(iii).       
1910.1018:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3)(i).         
  (h)(2)(ii)..............................  Revised; (h)(3)(ii).        
  (h)(2)(iii).............................  Removed.                    
  (h)(3)(i), (ii), and (iii)..............  Removed.                    
  (h)(3)(iv)..............................  Revised; (h)(2)(ii).        
  (h)(4)(i)...............................  Revised; (h)(2)(i).         
  (h)(4) (ii) and (iii)...................  Removed.                    
  (h)(5) (i) and (ii).....................  Removed.                    

[[Page 1300]]

                                                                        
  (h)(5)(iii).............................  Revised; (h)(4)(iii).       
1910.1025:                                                              
  (f)(1) and (f)(1)(i)....................  Revised.                    
  (f)(2)(i)...............................  Revised; (f)(3)(i).         
  (f)(2)(ii)..............................  Revised; (f)(3)(ii).        
  (f)(2)(iii).............................  Removed.                    
  (f)(3)(i) and (ii)......................  Removed.                    
  (f)(3)(iii).............................  Revised; (f)(2)(ii).        
  (f)(4)(i)...............................  Revised; (f)(2)(i).         
  (f)(4) (ii) and (iii)...................  Removed.                    
  Appendix B, Section IV..................  Revised second and fourth   
                                             paragraphs; removed sixth  
                                             paragraph.                 
  Appendix D..............................  Removed.                    
1910.1027:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (f)(3)(i).         
  (g)(2)(ii)..............................  Revised; (f)(3)(ii).        
  (g)(3)(i)...............................  Revised; (f)(2)(i).         
  (g)(3) (ii) and (iii)...................  Removed.                    
  (g)(3)(iv)..............................  Revised; (g)(2)(iii).       
  (g)(3)(v)...............................  Revised; (g)(2)(ii).        
  (g)(4)..................................  Removed.                    
Appendix C................................  Removed.                    
1910.1028:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (g)(3)(i).         
  (g)(2)(ii)..............................  Removed.                    
  (g)(2)(iii).............................  Revised; (g)(3)(ii).        
  (g)(3)..................................  Revised; (g)(2).            
  (g)(4)(i)...............................  Revised; (g)(2)(ii).        
  (g)(4)(ii)..............................  Revised; (g)(2)(iii).       
  (g)(4)(iii).............................  Removed.                    
  (g)(5)..................................  Removed.                    
  Appendix E..............................  Removed.                    
1910.1029:                                                              
  (g)(1)(i)...............................  Revised.                    
  (g)(1)(ii)..............................  Removed.                    
  (g)(2)(i)...............................  Revised; (g)(3).            
  (g)(2)(ii) and (iii)....................  Removed.                    
  (g)(3)..................................  Revised; (g)(2).            
  (g)(4)..................................  Removed.                    
1910.1043:                                                              
  (f)(1)..................................  Revised.                    
  (f)(2)(i)...............................  Revised; (f)(3)(i).         
  (f)(2)(ii)..............................  Removed.                    
  (f)(2)(iii).............................  Revised; (f)(3)(ii).        
  (f)(2)(iv)..............................  Revised; (f)(2)(ii).        
  (f)(3)..................................  Revised; (f)(2)(i).         
  (f)(4)..................................  Removed.                    
1910.1044:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3).            
  (h)(2)(ii)..............................  Removed.                    
  (h)(3)(i)...............................  Revised; (h)(3).            
  (h)(3)(ii)..............................  Removed.                    
1910.1045:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3).            
  (h)(2)(ii)..............................  Removed.                    
  (h)(3)(i)...............................  Revised; (h)(2)(i).         
  (h)(3)(ii)..............................  Revised; (h)(2)(ii).        
  (h)(3)(iii).............................  Removed.                    
  (h)(3)(iv)..............................  Removed.                    
  Appendix A, Section IV..................  Revised first paragraph.    
1910.1047:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (g)(3).            
  (g)(2)(ii)..............................  Removed.                    
  (g)(3)..................................  Revised; (g)(2).            
  (g)(4)..................................  Revised; (g)(4).            
  Appendix A, Section IV..................  Revised first paragraph.    
1910.1048:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (g)(3)(i).         
  (g)(2)(ii)..............................  Revised; (g)(3)(ii).        
  (g)(3)(i)...............................  Revised; (g)(2)(i).         
  (g)(3)(ii)..............................  Removed.                    
  (g)(3)(iii).............................  Revised; (g)(2)(ii)(A).     
  (g)(3)(iv)..............................  Revised; (g)(2)(ii)(B).     
  (g)(3)(v)...............................  Removed.                    
  Appendix E..............................  Removed.                    
1910.1050:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3)(i).         
  (h)(2)(ii)..............................  Removed.                    
  (h)(2)(iii).............................  Revised; (h)(3)(ii).        
  (h)(3)..................................  Revised; (h)(2).            
  (h)(4)..................................  Removed.                    
  (h)(5)..................................  Removed.                    
  Appendix A, Section III.................  Revised first paragraph.    
  Appendix E..............................  Removed.                    
1910.1051:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3)(i).         
  (h)(2)(ii)..............................  Revised; (h)(3)(ii).        
  (h)(2)(iii).............................  Revised; (h)(3)(iii).       
  (h)(3)..................................  Revised; (h)(2)(i).         
  (h)(4)(i)...............................  Revised; (h)(2)(ii).        
  (h)(4)(ii)..............................  Revised; (h)(2)(iii).       
  (h)(4)(iii).............................  Revised; (h)(2) (iv) and    
                                             (vi).                      
  (h)(4)(iv)..............................  Revised; (h)(2) (vi) and    
                                             (vi).                      
  (h)(4)(v)...............................  Removed.                    
  (h)(5)..................................  Removed.                    
  Appendix E..............................  Removed.                    
1910.1052:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)..................................  Revised; (g)(4).            
  (g)(3)..................................  Revised; (g)(3).            
  (g)(4)..................................  Revised; (g)(2)(i).         
  (g)(5)..................................  Removed.                    
  (g)(6)..................................  Revised; (g)(2)(ii).        
  (g)(7)..................................  Removed.                    
1926.57:                                                                
  (f)(1)(ii)..............................  Revised.                    
  (f)(5)(i)...............................  Revised.                    
  (f)(5)(iii).............................  Revised.                    
  (f)(6)..................................  Revised.                    
  (f)(6)(i), (ii), and (iii)..............  Removed.                    
  (h)(6)(iii)(A)..........................  Revised.                    
  (i)(9)(vi)..............................  Revised.                    
1926.60:                                                                
  (i)(1)..................................  Revised.                    
  (i)(2)(i)...............................  Revised; (i)(3)(i).         
  (i)(2)(ii)..............................  Removed.                    
  (i)(2)(iii).............................  Revised; (i)(3)(ii).        
  (i)(3)..................................  Revised; (i)(2).            
  (i)(4)..................................  Removed.                    
  (i)(5)..................................  Removed.                    
  Appendix E..............................  Removed.                    
1926.62:                                                                
  (f)(1)..................................  Revised.                    
  (f)(2)(i)...............................  Revised; (f)(3)(i).         
  (f)(2)(ii)..............................  Revised; (f)(3)(ii).        
  (f)(2)(iii).............................  Removed.                    
  (f)(3)(i)...............................  Removed.                    
  (f)(3)(ii)..............................  Removed.                    
  (f)(3)(iii).............................  Revised; (f)(2)(ii).        
  (f)(4)(i)...............................  Revised; (f)(2)(i).         
  (f)(4) (ii) and (iii)...................  Removed.                    
  Appendix B, Section IV..................  Revised second and fourth   
                                             paragraphs; removed sixth  
                                             paragraph.                 
  Appendix D..............................  Removed.                    
1926.103:                                                               
  All.....................................  Revised to a single         
                                             provision.                 
1926.800:                                                               
  (g)(2)..................................  Revised.                    
1926.1101:                                                              
  (h)(1)..................................  Revised.                    
  (h)(2)(i)...............................  Revised; (h)(3)(i).         
  (h)(2)(ii)..............................  Removed.                    
  (h)(2)(iii).............................  Revised; (h)(3)(ii).        
  (h)(2)(iv)..............................  Revised; (h)(3)(iii).       
  (h)(2)(v)...............................  Revised; (h)(3)(iv).        
  (h)(3)(i)...............................  Revised; (h)(2)(i).         
  (h)(3)(ii)..............................  Removed.                    
  (h)(3)(iii).............................  Removed.                    
  (h)(3)(iv)..............................  Revised; (h)(2)(ii).        
  (h)(4)..................................  Removed.                    
  Appendix C..............................  Removed.                    
1926.1127:                                                              
  (g)(1)..................................  Revised.                    
  (g)(2)(i)...............................  Revised; (g)(3)(i).         
  (g)(2)(ii)..............................  Revised; (g)(3)(ii).        
  (g)(3)(i)...............................  Revised; (g)(2)(i).         
  (g)(3)(ii) and (iii)....................  Removed.                    
  (g)(3)(iv)..............................  Revised; (g)(2)(ii).        
  (g)(3)(v)...............................  Revised; (g)(2)(iii).       
  (g)(4)..................................  Removed.                    
  Appendix C..............................  Removed.                    
------------------------------------------------------------------------

[FR Doc. 97-33843 Filed 12-31-97; 8:45 am]
BILLING CODE 4510-26-P`