Respiratory Protection
Federal RegisterJan 8, 1998
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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 SDnc 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
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
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\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.
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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.
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\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
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Labeling
Revision Certification for
SIC and industry written Annual fit Annual for emergency sorbent Recordkeeping Total
plans testing training respirator bed
inspections changes
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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
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Total................................................... 2,501,319 67,033,593 35,865,707 1,999,699 20,259 3,680,501 111,101,079
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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
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