[Federal Register Volume 63, Number 5 (Thursday, January 8, 1998)]
[Rules and Regulations]
[Pages 1152-1300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33843]
[[Page 1151]]
_______________________________________________________________________
Part II
Department of Labor
_______________________________________________________________________
Occupational Safety and Health Administration
_______________________________________________________________________
29 CFR Parts 1910 and 1926
Respiratory Protection; Final Rule
Federal Register / Vol. 63, No. 5 / Thursday, January 8, 1998 / Rules
and Regulations
[[Page 1152]]
DEPARTMENT OF LABOR
Occupational Safety and Health Administration
29 CFR Parts 1910 and 1926
[Docket No. H-049]
RIN 1218-AA05
Respiratory Protection
AGENCY: Occupational Safety and Health Administration (OSHA),
Department of Labor.
ACTION: Final rule; Request for comment on paperwork requirements.
-----------------------------------------------------------------------
SUMMARY: This final standard, which replaces the respiratory protection
standards adopted by OSHA in 1971 (29 CFR 1910.134 and 29 CFR
1926.103), applies to general industry, construction, shipyard,
longshoring, and marine terminal workplaces. The standard requires
employers to establish or maintain a respiratory protection program to
protect their respirator-wearing employees. The standard contains
requirements for program administration; worksite-specific procedures;
respirator selection; employee training; fit testing; medical
evaluation; respirator use; respirator cleaning, maintenance, and
repair; and other provisions. The final standard also simplifies
respirator requirements for employers by deleting respiratory
provisions in other OSHA health standards that duplicate those in the
final standard and revising other respirator-related provisions to make
them consistent. In addition, the standard addresses the use of
respirators in Immediately Dangerous to Life or Health (IDLH)
atmospheres, including interior structural firefighting. During
interior structural firefighting (an IDLH atmosphere by definition),
self-contained breathing apparatus is required, and two firefighters
must be on standby to provide assistance or perform rescue when two
firefighters are inside the burning building.
Based on the record in this rulemaking and the Agency's own
experience in enforcing its prior respiratory protection standards,
OSHA has concluded that compliance with the final rule will assist
employers in protecting the health of employees exposed in the course
of their work to airborne contaminants, physical hazards, and
biological agents, and that the standard is therefore necessary and
appropriate. The final respiratory protection standard covers an
estimated 5 million respirator wearers working in an estimated 1.3
million workplaces in the covered sectors. OSHA's benefits analysis
predicts that the standard will prevent many deaths and illnesses among
respirator-wearing employees every year by protecting them from
exposure to acute and chronic health hazards. OSHA estimates that
compliance with this standard will avert hundreds of deaths and
thousands of illnesses annually. The annual costs of the standard are
estimated to be $111 million, or an average of $22 per covered employee
per year.
DATES: The final rule becomes effective April 8, 1998.
Compliance: Start-up dates for specific provisions are set forth in
Sec. 1910.134(n) of the regulatory text. However, until the Department
of Labor publishes in the Federal Register the control numbers assigned
by the Office of Management and Budget (OMB), affected parties are not
required to comply with the new or revised information collection
requirements contained in the following paragraphs: Sec. 1910.134(c)
written procedures for selecting respirators, medical evaluations, fit
testing, use of respirators, maintaining respirators, training, and
periodically evaluating the effectiveness of the program; (e)(3)-(6)
medical questionnaire, examination, and information for the physician
or other licensed health care professional (PLHCP); (f)(1) fit testing;
(i)(4) tagging sorbent beds and filters; and (m)(1)-(2) and (4)
recordkeeping. Publication of the control numbers notifies the public
that the OMB has approved these information collection requirements
under the Paperwork Reduction Act of 1995. Although affected parties
will not have to comply with the revised standard's information
collection requirements until these have been approved by OMB, they
must comply with those requirements of 29 CFR 1910.134 (OSHA's existing
respirator protection standard) that have already been approved by the
OMB under the Paperwork Reduction Act. Approved requirements include
the written program, emergency-use respirator certification records,
and emergency-use respirator compartment marking.
Comments: Interested parties may submit comments on the information
collection requirements for this standard until March 9, 1998.
ADDRESSES: In compliance with 28 U.S.C. 2112(a), the Agency designates
the Associate Solicitor for Occupational Safety and Health, Office of
the Solicitor, Room S-4004, U.S. Department of Labor, 200 Constitution
Avenue, N.W., Washington, D.C. 20210, as the recipient of petitions for
review of the standard.
Comments on the information collection requirements of this final
rule (see Supplementary Information) are to be submitted to the Docket
Office, Docket No. ICR 97-5, U.S. Department of Labor, Room N-2625, 200
Constitution Avenue, N.W., Washington, D.C. 20210, telephone (202) 219-
7894. Written comments limited to 10 pages or less in length may also
be transmitted by facsimile to (202) 219-5046.
Copies of the referenced information collection request are
available for inspection and copying in the Docket Office and will be
mailed immediately to persons who request copies by telephoning Adrian
Corsey at (202) 219-7075. For electronic copies of the Respiratory
Protection Final Standard and the Information Collection Request,
contact OSHA's WebPage on the Internet at http://www.osha.gov/.
FOR FURTHER INFORMATION CONTACT: Bonnie Friedman, Director, OSHA Office
of Public Affairs, Room N-3647, U.S. Department of Labor, 200
Constitution Avenue, N.W., Washington, D.C. 20210; Telephone (202) 219-
8148. For additional copies of this regulation contact: OSHA, Office of
Publications, U.S. Department of Labor, Room N-3101, 200 Constitution
Avenue, N.W., Washington, D.C. 20210; Telephone (202) 219-4667.
SUPPLEMENTARY INFORMATION:
1. Collection of Information: Request for Comment
This final Respiratory Protection standard contains information
collection requirements that are subject to review by OMB under the
Paperwork Reduction Act of 1995 (PRA95), 44 U.S.C. 3501 et seq. (see
also 5 CFR 1320). PRA95 defines collection of information to mean,
``the obtaining, causing to be obtained, soliciting, or requiring the
disclosure to third parties or the public of facts or opinions by or
for an agency regardless of form or format.'' [44 U.S.C.
Sec. 3502(3)(A)]
The title, the need for and proposed use of the information, a
summary of the collections of information, description of the
respondents, and frequency of response required to implement the
required information collection are described below with an estimate of
the annual cost and reporting burden (as required by 5 CFR 1320.5
(a)(1)(iv) and Sec. 1320.8 (d)(2)). Included in the estimate is the
time for reviewing instructions, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
[[Page 1153]]
OSHA invites comments on whether the proposed collection of
information:
Ensures that the collection of information is necessary
for the proper performance of the functions of the agency, including
whether the information will have practical utility;
Estimates the projected burden accurately, including
whether the methodology and assumptions used are valid;
Enhances the quality, utility, and clarity of the
information to be collected; and
Minimizes the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submissions of responses.
Title: Respiratory Protection, 29 CFR 1910.134.
Description: The final Respiratory Protection standard is an
occupational health standard that will minimize occupational exposure
to toxic substances. The standard's information collection requirements
are essential components that will protect employees from occupational
exposure to these toxins. The information will be used by employers and
employees to implement the protection required by the standard. OSHA
will use some of the information to determine compliance with the
standard.
Respondents: The total number of respondents for the first year is
1,300,000, and for the second year 1,430,000 (1,300,000 (1st year) plus
10% (130,000)).
Average Time Per Response: 2.21 hours (this is the result of
dividing the total number of responses (19,767,461) by the total number
of burden hours (8,926,558)).
Average Time Per Firm: 6.87 hours (this represents the average time
a firm would need to comply with all of the information collection
provisions, including the written respiratory protection program. This
is a result of dividing the total number of burden hours (8,926,558) by
the total number of firms (1,300,000)).
Summary of the Collections of Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of No. of
Information collection requirement responses responses Frequency of response Time per response Total 1st year Estimated cost
(Yr 1) (Yr 2) burden (1st year)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respiratory Protection Program 1,274,000 26,000 All Existing Firms to 2 Hours for Small Firms; 2,652,000 $60,916,440
1910.134(c). Update Existing Program. 4 Hours for Large Firms.
127,400 2,600 Initially for New 8 Hours to Develop.......
Employers.
Updates (Every 5 Years)... 30 Minutes for Small
Firms; 1 Hour for Large
Firms.
Questionnaire Administration 5,000,000 575,000 All Employees Will Receive 15 Minutes for Employees 740,000 $13,593,800
1910.134(e)(3). in the First Year. to Complete.
50% of those Receiving
Exams Will Receive Follow-
up Questionnaires.
Medical Examinations 1910.134(e)(4).... 1,150,000 287,500 23% of the Existing All Medical Exams will 1,021,200 $18,759,444
Employees. Take 1.5 Hours to
2nd & Recurring Yrs--25% Complete which includes
of the 23% would receive travel time.
Follow-up Exams.
Information Provided to PLHCP 1,150,000 287,500 Dependent on the Number of 15 Minutes for Each 170,200 $2,358,972
1910.134(e)(5). Exams. Employee.
Fit Testing 1910.134(f)(1)............. 4,335,000 4,335,000 346,800 Employees to 30 Minutes for Employees 3,780,140 $76,813,315
Receive Quantitative Fit to be Fitted
Tests. (Quantitative and
799,640 Employees to Qualitative Fit Testing).
Receive Qualitative Fit 30 Additional Minutes for
Tests. Employers to Conduct
3,188,560 Employees to (Only for In-House Fit
Receive In-House Fit Testing).
Tests.
4,335,000 Total Employees.
Emergency-Use Respirator Marking 0 260,000 Only New Employers E...... 5 Minutes per Emergency- 0 $0
1910.134(h)(2)(ii)(B). xisting Employers Have Use Respirator.
Already Complied (Old
Requirement).
[[Page 1154]]
Emergency-Use Respirator Certification 671,880 67,200 Currently, 27,995 Assuming 2 Per Employer: 114,220 $2,098,221
1910.134(h)(3)(iv)(A)&(B). Employers Using Emergency- 10 Minutes (Total Time
Use Respirators (1st Per Month).
Year).
2nd Year = 1st Year
Employers plus 10%.
Certificate of Analysis of Cylinders 0 0 All Existing and New Provided by Supplier, 0 $0
1910.134(i)(4)(i)(B). Employers. therefore no burden
incurred.
Sorbent Beds and Filters 74,181 74,181 Currently, 24,727 3 Changes Per Year, 5,934 $109,008
1910.134(i)(4)(iii)(B). Compressors in Use. assuming 5 minutes per
change.
Medical Records 1910.134(m)(1)......... 1,150,000 287,500 Dependent on the Number of 5 Minutes Per Employee 54,464 $754,871
Exams. Examined.
Fit Testing Records 1910.134(m)(2)..... 4,335,000 4,335,000 Dependent on the Number of 5 Minutes Per Fit Test... 348,400 $4,828,824
Fit Tests.
Employee Access 1910.134(m)(4)......... 500,000 500,000 10% of the Total Number of 5 Minutes per Request.... 40,000 $554,400
Employees.
-------------------------- -------------------------------
Totals........................... 19,767,461 11,037,481 ........................ ....................... 8,926,558 $180,787,295
--------------------------------------------------------------------------------------------------------------------------------------------------------
Marginal Differences in Burden Hours and Costs (I.E., Between the Existing and Revised Standards)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Current OMB 2nd &
inventory Adjustment (to 1st yr. burden recurring yr.
Information collection requirement existing 1st year only) revised Estimated cost burden revised Estimated cost
1910.134 1910.134 1910.134
--------------------------------------------------------------------------------------------------------------------------------------------------------
Respiratory Protection Program.......................... 395,489 2,256,511 2,652,000 $60,916,440 1,570,400 $36,072,088
Questionnaire Administration............................ - 740,000 740,000 $13,593,800 85,100 $1,563,287
Medical Examinations.................................... - 1,021,200 1,021,200 $18,759,444 255,300 $4,689,861
Information Provided to PLHCP........................... - 170,200 170,200 $2,358,972 42,550 $589,743
Fit Testing............................................. - 3,780,140 3,780,140 $76,813,315 3,780,140 $76,813,315
Emergency-Use Respirator Marking........................ 433 -433 0 $0 448 $8,230
Emergency-Use Respirator Certification.................. 785,842 -671,622 114,220 $2,098,221 11,424 $209,859
Certificate of Analysis of Cylinders.................... - 0 0 $0 0 $0
Sorbent Beds and Filters................................ - 5,934 5,934 $109,008 5,934 $109,008
Medical Records......................................... - 54,464 54,464 $754,871 13,616 $188,718
Fit Testing Records..................................... - 348,400 348,400 $4,828,824 348,400 $4,828,824
Employee Access......................................... - 40,000 40,000 $554,400 40,000 $554,400
Hour Kept in Inventory for Revised 1910.134............. 1 -1 0 $0 0 $0
-----------------------------------------------------------------------------------------------
Totals............................................ 1,181,765 7,744,793 8,926,558 $180,787,295 6,153,312 $125,627,333
--------------------------------------------------------------------------------------------------------------------------------------------------------
Under the column for ``Current OMB Inventory,'' dashes denote burdens that were not taken for the Existing Respiratory Protection Standard, but are
counted in the Revised Respiratory Protection Standard. Both Medical Examinations and Fit Testing are required by the existing standard; however,
because these requirements are not accompanied by a recordkeeping requirement, no burden was taken. In the revised standard, recordkeeping is required
for these provisions, and thus burden is counted for these provisions.
Interested parties are requested to send comments regarding this
information collection to the OSHA Docket Office, Docket No. ICR 97-5 ,
U.S. Department of Labor, Room N-2625, 200 Constitution Avenue, N.W.,
Washington, D.C. 20210. Written comments limited to 10 pages or fewer
may also be transmitted by facsimile to (202) 219-5046.
Comments submitted in response to this notice will be summarized
and included in the request for Office of Management and Budget
approval of the final information collection request; they will also
become a matter of public record.
Copies of the referenced information collection request are
available for inspection and copying in the OSHA Docket Office and will
be mailed to persons who request copies by telephoning Adrian Corsey at
(202) 219-7075. Electronic copies of the Respiratory Protection Final
information collection request are available on the OSHA WebPage on the
internet at http://www.osha.gov/ under Standards.
[[Page 1155]]
2. Federalism
This final standard has been reviewed in accordance with Executive
Order 12612 (52 FR 41685, October 30, 1987), regarding Federalism. This
Order requires that agencies, to the extent possible, refrain from
limiting state policy options, consult with states prior to taking any
actions which would restrict state policy options, and take such
actions only when there is clear constitutional authority and the
presence of a problem of national scope. The Order provides for
preemption of state law only if there is a clear Congressional intent
for the Agency to do so. Any such preemption is to be limited to the
extent possible.
Section 18 of the Occupational Safety and Health Act (OSH Act)
expresses Congress' clear intent to preempt state laws relating to
issues on which Federal OSHA has promulgated occupational safety and
health standards. Under the OSH Act, a state can avoid preemption only
if it submits, and obtains Federal approval of, a plan for the
development of such standards and their enforcement. Occupational
safety and health standards developed by such Plan-States must, among
other things, be at least as effective in providing safe and healthful
employment and places of employment as the Federal standards. Where
such standards are applicable to products distributed or used in
interstate commerce, they may not unduly burden commerce and must be
justified by compelling local conditions (see OSH Act, Section 18(c)).
The final Federal standard on respiratory protection addresses
hazards which are not unique to any one state or region of the country.
Nonetheless, states with occupational safety and health plans approved
under Section 18 of the OSH Act will be able to develop their own state
standards to deal with any special problems which might be encountered
in a particular state. Moreover, because this standard is written in
general, performance-oriented terms, there is considerable flexibility
for state plans to require, and for affected employers to use, methods
of compliance which are appropriate to the working conditions covered
by the standard.
In brief, this final standard addresses a clear national problem
related to occupational safety and health in general industry,
construction, and maritime employment. Those states which have elected
to participate under Section 18 of the OSH Act are not preempted by
this standard, and will be able to address any special conditions
within the framework of the Federal Act while ensuring that the state
standards are at least as effective as that standard.
3. State Plans
The 25 states and territories with their own OSHA-approved
occupational safety and health plans must adopt a comparable standard
within six months of the publication date of a final standard. These 25
states are: Alaska, Arizona, California, Connecticut, New York (for
state and local government employees only), Hawaii, Indiana, Iowa,
Kentucky, Maryland, Michigan, Minnesota, Nevada, New Mexico, North
Carolina, Oregon, Puerto Rico, South Carolina, Tennessee, Utah,
Vermont, Virginia, Virgin Islands, Washington, and Wyoming. Until such
time as a state standard is promulgated, Federal OSHA will provide
interim enforcement assistance, as appropriate, in these states.
4. Unfunded Mandates
The final respiratory protection rule has been reviewed in
accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2
U.S.C. 1501 et seq.) and Executive Order 12875. As discussed below in
the Summary of the Final Economic Analysis (FEA) (Section VI of this
document), OSHA estimates that compliance with the revised respiratory
protection standard will require the expenditure of more than $100
million each year by employers in the private sector. Therefore, the
final rule establishes a Federal private sector mandate and is a
significant regulatory action, within the meaning of section 202 of
UMRA (2 U.S.C. 1532). OSHA has included this statement to address the
anticipated effects of the final respiratory protection rule pursuant
to section 202.
OSHA standards do not apply to state and local governments, except
in states that have voluntarily elected to adopt an OSHA State Plan.
Consequently, the respiratory protection standard does not meet the
definition of a ``Federal intergovernmental mandate'' (Section 421(5)
of UMRA (2 U.S.C. 658(5)). Thus, the final respiratory protection
standard does not impose unfunded mandates on state or local
governments.
The anticipated benefits and costs of this final standard, and
other issues raised in section 202 of the UMRA, are addressed in the
Summary of the FEA (Section VI of this preamble), below, and in the FEA
(Ex. 196). In addition, pursuant to section 205 of the UMRA (2 U.S.C.
1535), having considered a reasonable number of alternatives as
outlined in the preambles to the proposal and the final rule and in the
FEA (Ex. 196), the Agency has concluded that the final rule is the most
cost-effective alternative for implementation of OSHA's statutory
objective of reducing significant risk to the extent feasible. This is
discussed in the FEA (Ex. 196) and in the Summary and Explanation
(Section VII of this preamble) for the various provisions of the final
standard.
5. Executive Order 13045--Protection of Children From Environmental
Health and Safety Risks
Executive Order 13045, signed by the President on April 21, 1997,
requires that for certain Federal agency ``regulatory actions submitted
to OMB's Office of Information and Regulatory Affairs (OIRA) for review
pursuant to Executive Order 12866, the issuing agency shall provide to
OIRA the following information developed as part of the Agency's
decisionmaking process, unless prohibited by law:
(a) An evaluation of the environmental health or safety effects of
the planned regulation on children; and
(b) An explanation of why the planned regulation is preferable to
other potentially effective and reasonably feasible alternatives
considered by the agency.''
``Covered Regulatory Actions'' under this Order are rules that may:
(a) Be ``economically significant'' under Executive Order 12866 (a
rulemaking that has an annual effect on the economy of $100 million or
more or would adversely affect in a material way the economy, a sector
of the economy, productivity, competition, jobs, the environment,
public health or safety, or State, local, or tribal governments or
communities); and
(b) Concern an environmental health risk or safety risk that an
agency has reason to believe may disproportionately affect children.
``Environmental health risks and safety risks' mean risks to health
or to safety that are attributable to products or substances that the
child is likely to come in contact with or ingest (such as the air we
breathe, the food we eat, the water we drink or use for recreation, the
soil we live on, and the products we use or are exposed to).
The final standard on respiratory protection does not concern
``Environmental health risks and safety risks'' to children as defined
under the Executive order. The respirator standard is only concerned
with means of limiting employee exposures to toxic substances. The
Agency believes, therefore, that the requirement noted above to provide
OIRA with certain information does not apply since the respiratory
protection standard is not a
[[Page 1156]]
``covered regulatory action'' under Executive Order 13045.
Section 6(b) (8) of the OSH Act requires OSHA to explain ``why a
rule promulgated by the Secretary differs substantially from an
existing national consensus standard,'' by publishing ``a statement of
the reasons why the rule as adopted will better effectuate the purposes
of the Act than the national consensus standard.'' In compliance with
the requirement, the Agency has reviewed the standards proposed through
this rulemaking with reference to the ANSI Z88.2-1992 standard for
Respiratory Protection. OSHA has discussed the relationship between
individual regulatory provisions and the corresponding consensus
standards in the Summary and Explanation of the final rule.
6. Reasons Why the Revised Rule Will Better Effectuate the Purposes
of the Act Than the Existing Consensus Standard
This process was facilitated by the fact that the previous OSHA
standards on respiratory protection were start-up standards adopted
directly from the ANSI Z88.2-1969 standard, ``Practices for Respiratory
Protection'' under section 6(a) of the OSH Act, 29 U.S.C. 655(a).
Therefore, even with subsequent revisions to the ANSI standards and the
Agency's consideration of a widely varied and substantial body of
information in the rulemaking record, the requirements of the OSHA
final rule would tend to resemble the corresponding provisions of the
current ANSI standards. In a number of instances, OSHA has utilized
language identical to that in the current ANSI standard. These
instances are noted in the Summary and Explanation. Where the Agency
has determined that the pertinent ANSI language is not appropriate for
this OSHA standard, the Summary and Explanation provides the basis for
that decision.
I. General
The preamble accompanying this final standard discusses events
leading to the final rule, the types of respiratory hazards experienced
by employees, the degree and significance of the risk presented by
failure to comply with this revised standard, the Final Economic
Analysis, and the rationale behind the specific provisions set forth in
the final standard. The discussion follows this outline:
I. General
II. Pertinent Legal Authority
III. Events Leading to the Final Standard
A. Regulatory History
B. Justification for Revising the Previous Standard
1. Purpose of Revision
2. Respirator Use and Hazards
C. Responses to Advisory Committee
D. Assigned Protection Factors
E. Small Business Considerations
IV. Certification/Approval Procedures
V. Significance of Risk
VI. Summary of the Final Economic Analysis And Environmental Impact
Assessment
VII. Summary And Explanation of the Final Standard
A. Permissible Practice
B. Definitions
C. Respiratory Protection Program
D. Selection of Respirators
E. Medical Evaluation
F. Fit Testing Procedures
G. Use of Respirators
H. Maintenance and Care of Respirators
I. Breathing Air Quality and Use
J. Identification of Filters, Cartridges, and Canisters
K. Training
L. Respiratory Protection Program Evaluation
M. Recordkeeping and Access to Records
N. Dates
O. Appendices
P. Revisions to Specific Standards
VIII. Authority And Signature
IX. Amended Standards
II. Pertinent Legal Authority
The purpose of the Occupational Safety and Health Act, 29 U.S.C.
651 et seq. (``the Act'') is to ``assure so far as possible every
working man and woman in the nation safe and healthful working
conditions and to preserve our human resources.'' 29 U.S.C. 651(b). To
achieve this goal, Congress authorized the Secretary of Labor to
promulgate and enforce occupational safety and health standards. U.S.C.
655(a) (authorizing summary adoption of existing consensus and Federal
standards within two years of Act's enactment), 655(b) (authorizing
promulgation of standards pursuant to notice and comment), 654(b)
(requiring employers to comply with OSHA standards).
A safety or health standard is a standard ``which requires
conditions, or the adoption or use of one or more practices, means,
methods, operations, or processes, reasonably necessary or appropriate
to provide safe or healthful employment or places of employment.'' 29
U.S.C. 652(8).
A standard is reasonably necessary or appropriate within the
meaning of section 652(8) if it substantially reduces or eliminates
significant risk or prevents it from developing, and is economically
feasible, technologically feasible, cost effective, consistent with
prior Agency action or supported by a reasoned justification for
departing from prior Agency actions, supported by substantial evidence,
and is better able to effectuate the Act's purposes than any national
consensus standard it supersedes. See 58 FR 16612-16616 (March 30,
1993).
A standard is technologically feasible if the protective measures
it requires already exist, can be brought into existence with available
technology, or can be created with technology that can reasonably be
expected to be developed. American Textile Mfrs. Institute v. OSHA, 452
U.S. 490, 513 (1981) (``ATMI''), American Iron and Steel Institute v.
OSHA, 939 F.2d 975, 980 (D.C. Cir. 1991)(``AISI'').
A standard is economically feasible if industry can absorb or pass
on the cost of compliance without threatening its long term
profitability or competitive structure. See ATMI, 452 U.S. at 530 n.
55; AISI, 939 F. 2d at 980.
A standard is cost effective if the protective measures it requires
are the least costly of the available alternatives that achieve the
same level of protection. ATMI, 453 U.S. at 514 n. 32; International
Union, UAW v. OSHA, 37 F.3d 665, 668 (D.C. Cir. 1994)(``LOTO III'').
All standards must be highly protective. See 58 FR 16614-16615;
LOTO III, 37 F.3d at 668. However, standards regulating exposure to
toxic substances or hazardous physical agents must also meet the
``feasibility mandate'' of Section 6(b)(5) of the Act, 29 U.S.C.
655(b)(5). Section 6(b)(5) requires OSHA to select ``the most
protective standard consistent with feasibility'' that is needed to
reduce significant risk when regulating these hazards. ATMI, 452 U.S.
at 509.
Section 6(b)(5) also directs OSHA to base health standards on ``the
best available evidence,'' including research, demonstrations, and
experiments, 29 U.S.C. 655(b)(5). OSHA shall consider ``in addition to
the attainment of the highest degree of health and safety protection *
* * the latest scientific data * * * feasibility and experience gained
under this and other health and safety laws.'' Id.
Section 6(b)(7) of the Act authorizes OSHA to include among a
standard's requirements labeling, monitoring, medical testing and other
information gathering and transmittal provisions. 29 U.S.C. 655(b)(7).
Finally, whenever practical, standards shall ``be expressed in
terms of objective criteria and of the performance desired.'' Id.
Respiratory protection is a backup method which is used to protect
employees from toxic materials in the workplace in those situations
where feasible engineering controls and work practices are not
available, have not yet been implemented, are not in themselves
sufficient to protect
[[Page 1157]]
employee health, or in emergencies. The revisions to the respirator
standard made in this rulemaking are intended to ensure that, when
employers require employees to wear respirators to be protected from
significant risk, protective respirators will be selected and those
respirators will be used effectively to meet their design capabilities.
Otherwise respirators will not reduce significant risk. The standard's
provisions are designed to be feasible and cost effective, and are
expressed in terms of objective criteria and the performance desired.
Further authority is provided by section 8(c)of the Act, which
authorizes OSHA to require employers to maintain certain records.
Section 8(g)(2) authorizes OSHA ``to prescribe such rules and
regulations as (it) may deem necessary to carry out its
responsibilities under the Act.''
III. Events Leading to the Final Standard
A. Regulatory History
Congress created the Occupational Safety and Health Administration
(OSHA) in 1970, and gave it the responsibility for promulgating
standards to protect the health and safety of American workers. As
directed by Congress in the Occupational Safety and Health Act of 1970
(OSH Act; 29 U.S.C. 651 et seq.), OSHA adopted existing Federal
standards and national consensus standards developed by various
organizations such as the American Conference of Governmental
Industrial Hygienists (ACGIH), the National Fire Protection Association
(NFPA), and the American National Standards Institute (ANSI). The ANSI
standard Z88.2-1969, ``Practices for Respiratory Protection,'' is the
basis of the first six sections of OSHA's previous standard, 29 CFR
1910.134, ``Respiratory Protection.'' The seventh section was a direct,
complete incorporation of ANSI Standard K13.1-1969, ``Identification of
Gas Mask Canisters.'' OSHA's previous construction industry standard
for respiratory protection, 29 CFR 1926.103, was promulgated in April
1971. On February 9, 1979, 29 CFR 1910.134 was formally recognized as
also being applicable to the construction industry (44 FR 8577). Until
the adoption of these standards by OSHA, most guidance on respiratory
protective device use in hazardous environments was advisory rather
than mandatory.
OSHA's maritime standards were originally promulgated in the 1960s
by agencies that preceded OSHA. The original OSHA code designations of
these standards and their promulgation dates are: Shipyards--29 CFR
1915.82, February 20, 1960 (25 FR 1543); Marine Terminals--29 CFR
1917.82, March 27, 1964 (29 FR 4052); and Longshoring--29 CFR 1918.102,
February 20, 1960 (25 FR 1565). Section 1910.134 was incorporated by
reference into OSHA's Marine Terminals standard (part 1917) on July 5,
1983 (48 FR 30909). OSHA has recently updated and strengthened its
Longshoring and Marine Terminal standards, and both standards
incorporate 29 CFR 1910.134 by reference.
OSHA did not propose to expand coverage of 29 CFR 1910.134 to
agricultural workplaces covered by 29 CFR part 1928, and this final
Respiratory Protection standard, like the proposal, does not apply to
agricultural operations. The prior standard likewise did not apply to
agricultural operations. (See 29 CFR 1928.21.) OSHA received no public
comment requesting a change in coverage. Accordingly, the issue of
respirator use during agricultural operations was not a part of this
rulemaking. OSHA notes, however, that respirator use during pesticide
operations and handling is covered by EPA's Worker Protection Standard,
40 U.S.C. part 170, adopted under the authority of the Federal
Insecticide, Fungicide, and Rodenticide Act, as amended (7 U.S.C. 136-
136y).
Under OSHA's previous standard, employers needed to follow the
guidance of the Z88.2-1969 ANSI standard to ensure proper selection of
respirators (see discussion 59 FR 58887). OSHA published an Advance
Notice of Proposed Rulemaking (ANPR) to revise the respirator standard
on May 14, 1982 (47 FR 20803). Part of the impetus for this notice was
OSHA's inclusion of new respirator requirements in comprehensive
substance-specific standards promulgated under section 6(b) of the Act,
e.g., fit tests; use of powered air-purifying respirators (PAPRs) upon
request; change of the filter elements of a respirator whenever an
increase in breathing resistance is detected; employee permission to
wash faces and respirator facepieces; and referral to a physician
trained in pulmonary medicine for an employee who exhibits difficulty
breathing, either at fit testing or during routine respirator use (see,
e.g, 29 CFR 1910.1025 (lead standard)). The respirator provisions in
these substance-specific standards took account of advances in
respirator technology and changes in related guidance documents,
particularly the recognition that standardized fit testing protocols
greatly increase the effectiveness of respirators.
OSHA's 1982 ANPR sought information on the effectiveness of the
current respiratory protection provisions, the need for revision of
those provisions, and the substance of the revisions. Responses were
received from 81 interested parties. The commenters generally supported
revising OSHA's respiratory protection provisions and provided
suggestions for approaches the Agency might take (Ex. 15).
On September 17, 1985, OSHA announced the availability of a
preliminary draft of the proposed Respiratory Protection standard. The
preproposal draft standard reflected the public comments received on
the May 1982 ANPR, and OSHA's own analysis of changes needed in the
standard to take into account the current state-of-the-art for
respiratory protection. Responses were received from 56 interested
parties (Ex. 36), and their comments were reviewed in preparing the
proposal.
On November 15, 1994, OSHA published the proposed rule to revise 29
CFR 1910.134, and announced its intention to convene an informal public
hearing on the proposal (59 FR 58884). The informal public hearing was
convened on June 6, 1995, pursuant to notice and in accordance with
Section 6(b) of the OSH Act, 29 U.S.C. 655(b)(3). Post-hearing
submissions of data from parties at the hearing were received through
September 20, 1995.
On November 7, 1995, OSHA reopened the record (60 FR 56127) and
requested additional comment on a study performed for OSHA by Dr. Mark
Nicas titled ``The Analysis of Workplace Protection Factor Data and
Derivation of Assigned Protection Factors.'' That study, which was
placed in the rulemaking docket on September 20, 1995, addressed the
use of statistical modeling for determining respirator APFs. Comments
on the Nicas study were received through the end of January 1996. The
Nicas report, and comments received in response to the November 1995
notice, have convinced OSHA to deliberate further on the complex issues
surrounding the establishment of APFs.
The entire record including 200 exhibits, more than 3,000
individual items, and approximately 2,300 transcript pages, was
certified by the presiding administrative law judge on June 30, 1997,
in accordance with 29 CFR 1911.17. Copies of materials contained in the
record may be obtained from the OSHA Docket Office, Room N-2439, U.S.
Department of Labor, 200 Constitution Avenue, N.W.,
[[Page 1158]]
Washington, D.C. 20210; (202) 219-7894.
The final revisions to 29 CFR 1910.134 are based on consideration
of the entire record of this proceeding, including materials discussed
or relied upon in the proposal, the record of the informal hearing, and
all written comments and exhibits received.
B. Justification for Revising the Previous Standard
1. Purpose of the Revision
The intent of this revision is to enhance the protection of worker
health, promote more effective use of respirators, provide greater
compliance flexibility, and clarify the policies and procedures
employers must follow when implementing a respiratory protection
program. Evidence in the record, including case reports and studies of
respirator use among workers, indicates that selecting or using
respirators improperly can result in employee illness and even death.
(See discussion below.) The revised standard is therefore expected to
reduce the number of occupational illnesses and deaths among workers
who wear respirators. OSHA is also consolidating many of its
respirator-related provisions in other substance-specific health
standards into one standard to make these provisions easier for
employers to administer. Through consolidation, repetitive and
duplicative respirator requirements have been deleted from many
existing OSHA health standards, and future health standards will
reference the revised final rule for many respirator requirements.
Advances in technology also made the previous standard out-of-date
in many areas. Nearly all rulemaking participants, including
representatives of private industry, other Federal agencies, respirator
manufacturers, and unions, agreed that revision is necessary to address
these advances (e.g., NIOSH, Ex. 28; Eastman Chemical Co., Ex. 54-245;
3M, Ex. 54-218A; AFL-CIO, Ex. 54-315; Building and Construction Trades
Department/AFL-CIO, Ex. 29; American Petroleum Institute, Ex. 37; ISEA,
Ex. 54-363). (See also 59 FR 58889.) Other agencies and committees have
already updated their guidance on respirator use. For example, the ANSI
standard has been revised twice (Exs. 10, 50), and NIOSH has revised
its certification standard (42 CFR part 84; 60 FR 30336; 6/8/95), as
well as developed a Respiratory Decision Logic (1987) to provide
guidance to employers on the selection of respirators.
OSHA's experience in enforcing the previous standard also indicated
that some of that standard's requirements were not understood clearly
by the regulated community, and so were not adequately effective in
protecting workers. The clarifications in this new standard will
contribute to enhanced compliance by reducing misinterpretations and
inconsistencies. A review of OSHA enforcement data for 1994 and 1995
revealed that failure to comply with the previous standard was a
critical factor in at least 47 fatalities and 126 catastrophic
injuries. The most frequently cited deficiencies included failure to
provide respirators at all or to have standard operating procedures
governing respirator use, and failure to train or fit test respirator
users adequately [Source: OSHA's Federal Inspection Compliance Data
(IMIS; 10/92 to 12/95)].
In addition, considerable research has been performed to determine
the extent to which respirators used in workplaces actually reduce the
quantity of contaminant breathed by the respirator user. Researchers
have compared the in-mask concentrations of contaminants to the
concentration levels outside the masks. This work was begun by NIOSH
during the mid-seventies to assess respirator effectiveness in coal
mines and abrasive blasting operations (Ex. 64-5) and spray paint
operations (Ex. 64-68). The studies assessed the effectiveness of
respirators under various conditions, and measured employee exposure in
situations when respirators were not worn. The effectiveness ratings
obtained in these studies are usually termed ``Effective Protection
Factors'' (EPF).
More recent studies by NIOSH and private researchers have monitored
respirator use even more closely to isolate variables that may affect
the levels of respirator performance. Many of these studies concerned
the performance of powered air-purifying respirators (PAPRs), which
were not achieving in workplaces the levels of performance that had
been predicted based on laboratory tests (see, e.g., Exs. 64-46, 64-42,
and 64-47).
A third group of studies, ``workplace protection factor studies,''
conducted mostly by manufacturers and other private interests, was
designed to determine the optimum performance of respirators by
eliminating the impact of program defects under very tightly supervised
workplace conditions. The results of these studies may overstate the
degree of respirator effectiveness most employers can expect under
conditions of workplace use because study conditions are rarely
replicated in the field; nevertheless, these studies show the potential
for respirators to reduce employee exposure to workplace contaminants
(see, e.g., Exs. 64-25, 64-42, 64-47, 64-513).
This revised standard is intended to take account of up-to-date
knowledge and technology and to make the requirements in the standard
easier to understand. The standard now reflects current technology and
research, as well as the findings and guidance of other expert bodies.
OSHA has also included a new definitions section to enhance clarity.
The revised standard includes detailed protocols for performing fit
tests and lists the topics in which respirator users must be trained.
It also contains provisions addressing skin and eye irritation, both of
which must be considered in respirator selection. Wherever possible,
OSHA has used performance-oriented language to allow for flexibility in
accommodating future changes in respirator technology and to address
the needs of small businesses and unusual operations. Through these
improvements, OSHA expects to reduce the number of respirator-related
illnesses, fatalities, and catastrophic injuries occurring among
respirator wearers in U.S. workplaces.
2. Respirator Use and Hazards
The purpose of a respirator is to prevent the inhalation of harmful
airborne substances or oxygen-deficient air. Basically, a respirator is
an enclosure that covers the nose and mouth or the entire face or head.
Respirators are of two general ``fit'' types: (1) Tight-fitting
(quarter masks, which cover the mouth and nose; half masks, which fit
over the nose and under the chin; and full facepiece, which cover the
face from the hairline to below the chin); and (2) loose-fitting
(hoods, helmets, blouses, or full suits which cover the head
completely). There are also two major classes of respirators: air-
purifying respirators (which remove contaminants from the air), and
atmosphere-supplying respirators (which provide clean breathing air
from an uncontaminated source). In general, atmosphere-supplying
respirators are used for more hazardous exposures.
Effective respirator use can protect employees from exposure to a
wide variety of toxic chemicals. In 1994, approximately 215 deaths, or
five percent of all workplace fatalities, occurred as a result of
exposure to harmful substances and environments [CFOI, BLS, 6/11/96;
CFOI/FAX]. There are a number of workplace situations that involve
toxic substances and for which engineering controls may be inadequate
to control exposures, and respirators are used in these situations
[[Page 1159]]
as a back-up method of protection. Substances that have been associated
with death or serious incidents include carbon monoxide,
trichloroethylene, carbon dioxide, chromic acid, coal tar, several
toxic metal fumes and dusts, sulphur dioxide, wood dust, and welding
fumes; these substances cause adverse health effects ranging from
transient, reversible effects such as irritation or narcosis, through
disabling diseases such as silicosis and asbestosis, to death caused
either by acute exposure or by a cancer resulting from chronic
exposures (Rom, W., Environmental and Occupational Medicine, 2nd ed.,
Little, Brown & Co., Boston; 1992, p. 598.) Respirators are available
that can provide protection against inhalation of these toxic
substances.
Airborne contaminants may also be radioactive (``Radiologic Health
in Occupational Medicine Practice,'' George L. Voelz, pg. 500 in
Occupational Medicine, Carl Zenz, ed., Year Book Medical Publishers,
Inc., Chicago, 1975; Jacob Shapiro, Radiation Protection, 3rd ed.,
Harvard University Press, Cambridge, MA, 1990, pg. 273). (See also 29
CFR 1910.1096.) Exposure to ionizing radiation can cause acute effects
such as nausea and vomiting, malaise and fatigue, increased
temperature, and blood changes. More severe delayed effects include
leukemia, bone and lung cancer, sterility, chromosomal and teratogenic
damage, shortened life span, cataracts, and radiodermatitis, a dry,
hairless, red, atrophic skin condition which can include skin cracking
and depigmentation (George L. Voelz, M.D., ``Radiologic Health in
Occupational Medicine Practice'', in Zenz, Occupational Medicine, pp.
513-519; Herman Cember, Introduction to Health Physics, 2nd edition,
Pergamon Press, New York, 1983, pg. 181-194). Respirators to provide
protection against the inhalation of radioactive particles are commonly
used by workers exposed to these hazards.
``Bioaerosols'' are airborne contaminants that are alive or were
released from a living organism (OSHA Docket No. H-122; ACGIH
Guidelines; Ex. 3-61C, page 1; 1994). Pulmonary effects associated with
exposure to certain bioaerosols include rhinitis, asthma, allergies,
hypersensitivity diseases, humidifier fever, and epidemics of
infections including colds, viruses, tuberculosis, and Legionnaires
Disease. Cardiovascular effects manifested as chest pain, and nervous
system effects manifested as headache, blurred vision, and impaired
judgment, have occurred in susceptible people following exposure to
bioaerosols. Viral infections caused by the inhalation of bioaerosols
can result in health effects that range in intensity from undetected or
mild to more severe and even death. Bacterial infections resulting from
inhalation of bacteria and their products cause a range of diseases,
including tuberculosis, Legionnaires Disease, and hypersensitivity
pneumonitis. Among workers in sewage treatment plants, health-related
problems can be associated with occupational exposures to protozoa
[Burge, H., 1990, ``Bioaerosols: Prevalence and health effects in the
indoor environment,'' J. Allergy and Clinical Immunology; 86 (5); see
also Exs. 3-61B and 3-61C in Docket No. H-122.] Allergic asthma and
allergic rhinitis can be induced by chronic exposure to low levels of
antigens. Hypersensitivity pneumonitis can occur when a worker inhales
concentrated aerosols of particles released by bacteria, fungi, and
protozoa (Exs. 3-61B and 3-61C in Docket No. H-122). In 1994, the
Centers for Disease Control reported 41 deaths of workers for which
there was evidence of work-related hypersensitivity pneumonitis (Work-
Related Lung Disease Surveillance Report, 1994; USDHHS, CDC, DHHS
(NIOSH) Number 94-120). Respirators to protect against the inhalation
of biological agents are widely used in healthcare and other workplace
settings where exposure to such agents presents a hazard to workers.
Respirators can also provide protection from oxygen-deficient
atmospheres. Human beings must breathe oxygen in order to survive, and
begin to suffer adverse health effects when the oxygen level of their
breathing air drops below the normal atmospheric level. Below 19.5
percent oxygen by volume, air is considered oxygen-deficient. At
concentrations of 16 to 19.5 percent, workers engaged in any form of
exertion can rapidly become symptomatic as their tissues fail to obtain
the oxygen necessary to function properly (Rom, W., Env. Occup. Med.,
2nd ed; Little, Brown; Boston, 1992). Increased breathing rates,
accelerated heartbeat, and impaired thinking or coordination occur more
quickly in an oxygen-deficient environment. Even a momentary loss of
coordination may be devastating to a worker if it occurs while the
worker is performing a potentially dangerous activity, such as climbing
a ladder. Concentrations of 12 to 16 percent oxygen cause tachypnea
(increased breathing rates), tachycardia (accelerated heartbeat), and
impaired attention, thinking, and coordination (e.g., Ex. 25-4), even
in people who are resting.
At oxygen levels of 10 to 14 percent, faulty judgment, intermittent
respiration, and exhaustion can be expected even with minimal exertion
(Exs. 25-4 and 150). Breathing air containing 6 to 10 percent oxygen
results in nausea, vomiting, lethargic movements, and perhaps
unconsciousness. Breathing air containing less than 6 percent oxygen
produces convulsions, then apnea (cessation of breathing), followed by
cardiac standstill. These symptoms occur immediately. Even if a worker
survives the hypoxic insult, organs may show evidence of hypoxic
damage, which may be irreversible (Exs. 25-4 and 150; also reported in:
Rom, W., Environmental and Occupational Medicine, 2nd ed; Little,
Brown; Boston, 1992).
A number of workplace conditions can lead to oxygen deficiency.
Simple asphyxiants, or gases that are physiologically inert, can cause
asphyxiation when present in high enough concentrations to lower the
oxygen content in the air. Other toxic or chemical asphyxiants poison
hemoglobin, cytochromes, or other enzyme systems (Rom, W.,
Environmental and Occupational Medicine, 2nd ed., Little, Brown, and
Co., Boston, 1992). A number of asphyxiants are gases that can evolve
from explosions, combustion, chemical reactions, or heating. A high-
temperature electrical fire or arc welding accident causing a complete
flashover in an enclosed area can temporarily eliminate oxygen from
that area. Asphyxiation and the severe lung damage it can cause are
major concerns for firefighters; of 30 firefighter deaths investigated
by OSHA recently, five resulted from either asphyxiation, smoke
inhalation, or flashovers (IMIS; 8 State plan states; 10/91-3/97). (See
also mortality study of causes of death among firefighters, Guidotti,
37 JOEM 1348, 1995.)
In 1994, 110 employees died from oxygen deficiency [National Census
of Fatal Occupational Injuries (CFOI); BLS; CFOI/FAX; 6/11/96)], i.e.,
about two percent of the total number of employees who died of
occupational injuries. OSHA believes that many of these deaths could
have been prevented if the victims' employers had realized that
respirators were needed (BLS; CFOI/FAX, 6/96).
In some cases, respirator use itself can cause illness and injury
to employees. There are a number of physiological burdens that are
associated with the use of certain types of respirators. The
[[Page 1160]]
weight of the respirator, breathing resistances during both normal
operation and if the air-purifying element is overloaded, and
rebreathing exhaled air from respirator ``dead space'' can all increase
the physiologic burden of respirator use (Exs. 113, 22-1, 64-427). Job
and workplace conditions, such as the length of time a respirator must
be worn, the level of physical exertion required of a respirator user,
and environmental conditions, can also affect the physiological burden
(Exs. 113, 64-363). In addition, workers who wear glasses or hearing
aids may have problems achieving appropriate fit with some respirator
facepieces.
Evidence of Adverse Health Effects From Respiratory Hazards. There
is ample evidence that the previous standard was not doing an adequate
job of protecting workers from these respiratory hazards, and that
exposure to these hazards has continued to cause adverse health effects
among exposed workers. An analysis of OSHA inspection data from 1976
through 1982, when the previous standard had been in effect for between
five and eleven years (Ex. 33-5), found that in most cases (55.6%)
where respirators were used to protect employees from excessive levels
of air contaminants, respiratory protection programs were deficient in
one or more elements, thus increasing the potential for employee
exposure. Even more significant was the fact that in 72.1% of
inspections in which an overexposure to a substance listed under 29 CFR
1910.1000 was cited, respirator use did not comply with the respiratory
protection standard. OSHA performed a similar analysis of enforcement
data for 1990-1996, and found similar levels of noncompliance. [See
also Work-Related Lung Disease Surveillance Report, 1994; USDHHS, CDC,
DHHS (NIOSH) Number 94-120.] The provisions of the new respirator
standard are designed to regulate how an employer selects, maintains,
fit tests, and trains employees in the proper use of respiratory
equipment, and to provide employers with the tools needed to implement
an effective respiratory protection program. OSHA has concluded that
the new standard will eliminate many of the unnecessary illnesses and
deaths described in this section.
C. Responses to Advisory Committee on Construction Safety and Health
The revised respirator standard replaces the previous respiratory
protection standard in the construction industry (29 CFR 1926.103).
Since this revision affects the construction industry, the September
1985 preproposal draft standard was presented to the Advisory Committee
for Construction Safety and Health (ACCSH) for its comments. The ACCSH
comments, combined with the other comments received, were considered in
preparing a revision of the September 1985 draft proposal.
As part of the Notice of Proposed Rulemaking (NPRM) approval
process, the revised NPRM was presented at the March 1987 ACCSH meeting
and the Committee's comments were presented to OSHA at the August 1987
meeting (Ex. 39). OSHA responded to the Committee's comments in the
NPRM, published in November, 1994. As noted in that response, OSHA
modified the draft proposal to respond to the concerns of the Committee
(59 FR 58931-58935).
The final standard replaces the previous construction industry
standard for respiratory protection, 29 CFR 1926.103, with an amended
29 CFR 1926.103. The provisions of the previous respiratory protection
standard (29 CFR 1926.103) are deleted by this action. The title,
Respiratory Protection, will remain in the Code of Federal Regulations
but will now be followed by the statement ``Respiratory protection for
construction employment is covered by 29 CFR 1910.134.'' The full text
of this new standard will be printed in the general industry standards,
and the construction standard will reference the revised 29 CFR
1910.134.
The Agency's responses to the Committee's specific concerns follow:
Paragraph (a)--Permissible Practice
The Construction Advisory Committee recommended that paragraph
(a)(1) of the standard be changed to require that all feasible
engineering controls be used by employers and that the employer
demonstrate that engineering controls are not feasible before
respirators may be used. The recommended change also would have
eliminated the requirement that appropriate respirators be used while
engineering controls are being installed. OSHA has stated elsewhere in
the summary and explanation section of this preamble that paragraph
(a)(1) of the previous standard remains unchanged in the new final
standard because this paragraph was not proposed for revision and was
therefore not a subject of rulemaking in this proceeding. The purpose
of the Respiratory Protection standard is to improve the level of
protection provided to employees who use respirators to protect them
from respiratory hazards, regardless of whether that use occurs in an
environment where engineering controls are in place.
The Committee proposed that paragraph (a)(2) be modified to require
that employers provide respirators to employees exposed to contaminant
concentrations when the concentration reaches one-half the PEL or TLV,
and that employees be required to wear them before the PEL is exceeded.
To accompany this revision the Committee proposed a new definition
establishing an ``action level'' of one-half the PEL for all regulated
substances. OSHA has not adopted this ACCSH recommendation because the
recommended changes are beyond the scope of this rulemaking.
Paragraph (b)--Definitions
ACCSH suggested that OSHA add a definition for ``Grade D breathing
air'' to the standard. The properties of Grade D breathing air are
listed in paragraph (i) of the final standard, Supplied Air Quality and
Use. OSHA believes that repeating these elements in the definition
section is redundant and unnecessary.
The Committee also recommended that the rule include a definition
for ``competent person,'' as defined in 29 CFR 1926.32(f). The
competent person would review the respiratory protection program and
perform the function of the respiratory program administrator required
in paragraph (c)(2) of the proposal. OSHA has not included a definition
of competent person in the standard because 29 CFR 1926.32(f) already
has such a definition. OSHA recognizes, however, that, in construction
settings, the competent person is often also the administrator of the
respirator program.
The Committee also recommended that the NIOSH Recommended Exposure
Limits (RELs) be used along with the TLVs, to define a hazardous
exposure level in the absence of a PEL. This point is no longer
relevant because the concept of ``hazardous exposure level'' is not
included in the final respiratory protection standard.
The proposal would have limited the use of air-purifying
respirators for hazardous chemicals with poor or inadequate warning
properties. ACCSH recommended a change to the definitions of
``inadequate warning properties'' and that OSHA add a new definition
for ``odor threshold.'' Because the final standard takes a different
approach to determining when air-purifying respirators are appropriate,
OSHA has not adopted the changes recommended by ACCSH.
ACCSH also suggested that OSHA revise the proposed definition of
maximum use concentration (MUC). In
[[Page 1161]]
the final standard the definition of MUC has been reserved, pending
completion of a subsequent stage of this rulemaking that will
concentrate on establishing OSHA Assigned Protection Factors (APFs).
The Construction Advisory Committee also recommended replacing the
proposal's definition of ``respirator;'' because the final standard
contains no definition of ``respirator,'' this suggestion has not been
adopted. The Committee also recommened revising the proposed definition
of ``service life.'' However, since OSHA's definition of this term has
been broadened in the final rule and the rule contains detailed
requirements for change schedules for cartridges and canisters, ACCSH's
concerns have largely been addressed.
Paragraph (c)--Respirator Program
Paragraph (c)(1) of the proposal contained a requirement that the
employer establish a respirator program that ``covers'' certain
elements, as applicable. OSHA has followed the Commitee's
recommendation that OSHA change the word ``cover'' to ``include'' but
not removed the phrase ``as applicable,'' as recommended by the
Committee, because not all elements of the program apply in all
situations, and thus the ``as applicable'' language is appropriate.
The Committee also recommended that OSHA add an element to the
written respirator program on procedures for monitoring the work
environment, using monitoring results when selecting respirators, and
selecting the most protective respirators in situations where
monitoring cannot be performed (as is often the case in construction).
OSHA considered this comment in drafting the final standard, which
permits the employer to make reasonable estimates of exposure as part
of the respirator selection process. In most cases, as discussed in the
summary and explanation of paragraph (d), monitoring results will form
the basis of a reasonable estimate. Where the employer cannot estimate
exposure, the atmosphere must be considered immediately dangerous to
life or health (IDLH). For IDLH atmospheres, the most protective
respirators are required.
One of the elements in the written respirator program, paragraph
(c)(1)(vi), states that the program shall include procedures to ensure
proper air quality for atmosphere-supplying respirators. ACCSH asked
OSHA to add the words ``quantity and flow'' to provide more direction
for employers on what the procedures should cover. OSHA agrees and has
revised the wording of this element accordingly.
ACCSH recommended that OSHA substitute the term ``competent
person'' in paragraph (c)(2) for the language ``person qualified by
appropriate training and/or experience.'' This recommendation has
already been discussed above, in connection with ACCSH's comments on
paragraph (b).
The written respiratory protection program, in paragraph (c)(3), is
required to reflect current workplace conditions and respirator use.
The Committee urged OSHA to add the term ``training'' to this element.
OSHA has not done so because training is addressed in another program
element. The Committee also recommended that OSHA add to paragraph (c)
a provision allowing employees and designated representatives access to
exposure and medical records maintained by the employer. Because this
requirement is already included in 29 CFR 1910.1020, the medical and
exposure records access standard, and referenced in this final
respiratory protection standard, the Agency has not done so.
Proposed paragraph (c)(5) required employers to make the written
program available to affected employees, designated representatives,
and OSHA. The Committee requested that employers be required to send a
copy of the program to the OSHA Special Assistant for Construction.
However, the proposed requirement has been moved to paragraph (m) of
the final standard, which requires that all written materials
maintained under the standard be made available upon request to
affected employees and the Assistant Secretary. This requirement should
meet any need that may arise for copies of the written program.
The Committee further recommended that the written respirator
program be maintained and made available to employees at the job site,
and that the medical and monitoring results pertaining to respirator
use be available at the work site as well. The final standard in
paragraph (m) now requires employers to allow employees to examine and
copy written programs upon request. Access to medical and monitoring
records for employees exposed to toxic substances or harmful physical
agents is regulated by OSHA in a separate standard, 29 CFR 1910.1020.
That standard applies to construction workplaces as well as general
industry workplaces and requires the employer to ensure that access to
medical and monitoring records is provided in a reasonable time, place,
and manner (1910.1020(e)(1)(i)). Nothing in the final respiratory
protection standard is intended to alter this requirement.
Paragraph (d)--Selection of Respirators
In its review of paragraph (d) of the proposal on selection of
respirators, the Committee requested OSHA to add a new provision that
would require monitoring for contaminants when air-purifying
respirators are used. This request is related to the recommendation for
mandatory monitoring, discussed above. The final standard requires that
employers make reasonable estimates of employee exposure levels when
selecting all respirators, not just air-purifying ones. Even if current
monitoring results are unavailable, employers must base their exposure
estimates on reliable data, which might include, for example, the
results of past monitoring for similar construction jobs. Extensive
discussion of this issue is contained in the summary and explanation
section of this preamble for paragraph (d). OSHA believes that allowing
exposure estimates that may be based on past monitoring and other
representative data makes sense for the construction industry, where
jobs are often short-lived and current monitoring data relating to
specific employees/operations may not be available when respirators
must be selected. Because the final standard allows employers to rely
on reasonable estimates of exposure as well as monitoring results, OSHA
has not added a requirement to the standard mandating that employers
``obtain'' needed information, as recommended by the Committee.
The Committee also recommended removal of the proposed phrase
``when they exist'' to modify the requirement that employers select
only NIOSH-approved respirators. Instead, the Committee recommended use
of the most protective respirator available, an SCBA or supplied air
respirator, in cases where no approved air-purifying respirator exists.
OSHA has removed the phrase ``when they exist'' from the final
standard, for reasons explained in the summary and explanation
discussion relating to paragraph (d).
The Committee urged OSHA to include poor odor warning properties as
a reason for prohibiting the use of air-purifying respirators, and to
remove proposed paragraph (d)(6)(ii), which, under limited
circumstances, would have allowed their use with substances with poor
odor warning properties. Final paragraph (d)(3) modifies the proposal,
and places many limitations on air-purifying respirator use with gases
and vapors, regardless of the existence of warning properties.
The Committee objected to the use of air-purifying respirators in
an
[[Page 1162]]
atmosphere with an oxygen content of 19.5 percent at altitudes of
14,000 feet or below; in the Committee's view, supplied air respirators
should be required in this situation. OSHA continues to treat
atmospheres at altitudes of 14,000 feet or below that have oxygen
concentrations of at least 19.5% as non-oxygen-deficient, and to
require atmosphere-supplying respirators in these atmospheres. OSHA's
reasons for this determination are detailed in the summary and
explanation section for paragraph (d).
Paragraph (e)--Medical Evaluations
The Committee recommended that a mandatory medical examination be
required in accordance with ANSI Z88.2, and that the standard include a
list of diseases and conditions that should be considered in
determining an individual's ability to wear a respirator. The final
standard allows employers to rely on a screening questionnaire to
identify employees with specified conditions that will require follow-
up medical examinations. The questionnaire specifies medical conditions
that OSHA has determined often relate to an employee's ability to use a
respirator. OSHA believes that this provision responds to the
Committee's concern.
Based on the comments of ACCSH and others, OSHA has decided to
eliminate the proposed exemption for employees wearing respirators for
no more than 5 hours per week, for the reasons explained below in the
Summary and Explanation. The final rule also reflects the Committee's
recommendation that the medical opinion provided to the employer
include only limitations on the employee's ability to use a respirator.
The Committee recommended that OSHA add a provision to this
paragraph requiring the employer to inform the person performing the
medical examination of the atmospheric contaminants to which the
employee would be exposed. The final standard meets this concern by
requiring that the physician or other licensed health care professional
(PLHCP) receive a copy of the employer's written respirator program,
and information about other environmental conditions an employee may
encounter; this information will allow the medical professional to
judge whether the employee is medically capable of wearing the
respirator.
The final rule allows an employer who has, within the preceding 12
months, provided his or her employees with a medical evaluation that
fulfills the requirements of the revised standard to rely on the
results of that evaluation. OSHA believes that this provision is
responsive to the Committee's concern that limitations be placed on the
``portability'' of medical evaluations.
The Committee recommended that OSHA add a new provision to
paragraph (e) to require that the employer provide a powered air-
purifying respirator or atmosphere-supplying respirator to any employee
found medically unable to wear a negative pressure respirator but
otherwise able to perform the task to be done. The final standard
requires the employer to provide a PAPR to an employee when the PLHCP
informs the employer that the employee has a medical condition that may
place the employee's health at increased risk of material impairment if
the employee uses a negative pressure respirator (paragraph (e)(6)(ii))
and is thus responsive to the Committee's concern.
Paragraph (f)--Fit Testing
With respect to fit testing procedures, the Committee recommended
that proposed paragraph (f)(1) be rewritten to state that respirators
must fit the employee so as to ensure that no exposure above the TLV or
ceiling level occurs. OSHA agrees with the Committee's emphasis on fit
testing and believes that the final rule's fit testing requirements and
the fit test protocols in an appendix to the standard will ensure that
employees are protected from the overexposures of concern to the
Committee.
The Committee also suggested clarifying that a fit test is required
whenever a different make or size respirator is used or when the facial
characteristics of the employee change. The final rule addresses both
of these points.
The Committee recommended limiting the fit testing requirements to
tight-fitting negative pressure respirators. This issue, and OSHA's
reasons for requiring fit testing of all tight-fitting respirators, is
discussed in the fit testing section of the Summary and Explanation.
OSHA has also deleted the proposed provision, objected to by the
Committee, that would have allowed the employer to use a qualitative
fit test for selecting respirators for employees who require fit
factors greater than 10 in situations where outside contractors who do
the quantitative fit testing are not available.
Paragraph (g)--Respirator Use
Paragraph (g)(1) of the final standard adopts the proposed
provision prohibiting the use of respirators that rely on a tight
facepiece fit when facial conditions such as a beard or scarring would
prevent such fits. The Committee urged OSHA to extend this provision to
cover loose-fitting respirators as well as tight-fitting ones. OSHA
explains in the Summary and Explanation for this paragraph that
conditions such as a beard or facial scarring would have no effect on
the performance of loose-fitting hoods or helmets, and OSHA therefore
does not regard it as appropriate to make this change.
Employees who wear glasses were required in proposed paragraph
(g)(4) to wear them in a manner that does not interfere with the
facepiece seal of the respirator. The final standard continues this
requirement (paragraph (g)(l)(ii)). The Committee suggested an
additional requirement stating that, where the employee must wear
corrective lenses and the respirator requires that these be of special
design, the employer provide the lenses at no cost to the employee.
OSHA believes, however, that such a requirement is not necessary
because, in most cases where negative pressure respirators may be worn,
half-masks are acceptable, and half-masks eliminate the concern about
corrective glasses interfering with facepiece seal. Because the final
standard allows contact lenses to be worn, full facepiece respirators
can be worn by persons needing corrective lenses; contact lenses
obviously do not interfere with facepiece seal. Thus, the final rule
gives employers several options for addressing this concern of the
Committee's.
Paragraph (h)--Maintenance and Care of Respirators
The Committee urged OSHA to add the phrase ``on paid time'' to this
paragraph to ensure that employers not require employees to clean their
respirators on their own time. OSHA has decided in the final rule
simply to require employers to ensure that respirators are cleaned
according to mandatory procedures or their equivalents. OSHA believes
that this approach is appropriate because the record demonstrates that
on-site, employer-supervised cleaning is the prevalent cleaning
procedure and the standard's rigorous requirements for cleaning
respirators will limit off-site cleaning of respirators by employees.
Paragraph (k)--Training
The training section of the proposal would have required that
employers provide a training program for employees who are required to
wear respirators. The Committee urged OSHA to add language to paragraph
(k)(1) to require employers to provide, conduct and document the
effectiveness of the training program. The final standard takes a more
integrated approach in that
[[Page 1163]]
it requires employers to evaluate the entire respiratory protection
program rather than the training program specifically.
Paragraph (m)--Recordkeeping
OSHA has adopted the Committee's recommendation to add the phrase
``and make available'' to proposed paragraph (m)(1)(iii), which
required employers to maintain records of medical evaluations in
accordance with 29 CFR 1910.1020, the Access to Employee Exposure and
Medical Records standard (see paragraph (n)(1) of the final rule).
Appendix B--Recommended Practices
Appendix B-1 of the standard contains practices for performing
positive and negative pressure faceseal checks. Respirator wearers are
required by paragraph (g)(iii) to perform a faceseal check before
entering the work area either by following the mandatory faceseal check
methods in Appendix B-1 or by following the respirator manufacturer's
recommended method, if the employer shows that the manufacturer's
method is as effective as the required methods. The Committee urged
OSHA to add new fit check methods to Appendix B-1, and OSHA has
responded to this recommendation by allowing the methods suggested by
the Committee if they are as effective as the methods in the Appendix.
ACCSH also recommended that OSHA issue a separate respirator
standard for the construction industry. OSHA has reviewed the
Committee's comments to identify which construction-specific concerns
call for provisions that differ from those applicable to general
industry. First, many of the final standard's provisions are stated in
performance language, which is flexible enough to accommodate
differences in particular workplaces or industries. For example,
approved fit test systems, both quantitative and qualitative, are
portable and can be used on construction work sites as well as in fixed
industrial facilities. Another example is the final rule's requirement
for medical surveillance; the frequency of medical reevaluation is now
event driven, which will greatly simplify evaluations for employees who
frequently change employment, as is the case with many construction
workers. Thus, OSHA believes that the final rule is responsive to the
Committee's concerns about the uniqueness of the construction industry
and is sufficiently flexible to be used on worksites in this sector.
D. Assigned Protection Factors
OSHA is reserving the sections of this standard addressing assigned
protection factors (APFs) pending further rulemaking. OSHA is working
diligently to complete the reserved portions of the standard. In the
interim, OSHA expects employers to take the best available information
into account in selecting respirators. As it did under the previous
standard, OSHA itself will continue to refer to the NIOSH APFs in cases
where it has not made a different determination in a substance-specific
standard.
E. Small Business Considerations
Pursuant to 5 U.S.C. 605(b) of the Regulatory Flexibility Act, OSHA
certified to the Small Business Administration that the proposed
respiratory protection standard would not have a significant impact on
a substantial number of small entities.
For the purposes of fulfilling the requirements of the Regulatory
Flexibility Act, the Agency in its Preliminary Regulatory Impact
Analysis (PRIA) [Ex. 57] examined the impact of the standard on a
number of different small establishment-size classes (1-7 employees, 8-
19 employees, etc). Although some economies of scale associated with
the proposed standard were noted, the Agency found that, given the
modest costs per establishment and the limited impact of the proposed
regulatory revisions as a whole, the standard would not impose a
significant economic impact on a substantial number of small entities.
These findings were summarized in the NPRM (59 FR 58894). At the time
that OSHA published the NPRM for this rulemaking (Nov. 15, 1994), the
Agency transmitted the certification setting forth this conclusion,
along with the full PRIA, to the Small Business Administration.
In developing the final standard, the Agency has conducted a
screening analysis to identify any significant impacts on a substantial
number of small entities. The details of the screening analysis are
presented in the Final Economic Analysis, which is available in the
docket; a summary of the analysis appears in section VI. Based on this
screening OSHA has again determined that the final rule will not impose
a significant impact on a substantial number of small entities. The
costs of the standard will equal no more than 0.02 percent of revenues
for small firms in any affected industry, and will therefore pose no
threat of business disruption, whether these costs are absorbed by
affected firms or passed on to consumers. OSHA therefore certifies that
the final rule will not have a significant impact on a substantial
number of small entities.
Nevertheless, the Agency has designed the standard to minimize
impacts on all affected establishments, and particularly on small
entities. OSHA's special consideration of small businesses is in accord
with the Agency's continuing policy to remain sensitive to the needs of
small entities affected by Agency regulations.
Provisions that recognize the special needs of small businesses are
discussed in more detail under specific sections of the Summary and
Explanation of the standard, Section VIII. Examples of provisions where
consideration was given to small businesses in making regulatory
decisions include:
--Reduction in the number of repeat fit tests required for quantitative
fit testing;
--Allowing employers to use a questionnaire (Appendix C is an example)
as a minimal medical evaluation tool to ascertain an employee's ability
to use respirators, rather than requiring a hands-on physical
examination;
--Allowing medical evaluations to be conducted either by a physician or
by another licensed health care professional (PLHCP), which will reduce
medical surveillance costs without compromising employee protection;
--Making the frequency of medical evaluations, after the initial
assessment, event-related instead of time-related, e.g., only requiring
such evaluations when specific conditions indicate a need for a
reevaluation;
--Reducing the amount of paperwork required in connection with medical
evaluations. OSHA's previous standard required a physician to determine
pertinent health and physical conditions, and further required that the
respirator user's medical status be reviewed periodically (for
instance, annually). Historically, employers have had physicians
evaluate their employees' physical conditions, and have maintained
records documenting those evaluations;
--Revising the requirements for disinfecting respirators from ``after
each use'' to ``as necessary to be maintained in a sanitary condition''
to allow flexibility for small businesses;
--Requiring only that tags be used to document respirator inspections,
rather than requiring written records; and
--Allowing the employer to obtain a certificate of analysis of
breathing gas
[[Page 1164]]
from the supplier rather than requiring employers to conduct gas
analyses themselves.
In the Small Business Administration's Annual Report to Congress, a
summary of SBA's comments to the respirator docket (Ex. 54-318) was
provided. (Note that these comments pertain to the proposed rather than
final rule.) SBA's comments have been examined alongside others with
regard both to the proposal and its supporting economic analysis. As
indicated, many of SBA's suggestions have been adopted; the SBA's
comments on the Preliminary Regulatory Impact Analysis are discussed in
detail in the economic impact chapter of the Final Economic Analysis.
Revised 29 CFR 1910.134 is intended to serve as a ``building
block'' standard with respect to future standards that may contain
respiratory protection requirements; that is, future standards that
regulate respirator use in controlling employee exposure to hazardous
conditions will refer to provisions in the final respiratory protection
standard. Further, OSHA has found that the respirator provisions of
existing substance-specific standards (Asbestos, Cadmium, Lead, etc.)
were especially in need of revision in view of newly revised
Sec. 1910.134. Except for a limited number of respirator provisions
unique to each substance-specific standard, the remaining regulatory
text on respirators now reads virtually the same for each of these
standards. For example, all provisions addressing respirator use,
selection, and fit testing were deleted from the substance-specific
standards, making these standards consistent with the final respiratory
protection standard with respect to these requirements. The Agency
believes that the revisions being made to 29 CFR 1910.134 are
sufficiently comprehensive to allow deletion of those provisions in the
substance-specific standards that duplicated provisions in the revised
final rule. A provision was retained only when it addressed conditions
(for example, medical evaluation) that were unique and/or integral to
the substance-specific standard.
The Agency concludes that deletion of duplicative provisions from
the substance-specific standards will enhance compliance, especially
for small businesses, and will thus will improve the protection
afforded to employees who use respirators.
IV. Certification/Approval Procedures
Section 1910.134(b)(8) of the previous standard required that only
those respirators approved jointly by NIOSH and MSHA be used by the
employer. The current respirator testing and approval regulation, 30
CFR 11, which authorized the Bureau of Mines and NIOSH to jointly
approve respiratory protection devices, was promulgated on March 25,
1972 at 37 FR 6244. On November 5, 1974 the Mine Enforcement Safety
Administration (MESA) succeeded the Bureau of Mines and joined NIOSH in
jointly approving respirators. Following the transfer of MESA to the
Department of Labor, where it became the Mine Safety and Health
Administration (MSHA), authority was transferred on March 24, 1978 to
MSHA for joint approval with NIOSH of respirators. Most of the Bureau's
respiratory testing methods, developed in the 1950s or earlier, were
changed in the 1970s to reflect changes in testing technology.
NIOSH initiated revision of 30 CFR 11 in 1980. A public meeting was
held in July 1980 to address the certification program. On August 27,
1987, NIOSH published a notice of proposed rulemaking (52 FR 32402)
that would have allowed NIOSH to certify respirators under the new 42
CFR part 84 regulations, replacing the current joint NIOSH/MSHA 30 CFR
11 certification regulations. The proposed NIOSH certification
regulations contained new and revised requirements for testing and
certification of respirators, and included a set of assigned protection
factors for various classes of respirators. Public hearings on the
first draft of the NIOSH proposal were held in January 1988. On the
basis of the comments received, NIOSH prepared a revised proposal for
further public comment. On June 8, 1995 NIOSH published revised
respirator certification procedures for particulate respirators (60 FR
30336) and recodified the previous certification standards for the
other respirator classes as 42 CFR Part 84. These certification
procedures address N, P and R class particulate respirators at 95%,
99%, and 99.7% levels of effectiveness. Additional public comment was
sought at public meetings convened in June 1996 to assist NIOSH in
preparation of future rulemakings that will continue the revision of
the certification procedures for other classes of respirators. In
October 1997, NIOSH announced the intended priority order for these
future rulemakings. Relevant aspects of these proceedings are discussed
in the Summary and Explanation.
V. Significance of Risk
Respirators are used by American workers as a means of protection
against a multitude of respiratory hazards that include chemical,
biological, and radiological agents. Situations in which respirators
are relied upon to provide protection from these hazards include those
that involve immediately life-threatening situations as well as routine
operations where engineering controls and work practices are not able
to provide sufficient protection from these hazards. In these
situations, respirators must ``seal off'' and isolate the worker's
respiratory system from the contaminated environment. The risk that a
worker will experience an adverse health outcome when relying on
respiratory protection is a function of the toxicity or hazardous
nature of the air contaminants present, the concentrations of the
contaminants in the air, the duration of exposure, and the degree of
isolation provided by the respirator. When respirators fail or do not
provide the degree of protection expected by the user, the user is
placed at an increased risk of any adverse health effects that are
associated with exposure to the respiratory hazards present. Therefore,
it is critical that respirators perform as they are designed to do to
ensure that users are not at an increased risk of experiencing adverse
effects caused by exposure to respiratory hazards.
OSHA has discussed the nature of adverse health effects caused by
exposure to airborne chemical hazards many times in previous rulemaking
efforts (see, for example, Appendix A of the Hazard Communication
standard, 29 CFR 1910.1200 and the preambles to any of OSHA's single
substance standards codified in 29 CFR 1910.1001 to 1910.1052). In all
instances where OSHA has promulgated new or revised PELs for chemical
air contaminants, OSHA has determined that the health effects
associated with exposure to the contaminants represent material
impairment of health because the effects are life-threatening, cause
permanent damage, or significantly impair the worker's ability to
perform his or her job in a safe manner. As discussed in Section VI of
this preamble, OSHA expects that thousands of illnesses and hundreds of
fatalities that are presently being caused by exposure to hazardous
substances will be avoided annually among respirator wearers as a
result of improvements and clarifications made to the earlier standard
by this final rule.
Evidence on current workplace exposure levels confirms that
respirators are needed in many work situations to protect workers
against serious work-related illness. To illustrate, OSHA identified
several substances that represent a range of adverse effects and
[[Page 1165]]
for which OSHA's Integrated Management Information System (IMIS)
database has documented workplace exposures that exceed the current
PELs for these substances. The effects represented by this subset of
the IMIS and the associated substances for which there are documented
overexposures include:
--Sudden death/asphyxiation--carbon monoxide, carbon dioxide;
--Loss of lung function--wood dust, welding fume, manganese fume,
copper fume, cobalt metal fume, silica;
--Central nervous system disturbances--carbon monoxide,
trichloroethylene;
--Cancer--chromic acid, wood dust, silica; and
--Cardiovascular effects--carbon monoxide.
When respirators are used during operations where exposures exceed
OSHA's PEL, OSHA believes that there is little or no margin that would
protect the worker in the event that the respirator does not perform as
well as designed or expected. For all of the substances for which OSHA
has promulgated a comprehensive health standard (i.e., Arsenic, 29 CFR
1910.1018; Asbestos, 29 CFR 1910.1001; Benzene, 29 CFR 1910.1028; Lead,
29 CFR 1910.1025; Ethylene Oxide, 29 CFR 1910.1047), OSHA has
determined that exposure above the PEL is associated with a significant
risk of material impairment of health, and believes as a matter of
policy that exposures below the PEL may be associated with risk levels
that are significant. That is, there is no exposure level near or
somewhat above the PEL that can be considered to be at a low or
insignificant risk level. Therefore, where workers perform jobs that
result in exposures above the PEL for any of these substances, use of
properly functioning respirators is essential to ensure that workers
are not placed at significant risk of material impairment of health.
Throughout this preamble, OSHA has demonstrated that adequate fit
testing, proper respirator selection, worker training, and thorough
inspection and maintenance are essential elements of a respirator
program. Without these requirements, OSHA believes that there is a
greater chance that a respirator user will inhale potentially dangerous
air contaminants, either by improper selection of equipment, excessive
respirator leakage, improper use of the respirator, or any combination
of these. This section presents an analysis conducted by OSHA to
evaluate the improved protection to workers who use respiratory
protection equipment by the type of effective respirator program
required by the final rule.
In the context of a respiratory protection program, the health risk
presented to workers can be represented as the risk that a respirator
will fail to provide some minimum expected level of protection, which
increases the possibility that the user of the respirator will be
overexposed to a harmful air contaminant. This presumes that
respirators will be selected and used in work settings where exposure
to ambient concentrations of air contaminants poses an unacceptable
health risk, and, if the respirator performs as expected, the wearer
will be protected from that risk. For example, an employer who provides
a half-mask, chemical cartridge respirator for employee use might
typically assume that the respirator will filter out 90 percent of the
contaminant and base his or her choice of respirator on that
assumption. If the respirator performs less effectively than expected,
the employer's expectation that the respirator will provide effective
protection will not be fulfilled.
This concept of risk differs from that used by OSHA in its
substance-specific health standards, in which the Agency typically
defines risk as the probability that a worker will acquire a specific
work-related illness. Quantifying that kind of risk requires the
analysis of data that relates the magnitude or intensity of exposure to
the incidence or prevalence of adverse effects seen among exposed
populations or experimental animals. In contrast, the kinds of
hazardous situations covered by the final respiratory protection
standard are varied in terms of the nature of the hazard present (i.e.,
acute, chronic, or both), the frequency and magnitude of exposure, and
the types of illnesses associated with exposure to those hazards. As a
consequence, the health risks addressed by the final rule cannot be
described in terms of an illness-specific risk, but instead relate to
the more general probability that a respirator will provide
insufficient protection causing the wearer to be exposed to a dangerous
level of one or more air contaminants.
Certain studies, referred to as ``workplace protection factor''
(WPF) studies, have attempted to measure the effectiveness of
respirators under actual conditions of use in the workplace. The WPF is
a measure of the reduction in exposure achieved by using respiratory
protection and is represented by an estimate of the ratio of the
concentration of a contaminant found in the workplace air to the
concentration found inside the respirator facepiece while the
respirator is being worn. As the degree of protection afforded by the
respirator increases, the WPF increases. Alternatively, the degree of
protection provided by a respirator can be expressed as a penetration
value, which is the reciprocal of the WPF and reflects the ratio of the
concentration of contaminant inside the facepiece to the concentration
outside. For example, a WPF of 50 equates to a penetration value of
0.02 and means that the concentration inside the respirator facepiece
is one-fiftieth of the ambient level.
Because WPF studies are designed to evaluate the field
effectiveness of respiratory protection equipment, study protocols
usually have been designed to minimize factors that can reduce
respirator performance. Such factors include selecting the wrong type
of respirator for the working conditions under which the study is being
conducted, use of poorly fitting respirator facepieces (i.e., testing
of respirator fit is routinely done in well-conducted WPF studies),
inadequate training of wearers in proper respirator adjustment and use,
or excessive leakage caused by malfunctioning or dirty respirator
parts. Typically, WPF study protocols include procedures for properly
selecting respirators and ensuring that they are in good working order,
assigning respirators to workers on the basis of valid qualitative or
quantitative fit tests, training wearers on how to adjust strap tension
properly and use the respirator, and ensuring that neither facial hair
nor other personal protective equipment is likely to interfere with
respirator fit. In addition, workers included in WPF studies are
usually monitored throughout the period that respirators are worn to
verify that the equipment is being properly used. All of these
conditions reflect the principal elements of a strong respirator
program in which respirator performance is optimized; therefore, the
results from a good WPF study can mirror the results obtained by an
employer who implements a well-run respiratory protection program.
To quantitatively evaluate the impact of implementing a good
respirator program on respirator performance, OSHA identified several
WPF studies that were conducted using methods that reflect a
comprehensive program, and compared these results to other workplace
studies that did not employ all of the elements of a good program.
Quantitative approaches are used to develop (1) aggregate estimates of
respirator effectiveness in both the presence and absence of a good
[[Page 1166]]
respiratory protection program, and (2) estimates of the frequency with
which workers are likely to achieve inadequate protection while using a
respirator, given the presence or absence of a good underlying program.
All of the studies used in this analysis pertain to the effectiveness
of half-mask, negative-pressure respirators, and all are contained in
OSHA's rulemaking docket (H-049).
Many of the well monitored WPF studies conducted were reviewed by
Nelson et al. in 1995 (Ex. 64-514); these authors selected data from
seven such studies to evaluate the overall field effectiveness of half-
mask, negative-pressure respirators. Each of the studies described by
Nelson et al. ensured selection of properly fitted respirators either
by an accepted qualitative fit test (QLFT) (i.e., isoamyl acetate or
saccharin) or by a quantitative fit test (QNFT) where only respirators
that provided a minimum protection factor to the wearer of at least 100
were selected. Each of these studies provided for worker instruction in
proper respirator use, and workers were monitored during each study to
ensure proper use. An additional six studies were reviewed by Nelson et
al. but were rejected either because they allegedly used biased
sampling methods to determine ambient and in-facepiece contaminant
concentrations or because the authors believed that improper or
invalidated fit test procedures were employed.
In the studies selected by Nelson et al. for analysis, workers used
elastomeric or disposable respirators equipped with dust-mist, dust-
mist-fume, or high-efficiency particulate (HEPA) filters, and the
collection of studies represented a range of workplace exposure
situations, including pigment production, metals refining, asbestos
exposure during brake-repair work, welding, and spray painting.
Geometric Mean (GM) WPF values from these studies ranged from 47 to
3,360, with an overall GM WPF of 290. The 5th percentile WPF from the
data set was estimated to be 13, with a 95% confidence interval of 10-
18. Nelson et al. concluded from the analysis of the overall data set
that the assigned protection factor of 10 for half-mask, negative-
pressure respirators was reasonable given that a WPF of less than 10
would not likely occur more than 5 percent of the time. In addition,
Nelson et al. found no significant difference in the field performance
of disposable respirators compared to elastomeric models. OSHA has not
conducted a detailed comparative evaluation of WPF values obtained from
disposable vs. elastomeric respirators; if, in fact, disposable
respirators provide less protection than elastomeric respirators, the
WPFs that can be achieved under a good respirator program will be
overstated in this analysis since Nelson et al.'s compiled data reflect
the use of both types of respirators.
Each of the studies reviewed by Nelson involved worker exposures to
dusts. OSHA could identify only one WPF study, by Galvin et al. in 1990
(Ex. 64-22), that examined respirator effectiveness against exposure to
a vapor-phase contaminant rather than a particulate. In this study, WPF
measurements were taken on a group of 13 styrene workers who used half-
mask, air-purifying respirators equipped with chemical cartridge
filters. All employees were assigned respirators based on passing an
irritant smoke fit test, and all were trained on how to properly don
the respirator and conduct fit checks. In-mask and ambient styrene
concentrations were measured over one-hour periods, during which
employees were instructed not to readjust the facepiece. Chemical
cartridges were changed with each new sampling period to ensure that
there was no breakthrough. In-mask styrene concentrations were adjusted
upwards by 40 percent to account for pulmonary retention, which avoided
potentially overestimating the WPF. The GM WPF for the overall cohort
was reported to be 79, with a geometric standard deviation (GSD) of
3.51. There was no significant difference in WPF values between those
workers engaged in relatively physical operations, such as spraying,
compared to those performing less physical work tasks. The GM WPF found
by Galvin et al. for styrene-exposed workers lies within the range of
GM WPF values reported in the studies reviewed by Nelson for worker
cohorts exposed to particulate-contaminated environments.
Nelson in his 1995 report (Ex. 64-514) excluded the Galvin et al.
study from his analysis because fit tests were performed using the
irritant smoke protocol. As discussed in the Summary and Explanation
section of this preamble, OSHA has determined that the irritant smoke
qualitative fit test provides a valid, effective test of respirator
facepiece fit. The procedures used by Galvin et al. to ensure adequate
worker training and respirator use are consistent with the elements of
a permissible respirator program, and OSHA, therefore, finds it
appropriate to include this study in the set of WPF studies that are
representative of effective respiratory program practices.
In contrast, OSHA has identified three studies where investigators
also determined WPF values for half-mask, negative-pressure
respirators, but where few steps were taken to ensure maximum
respirator performance. OSHA believes that these studies illustrate the
relative lack of protection afforded by respirators when certain
critical elements of the respiratory protection program are missing or
inadequate. The studies identified by OSHA are those by Toney and
Barnhart in 1972 (Ex. 64-68), Moore and Smith in 1976 (Ex. 64-49), and
Harris et al. in 1974 (Ex. 27-11).
Toney and Barnhart (Ex. 64-68) conducted a WPF study to evaluate
the effectiveness of half-mask, chemical-cartridge respirators on
reducing exposures of spray painters to solvent vapors and aerosols.
Data were obtained from painters working at 39 different sites and
included both in-mask and ambient concentrations. WPFs were found to be
low; from the raw data presented in the study, OSHA calculated a GM WPF
of 3.8 for solvent exposure (GSD=2.28, N=39) and a GM WPF of 11.4 for
aerosol exposure (GSD=4.12, N=40). Penetration tests performed on
unused respirator cartridges of the same types used in the field
indicated that the poor WPFs achieved in the field tests were caused by
poor respirator fit and a lack of respirator maintenance, and were not
due to any inherent defect in the cartridges. The authors concluded
that respirators being used by painters were not effective and cited
several reasons, all pointing to the lack of a respiratory protection
program at the facilities tested. For example, 28 percent of
respirators used by the painters were poorly maintained. Some of the
conditions found by the investigators included deteriorating rubber on
the facepieces, the presence of stuck or warped valves, missing head
straps, and evidence of leakage around the cartridge seal. In addition,
it was apparent that some of the cartridges had not been changed for
extended periods of time. Many of the facilities studied supplied non-
approved respiratory protective devices (respirators were approved by
the Bureau of Mines at the time of the study), and most had no formal
training or maintenance program in place. The authors found that ``* *
* management and workers are extremely uninformed on the subject of
selection, use, and care of respiratory protective devices.'' (Ex. 64-
68, p. 93).
The second study, conducted by Moore and Smith in 1976 (Ex. 64-49),
measured WPF values obtained by workers exposed to sulfur dioxide
(SO2) during a furnace charging operation at a copper
smelter. Three models of half-mask, chemical cartridge respirators
[[Page 1167]]
were tested on each of nine workers; in-mask and ambient SO2
concentrations were measured during the furnace charging operation
while the respirators were worn. There is no indication in the study
that qualitative or quantitative fit testing was performed to verify
adequate facepiece fit. A total of 81 samples were collected, 5 of
which were excluded from the analysis because the subjects removed or
lifted the respirator facepiece during the sampling period. Average
ambient SO2 concentrations varied in the range of 53 to 61
mg/m3 (20.4 to 23.5 ppm) during the sampling period.
Geometric mean WPF values reported for each of the three models of
respirator were 22.1 (SD=22.6), 18.4 (SD=14.2), and 12.9 (SD = 11.0).
Moore and Smith concluded that the overall protection afforded by the
respirators was poor, and that between one-third and one-half of the
protection factors achieved would be below 10, the accepted minimum
protection factor for that type of respirator. Reasons given by the
authors for the poor fits observed among the subject workers included
the possibility that strap tension was not properly adjusted (the
authors did not control or monitor strap tension), variation in facial
hair (despite the lack of beards or wide sideburns), and normal work
activities that caused head motion and deep breathing associated with
heavy work.
The third study is that of Harris et al. in 1974 (Ex. 27-11), who
evaluated the performance of five half-mask dust respirators among 37
miners working in 4 coal mines. In-mask and ambient dust measurements
were made throughout the workshifts, during which miners intermittently
used respiratory protection. Thus, this study differs from the others
described above in that the ratio of in-mask to outside concentrations
included periods of time where the respirator was not worn, in contrast
to the typical WPF study. The ratio of in-mask to outside concentration
determined during periods of intermittent respirator use, termed the
``effective protection factor'' (EPF), is not directly comparable to
WPF values because, to the extent that workers spend time in
contaminated atmospheres without respiratory protection, the WPF will
tend to understate the actual protection obtained while the respirator
is being worn. However, according to Poppendorf in 1995 (Ex. 54-512),
it is possible to use EPF data to estimate the WPF that was likely to
have been achieved during periods of respirator use if both of the
following are known or can be estimated: (1) The fraction of time
during which the respirator was not worn by the subject, and (2) the
ratio of contaminant concentration in areas where the respirator was
worn to that in areas where the respirator was not worn. Poppendorf
(Ex. 54-512) described the mathematical relationship between the EPF
and WPF and suggested that the likely range of average WPF values
achieved by the miners during periods of respirator use was 3.6 to 5.7.
This estimate of WPF is based on an observation by Harris et al. that
miners wore their respirators about half of the time during the
sampling periods, and an assumption by Poppendorf (Ex. 54-512) that the
dust levels in the air while respirators were worn were at least 5
times higher than airborne dust levels during periods of respirator
non-use. OSHA believes that the latter assumption is reasonable given
that Harris et al. reported that, for the most part, miners wore their
respirators only when visible airborne dust was present. Harris et al.
noted that the hard hats worn by the miners interfered with proper
respirator strap positioning and adjustment; OSHA believes that this
factor, as well as the apparent lack of fit testing, is likely to have
contributed to the low protection factors experienced by the miners.
OSHA believes that the studies described above demonstrate that
improved respirator performance can be achieved under actual workplace
conditions if fit testing is used to select respirators, if respirators
are clean and in good working order, and if employees are properly
trained and supervised in their use. This is evident when the summary
statistics from aggregate protection factor data obtained from field
studies on groups of employees using respirators in the absence of a
strong respirator program (i.e., Moore and Smith, Toney and Barnhart,
Harris et al.) are compared with those obtained from cohorts using
respirators under the condition of a strong program (i.e., the studies
reviewed by Nelson and the study by Galvin et al.). Summary protection
factor data from these studies are presented in Table V-1 as geometric
mean and mean WPF values, and the geometric standard deviation (GSD) of
the distribution of WPF values. From these summary statistics, OSHA
computed a weighted geometric mean WPF across cohorts exposed to
particulate contaminants to compare the central tendency in protection
factors achieved both with and without an adequate underlying
respirator program (see footnote on Table V-1).
In general, groups of employees using respirators against
particulate exposures under a strong program achieved an overall GM
protection factor about 25-fold higher than groups using respirators
without the elements of a strong respiratory protection program. In
studies that did not implement all of these elements, mean WPF values
among the particulate-exposed worker cohorts tested ranged from about 6
to 22. Mean WPF values for particulate-exposed worker cohorts included
in the WPF studies where elements of a good program were implemented
ranged from 72 to 2,400, with the mean WPF from one study estimated to
be 11,500. The results from studies that examined respirator
effectiveness against gas or vapor, also included in Table V-1, show an
8-fold difference in overall GM WPF values. With only one exception,
the 95 percent confidence intervals around the GM WPF values computed
from the studies reflecting inadequate program practices do not overlap
with those computed from the studies reflecting strong program elements
(see Table V-1); thus, the hypothesis that there are no differences in
the GM WPF values between the two groups of studies is rejected. This
analysis suggests that implementation of a good respiratory protection
program containing the elements described by the final rule can
contribute to a substantial increase in the overall performance of
respirators used in actual workplace settings, as measured by the mean
WPF across groups of workers.
[[Page 1168]]
Table V-1.--Summary Results From Workplace Protection Factor (WPF) Studies and Estimated Frequencies of Respirator Failure, Based on a One-Factor ANOVA
Analysis of Data From Workplace Protection Factor (WPF) Studies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated percent of workers with:
---------------------------------------------------------------
Geometric WPF 10 at eq>2 at
WPF (95% C.I.\1\) deviation Mean WPF 10 \2\ thn-eq>2 \2\ the time \3\ the time \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Studies Reflecting Inadequate Program Elements
Particulate Exposure
Toney and Barnhart [1972] (Ex. 64-68)........ \4\ 11.4 (3.2-
39.6) \4\ 4.12 31.1 76.8 9.0 100 60.4
Harris et al. [1974] (Ex. 27-11)
Low Estimate............................. \5\ 3.6 (1-17.9) \5\ 2-93 6.4 99.7 38.8 100 96.4
High Estimate............................ \5\ 5.7 (1.6-
20.4) \5\ 2.93 10.2 97.0 12.5 100 82.3
Weighted Geometric Mean................ \6\ 5.6
Gas/Vapor Exposure
Moore and Smith [1976] (Ex. 64-69)
Respirator A............................. 15.29 (8.3-28.1) \7\ 2.36 22.1 36.2 <0.01 98.9 1.9
Respirator B............................. 13.72 (7.7-24.4) \7\ 2.15 18.4 41.3 <0.01 99.7 0.5
Respirator C............................. 9.59 (4.8-19.2) \7\ 2.16 12.9 83.1 <0.01 100 9.0
Toney and Barnhart [1972] (Ex. 64-68)........ \4\ 3.8 (1.2-
11.9) \4\ 2.28 5.3 100 14.7 100 95.7
Weighted Geometric Mean................ \6\ 9.4
Studies Reflecting Good Program Elements
Particulate Exposure
Dixon and Nelson [1984] \8\.................. 3360 (3101-3640) 4.8 11,498 <0.01 <0.01 <0.01 <0.01
Gaboury and Burd [1989] \8\.................. 47 (31-72) 2.5 72 0.2 <0.01 30.1 <0.01
Lenhart and Campbell [1984] \8\.............. 166 (120-228) 3.8 405 0.1 <0.01 9.0 0.02
Nelson and Dixon [1985] \8\.................. 258 (192-347) 5.2 1004 0.7 <0.01 14.5 0.3
Gosselink et al. [1986] \8\.................. 96 (75-123) 2.3 136 <0.01 <0.01 0.1 <0.01
Colton and Mullins [1992] \8\................ 147 (117-185) 2.5 224 <0.01 <0.01 0.1 <0.01
Myers [1990] \8\............................. 346 (256-468) 7.2 2,428 2.8 0.1 22.2 1.7
Weighted Geometric Mean................ \6\ 142
Gas/Vapor Exposure
Galvin et al. [1990] (Ex. 64-22)............. 79 (54-115) 3.5 173 1.1 <0.01 31.7 0.2
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 95% confidence interval of the geometric mean WPF calculated as follows for simultaneous confidence intervals: ySDnc tn-
1,1-/2, =1-(1-0.05)1/N
where n is the number of WPF measurements in each study and N is the number of studies being compared (i.e., 10 for particulate studies and 5 for gas/
vapor studies).
\2\ Calculated from equation 9 as described in the text; = 0.1 for WPF = 10, = 0.5 for WPF = 2.
\3\ Calculated from equation 10 as described in the text; = 0.1 for WPF = 10, = 0.5 for WPF = 2.
\4\ Calculated by OSHA from raw data presented by the authors.
\5\ Range of WPF values estimated by Popendorf [1995] (Ex. 54-512), from effective protection factor values (EPF) reported by Harris et al. GSDs
calculated by OSHA from median and mean EPF values reported by Harris et al.
\6\ Calculated as a weighted geometric mean as follows: exp[(lnGM/(lnGSD)\2\)/(1/(lnGSD)\2\)].
\7\ Calculated by OSHA from median and mean WPF values reported by Moore and Smith.
\8\ Studies reviewed by Nelson [1995] (Ex. 64-514).
The three WPF studies representing deficient program practices were
all conducted 10 to 20 years earlier than the WPF studies reflecting
good program elements. Thus, differences between the two groups of
studies in working conditions, processes and exposures, or respirator
equipment and technology could confound the comparison of respirator
effectiveness measures. OSHA is not aware of any recent studies that
have been conducted that were designed to evaluate the impact of
respirator program elements on respirator effectiveness, nor are recent
studies available that have attempted to measure respirator
effectiveness under conditions of a poor respiratory protection
program. OSHA believes that this analysis of program impacts on
respirator performance is based on the best available data. However,
OSHA has considered whether confounding factors related to the elements
of a good respirator program may also have contributed to the
differences in respirator performance reported by the two groups of WPF
studies. For example, respirator fit can be adversely affected by
vigorous work activity requiring head motion and deep breathing. Heavy
work loads also contribute to respirator discomfort, which may cause a
worker to wear a respirator too loosely. The nature of the air
contaminant affects respirator performance in that different types of
respirator filters have different capabilities in purifying
contaminated air and gas-phase contaminants and small-particulate
aerosols pass more readily through leak points than do aerosols
comprised mostly of larger particles.
OSHA does not believe that any systematic differences in working
conditions or respirator technology contribute substantially to the
differences in respirator effectiveness found between the two groups of
studies included in the analysis. For example, both groups of studies
represent a range of workplace situations that involve strenuous and
non-strenuous work. In the studies that do not reflect good program
practices, workers were engaged in active, strenuous work (smelter
operations and coal mining) as well as less active work (spray
painting). Similarly, studies that reflect good program practices have
also been conducted on worker cohorts engaged in both active work
(metals refining) and less active work (spray painting, brake repair).
Both groups of studies also involve a range of contaminants, including
both gas-phase and various kinds of particulate. Some of the studies
reviewed by Nelson included information on the size distribution of
[[Page 1169]]
particulates to which workers were exposed, with the range across these
studies including both respirable and non-respirable particles. Other
studies included in the Nelson analysis reported that workers were
exposed to both dust and fume. Therefore, the differences in WPFs found
between the two groups of studies cannot be explained by differences in
particulate sizes or characteristics. Both groups of studies also
represent a variety of half-mask respirator designs and filters,
including single-use respirators and respirators equipped with dust/
mist (i.e., non-HEPA) filters. OSHA believes it unlikely that the 14-
fold difference in overall WPFs between the two groups of studies can
be primarily attributed to any fundamental differences in respirator
equipment or technology. Therefore, OSHA finds that the differences in
WPF values obtained from the two groups of studies are more likely to
reflect differences in how well the respirators fit the subject
workers, the condition of the respiratory equipment used, and the
extent to which the equipment was used properly, rather than any
confounding caused by systematic differences in work settings, the
nature of the exposures, or the age of the WPF studies.
The kinds of summary statistics presented in Table V-1 have been
used by several investigators to demonstrate how poorly or how well
respirators can protect workers under actual conditions of use (see,
for example, Moore and Smith (Ex. 64-69), Nelson et al. (Ex. 64-514)).
However, such descriptive measures can only provide information on the
aggregate frequency distribution of protection factor values in a group
of workers. Although it is useful to rely on summary statistics from
aggregate protection factor data to make general statements about the
effectiveness of respirators, such measures do not adequately convey
information on the number or proportion of workers who remain at risk
of overexposure to air contaminants despite the use of respiratory
protection, or how frequently an individual worker might experience
poor fits.
Nicas (Ex. 156) and Nicas and Spear in 1992 (Ex. 64-425) have
suggested that using statistics from aggregate protection factor data
does not adequately describe the true risk of overexposure to workers
using respirators because the approach fails to recognize that there
are two different sources of variability that account for the overall
variation in protection factor values measured from a given cohort of
workers. One source of variability in protection factors is the
variation typically experienced by a single worker from one day to the
next; this is termed within-worker variability. The second source of
variability reflects the observation that different workers within a
group will achieve different average protection factors over a given
period of time; this is termed between-worker variability. In a peer-
reviewed article, Nicas and Spear (Ex. 64-425) have described a
statistical model that accounts for both sources of variability. This
model has been used by OSHA to estimate the following from the
protection factor studies described above to better characterize risks
to workers who use respirators both in the absence of and under a
strong respiratory protection program:
(1) The proportion of workers who fail to achieve a long-term
average protection factor at or above some specified target level,
exposing the worker to an increased risk of a chronic health hazard
(i.e., a health hazard that is typically associated with long-term
cumulative exposure); and
(2) The proportion of workers who achieve a protection factor
below some specified target level at least 5 percent of the time
that the respirator is worn, thus increasing the frequency with
which a worker may be exposed above an effect concentration
associated with an acute health hazard.
The Nicas and Spear model (Exs. 64-425, 156) used by OSHA in this
analysis is a one-factor analysis of variance and is described briefly
as follows. Let P denote a penetration value experienced by the wearer
of a respirator during a randomly selected wearing time (P is defined
as the reciprocal of the protection factor PF measured in the
workplace, or 1/PF). For example, a P value of 0.1 for a respirator
wearer reflects that a protection factor of 10 was achieved in the
workplace for that individual. If one were to measure the penetration
values among members of a group of workers over time and aggregate the
results, the total distribution of P values can be described by the
following parameters:
[GRAPHIC] [TIFF OMITTED] TR08JA98.000
Where:
P = the penetration value for a worker for a particular wearing period,
p = the arithmetic mean penetration value for the
population,
B = a lognormally distributed factor that transforms
p to the arithmetic mean penetration value for the
individual worker, and
W = a lognormally distributed factor that transforms
p x B to the P value experienced by the
individual worker for a particular wearing time.
The factors W and B describe within-worker variability and between-
worker variability, respectively.
Since workplace protection factor studies typically report the
geometric mean and geometric standard deviation of protection factor
values obtained from a cohort of respirator wearers (i.e., GM[P] and
GSD[P]), the parameters described above for within-worker and between
worker variability can be estimated as follows if the relationship
between GSD[B] and GSD[W] are known or assumed. Let R represent the
ratio of GSD[W]/GSD[B]; then GSD[B] can be estimated from GSD[P] and R
by the relationship
[GRAPHIC] [TIFF OMITTED] TR08JA98.001
[[Page 1170]]
GSD[W], GM[B], and GM[W] are estimated by:
[GRAPHIC] [TIFF OMITTED] TR08JA98.002
The arithmetic mean of the total distribution of penetration values
across the whole cohort, p, is estimated by:
[GRAPHIC] [TIFF OMITTED] TR08JA98.003
Nicas (Ex. 156) defines two additional values, and
, that are based on the parameters described above. The value
represents the 95th percentile of the between-wearer
distribution of average penetration values among a cohort of respirator
wearers; thus, there is a 5 percent chance that a respirator wearer in
the cohort could have an average penetration value of or
higher. If is set to some penetration value reflecting some
minimum acceptable value of protection, the probability that a
respirator wearer would fail, on average, to achieve the minimum
acceptable penetration value is Pr(Z>z), where
[GRAPHIC] [TIFF OMITTED] TR08JA98.004
and Z is the standard normal deviate. By estimating the parameters
p, GM[B], and GSD[B] from WPF data, one can
estimate the probability that a respirator wearer could have an average
penetration value greater than some specified value .
The value is defined by Nicas (Ex. 154) based on the
distribution of each worker's 95th percentile P value and represented
the P value experienced at least 5 percent of the time by 95 percent of
workers in the cohort. If is set to some minimum acceptable P
value, the estimated probability that a respirator wearer could fail to
achieve the minimum P value at least 5% of the time is Pr(Z>z), where
[GRAPHIC] [TIFF OMITTED] TR08JA98.005
and Z is the standard normal deviate. Thus, the proportion of workers
who fail to achieve a P value of at least 5 percent of the
time can be determined by estimating the parameters
p, GM[B], and GSD[W] from WPF data.
The following hypothetical example illustrates OSHA's use of the
model to estimate the risk to workers of experiencing an overexposure
while using respiratory protection. Suppose that the WPF values
obtained from a group of workers using half-mask, negative-pressure
respirators are found to have a geometric mean of 50 (i.e., GM[P] = 1/
50 = 0.02) and a geometric standard deviation of 3.0 (GSD[P] = 3.0).
Furthermore, from one of the WPF studies reviewed by OSHA (Galvin et
al.) (Ex. 64-22), it was reported that within-worker variability
exceeded between-worker variability in workplace protection factors,
with the ratio GSD[W]/GSD[B] = 1.5. From equations 4 through 7 above,
and assuming that R = 1.5, then GSD[B] = 1.73, GSD[W] = 2.60, GM[W] =
0.63, and GM[B] = 0.86. The arithmetic average of the cohort's P
values, p, is estimated from equation 8 to be
0.037. If a protection factor of less than 10 (the NIOSH minimum
assigned PF for half-mask respirators) is considered to place the
worker at risk of an overexposure, then equation 9 predicts a
probability of 1.8 percent that a worker in the group would be expected
to have an average WPF value of 10 or less (i.e., is set to
0.1 in equation 9); that is, 1.8 percent of the group of respirator
wearers would frequently encounter situations where they are working in
a hazardous environment without the minimum protection expected from
the respirators being used. By equation 10, there is a substantial
probability (47 percent) that a worker in the cohort would not achieve
a minimum protection factor of 10 at least 5 percent of the time that
respirators are used (i.e., is set to 0.1 in equation 10).
OSHA used the Nicas and Spear model, the summary data from the WPF
studies reviewed above, and the method outlined in the example
described above to estimate the probability that a respirator wearer
would fail to receive adequate protection from their respirator; the
detailed results of this analysis appear in Table V-1, and summary
findings are listed in Table V-2. From the studies that reflect the
lack of an adequate respiratory protection program, the Nicas and Spear
model predicts a high probability (between 36 and 100 percent) that a
wearer would
[[Page 1171]]
not achieve an average protection factor of 10. Data from two of these
studies by Toney and Barnhart (Ex. 64-68), and Harris et al. (Ex. 27-
11), when used in the model, suggest a probability of between 13 and 39
percent that the average WPF for a respirator wearer could be 2 or
less, which may be considered equivalent to receiving no long-term
protection at all. In contrast, workers included in the studies
reflecting good respirator program elements would be expected to
experience low WPFs much less frequently. The probability that a wearer
would attain an average WPF of 10 or less is estimated to be between
<0.01 and 3 percent. Results from the studies that reflect good
respiratory program practices also indicate that long-term average WPF
values at or below 2 would rarely occur. The results from this analysis
demonstrate that deficiencies in implementing a good respirator program
can greatly increase the chance that the wearer of a negative-pressure
respirator will receive less than the minimum expected average
protection from the respirator over the long-term, thus increasing the
chance that the worker will be exposed to a higher chronic health risk.
Table V-2.--Summary Estimates of the Probability of Achieving Inadequate
Fits for Half-Mask, Negative-Pressure Respirators Under Deficient and
Good Respiratory Protection Programs
------------------------------------------------------------------------
Percent probability that wearer will
achieve
-------------------------------------
Workplace fit
Quality of respirator program factor of less
Average workplace than 10 at least
fit factor of 5 percent of time
less than 10 that respirator
is worn
------------------------------------------------------------------------
Deficient......................... 36-100 99-100
Good.............................. <0.01-3 <0.01-32
------------------------------------------------------------------------
OSHA's analysis (Tables V-1 and V-2) also demonstrates that workers
using respiratory protection under a deficient program will be exposed
more frequently to higher concentrations of airborne contaminants,
which may increase the risk that the worker will experience acute
health effects. The Nicas and Spear model applied to the studies that
reflect inadequate respirator programs predicts nearly a 100 percent
chance that a protection factor of less than or equal to 10 would be
experienced at least 5 percent of the time. Under conditions of a good
respirator program, use of the model suggests no more than a 32 percent
chance that WPFs of less than or equal to 10 will occur more than 5
percent of the time.
OSHA finds that, without an adequate respiratory protection program
in place, a substantial fraction of respirator users are at risk of
being overexposed to hazardous air contaminants due to poor respirator
performance. The studies conducted under conditions of a poor
respirator program, when analyzed using the Nicas and Spear model,
suggest a greater than 50 percent probability that the wearer of a
half-mask, negative-pressure respirator will regularly fail to attain
the expected minimum level of protection, and that the chance of
receiving essentially no protection is substantial. OSHA considers
these risks of overexposure to be significant. The studies reviewed by
Nelson and the Galvin study indicate that these risks are considerably
lower in situations where respirators are used in conjunction with the
implementation of strong respiratory protection program elements such
as appropriate fit testing, adequate employee training, use of clean
respirators in good working order, and regular monitoring of employees
to ensure proper respirator use. Thus, OSHA finds that implementation
of a comprehensive respiratory protection program, such as the one
prescribed by the final rule, will substantially reduce the risk of
overexposure that is due to respirator failure. Because such
overexposures can place workers at a significant risk of health
impairment, as described earlier in this section, OSHA also finds that
promulgation of the final rule will substantially reduce the
significant health risks associated with those overexposures.
VI. Summary of the Final Economic Analysis
In the Final Economic Analysis, OSHA addresses the significant
issues related to technological and economic feasibility and small
business impacts raised in the rulemaking process. This analysis also
explains in detail the Agency's findings and conclusions concerning
pre-standard (baseline) conditions, such as respirator program
practices, in establishments in the regulated community, and discusses
how and why the requirements of the standard are expected to reduce
employee exposures. The preamble to the revised rule and the Final
Economic Analysis are integrally related and together present the
fullest statement of OSHA's reasoning concerning this standard. The
Final Economic Analysis has been placed in the rulemaking docket.
This analysis of OSHA's revised Respiratory Protection standard (29
CFR 1910.134) has been conducted in accordance with Executive Orders
(EOs) 12866 and 12875, the Regulatory Flexibility Act (as amended in
1996), the Small Business Regulatory Enforcement Fairness Act (SBREFA),
the Unfunded Mandates Reform Act (UMRA) and the Occupational Safety and
Health Act. The standard is a ``significant'' rule as defined by EO
12866, a ``major'' rule as defined by Sec. 804 of SBREFA, and a
``significant'' rule as defined by UMRA.
The purposes of this Final Economic Analysis are to:
Describe the need for a revised standard governing the use
of respirators;
Identify the establishments, industries and employees
potentially affected by the standard;
Evaluate the costs, benefits, economic impacts and small
business impacts of the standard on affected firms;
Assess the technological and economic feasibility of the
standard for affected establishments, industries, and small businesses;
and
Identify the availability of effective non-regulatory and
alternative regulatory approaches.
OSHA's final Respiratory Protection standard covers the use of
respiratory protection in general industry, construction and shipyard
employment, as well as marine terminals and longshoring. In all, about
5 million
[[Page 1172]]
employees are estimated to use respirators. 1 Workers use
respirators to protect themselves from a wide variety of occupational
exposures. Respirators are used, at least to some extent, in virtually
every industry, although the extent of respirator use varies by
industry. Manufacturing and construction have relatively heavy
respirator use; in contrast, use in many service industries is very
limited.
---------------------------------------------------------------------------
\1\ Approximately 5% of these respirator-using employees would
be subject to OSHA's substance-specific health standards rather than
to this standard.
---------------------------------------------------------------------------
Chapter II of the economic analysis describes the pattern of
respirator use within each affected industry. To develop this profile,
the Agency analyzed the results of several OSHA-sponsored nationwide
surveys. The results of OSHA's analysis appear in Table VI-1. The
Agency estimates that approximately five percent of workers wear
respirators at some time, and that approximately 1.3 million
establishments, or about 20 percent of all establishments, have
employees who use respirators. Approximately 900,000 of these
establishments are very small, i.e., have fewer than 20 employees. For
a discussion of the number of firms identified by the Small Business
Administration (SBA) as small, see Chapter V.
Table VI-1.--Number of Respirator Users and Their Employers by Industry
----------------------------------------------------------------------------------------------------------------
Number of
Number of Total number establishments
SIC and industry Total respirator of with
employment wearers establishments respirator
wearers
----------------------------------------------------------------------------------------------------------------
07 Agricultural services....................... 555,686 48,262 95,956 25,464
08 Forestry.................................... 17,716 2,764 2,251 950
13 Oil and gas extraction...................... 257,694 46,180 18,502 3,313
15 General contractors and operative builders.. 1,096,289 202,284 180,998 70,835
16 Heavy construction, except building......... 679,578 99,668 34,332 13,403
17 Special trade contractors................... 2,731,774 491,928 382,528 115,380
20 Food and kindred products................... 1,498,078 87,589 21,049 8,899
21 Tobacco products............................ 37,189 2,022 119 47
22 Textile mill products....................... 615,683 66,989 6,245 1,937
23 Apparel and other textile products.......... 972,060 26,431 24,293 5,238
24 Lumber and wood products.................... 675,081 89,970 37,087 15,922
25 Furniture and fixtures...................... 476,488 56,141 11,515 7,675
26 Paper and allied products................... 627,746 41,313 6,478 2,616
27 Printing and publishing..................... 1,500,580 19,185 65,416 6,393
28 Chemicals and allied products............... 851,720 230,405 12,371 10,744
29 Petroleum and coal products................. 112,984 29,647 2,117 1,398
30 Rubbber and miscellaneous plastics products. 915,166 53,800 16,048 6,805
31 Leather and leather products................ 104,747 4,406 2,025 324
32 Stone, clay, and glass products............. 471,639 69,904 16,208 8,798
33 Primary metal industries.................... 655,556 133,012 6,726 4,105
34 Fabricated metal products................... 1,371,072 124,289 36,416 17,134
35 Industrial machinery and equipment.......... 1,749,735 96,161 54,436 25,545
36 Electronic and other electronic equipment... 1,424,351 65,930 17,073 6,895
37 Transportation equipment.................... 1,601,554 185,783 11,420 7,649
38 Instruments and related products............ 878,379 35,188 11,419 4,207
39 Miscellaneous manufacturing industries...... 375,501 22,751 17,183 6,793
40 Railroad transportation..................... 49,200 1,790 1,000 225
41 Local and interurban passenger transit...... 366,657 13,337 18,603 4,194
42 Trucking and warehousing.................... 1,633,543 59,497 115,531 26,049
44 Water transportation........................ 162,478 7,458 8,412 605
45 Transportation by air....................... 344,822 12,543 11,436 822
46 Pipelines, except natural gas............... 17,143 2,808 811 521
47 Transportation services..................... 363,103 22,428 47,858 3,441
48 Communication............................... 1,299,658 15,176 40,399 3,457
49 Electric, gas, and sanitary services........ 924,373 187,298 21,040 10,148
50 Wholesale trade--durable goods.............. 3,414,441 373,644 317,418 118,387
51 Wholesale trade--nondurable goods........... 2,504,260 289,619 185,908 70,196
52 Building materials and garden supplies...... 696,228 95,688 69,965 19,822
53 General merchandise stores.................. 2,141,964 21,420 35,646 3,565
54 Food stores................................. 3,027,828 30,278 181,850 18,185
55 Automotive dealers and service stations..... 1,992,774 245,662 198,905 80,121
56 Apparel and accessory stores................ 1,194,121 15,788 143,526 14,353
57 Furniture and homefurnishings stores........ 754,024 12,348 112,254 11,225
58 Eating and drinking places.................. 6,727,618 67,276 441,512 44,151
59 Miscellaneous retail........................ 2,422,923 38,734 352,129 35,213
60 Depository institutions..................... 2,095,049 20,950 102,622 10,262
61 Nondepository institutions.................. 483,133 4,831 41,869 4,187
62 Security and commodity brokers.............. 449,826 4,498 34,325 3,433
63 Insurance carriers.......................... 1,570,356 15,704 43,784 4,378
64 Insurance agents, brokers, and service...... 656,007 13,452 122,292 12,229
65 Real estate................................. 1,335,048 25,846 234,961 23,496
67 Holding and other investment offices........ 254,172 3,016 27,420 2,742
70 Hotels and other lodging places............. 1,527,126 15,271 52,874 5,287
[[Page 1173]]
72 Personal services........................... 1,252,777 45,854 200,520 23,848
73 Business services........................... 5,832,261 255,034 322,668 38,375
75 Auto repair, services, and parking.......... 903,806 110,528 174,635 70,345
76 Miscellaneous repair services............... 439,495 5,103 72,763 3,810
78 Motion pictures............................. 500,889 5,009 42,457 4,246
79 Amusements and recreation services.......... 1,201,248 12,012 88,077 8,808
80 Health services............................. 10,403,118 217,118 471,873 108,337
81 Legal services.............................. 962,374 17,417 158,335 15,834
82 Educational services........................ 1,967,024 19,670 42,867 4,287
83 Social services............................. 2,028,694 20,287 145,998 14,600
84 Museums, botanical, zoological gardens...... 73,874 739 3,607 361
86 Membership organizations.................... 2,062,501 26,275 238,868 23,887
87 Engineering and management services......... 2,589,839 27,483 249,846 24,985
89 Services, n.e.c............................. 84,960 1,607 14,606 1,461
92 Fire Departments (State Plan States)........ 126,500 126,500 9,283 9,283
Other public sector (State Plan States)..... 7,677,000 114,570 203,158 20,316
---------------------------------------------------------------
Total..................................... 98,768,281 4,953,568 6,494,122 1,281,945
----------------------------------------------------------------------------------------------------------------
Sources: DOL, OSHA Office of Regulatory Analysis; County Business Patterns, 1993; OSHA's respirator, PEL, PPE,
and Construction PEL surveys.
The new standard is programmatic in nature, reflects current
practice at many facilities, and does not require the use of new
technology. Thus, OSHA finds that the standard is clearly
technologically feasible for affected firms of all sizes.
The benefits that will accrue to respirator users and their
employers are substantial and take a number of forms. Chapter IV of the
analysis describes these benefits, both in quantitative and qualitative
forms. The standard will benefit workers by reducing their exposures to
respiratory hazards. Improved respirator selection procedures, better
fit test procedures, and improved training, all areas strengthened by
the revised standard, will contribute substantially to greater worker
protection. Estimates of the benefits of the standard are complicated
by uncertainties about the effectiveness of the standard and the number
of covered work-related illnesses. The Agency estimates that the
standard will avert between 843 and 9,282 work-related injuries and
illnesses annually, with a best estimate (expected value) 2
of 4,046 averted illnesses and injuries annually. In addition, the
standard is estimated to prevent between 351 and 1,626 deaths annually
from cancer and many other chronic diseases, including cardiovascular
disease, with a best estimate (expected value) of 932 averted deaths
from these causes.3
---------------------------------------------------------------------------
\2\ OSHA believes that, for the purposes of this rulemaking, the
most reasonable way to summarize the uncertainties in benefits
estimates via a single numerical estimate is to use the expected
value; that is, the average of all plausible values weighted by
their relative probabilities. For simplicity's sake, OSHA will refer
to this point estimate as the ``best estimate.''
\3\ Because this regulation will not directly affect the
benefits for the estimated 5% of employees who wear respirators as a
result of OSHA's substance-specific health standards (except to the
extent that uniformity of provisions improve compliance), and these
respirator-wearing employees are included in the benefits estimates
presented here, the benefits of the revised respiratory protection
standard are somewhat overestimated. In particular, deaths and
illnesses caused by exposures to such OSHA-regulated substances as
asbestos and lead may in fact account for a disproportionate share
(more than 5%) of the occupational illnesses and deaths attributed
by this analysis to the respirator standard. This means that OSHA's
benefits estimates are likely to be overstated by more than 5%.
Nevertheless, OSHA believes that the substantial majority of the
benefits resulting from appropriate respirator use can be properly
attributed to the respirator standard.
---------------------------------------------------------------------------
The annual costs employers in the affected establishments are
estimated to incur to comply with the revised respirator standard total
$111 million.4 These costs, which are presented in detail in
Chapter III of the full economic analysis, are annualized over a 10-
year horizon at a discount rate of 7 percent; Table VI-2 shows
annualized costs by provision of the standard. The most costly
provisions are those requiring annual fit testing of respirators and
annual refresher training. These two provisions together account for
approximately 90 percent of the standard's compliance costs. As a rule,
costs are largely determined by the extensiveness of respirator use in
affected establishments. This analysis did not attempt to factor in the
offsetting value of cost savings from regulatory changes, such as
dropping the existing standard's prohibition against contact lens use,
providing for greater uniformity for substance-specific health standard
respirator provisions, or allowing employers to use licensed health
care providers in addition to physicians to perform medical
evaluations.
---------------------------------------------------------------------------
\4\ Because this regulation does not directly affect the costs
for the estimated 5% of employees who wear respirators as a result
of OSHA's substance-specific health standards, and these respirator
users are included in the cost estimates, the costs are somewhat
overestimated. Because costs are approximately proportional to the
number of employees affected, the magnitude of this overestimate is
likely to be about 5%.
[[Page 1174]]
Table VI-2.--Annual Cost of Respirator Standard Revisions for Respirator-Using Establishments, by Provision
--------------------------------------------------------------------------------------------------------------------------------------------------------
Labeling
Revision Certification for
SIC and industry written Annual fit Annual for emergency sorbent Recordkeeping Total
plans testing training respirator bed
inspections changes
--------------------------------------------------------------------------------------------------------------------------------------------------------
07 Agricultural services............................... $31,755 $441,836 $298,047 $0 $0 $35,858 $807,497
08 Forestry............................................ 1,228 25,475 13,849 0 0 2,054 42,606
13 Oil and gas extraction.............................. 8,769 734,048 315,180 41,551 0 34,312 1,133,860
15 General contractors and operative builders.......... 141,534 2,992,402 1,909,631 0 479 150,297 5,194,342
16 Heavy construction, except building................. 32,027 1,534,132 736,976 0 2,109 74,053 2,379,297
17 Special trade contractors........................... 256,681 7,820,459 4,340,977 0 1,344 365,502 12,784,963
20 Food and kindred products........................... 21,109 1,006,778 428,004 86,371 0 65,078 1,607,339
21 Tobacco products.................................... 210 37,254 16,252 0 0 1,502 55,218
22 Textile mill products............................... 4,349 728,823 286,222 9,703 0 49,773 1,078,870
23 Apparel and other textile products.................. 7,864 226,658 101,380 0 0 19,638 355,540
24 Lumber and wood products............................ 27,997 972,293 489,510 16,750 0 66,848 1,573,397
25 Furniture and fixtures.............................. 13,119 623,774 289,781 53,627 0 41,712 1,022,013
26 Paper and allied products........................... 8,373 877,037 280,715 66,279 105 30,696 1,263,205
27 Printing and publishing............................. 15,217 221,275 139,295 0 0 14,255 390,041
28 Chemicals and allied products....................... 33,159 4,194,240 1,656,678 741,170 763 171,191 6,797,201
29 Petroleum and coal products......................... 4,699 646,431 277,684 108,927 16 22,028 1,059,785
30 Rubber and miscellaneous plastics products.......... 14,100 676,734 284,187 2,068 0 39,974 1,017,063
31 Leather and leather products........................ 456 37,208 15,800 1,502 0 3,274 58,239
32 Stone, clay, and glass products..................... 20,743 1,018,192 464,833 28,365 11 51,939 1,584,083
33 Primary metal industries............................ 14,028 2,263,416 951,396 44,664 28 98,828 3,372,360
34 Fabricated metal products........................... 41,510 1,663,770 765,562 178,892 0 92,346 2,742,081
35 Industrial machinery and equipment.................. 64,626 1,498,968 786,251 0 868 71,447 2,422,161
36 Electronic and other electronic equipment........... 17,103 917,414 388,929 24,483 657 48,986 1,397,572
37 Transportation equipment............................ 23,876 3,413,486 1,568,463 100,401 8,775 138,037 5,253,038
38 Instruments and related products.................... 10,299 516,278 230,813 1,626 333 26,145 785,493
39 Miscellaneous manufacturing industries.............. 12,007 250,490 136,104 0 176 16,904 415,682
40 Railroad transportation............................. 937 37,818 16,134 0 0 1,330 56,219
41 Local and interurban passenger transit.............. 9,002 167,510 86,710 0 0 9,910 273,131
42 Trucking and warehousing............................ 64,666 791,301 511,259 570 0 44,206 1,412,003
44 Water transportation................................ 1,588 136,318 65,312 0 0 5,541 208,760
45 Transportation by air............................... 2,015 199,061 85,196 0 0 9,320 295,592
46 Pipelines, except natural gas....................... 1,637 87,121 31,182 0 15 2,086 122,041
47 Transportation services............................. 6,150 256,532 135,948 0 0 16,664 415,294
48 Communication....................................... 9,141 282,097 141,518 0 0 11,276 444,032
49 Electric, gas, and sanitary services................ 32,542 3,736,483 1,662,243 359,209 4,581 139,162 5,934,220
50 Wholesale trade--durable goods...................... 241,074 5,545,911 2,737,719 6,687 0 277,618 8,809,008
51 Wholesale trade--nondurable goods................... 134,760 3,979,336 1,728,752 126,854 0 215,187 6,184,888
52 Building materials and garden supplies.............. 24,193 922,814 418,187 0 0 71,096 1,436,291
53 General merchandise stores.......................... 5,369 135,056 56,819 0 0 15,915 213,160
54 Food stores......................................... 27,336 208,820 154,036 0 0 22,497 412,689
55 Automotive dealers and service stations............. 112,276 1,920,333 1,281,723 0 0 182,527 3,496,858
56 Apparel and accessory stores........................ 19,022 91,801 92,713 0 0 11,730 215,266
57 Furniture and homefurnishings stores................ 20,225 111,532 106,953 0 0 9,175 247,884
58 Eating and drinking places.......................... 47,123 257,557 214,860 0 0 49,986 569,526
59 Miscellaneous retail................................ 53,098 275,565 269,808 0 0 28,780 627,250
60 Depository institutions............................. 20,271 207,313 135,320 0 0 15,566 378,470
61 Nondepository institutions.......................... 10,608 51,626 53,951 0 0 3,590 119,776
62 Security and commodity brokers...................... 10,508 64,998 58,550 0 0 3,342 137,397
63 Insurance carriers.................................. 13,360 226,063 123,889 0 0 11,668 374,979
64 Insurance agents, brokers, and service.............. 36,394 200,209 199,277 0 0 9,995 445,875
65 Real estate......................................... 70,079 348,877 368,891 0 0 19,203 807,051
67 Holding and other investment offices................ 8,272 43,583 43,970 0 0 2,241 98,066
70 Hotels and other lodging places..................... 8,119 101,853 57,381 0 0 11,347 178,699
72 Personal services................................... 26,015 552,641 270,488 0 0 34,069 883,214
73 Business services................................... 58,974 3,325,952 1,172,726 0 0 189,490 4,747,142
75 Auto repair, services, and parking.................. 93,387 970,308 881,030 0 0 82,122 2,026,846
76 Miscellaneous repair services....................... 5,735 61,214 54,759 0 0 3,791 125,499
78 Motion pictures..................................... 11,425 62,923 61,091 0 0 3,722 139,160
79 Amusement and recreation services................... 14,128 93,683 76,484 0 0 8,925 193,220
80 Health services..................................... 183,206 2,510,780 1,948,071 0 0 161,319 4,803,376
81 Legal services...................................... 47,661 253,320 256,703 0 0 12,941 570,625
82 Educational services................................ 10,933 259,816 125,365 0 0 14,615 410,729
83 Social services..................................... 23,601 166,510 130,949 0 0 15,073 336,133
84 Museums, botanical, zoological gardens.............. 891 8,995 6,036 0 0 549 16,471
86 Membership organizations............................ 57,115 316,483 304,939 0 0 19,523 698,060
87 Engineering and management services................. 74,480 380,740 390,356 0 0 20,420 865,997
89 Services, n.e.c..................................... 4,082 28,754 22,201 0 0 1,194 56,231
[[Page 1175]]
92 Fire Departments.................................... 24,723 2,265,377 1,005,792 0 0 93,990 3,389,882
Other public sector................................. 48,361 49,739 1,147,899 0 0 85,126 1,331,125
-----------------------------------------------------------------------------------------------
Total................................................... 2,501,319 67,033,593 35,865,707 1,999,699 20,259 3,680,501 111,101,079
--------------------------------------------------------------------------------------------------------------------------------------------------------
Source: Department of Labor, Safety and Health Administration, Office of Regulatory Analysis.
Chapter V of the economic analysis analyzes the impact of these
compliance costs on establishments in affected industries. The standard
is clearly economically feasible: the cost in the average affected
establishment is 0.002 percent of sales and 0.03 percent of profits; in
the most heavily impacted industry--business services, SIC 73--
annualized compliance costs amount to only 0.1 percent of estimated
sales and 1.22 percent of profits. In the next most heavily impacted
industry--Special Trade Contractors, SIC 17--costs amount only to 0.02
percent of sales and 0.46 percent of profits. These results are shown
in Table VI-3.
TABLE VI-3.--Annual Cost of Final Respiratory Protection Standard as a Percent of Sales and Profits of
Respirator-using Establishments
----------------------------------------------------------------------------------------------------------------
Average Compliance Compliance
compliance Average sales/ Average cost as a cost as a
SIC and industry cost/ establishment profit/ percent of percent of
establishment establishment sales profits
----------------------------------------------------------------------------------------------------------------
07 Agricultural services................ $32 $269,290 17,425 0.01 0.18
08 Forestry............................. 45 897,908 69,720 0.00 0.06
13 Oil and gas extraction............... 364 11,234,630 1,021,330 0.00 0.04
15 General contractors and operative
builders................................ 73 1,131,765 52,585 0.01 0.14
16 Heavy construction, except building.. 178 2,709,660 146,028 0.01 0.12
17 Special trade contractors............ 111 476,348 24,098 0.02 0.46
20 Food and kindred products............ 192 20,620,629 999,788 0.00 0.02
21 Tobacco products..................... 1,169 869,935,367 204,319,114 0.00 0.00
22 Textile mill products................ 578 7,611,245 438,223 0.01 0.13
23 Apparel and other textile products... 68 3,228,588 194,177 0.00 0.03
24 Lumber and wood products............. 99 2,539,729 146,588 0.00 0.07
25 Furniture and fixtures............... 140 3,571,798 216,729 0.00 0.06
26 Paper and allied products............ 551 22,478,383 1,260,152 0.00 0.04
27 Printing and publishing.............. 61 2,096,632 152,975 0.00 0.04
28 Chemicals and allied products........ 909 29,454,052 2,231,368 0.00 0.04
29 Petroleum and coal products.......... 1,053 143,210,471 6,292,581 0.00 0.02
30 Rubber and miscellaneous plastics
products................................ 150 8,202,235 584,099 0.00 0.03
31 Leather and leather products......... 187 7,267,252 429,429 0.00 0.04
32 Stone, clay, and glass products...... 183 4,184,931 228,219 0.00 0.08
33 Primary metal industries............. 864 18,123,180 1,015,996 0.00 0.08
34 Fabricated metal products............ 170 4,348,383 266,070 0.00 0.06
35 Industrial machinery and equipment... 95 6,924,099 482,589 0.00 0.02
36 Electronic and other electronic
equipment............................... 207 11,591,397 684,946 0.00 0.03
37 Transportation equipment............. 724 44,334,058 1,948,012 0.00 0.04
38 Instruments and related products..... 187 10,720,444 763,426 0.00 0.02
39 Miscellaneous manufacturing
industries.............................. 61 1,568,937 111,245 0.00 0.06
40 Railroad transportation.............. 249 NA NA NA NA
41 Local and interurban passenger
transit................................. 65 1,014,732 43,699 0.01 0.15
42 Trucking and warehousing............. 54 1,286,872 58,437 0.00 0.09
44 Water transportation................. 345 NA NA NA NA
45 Transportation by air................ 359 3,106,975 197,717 0.01 0.18
46 Pipelines, except natural gas........ 234 13,802,633 585,566 0.00 0.04
47 Transportation services.............. 121 23,585,180 8,076,137 0.00 0.00
48 Communication........................ 128 1,894,095 82,755 0.01 0.16
49 Electric, gas, and sanitary services. 677 15,622,527 2,485,402 0.00 0.03
50 Wholesale trade--durable goods....... 74 14,371,043 1,350,007 0.00 0.01
51 Wholesale trade--nondurable goods.... 89 2,282,652 102,134 0.00 0.09
52 Building materials and garden
supplies................................ 72 4,447,849 172,734 0.00 0.04
53 General merchandise stores........... 60 1,075,912 36,708 0.01 0.16
54 Food stores.......................... 23 8,648,964 471,762 0.00 0.00
55 Automotive dealers and service
stations................................ 44 2,179,673 61,031 0.00 0.07
56 Apparel and accessory stores......... 15 2,010,075 47,296 0.00 0.03
57 Furniture and homefurnishings stores. 22 737,603 47,246 0.00 0.05
58 Eating and drinking places........... 13 672,234 34,798 0.00 0.04
[[Page 1176]]
59 Miscellaneous retail................. 18 734,358 34,558 0.00 0.05
60 Depository institutions.............. 37 547,141 30,254 0.01 0.12
61 Nondepository institutions........... 29 8,651,403 NA 0.00 NA
62 Security and commodity brokers....... 40 9,094,686 1,419,322 0.00 0.00
63 Insurance carriers................... 86 6,131,429 631,723 0.00 0.01
64 Insurance agents, brokers, and
service................................. 36 65,412,387 NA 0.00 NA
65 Real estate.......................... 34 674,913 NA 0.01 NA
67 Holding and other investment offices. 36 500,929 46,869 0.01 0.08
70 Hotels and other lodging places...... 34 5,183,873 573,368 0.00 0.01
72 Personal services.................... 37 1,243,240 97,027 0.00 0.04
73 Business services.................... 124 128,952 10,164 0.10 1.22
75 Auto repair, services, and parking... 29 975,693 74,455 0.00 0.04
76 Miscellaneous repair services........ 33 358,494 22,775 0.01 0.14
78 Motion pictures...................... 33 181,478 11,743 0.02 0.28
79 Amusement and recreation services.... 22 1,597,336 142,792 0.00 0.02
80 Health services...................... 44 631,398 31,198 0.01 0.14
81 Legal services....................... 36 1,167,682 71,435 0.00 0.05
82 Educational services................. 96 421,539 67,758 0.02 0.14
83 Social services...................... 23 2,613,764 174,383 0.00 0.01
84 Museums, botanical, zoological
gardens................................. 46 351,713 16,137 0.01 0.28
86 Membership organizations............. 29 560,217 40,331 0.01 0.07
87 Engineering and management services.. 35 320,236 15,070 0.01 0.23
89 Services, n.e.c...................... 38 1,030,962 81,876 0.00 0.05
92 Fire Departments..................... 365 NA NA NA NA
other public sector ................ 66 NA NA NA NA
----------------------------------------------------------------------------------------------------------------
Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.
In the Preliminary Regulatory Impact Analysis developed in support
of OSHA's 1994 Respiratory Protection proposal [Ex. 57], the Agency
examined the impact of the proposal on different sizes of
establishments. Based on that analysis, the Agency certified that the
proposed standard would not have a significant economic impact on a
substantial number of small entities. Upon review of comments and other
data submitted to the record of this rulemaking, the Agency has
analyzed the final rule's impact on small entities, as defined by the
Small Business Administration (SBA) and in accordance with the
Regulatory Flexibility Act. In addition, in order to ensure that even
the smallest entities are not significantly impacted, the Agency
performed an analysis of impacts on the smallest establishments, i.e.,
those with fewer than 20 employees.
The impacts of the standard on sales and profits did not exceed 1
percent for small firms in any covered industry, whether the analysis
used the SBA's definitions or the fewer-than-20-employee size class
definition. Because the incremental costs of the final rule are
primarily related to the number of respirator users per establishment
and because small entities do not have a higher percentage of
respirator users than large establishments, the standard does not have
a differential impact on small entities. If the costs of compliance
were influenced by economies of scale, such effects would have been
demonstrated by OSHA's analysis of the smallest firms, i.e., those with
fewer than 20 employees. However, no such effects were seen, even among
firms in this smallest size-class. Therefore, the Agency has no reason
to believe that establishments or firms in intermediate size groupings,
i.e., those in the range between 20 employees and the employment size
cutoff for the applicable SBA definition, would experience larger
impacts. Finding this, the Agency certifies that the final Respiratory
Protection standard will not have a significant adverse economic impact
on a substantial number of small entities. The results of OSHA's
analysis of small business impacts on firms 5 within the
SBA's size classifications are shown in Table VI-4.
---------------------------------------------------------------------------
\5\ The Agency also examined the impact of the costs of
compliance on governmental entities serving communities with fewer
than 50,000 people, and also found small impacts.
Table VI-4.--Annual Cost of the Respiratory Protection Standard as a Percent of Sales for Respirator-Using Small Firms \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number Average Compliance Compliance
of compliance Average cost as a Average cost as a
SIC and industry Small business definition \1\ affected cost per sales per percent of profit per percent of
firms firm firm sales firm profits
--------------------------------------------------------------------------------------------------------------------------------------------------------
07 Agricultural services............... $5 million \2\...................... 23,313 $36 $223,567 0.02 $14,466 0.25
08 Forestry............................ $5 million.......................... 860 41 470,247 0.01 36,513 0.11
13 Oil and gas extraction.............. 500 employees....................... 2,565 222 2,017,392 0.00 226,361 0.10
[[Page 1177]]
15 General contractors and operative $17 million......................... 70,232 75 954,486 0.01 43,794 0.17
builders.
16 Heavy construction, except building. $17 million......................... 12,628 135 1,611,092 0.00 72,025 0.19
17 Special trade contractors........... $7 million.......................... 114,097 117 490,343 0.02 24,806 0.47
20 Food and kindred products........... 500 employees....................... 5,583 143 7,070,622 0.00 288,666 0.05
21 Tobacco products.................... 500 employees....................... 27 434 419,423,746 0.00 98,271,892 0.00
22 Textile mill products............... 500 employees....................... 1,306 243 4,485,467 0.00 236,814 0.10
23 Apparel and other textile products.. 500 employees....................... 4,227 49 1,717,339 0.00 84,857 0.06
24 Lumber and wood products............ 500 employees....................... 13,854 96 1,520,435 0.00 80,494 0.12
25 Furniture and fixtures.............. 500 employees....................... 5,860 135 2,063,881 0.00 101,980 0.13
26 Paper and allied products........... 500 employees....................... 1,082 364 7,356,895 0.00 389,269 0.09
27 Printing and publishing............. 500 employees....................... 4,612 63 1,349,101 0.00 82,533 0.08
28 Chemicals and allied products....... 500 employees....................... 3,794 388 7,758,606 0.00 573,110 0.07
29 Petroleum and coal products......... 500 employees....................... 373 505 11,906,004 0.00 523,143 0.10
30 Rubber and miscellaneous plastics 500 employees....................... 3,926 192 4,132,970 0.00 252,124 0.08
products.
31 Leather and leather products........ 500 employees....................... 224 246 2,312,572 0.00 106,106 0.23
32 Stone, clay, and glass products..... 500 employees....................... 5,529 209 2,337,003 0.00 101,728 0.21
33 Primary metal industries............ 500 employees....................... 2,260 530 6,447,895 0.00 359,703 0.15
34 Fabricated metal products........... 500 employees....................... 12,435 167 2,782,599 0.00 138,568 0.12
35 Industrial machinery and equipment.. 500 employees....................... 18,625 152 2,001,196 0.00 118,786 0.13
36 Electronic and other electronic 500 employees....................... 4,356 237 3,836,835 0.00 184,646 0.13
equipment.
37 Transportation equipment............ 500 employees....................... 5,999 281 3,362,262 0.00 120,155 0.23
38 Instruments and related products.... 500 employees....................... 3,266 163 3,239,263 0.00 211,242 0.08
39 Miscellaneous manufacturing 500 employees....................... 5,149 102 1,539,311 0.00 95,981 0.11
industries.
40 Railroad transportation............. 1500 employees...................... NA NA NA NA NA NA
41 Local and interurban passenger $5 million.......................... 2,582 106 417,934 0.01 17,701 0.60
transit.
42 Trucking and warehousing............ $18.5 million....................... 15,626 79 670,885 0.01 29,993 0.26
44 Water transportation................ 500 employees....................... 187 243 1,781,166 0.01 90,917 0.27
45 Transportation by air............... 1500 employees...................... 157 449 2,031,762 0.00 70,300 0.64
46 Pipelines, except natural gas....... 1500 employees...................... 11 888 15,403,556 0.00 5,274,551 0.02
47 Transportation services............. $5 million.......................... 879 55 377,507 0.02 15,544 0.35
48 Communication....................... 1500 employees...................... 1,279 172 2,132,980 0.01 335,309 0.05
49 Electric, gas, and sanitary services $5 million.......................... 3,809 65 883,319 0.01 72,099 0.09
50 Wholesale trade--durable goods...... 100 employees....................... 52,553 43 1,828,263 0.00 73,131 0.06
51 Wholesale trade--nondurable goods... 100 employees....................... 30,785 44 2,682,104 0.00 85,196 0.05
52 Building materials and garden $5 million.......................... 13,619 19 712,058 0.01 24,294 0.08
supplies.
53 General merchandise stores.......... $5 million.......................... 482 14 398,828 0.01 16,892 0.08
54 Food stores......................... $5 million.......................... 6,419 140 763,042 0.00 20,647 0.68
55 Automotive dealers and service $5 million.......................... 38,985 26 774,574 0.01 18,225 0.14
stations.
56 Apparel and accessory stores........ $5 million.......................... 289 41 1,346,240 0.00 85,526 0.05
57 Furniture and homefurnishings stores $5 milion........................... 438 71 1,685,231 0.00 87,235 0.08
58 Eating and drinking places.......... $5 million.......................... 16,852 24 374,691 0.00 17,633 0.14
59 Miscellaneous retail................ $5 million.......................... 12,619 18 406,958 0.01 22,502 0.08
60 Depository institutions............. $5 million.......................... 788 123 1,060,910 0.00 NA NA
61 Nondepository institutions.......... $5 million.......................... 840 25 728,626 0.00 106,401 0.02
62 Security and commodity brokers...... $5 million.......................... 921 33 631,139 0.01 55,488 0.06
63 Insurance carriers.................. $5 million.......................... 365 92 740,731 0.01 NA NA
64 Insurance agents, brokers, and $5 million.......................... 5,583 54 335,823 0.01 NA NA
service.
65 Real estate......................... $5 million.......................... 10,714 56 533,940 0.01 48,369 0.12
67 Holding and other investment offices $5 million.......................... 1,036 36 889,373 0.00 95,534 0.04
70 Hotels and other lodging places..... $5 million.......................... 2,163 41 472,311 0.00 32,784 0.13
72 Personal services................... $5 million.......................... 9,786 80 190,546 0.02 15,019 0.53
73 Business services................... $5 million.......................... 14,343 160 517,986 0.01 37,783 0.42
75 Auto repair, services, and parking.. $5 million.......................... 43,985 47 342,341 0.01 21,749 0.22
76 Miscellaneous repair services....... $5 million.......................... 2,631 34 340,605 0.01 22,039 0.15
78 Motion pictures..................... $5 million.......................... 1,494 29 350,142 0.01 24,304 0.12
79 Amusement and recreation services... $5 million.......................... 4,052 46 469,977 0.00 23,222 0.20
80 Health services..................... $5 million.......................... 39,536 82 521,074 0.01 31,877 0.26
81 Legal services...................... $5 million.......................... 7,288 41 314,988 0.01 48,175 0.09
82 Educational services................ $5 million.......................... 1,739 99 649,462 0.01 35,911 0.28
83 Social services..................... $5 million.......................... 5,194 43 354,060 0.01 16,245 0.26
84 Museums, botanical, zoological $5 million.......................... 158 80 492,341 0.01 35,333 0.23
gardens.
86 Membership organizations............ $5 million.......................... 11,589 55 296,761 0.01 13,965 0.39
87 Engineering and management services. $5 million.......................... 11,383 62 457,931 0.01 34,480 0.18
89 Services, n.e.c..................... $5 million.......................... 679 58 423,854 0.01 36,402 0.16
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As defined by the Small Business Administration, 61 FR 3289.
\2\ Annual receipts.
[[Page 1178]]
Source: Department of Labor, Occupational Safety and Health Administration, Office of Regulatory Analysis.
Unfunded Mandates Analysis
The final Respiratory Protection standard has been reviewed by OSHA
in accordance with the Unfunded Mandates Reform Act of 1995 (UMRA) (2
USC 1501 et seq.) and Executive Order 12875. As discussed in Chapter V,
OSHA estimates that compliance with the revised Respiratory Protection
standard will require expenditures of more than $100 million each year
by employers in the private sector. Therefore, the Respiratory
Protection final rule establishes a Federal private sector mandate and
is a significant regulatory action within the meaning of Section 202 of
UMRA (2 U.S.C. 1532). OSHA has included this statement to address the
anticipated effects of the final rule pursuant to Section 202.
OSHA standards do not apply to state and local governments except
in states that have voluntarily elected to adopt an OSHA State plan and
have then adopted the specific standard in question or one that has
been deemed by OSHA to be equally effective. Consequently, the
Respiratory Protection standard does not impose a ``federal
intergovernmental mandate'' as defined by Section 421(5) of UMRA (2 USC
658 (5)). The revised Respiratory Protection standard therefore does
not impose an unfunded mandate on state and local governments.
Further, OSHA has found that the costs incurred by state and local
governments in those states that choose to adopt the standard will be
small compared to corresponding state and local government
expenditures. If State-plan states adopt the standard, the greatest
impact in some states would be on public fire departments. Bureau of
the Census data on the amount of revenue dedicated to fire protection
by local governments indicate that $14.4 billion was spent on this
service in 1992, the latest year for which such data are available
[Government Finances]. NFPA data indicate that 75.3 percent of the U.S.
population is served by fire departments that employ at least some
career firemen [NFPA, p. 15]. This means that approximately 37.7
percent of the population (approximately half of all state and local
government employees work in State-plan states) is served by at least
partly career fire departments in State-plan states. Assuming the
expenditures for fire protection are spread fairly evenly across the
population, approximately $5.3 billion is spent on fire protection
annually by affected fire departments. As indicated in the cost
analysis (see Table VI-2), the total annual cost of the standard for
public fire departments in State-plan states is approximately $3.5
million, which means that the costs of compliance constitute less than
0.1 percent of the revenue devoted by these states to fire protection.
Costs of this magnitude are clearly an insignificant portion of the
total fire protection budget.
The remainder of this section summarizes OSHA's findings, as
required by Section 202 of UMRA (2 USC 1532):
This standard is issued under Section 6(b) of the OSH Act.
This standard has annualized costs estimated at $111 million,
primarily in the private sector, and is estimated to save hundreds of
lives per year from cancer and cardiovascular disease. Compliance will
also prevent thousands of illnesses annually that would have been
caused by acute and chronic overexposures. The standard will impose no
more than minimal costs on state, local or tribal governments,
substantially less than $100 million. OSHA pays 50 percent of State
plan costs, although the Agency does not provide funding for state,
local or tribal governments to comply with its rules as employers.
OSHA does not anticipate any disproportionate budgetary effects
upon any particular region of the nation or particular state, local, or
tribal governments, or urban or rural or other types of communities.
The principal costs of this standard are to control worker exposures
associated with programmatic provisions such as annual fit testing and
training, activities that are engaged in by thousands of establishments
in hundreds of SIC codes that are widely distributed throughout the
country. Chapters III and V have provided detailed analyses of the
costs and impacts of the standard on particular segments of the private
sector. OSHA has analyzed the economic impacts of the standard on the
industries affected and found that compliance costs are no more than
0.1 percent of sales for establishments in any industry, and
consequently that no plant closures or job losses are anticipated in
the affected industries. As a result, impacts on the national economy
would be too small to be measurable by economic models.
Pursuant to Section 205 of the UMRA (2 USC 1535), after having
considered a variety of alternatives outlined in the Preamble and in
the Regulatory Flexibility Analysis, the Agency has concluded that the
final rule is the most cost-effective alternative for implementation of
OSHA's statutory objective of reducing significant risk to the extent
feasible.
Environmental Impact Analysis
The final Respiratory Protection standard has been reviewed in
accordance with the requirements of the National Environmental Policy
Act (NEPA) of 1969 (42 U.S.C. 4321 et seq.), the regulations of the
Council of Environmental Quality (CEQ) (40 CFR part 1500), and DOL NEPA
procedures (29 CFR part 11). As a result of this review, OSHA has
concluded that the rule will have no significant environmental impact.
References
Bureau of the Census, Government Finances, Series GF, No. 5,
annual, as reported in the Statistical Abstract of the United
States, 1995. GPO, 1995.
VII. Summary and Explanation
This section of the preamble summarizes and explains the provisions
of the final respiratory protection standard. It describes changes made
to the rule since the proposal was issued, discusses the comments
received by the Agency on the proposal, and presents OSHA's rationale
for making these changes. The record evidence supporting each of the
requirements of the final rule is also described in detail in this
section.
This final rule clarifies, updates, and strengthens OSHA's previous
respiratory protection standard, which was adopted by the Agency in
1971 and has remained essentially unchanged since that time. This
rulemaking is thus the first major revision to OSHA's respiratory
protection standard in more than 25 years. As discussed in connection
with several of the individual paragraphs of the revised standard, not
all of the provisions of the standard have been revised; in some cases,
OSHA found, and the record supported, leaving individual provisions
unchanged.
The final respiratory protection standard applies to respirator use
in general industry, construction, shipyards, marine terminals, and
longshoring operations. When used properly, respirators can help to
protect employees from the acute and chronic effects of exposure to
hazardous airborne contaminants, whether in the form of particulates,
vapors, or gases. Generally, OSHA requires respirators to be used to
protect employee health in
[[Page 1179]]
situations where engineering controls and work practices are not
feasible, where such controls have not yet been instituted, in
emergencies, or where such controls are not sufficient, by themselves,
to protect the health of employees.
As noted above, this final standard applies to respirator use in
general industry, construction, shipyards, marine terminals, and
longshoring operations. In the 1994 proposal, OSHA proposed to cover
general industry, shipyards and construction. The longshoring and
marine terminals final rule (48 FR 30908) already made this standard
applicable to those industries as well. To provide clarity, the final
respiratory standard explicitly contains a note setting forth the scope
of the respirator standard.
The preamble to the proposed rule asked for comments about the
appropriateness of applying the final rule to construction and maritime
workplaces. In the case of the construction industry, OSHA specifically
provided the Advisory Committee for Construction Safety and Health
(ACCSH) with a copy of the proposal for review and comment, and ACCSH
recommended that the revised standard apply to construction industry
workplaces. OSHA's responses to these comments are discussed above in
the introduction to this preamble.
In response to the question raised about the applicability of the
standard to the construction and shipyard industries, OSHA received
several comments from participants concerned about the rule's impact on
the construction industry (Exs. 54-102, 54-231, 54-288). These
commenters noted that the costs of the standard for construction
employers may be higher than for their counterparts in general industry
because of the higher turnover, decentralization of workplaces, and
multi-employer work arrangements typical of construction sites.
However, as reported in the Final Economic Analysis (Ex. 196), OSHA has
determined that the final rule is both technologically and economically
feasible for employers in the construction industry. There is no
question that many workers in this industry need respiratory protection
to prevent material impairment of their health; in fact, some of the
most hazardous exposures occur in this industry. For example, workers
engaged in the abrasive blasting of bridges are often exposed to high
concentrations of silica and other hazardous substances (contained in
the abrasive blasting media), as well as to lead, chromates, and other
toxic materials (contained in the paints, coatings, or preservatives
covering the substrate). Welders, demolition workers, tunnel workers,
and painters are other examples of construction trades that often
involve overexposure to toxic substances and require respirators for
control. In fact, respirators may be even more necessary in
construction than in general industry because the transient and
constantly changing nature of many construction worksites makes the use
of engineering controls more difficult in these environments. Finally,
OSHA's previous respiratory protection standard has applied to the
construction industry since 1971 (it is codified at 29 CFR 1926.103);
removing this protection for construction workers would thus decrease
existing safety and health protections despite the significant risk
confronting construction workers in many situations. Decreasing
feasible worker protections in the face of significant risk of material
impairment of health would clearly be contrary to the Agency's mandate.
OSHA received no comments on the applicability of the final rule to
shipyard employment. Like construction workers, shipyard workers have
been covered by the Agency's previous standard since 1971. In addition,
employees in shipyards engage in many of the same highly hazardous
operations as construction workers, including abrasive blasting,
welding, painting, and drilling. The Final Economic Analysis (Ex. 196)
has determined that it is both technologically and economically
feasible for employers in shipyard operations to achieve compliance
with the final rule.
OSHA has recently issued a revised final rule for the Longshoring
(shipboard) portion of marine cargo-handling operations, along with
revisions to the Agency's Marine Terminals (dockside) marine cargo-
handling standard. The scope and application sections of both final
maritime rules specifically incorporate OSHA's respiratory protection
standard (29 CFR 1910.134) by reference. Thus, consistent with the
proposal, this final respiratory protection standard will apply to
workplaces in general industry and in the construction, shipyards,
longshoring, and marine terminals industries.
At the public hearing, the Brotherhood of Maintenance of Way
Employees (BMWE) submitted testimony on the issue of OSHA's respiratory
protection standard's coverage of railroad construction and maintenance
employees (Ex. 122). The BMWE stated:
* * * the BMWE respectfully requests that * * * formal
recognition of the applicability of OSHA 1910.134 for railroad
employees be published in the Federal Register to remove any
lingering questions regarding the applicability of OSHA's
respiratory protection standards to working conditions which,
although located within the railroad industry, are in fact similar
to those of any industrial workplace.
In response to this comment, OSHA notes that both the prior
respiratory protection standard and the final revised standard being
published will apply to railway workers unless the Federal Railroad
Administration (FRA) exercises statutory authority to issue a separate
respirator standard for those workers. To date, the FRA has not issued
a respiratory protection standard applicable to railway workers. Unless
and until it does, this standard will apply to those workers.
This Summary and Explanation section follows the order of the final
rule. The abbreviation ``Ex.'' denotes exhibits in the docket for this
rulemaking, Docket H-049. The abbreviation ``Tr.'' denotes the
transcripts of the hearings conducted in connection with this
rulemaking.
Paragraph (a)--Permissible practice
Paragraphs (a)(1) and (a)(2) of the final rule are essentially
unchanged from the corresponding paragraphs of the prior rule and the
proposed rule. Indeed, in the proposal OSHA explained that this
rulemaking was not intended to address the substantive portion of
paragraph (a)(12). The only changes proposed by OSHA to the regulatory
language of paragraph (a) were non-substantive: (1) In the proposal,
the Agency titled this paragraph ``Scope and Application'' rather than
``Permissible Practice,'' which had been the title of this paragraph
since 1971; and (2) a cross-reference to paragraph (b) in the prior
standard was proposed to be changed to paragraph (c), because a new
paragraph (b), ``Definitions,'' was proposed to be added to the final
rule. In the final rule, OSHA has determined that the original title of
paragraph (a), ``Permissible Practice,'' better describes paragraph
(a), and thus this continues to be the title of this paragraph. The
proposed cross-reference to paragraph (c) is retained in the final
rule.
Paragraph (a)(1) requires the use of appropriate respiratory
protection when ``effective engineering controls are not feasible, or
while they are being instituted.'' This paragraph also stipulates that
the prevention of atmospheric contamination caused by ``harmful dusts,
fogs, fumes, mists, gases, smokes, sprays, or vapors'' shall
[[Page 1180]]
be accomplished, to the extent feasible, by the use of engineering
control measures.
As stated in the preamble of the proposed rule (59 FR 58895), OSHA
did not in this rulemaking open the record on the issue of the
hierarchy of industrial hygiene controls; the hierarchy language is
merely brought forward, verbatim, from this paragraph of the prior
rule. Paragraph (a)(1), which was adopted by OSHA in 1971 from the 1969
American National Standards Institute (ANSI) standard, Z88.2-1969,
established that a hierarchy of controls is to be used to protect
employees from hazardous airborne contaminants. According to this
hierarchy, engineering controls are the preferred method of compliance
for protecting employees from airborne contaminants and are to be
implemented first, before respiratory protection is used. According to
paragraph (a)(1), respirators are permitted to be used only where
engineering controls are not feasible or during an interim period while
such controls are being implemented.
Paragraph (a)(2) requires employers to provide employees with
respirators ``when such equipment is necessary to protect the health of
the employee.'' In addition, this paragraph specifies that the employer
must provide employees with respirators that are ``applicable and
suitable'' for the purpose intended, i.e., for the protection of
employee health. This paragraph thus clearly recognizes that, when
properly selected, used, and maintained, respiratory protection can
play an essential role in preventing adverse effects on the health of
employees exposed to hazardous airborne contaminants.
By leaving paragraphs (a)(1) and (a)(2) of the final rule unchanged
from the corresponding paragraphs of the respiratory protection
standard that has been in effect since 1971, OSHA accomplishes several
objectives. First, it continues the protection that employees have
relied on throughout OSHA's history. Second, it retains the language
that employers are familiar with and thus will not require them to
become familiar with new regulatory language. Third, leaving the
regulatory text of paragraphs (a)(1) and (a)(2) unchanged allows OSHA
and the affected public to continue to rely on OSHA interpretations,
decisions, and case law that have developed over the years.
As noted above, this standard is a respiratory protection standard.
OSHA has enforced this standard when employers fail to provide
respirators, when the respirators that are provided are inappropriate
for the form of the contaminant or for the atmospheric concentration of
the contaminant, when they are inappropriately used, and when they are
improperly maintained.
Although OSHA clearly stated in the preamble to the proposal that
the hierarchy of controls was not an issue in this rulemaking, the
Agency did receive comment on this provision. For example, one
commenter stated that, in its opinion, OSHA has ``a legal obligation to
provide interested parties with an opportunity to comment on the
methods of compliance provisions'' (Ex. 54-307). In the opinion of this
commenter, the American Iron and Steel Institute (AISI), ``Section
6(b)(2) of the OSH Act requires that OSHA provide interested persons an
opportunity to submit written data and comments on a proposed rule in
total'' [emphasis added].
The unchanged language of paragraph (a)(1) was included in the
proposed rule only to enable interested parties to view the rule as it
would ultimately appear in the Code of Federal Regulations in its
entirety. Since OSHA neither proposed nor adopted modifications to
paragraph (a)(1), the Agency believes that it is not legally required
to reconsider this issue at this time. OSHA has the authority to
identify which regulatory requirements it is proposing to revise and
which issues are to receive regulatory priority. Limiting this
rulemaking to issues concerning respirator programs is appropriate
because such programs are the exclusive focus of this rulemaking and to
collect comments and data on additional issues would divert resources
from the task at hand.
The preference for engineering controls has been reaffirmed in each
substance-specific health standard OSHA has published, most recently in
the Methylene Chloride standard (29 CFR 1910.1052). OSHA does not
believe that it is necessary or appropriate, in a rulemaking dealing
with respiratory protection, to reconsider its long-established policy
with regard to the hierarchy of controls.
A number of commenters raised another issue in connection with
paragraph (a)(1), and that is whether biological hazards, such as the
hazard posed by exposure to Mycobacterium tuberculosis, the infectious
agent that causes tuberculosis (TB), are covered by this paragraph
(Exs. 54-213, 54-239, 54-249). In response, OSHA emphasizes that this
respiratory protection standard does apply to biological hazards (see
Mahone Grain Corp., 10 OSHRC 1275, 1981). However, specifically with
regard to the use of respirators to protect employees from the risk of
occupational exposure to M. tuberculosis, OSHA stated at the public
hearing on this respiratory protection standard (Tr. 16-17), that the
Agency's tuberculosis standard, which has just been proposed (62 FR
54160) would contain specific requirements covering all aspects of
respirator use in environments where occupational transmission of
tuberculosis is possible. As explained in the preamble to that
standard, OSHA is committed to ensuring consistency between the
respirator requirements in the two standards.
As stated at the hearing, ``until the final tuberculosis standard
is promulgated, we will continue to enforce respirator usage for TB
under the current, unrevised respirator standard, 1910.134.'' (Tr. 18).
There was little comment on this issue during the rulemaking. The
entire previous respiratory protection standard is being redesignated
as 29 CFR 1910.139. It will be published in the next edition of the
Code of Federal Regulations under that designation. OSHA's enforcement
policy concerning required respirator use for TB is set out in OSHA's
Compliance Directive, ``Enforcement Procedures and Scheduling for
Occupational Exposure to Tuberculosis'' (OSHA Instruction CPL 2.106).
These enforcement procedures are based, in part, on the Centers for
Disease Control and Prevention's (CDC) ``Guidelines for Preventing the
Transmission of Mycobacterium Tuberculosis in Health-Care Settings,
1994.'' Like the CDC recommendations, OSHA's directive clarifies that
respiratory protection for employees exposed to TB is required when:
(1) Workers enter rooms housing individuals with suspected or confirmed
infectious TB; (2) workers are present during the performance of high-
hazard procedures on individuals who have suspected or confirmed
infectious TB; and (3) emergency medical response personnel or others
transport, in enclosed vehicles, an individual with suspected or
confirmed infectious TB. Under the directive, OSHA also enforces the
performance criteria recommended by CDC for selecting a respirator
suitable for use against TB. OSHA's directive further specifies that
where respirator use is required against TB, the program elements of
OSHA's respiratory protection standard apply. A copy of OSHA's
Compliance Directive can be obtained from OSHA's Office of Publications
(Telephone Number, 202-219-4667). Copies of the CDC Guidelines can be
obtained by calling CDC (Telephone Number, 1-800-342-2437).
As noted above, paragraph (a)(2) of the final rule is identical
both to the corresponding paragraph of the respiratory protection
standard in place
[[Page 1181]]
since 1971 and to proposed paragraph (a)(2). It specifies that
respirators must be provided by the employer ``when such equipment is
necessary to protect the health of the employee.'' OSHA considers
respirators to be necessary to protect the health of the employee
whenever feasible engineering and work practice controls are not
available, are not sufficient to protect employee health, have not yet
been instituted, in emergencies, and where the health of an employee is
at risk (e.g., whenever employee exposure exceeds an OSHA permissible
exposure limit (PEL)).
A violation of paragraph (a)(2) could exist, for example, if it can
be shown that exposure to an airborne contaminant could result in
illness or injury to the employee's health and that this could be
prevented by the appropriate selection and use of a respirator. An OSHA
Review Commission case illustrates such a situation: an employer was
held to have violated paragraph (a)(2) because his employees either did
not use respirators when working in an atmosphere contaminated with
grain dust or used respirators that were ``so caked with dust that
employees could not breathe through them'' and contracted a potentially
fatal disease caused by the inhalation of grain dust contaminated with
Histoplasma capsulatum spores (Mahone Grain Corporation, 10 OSHRC 1275,
1981). Paragraph (a)(2) was cited in this case even though OSHA has no
specific PEL for grain dust or for H. capsulatum spores.
In the past 5 years, OSHA has issued 99 citations for violations of
paragraph (a)(2) in conjunction with a citation of the General Duty
Clause (i.e., Sec. 5(a)(1) of the Act). These citations concerned
various situations involving the failure of the employer: (1) To
control exposures in emergencies; (2) to control exposure to unknown
concentrations of a toxic substance; (3) to control exposure to a
contaminant that was clearly a recognized hazard even though no OSHA
PEL existed; (4) to provide and require the use of a respirator for a
confined space entry; or (5) to ensure the proper use of a respirator
in a situation involving the improper storage of a chemical(s). OSHA
will continue to view these situations as citable under this standard
because they involve failure to implement the appropriate exposure
control necessary to protect the health of the employee from adverse
effects.
As proposed, paragraph (a)(3) of OSHA's prior standard does not
appear in the final rule. This paragraph, which was adopted by OSHA in
1971 from the ANSI Z88.2-1969 standard, stated that employees must use
the respiratory protection provided in accordance with instructions and
training they have received.
Several commenters (Exs. 54-79, 54-181, 54-226, 54-234, 54-295, 54-
307, 54-334) urged OSHA to retain this paragraph in the final rule.
According to these commenters, this paragraph is necessary to ensure
that employees take responsibility for their actions and that employees
are actively involved in the respirator program and conform to program
procedures. OSHA agrees that active employee involvement in the
respirator program is essential to program effectiveness but does not
believe that this principle should be stated in the standard, for a
number of reasons. First, the OSH Act itself, at Sec. 5(b), states that
``Each employee shall comply with occupational safety and health
standards and all rules, regulations, and orders issued pursuant to the
OSH Act which are applicable to his own actions and conduct.'' In
addition, the courts have repeatedly held that employers are
responsible under Section 5(a)(2) of the Act (29 U.S.C. 654(a)(2)) for
ensuring worker protection (see, e.g., Brock v. City Oil Well Service
Co., 795 F.2d 507, 511 (5th Cir. 1986)). In this case, the court held,
``it is the employer's responsibility to ensure that the employees are
protected. It may accomplish this objective through others if it
chooses, but the duty to provide the protection remains the
employer's.'' Accordingly, the final rule does not contain this
paragraph.
An issue raised by OSHA in connection with paragraph (a) of the
proposal, the use of respirators by employees when such use is required
by an individual employer or is chosen voluntarily by employees but not
mandated by OSHA in this final rule, is addressed below in connection
with paragraph (c) of this Summary and Explanation.
Paragraph (b)--Definitions
The final standard includes definitions of important terms used in
the regulatory text of the final rule. The previous and proposed
respiratory protection standards contained no definitions; however,
OSHA is adding a number of definitions to the final rule because the
Agency believes that employers and employees will benefit from this
additional information. This is consistent with the Agency's desire to
clarify its respiratory protection requirements, including those that
are not being substantively changed in this rulemaking.
A number of the definitions relate to specific types of respiratory
protection devices or to components or design characteristics of those
devices. For example, the terms ``air-purifying respirator,'' ``filter
or air-purifying element,'' and ``positive pressure respirator'' are
defined in the final rule. These definitions, which are derived from
generally recognized sources such as the current ANSI Z88.2-1992
respiratory protection standard, the NIOSH requirements for particulate
respirators in 42 CFR part 84, and the 1987 NIOSH Respirator Decision
Logic (Ex. 38-20), have been revised for clarity, consistency with
compliance interpretations of the Agency's respiratory protection
standard, and to respond to comments received during the rulemaking.
A number of commenters (Exs. 54-208, 54-218, 54-219, 54-410, 54-
424) suggested that OSHA adopt several of the definitions in the ANSI
Z88.2-1992 respiratory protection standard. The regulated community is
already familiar with the ANSI definitions of these terms, and OSHA
agrees that the potential for confusion will be reduced if terms mean
the same thing in both the OSHA and ANSI standards. Therefore, the ANSI
definitions of ``airline respirator (supplied-air respirator or airline
respirator),'' ``canister or cartridge,'' ``demand respirator,'' ``end-
of-service-life indicator,'' ``escape-only respirator,'' ``filter,''
``fit check (user seal check),'' ``fit test,'' ``helmet,'' ``hood,''
``loose-fitting facepiece,'' ``negative pressure respirator,''
``pressure demand respirator,'' ``powered air-purifying respirator
(PAPR),'' ``respiratory inlet covering,'' ``self contained breathing
apparatus (SCBA),'' ``service life,'' and ``tight-fitting facepiece''
have all been added to the final standard, with some minor word changes
to improve clarity and to recognize the mandatory nature of OSHA
standards. In other cases, OSHA has substituted an ANSI definition for
one the Agency originally proposed.
Several commenters urged OSHA to add other definitions to those in
the proposal (Exs. 54-208, 54-218, 54-219, 54-222, 54-251 54-267, 54-
283, 54-289, 54-363, 54-410, 54-437, 54-455). OSHA did not add some of
the suggested definitions, such as one for ``health screening,''
because the term is no longer used in the standard. Other terms, such
as ``medical evaluation,'' are defined where they appear in the
regulatory text.
The following discussion addresses changes made since the proposed
standard.
Adequate warning properties. The proposed definition of ``adequate
warning properties'' has not been
[[Page 1182]]
retained in the final standard because the term is no longer used in
the regulatory text. OSHA deleted the term after concluding that the
two major warning properties, odor and irritation, are unreliable or
inappropriate to use as indicators of sorbent exhaustion. This issue is
discussed further in this Summary and Explanation in connection with
paragraph (d).
Air-purifying respirator. The final standard defines the term
``air-purifying respirator'' as ``a respirator with an air-purifying
filter, cartridge, or canister that removes specific air contaminants
by passing ambient air through the air-purifying element.'' Marc Evans
of Baxter Diagnostics, Inc. (Ex. 54-38) stated that the proposed
definition, ``a respirator which is designed to remove air contaminants
[i.e., dust, fumes, mists, gases, vapors, or aerosols] from the ambient
air or air surrounding the respirator,'' was inaccurate since filter
elements can only remove air contaminants when air passes through the
filters; he stated that the ANSI definition was more accurate in this
regard.
Another commenter wanted to add the term ``biologicals'' to the
list of air contaminants removed by air-purifying respirators (Ex. 54-
249). In response, the definition has been revised to state more
clearly that an air-purifying respirator removes specific contaminants
from the ambient air by drawing air through appropriate filters,
cartridges, or canisters. Deleting the proposed definition's examples
of air contaminants makes clear that no type of air contaminant,
including biological agents, is excluded from the definition. Also, the
term ``filter'' has been changed to ``filter or air-purifying
element,'' which is also defined in the standard, and includes the
broad range of filters, cartridges, canisters and other air-purifying
elements used with respirators.
Assigned protection factor. The definition of ``assigned protection
factor'' has been reserved as part of OSHA's decision to address the
entire Assigned Protection Factor (APF) issue in a subsequent phase of
this rulemaking. OSHA proposed to reference the NIOSH assigned
protection factors from the 1987 NIOSH Respirator Decision Logic in the
respiratory protection standard and then to adopt new APF values issued
by NIOSH after that Agency had conducted rulemaking on APFs. In the
course of this rulemaking, OSHA has concluded that it should instead
develop its own set of assigned protection factors based on a thorough
review and analysis of all relevant evidence. Both the NIOSH and the
ANSI APFs, as well as all relevant data and information, will be
considered by OSHA at that time.
Atmosphere-supplying respirator. This term means ``a respirator
that supplies the respirator user with breathing air from a source
independent of the ambient atmosphere, and includes supplied-air
respirators (SARs) and self-contained breathing apparatus (SCBA)
units.'' As it has done in many of the definitions in this section,
OSHA has substituted the term ``breathing air'' for a number of
synonymous, but confusingly diverse, terms used in the proposal and in
the ANSI Z88.2-1992 standard. The minor changes from the proposed
definition have been made solely to enhance clarity.
Canister or cartridge. The final standard adopts the ANSI Z88.2-
1992 standard's definition: ``a container with a filter, sorbent, or
catalyst, or combination of these items, which removes specific
contaminants from the air passed through the container.'' Several
commenters suggested that this definition be added to the final rule
(Exs. 54-208, 54-218, 54-219, 54-410, 54-424).
Demand respirator is defined as ``an atmosphere-supplying
respirator that admits breathing air to the facepiece only when a
negative pressure is created inside the facepiece by inhalation.'' This
term was not defined in the proposal but is defined by ANSI, and
several commenters (Exs. 54-208, 54-218, 54-219, 54-410, 54-424) urged
that it be included in the final rule. As in other definitions, the
phrase ``breathing air'' has been substituted for ``respirable gas''
for clarity.
The proposal's definition of ``demand'' has been deleted from the
final standard because the addition of a definition for ``demand
respirator'' makes its inclusion unnecessary. (See the definition of
pressure demand respirator below for the distinction between the two
types of respirator.)
Dust mask. See the definition for ``filtering facepiece'' below.
Emergency situation. In the final rule, OSHA is adding this term to
paragraph (b) to clarify its use in the regulatory text. ``Emergency
situation'' is defined as ``any occurrence such as, but not limited to,
equipment failure, rupture of containers, or failure of control
equipment that may or does result in an uncontrolled substantial
release of an airborne contaminant.'' Under this definition, OSHA
intends that a potential release, and not just an actual release, be
considered an emergency situation requiring appropriate respiratory
protection. This definition is the same or similar to those used to
define emergency situations in other OSHA health standards (e.g.,
1910.1051, Butadiene; 1910.1028, Benzene; 1910.1048, Formaldehyde).
Employee Exposure. OSHA has added this term to paragraph (b) of the
final rule and has defined it to mean ``exposure to a concentration of
an airborne contaminant that would occur if the employee were not using
respiratory protection.'' This is the same definition that has been
used in many of OSHA's substance-specific health standards. It is
included to clarify that employee exposure is measured outside any
respiratory protection worn.
End-of-service-life indicator (ESLI) means ``a system that warns
the respirator user of the approach of the end of adequate respiratory
protection, for example, that the sorbent is approaching saturation or
is no longer effective.'' This definition was not in the proposal, but
has been derived from the definition in the ANSI Z88.2-1992 standard,
as requested by several commenters (Exs. 54-208, 54-218, 54-219, 54-
410, 54-424). OSHA has included the example at the end of the
definition to clarify the function of an ESLI.
Escape-only respirator. This term was not defined in the proposal,
but the final standard defines an escape-only respirator as ``a
respirator intended to be used only for emergency exit.'' The Dow
Chemical Company (Ex. 54-278) and the Chlorine Institute (Ex. 54-439)
recommended adding definitions for an ``escape'' respirator and an
``emergency'' respirator. Partially in response to these comments, and
to clarify OSHA's intent, OSHA has described in paragraph (d) the
narrow function of an ``escape-only respirator,'' and has added a
definition for ``escape-only respirator'' to this paragraph (b). The
definition of ``escape-only respirator'' derives from the ANSI Z88.2-
1992 standard, with the phrase ``egress from a hazardous atmosphere''
replaced by the word ``exit.''
Filter or air-purifying element. The final standard's definition of
this term is ``a component used in respirators to remove solid or
liquid aerosols from the inspired air.'' The parallel definition in the
proposal used ``filter'' instead of ``filter or air-purifying element''
and has been changed in response to comments (Exs. 54-208, 54-218, 54-
219, 54-410, 54-424). The phrase ``or air-purifying element'' has been
added to clarify that this definition applies to all filtration
mechanisms, not only to mechanical or electrostatic filtration of
particulates. The new definition derives from the definition of
``filter'' in the ANSI Z88.2-1992 standard.
[[Page 1183]]
Filtering facepiece (dust mask). The definition of ``filtering
facepiece'' in the final rule is ``a negative pressure particulate
respirator with a filter as an integral part of the facepiece or with
the entire facepiece composed of the filtering medium.'' This new
definition is derived from the definition of ``filtering facepiece'' in
the NIOSH Respirator Decision Logic (Ex. 38-20). As described in the
discussion of paragraph (c) below, employers who allow the use of these
respirators when such use is not required need to comply with only
paragraph (c)(2) of this standard, which requires that the employer
provide the employee with the information contained in Appendix D.
Fit factor. The definition of ``fit factor'' in the final rule is a
quantitative estimate of the fit of a particular respirator to a
specific individual, and typically estimates the ratio of the
concentration of a substance in ambient air to its concentration inside
the respirator when worn. In the proposal, OSHA's definition included
the terms ``challenge agent'' and ``test chamber.'' Several commenters
(Baxter Diagnostics, Ex. 54-38; American Subcontractors Association,
Ex. 54-293) stated that using these terms would have the unintended
effect of prohibiting the use of several existing QNFT test methods,
such as the TSI Portacount,TM and recommended that OSHA rely
on the ANSI definition of ``fit factor'' instead. OSHA agrees with this
point, and the final standard's definition derives primarily from the
ANSI Z88.2-1992 standard's definition, as commenters suggested (Exs.
54-208, 54-218, 54-219, 54-410, 54-424). The final definition uses the
word ``estimate'' instead of the ANSI definition's word ``measure''
because fit factors estimate, rather than measure, the fit obtained
during use. The phrase ``specific individual'' has been substituted for
``particular individual'' for clarity.
Fit test. A definition of ``fit test'' has been added to the final
rule and is defined as ``the use of a protocol to qualitatively or
quantitatively evaluate the fit of a respirator on an individual.''
(See also QLFT and QNFT.) This definition has been added because OSHA
is of the opinion, based on comments to the record, that such a
definition is needed (Exs. 54-208, 54-218, 54-219, 54-410, 54-424).
ANSI also has a definition of fit test, but OSHA's definition differs
from that in the ANSI Z88.2-1992 standard in that the term ``challenge
agent'' has been eliminated and replaced by the phrase ``protocol to
quantitatively or qualitatively evaluate.'' The use of the term
``challenge agent'' would limit the development of future fit test
technologies that do not involve a test agent (Exs. 54-208, 54-250, 54-
330, 54-424).
Hazardous exposure level. Because the final standard does not use
the term ``hazardous exposure level,'' it is not defined. The proposal
defined such levels as including the Permissible Exposure Limits (PELs)
contained in OSHA's Tables Z-1, Z-2, and Z-3 of 29 CFR 1910.1000; the
American Conference of Governmental Industrial Hygienists (ACGIH)
Threshold Limit Values (TLVs), as published in the latest edition of
that organization's ``Threshold Limit Values for Chemical Substances
and Physical Agents,'' for those substances without an OSHA PEL; the
NIOSH Recommended Exposure Limits (RELs) for those hazardous chemicals
without either an OSHA PEL or ACGIH TLV; and any exposure level based
on available scientific information, including Material Safety Data
Sheets, for those hazardous chemicals for which no OSHA PEL, ACGIH TLV,
or NIOSH REL has yet been published.
The proposed rule would have required employers to identify the
``hazardous exposure level'' applicable to each hazardous chemical in
the workplace and then to use this information in selecting the
appropriate respirator to provide protection against exposure to that
chemical. The final rule takes a different and much simpler approach to
assisting employers in the selection of appropriately protective
respirators in those cases where OSHA has not yet promulgated a PEL for
a hazardous chemical. OSHA has taken the approach reflected in the
final standard because there was widespread objection to the proposed
approach (Exs. 54-94, 54-175, 54-212, 54-226, 54-232, 54-275x, 54-283,
54-293, 54-306, 54-312, 54-324, 54-334, 54-347, 54-352, 54-361, 54-397,
54-443, 54-445). Some commenters (Exs. 54-91, 54-165, 54-181, 54-291,
54-316, 54-347, 54-397, 54-445) interpreted the proposed approach as an
attempt by OSHA to expand the number of hazardous chemicals with OSHA-
enforceable exposure limits, while others believed that implementing
the proposed approach would require employers to have risk assessment
expertise or to perform complex analyses, and pointed out that many
employers lacked such expertise (Exs. 54-106, 54-175, 54-210). In
general, rulemaking participants stated that OSHA's approach to this
problem should rely on the professional judgment of employers, based on
readily available information (Exs. 54-206, 54-210).
OSHA has decided, after a thorough review of the record, to follow
these recommendations, and in the final rule has adopted an approach
that requires employers to select appropriately protective respirators
on the basis of informed professional judgment. Accordingly, the final
rule does not identify the ACGIH TLVs or the NIOSH RELs as references
that would trigger required respirator use. The approach taken in the
final rule provides employers with the flexibility to rely on
professional judgment and available data sources when selecting
respirators for protection against hazardous chemicals that have no
OSHA PEL.
OSHA believes that it is prudent in such cases for employers to
select more rather than less protective respirators, i.e., to select a
respirator that will reduce employee exposure to a level below the
concentration indicated as hazardous by the scientific literature. OSHA
also believes that many employers will choose to rely on the ACGIH TLV
or NIOSH REL in those cases where OSHA has no PEL at the present time.
However, whatever approach employers choose to take, the respirator
selected must ``be applicable and suitable for the purpose intended,''
as required by paragraph (a).
Helmet. The final standard defines a helmet as ``a rigid
respiratory inlet covering that also provides head protection against
impact and penetration.'' This definition, which was not in the
proposal, has been added to the final standard at the request of
several commenters ( Exs. 54-208, 54-218, 54-219, 54-410, and 54-424).
The OSHA definition uses the term ``respiratory inlet covering''
instead of the word ``hood'' used in the ANSI definition in order to
include helmet-style powered air-purifying respirators (PAPRs).
High efficiency particulate air (HEPA) filter is defined as ``a
filter that is at least 99.97% efficient in removing monodisperse
particles of 0.3 micrometers in diameter. The equivalent NIOSH 42 CFR
84 particulate filters are the N100, R100, and P100 filters.'' Although
NIOSH has revised the particulate filter descriptions under the new 42
CFR Part 84 respirator certification regulation, and no longer uses the
term HEPA, this definition is included because ``HEPA filter'' is used
in many of OSHA's substance-specific standards. The definition, which
is similar to that used by ANSI, lists the NIOSH 42 CFR part 84
particulate filters that are equivalent, in terms of
[[Page 1184]]
efficiency, to the HEPA filter, i.e., the N100, R100, and P100 filters.
Hood. The final standard includes the following definition of
``hood'': ``a respiratory inlet covering that completely covers the
head and neck and may also cover portions of the shoulders and torso.''
This definition has been added to the final standard in response to
commenters (Exs. 54-208, 54-218, 54-219, 54-410, and 54-424). The
definition derives from the ANSI Z88.2-1992 standard; the word ``also''
has been added for clarity.
Immediately dangerous to life or health (IDLH). The final standard
defines IDLH as ``an atmosphere that poses an immediate threat to life,
would cause irreversible adverse health effects, or would impair an
individual's ability to escape from a dangerous atmosphere.'' In the
proposal, the definition of IDLH was ``an atmospheric concentration of
any toxic, corrosive, or asphyxiant substance that poses an immediate
threat to life or would cause irreversible or delayed adverse health
effects or would interfere with an individual's ability to escape from
a dangerous atmosphere.'' In the final rule, OSHA has decided that
including all atmospheres capable of causing the listed health effects
is more consistent with OSHA's intent than limiting the definition to
toxic, corrosive, and asphyxiant atmospheres and has also deleted the
word ``delayed'' from the definition because including it caused
considerable confusion among commenters.
Under the final standard's definition, atmospheres where a short,
one-time exposure (i.e., an acute exposure) may cause death or
irreversible adverse health effects immediately, within a few hours, or
within a few days or weeks are considered IDLH atmospheres. The
severity of the adverse effects and the certainty that health
impairment will occur following an acute exposure are more important
considerations in defining a potential IDLH situation than is the time
course of the health effect. For example, an atmosphere containing
life-threatening or health-impairing concentrations of fluorides,
cadmium fumes, or radioactive substances would be considered IDLH even
though a single exposure might not cause death or permanent impairment
for as long as days or even weeks after the exposure. On the other
hand, many situations involving atmospheres exceeding short-term or
ceiling exposure limits are not IDLH atmospheres; most short-term or
ceiling limits are designed to reduce the risk of less serious effects,
such as sensory irritation. Thus, only those situations where the acute
exposure would threaten life, initiate an irreversible process that
threatens life or health, or impede the ability of the worker to escape
from the atmosphere would constitute IDLH conditions. In contrast, if
chronic exposure to a toxic atmosphere is required to produce health
impairment or cause death, the atmosphere is not IDLH. Thus, the
relatively low atmospheric concentrations of carcinogenic substances
that cause work-related cancers are not considered IDLH atmospheres,
even though the effect of long-term exposure at such concentrations is
death or serious illness.
Paragraphs (d) and (g) of the final standard require employers
whose employees are exposed to an IDLH atmosphere to provide them with
the most protective and reliable respiratory protection, i.e., a full
facepiece pressure demand SCBA certified by NIOSH for a minimum of a
30-minute service life, or a combination full facepiece pressure demand
supplied-air respirator with auxiliary self-contained air supply, and
to implement specific rescue precautions and communication procedures.
Although OSHA's prior Respiratory Protection standard does not
explicitly use the term ``IDLH,'' it does require that respirators used
in ``immediately dangerous'' atmospheres keep inward leakage to a
minimum and be highly reliable (See paragraph (c) of prior 29 CFR
1910.134, which incorporates this language from the ANSI Z88.2-1969
standard by reference).
Commenters raised a number of issues specifically related to the
proposed definition of IDLH and to the IDLH concept in general. These
comments addressed the following points:
Whether the term IDLH should apply to all delayed effects,
some delayed effects, or be restricted to immediate effects;
How OSHA's definition of IDLH differs from those of other
organizations and how it relates to the definition of IDLH used in
other OSHA standards;
How the presence of an IDLH or potential IDLH atmosphere
affects respirator selection.
The following discussion addresses each of these points in turn.
The proposed definition of IDLH included the phrase ``delayed
adverse health effects.'' OSHA has omitted this phrase from the final
standard to respond to comments received and to remove a source of
confusion. Many commenters argued that the term IDLH should cover only
immediate, severe adverse health effects, such as those resulting from
exposures to hydrogen fluoride or oxides of nitrogen (e.g., Exs. 54-
208, 54-219; 54-316), while others favored taking chronic, delayed
effects into consideration when making an IDLH decision (See, e.g.,
Exs. 54-202 and 54-437). For example, OCAW stated that ``OSHA's IDLH
and acute hazard-based framework * * * does not properly emphasize the
need to consider long-term and cumulative health effects.''
Most participants, however, argued against including chronic health
effects in the IDLH definition because it would make the definition too
broad. These participants feared that including this term would mean
that exposures typically associated with chronic effects, such as
cancer, would be designated IDLH (Exs. 54-67; 54-153; 54-175; 54-208;
54-218; 54-219; 54-232; 54-266; 54-278; 54-307; 54-314; 54-316; 54-
326). Typical of these comments is one from the American Iron and Steel
Institute: ``The proposed definition, which includes ``delayed health
effects,'' is so broad that it goes far beyond the accepted IDLH
concept, and would expand it beyond its intended purpose'' (Ex. 54-
307). Arguing along the same lines, the Exxon Corporation stated that
``the phrase `delayed health effects' could include chronic toxins like
asbestos * * *'' (Ex. 54-266).
Other commenters urged OSHA to narrow the definition of IDLH by
adding the word ``acute'' before ``adverse'' in the phrase ``delayed
adverse health effects'' or by making other language changes that would
achieve the same effect (Exs. 54-67, 54-278, 54-326, 54-208A). For
example, the American Industrial Hygiene Association (Ex. 54-208A)
stated that the only atmospheric contaminants with delayed effects that
should be included in the definition are those, such as the oxides of
nitrogen, that cause delayed-onset severe adverse health effects (such
as pulmonary edema). Representatives of Pennzoil suggested that ``* * *
the phrase `immediate or delayed irreversible debilitating health
effects', be used'' to achieve the same end (Ex. 54-287).
These commenters objected to the inclusion of ``delayed health
effects'' in the proposed definition because the language suggested
that effects typically associated with long-term exposures, such as
cancer, would be included. The definition in the final standard
recognizes that the effects of concern must be the result of an acute
overexposure but does not specifically limit the length of time between
that overexposure and the resulting effect.
[[Page 1185]]
Where very serious health effects may arise from a single acute
exposure, even if such effects become apparent only after a relatively
long latency period, e.g., hours, days, or even weeks, the atmosphere
associated with the effect must be designated IDLH. OSHA is confident
that deleting the word ``delayed'' from the IDLH definition in the
final rule will reduce confusion but will not affect the level of
employee protection provided by the standard.
Many commenters urged OSHA to adopt an IDLH definition developed by
another organization, agency, or by OSHA itself in other standards.
Some commenters (Exs. 54-153, 54-214, 54-234, 54-251, 54-266, 54-278,
54-290, 54-330, 54-361, 54-363, 54-424, 54-439) urged OSHA to adopt the
ANSI Z88.2-1992 standard's definition of IDLH: ``any atmosphere that
poses an immediate hazard to life or poses immediate irreversible
debilitating effects on health'' (clause 3.33). For example, Bell
Atlantic (Ex. 54-361) suggested that the ANSI definition be used to
ensure that ``chronic toxins like asbestos would not be considered
IDLH.'' However, OSHA believes that adopting the definition contained
in the current ANSI standard could reduce employee protection because
it states that atmospheres are IDLH only in cases where the adverse
effects of exposure occur immediately. An example of an atmosphere that
OSHA believes must be considered IDLH but arguably would not be so
designated under the ANSI definition is one containing high
concentrations of cadmium fume, which may result in fatal collapse as
long as 48-72 hours after an acute overexposure.
The Exxon Corporation (Ex. 54-266) objected to the phrase ``ability
to escape'' in OSHA's proposed definition, and suggested that OSHA
instead adopt the ANSI definition, which does not refer to impairment
of the ability to escape. OSHA wishes to clarify that the proposed
terminology, ``interfere with an individual's ability to escape'' was
not meant to cover a minor or even moderate degree of interference but
to address interference of a kind sufficiently serious to impair the
individual's ability to escape from exposure to a dangerous
concentration of an air contaminant. To address Exxon's concern, the
final rule's definition has been revised to read ``impair the
individual's ability to escape.'' OSHA notes that it is imperative for
employees to be able to escape. There are atmospheres, for example one
contaminated with a severe eye irritant, that can effectively
incapacitate an individual in the short term and prevent the individual
from escaping in time to avoid more serious health consequences. OSHA
has therefore retained in the IDLH definition language that addresses
the need to protect workers escaping from dangerous atmospheres.
One commenter, Monsanto (Ex. 54-219), expressed concern about the
consistency of IDLH definitions in different OSHA standards. In
response, OSHA has reviewed the definitions of IDLH used in its
standards and believes that the final standard's definition is largely
consistent with those in the two OSHA safety standards that use the
term: 29 CFR 1910.146, the Permit-Required Confined Space standard
(``Confined Spaces standard'') and 29 CFR 1910.120, the Hazardous Waste
Operations and Emergency Response (HAZWOPER) standard.
Some commenters (Exs. 54-439, 54-330, 54-278) asked which IDLH
values OSHA endorses or pointed to the limitations of the available
information on IDLH concentrations. For example, OCAW noted that ``only
a handful of IDLH limits have been determined. In most worker exposure,
the IDLH limit is unknown. Even when [an] IDLH limit exists, workers do
not have access to this information. MSDSs rarely include IDLH
information'' (Ex. 54-202).
The final rule does not contain a prescribed list of IDLH values or
require employers to rely on any particular list. Some commenters (Exs.
54-278, 54-330, 54-361, 54-424, 54-439) criticized the IDLH values
listed in the 1994 NIOSH Pocket Guide to Chemical Hazards (Ex. 54-278)
or recommended that the Emergency Response Planning Guidelines (ERPGs)
developed under the auspices of the American Industrial Hygiene
Association be used instead. OSHA is aware that published IDLH values
are not available for many industrial contaminants and that employers
must therefore rely on their own knowledge and judgment, and that of
safety and health professionals, when deciding that a given atmosphere
has the potential to cause health effects of the kind envisioned by
OSHA's IDLH definition. During enforcement inspections, OSHA will
continue to accept any published IDLH value that is based on sound
scientific evidence; those published by NIOSH and the AIHA would
clearly meet this test.
OSHA's final IDLH definition does not separately mention
``potential'' IDLH atmospheres. Many OSHA enforcement cases have
involved the failure of employers to provide respirators in situations
that were not IDLH at the time workers entered the area but became so
thereafter. OSHA intends employers to interpret the respirator
selection requirements in paragraph (d)(1) proactively, i.e., where
employers are uncertain about the adequacy of a given respirator for a
highly hazardous atmosphere, cannot identify the atmospheric
concentration of a substance that poses a potentially life-threatening
or health-impairing risk, or cannot maintain the concentration of such
a substance below life-threatening or health-impairing levels, the
employer must consider the atmosphere IDLH and select a respirator
accordingly. For example, an employer in a chemical plant knows that
inadvertent releases or spills of highly hazardous chemicals may occur
at the facility and selects the most protective respirators available
for employees who must enter a spill area because, in an emergency,
there is no time to take airborne measurements to determine whether or
not the concentration is IDLH. OSHA encourages this kind of proactive
planning because it is protective of employee health.
Interior structural firefighting. The final respiratory protection
standard uses the OSHA definition for ``interior structural
firefighting'' contained in 29 CFR 1910.155, which applies to all
situations covered by Subpart L--Fire Protection. The definition is as
follows:
Interior structural firefighting means the physical activity of
fire suppression, rescue or both, inside of buildings or enclosed
structures which are involved in a fire situation beyond the
incipient stage.
Loose-fitting facepiece. The final standard now defines this term
to mean ``a respiratory inlet covering that is designed to form a
partial seal with the face.'' This definition was not in the proposal,
and has been added in response to commenters such as the AIHA (Ex. 54-
208), 3M (Ex. 54-218), Monsanto (Ex. 54-219), Martin Marietta Energy
Systems, Inc. (Ex. 54-410), and ORC (Ex. 54-424), who recommended that
OSHA adopt several of the ANSI Z88.2-1992 definitions for respirator
terms. OSHA has adopted only part of the ANSI definition for loose-
fitting facepiece. The phrase in the ANSI definition that states a
loose-fitting facepiece ``does not cover the neck and shoulders, and
may or may not offer head protection against impact and penetration''
has not been included. This phrase from the ANSI definition was not
adopted as part of the OSHA definition because adding this phrase would
not allow users to clearly distinguish between hoods, helmets, and
loose-fitting respirators. It is important for employers to be able to
distinguish loose-fitting from tight-
[[Page 1186]]
fitting respirators in order to correctly apply the fit testing
requirements.
Maximum use concentration. OSHA is not defining this term at this
time because the Agency has reserved the issue of Assigned Protection
Factors, which is associated with Maximum Use Concentrations, until a
subsequent phase of this rulemaking.
Negative pressure respirator (tight fitting). The final standard
defines this term as ``a respirator in which the air pressure inside
the facepiece is negative during inhalation with respect to the ambient
air pressure outside the respirator.'' The proposed definition was
revised in response to comments (Exs. 54-208, 54-218, 54-219, 54-410,
and 54-424) that recommended that OSHA adopt the ANSI Z88.2-1992
standard's definition. In the final rule, OSHA has accepted the ANSI
definition, with two changes: (1) The word ``facepiece'' has replaced
the term ``respiratory inlet covering'' to make clear that the
facepiece is the area of interest with negative pressure respirators;
and (2) the phrase ``outside the respirator'' has been added after the
phrase ``ambient air pressure'' to clarify that negative pressure
exists only when the outside air pressure is higher than the air
pressure inside the negative pressure facepiece.
Oxygen-deficient atmosphere. The proposed definition of an ``oxygen
deficient atmosphere'' was ``an atmosphere with an oxygen content of
less than 19.5% by volume at altitudes of 8000 feet or below.'' OSHA is
retaining the 19.5% definition of an oxygen-deficient atmosphere in the
final rule, but is removing the reference to altitudes. The use of a
19.5% oxygen level is well established and has even been incorporated
by Congress into other safety and health legislation (See Federal Mine
Safety and Health Act, 20 USC 863 (b), discussed in National Mining
Association v. MSHA, 116 F.3d 520 (D.C. Cir. 1997.) Paragraph d(2)(iii)
of the final rule requires employers to consider all oxygen-deficient
atmospheres to be IDLH and to require the use of pressure-demand SCBA
or a combination full-facepiece pressure-demand SAR with an auxiliary
self-contained air supply. However, this paragraph also contains an
exception that would permit employers to use any atmosphere-supplying
respirator in oxygen-deficient atmospheres where the employer can
demonstrate that oxygen levels cannot fall below the altitude-adjusted
concentrations prescribed in Table II of paragraph (d).
The ANSI Z88.2-1992 standard, NIOSH (Ex.164), and AIHA (Ex. 2098)
use an altitude-adjusted definition for oxygen deficiency. Although
there are some small differences, these organizations generally define
oxygen deficiency as an oxygen level of less than 19.5% at altitudes up
to 5,000 or 6,000 feet, and less than 20.9% at higher elevations. OSHA
chose not to adopt this approach to defining oxygen deficiency for
several reason. First, as was stated in the proposal (59 FR 58905),
OSHA's concern is that employees not be exposed to environments in
which the oxygen partial pressure is less than 100 mm Hg; this partial
pressure of oxygen is generally regarded as an appropriate IDLH level
(Exs. 164, 208). OSHA believes that using an oxygen concentration of
19.5 percent as a baseline oxygen level is appropriate because exposure
to such an atmosphere does not pose a serious health risk at elevations
below 8,000 feet, i.e., the oxygen partial pressure in such atmospheres
will remain above 100 mm Hg (Ex.164). Although OSHA realizes that the
partial pressure of oxygen may be at or above 100 mm Hg even at some
lower altitudes and lower oxygen concentrations, these lower-altitude,
lower-concentration situations are generally unstable and can quickly
deteriorate to life-threatening atmospheres. OSHA has accounted for
those rare situations where the employer controls the environment to
maintain a constant altitude-adjusted oxygen level through the
exception in paragraph (d)(2)(iii) of the final rule. OSHA's definition
of oxygen deficiency is also consistent with the Compressed Gas
Association's definition of Grade D breathing air as air containing a
minimum of 19.5% oxygen. OSHA finds that defining oxygen deficiency as
an atmosphere with an oxygen content below 19.5% is both protective and
straightforward, and is consistent with the definition that has been
used by the Agency in the past.
Oxygen-deficient IDLH atmosphere. The proposal originally included
a definition of oxygen-deficient IDLH atmosphere. Because the term has
not been used in the regulatory text of the final rule, OSHA is
deleting this term from paragraph (b).
Physician or other licensed health care professional (PLHCP) is
defined as ``an individual whose legally permitted scope of practice
(i.e., license, registration, or certification) allows him or her to
independently provide, or be delegated the responsibility to provide,
some or all of the health care services required by paragraph (e) of
this section.'' This definition has been added because paragraph (e)(2)
of the final standard requires that all medical evaluation procedures
be performed by a PLHCP.
OSHA has long considered the issue of whether, and if so how, to
specify the qualifications of the particular professionals who are
permitted to perform the medical evaluations required by its standards.
The Agency has determined that any professional who is licensed by
state law to perform the medical evaluation procedures required by the
standard may perform these procedures under the respiratory protection
standard. The Agency recognizes that this means that the personnel
qualified to provide the required medical evaluation may vary from
state to state, depending on state licensing laws. Under the final
rule, an employer has the flexibility to retain the services of a
variety of qualified licensed health care professionals, provided that
these individuals are licensed to perform a given service. OSHA
believes that this flexibility will reduce cost and compliance burdens
for employers and increase convenience for employees. The approach
taken in this final standard is consistent with the approach OSHA has
taken in other recent standards (e.g., cadmium, methylene chloride).
Positive pressure respirator. This term has been redefined in the
final standard to mean ``a respirator in which the pressure inside the
respiratory inlet covering is positive with respect to ambient air
pressure outside the respirator.'' Consistent with the recommendations
of several commenters (Exs. 54-208, 54-218, 54-219, 54-410, and 54-
424), the final standard's definition adopts the ANSI Z88.2-1992
definition but adds the phrase ``outside the respirator'' for clarity.
Powered air-purifying respirator. The final standard defines this
term as ``an air-purifying respirator that uses a blower to force the
ambient air through air-purifying elements to the inlet covering.''
This revision also reflects commenters' recommendations that OSHA adopt
ANSI Z88.2-1992 standard definitions (Exs. 54-208, 54-218, 54-219, 54-
410, and 54-424). The term ``ambient atmosphere'' in the ANSI
definition has been replaced with the term ``ambient air'' for
simplicity.
Pressure demand respirator. This type of respirator is defined as
``a positive pressure atmosphere-supplying respirator that admits
breathing air to the facepiece when the positive pressure is reduced
inside the facepiece by inhalation.'' This language has been taken
verbatim from the ANSI Z88.2-1992 standard's definition, except that
[[Page 1187]]
the term ``breathing air'' has replaced the term ``respirable gas'' for
clarity.
Qualitative fit test (QLFT). This definition has been revised to
read ``a pass/fail fit test to assess the adequacy of respirator fit
that relies on the individual's response to the test agent.'' OSHA has
replaced the proposal's QLFT definition with one derived from the ANSI
Z88.2-1992 standard but has added the phrase ``to assess the adequacy
of respirator fit'' to emphasize the purpose of QLFT. In addition, the
OSHA definition uses the phrase ``the individual's response'' instead
of the ANSI definition's phrase ``subject's sensory response'' for
clarity.
Quantitative fit test (QNFT). This definition has been revised and
simplified to accommodate both current and yet-to-be-developed fit test
technology. The final standard defines a quantitative fit test (QNFT)
as ``an assessment of the adequacy of respirator fit by numerically
measuring the amount of leakage into the respirator.'' Commenters
generally opposed the proposed definition of QNFT, which made reference
to challenge agents, because they feared that it might interfere with
the development of new fit test methods (Exs. 54-5, 54-222, 54-251, 54-
266, 54-275x, 54-350, 54-208, 54-218, 54-219, 54-278, 54-316, 54-424).
OSHA agrees and has revised the definition accordingly. OSHA believes
that the definition of QNFT must be usable, enforceable, and
understandable, and accommodate evolving technology.
Respiratory inlet covering. The final standard defines this term,
which is often used in descriptions of respiratory equipment, as ``that
portion of a respirator that forms the protective barrier between the
user's respiratory tract and an air-purifying device or breathing air
source, or both. It may be a facepiece, helmet, hood, suit, or a
mouthpiece respirator with nose clamp.'' This definition is adapted
from that in the ANSI Z88.2-1992 standard; the phrase ``that connects
the wearer's respiratory tract'' in the ANSI definition has been
modified to read ``that forms the protective barrier between the user's
respiratory tract'' in the OSHA definition for clarity.
Self-contained breathing apparatus (SCBA). The proposed definition
of self-contained breathing apparatus (SCBA) has been revised slightly
in the final standard to read ``an atmosphere-supplying respirator for
which the breathing air source is designed to be carried by the user.''
This revised definition was adopted from the ANSI Z88.2-1992 standard's
definition of SCBA.
Service life. The final standard defines service life as ``the
period of time that a respirator, filter, or sorbent, or other
respiratory equipment provides adequate protection to the wearer.''
This definition eliminates a reference in the proposal to substances
``breaking through'' the cartridge or canister, and deletes a statement
that respirator manufacturers are to determine service life
concentrations, since this is the employer's responsibility. The new
definition parallels ANSI's except that it contains additional language
covering filters, sorbents, and other respiratory equipment. This
definition is further explained in the discussion of paragraph (d) of
the Summary and Explanation.
Supplied-air respirator (SAR) or airline respirator. OSHA has
elected to retain a definition for supplied-air respirators, since the
term is used by NIOSH in the 42 CFR part 84 regulations. The final
standard's definition reads: ``Supplied-air respirator (SAR) or airline
respirator means an atmosphere-supplying respirator for which the
source of breathing air is not designed to be carried by the user.''
Participants (Exs. 54-208, 54-249) were more familiar with this term
than with the term ``air-supplied respirator'' recommended as an
alternative by some commenters (Exs. 54-218, 54-219, 54-363, 54-434).
The language of this definition is derived from the ANSI Z88.2-1992
definition for ``airline respirator,'' but also applies to supplied-air
respirators, a term that NIOSH uses to certify this class of
respirators. OSHA believes that using both names in the definition will
reduce confusion for respirator users.
Tight-fitting facepiece is defined as ``a respiratory inlet
covering that forms a complete seal with the face.'' This term was not
defined in the proposal, but numerous commenters requested that OSHA
add this definition (Exs. 54-222, 54-283, 54-363, 54-410, 54-424, 54-
428, 54-433, 54-455) to the final standard.
User seal check is defined as ``an action conducted by the
respirator user to determine if the respirator is properly seated to
the face.'' Such a check is performed by the user each time the
respirator is donned or adjusted to ensure that the tight-fitting
respirator is properly seated on the user's face, i.e., that the proper
seal has been achieved. Several commenters recommended that OSHA add
the definition for ``fit check'' from the ANSI Z88.2-1992 standard to
replace the term ``facepiece seal check'' that was used in Appendix B
of the proposal (Exs. 54-208, 54-218, 54-219, 54-410, 54-424). The term
``fit check'' has proven confusing to those respirator users who do not
realize that a daily fit check is not a substitute for an annual fit
test. The AIHA (Ex. 54-208) recommended that OSHA add a statement to
Appendix B to the effect that: ``Fit checks are not substitutes for
qualitative or quantitative fit tests,'' and OSHA has done so in this
final standard. Because OSHA believes that the similarity between the
terms ``fit check'' and ``fit test'' is responsible for this confusion,
OSHA has used the term ``user seal check'' rather than ``fit check'' in
the final standard. The definition of ``user seal check'' derives from
the ANSI Z88.2-1992 standard's definition for ``fit check,'' except
that the word ``action'' has been substituted for ``test'' to avoid any
possible confusion among respirator users.
Paragraph (c)--Respiratory Protection Program
This paragraph of the final standard requires employers to develop
and implement a written respiratory protection program, with workplace-
specific procedures addressing the major elements of the program,
whenever respirators are necessary to protect the health of the
employee. In addition, where an employer requires an employee to wear a
respirator, i.e., in a situation where the standard does not otherwise
require such use, a written program must be developed and implemented.
Employers who provide respirators at the request of their employees or
who allow their employees to bring their own respirators into the
workplace must ensure that the respirator used does not present a
hazard to the health of the employee. However, if the respirator
voluntarily worn is a filtering facepiece (dust mask), the employer is
not required to implement a written program. Paragraph (c)(1) also
requires employers to update the program when changes in the workplace
or in respirator use make such updating necessary.
As in the proposed rule, the final standard requires that the
respiratory protection program be written. OSHA's experience and that
of the industrial hygiene community have demonstrated that health and
safety programs can best be effectively implemented and evaluated when
written. In addition, because workplaces differ substantially, each
program must be tailored to the specific conditions of the workplace if
it is to protect employee health, and developing a written program is
the most efficient way of ensuring that the program reflects the unique
characteristics of each workplace. Developing and writing down
worksite-
[[Page 1188]]
specific procedures requires employers to design their respiratory
protection programs to address the respiratory hazards in their
particular workplace, and this process requires employers to think
about and document all relevant information pertaining to the hazardous
atmospheres that their employees may encounter under normal operating
conditions or during reasonably foreseeable emergencies that may occur
in the workplace. Finally, OSHA's enforcement data indicate that
compliance with the previous standard has not been optimal,
particularly in smaller workplaces, and a written program will help
employers, employees, and compliance officers gauge the adequacy of a
given program.
Paragraphs (c)(1)(i) through (c)(1)(ix) identify the elements that
must be included in the employer's program unless the particular
element does not apply to the employer's workplace. The previous OSHA
respiratory protection standard also required employers to develop
written standard operating procedures that covered the selection, use,
cleaning, maintenance, inspection, and storage of respirators and the
training and medical evaluation of respirator users (paragraphs (b)(1),
(e)(1), and (e)(3), among other provisions of the previous standard).
In the final standard, the general elements of the written program have
been expanded, reordered and updated, and the term ``written standard
operating procedures (SOP)'' used in the previous standard has been
replaced with the words ``worksite-specific procedures.'' Thus, the
standard identifies the basic elements of written programs for all
workplaces, but the employer has the flexibility to tailor these
general program elements to match the specific workplace conditions and
processes that occur in that workplace. In the Agency's previous
respiratory protection standard, the requirement for written standard
operating procedures tended to lead to the adoption of generic
procedures. Changing the terminology from ``SOPs'' to ``worksite-
specific procedures'' gives employers the incentive to develop
procedures that are unique and specific to the employer's workplace, to
describe the particular respirator selection process used in that
workplace, and to explain how employees are to use respirators in that
setting.
OSHA has also revised the required program elements themselves, for
several reasons. First, they have been modified to reflect those
provisions of the final standard that have been added or enhanced to
reflect advances in respiratory protection technology, such as the
development of atmosphere-supplying respirators and the widespread use
of modern methods of fit testing. Second, several of the provisions of
the previous standard were vague and had caused compliance difficulties
for employers over the years. OSHA wishes to provide employers with
clear notice of what elements OSHA considers essential to an effective
respirator program. Third, OSHA has adopted several changes suggested
by commenters.
OSHA also believes that clearer program elements will improve
employer compliance. According to the Minnesota Department of Labor and
Industry (Ex. 54-204), for example, many employers have had difficulty
complying with OSHA's previous standard because they were unsure what
elements a program was required to include. Several other data sources
also point to the lack of clarity in OSHA's previous standard; these
include OSHA's inspection data and compliance experience, comments to
the record (Ex. 54-219), and studies of workers (Ex. 64-65). As noted
in the NPRM, data collected on current respirator practices and
procedures in over 2300 manufacturing plants classified in 15 SIC codes
were reviewed by the Agency (See Summary of the Preliminary Regulatory
Impact Analysis, 59 FR 58892). This survey sample was used to produce
estimates of respirator-related practices for about 123,200
manufacturing plants with regular and occasional respirator use. Only
25.5% of these plants were estimated to have written standard operating
procedures, and only 7.9% had procedures that addressed all eight of
the program elements required by the previous standard (selection, use,
cleaning, maintenance, inspection and storage of respirators, and the
training and medical evaluation of respirator users). More than 80% of
the very large plants (those with 1000 or more employees) had written
procedures, while in small plants (those with fewer than 50 employees),
only about 22% had written procedures. This survey clearly showed that
improving the clarity of the elements to be addressed in standard
operating procedures would help employers to develop and implement
better respiratory protection programs and thus would provide greater
protection to workers as well.
Similarly, a study of OSHA citations for violations of the previous
OSHA respirator standard from 1977 to 1982 showed that 13% of these
citations were issued because standard operating procedures were either
inadequate or missing (Rosenthal and Paull; Ex. 33-5). OSHA's latest
citation data for the respiratory protection standard, for the period
October 1990 to December 1995, show that the number of citations issued
for inadequate or missing written respirator programs in general
industry has increased to 18.4% of all respirator standard-related
citations. These data indicate that the conclusions reached by
Rosenthal and Paull are still valid. The citation history for the
construction industry respiratory protection standard, 29 CFR 1926.103,
is similar, with citations for inadequate respirator programs
representing 10.5% of all respirator standard-related citations in that
industry. OSHA believes that the percentages of respirator standard-
related citations reported in these reviews substantially underestimate
the real incidence of deficient programs because it is OSHA policy not
to issue citations for an inadequate program unless an overexposure is
also documented.
Paragraphs (c)(1)(i) through (c)(1)(ix) of the final standard
provide additional detail about each of the required program elements
but remain performance based to enable employers to adapt them to their
workplaces. The program elements have been reorganized from those in
the previous standard so that they track the order of the major
paragraphs of the standard. OSHA believes that reordering the elements,
as suggested by one commenter (Ex. 54-204), is logical and should make
program development easier. OSHA also believes that the additional
detail and greater clarity provided by the final rule's program
elements will reduce confusion over the intent of these provisions,
lead to higher compliance rates, and result in better respiratory
protection for employees.
The ANSI Z88.2-1992 standard for respiratory protection also states
that written procedures covering the complete respirator program must
be established and implemented (Ex. 81). Thus, like OSHA, ANSI
recognizes the need for a written respiratory protection program and
implementing procedures to provide complete and consistent protection
to employees wearing respirators. Although the ANSI standard does not
contain detailed instructions on the content of these procedures, it
does describe, in clause 6, the elements to be included in the program
to cover routine and emergency use of respirators.
The program elements in the ANSI Z88.2-1992 standard (i.e., program
administration, respirator selection, training, respirator fit,
maintenance, inspection and storage) are similar to those in paragraphs
(c)(1)(i) through
[[Page 1189]]
(c)(1)(ix) of OSHA's final standard. The specific content of each
element of the written procedures is left to the employer, who can
tailor them to match the conditions that occur in his/her worksite.
Although many of the program elements are common to all respiratory
protection programs, such as respirator selection, care, use, and
program evaluation, some elements, such as the one addressing
specifications for air quality for atmosphere-supplying respirators,
apply only in workplaces in which those types of respirator are used.
OSHA received many comments, both on written programs in general
and on specific program elements. Some commenters (Exs. 54-160, 54-187,
54-238), questioned the need for a written respirator program with
worksite-specific procedures. For example, Transtar Railroads (Ex. 54-
160) stated that written procedures do not guarantee an effective
respiratory protection program and argued that requiring additional
written program elements would not cause those companies who presently
disregard OSHA's existing standard to become more conscientious.
Motorola (Ex. 54-187) urged OSHA to delete the requirement for a
written program and instead simply to require that employers ensure
that respirators are properly selected, fitted, used, and maintained as
necessary to protect employees when respirators are required. However,
the requirement for a written respirator program was widely supported
by many other participants in the rulemaking (Exs. 54-204, 54-219, 54-
304, 54-387, 54-389, 54-428, 54-435). For example, the United
Automobile Workers (Ex. 54-387) agreed that a written respiratory
protection program that is site-specific and detailed (for example,
that includes specific procedures for determining when a cartridge or
filter needs to be changed) should be required. The American Federation
of Labor and Congress of Industrial Organizations (AFL-CIO) (Ex. 54-
428) strongly supported the requirement for a written respiratory
program and identified such a program as the fundamental core of the
standard:
The AFL-CIO strongly supports the Agency's proposal that
employers who are required to use respirators or voluntarily use
respirators in the workplace establish a written respiratory
protection program. The written program constitutes an employer's
plan for dealing with worker protection from hazardous airborne
contaminants that may be present in the workplace, and as such, we
view these provisions as the fundamental core of the standard.
Requiring a written program is essential in providing uniformity and
consistency while supplying the maximum protection for workers who
use respirators in the workplace. (Ex. 54-428)
OSHA's expert witness, James Johnson of the Lawrence Livermore
National Laboratory, testified that respiratory protection programs
must be written because of their complexity:
* * * A respirator program involves many decisions. What kind of
respirator do I use, what kind of concentrations were measured, what
kind of contaminants were in the workplace
* * * So all this information is important to provide
documentation and understanding so that you can make sure the
program is adequate and you can make changes to it, to improve it
and to have it be a dynamic operation as the workplace changes * * *
(Tr. 212)
Commenting in the same vein, the National Pest Control Association
(Ex. 54-435), which represents many small businesses, agreed that
requiring employers to provide a written respiratory program was
sensible, and the Cambrex Corporation (Ex. 54-389) noted that ``A
performance approach in defining written program requirements will
provide needed flexibility to employee protection programs.'' David
Lee, CIH, CSP (Ex. 54-304), strongly supported the approach OSHA has
taken in the final rule; he stated that a written respiratory
protection program should be required in all places where respirators
are used, regardless of the circumstances, and that the program's
contents should be specifically tailored to conditions of use at the
place of employment.
OSHA agrees with these commenters that it is appropriate to retain
the previous standard's requirement for a written program, and that the
program must be flexibly tailored to worksite conditions. OSHA finds
that comments to the record, and the Agency's own compliance
experience, strongly suggest that many employers wish to comply but are
unsure about what is required; for these employers, greater clarity and
guidance will enhance compliance and enable them to provide their
employees with needed protection.
Paragraph (c)(1) of the final rule requires employers to update the
program as necessary to reflect changes in the workplace. This
requirement has been revised somewhat from the proposal. The proposed
standard stated that ``[t]he written program shall reflect current
workplace conditions and respirator use'' (59 FR 58939). OSHA received
several comments on this provision (Exs. 54-278, 54-213, 54-249). For
example, the Dow Chemical Company (Ex. 54-278) urged OSHA to revise
this language to require that the program reflect only those current
workplace conditions ``significantly impacting respirator use.'' In the
final rule, OSHA has moved this provision to paragraph (c)(1) and
revised it to require that the program be ``updated as necessary to
reflect those changes in workplace conditions that affect respirator
use.'' OSHA believes that this change is responsive to Dow's point. As
now written, when the workplace changes in a way that may affect
respirator use, such as when new processes are introduced, changes are
made in the types of chemicals used, or the types of respirators being
used changes, employers must revise the program as necessary to reflect
these new conditions.
One of the major issues raised in the rulemaking dealt with
situations in which respirator use is not specifically required by 29
CFR 1910.134 or other OSHA statutory or regulatory requirements, but
instead is required by employers as a condition of employment or is
permitted by employers upon the request of employees (i.e., voluntary
use). The preamble discussion for proposed paragraph (a) stated that
employers who required employees to use respirators would be covered by
the standard (59 FR 58895). OSHA also recommended in the NPRM that
employers who permit voluntary respirator use in their workplaces
implement the full respiratory protection program. In the final rule,
paragraph (c)(1) requires that a respiratory protection program be
developed and implemented ``wherever respirators are required by the
employer,'' but has greatly reduced the obligations of employers who
allow their employees to use respirators when such use is not required.
In the preamble to the proposal, OSHA discussed the reasoning
behind including employer-required respirator use within the scope of
the standard (59 FR 58895). OSHA stated that the requirement was
appropriate both because the use of a respirator could in itself
present a health hazard to the wearer, and because improper use of a
respirator in environments where respiratory hazards are present would
not sufficiently protect employees from those hazards. OSHA finds that
these are still valid reasons for requiring that a respiratory
protection program be implemented where employers require respirator
use. All of the elements of a respiratory protection program apply to
this situation. Employers must still select respirators that are
appropriate to the workplace conditions and types of respiratory
hazards present to ensure that respirators offer adequate protection.
Improperly selected
[[Page 1190]]
respirators may afford no protection at all (for example, use of a dust
mask against airborne vapors), may be so uncomfortable as to be
intolerable to the wearer, or may hinder vision, communication,
hearing, or movement and thus pose a risk to the wearer's safety or
health.
Employees who are required by their employers to wear respirators
must also be medically evaluated to determine that they are capable of
tolerating the increased physiological load associated with some
respirator use. Proper fit testing is necessary to ensure that
discomfort is minimized and that the respirator selected is offering
sufficient protection. It is also necessary that respirators required
by employers be cleaned, disinfected, stored, inspected, and repaired
according to the procedures contained in the final rule to ensure
proper respirator functioning and protection of employees from
dermatitis or exposure to hazardous contaminants that may result from
using a dirty respirator. Compliance with the provisions of the
standard dealing with supplied air quality and use is also essential
where employers require the use of supplied-air respirators. When
employers require employees to use respirators, OSHA believes it
necessary that employees be properly trained in their use and care, and
be informed of the limitations of using respirators. Paragraph (k) of
the final rule makes clear that employers must implement the employee
training requirements contained in paragraph (k) if they require their
employees to use respirators.
In contrast, not all of these protections are necessary in the
situation where an employer allows, but does not require, respirator
use. OSHA has therefore added a new paragraph (c)(2) to the final rule,
which applies when employers allow employees to use respirators when
such use is not required by the employer or by the standard. This
paragraph applies when employers either provide respirators to
employees who request them or allow employees to use their own
respirators. In both situations, paragraph (c)(2)(i) states that
employers must determine that the employees that they allow to use
respirators are medically able to do so, and that there are no other
conditions that could cause the respirator use to create a hazard.
If the employer allows voluntary respirator use, paragraph
(c)(2)(i) requires that the employer provide the employee with the
information contained in Appendix D to this standard, entitled
``Information for Employees Using Respirators When Not Required Under
the Standard.'' In the rare case where an employee is voluntarily using
other than a filtering facepiece (dust mask) respirator (paragraph
(c)(2)(ii)), the employer must implement some of the elements of a
respiratory protection program, e.g., the medical evaluation component
of the program and, if the respirator is to be reworn, the cleaning,
maintenance, and storage components. An exception to this paragraph
makes clear that, where voluntary respirator use involves only
filtering facepieces (dust masks), the employer is not required to
implement a written program.
Paragraph (c)(2) is necessary because the use of respirators may
itself present a health hazard to employees who are not medically able
to wear them, who do not have adequate information to use and care for
respirators properly, and who do not understand the limitations of
respirators. Paragraph (c)(2) is intended to allow employers
flexibility to permit employees to use respirators in situations where
the employees wish to do so, without imposing the burden of
implementing an entire respirator program. At the same time, it will
help ensure that such use does not create an additional hazard and that
employees are provided with enough information to use and care for
their respirators properly. This provision does not, of course,
preclude employers from adopting additional program elements if they
believe such elements are appropriate.
The great majority of voluntary use situations involve the use of
dust masks, i.e., filtering facepieces, which are provided for the
employee's comfort. For example, some employees who have seasonal
allergies may request a mask for comfort when working outdoors, or an
employee may request a dust mask for use while sweeping a dusty floor.
There are no medical limitations on the use of these respirators, so
employers who allow their use need only ensure that the masks are not
dirty or contaminated, that their use does not interfere with
employees' ability to work safely, and that they provide the employees
with the information contained in Appendix D, as required by paragraph
(k) of the final rule.
In rare cases where the employee requests and the employer allows
the use of a negative-pressure respirator (tight-fitting), or where the
employee brings such a respirator into the workplace, the employer must
implement some provisions of the respirator program described in
paragraph (c)(1) to ensure that such respirator use will not affect the
employee's health adversely. The employer can include these elements in
its existing respiratory protection program, if it is required to
maintain one. Some medical evaluation is necessary to determine that
the employee is physically able to use a tight-fitting negative
pressure respirator. In addition, if the respirators being used
voluntarily are reused, it is necessary to ensure that they are
maintained in proper condition to ensure that the employee is not
exposed to any contaminants that may be present in the facepiece, and
to prevent skin irritation and dermatitis associated with the use of a
respirator that has not been cleaned or disinfected. OSHA believes it
unlikely that voluntary use situations will involve the use of
supplied-air devices, but such use would also trigger these
requirements of the standard.
These requirements are necessary because use of a negative pressure
(tight-fitting) respirator imposes a significant physiologic burden on
a respirator user, and it is crucial to determine that the user can
withstand that burden without suffering adverse health consequences.
Similarly, reusable tight-fitting negative pressure respirators can
become contaminated if they are not cleaned, maintained, and stored
properly. Thus if an employer allows use of this type of respirator,
the employer must implement the program elements necessary to ensure
that contamination does not harm the employee.
The hazards addressed by this requirement are the same ones that
are already considered under OSHA's longstanding enforcement policy.
The Agency generally does not issue citations for violations of its
respirator standards unless there is also evidence of overexposure to a
hazardous substance, or some other hazard caused by improper or
inadequate respirator use. (OSHA Field Inspection Reference Manual
(FIRM), Ch. III. Sec. C.3.c). Other hazards referenced in the FIRM
include ingestion of harmful substances that may remain on improperly
cleaned and maintained respirators, or dermatitis caused by the same
condition. These are precisely the hazards that the requirements of
paragraph (c)(2) are designed to prevent. They can occur whether
respirator use is voluntary or required, and OSHA does not believe it
would be consistent with the OSH Act to allow employees to expose
themselves to preventable hazards, particularly where there are fairly
undemanding measures available to prevent that exposure.
Requiring employers to undertake these minimal obligations when
they allow voluntary respirator use is
[[Page 1191]]
consistent with the fact that employers control the working conditions
of employees and are therefore responsible for developing procedures
designed to protect the health and safety of the employees. Employers
routinely develop and enforce rules and requirements for employees to
follow based on considerations of safety. For example, although an
employer allows employees discretion in the types of clothing that may
be worn on site, the employer would prohibit the wearing of loose
clothing in areas where clothing could get caught in machinery, or
prohibit the use of sleeveless shirts where there is a potential for
skin contact with hazardous materials. Similarly, if an employer
determines that improper or inappropriate respirator use presents a
hazard to the wearer, OSHA finds that the employer must exert control
over such respirator use and take steps to see that respirators are
safely used under an appropriate program. It has been OSHA's experience
that employers will be able to determine whether employees are using
their own respirators in the workplace, just as they are able to
determine that employees are adhering to all other procedures and
requirements established by the employer.
Concomitantly, OSHA's decision to impose fewer requirements on
voluntary respirator use than on required use is supported by the
record. Many comments addressed the issue of how the final standard
should treat these two types of respirator use. Many commenters (Exs.
54-96, 54-109, 54-196, 54-222, 54-272, 54-341, 54-424, 145, 176, Tr.
2127, Tr. 2174 ) supported the inclusion of employer-required
respirator use, but not of voluntary use, within the full scope of the
standard. Many of these rulemaking participants believed that voluntary
respirator use should require a minimal program designed to provide
information and training to the employee, and that other elements of
the program should not be made mandatory. Typical of these was the
post-hearing comment of Organization Resources Counselors, Inc. (ORC):
OSHA should not require a complete respirator program for the
voluntary use of respirators by employees, when not required by an
OSHA standard, or by the employer. Some employees will wish to use
respirators even though they are not required to protect against
overexposure to a toxic hazard. In these instances the employer
should be required only to inform the employee of the safe and
proper use of such respirators and any associated limitations on the
particular device chosen (Ex. 145).
In addition, some of these commenters (Exs. 54-341, 176, Tr. 594, Tr.
2100) suggested that requiring employers to comply with all or most of
the requirements would discourage employers from permitting voluntary
respirator use in their workplaces. For example, in its post-hearing
submission, the North American Insulation Manufacturers Association
(NAIMA) commented as follows:
NAIMA agrees with many other hearing participants that employers
should be required to train voluntary respirator users in the proper
function and use of respirators * * * OSHA should, however, tailor
other aspects of the Proposed Rule to ensure that the more onerous
and unnecessary additional requirements, such as comprehensive
medical examinations, are not imposed in truly voluntary use
situations. Applying unnecessary ancillary requirements to voluntary
use situations would discourage employers from allowing workers such
use (Ex. 176).
OSHA believes that the final rule provides for the kind of
tailoring suggested by NAIMA's comment. Employers who permit the
voluntary use of tight-fitting negative-pressure respirators must
utilize the procedures necessary to address the health hazards
associated with the use of such respirators, but in the vast majority
of voluntary-use situations where employees are using dust masks
(filtering facepieces), the standard does not require the employer to
implement a written respirator program to ensure employee health. Thus,
the final rule does not require employers providing dust masks
(filtering facepieces) to their employees to comply with the
requirements that NAIMA considers ``onerous and unnecessary'' in this
situation. However, where respirators are used voluntarily by
employees, and the use of a given type of respirator, e.g., a tight-
fitting negative pressure respirator, is associated with an increased
health risk, OSHA finds that applying relevant portions of the
respiratory protection program is essential to ensure worker
protection.
Other commenters (Exs. 54-214, 54-218, 54-278, 54-389) believed
that application of the standard should be limited in situations where
there was no exposure to a respiratory hazard, regardless of whether
respirator use is required by employers in this situation or is
voluntary. In discussing this issue, the 3M Company commented as
follows:
1. Any use of respirators or masks in the workplace should
trigger a requirement for at least a minimal respiratory protection
program. Regardless of whether use is required or recommended by an
employer or is self-imposed by an employee, the employer should be
responsible for the safe use of respirators and masks in the
workplace.
2. Where it is documented by an employer that no hazard exists--
such as when used against non-toxic materials, exposures well below
the permissible exposure limit (PEL) or hazard level, or voluntary
use against such conditions as discomfort or allergies--the rule
should only require an abbreviated respiratory protection program *
* *. (Ex. 54-218)
In a similar argument, the Dow Chemical Company (Ex. 54-278) suggested
that employers be exempt from the standard's requirements if they
require employees to use respirators as a precautionary measure where
exposures are below the PELs.
OSHA did not adopt this approach in the final rule because the
Agency believes that, in most cases of employer-required respirator
use, respirators are being used as protection against actual or
potential exposure to a respiratory hazard. In these cases, OSHA finds
that it is necessary and appropriate that the employer implement all
elements of the respiratory protection program that apply to the
worksite-specific conditions under which respirators are used. If
respirators are used as protection against a real or potential risk
caused by exposure to a respiratory hazard, OSHA believes it essential
for the employer to provide for proper respirator selection, fit
testing, medical evaluation, and care and maintenance to ensure that
the respirator is providing sufficient protection against the hazard
and that use of the respirator is not imposing an additional health
risk. OSHA also believes that, by distinguishing between employer-
required and voluntary respirator use in the final rule, it will be
easier for employers to determine the extent to which the standard will
apply to their specific workplaces.
Other rulemaking participants (Exs. 54-208, 177, Tr. 782, Tr. 1722)
were of the opinion that voluntary respirator use should not be
distinguished from employer-required use in determining how the
standard should apply, or reported that some employers already
implement a program for voluntary use. The AIHA, in support of full
coverage of the standard for voluntary respirator use, stated in
written comment:
The position of AIHA is that all use of respiratory protection
should be covered by an employer's respiratory protection program.
That includes both voluntary use as well as required use. Both
groups should participate in all elements of the respiratory
protection program. An individual desiring to wear a respirator to
obtain some level of comfort or to further reduce their exposure to
[[Page 1192]]
a chemical in the workplace should receive the full benefits of an
established program: training to convey proper knowledge in
equipment selection, maintenance, and use; medical evaluation to
confirm that its use will not present a risk to the individual; and
fit testing to confirm that the equipment fits properly and
workplace surveillance to confirm that the equipment being utilized
is suitable for the exposure level. (Ex. 54-208)
At the public hearing, Larry Janssen of the AIHA elaborated that ``* *
* there should be some kind of a minimum framework to prevent the
misuse of respirators in those voluntary use situations, that you don't
do harm by allowing a respirator to be used where it's not really
needed'' (Tr. 782). Similarly, in a post-hearing comment, the
Industrial Safety Equipment Association (ISEA) stated that it was
important to cover voluntary use in the standard since ``* * *
[r]espirators that are not used properly could present a hazard'' (Ex.
177). This practice is already being implemented in some workplaces;
Richard Holmes of Union Carbide, representing the Chemical
Manufacturers Association (CMA) at the hearings (Tr. 1722), testified
that ``* * * [w]e treat the voluntary user just like a mandatory user
so they're in the program just as though they were required to wear the
respirator and the * * * medical surveillance is all handled the same *
* * [as is the training].''
As discussed above, OSHA agrees that some voluntary respirator use
(e.g., that involving tight-fitting negative-pressure respirators) may
present a health hazard to employees if the respirator is not properly
selected, maintained, and used. Therefore, OSHA has revised the final
rule to ensure that employers who permit voluntary use of such
respirators in their workplaces implement those portions of the
standard necessary to protect employees from any health risks
associated with respirator use. The position taken in the final rule
also reflects OSHA's long-standing enforcement policy with the previous
respiratory protection standard, as stated in the FIRM and in several
letters of interpretation issued by the Agency (See letters dated 10/2/
87 from Thomas J. Shepich, 4/11/91 from Patricia K. Clark, 3/19/91 from
Patricia K. Clark, 3/4/93 from Roger A. Clark (2 letters), and 3/15/95
from Ruth McCully). For example, in the letter of March 4, 1993 from
Roger A. Clark, OSHA stated its policy regarding the application of 29
CFR 1910.134 to the voluntary use of respirators:
OSHA's policy is that if the respirator itself could present an
adverse health condition if a specific requirement of the
respiratory protection standard is not observed, then the
requirement applies. Examples may include a dirty respirator that is
causing dermatitis, a worker's health being jeopardized by wearing a
respirator due to an inadequately evaluated medical condition, or a
significant ingestion hazard created by an improperly cleaned
respirator. This is so regardless of whether the employee purchased
the respirator or the employer provides it.
OSHA also has determined that complete training is not required for
employees using respirators voluntarily. Instead, paragraph (k) of the
final rule requires employers to provide the information contained in
Appendix D to ensure that employees are informed of proper respirator
use and the limitations of respirators.
Paragraphs (c)(1)(i) through (c)(1)(ix) list the elements of the
respirator program required by this standard. Paragraph (c)(1)(i)
requires the program to contain procedures for the selection of
respirators appropriate to protect employees from the respiratory
hazards present in the particular workplace. This provision is
unchanged from the corresponding provision in the proposal and is also
similar to paragraph (b)(2) of OSHA's previous standard. Paragraph
(c)(1)(ii) addresses the medical evaluation of employees required to
wear respirators and is unchanged from the parallel requirement in the
proposal. The AIHA (Ex. 54-208) recommended that paragraph (c)(1)(ii),
which requires employers to develop procedures addressing ``medical
evaluations of employees required to wear respirators,'' be changed to
specify that these procedures need only cover employees who are
``authorized by the employer to wear respirators''; the AIHA wanted
this word change to ensure that employers understood that these
procedures must cover both voluntary and required use. However, as
explained above, OSHA has decided to require medical evaluation of
employees who use respirators voluntarily only when such use may
present a health hazard to employees, e.g., in the case of tight-
fitting negative pressure respirators. Therefore, OSHA has not included
the language suggested by the AIHA in the final rule.
Paragraph (c)(1)(iii) covers the fit test element of the program
and has been modified since the proposal to respond to comments. The
proposal would have required the program to contain fit testing
procedures ``for air-purifying respirators and tight-fitting positive
pressure respirators.'' The Service Employees International Union (Ex.
54-455) commented that this provision only needed to address ``tight-
fitting respirators'' because this language adequately describes the
respiratory equipment to be covered. Since OSHA has revised the fit
testing requirements in paragraph (f) to cover all tight-fitting
respirators, the language in paragraph (c)(1)(iii) has been revised
accordingly.
Paragraph (c)(1)(iv) states that employers shall include
``Procedures for proper use of respirators in routine and reasonably
foreseeable emergency situations.'' In the NPRM, this requirement was
addressed under paragraph (g)(1), but it has been moved into paragraph
(c)(1) of the final rule to ensure that employers are aware that
written workplace-specific procedures must address both routine and
non-routine respirator usage, including that in reasonably foreseeable
emergency situations. OSHA received no comments on this provision.
Paragraph (c)(1)(v) requires the workplace-specific procedures to
cover ``procedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, discarding, and otherwise maintaining
respirators.'' This provision is unchanged from that proposed. The
American Iron and Steel Institute (AISI) urged OSHA to remove the word
``schedules'' from paragraph (c)(1)(iv) and to substitute the word
``frequencies'' instead. AISI stated that the term ``schedules''
connotes a requirement for extensive recordkeeping and paperwork. OSHA
does not agree. Since OSHA requires the respirator program to be
written, as required under the prior standard and as proposed and
supported by comments in this rulemaking, it is OSHA's conclusion that
including the employer's schedule for cleaning, disinfecting, or
otherwise maintaining respirators is not unduly burdensome. A schedule
is needed to inform employees when they are to have their respirators
fit tested, cleaned, and maintained. Therefore, OSHA is retaining the
word ``schedule.'' Representatives of the Service Employees
International Union [(SEIU) Ex. 54-455)] strongly supported the
requirement for maintenance schedules as proposed under paragraph
(c)(1)(v) of the NPRM for the same reason.
Paragraph (c)(1)(vi) is essentially unchanged from the proposal and
requires ``Procedures to ensure adequate air quality, quantity, and
flow of breathing air for atmosphere-supplying respirators.''
Representatives from SEIU (Ex. 54-455) supported OSHA's addition of
``quantity and flow'' to paragraph (c)(1)(vi) in the NPRM. Proper air
quality and quantity are crucial to the use of supplied air respirators
to protect worker health. The revised provision has been slightly
modified from the provision in the NPRM that
[[Page 1193]]
read ``* * * ensure proper air quality, quantity, and flow * * *'' for
atmosphere-supplying respirators. The addition of the words ``* * * for
breathing air * * *'' is to clarify that under no circumstances should
air for atmosphere-supplying respirators be of less than Grade D
breathing air quality.
Paragraph (c)(1)(vii), as proposed, would have required employers
to include ``[t]raining of employees in the respiratory and health
hazards of the hazardous chemicals to which they are potentially
exposed as required under the Hazard Communication standard (29 CFR
1910.1200).'' Several commenters questioned the need to cross-reference
an existing OSHA standard in the respirator standard, and recommended
that this provision be deleted (Exs. 54-154, 54-271, 54-278, 54-295,
54-307). OSHA agrees that the cross-reference is unnecessary, and the
reference to the Hazard Communication standard has been removed from
the final standard. However, the requirement that employers develop
procedures that address the ``Training of employees in the respiratory
hazards to which they are potentially exposed during routine and
emergency situations'' remains, because there are respiratory hazards,
such as biological hazards and radioactive particles, that are not
covered by the Hazard Communication standard.
Paragraph (c)(1)(viii) requires employers to develop procedures for
the training of employees in the proper use of respirators, including
putting on and removing them, the limitations of these devices, and
maintenance procedures for respirators. OSHA received no comments on
this provision, which has been revised slightly since the proposal for
clarity.
Paragraph (c)(1)(ix) states that the program should include
``Procedures for regularly evaluating the effectiveness of the
program.'' This provision is basically the same as in the NPRM except
that the word ``periodically'' has been deleted to avoid the suggestion
that OSHA has a fixed interval in mind. This provision notifies
employers that their written workplace procedures must include routine
evaluation of the program to ensure that it is effective, up-to-date,
and includes all necessary provisions. In workplaces where worksite-
specific conditions are relatively stable, such as a manufacturing
site, program evaluation may be conducted on a fixed schedule. In other
workplaces where worksite conditions are less stable, employers must
develop schedules for evaluating the program that make sense in that
context.
In a general comment, the United States Enrichment Corporation (Ex.
54-283) stated that the final rule's requirements for work procedures
in paragraphs (c)(1)(i) through (c)(1)(ix) implied that OSHA intended
separate documents to be developed to meet each of the requirements,
and asked OSHA to clarify this. It has always been OSHA's intention
that the employer can address the required program elements and the
development of worksite-specific procedures in a single document, the
written respiratory protection program. OSHA believes that reorganizing
the elements of this program to track the order of the standard will
facilitate the inclusion of all worksite-specific procedures into one
document.
In another general comment, Peter Hernandez of the American Iron
and Steel Institute (AISI) (Ex. 54-307) urged OSHA to revise paragraph
(c) and other paragraphs of the final rule to remove the term
``ensure,'' which he interpreted as imposing an impossible burden on
employers. OSHA disagrees with this interpretation, however. OSHA
standards use the word ``ensure'' because they impose a mandatory
requirement to comply on employers and because the OSH Act and
subsequent case law have made it clear that it is the employer's
responsibility to compel compliance. The reasoning behind this body of
case law is that it is the employer, and not the employee, who controls
the conditions of work at a given workplace. OSHA believes that the
word ``ensure'' is appropriate because it indicates that the employer
must manage, lead by example, train, direct, and, if necessary, set up
a disciplinary system so that employees understand that they must
follow safe and healthful practices on the job. However, case law also
makes it clear that employers are not the ``insurers'' of their
employees' behavior. In other words, if an employer establishes,
implements, trains employees in, and enforces safe operating
procedures, and does so in a consistent manner, the employer will not
be liable for an employee's unforeseeable violation of its safety rule.
Paragraph (c)(3) of the final rule requires employers to designate
a person as program administrator and to ensure that this person is
qualified to perform the responsibilities of this position. The person
can be qualified either by appropriate training or experience or both.
The administrator is also the person responsible for evaluating the
program, as stated in paragraph (c)(3). This requirement is essentially
unchanged from the proposal, although its language has been clarified.
The ANSI Z88.2-1992 respiratory protection standard (Ex. 81) also
contains a description of the responsibilities of the program
administrator and a requirement that the respirator program be
``periodically audited to ensure that (a) the program procedures
reflect the requirements of current applicable regulations and industry
accepted standards and (b) the program as implemented reflects the
written procedures'' (See clause 5.3). The ANSI standard recommends
that the audit be conducted by a knowledgeable person not directly
associated with the program, rather than by the program administrator.
OSHA has not adopted the ANSI recommendation that periodic audits be
performed by knowledgeable outside persons because the OSHA standard
requires the administrator to be qualified to perform this task; thus,
an additional requirement for audits to be performed by an outside
party is unnecessary and may prove unduly burdensome for some
employers.
The training requirements and experience level necessary for the
program administrator were the subject of substantial comment. OSHA
proposed that the program supervisor be a person ``qualified by
appropriate training and/or experience'' to be responsible for the
respirator program. Many commenters supported this performance-based
requirement (Exs. 54-68, 54-80, 54-91, 54-175, 54-187, 54-208, 54-219,
54-220, 54-222, 54-252, 54-319, 54-352, 54-361, 54-435, 54-455). For
example, the Service Employees International Union (Ex. 54-455)
supported the proposed ``performance-oriented qualifications for the
designated person (program administrator).'' Allied Signal (Ex. 54-175)
stated that ``there should be no specific minimum training for program
administrators. We believe the level of training for the respirator
program administrator must be adequate to deal with the complexity of
the program.'' Motorola (Ex. 54-187) commented that ``Training
requirements for those individuals designated by the employer to
administer the program should be commensurate with the type of
respirator program needed at the workplace.''
Several commenters urged OSHA to add a phrase to this requirement
in the final rule to require that the level of program supervisor
training must be adequate to deal with the complexity of the program
because the level of training appropriate for a workplace with
extensive respirator use is substantially different from one with
limited respirator use (Exs. 54-175, 54-
[[Page 1194]]
187, 54-200, 54-206, 54-214, 54-219, 54-222, 54-245, 54-265, 54-266,
54-275, 54-361). As Monsanto (Ex. 54-219) stated:
An employer's respirator usage may be limited to dust
respirators or may have a wide variety of types covering both air-
purifying and atmosphere-supplying respirators. Program
administrator training/qualifications would need to cover a wider
range of topics in the latter case than in the former case.
However, some commenters, e.g., the Sparks Nevada Fire Department
(Ex. 54-129), wanted to avoid imposing overly stringent requirements on
choosing a program administrator, while others, e.g., the Grain
Elevator and Processing Society (Ex. 54-226), urged OSHA to delete the
phrase ``qualified by training and/or experience'' on the grounds that
there are no widely accepted criteria for determining such a program
administrator's qualifications. A few commenters acknowledged that
since the program administrator's tasks often vary by type of
workplace, it would be difficult for OSHA to establish a required
minimum level of training that would be appropriate for all program
supervisors in all workplaces. Michael Rehfield, Safety Officer for the
Westminster, Maryland Fire Department (Ex. 54-68) stated:
I am in total agreement that the person fulfilling this role and
the ``qualifications'' should be ``performance oriented''. That
language should appear in this section. It is imperative that the
emergency response community be represented by performance oriented
standards or regulations since the associated tasks are so diverse.
A working group from the State Universities of New York (Ex. 54-
357) felt that the performance language regarding program supervisors
was too vague, and suggested that a nonmandatory appendix be added to
identify the types of qualifications a program supervisor would need.
The United Automobile, Aerospace & Agricultural Implement Workers of
America (UAW) (Ex. 54-387) wanted OSHA to define a body of knowledge
necessary to carry out the duties of a qualified program administrator.
OSHA discussed these qualifications in the preamble to the NPRM at
59 FR 58898-58899. That proposal discussion reiterated many of the
points that are described above: that the level of training appropriate
for a workplace with limited respirator use would be quite different
from another with extensive use of different respirator types, and that
the program administrator can work with a workplace respirator
committee, or assign responsibility for portions of the program to
industrial hygienists, safety professionals, or other respirator
experts while retaining overall responsibility for the program. In
other words, the level of training of the program administrator must be
adequate to deal with the complexity of the respirator program.
The AFL-CIO (Exs. 54-428, 255) urged OSHA to add a new definition
to paragraph (b) for qualified person as follows:
Qualified Person: This should be defined as, someone who is
capable of identifying existing and predictable respiratory hazards
in the workplace and who maintains a common knowledge of the
respirator standard. This individual should possess the authority to
take prompt corrective action to eliminate hazards including the
measures required in subsection (c). The qualified person shall be
certified by the manufacturer(s) for their ability to select and
maintain the type(s) of respirator(s) that is/are used on the job
site or possess the experience and knowledge needed to properly
select respirators for the employees and job situation.
Instead of adopting the AFL-CIO definition for ``qualified
person,'' OSHA has relied on the type of wording used in the ANSI
standard, which is more performance oriented. Specifying in detail the
type and extent of training required for program administrators depends
upon the type of workplace and is best left to the employer, in OSHA's
opinion. For example, the level of training that would be appropriate
for a workplace with limited respirator use would be quite different
from that required at another workplace with extensive respirator use
for IDLH atmospheres, highly toxic chemicals, or other complex
respirator use operations. Therefore, OSHA has adopted a definition of
training and experience that uses performance language and is similar
to the ANSI Z88.2-1992 standard's requirement. However, OSHA does
require employers to ensure that the level of training for the
respirator program administrator is adequate to deal with the
complexity of the workplace.
In keeping with this approach, OSHA has not established any one
training program, such as the NIOSH respirator course, as the level of
training program administrators must achieve. OSHA believes that
NIOSH's course is excellent, and therefore more than sufficient in most
cases. However, OSHA acknowledges commenters' concerns that a general
respirator training course covers a broad range of many different
respirator types and uses, and provides information that is not
tailored to any one particular workplace (Exs. 54-220, 54-265, 54-342,
54-435). Typical of these comments is one by the United Parcel Service
(Ex. 54-220), which stated: ``An attempt to fashion uniform standards
for all administrators of all respiratory programs could result in
inadequate training for administrators of particularly sophisticated or
specialized programs and irrelevant training for administrators of
relatively simple programs.'' The North American Insulation
Manufacturers Association agreed, stating (Ex. 54-342) ``A requirement
that supervisors undergo a rigid minimum training regimen, which would
require instruction on many issues irrelevant to the supervisor's own
situation, would be excessive and beyond the rule's intended
objective.'' For example, extensive training on certain types of
respirators such as SCBAs would be inappropriate for program
administrators with simple programs that don't use SCBAs. In other
cases, respirator program administrators with highly complex respirator
programs may need an even more comprehensive course than that provided
by a general respirator training course. Based on the above discussion,
OSHA has retained a performance-based program approach. OSHA
anticipates that larger establishments will develop training
requirements for respirator program administrators that fit the needs
of a workplace-specific respirator program.
OSHA has prepared a Small Entity Compliance Guide setting forth how
a small business owner, manager or an employee of the small business
can be qualified to be a program administrator. It also sets forth a
sample respirator program to guide small businesses. If the employees
of a small business are only exposed to nuisance dusts and relatively
non-toxic chemicals and use only a few types of relatively simple
respirators, knowledge of the guide and materials supplied by the
respirator manufacturer may be sufficient for the small business owner
or an employee to become qualified as a program administrator. If more
dangerous chemicals or high exposures are present, or sophisticated
respirators are used, the program administrator must have more
knowledge or experience. In these circumstances, it may be necessary
for the administrator to seek out the expertise needed or to obtain
appropriate training.
The need for a specific individual to be in charge of the
respirator program was discussed by several commenters. One commenter
argued that requiring that a specific person be selected as program
administrator requires the equivalent of a full-time person to
[[Page 1195]]
manage the program and conduct periodic reviews of its performance (Ex.
54-160). Motorola (Ex. 54-187) stated that one overall program
administrator would be a problem for decentralized workplaces. Motorola
recommended that OSHA permit a committee or multiple employees to be
responsible for the respirator program, thus allowing the employer to
tailor the program to meet the needs of each particular workplace. Dow
(Ex. 54-278) also supported the use of a committee or team with joint
responsibility for the respirator program at large sites. Duke Power
(Ex. 54-326) stated that at large facilities, such as nuclear stations,
it is often necessary to designate more than one program administrator
to address radiological and non-radiological use of respirators. The
Public Service Electric and Gas Company (Ex. 54-196) said it may be
more effective to have a program administrator for each ``business
unit'' in a decentralized, diversified company, particularly where each
unit's respiratory protection needs are different (Ex. 54-196). The
AFL-CIO (Ex. 54-428) wanted to have one qualified person responsible
for the program, with a ``site person'' at each work site, who would be
responsible for the program at that site, but who would report to the
qualified person. The Department of Defense (Ex. 54-443), specifically
the Navy, urged OSHA to add language to require that each ``activity''
designate a person responsible for the respiratory protection program
because a single program administrator would be a potential problem for
a large, multi-tiered employer with activities throughout the world,
such as the Navy.
The final standard continues to require that a person qualified by
training or experience be designated to be responsible for the overall
management and administration of the program to ensure that the
integrity of the respiratory protection program is maintained through
the continuous oversight of one responsible individual. The program
administrator may serve largely in an oversight and coordination role
between the various subunits or departments that perform duties in
support of the respiratory program. Regardless of the number of
subunits, each employer must ensure that all subunits report to one
overall program administrator for coordination of the program. The
program administrator can use the assistance of industrial hygienists,
safety professionals, or other respirator experts to help run the
respirator program. The program administrator can work with a committee
or assign responsibility for portions of the program to other
personnel, but the overall responsibility for the operation of the
program must remain with the designated program administrator. This
approach promotes coordination of all facets of the program. For large
companies or multiple worksites, the program administrator can delegate
to a qualified person the responsibility for the day-to-day operation
of the program at a specific site or for a specific activity. However,
coordination between different worksites is an important aspect of the
operation of a good program; therefore, ensuring implementation of the
overall respirator program remains the duty and responsibility of the
program administrator. For small and moderate sized employers, OSHA
believes that the duties of a program administrator will require only a
small part of one employee's time.
Paragraph (c)(4) of the final rule requires employers to provide
respirators at no cost to the employee. This was included in the
proposal in paragraph (d)(1) and has been moved to paragraph (c) of
this final standard. This provision reflects OSHA's strong orientation
that the costs of complying with safety and health requirements must be
borne by the employer. OSHA has a long-standing policy that employers
are obligated to provide and pay for necessary personal protective
equipment (PPE) such as respirators used by employees on the job. A
compliance memorandum of October 18, 1994, titled ``Employer Obligation
to Pay for Personal Protective Equipment'' provides detailed guidance
on this issue. It is available online on the Internet on OSHA's home
page at http://www.OSHA.gov. The inclusion of this provision is
consistent with recent OSHA standards, e.g., Cadmium, 29 CFR
Sec. 1910.1027; 1,3-Butadiene, 29 CFR 1910.1051; and Methylene
Chloride, 29 CFR 1910.1052.
OSHA is aware that the Occupational Safety and Health Review
Commission has not always agreed with the Agency that standards
requiring an employer to ``provide'' safety or health equipment also
require the employer to pay for that equipment. See, e.g., Union Tank
Car Co., OSHRC No. 96-0563 (October 16, 1997). OSHA believes the
Commission is wrong about this issue. OSHA intends the language ``at no
cost to the employee'' in paragraph (c)(4) to make the employer's
obligation to pay for the respiratory protection required by this
standard crystal clear.
The requirement that the employer bear the costs of employee
training and medical evaluations has also been moved to paragraph
(c)(4) of the final rule, in order to consolidate all similar
provisions of the standard that clarify that, for these provisions,
there is no cost to the employee. Section 6(b)(7) of the OSH Act
requires that employers provide medical exams and evaluations at no
cost to employees.
Paragraph (d)--Selection of Respirators
Overview
Paragraph (d) of the final rule contains respirator selection
criteria and requirements. OSHA has included these provisions in the
final rule because the record contains many examples of workers using
respirators that are inappropriate for the type of respiratory hazards
present (e.g., wearing paper dust masks where the exposure is to a gas
or vapor contaminant (UAW, Ex. 54-387); using half facepiece
respirators in acrylonitrile IDLH atmospheres of 20 ppm (International
Chemical Workers Union (ICWU), Ex. 54-427)). In addition, OSHA's long
enforcement experience has shown that employers often lack the
information necessary to make informed choices about respirator
selection. OSHA stated in the proposal (59 FR 58899) that a major
deficiency of the previous standard is that it did not contain
selection criteria; instead, it merely referred employers to the ANSI
Z88.2-1969 standard.
No participant in this rulemaking disagreed with OSHA's decision
that the final standard should include mandatory selection criteria.
The record does show, however, that there are differences of opinion
about how restrictive and comprehensive the required criteria should
be, and how much flexibility should be left to employers in the
selection process. For example, the Association of American Railroads
(Ex. 54-286) stated that the details of respirator selection should be
left to the regulated community and that OSHA should only specify the
outcome desired, while the Service Employees International Union (SEIU)
(Ex. 54-455) commented that OSHA should ``strengthen the wording to
make it clear employers must obtain and account for all of the factors
listed.'' OSHA believes that those employers who employ on-site
occupational health professionals generally have the expertise to
select respirators that are appropriate for their workers. The record
contains a number of examples of well-thought-out selection programs
(e.g., Exs. 142, 155, 163). These examples show that the current
practice of many employers already conforms to the selection
requirements of paragraph (d). For other employers, however, clearly
stated
[[Page 1196]]
respirator selection rules and guidance are required.
OSHA notes that advice on the selection of respirators is available
from many sources. NIOSH has developed a respirator decision logic,
widely available and used since 1987, which provides a schematic
selection guide covering all critical areas of respirator selection
(Ex. 9). The selection guide for the ANSI Z88.2-1969 respirator
standard was incorporated by reference into the previous OSHA standard,
and the 1992 Z88.2 ANSI standard contains updated and comprehensive
recommendations on respirator selection. OSHA believes that employers
will find useful information in each of these guides on various
technical problems that this standard may not cover explicitly. In
addition, information is provided by respirator manufacturers who
publish selection guides relating to their models (See, e.g., Mine
Safety Appliances Company (MSA) Respirator Selection Guide, Ex. 150;
and ISEA's Respirator Buyers Guide and Safety Video Resource List,
referenced in Ex. 147). Manufacturers also provide selection advice
through telephone help lines, sales staff, verbal communications or
distribution of company product information, and on-site evaluations of
product use (See, e.g., Tr. at 1438-1439). Chemical manufacturers also
provide information about respirator selection to help the purchasers
of their products (See CMA, Tr. 1726-7; Union Carbide Corporation, Ex.
54-255).
Because of the variety and detail of selection information
available, OSHA believes it is necessary in the final rule to specify
broad performance criteria, in addition to a few specific rules
relating to highly hazardous operations (i.e., IDLH situations). The
final rule sets forth general rules for selecting respirators for
routine operations, prescribes specific kinds of respirators for
identified highly hazardous atmospheres and emergency situations, and
specifies when air-purifying respirators can reliably be used. OSHA
chose not to specify in the regulatory text all the situations and
respirator-related factors that an employer should consider but instead
to state performance objectives. Only for workplace situations widely
accepted as highly hazardous, such as those associated with IDLH
atmospheres, does the standard require maximally protective
respirators.
Because paragraph (d) does not address in detail all the relevant
factors that may affect employers' selection of particular respirators,
employers should rely on other information sources to ensure that the
respirators they select are appropriate for conditions in their
specific workplaces. Respirator manufacturers are the source of much
useful information, and the record of this rulemaking indicates that
much of this information is both helpful and reliable. Indeed, market
mechanisms work to encourage the dissemination of accurate information.
OSHA expects that smaller employers will thus generally be able to rely
on the technical assistance provided by manufacturers on respirator
selection and that doing so will mean that they will usually be in
compliance with this standard. For these reasons, paragraph (d)
concentrates on the minimum selection criteria that the record shows
must be adhered to by all employers when selecting respirators for
their employees' use.
In the following provision-by-provision summary and explanation,
OSHA explains the changes reflected in the final rule, both from the
provisions proposed and those in the Agency's previous respiratory
protection standard (Sec. 1910.134).
Paragraph (d)(1)--General Requirements
Paragraph (d)(1) prescribes general rules that apply to the
selection of all respirators. Paragraph (d)(1)(i) requires the employer
to select and provide an appropriate respirator based on the
respiratory hazard(s) to which the worker is or will be exposed and on
the workplace and user factors that have the potential to affect
respirator performance and reliability. This provision continues a
requirement from the previous standard: (``respirators shall be
selected on the basis of hazards to which the worker is exposed''
(Sec. 1910.134(b)(2)) and clarifies that the hazard must be viewed in
the context of the workplace and worker conditions that may reduce or
impair the effectiveness of a respirator otherwise appropriate for the
hazard. There is general agreement that taking working conditions into
account is crucial to proper respirator selection: a respirator that is
protective under some conditions of wear will fail under others, while
a respirator that is appropriate for a given hazard may not be workable
in a particular workplace (e.g., an air supplied respirator in a
tightly configured space). For example, a worker wearing SCBA who is
required to perform extremely heavy work may deplete the air supply of
the respirator well before its calculated service life is reached. This
means that the employer must evaluate the employee's level of exertion
in order to determine whether to choose a supplied-air respirator
rather than a SCBA. The recent ANSI standard also states that the
purpose of respirator selection is to determine which respirator type
or class will offer ``adequate protection'' (ANSI Z88.2-1992).
Final paragraph (d)(1)(i) also requires employers to consider
workplace and user factors that may affect the respirator's performance
and reliability when making a respirator selection. Although other
paragraphs of the standard address the major factors affecting
respirator performance, i.e., fit, faceseal leakage, and maintenance
and cleaning, factors specific to the job, user, or worksite often play
an important role in respirator performance. OSHA noted in the proposal
(59 FR 58900) that work activities and factors such as temperature and
humidity ``also affect the stress level associated with wearing a
respirator as well as the effectiveness of respirator filters and
cartridges; employees using respirators for longer periods of time
[under such stressful conditions] may need different types of
respirators for more comfortable wear.''
Similarly, where the respirator-wearing employee must communicate
with other workers, perhaps to warn them about the presence of
workplace hazards, the respirator must allow the employee to perform
this vital function. OSHA thus agrees with ANSI that ``it is important
to ensure that respirator wearers can comfortably communicate when
necessary, because a worker who is speaking very loudly or yelling may
cause a facepiece seal leak, and the worker may be tempted to
temporarily dislodge the device to communicate'' (ANSI Z88.2-1992,
clause A.13). Therefore, for example, the employer must ensure that
speaking will not interfere with the fit of the negative-pressure
elastomeric respirator selected. If the employees are using PAPRs or
SCBA, amplification devices, including speaking diaphragms and
microphones, that can be worn with the respirators are available.
The proposal (59 FR 58900) noted another example in the proposal of
worksite conditions that could affect respirator selection: ``* * *
airline respirators should not be used by mobile employees around
moving machinery unless entanglement of airlines in equipment is easily
avoided.'' Employers have always been required by OSHA to consider such
factors as these, because paragraph (a)(2) of the previous respirator
standard required employers to select respirators that are ``applicable
and suitable for the purpose intended.''
Paragraph (d)(1)(i) applies whenever employers provide respirators
to their
[[Page 1197]]
employees and require their use, whether or not an OSHA standard
mandates respirator use in the particular environment. The preamble
discussion relating to paragraph (c)(1) discusses employer-required
respirator use in more detail and explains OSHA's reasons for reaching
this conclusion.
Paragraph (d)(1)(ii) requires the employer to select a NIOSH-
certified respirator and to use the respirator only in ways that comply
with the conditions of its certification. There was little controversy
about this requirement, and there is no disagreement that respirators
must be tested and found to be effective before they can be marketed.
NIOSH has performed this function in the past and has begun to revise
its certification requirements to ensure that its procedures continue
to define the performance capabilities of acceptable respirator models,
and to identify unacceptable models. The ISEA (Ex. 65-363), the trade
association that represents most major respirator manufacturers, urged
OSHA to require that only NIOSH-certified respirators be used to comply
with this standard, and other commenters agreed (Exs. 54-187, 54-213,
54-387, 54-428).
The wording of this provision of the final rule differs slightly
from that of the proposed provision. The proposal would have required
that only NIOSH ``approved and certified'' respirators be selected. For
clarity, the reference to NIOSH-approved respirators has been replaced
in the final rule by a requirement that respirators be used only in
accordance with the conditions of their certification. NIOSH approves
respirators by certifying them; however, some certifications contain
conditions limiting the situations in which the respirator may be used.
This is sometimes described as NIOSH ``approval'' of the respirator for
a particular use.
Increasingly, however, NIOSH does not certify respirators for
specific uses. For example, NIOSH does not currently certify
respirators for use against biological hazards. Where NIOSH has not
specifically certified any respirator for use against the particular
contaminant present in the workplace, the employer must select a NIOSH-
certified respirator that has no limitation prohibiting its use against
that contaminant. The respirator must be appropriate for the
contaminant's physical form and chemical state and the conditions under
which it will be used. All respirators must be chosen and used
according to the limitations of the NIOSH certification, which appears
on the NIOSH certification label.
The requirement for NIOSH certification is unconditional in the
final standard, as it was in the proposal. However, because OSHA stated
in the proposed preamble that this requirement would apply only when
such respirators ``exist'' (59 FR 58901), some commenters urged OSHA to
state in the regulatory text that the requirement for NIOSH
certification applied only to existing certifications (See, e.g., Ex.
54-434). For example, the Department of the Army (Ex. 54-443) urged
OSHA to permit the use of respirators not approved by NIOSH in
situations where another authority has jurisdiction and the
documentation to attest to the adequacy of the respirator's
effectiveness against the contaminant of concern. The Army (Ex. 54-
443D) stated that its employees and contractors may be exposed to
certain ``military unique contaminants'' for which no NIOSH-approved
respirator exists but for which military respirators, e.g., gas masks,
have specifically been developed and tested and are being used by
civilian and contractor personnel in operations subject to OSHA's
jurisdiction. The Army urged OSHA to include in the standard ``approval
authority of the Secretary of the Army for military respirators * * *
for which no NIOSH approved respirator exists'' (Ex. 54-443D).
OSHA recognizes that there are unique contaminant situations, such
as those involving chemical warfare agents, that involve primarily
military exposure and that may require specialized respiratory
protection equipment. NIOSH certification for respiratory protection
specific to such hazards does not exist and is not likely to be
forthcoming. OSHA also notes, however, that, although the Department of
the Army argued strongly for OSHA recognition of Army authority to test
and approve respirators, the Department of the Air Force commented that
it uses only NIOSH-certified respirators, and requested no exception
(Ex. 54-443A). OSHA will examine on a case-by-case basis those
situations involving civilian contractors whose employees wear non-
NIOSH tested respirators that they believe protect employees adequately
and that have been tested and approved by other Federal agencies for
use against unique contaminants.
A similar comment was raised by DOE regarding radioactive hazards
(Ex. 54-215). DOE stated that, in the nuclear industry, no NIOSH-
certified respirator exists for tritium applications and workers
therefore must wear non-approved supplied-air suits; this equipment has
been tested by Los Alamos National Laboratory, and the suits have been
successfully used for many years. The DOE administers its own job-by-
job approval system for these suits. OSHA's authority to enforce the
Agency's safety and health standards at gaseous diffusion plants owned
by DOE and leased to the United States Enrichment Corporation was
established legislatively in 1992, and OSHA has recently completed a
memorandum of understanding with DOE on this issue (60 FR 9949, Jan.
31, 1995). OSHA is currently evaluating an application from one of
these facilities for a variance relating to these suits. The criteria
set out in Section 6(d) of the OSH Act will govern this determination.
OSHA is not determining the acceptability of supplied-air suits as part
of this rulemaking proceeding, because the Agency believes the variance
proceeding, which can focus closer attention on the strengths and
limitations of these suits for the particular use situations, is the
appropriate forum to decide this issue.
OSHA notes that NIOSH certification is a minimum qualification. The
employer must still assess whether the respirator meets all other
selection criteria in this standard before it can be chosen for a
particular application. For example, as pointed out by an exchange with
Richard Duffy of the International Association of Fire Fighters (IAFF),
NIOSH representatives acknowledged that the employer must evaluate
whether NIOSH-certified equipment will withstand the specific
environmental conditions for firefighting because NIOSH flow rate
requirements do not consider the stresses involved in firefighting, nor
does NIOSH currently evaluate respirators for their ability to
withstand those stresses (Tr. 364-365).
In his testimony at the OSHA hearings, Richard Duffy of the IAFF
recommended that OSHA require that SCBAs used in firefighting meet the
requirements of the National Fire Protection Association's NFPA-1981
Standard on Open Circuit Breathing Apparatus (Tr. 455). This NFPA
standard establishes more stringent performance criteria for SCBAs used
in firefighting than those currently used by NIOSH. NIOSH recognizes
that its current 42 CFR 84 respirator certification standards may not
be protective enough for respirators used in firefighting. In an
October 7, 1997 letter to all manufacturers and interested parties,
NIOSH announced its intent to develop new technical modules to update
42 CFR 84. One of the proposed technical modules to which NIOSH intends
to give priority treatment will address SCBAs, including the
[[Page 1198]]
incorporation of NFPA performance requirements for SCBAs. NIOSH also
intends to propose an Administrative/Quality Assurance module on the
use of independent testing laboratories in the certification program,
another issue raised by commenters in this proceeding. OSHA believes
that NIOSH will resolve any deficiencies in its current respirator
certification standards through these new 42 CFR 84 rulemaking modules.
OSHA simply is not equipped to take on the respirator approval and
certification process currently performed by NIOSH. Therefore, the
final OSHA respirator standard continues to require the use of NIOSH-
certified respirators and does not incorporate the NFPA performance
requirements for SCBAs.
OSHA believes that carving out even limited exceptions to NIOSH
control of respirator certification authority would confuse the
regulated community and would not resolve the needs of the vast
majority of respirator users. Comments by respirator users and worker
representatives support OSHA's final decision (See, e.g., Exs. 54-265,
54-118, 54-213, 54-387, 54-455). The final rule, in paragraph (h), also
requires that when respirator parts are replaced or changed, the
replacement parts must be NIOSH certified.
In the proposal (59 FR 58901), OSHA stated that developing an OSHA
respirator approval mechanism to fill in the gaps in NIOSH
certification would not be an efficient use of government resources.
Nonetheless, the Agency asked for comment on this issue. There was no
consensus among the participants who commented on this point. Some
commenters supported an OSHA role in approval on a temporary basis,
while an employer waits for NIOSH approval, or an alternative
governmental approval process (Exs. 54-213, 54-346, 54-443). Still
others opposed OSHA's involvement in an approval process (Exs. 54-278,
54-265, 54-118, 54-213, 54-387, 54-455). The final rule is therefore
similar to the proposal, which also discussed limited alternatives to
NIOSH certification and concluded that ``it is inappropriate for OSHA
to try to correct problems with present NIOSH/MSHA regulations in the
revised respirator standard'' (59 FR 58891).
OSHA believes that NIOSH has focused on closing any gaps in its
certification program. NIOSH's ability and experience in this area are
unparalleled, and OSHA believes that NIOSH can best resolve any
concerns through its own proceedings. Further, as stated in the
proposal, OSHA lacks the resources to perform respirator testing. OSHA
will, however, continue to evaluate, on a case-by-case basis, whether
variance or compliance interpretations are appropriate in cases where
employers claim that there are no NIOSH-certified respirators for use
in a particular situation.
Paragraph (d)(1)(iii) of the final rule requires the employer to
identify and evaluate the respiratory hazard(s) in the workplace. To
perform this evaluation, the employer must make a ``reasonable
estimate'' of the employee exposures anticipated to occur as a result
of those hazards, including those likely to be encountered in
reasonably foreseeable emergency situations, and must also identify the
physical state and chemical form of such contaminant(s). Where
conditions are such that the employer cannot carry out such an
evaluation, e.g., where exposure monitoring or other means of
estimation cannot be used, paragraph (d)(1)(iii) requires the employer
to treat the atmosphere as IDLH. Many of the components of paragraph
(d)(1)(iii) of the final standard have been required practice since
1971 because they were included in the selection provisions of the 1969
ANSI standard incorporated by reference into OSHA's previous
respiratory protection standard. Paragraph (d)(1)(iii) of the new
standard makes these provisions clearer by stating them explicitly in
the regulatory text.
Identifying and evaluating the hazards a respirator is to provide
protection against clearly play a pivotal role in respirator selection.
For example, according to ANSI, ``Respirator selection involves
reviewing each operation to * * * determine what hazards may be present
(hazard determination)'' (ANSI Z88.2-1992, clause 7.2.2; See also AISI,
Tr. 639). Many other commenters emphasized the important role of hazard
identification in respirator selection (Exs. 54-168, 54-181, 54-186,
54-208, 54-234, 54-273, 54-307, 54-327, 54-346, 54-426, 54-428). Once
an employer identifies the nature of the respiratory hazard or hazards
present, the employer must evaluate the magnitude of the hazard to
determine the potential exposure of each employee and the extent to
which respirators of various types can reduce the harm caused by that
exposure.
There was extensive comment on the selection process outlined in
the proposed paragraph dealing with hazard evaluation (Exs. 54-154, 54-
168, 54-181, 54-202, 54-219, 54-245, 54-278, 54-428). Commenters
representing workers generally supported the detailed approach taken in
the proposal toward hazard evaluation. For example, the Service
Employees International Union ``support[ed] the detailed list of
factors to be considered in respirator selection * * * [which]
successfully incorporates the important framework from the NIOSH
decision logic criteria in an easy-to-understand form'' (Ex. 54-428).
Some commenters, however (Exs. 54-154, 54-168, 54-181, 54-219, 54-
245, 54-278), stated that the scope and depth of the hazard evaluation
and the items to be covered should be left to the discretion of the
employer. For example, the Eastman Chemical Company (Ex. 54-245) and
the Dow Chemical Company (Ex. 54-278) requested that OSHA make the
requirement ``performance oriented'' and ``flexible''; the Department
of the Navy, Portsmouth Naval Shipyard (Ex. 54-154), noted that
detailed analysis for each work situation is not necessary for
shipbuilding, and that the timing and content of an appropriate
evaluation vary.
In response to these comments, OSHA has revised paragraph
(d)(1)(iii) to be more performance oriented; this provision of the
final standard no longer specifies precisely how employers are to
conduct the required evaluation. The proposal (at paragraph (d)(3))
would have required employers to ``obtain and evaluate'' information on
eleven specific factors for each work situation. These proposed factors
were the nature of the hazard; its physical and chemical properties;
its adverse health effects; the occupational exposure level; the
results of workplace sampling; the work operation; the time period of
respirator wear; the work activities and stresses on the wearer; fit
test results; warning properties; and the capabilities and limitations
of respirator types. Although OSHA continues to believe that each of
these factors is relevant to respirator selection under some
circumstances, a review of the record has convinced OSHA that each
factor is not crucial in every respirator selection process and that
the proposed requirement would have led to needless duplication of
effort and unnecessarily detailed evaluations.
The Oil, Chemical and Atomic Workers International Union (OCAW)
(Ex. 54-202) urged OSHA to require a written hazard assessment each
time that a respirator was selected. Paragraph (d)(1)(iii) of the final
rule does not require a written assessment; this was not proposed, and
OSHA believes that employers should be free to adopt the best approach
for justifying their respirator selections, based on the hazard
assessment. The final rule requires the employer to identify and
evaluate the respiratory hazards present, determine their physical
state and
[[Page 1199]]
chemical form (e.g., whether they are present in the form of a gas or
vapor; what their valence state or condition is, where relevant), and
assess the magnitude of the hazard they present to workers under normal
conditions of use and in reasonably foreseeable emergency conditions.
OSHA finds that it is essential for employers to characterize the
nature and magnitude of employee exposures to respiratory hazards
before selecting respiratory protection equipment. The language
contained in paragraph (d)(1)(iii) of the final rule does not specify
how the employer is to make reasonable estimates of employee exposures
for the purposes of selecting respirators, nor does the standard
require the employer to measure worker exposures to airborne hazards.
OSHA has always considered personal exposure monitoring the ``gold
standard'' for determining employee exposures because this is the most
reliable approach for assessing how much and what type of respiratory
protection is required in a given circumstance. This general view is
also shared by the industrial hygiene community. All of OSHA's
comprehensive substance-specific health standards have required
employee exposure monitoring to determine both the effectiveness of
existing control measures and the type of respiratory protection
needed.
OSHA continues to hold this view with regard to assessing employee
exposure in connection with this respiratory protection standard.
However, OSHA recognizes that there are many instances in which it may
not be possible or necessary to take personal exposure measurements to
determine whether respiratory protection is needed. Although sampling
and analytical methods exist for the vast majority of substances for
which OSHA has a PEL (29 CFR 1910.1000), there are numerous other
substances for which there are no readily available methods for
personal sampling. In other cases, the nature of the materials and
products being used in the workplace, and the way in which they are
used, make it highly unlikely that an employee working with them would
be exposed in a manner that would make respiratory protection
necessary. In these kinds of situations, the final rule permits
employers to use other approaches for estimating worker exposures to
respiratory hazards.
For example, employers may rely on information and data that
indicate that use or handling of a product or material cannot, under
worst-case conditions, release concentrations of a respiratory hazard
above a level that would trigger the need for respirator use or require
use of a more protective respirator. This approach is similar to that
used in several OSHA substance-specific health standards, which permit
employers to use objective data in lieu of exposure monitoring to
demonstrate that their employees cannot be exposed above an action
level (See, for example, 29 CFR 1910.1027, Cadmium; 1910.1048,
Formaldehyde; 1910.1047, Ethylene Oxide; 1910.1028, Benzene). Objective
data can be obtained from an industry study or from laboratory test
results conducted by manufacturers of products or materials being used
in the workplace. To generalize from data in an industry-wide survey to
conditions in a specific workplace, the survey must have obtained data
under conditions closely resembling the processes, types of materials,
control methods, work practices, and environmental conditions in the
workplace to which it will be generalized, i.e., the employer's
operation.
Data from industry-wide surveys by trade associations for use by
their members, as well as from stewardship programs operated by
manufacturers for their customers, are often useful in assisting
employers, particularly small-business owners, to obtain information on
employee exposures in their workplaces. For example, representatives of
the North American Insulation Manufacturer's Association (NAIMA)
testified (Tr. 597) that * * * ``[w]e have conducted numerous surveys
on end use customers, conducted research with Johns Hopkins University,
for example to provide estimates of routine exposures and * * * those
data, when collected appropriately and with organized labor and with
other industry groups, * * * can assure that the right respirator is
selected.'' NAIMA stated (Tr. 616, 618), ``it is ultimately the
employer's responsibility'' to evaluate whether data provided by
suppliers or others relate to their workplace conditions and
operations. However, it is clear that such programs can often assist
employers to estimate workplace exposures reliably enough to make
correct respirator choices without the need for employee monitoring.
Another approach that can be used by employers to estimate employee
exposures involves using mathematical approaches and obtainable
information. Employers can use data on the physical and chemical
properties of air contaminants, combined with information on room
dimensions, air exchange rates, contaminant release rates, and other
pertinent data, including exposure patterns and work practices, to
estimate the maximum exposure that could be anticipated in the
workplace. Methods that utilize this approach are readily available in
several textbook sources; for example, the ACGIH Industrial Ventilation
Manual contains calculations that can be applied to certain situations
to estimate worker exposures. Relying on such an approach to estimate
exposures requires the use of safety factors to account for uneven
dispersion of the contaminant in the air and the proximity of the
worker to the emission source. Usually, this approach works best in
situations where employees use small amounts of a chemical product
intermittently, or where contaminant releases are fairly constant and
predictable. This approach must be used continuously, and the data
obtained should therefore be interpreted conservatively (i.e., should
err on the side of worker protection).
In workplaces involving many complex factors, the use of estimation
techniques to characterize worker exposure is associated with a high
degree of uncertainty. In these instances, OSHA recommends that
employers conduct exposure monitoring instead of relying on estimation
techniques because they will then be able to have confidence that the
appropriate respiratory protection device has been selected and that
they are in compliance with the standard. Furthermore, OSHA believes
that in workplaces where many complex factors add uncertainty to
exposure estimates obtained through modeling, employers will find it
easier and less costly to conduct personal exposure monitoring to
evaluate the need for respiratory protection.
Many commenters urged OSHA not to specifically require monitoring
in the standard because other means of assessing potential exposures
are available (Exs. 54-153, 54-208, 54-219, 54-237, 54-273, 54-307, 54-
327, 54-443). These participants asked the Agency instead to adopt the
approach taken in the ANSI standard Z88.2-1992, clause 7.2.2.1(e),
which allows employers to estimate, as well as measure, exposures in
the workplace. One commenter questioned the utility of exposure
monitoring data for respirator selection because exposure sampling
provides only a ``snapshot'' of hazards on any given day (Ex. 54-178).
Other commenters disagreed, however. For example, Scott Schneider (Tr.
1520) of the AFL-CIO stated, ``In most workplaces that I've been in
there really is very, very little exposure data to know how much a
person is exposed to * * * exposures are quite variable from
[[Page 1200]]
day to day. And from worker to worker.'' (See comments to same effect
by OCAW, Ex. 54-202.) Some participants specifically asked OSHA to make
workplace sampling of airborne concentrations of contaminants explicit
(Tr. 1009 and Ex. 54-428; Ex. 54-427).
That some exposure monitoring results may be inadequate begs the
question of whether adequate monitoring should be conducted. OSHA's
experience in enforcing permissible exposure limits in the Air
Contaminant standard, 29 CFR 1910.1000, and for substance-specific
standards, confirms that, unless operations are highly repetitive,
conditions are constant, and estimates based on ``historical'' and
``objective data'' are made by experienced industrial hygiene
professionals, most employers need exposure monitoring results to
estimate employee exposure levels reliably. OSHA enforcement experience
also demonstrates that, where exposures are highly variable,
fragmentary monitoring results may mislead employees and employers,
unless they are based on competent sampling strategies. The frequency
and duration of monitoring, the representativeness of the employees and
operations sampled, and the skill with which sampling and analysis are
performed all influence the reliability of monitoring results. In
making reasonable estimates of employee exposures to satisfy the
requirements contained in paragraph (d)(1)(iii), OSHA expects employers
to account for potential variation in exposure and to rely on data or
information that reflect such variation. This is accomplished by using
exposure data collected with a strategy that recognizes exposure
variability, or by using worst-case assumptions and estimation
techniques to evaluate the highest foreseeable levels to which
employees may be exposed. The hazard assessment requirements in final
paragraph (d)(1)(iii) carry over from the requirement of the previous
standard, which incorporates by reference the ANSI Z88.2-1969 (clause
6.2) statement that ``[a]ny erring in the selection of respirators
shall be on the safe side.''
Paragraph (d)(1)(iii) also requires an employer to consider the
environment IDLH if employee exposures cannot be estimated reasonably.
This provision is intended to address those limited situations where
neither exposure monitoring, professional judgment, nor estimation
techniques can be relied on to reliably select adequate respiratory
protection equipment. This provision reflects a similar one in the 1992
ANSI standard, which requires atmospheres to be considered IDLH if it
is not possible ``to determine what potentially hazardous contaminants
may be present * * * or if no exposure limit or guideline is available,
and estimates of toxicity cannot be made'' (ANSI Z88.2-1992, clause
7.2.2.2 (b)(c)).
Several commenters (Exs. 54-381, 54-352, 54-267) objected to OSHA's
proposed requirement that atmospheres be considered IDLH ``where the
concentration of the hazardous chemical is unknown'' (59 FR 58939), and
stated that it would be neither practical nor necessary to wear
positive pressure respirators in all such situations (Ex. 54-352). One
commenter believed that requiring the most protective respirators for
``every unknown hazardous chemical atmosphere'' would result in 95
percent of the workforce being required to use them (Ex. 54-267). OSHA
did not intend the absence of workplace-specific exposure measurements
automatically to trigger selection of the most protective respirator;
instead, the Agency intends employers to use such equipment when they
do not have confidence that a less protective respirator is sufficient.
An example of the kind of situation that should trigger the use of the
most protective respirator was provided by a representative of CMA, who
testified (Tr. at 1707) that, when a maintenance person opens a closed
cycle manufacturing process to work on it for the first time, ``we
don't know what the air concentration is so we put people in supplied-
air respiratory protection under those circumstances.'' That is, the
company in this case assumes that exposures will be extremely high and
selects a respirator accordingly. OSHA believes that the language used
in paragraph (d)(1)(iii) of the final rule makes OSHA's intent clear,
i.e., that when reliable data or reasonable estimates of exposure are
not available, the atmosphere must be considered IDLH.
Finally, a few participants suggested that exposure estimates
should only be made by credentialed individuals (See, e.g., Ex. 54-
327). OSHA agrees that persons trained and experienced in evaluating
the respiratory hazards posed by workplace atmospheres are the most
competent to evaluate exposure levels, especially in the absence of
current exposure measurements. ANSI defines an ``occupational health
professional'' as ``(a)n individual whom, by experience and education,
is competent at recognizing, evaluating, and controlling health hazards
in the workplace'' (ANSI Z88.2-1992, clause 3.39). This is the person
who is responsible for performing expert evaluations under ANSI's
recommended standard. OSHA believes that this definition has merit, and
that employers whose workplaces have highly toxic respiratory hazards,
or many different hazardous chemicals or mixtures, as well as other
employers with the resources to do so, should utilize such
professionals wherever possible. However, OSHA is not specifically
including this requirement in the final rule because reasonable
estimations can be conducted in many workplaces by persons with the
qualifications required in the final rule for the respiratory
protection program administrator.
Paragraph (d)(1)(iv) requires that the employer choose respirators
from a sufficient number of respirator models and sizes so that the
respirator is acceptable to and correctly fits the wearer. The 1992
ANSI standard includes a similar requirement aimed at achieving
satisfactory fit and wearer acceptance (Z88.2-1992, clause 9.3.1. and
9.3.2.). This provision of the final standard revises the corresponding
proposed provision, which would have required employers to provide for
fit testing an array of three sizes and two brands of respirators with
elastomeric facepieces. The dual intent of this provision was to assure
that wearer acceptability plays a role in respirator selection, and
that the respirators chosen maintain their fit over the period of use.
OSHA continues to believe that these goals for respirator selection
are appropriate. However, OSHA was persuaded by this record that
specifying the number of sizes, models and brands that an employer must
provide is unnecessary. Therefore, the final provision deletes the
specification language for the number of sizes, models and brands that
must constitute the selection pool. Since this provision of the final
standard applies to all respirators, the proposal's application only to
``elastomeric'' facepieces has been dropped.
Most participants (Exs. 54-1, 54-5, 54-75, 54-80, 54-91, 54-161,
54-208, 54-214, 54-237, 54-238, 54-246, 54-263, 54-273, 54-280, 54-291,
54-287, 54-350, 54-363, 54-389) endorsed the inclusion in the final
rule of a performance-based provision addressing the selection of
comfortably fitting respirators. Thus, most comment on this issue
recognized that a sufficient assortment of respirators must be provided
so that employees will obtain acceptable fits, but that more
flexibility should be provided in the final rule. Commenters also
stated that, in some cases, a single manufacturer has a variety of
respirator models sufficient to
[[Page 1201]]
provide acceptable fit for their employees (Exs. 54-389, 54-150, 54-
161), although others provided only one or two sizes of a particular
model (Exs. 54-139, 54-38, 54-22, 54-163, 54-196). Some rulemaking
commenters stated that mandating that respirators from two
manufacturers be available would be costly and burdensome for small
employers (Exs. 54-161, 54-295), would not provide any tangible
improvement in the respirator program (Ex. 54-154), and would
complicate training and inventory functions (Ex. 54-156).
In the case of SCBAs, participants pointed out that buying and
storing two brands for fitting would be extremely costly, would create
congested storage areas, and would pose the risk that parts could
inadvertently be interchanged (Exs. 54-208, 54-209, 54-214, 54-250, 54-
300, 54-233, 54-331, 54-348, 54-45, 54-458). Even the AFL-CIO, which
generally supported the requirement that employers have respirators
from different manufacturers available, stated that requiring a multi-
manufacturer assortment was not feasible for SCBAs (Ex. 54-428).
OSHA concludes that providing a wide selection of sizes and models
of respirators will improve both fit and acceptability, and most
commenters agreed. In light of the comments, however, OSHA is making
the final rule's provision more performance-oriented, and is not
requiring a specific number of types and sizes. As ANSI noted, larger
employers are more likely to need a larger variety of respirators to
fit their employee population (Tr. 1426). Concomitantly, this change
will reduce the burden on smaller employers who will not need to
maintain such a wide array of respirator choices. OSHA believes
therefore that employers are in the best position to determine whether
their employee population is so diverse as to require the availability
of respirators from more than one manufacturer. OSHA encourages
employers to offer employees as wide a choice as practical when
performing fit tests.
In addition to the general requirement of assuring that employers
consider employee acceptability, some commenters requested that OSHA
require employers to offer PAPRs to employees ``who wear respirators
for long periods of time.'' These commenters stated that PAPRs are
cooler, more comfortable, and offer less breathing resistance than
negative pressure respirators (Exs. 54-387, 54-23). OSHA has included
such provisions in various substance-specific standards based on
evidence in those records that proper respirator use is likely to be
increased if more comfortable respirators are available (See, e.g., Ex.
330 in Docket H-033C, Asbestos in Construction standard, discussed at
51 FR 22719, June 20, 1986). For example, OSHA stated in the preamble
to the Lead standard (43 FR at 52933, Nov. 14, 1978) that ``PAPRs
provide greater protection to individuals, especially those who cannot
obtain a good face fit on a negative pressure respirator, and will
provide greater comfort when a respirator needs to be worn for long
periods of time. OSHA believes employees will have a greater incentive
to wear respirators if discomfort is minimized.''
OSHA continues to believe that under some circumstances PAPRs
provide superior acceptability. These include situations where
employees wear respirators for full shifts, where employees frequently
readjust their negative pressure respirators to achieve what they
consider a more comfortable or tighter fit, and where the air flow
provided by a PAPR reduces the employee's psychological and
physiological discomfort. However, where ambient temperatures are
extremely high or low, PAPRs are often unacceptable because of the
temperature of the airstream in the facepiece (See preamble to Coke
Oven standard, 41 FR at 46774).
OSHA's experience in enforcing standards that contain a provision
requiring PAPRs to be supplied is that the provision is rarely invoked
by employees, and even less rarely cited. The Agency continues to
believe that it is good industrial hygiene practice to provide a
respirator that the employee considers acceptable. Fit testing
protocols require that employees have an opportunity to reject
respirator facepieces that they consider unacceptable (See Appendix A).
However, this record does not provide a sufficient basis for the
Agency to require PAPRs upon employee request in all situations where
the standard applies. For example, Popendorf et al. (Ex. 64-513)
reported results from a survey of respirator users in indoor swine
production, poultry production, and grain handling facilities.
``Acceptability among four classes of respirators (disposable, quarter-
mask, half-mask and powered air-purifying helmets), varied among the
three user groups. * * * Powered helmets were rated best for breathing
ease, communication ease, skin comfort and in-mask temperature and
humidity, while disposables were rated best for weight and
convenience.'' OSHA emphasizes, however, that if the medical evaluation
required by this standard finds that an employee's health may be
impaired by using a negative pressure respirator, the employer must
provide a PAPR (See paragraph (e)(6)(ii)).
Paragraph (d)(2)--Respirators for IDLH Atmospheres
Paragraph (d)(2) covers respirators for use in atmospheres that are
immediately dangerous to life or health (IDLH). The comparable
provision in the proposal was paragraph (d)(10), which several
commenters stated was not clearly written (Exs. 54-38, 54-167, 54-213,
54-280, 54-297, 54-309, 54-455). OSHA has rewritten and reorganized the
provision so that paragraph (d)(2) of the final rule covers all IDLH
atmospheres, and paragraph (d)(3) covers all non-IDLH atmospheres.
The standard requires that the most protective and reliable
respirators be used for ILDH atmospheres: either a full facepiece
pressure demand SCBA certified for a minimum service life of thirty
minutes, or a combination full facepiece pressure demand supplied-air
respirator with an auxiliary self-contained air supply (paragraph
(d)(2)(i)). The proposal would have imposed the same requirement,
except for the addition of the requirement for a minimum service life
in the final rule.
OSHA has determined, as have most respirator authorities, that IDLH
atmospheres require the highest level of respiratory protection and
reliability. These atmospheres, by definition, are the most dangerous
environments in which respirators may be used. As OSHA explains in the
summary and explanation for the definition of ``IDLH,'' the term
includes atmospheres that pose an immediate threat to life or health,
would cause irreversible adverse health effects, or would impair an
employee's ability to escape. In these atmospheres there is no
tolerance for respirator failure. This record supported OSHA's preamble
statement that IDLH atmospheres ``require the most protective types of
respirators for workers'' (59 FR 58896). Commenters and authorities,
including NIOSH, ANSI, and both labor and management, agree that, for
these atmospheres, the most highly protective respirators, with escape
capability, should be required (See the NIOSH Respirator Decision
Logic, pg. 10; ANSI Z88.2-1992, clause 7.3.2; Ex. 54-38).
Paragraph (d)(2)(ii) requires employers to select respirators that
are to be used exclusively for escape from IDLH atmospheres from those
certified by NIOSH for escape from the atmosphere in which they will be
used.
[[Page 1202]]
This provision addresses the selection of escape-only respirators from
IDLH atmospheres involving different substances and situations. For
example, under current 29 CFR 1910.1050, the standard covering exposure
to methylenedianiline (MDA), escape respirators may be any full
facepiece air-purifying respirator equipped with HEPA cartridges, or
any positive pressure or continuous flow self-contained breathing
apparatus with full facepiece or hood; for formaldehyde exposure,
escape respirators may be a full facepiece with chin style, front, or
back-mounted industrial canister approved against formaldehyde (29 CFR
1910.1048).
Paragraph (d)(2)(iii) requires employers to consider all oxygen-
deficient atmospheres to be IDLH atmospheres. An oxygen-deficient
atmosphere is defined in paragraph (b) of the standard as one that
contains less than 19.5 percent oxygen. Below this level, employers are
required to use the same respirators as are required for IDLH
atmospheres, i.e., a full facepiece pressure-demand supplied-air
respirator with auxiliary SCBA or pressure-demand SCBA. This paragraph
contains an exception to permit employers to use any supplied-air
respirator, provided that the employer demonstrates that oxygen levels
in the work area can be maintained within the ranges specified in Table
II of the final rule, i.e., between 19.5 percent and a lower value that
corresponds to an altitude-adjusted oxygen partial pressure equivalent
to 16 percent oxygen by volume at sea level. The language of paragraph
(d)(2)(iii), along with the exception, reflects the same requirement as
that proposed, but avoids the potential confusion associated with
having separate definitions and requirements for oxygen-deficient, and
oxygen-deficient IDLH, atmospheres, as originally proposed. The
language used in the final rule also reinforces OSHA's belief that all
atmospheres containing less than 19.5 oxygen must be considered IDLH
unless the employer has good information that oxygen levels cannot fall
to dangerously low levels; in atmospheres below this level but falling
within the ranges showin in Table II, a SAR must be provided.
In the preamble discussion for paragraph (b), OSHA provided several
reasons for the selection of the 19.5 percent cutoff to define oxygen
deficiency. First, OSHA believes that consistency with the Agency's
confined space standard is essential because most oxygen-deficient
atmospheres will be associated with work in confined spaces. In the
preamble to the permit-required confined space standard, 29 CFR
1910.146(b), OSHA used the term ``asphyxiating atmosphere'' when
referring to an atmosphere containing less than 19.5 percent oxygen (58
FR 4466, January 14, 1993). In the confined space standard itself, OSHA
included ``atmospheric oxygen concentrations [of] less than 19.5
percent'' within the standard's definition of ``hazardous atmosphere.''
Using the same 19.5 percent cutoff point for defining an IDLH oxygen-
deficient atmosphere in this respiratory protection standard will
reduce the potential for confusion. In addition, OSHA's use of a 19.5
percent cutoff is consistent with the requirement that Grade D
breathing air contain a minimum of 19.5 percent oxygen (See paragraph
(i)).
OSHA believes that employers will only rarely have occasion to
avail themselves of the exception in paragraph (d)(2)(iii), which
allows the use of any supplied-air respirator (SAR) if oxygen levels
can be maintained within the ranges shown in Table II. Except for
confined spaces, there were no examples in the record of work
operations being routinely conducted in well-controlled atmospheres
where oxygen levels are below 19.5 percent. Most atmospheres with
oxygen content between 16 and 19.5 percent are not well-controlled, and
a drop in oxygen content could have severe consequences. OSHA's review
of enforcement data also confirms that, except for confined spaces,
such atmospheres are uncommon, although they occasionally occur when
work is conducted in basements, open pits, and other enclosed spaces.
If an employer can meet the difficult evidentiary burden of showing
that the oxygen content can be controlled reliably enough to remain
within the ranges specified in Table II, the atmosphere is not
considered IDLH under this standard, and the employer may provide any
SAR.
The low end of the ranges of oxygen concentrations in Table II are
the same as those used to define oxygen-deficient IDLH atmospheres in
the proposal: 16 percent oxygen by volume for altitudes from sea level
to 3,000, and 19.5% oxygen content for altitudes above 8,001 feet. For
altitudes from 3,001 to 8,000 feet, the listed oxygen concentrations
correspond to an oxygen partial pressure of 100 mm mercury (Hg). OSHA
explained in the proposal (59 FR at 58906) that these values are
consistent with those in ANSI's Z88.2-1980 standard and with ANSI's
definition of ``oxygen deficiency--immediately dangerous to life or
health'' as a partial pressure of 100 mm Hg at sea level.
ANSI's more recent 1992 standard permits lower oxygen
concentrations before classifying an atmosphere as IDLH, provided that
the employer has determined that the source of the oxygen reduction is
understood and controlled. OSHA noted in the proposal that IDLH oxygen
deficiency is now defined by ANSI as an oxygen content at sea level
that is equivalent to less than 12.5% oxygen (i.e., an atmosphere with
an oxygen partial pressure of 95 mm Hg or less). However, there is
general agreement that employees could be seriously and rapidly
debilitated if their supplied-air respirators should fail in a 12.5%
oxygen atmosphere. OSHA stated in the proposal that that level
represents the ``bare minimum safety factor.'' By choosing such a low
oxygen partial pressure as the ``floor'' for oxygen-deficient IDLH
atmospheres, the ANSI standard effectively removes any safety margin
(59 FR 58905). ANSI representatives (Tr. 1289) agreed with OSHA during
the hearing that OSHA's proposal offered a greater safety buffer than
the 1992 ANSI standard. In addition, ANSI itself acknowledged in Table
A-1 of its Z88.2-1992 standard (pg. 22, Ex. 54-50) that an oxygen level
of 12.5% at sea level would produce effects such as ``Very poor
judgment and coordination * * * impaired respiration that may cause
permanent heart damage * * * nausea and vomiting.'' OSHA considers
these effects unacceptable and intends this standard to prevent their
occurrence. The ANSI table also states that a 16% oxygen level would
produce effects such as ``Increased pulse and breathing rates * * *
impaired thinking and attention * * * reduced coordination,'' and at an
oxygen level of 14% effects would include ``Abnormal fatigue upon
exertion * * * emotional upset * * * faulty coordination * * * poor
judgment.'' All of these effects are potentially incompatible with the
safe performance of duties.
The ANSI table shows that the adverse health effects of oxygen
deficiency become significant at the 16% oxygen level, and that these
effects increase in severity as the oxygen level decreases. ANSI chose
the 12.5% level because that level represents the point below which
significant reductions in blood oxygen levels occur. As ANSI stated in
clause A.5.2 of the Z88.2-1992 standard ``[t]his rapid rate of change
then can present an unforgiving situation to an unprotected worker
where debilitating physiological symptoms can appear suddenly, without
warning, after only relatively
[[Page 1203]]
small changes in ambient oxygen levels.''
The ANSI standard anticipates that all atmospheres with reduced
oxygen levels would be treated as IDLH unless the source of the oxygen
reduction is understood and controlled (Clause 7.3.1 ANSI Z88.2-1992).
OSHA found that situations with controlled reduced-oxygen atmospheres
(below 16% oxygen by volume) are rare and are already treated as an
IDLH atmosphere by employers. Outside of confined spaces, such as in a
pit or a basement, a reduced-oxygen atmosphere is rarely stable.
Reduced-oxygen atmosphere situations may result as a byproduct of
dynamic processes such as oxygen-consuming operations caused by the
combustion of fuels or the digestion of organic matter. OSHA considers
all confined spaces with atmospheric concentrations of less than 19.5%
oxygen hazardous, and does not permit an oxygen level below 19.5% for
occupied confined spaces (See 29 CFR 1910.146(b)), because it is
difficult to ensure that, in a confined space, oxygen levels will not
drop precipitously with little or no warning. The work being performed
can itself reduce the oxygen levels, due to displacement of air by
asphyxiants or through consumption of oxygen by work processes or by
employees performing the work. Such sources of variability in oxygen
content, even in workplaces where employers are attempting to stabilize
the atmospheric oxygen content, can cause oxygen levels to drop to a
lower level, placing workers at risk. Furthermore, the accurate
monitoring of oxygen levels can be difficult, since sampling
instruments test a limited number of areas, and pockets of lower oxygen
content can exist inside a confined space or in a basement that can
cause a worker to be overcome. Thus, OSHA has chosen an oxygen level of
16% by volume as the level at which SCBA or an airline respirator with
auxiliary air supply must be used because that is the level below which
severe symptoms from oxygen deprivation first appear, because
maintenance of oxygen levels below 16% is difficult, and because
employees who are not protected risk their lives if an employer
mistakenly believes oxygen content can be controlled.
OSHA's determination that, at altitudes of up to 3,000 feet,
atmospheres containing less than 16% oxygen must be considered IDLH was
based on evidence that NIOSH submitted to the preproposal docket (See
59 FR at 58905). NIOSH showed that in an oxygen concentration of less
than 16% at sea level, employees may experience impaired attention,
thinking and coordination. The American Thoracic Society (Ex. 54-92)
questioned whether allowing work to be performed in an atmosphere with
as little as 16% oxygen, with no supplemental oxygen supply, at
altitudes below 3000 feet is sufficiently protective and suggested that
mandatory medical examinations might be necessary in such circumstances
to avoid pulmonary or cardiac disease complications. OSHA believes that
this comment reflects some of the confusion among rulemaking
participants concerning the proposed language covering oxygen
deficiency. OSHA wishes to make clear that, in both the proposed and
the final rules, employees are not permitted to work in atmospheres
containing less than 19.5 percent oxygen without the use of a supplied-
air respirator. In the majority of these cases, employers will be
obligated to provide highly protective respirators that can be used in
IDLH conditions. In a few cases, employers may be able to justify use
of any supplied-air respirator. In either case, employees will be
provided a supplemental source of breathing air when working in oxygen-
deficient atmospheres.
OSHA has not adopted NIOSH's recommendations that the IDLH
concentration of oxygen be increased to a concentration above 19.5% for
work above 8,001 feet. OSHA's experience confirms the record evidence
that most work at higher altitudes is performed by fully acclimated
workers (Exs. 54-6, 54-208). These provisions will allow acclimated
workers to continue to perform their work without oxygen-supplying
respirators, at any altitude up to 14,000 feet altitude, as long as the
ambient oxygen content remains above 19.5% and the employee has no
medical condition that would require the use of supplemental oxygen.
As noted above, oxygen deficiency frequently occurs in atmospheres
that are not well controlled, and OSHA's decision to consider all
oxygen-deficient atmospheres as IDLH except under certain strict
conditions is appropriate for work conducted in such dangerous
conditions. The requirement to use the most protective and reliable
respirators for IDLH atmospheres is proper to protect workers from the
dire consequences of exposure to these atmospheres.
Paragraph (d)(3)--Respirators for Atmospheres That Are Not IDLH
Paragraph (d)(3) sets out criteria and requirements for choosing
respirators for all non-IDLH atmospheres. These provisions supplement
the general requirements in paragraph (d)(1). This paragraph has been
reordered from the parallel paragraph of the proposed standard.
Paragraph (d)(3)(i) requires the employer to provide a respirator
that is adequate to reduce the exposure of the respirator wearer under
all conditions of use, including in reasonably foreseeable emergencies.
Employers must also provide respirators that will ensure compliance
with all other statutory and regulatory requirements, such as the
permissible exposure limits (PELs) for substances in 29 CFR 1910.1000,
substance-specific standards, and other OSHA standards. For example, 29
CFR 1910.120 (g)(2) of OSHA's Hazardous Waste Operations and Emergency
Response standard has additional exposure limits that apply to
hazardous waste sites and emergency response operations. In addition,
the general duty clause (Sec. 5(a)(1)) of the OSH Act may require
employers to protect their employees from substances that are not
regulated but that are known to be hazardous at the exposure levels
encountered in the workplace. However, as was discussed at length in
the ``Definitions'' section of this summary and explanation, the final
standard does not use the term ``hazardous exposure levels,'' in part
because the proposal was widely misunderstood to require compliance
with ACGIH's TLVs or NIOSH's RELs in the absence of an OSHA standard.
Moreover, as also noted above, this rulemaking does not address the
hierarchy of exposure controls in paragraph (a)(1). Thus, employers may
not rely on respirators to control exposures when feasible engineering
controls are available and are sufficient to reduce exposures.
As explained earlier, OSHA intends to address the issue of assigned
protection factors (APFs) and their impact on respirator selection in a
subsequent phase of this rulemaking. OSHA noted in the proposal (59 FR
58901) that APFs are ``a recognition of the fact that different types
of equipment provide different degrees of protection, and equipment
limitations must be considered in selecting respirators.'' A respirator
with a higher APF will provide more protection than a respirator with a
lower APF. Considerable information on APFs has developed since OSHA
adopted its existing standard in 1971. OSHA intends to promulgate APF
provisions in the future. Accordingly, paragraphs (d)(3)(i) (A) and (B)
are reserved at this time and will be addressed in the next phase of
this rulemaking. In the interim, OSHA expects employers to take the
best available information into account
[[Page 1204]]
in selecting respirators. As it did under the previous standard, OSHA
itself will continue to refer to the NIOSH APFs in cases where it has
not made a different determination in a substance-specific standard. In
addition, where OSHA has specific compliance interpretations for
certain respirators, e.g., respirators used for abrasive blasting (such
as for lead), these should be followed.
Based on the Agency's enforcement experience with the previous
standard, OSHA does not believe that differences in the APFs set by
NIOSH and ANSI will have a serious impact on respirator selection,
because the major differences in NIOSH and ANSI APFs occur with
respirators having APFs of 25 or greater, and most overexposures
involve exposures at relatively small multiples of the PELs. An
analysis of OSHA's Integrated Management Information System (IMIS) data
showed that only 2 percent of the measurements taken by OSHA exceeded
the PEL by more than 10 times.
Paragraph (d)(3)(ii) of the final standard provides that the
respirators selected must protect employees against the physical state
and chemical form of the particular contaminant or contaminants present
in the workplace. For air-purifying respirator selection, the form of
the contaminant is a critical factor. Different types of air filtration
respirators are needed for dusts and gases, for example, and, among
gases, different types are needed for acid gases and for carbon
monoxide. If the respirator is not equipped with a filter suitable for
the form of the contaminant to which a worker is exposed, then the
worker has no protection against that contaminant. No commenter opposed
this requirement. ANSI's standard acknowledges that this information is
critical to appropriate respirator selection (ANSI Z 88.2-1992, clause
4.5.4.(b)).
Paragraph (d)(3)(iii) covers respirator selection for protection
against gases and vapors. OSHA's primary intent in this paragraph is to
ensure that air-purifying respirators are not used in situations where
a chemical cartridge or canister becomes saturated such that the gas or
vapor contaminant can ``break through'' the filter's sorbent element
and enter the respirator and the worker's breathing zone. If this
happens, even correctly fitting, well-maintained respirators provide no
protection to their users. This breakthrough problem is avoided
entirely by the use of atmosphere-supplying respirators. Such
respirators do not rely on filter sorbents and instead deliver clean
outside air to the wearer's respirator.
This paragraph establishes the requirements for selecting
respirators for protection against gas and vapor contaminants.
Paragraph (d)(3)(iii)(A) allows the use of atmosphere-supplying
respirators against any gas or vapor, and paragraph (d)(3)(iii)(B)
specifies the conditions under which air-purifying respirators may be
used. These conditions protect users against the gas or vapor
contaminant breaking through the canister/cartridge filter. Thus, this
paragraph allows an air-purifying respirator to be used if it is
equipped with a NIOSH-approved end-of-service life indicator (ESLI)
(paragraph (d)(3)(iii)(B)(1)) or if the employer enforces a sorbent
change schedule based on reliable information and data on the service
life of cartridges and canisters used by the employer (paragraph
(d)(3)(iii)(B)(2)).
These provisions differ significantly from those in the proposal.
In proposed paragraphs (d)(8) and (d)(9), OSHA would have allowed air-
purifying respirator use for gases and vapors with ``adequate warning
properties,'' such as odor or irritation, and would not have imposed
additional conditions on their use. A substance would have been
considered to have adequate warning properties if the threshold for
detection was no higher than three times the hazardous exposure level.
For contaminants having poor warning properties, the standard as
proposed would have required employers to use an ESLI or develop a
cartridge/canister change schedule that would ensure replacement of the
sorbent element before 80 percent of its useful service life had
expired.
Commenters expressed significant dissatisfaction with the proposed
provisions, and some asked OSHA to reevaluate them in major respects
(Exs. 54-414, 54-249, 54-374). Many rulemaking participants urged OSHA
to rely much more heavily on end-of-service-life indicators (ESLIs) or
appropriate cartridge or canister change schedules for air-purifying
respirators, and some suggested that OSHA require NIOSH-certified ESLIs
on these respirators (Exs. 54-387, 54-443). Other commenters opposed
limiting the use of air-purifying respirators equipped with ESLIs or
reliable change out schedules to situations where the odor/irritation
threshold was less than three times the PEL. However, the Occidental
Chemical Corporation (Ex. 54-346) stated that adopting this restriction
would prohibit the use of air-purifying respirators for benzene
exposures in excess of 3 ppm unnecessarily, and ``counter 10 years of
effective employee protection that industry has provided.''
Many other participants criticized the proposal's reliance on
sensory thresholds such as odor and irritation to indicate when a
respirator's filtering capacity is exhausted, stating that there is too
much variation between individuals, that there is no good screening
mechanism to identify persons with sensory receptor problems, and that
the proposal would have allowed employees to be overexposed to
hazardous air contaminants (Exs. 54-151, 54-153, 54-165, 54-202, 54-
206, 54-214, 54-414, 54-280, 54-386, 54-410, 54-427). Still other
commenters suggested that the kind of respirator required should depend
on the severity of the harm resulting from overexposure, with exposure
to more serious hazards requiring supplied-air respirators (Exs. 54-
202, 54-212, 54-347). Finally, some commenters interpreted the proposed
provision as prohibiting the use of air-purifying respirators against
particulates ``without adequate warning properties'' (Ex. 54-309).
This, according to the Associated Builders and Contractors (Ex. 54-
309), would require, for example, a ``pipefitter who is torch cutting
metal with a galvanized coating to use an air-supplied respirator or
SCBA--even when working outdoors * * * [and] could add one more item to
the array of electrical power cords, pneumatic lines, and fall-
protection devices already attached to or trailing many construction
workers.''
ORC testified (Tr. 2164-65) that in general, the experience of most
of its member companies is that most toxic substances do not have
appropriate sensory warning properties. Indeed, in the preamble to its
proposed Glycol Ethers standard, OSHA noted that reported values for
the odor threshold of any substance vary widely, both because of
differences between individuals' ability to perceive a particular odor
and because of the methodology employed in conducting the odor
threshold determination (58 FR 15526).
NIOSH's ``Guide to Industrial Respiratory Protection--Appendix C''
reports that on average, 95% of a population will have a personal odor
threshold that lies within the range from about one-sixteenth to
sixteen times the reported mean odor threshold for a substance. As
stated by Amoore and Hautala(1983):
[t]he interpretation of these data * * * will depend markedly on the
individual circumstances. The threshold data * * * are based on
averages for samples of the population, presumably in good health.
Individuals can differ quite markedly from the population average in
their smell sensitivity, due to any of a variety of innate,
[[Page 1205]]
chronic, or acute physiological conditions * * * Continuing exposure
to an odor usually results in a gradual diminution or even
disappearance of the smell sensation. This phenomenon is known as
olfactory adaption or smell fatigue. If the adaption has not been
too severe or too prolonged, sensitivity can often be restored by
stepping aside for a few moments to an uncontaminated atmosphere, if
available. Unfortunately, workers chronically exposed to a strong
odor can develop a desensitization which persists up to two weeks or
more after their departure from the contaminated atmosphere * * *
Hydrogen sulfide and perhaps other dangerous gases can very quickly
lose their characteristic odor at high concentrations * * * Certain
commercial diffusible odor masking or suppressing agents may reduce
the perceptibility of odors, without removing the chemical source.
Other commenters agreed that odor threshold levels are so variable
that it is ``virtually impossible'' to set general rules for uniform
application (Moldex-Metric, Ex. 54-153; See also Phillips Petroleum,
Ex. 54-165 and Ex. 54-151). OSHA notes that NIOSH, in its 1987
Respirator Decision Logic (Ex. 9 at pg. 3) stated that ``[w]hen warning
properties must be relied on as part of a respiratory protection
program, the employer should accurately, validly, and reliably screen
each prospective wearer for the ability to detect the warning
properties of the hazardous substance(s) at exposure levels that are
less than the exposure limits for the substance(s).''
In light of this evidence, OSHA has reconsidered the conditions
under which air-purifying respirators may be used. The final standard
requires the use of ESLIs where they are available and appropriate for
the employer's workplace, whether or not warning properties exist for a
contaminant. If there is no ESLI available, the employer is required to
develop a cartridge/canister change schedule based on available
information and data that describe the service life of the sorbent
elements against the contaminant present in the employer's workplace
and that will ensure that sorbent elements are replaced before they are
exhausted. Reliance on odor thresholds and other warning properties is
no longer explicitly permitted in the final rule as the sole basis for
determining that an air-purifying respirator will afford adequate
protection against exposure to gas and vapor contaminants.
To date, only five contaminant-specific ESLIs have been granted the
NIOSH approval necessary to allow them to be used. To the extent that
NIOSH certified end-of-service life indicators are available, OSHA
finds that there are considerable benefits to their use. As a
representative of the Mine Safety Appliances Company (MSA) testified
(Tr. 821), ``ESLIs * * * simplify administration of the respirator
program. The idea of trying to administer control on the change out
schedule for these cartridges leads to human error or could lead to
human error. Where the end-of-service-life indicator is a more active
indicator for the actual respirator user that his cartridge needs
replacement, it takes the guesswork out of the respirator program and
change out schedule.''
NIOSH has established rigorous testing criteria for end-of-service
life indicators. An applicant must supply NIOSH with data
``demonstrating that the ESLI is a reliable indicator of sorbent
depletion (equal to or less than 90% of service life). These shall
include a flow-temperature study at low and high temperatures,
humidities, and contaminant concentrations which are representative of
actual workplace conditions where a given respirator will be used * *
*. Additional data concerning desorption of impregnating agents used in
the indicator, on the effects of industrial interferences commonly
found, on reaction products, and which predict the storage life of the
indicator'' are also required (NIOSH 1987, Ex. 9 at 45-46). Other
criteria cover the durability of an ESLI, and whether it interferes
with respirator performance or otherwise constitutes a health or safety
hazard to the wearer.
OSHA finds that these rigorous testing requirements will ensure
that employers who can rely on ESLIs can be confident that their
employees are adequately protected while using air-purifying
respirators against gas and vapor contaminants, and is therefore
requiring their use in the final rule. One commenter pointed out that
the use of cartridges with moisture-dependent end-of-service life
indicators will allow dangerously high exposures in dry atmospheres
(Ex. 54-455). However, the final rule requires the use of cartridges
and canisters equipped with an ESLI only if its use is appropriate for
the conditions of the employer's workplace. Thus, employers would not
be required to rely on an ESLI if the employer could demonstrate that
its use presents a hazard to employees.
There was much agreement in the record that it would not be
possible or feasible to require replacement of cartridges and canisters
before 80 percent of the useful service life of the sorbent element had
expired, primarily due to the lack of data available to employers to
make this determination (Exs. 54-6, 54-48, 54-165, 54-178, 54-181, 54-
226, 54-231, 54-289, 54-374). To implement this requirement as it was
proposed, the employer would need quantitative information that
describes how long a cartridge or canister would last when challenged
with a specific concentration of a gas or vapor. Such studies are
called ``breakthrough studies'' and require the use of elaborate
instrumentation and rigid test protocols. Several published
breakthrough studies of a few dozen commonly used industrial chemicals
are available in the literature (See, for example, Exs. 21-5, 21-7, 21-
8, 21-10, 38-13, 38-14, 38-15). OSHA recently used breakthrough data to
develop a general cartridge and canister change schedule for air-
purifying respirators used against 1,3-butadiene (61 FR 56817). Under
Section 5 of the Toxic Substances Control Act (TSCA), EPA's Office of
Pollution Prevention and Toxics (OPPT) requires manufacturers and
importers of new chemicals to conduct breakthrough studies and develop
cartridge/canister change schedules based on this service life testing.
As described above, however, comments to the record indicate that
breakthrough test data are not likely to be available for many
hazardous gases or vapors encountered in American workplaces. For
example, one commenter agreed that, although there is a need to protect
employees against contaminant breakthrough, it disagreed with relying
on employer-devised schedules because there has not been enough
breakthrough testing (Laidlaw Environmental Services, Ex. 54-178). The
American Electric Power Service Corporation asked OSHA to provide
needed guidance on how to assess the useful life of gas and vapor
cartridges under widely varying conditions (Ex. 54-181).
The record shows clearly that respirator manufacturers, chemical
manufacturers, and even NIOSH must provide more information about how
long respirator cartridges and canisters can be expected to provide
protection for employees, as well as additional tools to assess whether
the cartridges are still functioning. NIOSH's certification process
does not require respirator manufacturers to provide information on the
maximum or expected life span for gas and vapor cartridges. Nor do
chemical manufacturers written specifications routinely include this
information. The certification process tests only for minimum service
life, which for most cartridges is 25 to 50 minutes, and for most
canisters is 12 minutes (42 CFR part 84, Tables 6, 11). Also, as stated
by Cohen and Garrison of the University of Michigan (Ex. 64-
[[Page 1206]]
207, at 486), ``(c)urrent certification by NIOSH involves testing
respirator cartridges containing activated carbon against carbon
tetrachloride in the presence of water vapor. Testing cartridges with
carbon tetrachloride cannot predict how other organic vapors will be
adsorbed.''
Alternatives to OSHA's proposal that were suggested by rulemaking
participants included adopting the ANSI requirement to develop and
implement a cartridge change schedule based on cartridge service data
(which would require the use of breakthrough test data) and information
on expected exposure and respirator use patterns (Ex. 54-273), or
following manufacturers' recommendations for cartridge and canister use
(Ex. 54-6). Therefore, in the final rule, OSHA is not retaining the
proposed requirement for employers to ensure that chemical cartridges
and canisters be replaced before 80 percent of their useful life.
Instead, OSHA is requiring that employers develop cartridge/canister
change schedules based on available data or information that can be
relied upon to ensure that cartridges and canisters are changed before
the end of their useful service life. Such information may include
either information based on breakthrough test data or reliable use
recommendations from the employer's respirator and/or chemical
suppliers.
Unlike the proposal, the requirement in the final rule would not
require the employer to search for and analyze breakthrough test data,
but instead permits the employer to obtain information from other
sources who have the expertise and knowledge to be able to assist the
employer to develop change schedules. OSHA has revised the final rule
from the proposal in this manner to recognize that there may be
instances in which specific breakthrough test data are not available
for a particular contaminant, but manufacturers and suppliers may
nevertheless still be able to provide guidance to an employer to
develop an adequate change schedule. If the employer is unable to
obtain such data, information, or recommendations to support the use of
air-purifying respirators against the gases or vapors encountered in
the employer's workplace, the final rule requires the employer to rely
on atmosphere-supplied respirators because the employer can have no
assurance that air-purifying respirators will provide adequate
protection.
Ideally, change schedules should be based on tests of cartridge/
canister breakthrough that were conducted under worst-case conditions
of contaminant concentration, humidity, temperature and air flow rate
through the filter element. One such protocol is described in the EPA
Interim Recommendations for Determining Organic Vapor Cartridge Service
Life for NIOSH Approved Respirators (dated May 1, 1991), as revised in
May 1994. This protocol requires breakthrough testing at three
different concentrations at 80 and 20 percent relative humidity.
Additional testing is required if it is determined that the substance
may be used in workplaces where there are elevated temperatures, or
where breakthrough is evident at lower humidity. The protocol also
requires manufacturers to develop change schedules that incorporate a
safety factor of 60 percent of the measured service life.
OSHA emphasizes that a conservative approach is recommended when
evaluating service life testing data. Temperature, humidity, air flow
through the filter, the work rate, and the presence of other potential
interfering chemicals in the workplace all can have a serious effect on
the service life of an air-purifying cartridge or canister. High
temperature and humidity directly impact the performance of the
activated carbon in air-purifying filters. OSHA believes that, in
establishing a schedule for filter replacement, it is important to base
the schedule on worst-case conditions found in the workplace, since
this will provide the greatest margin for safety in using air-purifying
respirators with gases and vapors. Thus, to the extent that change
schedules are based on test data that were not obtained under similar
worst-case conditions, OSHA recommends that employers provide an
additional margin of safety to ensure that breakthrough is not likely
to occur during respirator use. OSHA encourages respirator and chemical
manufacturers to perform their own tests to provide appropriate
breakthrough test data to employers, particularly to small companies
with limited resources, for those situations where the data are not
already publicly available.
If breakthrough data are not available, the employer may seek other
information on which to base a reliable cartridge/canister change
schedule. OSHA believes that the most readily available alternative is
for employers to rely on recommendations of their respirator and/or
chemical suppliers. To be reliable, such recommendations should
consider workplace-specific factors that are likely to affect
cartridge/canister service life, such as concentrations of contaminants
in the workplace air, patterns of respirator use (i.e., whether use is
intermittent or continuous throughout the shift), and environmental
factors including temperature and humidity. Such recommendations must
be viewed by the employer in light of the employer's own past
experience with respirator use. For example, reports by employees that
they can detect the odor of vapors while respirators are being used
suggest that cartridges or canisters should be changed more frequently.
Another potential approach involves the use of mathematical models
that have been developed to describe the physical and chemical
interactions between the contaminant and sorbent material. Theoretical
modeling has been conducted to determine the effect of contaminant
concentration on breakthrough time and other similar relationships. It
is generally agreed, however, that the relationships between
contaminant concentrations, exposure durations, breathing rates, and
breakthrough times are complex and heavily dependent upon assumptions
concerning several factors, including environmental conditions (See
references 1-8 in Ex. 64-331). As a result, predictive models are
probably not likely to present an acceptable alternative for most
employers, and their use would require that a considerable margin of
safety be incorporated into any change schedule developed from such
estimation techniques.
Research is also underway to develop a field method for evaluating
the service lives of organic vapor cartridges using a small carbon-
filled tube to sample air from the work environment. The principal
investigator for this research stated in 1991 that ``(a) field
evaluation of the method is currently underway. It is expected to be
the final step in evaluating and validating the method for predicting
the service lives of organic vapor respirator cartridges in workplace
environments' (Ex. 64-208 at 42). Although OSHA cannot at this time
evaluate the utility of this method because results of the field
testing of this device have not been reported, the development of such
tools to assist employers to better estimate cartridge/canister service
times is encouraged, and their use would be permitted under the
standard providing that the reliability of such a method had been
appropriately demonstrated.
Representatives of CMA testified in favor of requiring the employer
to provide some written documentation for determining service life or a
change out schedule (Tr. 1736-1737). OSHA agrees that it is important
for the employer to
[[Page 1207]]
document the basis for establishing the change schedule and has
included in paragraph (d)(3)(iii)(B)(2) a requirement for the employer
to do so as part of his or her written respiratory protection program.
The written respirator program is the proper place for employers to
document change schedules, since the written program is the place where
employers give specific directions on workplace-related operations and
procedures for their employees to follow. The written program also
documents the exposure measurements or reasonable estimates that were
made, which form the basis of the calculations used to make the filter
change schedules. Developing a filter change schedule involves a number
of decisions. The employer must evaluate the hazardous exposure level,
the performance capacity of the filters being used, and the duration of
employee use of the respirator, which impact on the service life
calculations. OSHA believes that including the basis for the change
schedule in the written program will cause employers to better evaluate
the quality and reliability of the underlying information, and will
prompt the employer to obtain additional information, ask additional
questions of their suppliers, or seek competent professional help to
develop a change schedule that will ensure adequate performance of
cartridges and canisters used in the employer's workplace.
OSHA proposed in paragraph (d)(3)(ii) that, as part of the required
selection evaluation, the employer evaluate the physical properties of
the relevant contaminant and, in the preamble, listed ``the particle
size for dusts'' as a factor affecting respirator selection (59 FR
58900). ANSI recommended in its 1992 standard particle size/filter
selection criteria as follows: if the contaminant is an aerosol, with
an unknown particle size or a size less than 2 m, use a high
efficiency filter; if the contaminant is a fume, use a filter approved
for fumes or a high efficiency filter; and if the contaminant is an
aerosol, with a particle size greater than 2 m, use any filter
type (ANSI Z88.2-1992, clause 7.2.2.2.j, k, and l).
NIOSH agreed with ANSI's recommendations insofar as particulate
filtering respirators certified under former 30 CFR 11 are concerned.
However, NIOSH expressed particular concern about very small particles:
``Laboratory research beginning in the early 1970s, and continuing into
the 1990s, demonstrated that some, but not all, members of the Dust
Mist (DM) and Dust Fume Mist (DFM) filter classes allow significant
penetration of submicron-sized particles. Additionally submicron
particulates present special medical concerns because they can diffuse
throughout the respiratory system * * *'' In NIOSH's new 42 CFR part
84, classes of particulate filters now certified as filter series N, R,
and P may be used against any size particulate in the workplace (Ex.
54-437).
Based on this evidence, OSHA has determined that where employees
are exposed to submicron particles of a respiratory hazard, OSHA will
enforce paragraph (d)(3)(iv) as limiting the use of DM and DFM filters
certified under former 30 CFR 11 to employers who can demonstrate that
exposure in their workplace is limited to particulates that have a mass
median aerodynamic diameter of 2 m or larger. OSHA notes that
employers have alternative choices to using HEPA filters where the
sizes of particles are unknown or are less than 2 m. The new
filter media certified by NIOSH under new 42 CFR part 84 as series N, R
and P, may be used for any size particulate; however, where another
OSHA standard requires the use of HEPA-filtered respirators, the
employer may only use HEPA filters defined under 30 CFR 11 or N100,
R100, or P100 filters defined under 42 CFR part 84.
Paragraph (e)--Medical Evaluation
Medical evaluation to determine whether an employee is able to use
a given respirator is an important element of an effective respiratory
protection program and is necessary to prevent injuries, illnesses, and
even, in rare cases, death from the physiological burden imposed by
respirator use. The previous standard stated, at 29 CFR
1910.134(b)(10), that employees should not be assigned to tasks
requiring the use of respirators unless it has been determined that
they are physically able to perform the work while using the
respiratory equipment. That standard also provided that ``the local
physician shall determine what health and physical conditions are
pertinent,'' but listed no specific medical or workplace conditions to
consider when making such a determination. The previous standard also
stated that regular reviews of the medical status of respirator users
should be undertaken, and suggested that a once yearly evaluation would
be appropriate. Employers are thus aware of the need for medical
evaluations of respirator users and have been conducting such
evaluations as part of their respiratory protection programs for years.
OSHA believes that, to ensure employee protection, medical
evaluations for respirator use must be conducted before initial
respirator use, and that such evaluations must consist of effective
procedures and methods. Accordingly, the final standard's medical
evaluation requirements for respirator use identify who is to be
evaluated, and address the frequency and content of these evaluations.
It authorizes licensed health care professionals, both physicians and
nonphysicians, to evaluate employees for respirator use to the extent
authorized by the scope of their state licensure, and to conduct
follow-up medical evaluations based on specific indicators of need.
In the proposal, OSHA described three alternative approaches to
medical evaluation for respirator users. The first proposed alternative
in the regulatory text would have required employers annually to obtain
a physician's written opinion for every employee using a respirator for
more than five hours in any work week. The physician's opinion was to
inform the employer whether or not a medical examination of the
employee was necessary and, if so, was to specify the content of the
medical examination.
The second proposed alternative required a mandatory medical
history and examination, using questions and procedures similar to
those contained in the ANSI standard on physical qualifications for
respirator use, ANSI Z88.6-1984 (Ex. 38-4). This alternative would have
applied only to employees using a respirator for more than five hours
during any work week. Medical evaluation was to be performed annually
and whenever an employee experienced breathing difficulty while being
fitted for, or using, a respirator. The medical evaluation was to be
conducted by a physician or a health care professional supervised by a
physician, who, in arriving at a decision regarding the employee's
medical ability for respirator use, was to consider a number of
respirator and workplace conditions (e.g., type of respirator used,
duration and frequency of respirator use, substances to which the
employee is exposed, work effort and type of work, need for protective
clothing, and special environmental conditions (e.g., heat, confined
spaces)) that could affect the health and safety of respirator users.
The resulting medical opinion, which was to be written by a physician,
was to recommend any medical limitation on respirator use, and was to
be provided to both the employer and employee. This proposed
alternative contained an exemption for employees who had received a
comparable medical history and examination within the previous year for
the same respirator and conditions of respirator use. OSHA proposed a
nonmandatory Appendix C
[[Page 1208]]
with this alternative that specified the elements of the medical
evaluation.
The third proposed alternative would have required that a medical
questionnaire be administered to every respirator user, regardless of
the duration of respirator use. The medical questionnaires could be
administered by health professionals or other personnel who had been
trained in medical administration by a physician. If the answers to the
medical questionnaire showed that a medical examination was needed, the
employee had to be provided such an examination (see 59 FR 58911).
Medical examinations were to be mandatory for employees who would be
required to use SCBAs when assigned to emergency or rescue operations.
Medical examinations were to be conducted by physicians or physician-
supervised health care professionals. The medical opinion was to be
written by a physician; consider the same respirator and workplace
conditions specified for the second alternative; specify any medical
limitations on respirator use; and be provided to both the employer and
employee.
In addition to proposing three medical evaluation alternatives, the
proposal requested comments on medical removal protection, including
the need to provide alternative respirators or job assignments to
employees found to be medically unable to use the required respirator.
Overview of the Final Rule's Provisions
The provisions of paragraph (e) in the final Respiratory Protection
standard are based on an extensive review of the comments received on
the proposal, especially comments regarding the three proposed medical
evaluation alternatives. Final paragraph (e)(1) specifies that every
employee must be medically evaluated prior to fit testing and initial
use of a respirator. Paragraph (e)(2) states that employers must select
a physician or other licensed health care professional (PLHCP) to
conduct the medical evaluation, which must consist either of the
administration of a medical questionnaire or an initial medical
examination. Mandatory Appendix C contains the medical questionnaire to
be administered to employees if the medical questionnaire approach is
taken.
Paragraph (e)(3) requires the employer to provide a follow-up
medical examination to an employee who answers ``yes'' to any question
among questions 1 through 8 in Section 2, Part A of the medical
questionnaire in Appendix C. The follow-up medical examination is to
consist of any tests, consultations, or diagnostic procedures that the
PLHCP deems necessary.
Paragraph (e)(4) specifies that the medical questionnaire and
examinations shall be administered confidentially and at a time and
place, during working hours, that is convenient to the employee, and
that the employee understands the content of the questionnaire.
Paragraph (e)(5) requires the employer to provide the PLHCP with
specific information needed to make an informed decision about whether
the employee is able to use a respirator. The information includes
descriptions of the respirator to be used and workplace conditions that
may impose physiological burdens on respirator users, or that may
interact with an existing medical condition to increase the risk that
respirator use will adversely affect the employee's health.
Final paragraph (e)(6) requires the employer to obtain a written
recommendation from the PLHCP on whether or not the employee is
medically able to use a respirator. The recommendation must identify
any limitations on the employee's use of the respirator, as well as the
need for follow-up medical evaluations to assist the PLHCP in
determining the effects of respirator use on the employee's health. The
employee must receive a copy of the PLHCP's written recommendation. The
last provision of paragraph (e)(6) requires that a powered air-
purifying respirator (PAPR) be provided to an employee when information
from the medical evaluation shows that the employee can use a PAPR but
not a negative pressure respirator. If the PLHCP determines at a
subsequent time that the employee is able to use a negative pressure
respirator, the employer is no longer required to provide a PAPR to
that employee.
Paragraph (e)(7) specifies circumstances that require the employer
to provide additional medical evaluations to respirator users. Medical
reevaluations must be provided under the following conditions: when the
employee reports signs or symptoms that are relevant to the employee's
ability to use a respirator; when a PLHCP, supervisor, or respirator
program administrator informs the employer that an employee needs to be
reevaluated; when information from the respirator program, including
observations made during fit testing or program evaluation, indicates a
need for employee reevaluation; or if a change in workplace conditions
occurs that may result in a substantial increase in the physiological
burden that respirator use places on the employee. The following
paragraphs describe the comments received in connection with each
medical evaluation requirement, and discuss OSHA's reasons for
including each requirement in the final rule.
Introduction
OSHA is including an introduction to the regulatory text that
provides a brief rationale for requiring employers to implement a
medical evaluation program as part of their overall respiratory
protection program. The introduction is provided for informational
purposes, and does not impose regulatory obligations on employers.
The purpose of a medical evaluation program is to ensure that any
employee required to use a respirator can tolerate the physiological
burden associated with such use, including the burden imposed by the
respirator itself (e.g., its weight and breathing resistance during
both normal operation and under conditions of filter, canister, or
cartridge overload); musculoskeletal stress (e.g., when the respirator
to be worn is an SCBA); limitations on auditory, visual, and odor
sensations; and isolation from the workplace environment (Exs. 113, 22-
1, 64-427). Certain job and workplace conditions in which a respirator
is used can also impose a physiological load on the user; factors to be
considered include the duration and frequency of respirator use, the
level of physical work effort, the use of protective clothing, and the
presence of temperature extremes or high humidity. Job- and workplace-
related stressors may interact with respirator characteristics to
increase the physiological stress experienced by employees (Exs. 113,
64-363). For example, being required to wear protective clothing while
performing work that imposes a heavy workload can be highly stressful.
Specific medical conditions can compromise an employee's ability to
tolerate the physiological burdens imposed by respirator use, thereby
placing the employee at increased risk of illness, injury, and even
death (Exs. 64-363, 64-427). These medical conditions include
cardiovascular and respiratory diseases (e.g., a history of high blood
pressure, angina, heart attack, cardiac arrhythmias, stroke, asthma,
chronic bronchitis, emphysema), reduced pulmonary function caused by
other factors (e.g., smoking or prior exposure to respiratory hazards),
neurological or musculoskeletal disorders (e.g., ringing in the ears,
epilepsy, lower back pain), and impaired sensory function (e.g., a
perforated ear drum, reduced olfactory
[[Page 1209]]
function). Psychological conditions, such as claustrophobia, can also
impair the effective use of respirators by employees and may also
cause, independent of physiological burdens, significant elevations in
heart rate, blood pressure, and respiratory rate that can jeopardize
the health of employees who are at high risk for cardiopulmonary
disease (Ex. 22-14). One commenter (Ex. 54-429) emphasized the
importance of evaluating claustrophobia and severe anxiety, noting that
these conditions are often detected during respirator training.
The introduction states that the medical evaluation requirements in
paragraph (e) of the final rule are minimal requirements that OSHA
believes are necessary to protect the health of respirator users.
Paragraph (e)(1)--General
This paragraph requires that employees required to wear a
respirator, or those voluntarily wearing a negative pressure air
purifying respirator, be medically evaluated, and that a determination
be made that they are able to use the respirators selected by the
employer. A medical evaluation must be performed on every employee
required to use a respirator, regardless of the duration and frequency
of respirator use. In addition, as discussed above in connection with
paragraph (c)(2), employers must provide a medical evaluation to any
employee who elects to use a respirator that may place a physiological
burden on the user, e.g., a negative pressure air-purifying respirator.
By medically evaluating employees prior to respirator use, employers
will avoid exposing employees to the physiological stresses associated
with such use. Paragraph (e)(1) is similar to a provision in the
American National Standards Institute (ANSI) consensus standard Z88.2-
1992 (``American National Standard for Respiratory Protection) that
states: ``any medical conditions [of an employee] that would preclude
the use of respirators shall be determined.''
Commenters (Exs. 54-21, 54-307, 54-361, 54-419, 54-420, 54-421, 54-
441) generally agreed that medical evaluation should precede initial
respirator use, i.e., should take place before fit testing and first
time use of the respirator in the workplace. For example, the
International Brotherhood of Electrical Workers (Ex. 54-441) stated,
``The physical fitness of respirator users must be known prior to them
donning a respirator, not after they become injured.'' Three other
commenters (Exs. 54-419, 54-420, 54-421) agreed, without elaboration,
that medical evaluations should be performed before respirator use. One
commenter (Ex. 54-21) recommended that employees receive medical
evaluations after fit testing but before actual use so that
difficulties with respirator use during fit testing could be reported
to the PLHCP, and two other commenters (Exs. 54-307, 54-361) also
suggested that the medical evaluation be conducted prior to fit
testing.
OSHA believes that the initial medical evaluation must be conducted
prior to fit testing to identify those employees who have medical
conditions that contraindicate even the limited amount of respirator
use associated with fit testing. If medical problems are observed
during fit testing, the employee must be medically reevaluated (see
final paragraph (e)(7)).
Final paragraph (e)(1) requires the medical evaluation of employees
who use respirators, regardless of duration of use. This final
requirement differs from proposed alternatives 1 and 2, which would
have exempted from medical evaluation those employees who used a
respirator for five or fewer hours during any work week. The
overwhelming majority of commenters stated that the exemption should be
eliminated entirely or be limited only to those employees who are
exposed to minimal physiological stresses or workplace hazards. These
comments can be grouped, and are summarized, as follows:
(1) If the five-hours-per-week threshold were used, employers would
avoid the proposed medical evaluation requirement by rotating employees
who use respirators into jobs not requiring respirators just short of
the five-hour limit (Exs. 54-5, 54-165, 54-178, 54-419);
(2) Employees who use respirators frequently for periods of less
than five hours per work week, or who use respirators for more than
five hours per work week but do so infrequently, are still at risk of
the adverse health effects potentially associated with respirator use
and, therefore, they should also be medically evaluated (Exs. 54-163,
54-178, 54-308, 54-345);
(3) The five-hour exemption should not apply to respirator use that
is known to be physiologically burdensome (e.g., use of SCBAs by
emergency responders) or to use under the job or working conditions
(including hazardous exposures) that impose a significant physiological
burden on employees (Exs. 54-5, 54-68, 54-92, 54-107, 54-137, 54-153,
54-158, 54-159, 54-187, 54-194, 54-195, 54-206, 54-208, 54-213, 54-224,
54-247, 54-264, 54-265, 54-275, 54-283, 54-290, 54-327, 54-342, 54-348,
54-363, 54-395, 54-415, 54-427, 54-429, 54-453);
(4) The five-hour exemption would be too difficult for OSHA to
enforce or could not be administered effectively and efficiently by
employers (Exs. 54-70, 54-136, 54-167, 54-196, 54-244, 54-250, 54-267,
54-327, 54-348, 54-443);
(5) The health of employees with preexisting medical problems would
be endangered because these problems may go undetected until the five-
hour limit is reached (and, in some cases, may never be detected if
employees ``self-select'' into jobs with little respirator use because
of their medical problems) (Exs. 54-92, 54-159, 54-247, 54-415, 54-441,
54-455); and
(6) The five-hour exemption is not appropriate because every
employee who uses a respirator should have a medical evaluation (Exs.
54-6, 54-46, 54-79, 54-196, 54-202, 54-208, 54-214, 54-218, 54-233, 54-
272, 54-275, 54-287, 54-289, 54-295, 54-357, 54-394, 54-420, 54-424,
54-430, 54-434, 54-453), or the exemption is arbitrary, has no
scientific basis, or would increase an employer's risk of liability
(Exs. 54-188, 54-434).
Several commenters recommended that medical evaluation not be
required for SCBA users (Exs. 54-68, 54-320, 54-331, 54-353); that
medical evaluations for emergency responders be contingent on
respirator use exceeding five hours per year (Ex. 54-429); or that
emergency responders be exempted from medical evaluation requirements
that are unique to employees who use airline respirators or SCBAs (Ex.
54-420).
Some commenters recommended adopting the five hours per week
exemption (Exs. 54-14, 54-80, 54-91, 54-182, 54-220, 54-223, 54-224,
54-252, 54-283, 54-319) to achieve cost savings and improve the
efficiency of the respiratory protection program. Two commenters (Exs.
54-177, 54-402) stated that the five-hour limit represented the point
at which the effects of job-related physical stress should be medically
evaluated. Although generally endorsing the provision, several
commenters (Exs. 54-168, 54-206, 54-209, 54-295, 54-357, 54-366) found
the phrase ``during any work week'' to be vague, confusing, or in need
of being defined.
Several commenters wanted the five hours per week limit revised
upwards. One commenter (Ex. 54-300) recommended that the limit be
raised to 10 hours per week, while another commenter (Ex. 54-249)
endorsed a limit of 30 days per year. A third commenter (Ex. 54-116)
stated that the limit could be increased, without
[[Page 1210]]
danger, to 10 hours per week for firefighters who use SCBAs, but
presented no data to support this position, while three other
commenters (Exs. 54-209, 54-254, 54-454) stated that a 10 or 15-hour
per week limit could be tolerated without stress by most employees who
use respirators. One commenter (Ex. 54-435) believed that the exemption
should be broadened to cover seasonal employees because medical
evaluations are too difficult to administer to these employees. Another
commenter (Ex. 54-263) opposed any requirement for the medical
evaluation of employees who use respirators.
One commenter recommended that medical evaluations not be required
for employees who use disposable half-mask or dust mask respirators,
regardless of workplace exposure conditions (Ex. 54-329). A number of
commenters suggested eliminating medical evaluations if employers
choose to provide respirators to their employees (i.e., if they are not
required by OSHA to provide such respirators) (Exs. 54-69, 54-91, 54-
265, 54-287, 54-295, 54-320, 54-327, 54-339, 54-346, 54-421); two of
these commenters (Exs. 54-69, 54-339) expressed the concern that
employers may stop offering respirators to their employees if medical
evaluation is required in these cases.
The final standard, as noted above, provides an exception from the
requirement that employees who use dust masks on a voluntary-use basis,
as defined in paragraph (c), must be medically evaluated. OSHA based
the decision to require medical evaluation for all employees required
to use respirators, and for those employees voluntarily using negative
pressure respirators, on a number of scientific studies, discussed
below, which demonstrated that adverse health effects can result, in
some cases, even from short duration use of respirators. Several
experimental studies in the record show that even healthy individuals
using what is generally believed to be a ``low risk'' respirator for
short periods can experience adverse physiological and psychomotor
effects. In one experiment (Ex. 64-388), 12 individuals using low
resistance, disposable half-mask respirators under heavy workloads
(using a treadmill apparatus) for only five minutes experienced
statistically significant elevations in heart and respiratory rates,
systolic and diastolic blood pressure, and body temperatures compared
with these measures in the same individuals under control (i.e., no
respirator use) conditions. Some of these effects were observed while
the study participants were working at light and moderate workloads.
For two of these individuals, the study's author classified blood
pressure changes at heavy workload levels as ``clinically important.''
These results suggest that in an individual with cardiac insufficiency,
such physiological stress could cause fatal arrhythmia.
In another study (Ex. 64-444), 15 individuals used a full facepiece
respirator while performing light, moderate, and heavy workloads on a
bicycle ergometer for 15 minutes. Immediately following the 15 minute
exercise period, the ability of the individuals to maintain their
equilibrium (i.e., postural stability) was assessed using a special
platform designed for this purpose. Under every workload condition,
respirator use resulted in significantly increased heart rates and
impaired equilibrium compared to conditions when the individuals did
not use respirators.
A third study (Ex. 64-490) involved 12 individuals, each of whom
exercised for 30 minutes on a bicycle ergometer at a light-to-moderate
workload while using one of three types of respirators, i.e.,
disposable half-mask, negative pressure half-mask, and full facepiece
airline respirators. After taking a 10 minute rest, the study
participants repeated the procedure until each respirator type had been
tested. Compared to the control condition in which the subjects
exercised without respirators, the individuals were found to consume
more oxygen while exercising with the negative pressure half-mask and
full facepiece airline respirators, and to have higher systolic and
diastolic blood pressures while using the full facepiece airline
respirator. Under the test conditions of this study, therefore,
negative pressure half-mask and full facepiece airline respirators
imposed significant physiological stress on the respirator users.
Louhevaara (Ex. 164, Attachment D), after reviewing the available
research literature on respirator physiology, concluded that the major
physiological effects of negative pressure respirators and supplied-air
respirators, as well as SCBAs, are ``alterations in breathing patterns,
hypoventilation, retention of carbon dioxide, and [an] increase in the
work of breathing,'' and that these effects are worse under conditions
of increased filter resistance, poor respirator maintenance, and heavy
physical work. Sulotto et al. (Ex. 164, Attachment D) found that
negative pressure respirators resulted in higher breathing resistances
as physical workload on a bicycle ergometer increased, leading to
substantially reduced breathing frequency, ventilation rate, oxygen
uptake, and carbon dioxide production.
One study (Ex. 164, Attachment D, Beckett) that reviewed the
scientific literature on the medical effects of respirator-imposed
breathing resistance among healthy young men noted that ``[t]hese and
other studies indicate no clinically significant impairment of normal
respiratory function at submaximal workloads with the loads imposed by
currently approved, properly maintained, negative pressure respiratory
protective devices.'' This reviewer stated further, however, that
``[r]elatively less is known about the use of respirators by those with
abnormal physiology (for example, obstructive or restrictive pulmonary
diseases) and about the use of respirators whose resistance
characteristics are altered by excessively long use, such that
inspiratory resistance is increased by the deposition of matter within
the filter or absorptive elements of the canister.''
The Agency finds that these studies demonstrate the potential for
adverse health effects resulting from respirator use, even for healthy
employees using respirators designed for low breathing resistance and
used for short durations. The Agency believes, therefore, that
respirator use would impose a substantial risk of material impairment
to the health of employees who have preexisting respiratory and
cardiovascular impairments. As the earlier discussion of final
paragraph (e)(1) indicates, the record contains overwhelming support
for requiring medical evaluation of respirator users; many employers
who provided comments to the record have established medical evaluation
programs for all employees who use respirators (see, e.g., comments by
Organization Resources Counselors, Inc., Ex. 54-424). Consequently,
OSHA finds, consistent with the results of these studies and the entire
record, that the use of any respirator requires a prior medical
evaluation to determine fitness.
Other considerations that have caused OSHA to make this decision
are the potential impairment of health that may occur among employees
with preexisting medical problems if these problems are not detected
before respirator use; the need to identify medical problems that can
arise even from short term use of respirators of the types known to
impose severe physical stress on employees (e.g., SCBAs); and the
administrative difficulties and inefficiencies that employers would
experience if OSHA adopted a provision that required medical
evaluations only of some respirator users, i.e., those using certain
types of respirators or those
[[Page 1211]]
using them for a specified number of hours per week.
OSHA specifically disagrees with those commenters who stated that
no medical evaluations are needed for employees who only occasionally
use SCBAs. SCBAs create the highest cardiovascular stress of any type
of respirator because of their weight, and they are often used in high
physical stress situations, such as fires and other emergencies. This
combination of stressors makes medical evaluation necessary to avoid
myocardial infarction in susceptible individuals; at least 40 million
people in the United States have some form of heart disease (Levy, in
54 FR 2541).
One commenter (Ex. 54-284) recommended that the required medical
evaluations should be discontinued after an employee stops using
respirators. OSHA agrees with this recommendation, and has revised
final paragraph (e)(1) accordingly.
Paragraph (e)(2)--Medical Evaluation Procedures
Paragraph (e)(2)(i). This final paragraph requires the employer to
identify a physician or other licensed health care professional (PLHCP)
to perform medical evaluations using a medical questionnaire or medical
examination. Two major issues were raised in the rulemaking record: (1)
What must be done to evaluate employees, and (2) who must perform the
evaluation. Proposed paragraphs (e)(1) and (e)(3) would have required
physician involvement in the medical evaluation process, with
nonphysician health care professionals permitted to review the
employee's medical status only under the supervision of a licensed
physician. The final rule allows the evaluation to be performed either
by a physician or other licensed health care professional (e.g., nurse
practitioners, physician assistants, occupational health nurses),
provided that their license permits them to perform such evaluations.
Many commenters, representing labor, management, occupational
nurses, nurse practitioners, and physician assistants, recommended that
OSHA permit the use of nonphysician health care professionals (usually
nurse practitioners, physician assistants, occupational health nurses,
or registered nurses) to take medical histories, conduct physical
examinations (including pulmonary function tests), and administer and
review employee responses to medical questionnaires, provided that they
do so under the supervision of a licensed physician (Exs.54-6, 54-7,
54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187, 54-205,
54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304, 54-357,
54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443, 54-
453). Some commenters stated that nonphysician health care
professionals are competent to conduct medical assessments, while
physician supervision or involvement would guarantee that quality
control was maintained over the assessment process (Exs. 54-273, 54-
363, 54-381, 54-443, 54-453). Two of these commenters (Exs. 54-278, 54-
430) noted that any health care professional could review medical
questionnaires without physician supervision, but that physicians
should conduct or supervise any medical examinations conducted on the
basis of answers to the medical questionnaires.
Many other commenters, representing labor, management, and
physicians, preferred that only physicians be involved in medical
evaluation programs (Exs. 54-14, 54-46, 54-70, 54-101, 54-107, 54-150,
54-151, 54-165, 54-175, 54-180, 54-186, 54-189, 54-199, 54-217, 54-219,
54-220, 54-249, 54-271, 54-295, 54-313, 54-352, 54-455). This
preference was usually based on the prior or current practices of these
commenters. For example, the American College of Occupational and
Environmental Medicine (ACOEM) (Ex. 54-453) stated that the health
status of employees in a respiratory protection program should be
reviewed by physicians with specific training and experience in
occupational medicine because these medical specialists have knowledge
of the physical demands of respirator use needed to make valid
decisions regarding an employee's medical ability for the program. A
similar recommendation was made by the Service Employees International
Union (Ex. 54-455).
Some commenters recommended that the employee's medical ability to
use a respirator be evaluated solely by nonphysician health care
professionals (Exs. 54-16, 54-19, 54-25, 54-32, 54-79, 54-159, 54-184,
54-213, 54-222, 54-226, 54-253, 54-265, 54-272, 54-278, 54-397). Most
of these commenters cited their favorable experiences with nonphysician
health care professionals, and pointed to the cost savings of using
nonphysicians (Exs. 54-19, 54-79, 54-184, 54-226, 54-253). Several of
these commenters provided additional justifications. For example, one
commenter (Ex. 54-184) stated that ``physician assistants, by
education, training, and state regulation, are well qualified and
legally able to perform all aspects of a medical evaluation,'' and
argued that the scope of practice with regard to medical evaluations
should remain the prerogative of state licensing boards.
Another commenter (Ex. 54-213) noted that ``many physicians are not
familiar with occupational health risks as they relate to respiratory
exposures, types of respiratory protection available, and work
requirements.'' This commenter stated further that ``nurse[s] or other
qualified health care professional[s], operating within their licensed
scope of practice, [have] clinical expertise and knowledge of the work
environment and can best evaluate the physical requirements placed on
the user of respiratory protective equipment'' and that ``[u]se of
qualified health care professionals other than physicians is cost-
beneficial to employers, particularly [in] small business settings''
(Ex. 54-213).
The American Thoracic Society (Ex. 54-92), which recommended the
use of medical questionnaires rather than medical examinations, stated
that ``there is no demonstration that [physician-based] examinations
actually predict who will develop difficulties with respirator use''
because ``[v]ery few physicians have in-depth knowledge of respiratory
protection and workplace hazards sufficient to render a fully reasoned
view.''
None of the commenters, including those who used nonphysician
health care professionals to conduct medical evaluations as part of
their respiratory protection programs, cited any data or experience
showing that the type of PLHCP qualification and licensure, or the
manner in which PLHCPs are involved in the medical evaluation process,
had compromised the medical evaluation process or had resulted in
faulty medical evaluations.
After reviewing the entire record, OSHA decided to allow any PLHCP
to evaluate an employee's medical ability to use a respirator,
providing that the PLHCP is authorized to do so by his or her state
license, certification, or registration. Although OSHA agrees that
physicians with training and experience in occupational medicine are
highly qualified to conduct medical evaluations for respirator use, an
insufficient number (slightly more than 2,000 nationally) of these
specialists are available for this purpose (personal communication,
American Board of Medical Specialties, to Vanessa Holland, M.D., 5/29/
97). In addition, in circumstances where questions arise as to the
employee's physical condition and capability, OSHA believes that the
PLHCP can be relied on to consult with an appropriate specialist or
physician.
[[Page 1212]]
After a review of the licensing provisions of the 50 states and
Puerto Rico, OSHA concludes that state licensing laws often require
some physician involvement in conducting the medical evaluations
required by the final standard. For example, the majority of states
require that nurse practitioners perform their medical functions under
a formal written agreement with a physician. Only six states (i.e.,
Montana, New Mexico, North Dakota, Oregon, Vermont, and Washington) and
Puerto Rico allow licensed nurse practitioners to function
independently of physician supervision. Even these jurisdictions,
however, require licensed nurse practitioners to refer patients to a
physician for further evaluation and treatment when a medical problem
beyond the nurse practitioner's level of expertise arises. OSHA
believes that the states are best suited to judge the medical
competencies of those PLHCPs who practice within their jurisdictions,
and to regulate the scope of practice of these individuals.
To summarize, the final rule allows any PLHCP to administer the
medical questionnaire or to conduct the medical examination if doing so
is within the scope of the PLHCP's license. The basis for this decision
includes the following:
(1) The record (Exs. 54-19, 54-79, 54-92, 54-184, 54-253) generally
supports the position that properly qualified PLHCPs, regardless of the
type of health care specialization, are competent to assess the medical
ability of employees to use respirators using accepted medical
questionnaires or medical examinations;
(2) Evidence in the record that employers who operate respiratory
protection programs have successfully used PLHCPS, including
nonphysicians, to conduct medical evaluations and to make medical
ability recommendations, shows that nonphysicians have done so safely
and efficaciously (Exs. 54-213, 54-240, 54-389);
(3) Providing employers with ready access, at reasonable cost, to
the basic medical assessment skills required to perform at least the
initial phases of employee medical evaluation for respirator use
contributes to the efficient and effective allocation health care
resources; and
(4) The lack of record support for a requirement allowing medical
evaluations to be performed only by physicians. The record (Exs. 54-6,
54-7, 54-21, 54-134, 54-153, 54-157, 54-171, 54-176, 54-185, 54-187,
54-205, 54-239, 54-240, 54-244, 54-245, 54-251, 54-267, 54-273, 54-304,
54-357, 54-363, 54-381, 54-387, 54-389, 54-396, 54-424, 54-432, 54-443,
54-453) indicates that medical evaluations performed independently by
nonphysician health care professionals, as defined by this section, are
effective for at least the initial phases of an employer's medical
evaluation program (i.e., evaluating the medical questionnaire or
conducting an initial medical examination), and protect employee health
as well as medical evaluations conducted only by physicians or with
physician oversight. Employers are free, however, to select any PLHCP
they wish to satisfy this requirement, provided that the PLHCP is
qualified by license to do so. In some cases, the medical condition of
the employee or the conditions of respirator use may warrant physician
involvement, and OSHA is confident that LHCPs faced with such
situations will seek such medical advice.
Paragraph (e)(2)(ii). Paragraph (e)(2)(i) requires employers to
identify a PLHCP to perform the medical evaluations required by the
final rule. It also specifies that employers may choose to use the
medical questionnaire in Appendix C to conduct the initial medical
evaluation or provide a medical examination that obtains the same
information as the medical questionnaire. Employers are free to provide
respirator users with a medical examination in lieu of the medical
questionnaire if they choose to do so, but they are not required by the
standard to administer a medical examination unless the employee gives
a positive response to any question among questions 1 through 8 in
Section 2, Part A of Appendix C (see paragraph (e)(3)).
The approach taken in the final rule thus resembles the third
alternative proposed by OSHA in the NPRM: reliance on a medical
questionnaire (with medical examination follow-up if positive responses
are given to selected questions on the medical questionnaire). Those
commenters (Exs. 54-3, 54-14, 54-46, 54-67, 54-107, 54-151, 54-168, 54-
175, 54-180, 54-218, 54-220, 54-224, 54-226, 54-227, 54-240, 54-244,
54-264, 54-292, 54-294, 54-295, 54-324, 54-326, 54-327, 54-339, 54-346,
54-352, 54-366, 54-370, 54-210, 54-432, 54-434, 54-443, 54-445, 54-453)
who preferred the other alternatives (i.e., medical history and medical
examination for all respirator users, or medical examination and
written opinion) supported their views with a variety of opinions.
A number of the commenters who recommended the medical history and
examination alternative (Exs. 54-153, 54-165, 54-218, 54-226, 54-227,
54-263, 54-264, 54-294, 54-326, 54-327, 54-363, 54-443) favored this
approach only in those cases when employees would be using SCBAs, while
others (Exs. 54-16, 54-220) stated that medical questionnaires should
be used only for employees who use dust masks, and that other
respirator users should receive a medical history and examination
regardless of the duration of respirator use. Another commenter (Ex.
54-101) recommended that medical questionnaires be administered to
employees who use dust masks for fewer than five hours per week, while
other employees should receive a medical history and examination. One
commenter favored medical questionnaires only for respirator users who
perform ``isolated operations,'' while recommending that respirator use
in other employment settings require a medical history and/or
examination (Ex. 54-46). Another commenter stated that employees using
respirators under workplace exposure conditions exceeding an OSHA PEL
should receive a medical history and examination, while respirator
users exposed to other workplace atmospheres should only be required to
complete a medical questionnaire (Ex. 54-339).
Those commenters (Exs. 54-7, 54-16, 54-21, 54-25, 54-32, 54-69, 54-
91, 54-92, 54-101, 54-134, 54-142, 54-153, 54-154, 54-157, 54-158, 54-
165, 54-170, 54-171, 54-172, 54-173, 54-176, 54-187, 54-190, 54-192,
54-154, 54-197, 54-205, 54-206, 54-208, 54-209, 54-213, 54-14, 54-219,
54-222, 54-223, 54-234, 54-239, 54-241, 54-242, 54-245, 54-251, 54-252,
54-253, 54-254, 54-262, 54-263, 54-265, 54-267, 54-269, 54-272, 54-273,
54-275, 54-278, 54-284, 54-286, 54-289, 54-296, 54-304, 54-309, 54-319,
54-320, 54-325, 54-330, 54-332, 54-334, 54-342, 54-350, 54-357, 54-361,
54-363, 54-381, 54-389, 54-396, 54-401, 54-421, 54-424, 54-426, 54-428,
54-429, 54-430, 54-441, 54-453, 54-455) recommending medical
questionnaires (proposed alternative 3) objected to the medical
examination and written opinion approaches because, in their view,
medical examinations and opinions are difficult to obtain, have poor
predictive value, and are expensive, especially for workplaces that
have high employee turnover. Regarding costs, the American Iron and
Steel Institute (Ex. 175) stated that the medical opinion required by
alternative 1 would cost their industry $195 per employee, including
$150 for the medical examination and opinion, and $45 in lost work time
for the employee.
The record does not demonstrate that any of the three alternatives
were
[[Page 1213]]
superior in detecting medical conditions that could potentially limit
employee use of respirators. Testimony at the hearing by the United
Steel Workers of America (USWA) (Tr. 1059 and following) in support of
alternative 2 (medical history and examination) provided information on
the ability of different medical assessment procedures to detect
disqualifying medical conditions. This information showed that, among
126 employees, 16 were disqualified for respirator use because of
various medical conditions. Medical histories identified six of the
employees with these conditions, while a medical examination conducted
by a physician identified the remaining 10 employees. The USWA
attributed the reduced effectiveness of the medical histories in this
instance to the lack of awareness among employees of the medical
conditions that could potentially limit such use.
The United Steel Worker's testimony (Tr. 1059 and following) also
described a study in which physician-administered medical examinations
were found to be about 95 percent accurate and medical questionnaires
were found to be 60 to 70 percent accurate in identifying specific
medical problems. The final rule is designed to overcome this problem
to some extent by requiring that employees be trained to recognize the
medical signs and symptoms associated with the physiological burden
imposed by respirator use; see paragraph (k)(1)(vi).
A number of commenters supported the medical questionnaire option
on the grounds that this approach is more efficient and effective. The
United States Air Force (Ex. 54-443G) stated, ``After working under the
provisions of [proposed] alternative 2 for several years and comparing
the Air Force's occupational health and cost savings by reducing
unnecessary medical evaluations and freeing physician time under
[proposed] alternative 3, the Air Force supports [proposed] alternative
3.'' Similarly, the CITGO Petroleum Corporation (Ex. 54-251) endorsed
medical questionnaires as more cost-effective than medical
examinations. CITGO administered medical examinations to a sample of
1634 employees in 1994 to detect respiratory disorders, a major medical
concern for respiratory protection programs, and identified only one
abnormal case that was confirmed after referral for follow-up medical
examination.
An additional study involving validation of medical questionnaires
was described by Organization Resources Counselors, Inc. (ORC) (Ex. 54-
424). One of ORC's member companies, a large, diversified manufacturing
organization, recently reviewed approximately 700 records of employee
respirator medical examinations to determine the effectiveness of using
a medical questionnaire as a screening tool. This company currently
gives all respirator users a full medical examination in addition to
having them fill out a medical questionnaire. The records review
revealed that, out of 700 examinations, only 10 (less than 2%) required
medical limitations on respirator use. These limitations were due to
claustrophobia, asthma, and heavy smoking. All of these limitations
would have been identified, in the company's view, by a medical
questionnaire. The employees identified through the medical
questionnaire could then have been given a complete medical
examination. By using the medical questionnaire as a screening tool,
this company believes it could have eliminated unnecessary examinations
for 98% of its worker population.
A private physician and three management groups (Exs. 54-32, 54-
424, 55-29, 155) submitted medical questionnaires to the record and
expressed satisfaction with these medical questionnaires, in terms of
both the medical conditions that were detected and the administrative
efficiency of the process; these commenters, however, recommended that
physicians be involved in reviewing the medical questionnaires. Several
commenters (Exs. 54-70, 54-159, 54-215) endorsed the medical evaluation
procedures specified in the American National Standard Institute's
(ANSI) consensus standard Z88.6-1984, titled ``American National
Standard for Respiratory Protection--Respirator Use--Physical
Qualifications for Personnel.'' This ANSI standard recommends that a
medical history questionnaire be administered to employees who are
enrolled in respiratory protection programs, and that a physician
review each employee's responses to the medical questionnaire to
determine if additional medical examinations are required.
OSHA concludes that information in the record supports the use of
medical questionnaires for detecting medical conditions that may
disqualify employees from, or limit employee participation in,
respiratory protection programs. OSHA believes that the ORC study (Ex.
54-424) provides support for the conclusion that medical questionnaires
are an efficient and effective means of screening employees for
subsequent medical examination. OSHA also believes that the training
required by paragraph (k)(1) of the final rule, which requires that
employees understand the limitations of respirator use and recognize
the signs and symptoms of medical problems associated with respirator
use, will increase employee awareness and overcome the problems that
the USWA (Tr. 1059 and following) noted in its testimony. A number of
commenters (Exs. 54-107, 54-151, 54-153, 54-165, 54-190, 54-218, 54-
251, 54-253, 54-272, 54-339, 54-361, 54-401) stated that medical
questionnaires had several advantages over the other alternatives,
including simplicity and efficiency of use, completeness and accuracy
of the medical information obtained, and adaptability (i.e., easily
revised to accommodate new or different medical problems, different
employee groups, and changing job, workplace, and respirator
conditions). An additional advantage of medical questionnaires is lower
cost, most notably in terms of development, administration, and
analysis.
Employers are free to use medical examinations instead of medical
questionnaires, but are not required by the standard to do so (see
paragraph (e)(2) of the final standard). OSHA also recognizes that
medical examinations are necessary in some cases, e.g., where the
employee's responses to the medical questionnaire indicate the presence
of a medical condition that could increase the risk of adverse health
effects if a respirator is used. Examples of such cases are employees
who report a history of smoking, pulmonary or cardiovascular symptoms
or problems, eye irritation, nose, throat, or skin problems, vision or
hearing problems (for employees who use full facepiece respirators),
and musculoskeletal problems (for employees who use SCBAs). In
addition, certain workplace conditions or job requirements, such as
SCBA use, being an emergency responder or a member of a HAZMAT team,
working in an IDLH atmosphere, wearing heavy protective clothing, or
performing heavy physical work, may warrant a medical examination. In
the future, however, OSHA may, on a case-by-case basis, require medical
examinations to detect respirator-related conditions in its substance-
specific standards, depending on the particular circumstances and
physiological effects of the toxic substance being regulated.
The medical questionnaire in Appendix C of the final standard is
based on the medical history questionnaire contained in ANSI Z88.6-
1984, as well as medical questionnaires submitted to the record by
commenters
[[Page 1214]]
(Exs. 54-32, 54-424, 55-29). The medical questionnaire is designed to
identify general medical conditions that place employees who use
respirators at risk of serious medical consequences, and includes
questions addressing these conditions. These medical conditions include
seizures, diabetes, respiratory disorders and chronic lung disease, and
cardiovascular problems. As the discussion of the Introduction and
paragraphs (e)(1) and (5) in this Summary and Explanation demonstrate,
these conditions have been found to increase the risk of material
impairment among employees who use respirators. A question asking about
fear of tight or enclosed spaces was included in the medical
questionnaire because claustrophobia and anxiety associated with such
spaces were mentioned by a commenter as the most frequent medical
problem detected during respirator training (Ex. 54-429); additionally,
research submitted to the record (Ex. 164, Attachment D, Morgan)
indicates that more than 10 per cent of ``normal'' young men experience
dizziness, claustrophobia, or anxiety attacks while exercising during
respirator use.
Questions 10 through 15 of the medical questionnaire in Appendix C
must be answered only by employees who use a full facepiece respirator
or SCBA. These questions ask about hearing and vision impairments, as
well as back and other musculoskeletal problems. Employees who use full
facepiece respirators, for example, must be asked about eye and hearing
problems because the configuration of these respirators (e.g., helmets,
hoods) can add to the limitations associated with existing visual and
auditory impairments, resulting in an elevated risk of injury to
employees with such impairments, as well as to other employees who may
rely on the impaired employee to warn them of emergencies (Ex. 164,
Attachment D, Beckett). The heavy weight and range-of-motion
limitations of SCBAs may prevent employees who have existing problems
in the lower back or upper or lower extremities from using these
respirators.
A physician (Ex. 54-16) commented that an employee's medical
history should be considered by the PLHCP in making a recommendation
about the employee's ability to use respirators. This commenter
specified a number of prior medical conditions, including those
involving cardiovascular and respiratory health, psychological
variables, neurological and sensory organ status, endocrine function,
and the use of medications that would be useful to PLHCPs in arriving
at a medical ability recommendation. OSHA believes that these
variables, especially cardiovascular and respiratory fitness, are
important determinants of respiratory fitness, and, therefore, included
items specific to these medical conditions in the medical
questionnaire. OSHA concludes that the employee's answers to the
medical questionnaire will provide an adequate medical history for the
PLHCP.
Two commenters (Exs. 54-222, 54-251) requested that OSHA define
medical evaluation procedures and provided sample definitions. OSHA
believes that the regulatory text of the final rule, which has been
clarified and simplified since the proposal, provides clear guidance
and that these definitions are, therefore, not necessary. As used in
the final rule, ``medical evaluation'' means the use of subjective
(e.g., medical questionnaires) or objective methods (e.g., medical
examinations), as well as other available medical, occupational, and
respirator information, to make a determination or recommendation about
an employee's medical ability to use respirators; ``medical
examination'' means the use of objective methods (i.e., manipulative,
physiological, biochemical, or psychological devices, techniques, or
procedures) to directly assess the employee's physical and mental
status for the purpose of making a recommendation regarding the
employee's medical ability to use the respirator.
Paragraph (e)(3)--Follow-up Medical Examination
Paragraph (e)(3) addresses follow-up medical examinations and
states that the employer must provide such examinations to any employee
who gives a positive response to any question among questions 1 through
8 in Section 2, part A in Appendix C. The PLHCP is free to include any
medical tests, consultations, or diagnostic procedures that he or she
determines to be necessary to assist him or her in making a final
determination of the employee's ability to use a respirator. OSHA
expects that the number of cases where PLHCPs will have to provide
follow-up examinations will be small, because it is generally possible
to recommend against respirator use, or determine the limitations to
place on an employee's use of respirators, on the basis of responses to
the medical questionnaire. However, where difficult medical issues are
involved, such as the need to make a differential diagnosis or to
assess an employee's ability to handle the physical stress imposed by
an extra-hazardous job, a medical examination and involvement of a
physician may be needed. Many commenters (Exs. 54-92, 54-101, 54-134,
54-171, 54-223, 54-278, 54-304, 54-363, 54-389) endorsed this
requirement. Two commenters (Exs. 54-151, 54-189) stated that medical
examinations should not be limited to answers on the medical
questionnaire that indicate a need for medical examinations. A few
commenters (Exs. 54-153, 54-176, 54-218) recommended that a mandatory
medical examination requirement based on the employee's responses to
the medical questionnaire is wasteful and unnecessary.
OSHA agrees that PLHCPs should be permitted to obtain any medical
information they believe would be useful in arriving at a final medical
recommendation, and they should not be limited to investigating
problems associated only with answers on the medical questionnaire.
Information from medical examinations may also be needed to validate an
answer that a PLHCP believes is incorrect. Also, as recommended by ORC
(Ex. 54-424), a PLHCP should be free to investigate through medical
examination any medical conditions related to respirator use that may
not have been addressed by the medical questionnaire or may not have
been obtained from other sources.
Paragraph (e)(4)--Administration of the Medical Questionnaire and
Examinations
Paragraph (e)(4)(i). This paragraph sets out the procedures
employers must follow when administering the medical questionnaire or
examinations required by paragraph (e)(2). Paragraph (e)(4)(i) requires
employers to administer the required medical questionnaire or
examinations in a manner that protects the confidentiality of the
employee being evaluated. In addition, the evaluation must be
administered during normal work hours or at a time and place convenient
to the employee, and in a manner that ensures that the employee
understands the questions on the medical questionnaire. Although this
requirement was not specifically proposed, it is consistent with OSHA
policy and with Section 6(b)(7) of the Act. OSHA has included similar
requirements in a number of substance-specific health standards (see,
e.g., the Cadmium standard, 29 CFR 1910.1027, the Lead standard, 29 CFR
1910.1025, and the Benzene standard, 29 CFR 1910.1043). If an employee
must travel off-site for medical evaluation, travel arrangements must
be made, and costs incurred paid or reimbursed, by the employer.
The final standard differs from the proposal in that it does not
specify who
[[Page 1215]]
must supervise the administration of the medical questionnaire.
Alternative 3 in the proposal would have required that the medical
questionnaires be administered by ``a health professional or a person
trained in administering the questionnaire by a physician.'' (See 59 FR
58911.) Commenters (Exs. 54-25, 54-69, 54-153, 54-165, 54-190, 54-218,
54-251, 54-253, 54-272, 54-339, 54-361, 54-401) recommended that
persons performing this function have various qualifications, e.g., be
a trained designee of the employer, a safety or health professional, a
physician, or a nonphysician health care professional operating under
the supervision of a physician. Some commenters (Exs. 54-25, 54-101,
54-214, 54-389, 54-421) recommended that a PLHCP be present during
administration of the medical questionnaire to ensure the accuracy and
validity of the employee's answers. Others (Exs. 54-69, 54-361) stated
that the medical questionnaire should be designed so as to be easily
comprehended by the employee and simple to administer, thereby
requiring only minimal involvement by an employer. OSHA agrees with
those commenters (Exs. 54-69, 54-361) who urged that the medical
questionnaire be easy to understand, and has developed the medical
questionnaire in Appendix C accordingly. OSHA does not believe that
oversight is necessary because the standard requires that the medical
questionnaire be understandable to the employee and that the employee
be given an opportunity to ask questions of the PLHCP administering the
questionnaire.
Although the OSHA medical questionnaire is designed to be easily
comprehended by employees, paragraph (e)(4)(i) of the final standard
specifically requires that employers ensure that employees understand
the medical questionnaire. For employees who are not able to complete
the medical questionnaire because of reading difficulty, or who speak a
foreign language, OSHA requires that the employer take action to ensure
that the employee understands the questions on the medical
questionnaire. Language and comprehension deficits could invalidate the
answers of such employees and result in inaccurate determinations.
Under these circumstances, the PLHCP may assist the employee in
completing the medical questionnaire (perhaps with the aid of an
employer-supplied interpreter). The employer also may have the medical
questionnaire translated into the employee's language or administer a
physical examination that meets the requirements of paragraph (e)(2) of
the final standard. In fulfilling this requirement, OSHA is not
requiring employers to hire professional interpreters. Instead,
employers may use an English-speaking employee who can translate the
medical questionnaire into the questionnaire taker's native language,
or other nonprofessional translators who can perform the same function
(for example, a friend or family member of the test taker).
Paragraph (e)(4)(ii). This paragraph requires the employer to
permit the employee to discuss the medical questionnaire results with a
PLHCP. Employees who are uncertain of the significance of the questions
asked will thus be able to obtain clarification. One commenter, Dr.
Ross H. Ronish, Site Medical Director for the Hanford Environmental
Health Foundation (Ex. 54-151), agreed that the opportunity for
discussion between the PLHCP and the employee would improve the
usefulness of the medical questionnaire. The standard does not require
the employer to follow a specific procedure in providing employees with
the opportunity to discuss the medical questionnaire with a PLHCP.
Employers must, however, at least inform employees that a PLHCP is
available to discuss the medical questionnaire with them and notify the
employees how to contact the PLHCP. For example, the employer could
post the PLHCP's name and telephone number in a conspicuous location,
or include this information on a separate sheet with the medical
questionnaire.
Paragraph (e)(5)--Supplemental Information for the PLHCP
Paragraph (e)(5)(i). The first requirement in this paragraph
requires employers to provide the PLHCP with specific information for
use in making a recommendation regarding the employee's ability to use
a respirator. OSHA had proposed a similar requirement, stating that
``[i]n advance of the medical examination the employer shall provide
the examining professional with [supplemental] information * * *'' OSHA
received four comments (Exs. 54-181, 54-234, 54-330, 54-445) on this
proposed requirement. These commenters stated that only supplemental
information requested by the PLHCP should be provided because PLHCPs
can best determine what information they need to make medical-ability
recommendations; additionally, limiting the requirement to information
requested by the PLHCP would lower the associated paperwork burden. The
Boeing Company (Ex. 54-445), for example, stated, ``The employer should
not be required to provide additional information unless requested to
do so by the examining physician.'' Another commenter (Ex. 54-434)
stated that the proposed supplemental information might not be
meaningful to every PLHCP.
OSHA believes that the supplemental information specified is
important to the PLHCP in making a recommendation regarding the
employee's medical ability to use the respirator. However, as indicated
in paragraph (e)(5)(ii) of the final standard, this information need
only be provided once to the PLHCP unless the information differs from
what was provided to the PLHCP previously, or a new PLHCP is conducting
the medical evaluation.
With few exceptions, the supplemental information that must be
provided by the employer to the PLHCP is the same information listed in
the proposed regulatory language for alternative 3 (59 FR 58911,
paragraphs (e)(vi) (A) to (G)). Three commenters (Exs. 54-160, 54-191,
54-287) endorsed the entire list of supplemental information items in
the proposal. Most of the commenters who took exception to the proposed
list disagreed with the item requiring that information be provided to
the PLHCP on the substances to which the employee will be exposed
(i.e., paragraph (e)(vi)(B) of proposed alternative 3); two commenters
(Exs. 54-352, 54-453), however, believed it was important to specify
these substances so that the PLHCP would be aware of the hazards in the
workplace. One commenter (Ex. 54-339) stated that information on
substance exposure would be useful to the program administrator for fit
testing, but was not needed by the PLHCP. Another commenter (Ex. 54-
208) stated that information about these substances was unnecessary
because OSHA intended to propose a separate rule for medical
surveillance, and one commenter (Ex. 54-273) wanted this item to be
deleted and replaced by an item informing the PLHCP about the
employee's use of impervious clothing because such clothing, if worn,
may impose serious heat stress on the employee.
The record also contains an article by Dr. William S. Beckett
advising occupational health professionals on medical evaluations for
respirator use (Ex. 164, Attachment D). The article addressed the need
to provide these professionals with exposure information: ``An
employer's inability to provide this basic information [regarding
employee exposure levels] on which a respirator choice has been
[[Page 1216]]
made should throw the adequacy of the respiratory protection program
into serious doubt.'' Dr. Beckett explained that such information was
necessary because preexisting lung impairments make some employees
``more sensitive to the effects of some occupational agents and [these
employees] may thus suffer further impairment at exposure
concentrations that would not affect a normal worker.'' In explaining
these effects, Dr. Beckett stated that employees who have become
``sensitized immunologically to a workplace substance may not be able
to attain protection factors using usual respirator precautions even
though the same respirator might be adequate for individuals not
sensitized to the substance.'' Dr. Beckett noted that ``the worker
sensitized to toluene di-isocyanate (TDI) * * * will experience
alterations in pulmonary function at an air concentration of 0.001 ppm
TDI while normal individuals will not experience symptoms at 20 times
this concentration.''
In response to these comments, OSHA has modified the proposed
requirement specifically requiring employers to inform PLHCPs of the
substances to which employees may be exposed. Under paragraph
(e)(5)(iii) of the final rule, employers must provide the PLHCP with a
copy of the written respiratory protection program. As required by
paragraph (c)(1)(i) of the final rule, the written program must specify
the procedures for selecting respirators for use in the workplace;
accordingly, these procedures must describe the workplace exposure
conditions that require respirator use. OSHA believes these
descriptions will provide the necessary information, while imposing
little additional burden on employers.
These requirement are necessary, the Agency concludes, because
employees can have medical conditions that predispose them to respond
adversely to the workplace substances to which they are exposed, and
the resulting effects can impair an employee's ability to use some
types of respirators. Consequently, providing PLHCPs with information
about the workplace substances to which employees are exposed will
assist the PLHCPs in determining if these substances may interact with
preexisting medical conditions to impair an employee's ability to use
the respirator. In addition, the Agency believes that knowledge about
the substances to which employees are exposed will provide an indirect
means of determining the effectiveness of the overall respiratory
protection program. If employees experience signs and symptoms
typically associated with exposure to the workplace substances
documented in the written respiratory protection program, the PLHCP can
alert the employer to these effects, and corrective action can be
taken.
In response to the commenter who urged OSHA to include information
on impervious clothing, OSHA notes that the final standard requires
employers to provide information on other protective clothing and
equipment to be worn by the employee. This item will provide
information on impervious clothing, and, therefore, addresses the
commenter's concerns regarding the heat stress imposed on employees by
such clothing.
One commenter (Ex. 54-214) stated that descriptions of the type of
work performed and physical work effort should be dropped from the
list, while another commenter (Ex. 54-445) believed that information
about the type of respirator would not be useful to the PLHCP. As noted
in the discussion of final paragraph (e)(1) in this Summary and
Explanation, cardiovascular and respiratory fitness are important
variables in determining the ability of an employee to use a
respirator. The physical work effort required by the employee's job, in
combination with the characteristics of the respirator (e.g., weight,
breathing resistance, interference with range of motion), are variables
that must be considered by a PLHCP in making a recommendation regarding
the employee's fitness to use the respirator.
A study conducted by NIOSH (Ex. 64-469) found that tolerance to
work conditions, heart rate, and skin temperature were affected by
three variables: the type of personal protective clothing worn, the
weight of the respirator, and the level of physical work effort. In the
NIOSH study, nine healthy young men who had prior experience with
respirators and personal protective clothing (most of them were
firefighters), exercised on a treadmill at low and high physical
workloads under each of the following conditions: wearing light work
clothing and using a low-resistance disposable half-mask respirator (LT
condition); wearing light work clothing and using an SCBA (SCBA
condition); wearing firefighter turnout gear and using an SCBA (FF
condition); and wearing chemical protective clothing and using an SCBA
(CBC condition). While exercising at low physical workloads under the
LT, SCBA, FF, and CBC conditions, the study participants tolerated
these work conditions for 167, 130, 26, and 73 minutes, respectively;
at high physical workloads, the four protective clothing conditions
were tolerated for 91, 23, 4, and 13 minutes. Heart rates and skin
temperatures rose as tolerance diminished. At the high workload level,
testing under the SCBA, FF, and CBC conditions had to be terminated
early because the heart rates of the study participants reached
critically high levels (i.e., 90% of the predicted maximal heart rate).
At low physical workloads, heart rate rose progressively under the SCBA
conditions (about 15 beats per minute) compared to the LT condition,
then remained steady. Under high physical workloads, heart rates rose
sharply and never reached a steady level until after the testing was
terminated.
The authors of the NIOSH study noted that the work tolerance, heart
rate, and skin temperature effects found in the study would be more
severe among individuals who were not as healthy or experienced as the
study participants. They attributed these effects both to the weight of
the respirator and to the poor evaporative cooling properties of the
personal protective clothing (i.e., the capacity to remove body heat
under the humid conditions generated inside the protective clothing as
a result of physical work). Based on these findings, the authors
concluded that ``[the study participants] wearing protective clothing
and respirators during exercise exhibited a significant degree of
cardiorespiratory and thermoregulatory stress * * *''
The conclusion reached by the NIOSH study is supported by other
researchers who have tested the physiological effects of personal
protective clothing combined with SCBA use among healthy men performing
exercise or simulated work tasks under light to moderate levels of
physical exertion. (See Ex. 164, Attachment D, Smolander et al. (1984),
and Smolander et al. (1985).) These researchers found that personal
protective clothing substantially increased oxygen consumption and
carbon dioxide production, and recommended careful evaluation of the
cardiovascular health and heat tolerance of workers who must wear
personal protective clothing.
In another study (Ex. 64-445), healthy young men (average age: 29
years), older men (average age: 47 years), and women (average age: 29
years) used air-purifying respirators while performing the following
simulated, low physical workload, mining task: lifting a shovel
weighing 3.1 lbs. (6.8 kg.) from the floor to the top of a table (a
distance of 3 feet (90 cm)), releasing the shovel's grip, then lifting
the shovel from the table back to the floor and releasing the grip
again. The task was performed at a rate
[[Page 1217]]
of 10 cycles per minute for 20 minutes at temperatures of 73 deg. F
(23 deg. C) and 104 deg. F (40 deg. C). The study participants wore
appropriate mining clothing (i.e., pants, heavy shirt, gloves, leather
apron, and safety helmet) while performing the task. The results showed
that respirator use and heat combined to raise the heart rate
substantially more than either variable alone, and that this effect was
especially pronounced for the women.
This study, and the NIOSH study described earlier, demonstrated
that information regarding such physiological stressors as physical
work effort, respirator type and weight, personal protective clothing,
and temperature and humidity conditions must be provided to PLHCPs who
are responsible for medically evaluating employees for respirator use.
The studies found that these stressors, especially respirator weight,
impose physiological burdens that result in substantial impairment to
functional capacity, even among healthy respirator users. OSHA
believes, therefore, that information on respirator type and weight,
personal protective clothing, and temperature and humidity must be
provided to, and be considered by, PLHCPs to ensure that only employees
who can endure these stressors without adverse medical consequences are
recommended for the respiratory protection program; consequently, these
items were included in paragraph (e)(5)(i) of the final standard.
The United Steelworkers (Tr. 1057) stated that ``[PLHCPs should be]
mandated to have knowledge of the workplace, and possibly to have
visited it at some point in time.'' OSHA agrees that familiarity with
the workplace is important, and believes that many employers will make
such visits a requirement. OSHA believes, however, that making such
visits a requirement is unnecessary because the information required to
be given to the PLHCP by the standard will be sufficient for the PLHCP
to make a valid recommendation regarding the employee's ability to use
the respirator.
Other revisions made to the proposed paragraph include a
requirement that the weight of the respirator be provided to the PLHCP,
principally to inform the PLHCP of the physical stress that a heavy
respirator may impose on an employee's cardiovascular and respiratory
systems. This revision was made in response to the number of commenters
(Exs. 54-153, 54-165, 54-218, 54-226, 54-227, 54-263, 54-264, 54-294,
54-326, 54-327, 54-363, 54-443) who recommended that employees using
SCBAs and other heavy respirators be administered medical examinations,
largely because of the additional workload associated with using these
respirators. A physician (Tr. 398) testified that SCBAs in particular
increased an employee's workload by 20 percent. The studies just
discussed also demonstrate that respirator weight plays a significant
role in the increased burden that a respirator places on the user. In
addition, scientific evidence obtained by Louhevaara et al. (Ex. 164,
Attachment D) demonstrates that use of SCBAs by experienced
firefighters performing light to moderate exercise on a treadmill
substantially reduces tidal volume and increases heart rate, oxygen
consumption, and ventilation rate. These physiological effects led
Kilbom (Ex. 164, Attachment D) to recommend that no firefighter over
the age of 50 be assigned tasks that require SCBA use.
In the NPRM, OSHA asked whether information on the duration and
frequency of respirator use should be provided to the PLHCP. No
comments were received on this subject. The research studies described
earlier in this Summary and Explanation show that duration and
frequency of respirator use interact with other respirator use
conditions (e.g., respirator weight, protective clothing, temperature
and humidity) in imposing pulmonary and cardiovascular stress on
respirator users. OSHA believes that information about the duration and
frequency of respirator use will be important to PLHCPs in making
medical ability recommendations, and concludes that this information
must be included in the information required to be provided to the
PLHCP.
Paragraph (e)(5)(ii). As noted above, OSHA received recommendations
from several commenters (Exs. 54-181, 54-234, 54-330, 54-445) to reduce
the amount of information required to be submitted to the PLHCP. In
responding to this recommendation, OSHA first reduced the number of
items required. Second, OSHA revised the requirement so that employers
only need to provide the supplemental information once to the PLHCP,
unless the information differs from the information provided to the
PLHCP previously or a new PLHCP is conducting the medical evaluations.
Under the revised provision, therefore, the employer must ensure that:
the PLHCP retains the supplemental information that is provided by the
employer; the supplemental information is updated appropriately and in
a timely fashion; and a new PLHCP is provided with the required
supplemental information. The requirement to provide the new PLHCP with
the appropriate information does not mean that the new PLHCP must
medically reevaluate employees, only that the new PLHCP obtains the
information required under this paragraph. The employer can meet this
requirement by either providing the relevant documents to the new PLHCP
or ensuring that the documents are transferred from the former PLHCP to
the new PLHCP.
Paragraph (e)(5)(iii). OSHA believes that the requirement for
employers to provide a copy of the final standard and a copy of the
written respiratory program to the PLHCP, although not included in the
proposed standard, is needed to assure that PLHCPs have a thorough
understanding of their duties and responsibilities in the medical
evaluation process, thereby enhancing their ability to make a sound
medical recommendation on an employee's ability to use the respirator.
The written program is site-specific, and will inform the PLHCP of the
working conditions the employee will encounter during respirator use.
This information is critical if the PLHCP is to make a thorough and
accurate evaluation of the employee's ability to use the assigned
respirator. The PLHCP's ability to conduct appropriate medical
evaluation will also be aided by knowledge of the standard, which sets
forth the requirements of the medical evaluation program, as well as
other requirements that affect the employee's respirator use.
Consequently, this requirement will help ensure that medical
evaluations conducted by PLHCPs are thorough and accurate;
recommendations regarding an employee's medical ability to use the
respirator are valid; employees are informed of these recommendations;
and the privacy and confidentiality of employees are maintained. OSHA
believes that this requirement is necessary to ensure that the
objectives and other requirements of final paragraph (e) are fulfilled.
As noted in the previous discussion of paragraph (e)(5)(ii), this
information must be provided to the PLHCP only once for all employees
who are involved in the employer's respiratory protection program. This
information does not have to be provided again to the same PLHCP unless
the standard or the employer's respiratory protection program is
substantially revised. For example, the information does not have to be
provided again when only minor revisions have been made to either the
standard or the respiratory protection program. When the employer hires
a different PLHCP to conduct medical evaluations, the employer must
ensure that the new PLHCP has this information, by either providing the
new PLHCP with the appropriate documents or ensuring that the
[[Page 1218]]
documents are transferred from the former PLHCP to the new PLHCP.
Paragraph (e)(6)--Medical Determination
Paragraph (e)(1) of the NPRM proposed that the employer be
responsible for making the final determination regarding the employee's
ability to use the respirator. The proposed regulatory language
required the physician (now a PLHCP) to deliver a medical opinion
regarding the employee's medical ability to use the respirator,
including any recommended limitations on this use, to the employer.
OSHA proposed, consistent with its substance-specific standards, to
make the employer responsible for the final determination regarding an
employee's ability to use the respirator. This determination was to be
based on all of the information available to the employer, including
the physician's opinion and recommendations. The final standard follows
this approach, although the final rule's requirements have been revised
to reflect the record.
Paragraph (e)(6)(i). This provision states that the ``employer
shall obtain a written recommendation regarding the employee's ability
to use the respirator from the PLHCP * * * `` Because the PLHCP's
recommendation is an important element in the employer's determination
as to whether it is hazardous for an employee to use a respirator, the
recommendation needs to be clear and in writing.
Final paragraph (e)(6)(i) requires that the PLHCP's recommendation
be restricted to the three elements listed in paragraphs (e)(6)(i)(A)
through (C) (i.e., ``[t]he recommendation shall provide only the
following information'') [emphasis added]. This requirement is similar
to the proposed regulatory language for paragraph (e)(1) and paragraph
(e)(1)(v) of proposed alternative 3. The purpose of this limitation is
to protect employee privacy with regard to medical conditions not
relevant to respirator use.
Several commenters (Exs. 54-92, 54-455) supported the need for
privacy but recommended further that the basis of the PLHCP's medical
recommendation not be disclosed to employers because such information
could be used by an employer to remove an employee from the workforce.
The AFL-CIO (Ex. 54-428) stated that ``[medical] reports to employers
should contain only a statement of approval or disapproval for
employees who are tested.'' The Brotherhood of Maintenance of Way
Employees (BMWE) (Ex. 122) supported limiting the medical information
provided to the employer to whether or not the employee can perform the
required work while using the respirator, and whether or not
restrictions need to be applied to the employee's respirator use. The
BMWE stated further that no information should be provided on the
specific medical conditions detected during the medical evaluation.
OSHA believes that protection of employee privacy and
confidentiality is important to obtain accurate and candid responses
from employees about their medical conditions. OSHA has retained this
requirement in the final standard and believes that, as worded, it
strikes the proper balance between the need to provide sufficient
information to the employer to make a decision on respirator use and
the need to protect employee privacy.
Paragraph (e)(6)(i)(A) in the final standard also specifies the
information the PLHCP is to include in the recommendation to the
employer: ``Any limitations on respirator use related to the medical
condition of the employee, or relating to the workplace conditions in
which the respirator will be used, including whether or not the
employee is medically eligible to use the respirator.'' OSHA's
experience in enforcing standards with similarly worded provisions
indicates that this language is appropriate; also, OSHA believes a
statement regarding the employee's medical ability to use the
respirator will assist both the employer and employee in determining
the final medical disposition of the employee.
Paragraph (e)(6)(i)(B) of the final standard specifies that the
PLHCP must state whether there is a need for follow-up medical
evaluations. This provision was added to the final standard for several
reasons. First, the initial medical evaluation may indicate that there
is a possibility that the employee's health may change in a way which
would reduce the employee's ability to use a respirator. In these
circumstances, the PLHCP is required to specify appropriate follow-up
medical evaluations. Second, the final standard does not provide for
periodic (such as annual) evaluations, as most other OSHA health
standards do. It is therefore important that the PLHCP specify whether
an employee requires follow-up medical evaluation so that the
employee's ability to use a respirator can be carefully monitored by
the PLHCP. This requirement will ensure that employees are using
respirators that will not adversely affect their health.
Paragraph (e)(6)(i)(C) requires that the employee be provided with
a copy of the PLHCP's written recommendation. No comments were received
by the Agency on this proposed requirement. OSHA believes that a copy
of the PLHCP's written recommendation will provide employees with
information necessary to ensure that they are using respirators that
will not adversely affect their health.
The employer may either transmit the PLHCP's written recommendation
to the employee or arrange for the PLHCP to do so. The employer shall
allow the employee, consistent with paragraph (e)(4)(ii) of the final
standard, to discuss the recommendation with the PLHCP. During the
discussion, the PLHCP may inform the employee of the basis of the
recommendation, as well as other medical conditions that are indicated
by the results of the medical evaluation but that are not directly
related to the employee's medical ability to use the respirator. OSHA
believes that the additional information provided to the employee by
the PLHCP should be determined by the legal, professional, and ethical
standards that govern the PLHCP's practice and, therefore, should not
be regulated by the final standard.
Paragraph (e)(6)(ii). If the PLHCP's medical evaluation finds that
use of a negative pressure respirator would place the employee at
increased risk of adverse health effects, but that the employee is able
to use a powered air-purifying respirator (PAPR), this paragraph
requires employers to provide the employee with a PAPR. The rationale
for this provision was discussed in the proposal (59 FR 58906).
Negative pressure respirators can result in sufficient cardiovascular
and respiratory stress to make employees medically unable to use this
class of respirators. The use of PAPRs involves lower cardiovascular
and respiratory stress, and PAPRs can often be tolerated by employees
when negative pressure respirators cannot. Consequently, OSHA believes
that this requirement is consistent with the requirements of paragraph
(a)(2) of the final standard, which states that ``employers [must]
provide the respirators which are applicable and suitable for the
purpose intended.''
Several commenters endorsed this provision (Exs. 54-101, 54-363,
54-455). ISEA (Ex. 54-363) recommended that ``employers ensure that all
alternative types [of respirators] be considered and made available''
to employees found to be medically unable to use the respirator
selected initially by the employer. The proposal was consistent with
this recommendation in requiring that alternative respirators be
selected from among existing positive pressure respirators, including
supplied-air respirators. OSHA has
[[Page 1219]]
determined, however, that supplied-air respirators should not be listed
as alternative respirators in the final standard because, as noted
earlier in this Summary and Explanation, these respirators impose many
of the same pulmonary and cardiovascular burdens on employees as
negative pressure respirators. The Brotherhood of Maintenance and Way
Employees (BMWE) (Ex. 126) found that PAPRs would be an effective
substitute for negative pressure respirators, and endorsed issuing
PAPRs to employees who were found to be medically unable to use
negative pressure respirators. In making this endorsement, the BMWE
estimated that less than 1 percent of its membership would require such
an upgrade. Consequently, OSHA removed the requirement for supplied-air
respirators from the final standard, and now requires only that
employers provide PAPRs to employees who are medically unable to use
negative pressure respirators but who are able to use PAPRs. In
addition, paragraph (e)(6)(ii) of the final standard specifies that if
a subsequent medical evaluation finds that the employee is able to use
a negative pressure respirator, then the employer is no longer required
to provide that employee with a PAPR.
Paragraph (e)(7)--Additional Medical Evaluations
Paragraph (e)(7) of the standard requires the employer to provide
additional medical evaluations whenever there is any indication that a
reevaluation is appropriate. At a minimum, this would occur: if the
employee reports any signs or symptoms that are related to the ability
to use a respirator; if the PLHCP, program administrator or supervisor
determines that a reevaluation is necessary; if information from the
respiratory protection program indicates a need for reevaluation; or if
a change in workplace conditions could affect the physiological burden
placed on the employee. This is a significant change from the proposal,
which in alternatives 2 and 3 would have required reevaluation on an
annual basis of employees subject to medical evaluation. Although this
would not necessarily have required a medical examination, proposed
paragraph (e)(3) and alternative 3 would have required a written
medical opinion. The provision in the final standard is similar to the
requirement in several of OSHA's substance-specific standards that
employees be medically reevaluated if they experience breathing
difficulties during fit testing or under other respirator use
conditions (see, e.g., the Cadmium standard at 29 CFR
1910.1027(l)(6)(iii)).
OSHA also made a specific request for comments on the
appropriateness of requiring medical evaluations at the age-related
intervals used by ANSI or NIOSH. ANSI and NIOSH recommend that older
employees should be screened more frequently than younger employees
because of the heightened risk of cardiovascular and respiratory
disease associated with age. The ANSI Z88.6-1984 consensus standard
recommends medical evaluations at the following age intervals: every
five years below age 35, every two years for employees aged 35 to 45,
and annually thereafter. NIOSH's Respirator Decision Logic (Ex. 9)
calls for medical evaluations at similar intervals, except that
employees over 45 years old should be evaluated every one to two years.
One commenter (Ex. 54-394) stated that age-based medical evaluations
are important because the American workforce is aging.
The proposed requirement that medical reevaluation be conducted
annually resulted in numerous comments, most of which recommended that
the requirement be revised. Eight commenters (Exs. 54-219, 54-224, 54-
253, 54-264, 54-348, 54-421, 54-441, 54-455) endorsed the proposed
requirement without revision. Three commenters (Exs. 54-70, 54-326, 54-
357) stated that cost concerns and the administrative burden should
limit annual medical evaluations to employees who use SCBAs. Other
commenters (Exs. 54-70, 54-185, 54-206, 54-326, 54-357, 54-429)
recommended that annual medical evaluations be administered to
employees who use non-SCBA respirators only if such use is on a daily
basis, for more than 50 per cent of the work week, or at least five
hours per work week. A few commenters (Exs. 54-220, 54-244, 54-327, 54-
424, 54-429) recommended annual medical evaluations if the evaluations
consisted entirely of a medical questionnaire.
The Boeing Company (Ex. 54-445) was one of the commenters
recommending that OSHA reconsider the requirement for annual medical
examinations. Boeing stated:
[Our] experience with annual review has been that approximately
1-2% of [our] employees reviewed per year are restricted from
respirator use. Very rarely to never are these restrictions due to a
medical condition that would make respirator use dangerous for an
employee. Rather, the restrictions are related to other aspects of
an employee's job or to administrative reasons, such as failure to
undergo the review or employee preference.
The American Iron and Steel Institute (AISI) (Ex. 175) also
provided limited evidence that regular (e.g., annual) medical
examinations are ineffective. AISI cited an industry study in which
2,195 medical examinations were administered to 1,816 employees
subsequent to their initial medical examination; the elapsed interval,
however, was unspecified. The medical reevaluations found only two
employees who had unknown (to the employees) medical conditions; one of
the employees had claustrophobia, and the other employee had reduced
pulmonary function and an abnormal chest x-ray. AISI recommended that
the frequency of medical reevaluation be ``determined by a licensed
medical provider or to verify a suspected functional disability that
might affect the ability to wear a respirator.''
The statements and recommendations made by commenters who believed
that the requirement should be revised or eliminated are summarized as
follows:
(1) An annual interval is arbitrary or unnecessary (Exs. 54-234,
54-263, 54-267);
(2) A biannual interval should be used (Exs. 54-191, 54-278, 54-
326);
(3) The intervals should be age-based, using either the ANSI or
NIOSH age intervals (Exs. 54-66, 54-172, 54-215, 54-245, 54-250, 54-
273, 54-318, 54-374, 54-381, 54-388, 54-426, 54-441, 54-450, 54-451,
54-452, 54-453), the age intervals recommended by the National Fire
Protection Association (NFPA) under NFPA standard 1582 (Ex. 54-155), or
unspecified age intervals (Exs. 54-67, 54-218, 54-240, 54-271, 54-326,
54-327, 54-342, 54-346, 54-361, 54-363, 54-429, 54-445, 54-454);
(4) Medical reevaluation should be conducted only at the request of
the PLHCP (Exs. 54-70, 54-150, 54-180, 54-217, 54-224, 54-313, 54-348,
54-350, 54-361, 54-432, 54-448, 54-449, 54-450, 54-451, 54-452),
employers (Ex. 54-251), employees (Ex. 54-157), or employees trained to
recognize respirator-induced medical effects (Exs. 54-181, 54-219, 54-
242);
(5) Medical reevaluation should be event-driven, with the events
specified as a combination of age, physical condition or medical
symptoms (including breathing difficulty), job conditions, respirator
type, frequency of respirator use, medical history, or type of exposure
(Exs. 54-79, 54-187, 54-189, 54-217, 54-218, 54-219, 54-220, 54-242,
54-253, 54-265, 54-275, 54-278, 54-318, 54-319, 54-342, 54-357, 54-381,
54-395, 54-439), or when job conditions or the type of respirator used
by the employee increase the risk of
[[Page 1220]]
adverse effects on the employee's health (Exs. 54-151, 54-153).
Several commenters (Exs. 54-38, 54-191, 54-388) stated that medical
reevaluation should not be conducted when employees experience
breathing difficulties during respirator use because these effects
usually occur as a result of canister or filter overloading rather than
an employee's medical condition.
The commenters who endorsed the proposed requirement for an annual
medical evaluation stated that annual medical evaluations would
identify or prevent medical problems that may arise as a result of less
frequent or event-driven medical evaluations. After carefully reviewing
the entire record, OSHA decided to revise the proposed requirement and
to make medical reevaluation contingent on specific events that may
occur during respirator use, regardless of the duration of respirator
use. OSHA also has determined that a rigid approach to medical
reevaluation based on age may ignore serious medical conditions among
younger employees that could be aggravated by continued respirator use.
As noted by Dr. Ross H. Ronish, Site Medical Director for the Hanford
Environmental Health Foundation (Ex. 54-151), ``[m]edical conditions
which can affect the ability of an individual to use various types of
respirator occur even in young people.''
This approach is appropriate because medical problems requiring
evaluation by a PLHCP can occur after any period of respirator use and
in workers of any age, and the requirement for medical reevaluation
must be sufficiently flexible to accommodate this variability. In
addition, the employee, supervisor, and program administrator are in a
position to note conditions, such as breathing difficulty, which would
trigger the need for a medical reevaluation.
The events described in paragraph (e)(7) of the final standard
include significant medical, occupational, and respirator use
conditions that warrant medical reevaluation because these conditions
are known to impose additional physiological stress on employees, or
are recognized indicators of medical problems associated with
respirator use. This paragraph, therefore, will provide for flexible
and prompt detection of medical problems among employees who use
respirators.
The specific events OSHA has listed in paragraphs (e)(7)(i), (ii),
(iii) and (iv) that trigger medical reevaluation are based on OSHA's
experience with substance-specific standards and the record of this
rulemaking. OSHA believes that these events cover most situations in
which employees are at risk of experiencing adverse health effects
because of respirator use and in which the employee's underlying
medical conditions or workplace conditions have changed sufficiently to
make the initial medical evaluation obsolete. As noted earlier in the
discussion of this paragraph, these variables were considered by many
commenters to be important in determining the frequency with which
employees should be medically reevaluated.
Medical Removal Protection
The proposed rule did not include a provision for medical removal
protection (MRP). Such a provision requires employers to provide
employees who are unable to use respirators with alternative jobs at no
loss of pay and other benefits. In the notice of proposed rulemaking
(59 FR 58912), the Agency noted that MRP provisions had been included
in some earlier substance-specific standards, but stated that
insufficient information had been provided in response to the ANPR to
include in the proposed rule an MRP provision that would be applicable
to all workplaces in which respirators are used. To enable it to
evaluate whether an MRP provision might be appropriate for this generic
respirator standard, OSHA asked for comments and information about
cases in which employees were found to be unable to use respirators in
their jobs. The Agency specifically requested information about the
frequency of cases in which employees were found to be unable to use
respirators and the details of such cases, including how the
determination of an employee's inability to use a respirator affected
the worker's job responsibilities.
Numerous comments were received on this issue. Most of the
commenters who addressed the issue (Exs. 54-92, 54-206, 54-220, 54-240,
54-250, 54-267, 54-273, 54-286, 54-295, 54-342, 54-381, 54-435, 54-443)
suggested that a provision requiring employers to provide alternative
jobs as a consequence of medical removal be excluded from the final
standard, although some (Exs. 54-213, 54-387, 54-427, 54-428, 54-455)
endorsed such a provision. The commenters who opposed the provision
argued that: employees already receive adequate protection against
medically related job displacement and unemployment through existing
federal, state, and local law (e.g., the Americans with Disabilities
Act and the Rehabilitation Act of 1973); the requirement exceeded
OSHA's statutory authority; and OSHA failed to justify the provision
adequately in the proposal. Commenters who favored MRP believed that
such a provision was needed for medical evaluation to be effective.
They stated that employees will refuse necessary medical evaluation if
they believe their jobs might be placed in jeopardy. The Brotherhood of
Maintenance of Way Employees (BMWE) (Ex. 126) endorsed MRP, claiming
that in most cases such protection is feasible on both a temporary and
permanent basis for the railroad industry; infeasible or inconvenient
cases could be resolved, according to this commenter, under their
collective bargaining agreement. The BMWE also recommended that
employees who have been determined by employers to be unable to use
respirators be allowed to seek a second medical opinion (i.e., to have
multiple physician review) ``unencumbered by ulterior motives on the
part of the employer.''
As noted above, OSHA has included MRP in some of its existing
substance-specific standards for employees who are unable to use
respirators. In the Cotton Dust standard, for example, OSHA provided
that if a physician determines that an employee is unable to use any
type of respirator, the employee must be given the opportunity to
transfer to an available position in which respirator use is not
required, with no loss of wages or benefits (50 FR 51154-56). OSHA
specifically found, based on the evidence in the Cotton Dust rulemaking
record, that some employees would be reluctant to reveal information
necessary for proper health care if the employee feared that the
information might result in transfer to lower paying jobs. Similar MRP
provisions for employees unable to use respirators have been included
in OSHA's Asbestos and Cadmium standards. However, MRP provisions for
workers unable to use respirators have not been included in most of
OSHA's substance-specific standards, even though all such standards
require that employees who use respirators undergo medical evaluation
to determine their ability to do so (e.g., the 1,3-Butadiene,
Formaldehyde, Ethylene Oxide, Acrylonitrile, Benzene, and Lead
standards).
OSHA believes that a number of provisions of the final standard
will effectively avoid any disincentive on the part of employees to
cooperate with medical evaluation. Paragraph (e)(1) requires the
employer to provide medical evaluation to an employee before the
employee uses a respirator in the workplace. Therefore, employees
[[Page 1221]]
cannot refuse to undergo medical evaluation and continue in a job that
requires respirator use. All employees who use SCBAs, the type of
respirator that imposes the greatest physiological burden on the user,
must receive medical examinations, and the PLHCP who conducts the
examination has discretion to determine the tests, consultations, and
diagnostic procedures to be included in the examination. Given this
discretion on the part of the PLHCP, and the PLHCP's awareness of the
considerable physiological burden that SCBA use places on the user,
OSHA believes that the PLHCP will be able to evaluate the employee's
ability to use an SCBA even if the employee is reluctant to cooperate
fully with the examination.
Moreover, paragraph (e)(7) requires the employer to medically
reevaluate an employee when a PLHCP, supervisor, or program
administrator observes that the employee is having a medical problem
during respirator use and they inform the employer of their
observation. Many of the jobs in which SCBA use is required are
strenuous, and any undue physiological burden the respirator places on
an employee will often be readily observable by the employer, PLHCP,
supervisors, or program administrator. Paragraph (e)(7), therefore,
will help ensure that an employee who is medically unable to use a
respirator, whether a SCBA or another type of respirator, cannot avoid
medical evaluation by refusing to cooperate.
The final standard also encourages cooperation in medical
evaluation by employees who are assigned to use negative pressure
respirators. Some employees will be unable to use negative pressure
respirators because of breathing resistance caused by medical
conditions such as asthma and bronchitis. The final standard provides
these employees with a strong incentive to cooperate with medical
evaluation by requiring the employer to provide them with a powered
air-purifying respirator (PAPR) when the PLHCP who conducts the
evaluation determines that the employees cannot use a negative pressure
respirator but can use a PAPR. OSHA believes that many workers who are
medically unable to use a negative pressure respirator will be able to
use a PAPR, which offers considerably less breathing resistance than a
negative pressure respirator. Therefore, those employees who are
concerned about their medical ability to use a respirator will have a
strong incentive to cooperate fully with the medical evaluation because
they are likely to be provided with a less physiologically burdensome
respirator that will enable them to continue in their jobs.
Paragraph (f)--Fit Testing
Introduction
The final rule requires that, before an employee is required to use
any respirator with a negative or positive pressure tight-fitting
facepiece, the employee must be fit tested with the same make, model,
style and size of respirator that will be used. The ANSI Z88.2-1992
respiratory protection standard also recommends such testing before
respirator use. Employers who allow employees to voluntarily use
respirators need not provide fit testing for those employees, although
OSHA encourages them to do so.
It is axiomatic that respirators must fit properly to provide
protection. If a tight seal is not maintained between the facepiece and
the employee's face, contaminated air will be drawn into the facepiece
and be breathed by the employee. The fit testing requirement of
paragraph (f) seeks to protect the employee against breathing
contaminated ambient air and is one of the core provisions of the
respirator program required by this standard.
In the years since OSHA adopted the previous respirator standard, a
number of new fit testing protocols have been developed and tested
(Exs. 2, 8, 24-2, 24-12, 24-20, 46, 49). During the same period
manufacturers have developed multiple sizes and models of respirator
facepieces in order to provide better fits for the variety of facial
sizes and shapes found among respirator users. Incorporation of these
advances into the standard is particularly important because facepiece
leakage is a major source of in-mask contamination.
Studies show that lack of fit testing results in reduced
protection. In a health hazard evaluation (HHE) conducted by NIOSH at a
medical center (Ex. 64-56), NIOSH found that workers using disposable
respirators were not getting adequate protection because the
respirators had not been fit tested. Other HHEs conducted by NIOSH show
that workers who used respirators where there was no fit testing
suffered adverse health effects resulting from overexposure to airborne
contaminants (See HETAs 81-283-1224 and 83-075-1559).
Based on the record evidence, OSHA concludes that poorly fitting
facepieces expose workers to contaminants and that the use of an
effective fit testing protocol is the best way of determining which
respirator facepiece is most appropriate for each employee. Indeed, the
need to include fit testing requirements in the standard, and to
specify the proper method of accomplishing such testing, were among the
major reasons OSHA proposed to revise the existing respirator standard.
Fit testing may be either qualitative or quantitative. Qualitative
fit testing (QLFT) involves the introduction of a gas, vapor, or
aerosol test agent into an area around the head of the respirator user.
If the respirator user can detect the presence of the test agent
through subjective means, such as odor, taste, or irritation, the
respirator fit is inadequate. In a quantitative respirator fit test
(QNFT), the adequacy of respirator fit is assessed by measuring the
amount of leakage into the respirator, either by generating a test
aerosol as a test atmosphere, using ambient aerosol as the test agent,
or using controlled negative pressure to measure the volumetric leak
rate. Appropriate instrumentation is required to quantify respirator
fit in QNFT.
OSHA's prior respirator standard required training that provided
opportunities for each user to have the respirator ``fitted properly''
and to wear it in a test atmosphere. However, it did not specify the
test protocols to be used. The previous standard also required that
employees be trained to check the fit each time the respirator is put
on, although without specifying how the fit check was to be performed
or the types of fit checks that were acceptable. OSHA's own compliance
experience, and the experience gained from respirator research over the
past 25 years, demonstrates that the existing standard's limited fit
testing requirements do not provide employers with adequate guidance to
perform appropriate fit testing.
The substance-specific standards that have been issued over the
past 20 years show the evolution of OSHA's recognition of the need for
fit testing guidance. The early standards, such as the 1978
Acrylonitrile standard (29 CFR 1910.1045) and the 1978 Lead standard
(29 CFR 1910.1025), required quantitative fit tests but did not provide
specific protocols. Subsequently, in 1982, the lead standard was
amended to allow qualitative fit testing for half mask negative
pressure respirators, provided that one of three specified protocols
was followed (47 FR 51110). These specified qualitative fit testing
(QLFT) protocols use isoamyl acetate, irritant smoke, or saccharin as
the test agents. They have been used in all subsequent standards (e.g.,
Cadmium, Sec. 1910.1027; 1-3 Butadiene, Sec. 1910.1051; Methylene
Chloride, Sec. 1910.1052) with fit testing requirements.
[[Page 1222]]
One of the major changes from requirements in the previous standard
made by this final standard is its requirement that fit testing be
conducted according to specific protocols and at specific intervals or
on the occurrence of defined triggering events. Paragraphs (f)(1) and
(f)(2) of the standard require employers to ensure that each employee
using a tight-fitting facepiece respirator passes an appropriate fit
test before using such a respirator for the first time and whenever a
different respirator facepiece is used, as well as at least annually
thereafter. Paragraph (f)(3) requires the employer to provide an
additional fit test whenever the employee reports, or the employer,
PLHCP, supervisor, or program administrator observes, changes in the
employee's physical condition that could affect respirator fit.
Examples of conditions causing such changes could be the wearing of new
dentures, cosmetic surgery, or major weight loss or gain. Paragraph
(f)(4) specifies that if an employee who has passed a fit test
subsequently notifies the employer, program administrator, supervisor,
or PLHCP that the fit of the respirator is unacceptable, the employee
must be given a reasonable opportunity to select a different respirator
facepiece and to be retested. Paragraph (f)(5) requires that the fit
test be administered according to one of the protocols included in
mandatory Appendix A.
Paragraph (f)(6) limits qualitative fit testing to situations where
the user of a negative pressure air-purifying respirator must achieve a
minimum fit factor of 100 or less. Paragraph (f)(7) explains that a
quantitative fit test has been passed when the fit factor, as
determined through an OSHA accepted protocol, is at least 100 for
tight-fitting half masks or 500 for tight-fitting full facepiece
respirators.
Paragraph (f)(8) requires that all QLFT or QNFT fit testing of
tight-fitting atmosphere-supplying respirators and tight-fitting
powered air-purifying respirators be performed with respirators in the
negative pressure mode, even if they are to be used in positive
pressure mode in the workplace, and contains additional requirements
for measuring fit testing results. It also requires that all facepieces
modified to perform a fit test be restored to their NIOSH-approved
configuration before being used in the workplace.
Detailed discussions of each of the paragraphs related to fit
testing follow.
Fit Testing--Paragraph (f)(1)
Paragraph (f)(1) of the final standard requires that all tight-
fitting respirators be fit tested in accordance with the requirements
of the final standard. The ANSI Z88.2-1992 standard has a similar fit
testing requirement, as did proposed paragraph (f)(3). The need to fit
test ``negative pressure'' respirators was widely supported (Exs. 54-5,
54-38, 54-67, 54-153, 54-158, 54-167, 54-172, 54-173, 54-185, 54-208,
54-219, 54-263, 54-273, 54-278, 54-313, 54-330, 54-424). No comments
opposing this requirement were received.
However, the record contains comments both supporting and opposing
the need to require the same type and frequency of fit testing for
``positive pressure'' respirators, which are defined in the final
standard as respirators ``in which the pressure inside the respiratory
inlet covering exceeds the ambient air pressure outside the
respirator.'' A number of commenters stated that positive pressure
atmosphere-supplying respirator users should not be required to pass a
fit test (Exs. 54-271, 54-280, 54-290, 54-297, 54-314, 54-324, 54-330,
54-339, 54-346, 54-350, 54-352, 54-361, 54-424). These commenters
believed that fit testing of such respirators was not needed because
the positive pressure inside the facepiece would prevent contaminated
ambient air from leaking from the outside atmosphere to the area inside
the facepiece.
For example, the Southern California Edison Company (Ex. 54-316)
stated that there was no need to fit test tight-fitting positive
pressure respirators because ``[t]he chances of these type of
respirators becoming negative pressure under normal use conditions are
very slim and generally occur only when there has been a restriction or
failure of the air supply system.'' The Alabama Power Company (Ex. 54-
217) similarly stated that there was no need to fit test tight-fitting
supplied air respirators (SARs) or powered air-purifying respirators
(PAPRs) because the chance was slight that a negative pressure
condition would occur during normal use. The Reynolds Metals Company
(Ex. 54-222) stated that, with positive pressure respirators, gross
leaks were unlikely to occur if the user was trained. Beaumont &
Associates (Ex. 54-246) stated that a well trained user of pressure
demand or continuous flow respirators would quickly be aware of any
gross leakage. Eric Jaycock, CIH, (Ex. 54-419) questioned whether
requiring the fit testing of positive pressure respirators would cause
employers to choose other, less protective, respirators. The County of
Rockland Fire Training Center (Ex. 54-155) stated that positive
pressure SCBAs may, theoretically, leak around the seal, but that, in
its experience, this was unlikely to happen in normal working
situations. It recommended that positive pressure SCBAs be exempted
from the fit test requirement if the user passes a negative pressure
fit check upon donning to ensure an effective seal.
Other evidence in the record, however, demonstrates that, even with
positive pressure respirators, facepiece leakage can occur when the
high inhalation rates associated with increased workloads cause the
facepiece pressure to become negative in relation to the outside
atmosphere. An evaluation of the performance of powered air-purifying
respirators equipped with tight-fitting half masks by the Lawrence
Livermore National Laboratory (Ex. 64-94) demonstrated what its authors
called the ``Myth of Positive Pressure.'' The study found that, at the
NIOSH-required flow rate of 4 cubic feet/minute (cfm), a half mask PAPR
tested at an 80% work rate had a negative facepiece pressure during
inhalation for all subjects. The authors concluded that the respirator
protection that the device can provide is dependent in large part on
the tightness of the seal to the face of the wearer.
Dahlback and Novak (Ex. 24-22) also found negative pressure inside
the facepieces of pressure-demand respirators when workers engaged in
heavy work and had inhalation peak flow rates of 300 liters a minute.
Workers in this study who had not been fit tested developed negative
pressure inside their masks much more frequently than those who had
been fit tested.
Some commenters (Exs. 54-214, 54-217, 54-222, 54-232, 54-234, 54-
245, 54-251, 54-278, 54-330, 54-424) stated that any negative pressure
due to leaks on inhalation can be countered by the increased air flow
of a positive pressure respirator. While increased air flow can reduce
the number of negative pressure episodes (Ex. 64-94), OSHA does not
believe that the realities of respirator usage allow exclusive reliance
on this mechanism to substitute for fit testing. Moreover, the air
pressure that positive pressure respirators provide inside the
facepiece is intended to overcome the momentary leakage that may occur
even with a properly fitting facepiece. This positive airflow alone is
not an adequate substitute for a properly fitting facepiece, and cannot
be relied upon to overcome the leakage that can occur into poorly
fitting facepieces.
[[Page 1223]]
Requiring fit tests for positive pressure respirators is also
necessary because the consequences of facepiece leakage into positive
pressure respirators can be extremely serious. Positive pressure
respirators are usually worn in more hazardous situations than those in
which negative pressure respirators are worn. For example, only
positive pressure respirators can be worn in IDLH atmospheres. By
definition, there is little tolerance for facepiece leakage in such
atmospheres. Positive pressure respirators also are used when the
concentration of the toxic substance is many times greater than the
permissible exposure limit. Even where positive pressure respirators
are worn in lower risk situations, they are often selected because the
hazardous gas or vapor in the atmosphere lacks adequate sensory warning
properties, clearly a factor calling for the minimum amount of
facepiece leakage. Employees also may believe that they can afford to
use less care in using a respirator that appears to be highly
protective; they may ignore seal checks and strap tensioning because
they are relying on air flow to overcome any leaks. Fit testing
demonstrates to employees that positive pressure respirators can leak,
and offers an opportunity for the employee to see, via quantification,
what actions (e.g., bending at the waist, jerking the head, talking)
relating to fit will decrease protection.
Similarly, although a negative or positive pressure user seal check
is important to ensure proper donning and adjustment of the respirator
each time it is put on, it is not a substitute for the selection of an
adequately fitting respirator through fit testing. Most respirator fit
testing is preceded by a user seal check, but experience with
respirator fit testing has shown that some individuals who pass this
user seal check with what they think is an adequately fitting facepiece
subsequently fail their fit test due to poor respirator fit. As John
Hale of Respirator Support Services (Ex. 54-5) stated, ``Yes, there is
some information to be obtained about gross facepiece-to-face leakage
by performing these checks. But, there are no performance criteria,
there is no known correlation between the result of this check and
respirator fit or performance * * * .''
A number of experts and consensus organizations supported the
proposal's requirement for fit testing of all tight-fitting
respirators. The Washington State Department of Labor and Industries
(Ex. 54-173), the Aluminum Company of America (Ex. 54-317) and the
United Auto Workers (Ex. 54-387) endorsed fit testing for positive
pressure respirators because these respirators do not always maintain
positive pressure due to overbreathing or physical exertion. The
Industrial Safety Equipment Association (ISEA)(Ex. 54-363) supported
OSHA's proposal for fit testing of all tight-fitting respirators,
stating that it was consistent with the ANSI Z88.2-1992 standard's
requirements. Fit testing for all tight-fitting respirators is found in
clause 9.1.2 of the ANSI Z88.2-1992 respirator standard (Ex. 81), which
requires that positive pressure respirators with tight-fitting
facepieces be qualitatively or quantitatively fit tested in the
negative pressure mode. The National Fire Protection Association (NFPA)
standards 1500 and 1404 also require that firefighters using SCBAs pass
a fit test (Tr. 479). The American Industrial Hygiene Association (Ex.
54-208) also supported the fit testing of all tight-fitting
respirators. Moreover, workplace protection factor studies conducted by
respirator manufacturers, NIOSH, national laboratories and others
always fit test subjects to reduce the effect of facepiece leakage that
is unrelated to design and construction (See, e.g., Exs. 64-14, 64-36,
64-94).
This record has convinced OSHA that it is necessary to require the
fit testing of both positive and negative pressure tight-fitting
respirators. Even positive pressure respirators do not always maintain
positive pressure inside the facepiece, particularly when facepiece fit
is poor, strenuous work is being performed, and overbreathing of the
respirator occurs (Exs. 64-94, 64-101). Leakage must be minimized so
that users consistently achieve the high levels of protection they
need. Most workplace use of positive pressure atmosphere-supplying
respirators occurs in high hazard atmospheres (e.g., emergencies,
spills, IDLH conditions, very high exposures, abrasive blasting), where
a high degree of certainty is required that the respirator is maximally
effective. Positive pressure respirators, like negative pressure
respirators, come in a variety of sizes and models, each with its own
unique fit characteristics. The only reliable way to choose an
adequately fitting facepiece for an individual user from among the
different sizes available is by fit testing. The problem of leakage due
to poor facepiece fit can be minimized by choosing good fitting
facepieces through fit testing for positive pressure respirator users.
OSHA concludes that the requirement to fit test tight-fitting positive
pressure respirators is appropriate to reduce leakage into facepieces,
and to improve the protection that all kinds of tight-fitting
respirators provide in the workplace.
Frequency of Fit Testing--Paragraph (f)(2)
Final paragraph (f)(2), like the proposal, requires that fit
testing be performed prior to an employee's initial use of a respirator
in the workplace; whenever a different model, size, make, or style of
respirator facepiece is used; and at least annually thereafter. Only
the requirement to conduct fit testing annually was disputed in the
rulemaking. Commenters generally agreed that some additional fit
testing beyond an initial test was necessary, but opinions varied
widely on the appropriate intervals at which such tests should be
performed. A few participants, including the UAW (Ex. 54-387), urged
that fit testing be required every six months, since changes in weight,
facial hair and scarring, dental work, and cosmetic surgery may alter
respirator fit. The UAW also stated that visual observation was not a
reliable way to identify the presence of these changes.
A number of commenters suggested that longer intervals, generally
two to three years, would be appropriate. For example, Allied Signal
(Ex. 54-175) recommended ``periodic'' or ``every two-years'' as the fit
testing interval. Public Service Electric and Gas Co. (Ex. 54-196)
stated that a ``two year time frame strikes a good balance between
safety concerns and practicality.'' The Texas Chemical Council (Ex. 54-
232) stated that, in its members' experience, ``* * * virtually no
individuals fail fit tests a year after initial testing for a given
chemical exposure using the same manufacturer's respirator.'' The Exxon
Company (Ex. 183), in response to questions asked at the June hearings,
reported that of the 230 employees at their Baton Rouge refinery given
an annual QNFT in 1995, a year after their initial respirator selection
in 1994, less than one percent (two employees) changed their respirator
size because of failing the annual QNFT. Exxon stated that few
employees change the size of their respirator from year to year, and
that ``the data suggest that annual quantitative fit-testing should not
be necessary and such testing may be done on a less frequent basis than
once per year.'' The Peco Energy Company (Ex. 54-292) stated that its
experience showed that a three year interval is sufficient to ensure a
proper fit, provided that mandatory refitting is conducted if there are
changes in the respirator user's physical condition. The Eastman
Chemical Co. (Ex. 54-245) recommended that the time limit be not
[[Page 1224]]
less than two years. The International Paper Co. (Ex. 54-290) stated
that ``bi-annual (sic) [every two years] fit-testing with proper
training should be adequate'' and that proper training would require
that employees report to the employer facial feature changes that have
occurred or failure to get an adequate seal during the positive/
negative pressure seal check.
Other participants believed that fit testing beyond initial fit
testing should be required only when an employee switches to a
different respirator, or when a significant change occurs in an
employee's physical condition that may interfere with obtaining an
adequate facepiece seal (Exs. 54-177, 54-187, 54-190, 54-193, 54-197,
54-214, 54-286, 54-297, 54-396, 54-397, 54-435, 54-323, 54-422, Ex.
123). The American Iron and Steel Institute (Ex. 54-307, Ex. 175)
stated that annual fit testing was unnecessary, and that the steel
industry experience shows that once a wearer has been fit tested and
has an acceptable fit, subsequent fit tests demonstrate consistent fit
factors. Mallinckrodt Chemical (Ex. 54-289) questioned the need for
annual fit testing for those employees who may use a respirator
infrequently, such as once or twice a year.
However, a large number of rulemaking participants supported OSHA's
proposal to require the testing of respirator fit on an annual basis
(Exs. 54-5, 54-6, 54-20, 54-153, 54-167, 54-172, 54-179, 54-219, 54-
273, 54-289, 54-293, 54-309, 54-348, 54-363, 54-410, 54-428, 54-455,
Ex. 177; Tr. 1573, 1610, 1653, 1674). The comments of these
participants and other evidence in the rulemaking record convince OSHA
that the annual testing requirement is appropriate to protect employee
health.
Annual retesting of respirator fit detects those respirator users
whose respirators no longer fit them properly. The Lord Corporation,
which already performs annual fit tests, reported that of its 154
employees who wear respirators, one to three (2 percent or less) are
identified each year as needing changes in model or size of mask (Ex.
54-156). Hoffman-LaRoche only performs fit tests at two-year intervals,
and it reported a much higher incidence of fit test failures. Sixteen
of the 233 people tested in a recent two year cycle of fit testing
(6.86%) needed a change in their assigned respirators (Ex. 54-106).
The Lord experience (Ex. 54-156) indicates that annual retesting of
facepiece fit detects poorly fitting facepieces, while the Hoffman-
LaRoche evidence demonstrates that waiting two years for retesting can
result in the discovery that quite a high percentage of workers have
been relying on poorly fitting respirators. Extending the retest
interval to more than one year would allow those individuals with poor
fits that could have been detected by annual fit testing to wear their
respirator for a second year before the poor fit is detected.
This evidence also supports OSHA's view that triggering the
requirement to retest only by certain events, such as a change in the
worker's condition, and not including a required retest interval, would
allow poor fits to continue. Changes in a worker's physical condition,
such as significant weight gain or loss, new dentures or other
conditions, can cause alterations in facial structure and thus
respirator fit. Physiological changes that affect facepiece fit can
occur gradually over time and are easily overlooked by observers, and
by the users themselves. Individuals with poorly fitting respirators
were often detected only through fit testing, and not by other methods
such as observation of changes in facepiece fit, failure to pass a user
seal check, or an employee reporting problems with the fit of the
respirator. Retesting facepiece fit solely on the basis of physical
changes in individual respirator users would not be a reliable
substitute for fit testing on an annual basis. These changes in an
individual's physical condition do, however, indicate the need for
retesting that individual's facepiece, and paragraph (f)(3) requires
additional fit testing whenever any of these changes is detected.
Moreover, fit testing not only determines whether a facepiece seal
is adequate; it also provides an opportunity to check that fit is
acceptable, permits the employee to reduce unnecessary discomfort and
irritation by selecting a more comfortable respirator, and reinforces
respirator training by providing users with a hands-on review of the
proper methods of donning and wearing the respirator. Therefore, as
well as providing the opportunity to detect poorly fitting respirator
facepieces, the annual fit testing requirement complements OSHA's
requirement for, and may partially fulfill, annual training under final
paragraphs (k)(1), (k)(3) and (k)(5). For the reasons presented above,
and based on a thorough review of the record, OSHA has included an
annual fit test requirement in the final rule.
Refitting Due to Facial Changes--Paragraph (f)(3)
Paragraph (f)(7) in the proposal addressed the need to refit
respirators when changes in the employee's physical condition occur.
The proposal identified facial scarring, cosmetic surgery, or an
obvious change in body weight as conditions requiring refitting. Some
commenters (Exs. 54-280, 54-428, 54-455) suggested that dental work
affecting facial shape should also trigger refitting. The International
Chemical Workers Union (ICWU) suggested that a change of five percent
in body weight or twenty pounds should be regarded as an obvious change
in body weight that requires refitting (Ex. 54-427). One commenter
opposed requiring the employer to determine whether an employee's
physical change should trigger refitting, stating that the
responsibility for reporting physical changes should rest with the
employee (Ex. 54-357).
The language of the proposed paragraph has been revised in the
final rule to provide greater clarity and to account for these
comments. Because weight loss or gain affects the facial configuration
of different individuals differently, OSHA does not believe it possible
to stipulate a given weight change ``trigger'' for requiring a new fit
test. The final standard thus retains the proposed language regarding
an obvious change in body weight. In response to the comments that
dental work can affect facial shape and respirator fit, the language in
final paragraph (f)(3) has been revised to add dental changes as
another item that can trigger a new fit test requirement. The provision
has been modified to trigger retests based on employee reports of
facial changes, in addition to changes observed by the employer,
supervisor, program administrator, or PLHCP that may affect facepiece
fit. Employer observations of potential problems with fit, along with
self-reported problems with facepiece fit or changes in facial
configuration, would trigger a respirator fit retest under final
paragraph (f)(3).
Paragraph (f)(3) requires employers to conduct an additional fit
test whenever an employee reports changes, or there are observations of
changes, in the employee's physical condition that could affect
respirator fit. This provision addresses the rare situation in which an
employee's facial features change to the extent that a respirator that
once fit properly may no longer fit. The conditions listed in the
standard that may cause such changes in facial features--facial
scarring, dental changes, cosmetic surgery, or an obvious change in
body weight--will generally be observable by the employer. If the
employee reports facial changes that are not readily observable, the
employer may require verification of
[[Page 1225]]
the changes before offering an additional fit test.
Retesting for Unacceptability--Paragraph (f)(4)
Paragraph (f)(4) of the final standard requires retesting whenever
the respirator becomes ``unacceptable'' to the employee. An employee
who notifies the employer, the program administrator, supervisor, or
the PLHCP that the fit of the respirator is unacceptable must be given
a reasonable opportunity to be retested and to select a different
respirator facepiece. This requirement was derived from paragraph
(f)(8) in the proposal, which required refitting within the first two
weeks of respirator use for masks that become ``unacceptably
uncomfortable.''
Although some commenters wanted to delete this provision on the
grounds that a properly fitted and trained worker should have no reason
to exchange the respirator (Exs. 54-6, 54-20, 54-156, 54-209, 54-215),
others urged that the employee be allowed to request a refit at any
time a respirator becomes unacceptable. These commenters saw no reason
to limit this period to two weeks (Exs. 54-154, 54-165). The utility of
the two week period was specifically questioned for situations where
respirators are not routinely used for long periods of time (Ex. 54-
66), or are used only occasionally (Ex. 54-220). Exxon (Ex. 54-266)
stated that the two week provision was too restrictive, and that
employees should be allowed to select another respirator or facepiece
as necessary . Dow (Ex. 54-278) also suggested dropping the two week
limitation. The American Petroleum Institute (Ex. 54-330) recommended
revised performance language for this provision. The Occidental
Chemical Company (Ex. 54-346) saw no reason to specify a two week
period, and stated that employees should be permitted to select a new
respirator facepiece at any time because of unacceptable discomfort.
In the final rule, OSHA has deleted the two week limitation on the
time in which an employee may have a respirator retested. In addition,
the term ``unacceptable'' has been substituted for the term
``uncomfortable,'' which was used in the proposal and was objected to
by several commenters (Exs. 54-154, 54-266, 54-278, 54-330). A
respirator may be unacceptable if it causes irritation or pain to an
employee or if, because of discomfort, the employee is unable to wear
the respirator for the time required.
Fit Testing Protocols--Paragraph (f)(5)
Paragraph (f)(5) in the final standard, which is substantively the
same as proposed paragraph (f)(3), requires that the employer use an
OSHA-accepted QLFT or QNFT protocol for fit testing. These protocols
are described in mandatory Appendix A. Appendix A also describes the
methods OSHA will use to determine whether to approve additional fit
test methods. The provisions in proposed paragraphs (f)(3), (f)(4), and
(f)(5) that referenced alternative fit test procedures therefore have
been removed from the final rule.
For qualitative fit testing (QLFT), Part I of Appendix A contains
the OSHA-accepted qualitative fit testing protocols for the isoamyl
acetate QLFT protocol; the saccharin QLFT protocol; and the irritant
smoke QLFT protocol, which were first adopted in the Lead standard (29
CFR 1910.1025). In addition, Appendix A contains an OSHA-accepted
protocol for the BitrexTM (Denatonium benzoate) QLFT method,
which was submitted to the rulemaking record and commented on during
this rulemaking.
Appendix A also lists three protocols for the QNFT methods that are
OSHA-accepted. The first is the traditional generated aerosol QNFT
method in which a test atmosphere (corn oil, DEHS, or salt) is
generated inside a test enclosure and the concentration inside and
outside the mask is measured. The second method is the ambient aerosol
QNFT method, commonly called the PortacountTM method, which
uses a condensation nuclei counter to measure the ambient aerosol
concentrations inside and outside the mask. The third method that has
been added is the controlled negative pressure (CNP) QNFT method
(Dynatech Nevada FitTester 3000TM), which was the subject of
comments during this rulemaking. These OSHA-accepted QLFT and QNFT
methods are described further in the discussion of Appendix A that
follows.
The only fit test method that generated any controversy during the
rulemaking proceeding was the irritant smoke QLFT protocol. OSHA is
continuing to accept the irritant smoke QLFT protocol for use under
this standard because the method is valuable when used properly and is
often used by small employers because it is relatively inexpensive.
Moreover, it is also the only QLFT method where facepiece leakage
elicits an involuntary response, which can eliminate the possibility
that a wearer could pretend to pass the fit test in order to be
eligible for a job requiring respirator use.
Nevertheless, OSHA is aware that high levels of irritant smoke can
be produced during a fit test and that these concentrations can be
dangerous. Employees exposed to excessive concentrations of irritant
smoke have suffered severe reactions (Ex. 54-437; Tr. 390). For this
reason, it is particularly important that employers using the irritant
smoke protocol ensure that test operators are well trained in this
method and comply with all the steps in the OSHA protocol. To ensure
that any leakage will be as minimal as possible, the test must not be
performed until the employee has passed a user seal check. In
performing the sensitivity check necessary to determine that the
particular user is sensitive to irritant smoke, it is extremely
important to assure that the employee is exposed to the least amount of
irritant smoke necessary to trigger a response. Appendix A is a
mandatory appendix, and failure to comply completely with its protocols
will constitute a violation of this standard.
QLFT Limits--Paragraph (f)(6)
Paragraph (f)(6) of the final standard limits qualitative fit
testing to situations where the user of a negative pressure air-
purifying respirators must achieve a minimum fit factor of 100 or less.
A similar limitation was contained in the proposal (paragraph
(f)(6)(i)(A)). This limitation is based on the fact that the existing
evidence only validates the use of qualitative fit testing to identify
users who pass the QLFT with a respirator that achieves a minimum fit
factor of 100. Dividing the fit factor of 100 by a standard safety
factor of 10 means that a negative pressure air-purifying respirator
fit tested by QLFT cannot be relied upon to reduce exposures by more
than a protection factor of 10. The safety factor of 10 is used because
protection factors in the workplace tend to be much lower than the fit
factors achieved during fit testing; the use of a safety factor is a
standard practice supported by most experts to offset this limitation.
For example, the ANSI Z88.2-1992 standard states, in clause 9.1.1, ``If
a quantitative fit test is used, a fit factor that is at least 10 times
greater than the assigned protection factor (table 1) of a negative-
pressure respirator shall be obtained before that respirator is
assigned to an individual. If a qualitative test is used, only
validated protocols are acceptable. The test shall be designed to
assess fit factors 10 times greater than the assigned protection
factor.''
The only objection to this limitation was expressed by a few
commenters (Exs. 54-153, 54-178) who noted that in
[[Page 1226]]
the future, new QLFT protocols may be developed allowing the
measurement of higher fit factors. If new methods are developed that
permit QLFT use for higher fit factors, OSHA will, as part of the
acceptance process for these new methods, adjust this requirement
appropriately.
QNFT Minimum Fit Factors--Paragraph (f)(7)
Paragraph (f)(7) of the final standard lists the minimum fit
factors required to be achieved during quantitative fit testing. These
minimum fit factors were listed in paragraphs (f)(6)(i)(B) and
(f)(6)(ii)(B) of the proposal. Half masks are required to achieve a
minimum fit factor of 100 during QNFT, and full facepiece respirators
must achieve a minimum fit factor of 500. Paragraph (f)(7) in the final
standard consolidates the minimum QNFT fit factors for half mask and
full facepiece respirators into one provision. The safety factor of ten
used for full facepiece respirators is the same as that for half masks.
The minimum fit factors in the final standard for QNFT are the same
as those that were proposed, and are identical to the minimum fit
factors required in OSHA substance-specific standards that require QNFT
(See e.g., Asbestos, 29 CFR 1910.1001; Cadmium, 29 CFR 1910.1027;
Benzene, 29 CFR 1910.1028; Formaldehyde, 29 CFR 1910.1048; 1,3-
Butadiene, 29 CFR 1910.1051).
Most participants who commented on the issue agreed with these
minimum fit factors. A few participants argued for higher minimum fit
factors (Exs. 67, 54-405). For example, Robert da Roza, citing his
study on the reproducibility of QNFT (Ex. 24-9), stated in his
testimony at the OSHA hearings on minimum fit factors that ``What I
feel confident in is that you do need something higher than a ten. It
may be as high as 800. I'm suggesting that some statistician look at
this a little more rigorously and come up with some better number.''
(Tr. 102)
TSI, Inc. (Ex. 54-405), in discussing the pass/fail levels for
QNFT, recommended the following:
The proposed requirement that a successful QNFT achieve a fit
factor of at least 100 for a half mask and 500 for a full-face mask
should be raised. The proposed values allow employers to accept what
in reality is a very poor fit compared to what can be achieved with
proper employee training * * * We feel that a fit factor of at least
1000 for half masks and at least 2000 for full face respirators is
justifiable and readily achievable with minimal extra effort by the
employer.
However, empirical data or statistical analyses that supported the
need to increase the minimum fit factors proposed were not presented.
Although fit factors substantially higher than the minimum values are
frequently achieved, OSHA's experience enforcing the substance-specific
standards that have similar requirements to the minimum fit factors
contained in the final respiratory protection standard shows that these
factors are adequate to distinguish well fitting respirators from those
that fit poorly, which is the purpose of fit testing. Accordingly, OSHA
is retaining the proposed fit factors in the final standard.
Testing Positive Pressure Respirators--Paragraph (f)(8)
Paragraph (f)(6)(iii)(B) in the proposal required that fit testing
of positive pressure respirators be conducted without any of the air-
supplying equipment or attachments that produce a positive pressure
inside the facepiece during respirator use. Thus, the proposal required
positive pressure respirators to be tested under negative pressure.
Final paragraph (f)(8) similarly requires that positive pressure tight-
fitting respirators be fit tested in the negative pressure mode. Fit
testing seeks to measure the tightness of the facepiece seal. If the
air pressure inside the facepiece is higher than that outside, the
pressure differential reduces the amount of ambient air leaking into
the facepiece, and the measurements obtained during the fit test do not
represent the tightness of the seal between the face and the facepiece.
Many tight-fitting respirator facepieces are available in both air-
purifying models and atmosphere-supplying units. For these, fit testing
can be performed using an identical negative pressure air-purifying
respirator facepiece, with the same sealing surfaces, as a surrogate
for the atmosphere-supplying facepiece the employee will actually be
using. Where an identical negative pressure facepiece is unavailable,
the employer may convert the facepiece of the employee's unit to allow
for qualitative or quantitative fit testing. Many SCBA manufacturers
(e.g., MSA, Interspiro and Survivair) sell fit testing adaptors for
this purpose that allow for fit testing of their SCBA facepieces.
Final paragraphs (f)(8)(i) and (f)(8)(ii) describe the specific
ways in which these alternatives apply for performing QLFT and QNFT
measurements, respectively. If the respirator facepiece has been
modified for fit testing, final paragraph (f)(8)(iii) requires that the
modifications must be completely removed and the respirator restored to
its NIOSH-approved configuration before it is used in the workplace.
These requirements replace the similar provisions in proposed paragraph
(f)(6), and should clearly inform employers of the requirements for fit
testing tight-fitting atmosphere-supplying or powered air-purifying
respirators. These provisions are designed so that the testing reflects
the conditions of respirator use as accurately as possible. There were
no significant objections to this provision in the record.
Proposed Paragraph (f)(9)--Interim Use of QLFT
The final standard deletes proposed paragraph (f)(9), which would
have allowed an employer initially to perform a qualitative fit test to
fit the respirator user where an assigned protection factor greater
than 10 is required if the employer had an outside party conduct
quantitative fit testing within 30 days. OSHA proposed this provision
to address those few instances when contractors were not available to
test employees who had been hired after the annual fit testing for a
given establishment had been conducted. There was considerable
opposition to this provision. John Hale of Respirator Support Services
(Ex. 54-5) recommended that this provision be eliminated because the
provision could be abused. The Exxon Company (Ex. 54-266) also
recommended that the provision be deleted, suggesting that full
facepiece respirators fit tested using a QLFT be limited to use in
atmospheres containing 10 times the exposure limit of a hazardous
substance until an adequate QNFT is performed. Other commenters stated
that retaining the provision could result in overexposure of the
employee to workplace contaminants (Exs. 54-280, 54-303, 54-408). The
Los Alamos National Laboratory (Ex. 54-420) criticized the provision on
the basis that it is the employer's responsibility to provide
appropriate fit testing prior to assigning employees to work where
respirators are required. The U.S. Army (Ex. 54-443D) stated that if
employers have a functioning respirator program and know of the
requirement for annual testing, then they should be able to schedule
fit testing appropriately, with no need for an extra 30 days.
Some participants who supported the proposed requirement stated
that QNFT has not been shown to be a better predictor of workplace
protection than QLFT, and recommended that QNFT be an optional, rather
than a required method, when fit factors greater than 10 are needed.
Moldex Metric Inc. (Ex. 54-153) recommended that the provision be
broadened to allow the employer some
[[Page 1227]]
latitude in selecting which fit testing methods must be used. Bayer
Corporation (Ex. 54-210) recommended the period be extended to 90 days,
and that the provision be broadened to include repair and/or
calibration of fit testing instruments; other participants also
recommended a 60 or 90 day period (Exs. 54-222, 54-278, 54-330, 54-361,
54-424, Ex. 54-430).
OSHA has concluded that the rulemaking record demonstrates that
proposed paragraph (f)(9) is unnecessary. Contractors who perform QNFT
services are located throughout the country, and an employer can
arrange a schedule to ensure that fit testing will be available when
required. QNFT instruments are also available for rent and can be used
by employers themselves after appropriate training if no contractor is
available. Several different types of reasonably priced QNFT
instruments are manufactured, and OSHA believes many employers can
readily purchase one to perform their own QNFT. The instruments are
highly portable and can be readily shipped to where they are needed. As
the Army points out (Ex. 54-433D), an employer with a respirator
program that requires annual fit testing can readily schedule fit
testing appropriately.
In addition, the comments OSHA received urging that the provision
be expanded increase OSHA's concern that leaving the option in the
standard could expose employees unnecessarily to excessive
concentrations of hazardous substances. The QNFT exemption as proposed
was intended to be narrow in scope and to apply only when contractors
were not readily available to test new employees who were hired after
the annual fit testing session. The reasons advanced for extending this
QNFT exemption were not convincing. OSHA believes that there are other
ways to address the concerns raised by commenters in support of this
QNFT exemption. For example, employers can schedule QNFT instrument
calibration during times when fit testing is not scheduled and can
obtain a substitute QNFT instrument when their own unit needs repair.
OSHA concludes that this provision is not appropriately included in the
final standard.
Appendix A--Mandatory Fit Test Protocols
Appendix A contains the fit test protocols that employers must
follow in performing qualitative and quantitative fit testing for
tight-fitting respirators. The Appendix also contains procedures OSHA
will use to evaluate ``new'' fit testing methods. Proposed Appendix A
addressed the same subjects. Employers who have in the past performed
fit tests pursuant to a substance-specific standard must now follow the
protocols for OSHA-accepted fit tests that are set out in Appendix A.
OSHA has removed the fit testing protocols in the substance-specific
standards to eliminate duplication and consolidate all fit testing
protocols in Appendix A.
Appendix A has been reorganized from its proposed format to improve
clarity and usefulness. The provisions dealing with administering OSHA-
accepted fit testing protocols have been moved to part I.
Section A of part I contains general provisions and test exercises
that apply to both QLFT and QNFT.
Section B contains the OSHA-accepted QLFT protocols for isoamyl
acetate, saccharin, Bitrex, and irritant smoke fit tests.
Section C contains the OSHA-accepted QNFT protocols for generated
aerosol, ambient aerosol (CNC), and controlled negative pressure (CNP)
fit tests.
Part II addresses the methodology OSHA will use to evaluate new fit
test methods and technology.
Appendix A provides general instructions for performing fit testing
which have been simplified and clarified by combining the common
elements for both QLFT and QNFT and presenting them in Section A of
Part I. This includes directions for such procedures as selecting a
respirator for fit testing and performing the required test exercises.
By combining common elements and eliminating the duplication of fit
test protocols in the substance-specific standards, OSHA has reduced
the number of pages in its regulations dedicated to fit testing. The
purpose of the OSHA fit testing protocols is to tell fit test operators
how to perform fit testing to ensure that an adequately fitting
facepiece is selected. The protocols reflect the fit test elements
(i.e., equipment and basic procedures) that were performed during the
validation testing that initially led to their acceptance by OSHA. The
protocols do not contain specific instructions on operating any
particular fit test instrument because each instrument has specific
manufacturer's operating instructions that must be followed to obtain
valid results.
The fit testing procedures and specific requirements in the QLFT
and QNFT protocols in Sections B and C of part I reflect both the
experience that has been gained in performing fit testing and the
validation testing that was done initially in order for each method to
be accepted by OSHA. The OSHA-accepted methods were evaluated by
comparing their performance with that of another accepted fit test to
demonstrate that each new method would reliably identify adequately
fitting facepieces. The OSHA-accepted protocols reflect the specific
procedures and equipment that were used in validation testing, and they
must be followed to ensure minimum reproducibility. These elements in
the OSHA protocols are not written in performance-oriented language,
since any significant variation from the required protocols would
invalidate the reliability testing that was performed initially to gain
OSHA acceptance and would add uncertainty to the validity of fit test
results.
Fit Testing Procedures--General Requirements
The general requirements for fit testing contained in Appendix A,
part I.A apply to all OSHA-accepted fit test methods, both QLFT and
QNFT. These provisions contain general requirements and instructions
for both the person being fit tested, and the person conducting the fit
testing. The provisions have been modified slightly from the proposal.
Provision A.1 requires that the test subject be afforded a
selection of respirators of various sizes and models from which to pick
the most acceptable. The revised language of this provision reflects
the substitution of the term ``acceptable'' for ``comfortable'' in
paragraph (d)(1)(iv). Provision A.2 is identical to that proposed. The
test operator shows the person being fit tested how to don the
respirator properly. This instruction may complement the training
required by paragraph (k) of this standard. Provisions A.3 to A.7
contain instructions for selecting the most acceptable respirator for
fit testing.
Provision A.8 requires the subject to perform a ``user seal check''
before the fit test is performed. The language in this provision has
been modified to reflect the use of the new definition for ``user seal
check.'' Provision A.9 restates that fit testing shall not be conducted
if there is any hair growth between the skin and sealing surface of the
respirator. If the test subject exhibits breathing difficulty during
fit testing, provision A.10 requires that he or she be referred to a
PLHCP. Minor revisions to this provision reflect changes made to
paragraph (e) of the standard on medical evaluation. Provision A.11
requires retesting whenever the employee finds the fit unacceptable.
Provision A.12 of Appendix A, Part II of the proposal regarding fit
testing records has been moved to paragraph (m) of the final
[[Page 1228]]
standard to consolidate all recordkeeping provisions.
Provisions A.12 through A.14 of this final standard describe the
specific exercises to be performed under all qualitative and
quantitative fit tests protocols. The exercises are mostly the same;
however, the grimace exercise is not performed for QLFT protocols. In
addition, a separate test regimen is prescribed in Section C for the
CNP quantitative fit test. Except for minor modifications, the
exercises are identical to those in the proposal and to those in OSHA's
substance-specific health standards. Participant comments focussed on a
few issues: the number and duration of fit test exercises (Exs. 54-158,
54-187, 54-206, 54-218, 54-219, 54-261, 54-271, 54-273, 54-350, 54-325,
155), and the need for the grimace, bending over/jogging-in-place, and
talking exercises (54-153, 54-173, 54-175, 54-179, 54-208, 54-218, 54-
219, 54-261, 54-273, 54-317, 54-363, 54-408, 54-420, 54-424). These
comments are addressed below.
Provision A.14 requires the employee being fit-tested to perform
eight exercises. Seven of the exercises must be performed for one
minute, while the grimace exercise lasts for only 15 seconds. The test
exercises and exercise sequence are: normal breathing; deep breathing;
turning the head side to side; moving the head up and down; talking;
grimacing; bending over (or jogging in place if the test unit is not
large enough for the test subject to bend at the waist); and normal
breathing.
Some participants complained that the number and length of the
exercises required to be performed were excessive. For example, the 3M
Company stated that OSHA has made numerous changes to accepted
protocols without verifying the effect of the changes on test
performance (Ex. 54-218). According to 3M, OSHA arbitrarily altered the
fit tests by requiring the test exercises to be performed for one
minute, rather than 30 seconds, and by including the grimace and the
bending over/jogging-in-place exercises, and that this alteration
violates the original validation of the fit test protocols. In fact,
the protocols in this standard are virtually identical to those in
other OSHA health standards that have been promulgated over the past
fifteen years. The isoamyl acetate (IAA) QLFT test that was evaluated
and adopted in the lead standard in 1982 has six exercises. Five of the
exercises must be performed for one minute, and the talking exercise is
performed for ``several'' minutes. Thus, the total test time for the
six exercises is seven to eight minutes, compared to the seven minutes
and 15 seconds that completion of the exercises in this standard will
take. Since the length of the two test protocols is similar, OSHA
concludes that the IAA concentration at the end of the fit test under
this standard would be the same as if the fit test was performed under
the IAA QLFT protocol contained in the lead standard.
The grimace exercise drew a number of comments. The test is
intended to simulate the type of normal facial movements that could
break a respirator seal. It was developed in the asbestos standard in
1986 and has been incorporated into subsequent OSHA standards.
Participants questioned the need for the grimace exercise, particularly
with QLFT, where a break in the facepiece seal could cause sensory
fatigue (Exs. 54-153, 54-208, 54-218, 54-219, 54-263, 54-273, 54-363,
54-408, 54-424). Several commenters (Exs. 54-173, 54-179, 54-261, 54-
317) stated that the grimace exercise cannot be described so that its
effects are standardized and reproducible. DuPont (Ex. 54-350)
recommended that the standard incorporate only six exercises, deleting
both the grimace and bending/jogging exercises. DuPont stated that if
the grimace remained in the fit test protocol, it should be performed
last, with the results excluded from the calculations. Allied Signal
(Ex. 54-175) also recommended that the grimace exercise be deleted;
however, if retained, it should be performed at the completion of the
other test exercises. In contrast, the Los Alamos National Laboratory
(Ex. 54-420), which originated fit testing protocols, stated that their
researchers included the grimace exercise as part of the test exercises
for full facepieces in the early 1970s. Los Alamos stated that an
exercise that simulates a worker's normal facial movements should not
be excluded from the test exercises, and recommended that it be
retained.
These comments have persuaded OSHA to delete the grimace exercise
as one of the required fit testing exercises for QLFT, but to retain it
for QNFT. A break in the facepiece seal during a QLFT could cause
sensory fatigue that would invalidate the results of the grimace test
and any remaining fit test exercises. Performing the exercise as the
final element of the qualitative fit test would not address this
concern because one purpose of the test is to determine whether the
respirator reseals after the seal has been broken, and performing the
grimace test after all the others have been completed will not allow a
determination of whether the respirator has resealed effectively after
the test.
The concern about sensory fatigue does not exist with quantitative
fit tests, however, and OSHA believes the grimace exercise is a
valuable aspect of these tests. Because the exercise stresses the
facepiece seal, it allows the test to determine whether the facepiece
reseats itself during subsequent exercises. The results from the
grimace exercise are not to be used in calculating the fit factor for
QNFT (provision C(2)(h)(1)), since breaking of the seal would
necessarily produce a low fit factor for the grimace exercise. However,
if the respirator facepiece fails to reseat itself, the fit factors
measured for the subsequent exercises would reflect this failure,
causing the employee to fail the fit test. Therefore the grimace
exercise has been retained as one of the required QNFT fit testing
exercises.
The Air Conditioning Contractors of America (Ex. 54-248) questioned
the need to require employees to read from a text, such as the Rainbow
Passage. Members of the association stated that their technicians had
their own methods of determining fit. As stated above, however, OSHA
believes that standardized fit testing protocols provide important
safety benefits to employees. To the extent that employers develop
other valid fit test methods, Part II of Appendix A provides a
procedure through which they can seek OSHA approval of those fit test
protocols. The talking exercise requirement is also not onerous. To
perform this exercise, the employee must either read from a prepared
text such as the Rainbow Passage, count backward from 100, or recite a
memorized poem or song. These alternatives provide employers and
employees with some flexibility when performing this exercise.
Qualitative Fit Test (QLFT) Protocols--Appendix A, Paragraph B
B.1. General. Provision B.1.(a) of Part I of Appendix A on
qualitative fit test protocols contains two general provisions relating
to QLFT. The provisions are substantively the same as in the proposal.
The term ``assure'' has been replaced by ``ensure,'' reflecting a
change that has been made throughout the regulatory text.
Provision B.1.(a) requires the employer to ensure that the person
administering QLFT be able to perform tests correctly, to recognize
invalid tests, and to ensure that the test equipment is in proper
working order. This applies regardless of whether the tester works
directly for the employer or for an outside contractor. When QLFT is
performed by the employer's own personnel, the testers must be properly
[[Page 1229]]
trained in the performance of the particular QLFT protocol that will be
used. If outside contractors are used to provide fit testing support,
the employer must ensure that the test operators performing the fit
testing protocols are trained, and can competently administer the QLFT
according to the OSHA protocols. This provision is performance
oriented, since it lists the abilities the test operator needs, but
does not describe a specific training program. The type of QLFT
operator training needed is specific to the QLFT method selected, and
new methods may be developed in the future that require additional
training.
The second provision, B.1.(b), requires that the QLFT equipment be
kept clean and well maintained so it operates within its designed
parameters. For example, the nebulizers used for the saccharin and
Bitrex QLFT protocols can clog when not properly cleaned and
maintained, resulting in invalid tests. The test operator must maintain
the equipment used for fit testing to ensure proper performance. The
requirement is again performance oriented, since the QLFT equipment
used will vary with the type of QLFT selected.
There are four qualitative fit test protocols approved in this
Appendix. The isoamyl acetate (IAA) test determines whether a
respirator is protecting a user by questioning whether the user can
smell the distinctive odor of IAA. Both the saccharin and Bitrex tests
involve substances with distinctive tastes, which should not be
detected through an effective respirator. The irritant smoke test
involves a substance that elicits an involuntary irritation response in
those exposed to it.
B.2--Isoamyl acetate protocol. The IAA test protocol included in
the final standard evolved out of the IAA protocol OSHA originally
adopted for the lead standard (29 CFR 1910.1025). It requires that an
employee first be tested to determine if the employee can detect the
odor of IAA, often called banana oil because it gives off a distinctive
banana-like smell. The fit test is only to be conducted on employees
who can detect this odor. An employee passes the fit test with a
particular respirator if he/she cannot detect the IAA odor while
wearing the respirator. The primary drawback of the test is the strong
ability of IAA to induce ``odor fatigue,'' so that an individual
quickly loses the ability to detect the odor if exposed to it for any
period of time. Odor sensitivity is the key to the IAA fit test, and
any decrease in the employee's odor sensitivity due to background
levels of IAA could invalidate IAA fit testing. For this reason several
provisions of the protocol are intended to minimize the possibility of
background exposure to IAA that could impair the test subject's ability
to detect the odor in the fit test.
IAA vapor easily penetrates a particulate filter, and the IAA
protocol therefore cannot be used to fit test particulate respirators
unless the respirator is equipped with an organic vapor filter. The
protocol requires that separate rooms be used for the odor screening
and fit tests, and that the rooms be ventilated sufficiently to ensure
that there is no detectable odor of IAA prior to a test being
conducted. In prior standards, OSHA has required that separate
ventilation systems, in addition to separate rooms, be used for these
functions (e.g., Lead [47 FR 51114]). OSHA proposed to do the same in
this standard. However, OSHA has been convinced by the comment of Mobil
Oil Corporation (Ex. 54-234) that this elaborate precaution against
odor fatigue and general background contamination is burdensome and
unnecessary. OSHA agrees with Mobil that the ventilation simply needs
to be adequate to prevent IAA odor from becoming evident in the rooms
where odor sensitivity testing and respirator selection and donning
take place, and that the need to have separate ventilation systems for
IAA fit testing will make it unnecessarily difficult to find an
acceptable building in which to perform fit testing. OSHA is therefore
removing the requirements that the odor threshold screening test and
fit test rooms not be connected to the same ventilation system.
Instead, the ventilation requirement is stated in performance language
in the final standard: the testing rooms must be sufficiently
ventilated to prevent the odor of IAA from becoming evident to the
employee to be tested. OSHA believes that this performance-based
language will be sufficient to alert employers to the requirement to
prevent olfactory fatigue among workers being fit tested by preventing
a buildup of IAA in the general room air.
The proposed IAA protocol required that the test atmosphere be
generated by wetting a paper towel or other absorbent material with
0.75 cc of pure IAA and suspending the towel from a hook at the tip
center of the test chamber. Two commenters stated that the standard
should also allow the test atmosphere to be generated by the use of
commercially prepared test swabs or IAA ampules as long as these
methods generate the required airborne concentrations of IAA (Mobil Oil
(Ex. 54-234); Bath Iron Works (Ex. 54-340)).
OSHA agrees that alternative methods of generating the IAA test
atmosphere should be permitted as long as those methods have been shown
to reproducibly generate the minimum concentration of IAA needed for a
successful fit test. The National Bureau of Standards (Ex. 64-182), in
its report on fit testing of half mask respirators using the IAA
protocol in the OSHA lead standard, found that the minimum IAA
concentration inside the test chamber was 100 ppm during fit testing.
Accordingly, the IAA protocol in Appendix A of the final standard has
been modified to permit the use of test swabs or ampules as long as
these have been shown to generate a test atmosphere concentration
comparable to that generated by the towel-saturation method in the
proposed standard. An employer who wishes to use test swabs or ampules
would need to demonstrate that the swabs or ampules generate an
acceptable test atmosphere. For this purpose, the employer may rely on
data obtained from the manufacturer of the swabs or ampules as long as
the employer uses the products in a way that reproduces the
concentrations obtained by the manufacturer under the manufacturer's
test conditions.
OSHA has also added a provision recommended by the American
Industrial Hygiene Association (Ex. 54-208) to reduce the possibility
of test area contamination from used paper towels. AIHA recommended
that B.2.(b)(10) be revised to ensure that the used towels are stored
in self-sealing bags to prevent test area contamination. OSHA adopted
the language changes the AIHA proposed; the final standard requires
that used IAA towels be removed from the test chamber to avoid test
area contamination.
AIHA (Ex. 54-208) also recommended that OSHA remove the language in
B.2.(b)(2) of the IAA fit test protocol requiring that organic vapor
cartridges be changed at least weekly. AIHA stated that a fit test
operator who is competent to implement an adequate QLFT program will be
able to determine an adequate cartridge change schedule. OSHA agrees,
and has removed the language requiring weekly filter changes, because
weekly changes may overstate or understate appropriate frequencies.
However, the program administrator or the fit test operator must
replace the cartridges as appropriate to ensure their proper function.
After the close of the NPRM comment period and the hearings, during
the post-hearing comment period, the ISEA (Ex. 54-363B) submitted a
report on fit testing for full facepiece respirators
[[Page 1230]]
using an IAA QLFT protocol for which the test concentration of IAA was
raised to 10 times the concentration used in the OSHA-accepted IAA
protocol. ISEA reported that the pass/fail cutoff for the modified IAA
QLFT was a required fit factor of 1000, and that this increased IAA
concentration fit test could therefore be used to test full facepiece
respirators for use where ambient exposures were 100 times the PEL.
ISEA stated that the validation data that it submitted for this new IAA
fit test meet the validation requirements of the September 17, 1989
ANSI Z88.10 draft standard entitled ``Respirator Fit Test Methods.''
OSHA notes, however, that all draft provisions of the draft ANSI fit
testing standard are still subject to change until published as part of
the final ANSI Z88.10 standard. Further, ISEA did not indicate that the
test met the validation criteria proposed by OSHA. In addition, no
comments were received from the regulated community on this modified
IAA protocol. Since the proposed, ISEA-modified, IAA qualitative fit
test was submitted as a post-hearing comment, an opportunity did not
exist for the regulated community to comment on it as part of this
rulemaking record. The revised IAA fit test, therefore, has not
received the review and public comment to which the other new fit tests
(i.e., Portacount, CNP, Bitrex) were subjected during this rulemaking.
Accordingly, OSHA is not adding the modified IAA fit test for full
facepieces to the final standard's fit test protocols. This Appendix
establishes procedures for OSHA acceptance of new fit test protocols,
and a proponent of the modified IAA fit test may submit it for review
under those procedures.
B.3 and B.4--Saccharin Solution and BitrexTM (Denatonium
benzoate) Solution Aerosol Protocols. The protocols for the saccharin
and Bitrex solution aerosol fit test methods are similar. Both involve
test agents that a test subject will taste if his or her respirator is
not functioning effectively. Saccharin is a sugar substitute with a
sweet taste, and Bitrex is a bitter taste-aversion agent. In both
cases, the subjects are first tested to ascertain that they are in fact
able to taste the test agent being used, and then are tested with a
respirator. During the fit test the subjects are instructed to breathe
with their mouths slightly open and their tongues extended. If they can
taste the test agent during the fit test, the test has failed.
The proposal included the saccharin protocol but not the Bitrex
protocol, which was not validated until after the proposal was issued.
The saccharin protocol was identical to that contained in the Lead
standard (29 CFR 1910.1025, Appendix D II; 29 CFR 1910.1027 (Cadmium);
29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048 (Formaldehyde); 29 CFR
1910.1050 (Methylenedianaline); 29 CFR 1910.1051 (1-3 Butadiene)).
Several commenters (Exs. 54-208, 54-218, 54-219, 54-363) recommended
minor revisions to the language of the protocol to correct specific
problems, and to clarify the procedures. In response to these comments,
the formula for preparing the threshold check solution has been revised
to remove an error in dilution contained in the lead standard protocol.
OSHA has also changed the requirement that employees being tested open
their mouths wide to a requirement that they open their mouths
slightly, since opening the mouth wide could distort normal facepiece
fit and invalidate the test results. Opening the mouth slightly is
sufficient to allow the employee to detect leakage of the test agent
into the respirator when testing for facepiece seal leakage.
The final standard also does not restrict employers to using a
DeVilbiss Model 40 nebulizer but also allows them to use an equivalent
test nebulizer. Allowing the use of alternative nebulizers that can
produce an acceptable test atmosphere is a change from the lead
standard protocol, which allowed only the use of the DeVilbiss
nebulizer. Finally, the protocol now states clearly that, to elicit a
taste response, a minimum of ten nebulizer squeezes is required during
the threshold screening. This matches the minimum number of squeezes of
the fit test nebulizer required by the protocol.
NIOSH (Ex. 54-437) was the only participant to object to the
saccharin aerosol protocol. NIOSH is concerned that saccharin is a
potential carcinogen, and it believes that Bitrex is an acceptable
alternative test agent. Although saccharin is suspected of being a
carcinogen when ingested in large quantities over long periods of time,
it is not a substance that OSHA has regulated, and even NIOSH does not
have a Recommended Exposure Limit for it. A test subject would be
exposed to saccharin only for a brief time during the pre-test
sensitivity check, and again either upon failing the test or during the
post-test sensitivity check. Either exposure would likely occur only
once a year. These exposures would be very low, at or near the
threshold of detectability, and it is extremely unlikely that they pose
a significant risk to the health of employees or that they would exceed
any realistic exposure limit that may be established.
Moreover, although the Bitrex fit test protocol is an acceptable
alternative for situations in which the saccharin protocol is used,
Bitrex is not as widely available as saccharin, and the test is not as
widely accepted. The Bitrex QLFT protocol was developed by 3M (Ex. 54-
218). The test protocol is essentially the same as that for the
saccharin QLFT, with changes made in preparing the threshold check
solution and the fit test solution to account for the non-linear taste
sensitivity of Bitrex. A recent paper by Mullins, Danisch, and Johnston
(Ex. 178) in the November 1995 AIHA journal describes the development
of the Bitrex QLFT method. Validation testing consisted of 150 paired
qualitative and quantitative fit tests, with test volunteers using half
mask respirators. The Bitrex fit test was evaluated against the
saccharin fit test and found to have a test sensitivity of 0.98 and a
predictive value for passing of 0.98 at a fit factor of 100. The
overall test results were identical for the Bitrex and saccharin fit
test methods.
Only one rulemaking participant objected to the possibility that
OSHA would approve the Bitrex test. Robert daRoza of the Lawrence
Livermore Laboratory (personal communication with John Steelnack, OSHA,
6/4/97) stated that this method has not been adequately tested by
multiple facilities, and that the ratio of the concentrations specified
does not follow the same logic used in the saccharin method. Until the
method is validated by multiple facilities and the logic of the
specified concentrations determined, Mr. daRoza believes that the test
should not be incorporated into the final standard.
In contrast, NIOSH has recommended Bitrex as an acceptable
alternative test agent for saccharin (Ex. 54-437). OSHA has reviewed
the validation studies (Ex. 178) in depth, and believes that they
establish the Bitrex protocol as an appropriate fit test method.
Therefore, OSHA is approving this protocol.
Irritant Smoke (Stannic Chloride) Protocol
The irritant smoke protocol (also called irritant fume) uses
stannic chloride smoke tubes to produce a smoke containing hydrochloric
acid. Exposure to this test agent causes irritation resulting in
coughing. Because the response to irritant smoke is involuntary, the
irritant smoke fit test is the only QLFT method that does not rely on
the subjective response of the employee being tested (Exs. 54-325, 54-
424). The protocol contains a number of provisions intended to minimize
employee exposure to the irritant
[[Page 1231]]
smoke, which can be harmful to some individuals at high exposure
levels.
Irritant smoke is the oldest method of fit testing still in use. It
was developed at the Los Alamos National Laboratory more than fifty
years ago (Ex. 25-4). OSHA has approved the protocol in all of its
health standards that allow QLFT (See 29 CFR 1910.1025 (Lead); 29 CFR
1910.1027 (Cadmium); 29 CFR 1910.1028 (Benzene); 29 CFR 1910.1048
(Formaldehyde)).
The irritant smoke protocol also has the drawback, however, that
excessive exposure to irritant smoke can cause severe irritation and,
in some cases, permanent harm. For this reason, NIOSH (Ex. 54-437)
recommended against the continued use of irritant smoke for qualitative
fit testing. NIOSH has conducted the only study known to OSHA that
assessed the concentrations of hydrogen chloride produced from irritant
smoke tubes. When smoke tubes were attached to an aspirator bulb, NIOSH
measured concentrations of hydrochloric acid that ranged from 100 ppm
(measured at a distance of six inches from the end of the smoke tube)
to 11,900 ppm (measured at a distance of two inches). The use of a low-
flow pump produced hydrogen chloride concentrations ranging from 1500
ppm to more than 2000 ppm within 10 seconds of turning on the pump.
NIOSH did not measure the amount of irritant smoke inside any
respirator facepieces (Tr. 411). The OSHA PEL for hydrogen chloride is
a ceiling limit of 5 ppm, which may not be exceeded at any time (29 CFR
1910.1000(a)). NIOSH has established an IDLH value of 50 ppm and notes
that a concentration of 309 ppm has been reported as the level of
hydrogen chloride causing a severe toxic endpoint in laboratory
animals. NIOSH also cited a recommendation by a National Academy of
Sciences committee to limit emergency exposure to 20 ppm (Ex. 54-437R
at p. 6).
NIOSH performed these measurements after evaluating irritant smoke
testing at the request of the Anchorage Alaska Fire Department (Ex. 54-
437R) because four firefighters had reported experiencing either skin
or eye irritation during irritant smoke fit testing inside a test
enclosure. NIOSH additionally described a telephone report it had
received of vocal chord damage caused by exposure to hydrochloric acid
during an irritant smoke fit test. OSHA notes, however, that this fit
test was performed inside a test enclosure and that the test subject
failed four consecutive fit tests using this challenge agent (Tr. 411).
TSI, Inc. (Ex. 54-303), the manufacturer of the Portacount QNFT
system, also recommended that the irritant smoke QLFT protocol be
deleted from the final standard. Like NIOSH, TSI was concerned that
employees being fit tested may be exposed to hydrochloric acid in
excess of the PEL and, sometimes, in excess of the IDLH level. TSI also
stated that the proposed protocol did not contain a threshold test to
measure the employee's sensitivity to irritant smoke, and does not
provide a means for generating a stable test-agent concentration. The
3M Company (Ex. 137), citing the NIOSH recommendation that irritant
smoke not be used for fit testing, also recommended against its use. In
addition, 3M stated that ``the irritant smoke test has not yet been
completely validated. Neither the level of smoke necessary to evoke a
response nor the challenge concentration during the fit test have been
measured and shown to be reproducible.''
In contrast, OSHA received comments urging that it continue to
approve the irritant smoke protocol. The Organization Resources
Counselors, Inc. (ORC) (Ex. 54-424) noted that the irritant smoke
protocol is generally considered to be one of the easiest, cheapest,
quickest, and most effective QLFT methods available, although ORC
recognized that precautions must be taken to minimize exposures. For
example, ORC pointed out that irritant smoke fit testing should not be
performed in a small chamber, such as an inverted plastic bag or hood,
since this could allow the accumulation of high concentrations of
hydrogen chloride. SEIU (Ex. 54-455) supported the use of irritant
smoke QLFT because of the benefits of its involuntary response. The
SEIU stated:
SEIU objects to the use of non-irritant challenge agents
(isoamly acetate and saccharine). We have found that many of our
members are pressured to complete fit tests quickly and get back to
work, and hence will not acknowledge when a respirator has leaked
during a fit test. The reaction to an irritant fume is very
difficult to disguise.
Willson Safety Products (Ex. 54-86) also supported the use of the
irritant smaoke fit test, citing ``the thousands of businesses who now
use the irritant smoke fit test procedure with a 50 ml squeeze bulb.
They find the irritant fume protocol the least complicated and most
easily performed of the QLFT protocols.''
All of the comments urging OSHA not to approve the irritant smoke
protocol were based on the possibility that the test could expose
employees to high levels of hydrogen chloride. The irritant smoke
protocol in Appendix A has been carefully designed to minimize such
exposures. The initial and post fit-test sensitivity checks must be
performed with ``a small amount'' of ``a weak concentration'' of
irritant smoke, with care being taken to use ``only the minimum amount
of smoke necessary to elicit a response.'' (See provisions I.B.5(a)(4);
and 5(b)(3)). Test subjects are to be instructed to close their eyes to
prevent eye irritation during the test. The test must be performed in a
well-ventilated area to prevent any build-up of irritant smoke in the
general atmosphere (provision I.B.5(a)(5)). Unlike other QLFT methods,
the irritant smoke test may not be performed inside a test enclosure or
hood (provision I.B.5(a)(3)).
Persons being fit tested must pass a user seal check before the fit
testing begins (See provision I.A.8). The irritant smoke fit test
starts with a small amount of the irritant smoke being produced from a
smoke tube, and the person being tested wafting a small portion of the
smoke toward his or her breathing zone to determine if any gross
facepiece leakage occurs. Only after determining that the initial fit
is adequate does the operator direct smoke at the facepiece seal area,
starting at least 12 inches away from the head and working around the
seal area and gradually approaching the test subject's face. Because
the test is performed in an open area, the person being tested can step
back into clean air any time irritant smoke is detected within the
mask. This limits the maximum exposure to as little as one breath of
irritant smoke.
Following this protocol would have avoided both of the adverse
reaction incidents NIOSH described. In the Anchorage case, positive
pressure SCBAs were fit tested by placing the users inside a test
enclosure and pumping it full of irritant smoke. The users were
apparently not warned to close their eyes during the fit test. The use
of a test enclosure is expressly prohibited in the OSHA protocol, as is
exposing test subjects to more than the minimum amount of smoke
necessary to elicit a response. And test subjects must be instructed to
close their eyes during testing. The test subject in the second
incident who suffered damage to her vocal cords was also tested inside
a test enclosure; in addition, she failed four consecutive fit tests
involving this agent. Repeated testing of a subject who fails the test
not once, but four consecutive times, inside a test enclosure filled
with irritant smoke is prohibited by the OSHA protocol. Following the
OSHA-accepted protocol would have reduced to substantially lower levels
the exposures received by these employees.
[[Page 1232]]
In approving this fit test protocol, OSHA is not discounting the
evidence that irritant smoke can cause adverse reactions in test
subjects. All of the cases OSHA is aware of, however, involve tests
that were not done in a way that OSHA considers acceptable, and
consequently exposed the test subjects to excessive concentrations of
irritant smoke. OSHA emphasizes the critical importance of following
its approved protocol, including all of the safeguards against
excessive exposure, when this test is used. Indeed, paragraph (f)(5)
requires that employers follow these protocols and failure to do so
constitutes a violation of the standard.
Participants also made a number of suggestions about specific
aspects of the protocol. The proposed irritant smoke protocol, which
was derived from protocols promulgated in other standards (29 CFR
1910.1025 and subsequent health standards), required the use of a low-
flow air pump set to deliver 200 milliliters of irritant smoke per
minute. Several participants commented that an aspirator bulb should be
acceptable for generating an irritant smoke test agent, and that
further justification was needed for requiring a low-flow air pump
(Exs. 54-38, 54-86, 54-135, 54-309, 54-316, 54-324, 54-363, 54-424).
The Coastal Corporation (Ex. 54-272) said that requiring only the low-
flow air pump would impose an unnecessary financial burden, and
recommended that OSHA allow for alternative methods, such as an orifice
adapter on a compressed air system, for delivering a uniform stream of
irritant smoke. The ISEA (Ex. 54-363) stated that its members were not
aware of a commercially available low-flow air pump, and also
recommended that an aspirator bulb, which it said was now used by many
fit test operators, be allowed instead.
In response to these comments, the requirement that only a low-flow
pump may be used to generate the irritant smoke has been changed in the
final standard. In addition to the low-flow pump, an aspirator squeeze
bulb may be used to generate the irritant smoke for fit testing.
However, care must be taken by the fit test operator to ensure that the
aspirator bulb produces irritant smoke at the required flow rate of 200
ml/minute. Since aspirator bulbs vary in size, the person performing
the fit test must know the volume of the aspirator bulb being used to
push air through the smoke tube. The number of bulb squeezes per minute
will vary depending on bulb volume. For example, a large 50 ml bulb
would need four squeezes per minute to produce the required volume of
irritant smoke, while a smaller 25 ml bulb would need eight squeezes
per minute. The squeezes should be uniform, and evenly spaced out
through each minute to maintain a relatively constant flow of irritant
smoke. The use of an aspirator bulb to deliver the test agent at a
stable, constant rate requires some skill on the part of the test
operator, since each squeeze can be different, and care must be taken
by the fit test operator to produce a steady stream of irritant smoke.
An aspirator bulb can produce a large amount of irritant smoke during a
single squeeze. However, the squeeze bulb method when properly
performed can be an effective fit test for determining facepiece fit.
Willson Safety Products (Exs. 54-86) submitted a March 4, 1991 letter
of interpretation it had received from Thomas Shepich of the OSHA
Directorate of Technical Support regarding the use of a squeeze bulb
for performing the irritant smoke QLFT under the asbestos, lead,
benzene and formaldehyde standards. Mr. Shepich stated:
In your letter you indicated that a majority of your customers
use a 50 ml rubber squeeze bulb that is capable of delivering a flow
of 200 ml of air per minute if used correctly. You also express
concern over the need to spend $500.00 or more to use a mechanical
pump since the rubber squeeze bulb can adequately meet the intent of
the OSHA standard.
The QLFT method is a pass/fail test. Since a rubber squeeze bulb
generated challenge agent can be as effective as a mechanically
aspirated one, the intent of the standards has been met. The
training of individuals administering QLFT by the rubber squeeze
bulb method must include techniques on the proper number of
compressions per minute necessary to generate an appropriate air
flow.
A few other modifications to the protocol have also been made. As
the ISEA (Ex. 54-363) recommended, the term ``irritating properties''
has been substituted for ``characteristic odor'' in the irritant smoke
protocol in Appendix A, since the term better describes what the
employee experiences. Based on ORC recommendations (Ex. 54-424), the
reference to the MSA smoke tube has been removed, and language has been
added requiring that the end of the smoke tube be covered with a short
length of tubing to prevent injury from any jagged glass where the tube
has been opened. As the AIHA (Ex. 54-298) recommended, the description
``involuntary cough'' has been added to the description of the response
to irritant smoke. A clear statement that no form of test enclosure or
hood is to be used with irritant smoke has been added, as supported by
ORC (Ex. 54-424), and in response to the problems described by NIOSH
and TSI (Exs. 54-303; 54-437R).
Quantitative Fit Test (QNFT)
Appendix A includes three quantitative fit test protocols, the
generated aerosol protocol, the Portacount TM protocol that
uses ambient aerosol as the test agent and a condensation nuclei
counter (CNC) as the test instrumentation, and the controlled negative
pressure (CNP) protocol (i.e., the Dynatech FitTester 3000
TM). Only the generated aerosol protocol was included in the
proposal. Each QNFT method is described in a separate section of
Appendix A.
Part I of section C contains general requirements for QNFT. The
employer is to ensure that the individuals who perform the QNFT,
whether employees or contractors, are able to calibrate equipment and
perform tests properly, recognize invalid tests, calculate fit factors
properly and ensure that test equipment is in proper working order. The
employer is also responsible for ensuring that the QNFT equipment is
cleaned, maintained, and calibrated according to the manufacturer's
instructions so that it will operate as designed.
Respirators used for QNFT must be in proper working condition.
Respirators are to be rejected if leakage is detected from exhalation
valves that fail to reseat adequately, near the probe or hose
connections, or if the respirator is missing gaskets. The requirement
in paragraphs (h)(1)(iv) and (h)(3)(i)(A) that all respirators used in
non-emergency situations be inspected for defects before each use and
cleaned after each use also apply to fit testing. The test operator
must inspect the test respirator for: cracking, holes, or tears in the
rubber body of the facepiece; cracks or tears in valve material and in
the inhalation and exhalation valve assemblies; foreign material
between the valve and valve seats; proper installation of the valve
body in the facepiece; and warped or wrinkled valves. Respirators with
any of these defects cannot be used for fit testing.
A user seal check must be conducted prior to starting QNFT to
ensure that the respirator facepiece is properly adjusted. The use of
an abbreviated, or screening, QLFT before QNFT fit testing to identify
poorly fitting respirators is optional.
Paragraph 2--Generated Aerosol QNFT
The procedures for conducting the generated aerosol quantitative
fit test are widely recognized and accepted by the industrial hygiene
community. The test is performed inside a test unit such as
[[Page 1233]]
a hood, portable booth, or chamber. An aerosol of a test agent is
generated inside the enclosure. A stable ambient test agent
concentration must be achieved prior to beginning the test exercise
regimen. The test unit must be large enough to permit the employee
being tested to freely perform the QNFT exercise regimen without
disturbing the test agent concentration, and the unit must effectively
contain the test agent in a uniform concentration.
During the test, the respirators are fitted with filters, such as
high efficiency HEPA, or P100 filters, that offer 99.97% efficiency
against 0.3 micron aerosols as defined by NIOSH in 30 CFR part 11 or 42
CFR part 84. Therefore, virtually any measurable leakage should be the
result of leaks between the respirator sealing surface and the
respirator user's face. If test agents other than particulates are
used, the sorbent/filters must offer a similar degree of collection
efficiency against the test agent. The concentration of the test agent
is measured both inside and outside the respirator. Commonly used
detection methods include forward light-scattering photometry or flame
photometry.
Three methods were proposed for using the results of these
measurements to calculate fit factors: the average peak penetration
method; the maximum peak penetration method; and the use of an
integrator to calculate the area under the individual peak for each
exercise (59 FR 58919). OSHA proposed that the fit factor derived from
QNFT using test agents be calculated by dividing the average test agent
concentration inside the chamber (i.e., the ambient concentration) by
the average test agent concentration inside the respirator for each
test exercise (excluding the grimace exercise). The average ambient
concentration is derived from the measurement of the test agent
concentration in the test chamber (i.e., outside the respirator) at the
beginning and end of the test. TSI, Inc. (Ex. 54-8) stated that while
the language proposed for determining the average test chamber
concentration was correct, better accuracy could be obtained by
averaging the chamber concentration before and after each exercise, and
by allowing for continuous chamber concentration measurements. OSHA
agrees that the standard should allow for these other methods of
measuring average test chamber concentration, and has adopted the
revised language submitted by TSI.
In the proposal, the average test agent concentration inside the
respirator was to be determined from the aerosol penetration during
each test exercise using one of three approved methods for calculating
the overall fit factor. TSI, Inc. (Ex. 54-8) noted that the intuitive,
but algebraically incorrect, method of computing the arithmetic average
of the fit factors for all exercises (i.e., for instruments that report
their exercise results as fit factors instead of peak penetrations)
would result in an overestimation of the overall fit factor. This
commenter suggested that OSHA adopt the equation from the draft ANSI
Z88.10 fit testing standard that correctly states how to perform the
fit factor calculation for instruments that report results as exercise
fit factors instead of peak penetration values. OSHA agrees and has
added this equation to Appendix A in the final standard.
The test aerosol penetration measured for the grimace exercise is
not to be used in calculating the average test agent concentration
inside the respirator (See provision I.C.2(b)(8)(i)). The purpose of
the grimace exercise is to determine whether the respirator being fit
tested will reseat itself on the face after the respirator seal is
stressed during the exercise. With a properly fitting respirator, the
test instrumentation should record a rise in test agent concentration
inside the mask during the grimace exercise, and a drop in test agent
concentration when the respirator reseats itself. If the respirator
fails to reseat itself following the grimace exercise, the subsequent
normal breathing exercise will show excessive leakage into the mask and
result in a failed fit test. Since even a properly fitting respirator
may show increased test agent penetration during part of the grimace
exercise, the penetration value measured during the grimace exercise is
not to be used in calculating the overall fit factor.
A clear association is required between an event taking place
during testing and the record of the event. This requirement is
critical for the proper calculation of aerosol penetration for specific
test exercises. Short duration leaks (displayed as peaks on the
recording instrument) can occur during, and as a result of, each fit
test exercise, and these leaks indicate poor respirator fit. These
penetration peaks are used to determine the fit factor. An inability to
measure these penetration peaks could result in the fit factor being
overestimated, since averaging all the test exercise penetration peaks
may obscure the high penetration levels that occur during a test
exercise. An inability to clearly associate the exercise event with the
recording makes correct calculation of the fit factor impossible.
Several factors can affect the time interval between an exercise
event occurring during QNFT and the recording of the event, such as the
diameter of the sampling line, sampling rate, and the length of the
sampling line. Response time will increase with an increase in the
length and/or diameter of the sampling line. Therefore, the length and
inside diameter of the sampling line should be as small as possible.
The line used for sampling the test chamber test agent concentration,
and the line used for testing the test agent concentration inside the
respirator, must have the same length and inside diameter so that
aerosol loss caused by aerosol deposition in each sample line is
equivalent for the two lines.
To minimize both contamination of the general room atmosphere and
test operator exposure to the test agent, the generated aerosol
protocol requires that air exhausted from the test unit must pass
through a high-efficiency filter (or sorbent).
Since the relative humidity in the test chamber may affect the
particle size of sodium chloride aerosols, the protocol further
requires that the relative humidity of the test unit be kept below 50
percent. This requirement is consistent with manufacturer's
instructions for sodium chloride units.
Prior to beginning the generated aerosol QNFT, a stable test agent
concentration must be achieved inside the test unit. The concentration
inside small test booths or waist-length hoods may be diluted
significantly when the employee enters the booth. Normally, the test
agent concentration will stabilize within two to five minutes.
Adjustments to the respirator must not be made during the QNFT. Any
facepiece fit adjustments must be made by the employee before starting
the exercise regimen. This requirement will prevent manipulation of the
respirator during fit testing to achieve higher fit factors. The fit
test is to be terminated whenever any single peak penetration exceeds
two percent for half masks and quarter facepiece respirators, and one
percent for full facepiece respirators. Such leaks correspond to fit
factors below 100 for half masks and 500 for full facepiece
respirators, and indicate an unacceptable respirator fit. In such
cases, the respirator may be refitted or adjusted, and the employee
retested. If a subsequent QNFT test performed after the respirator has
been refitted or adjusted is terminated because of excessive
penetration, then the respirator fit for that individual must be
considered unacceptable, and a different respirator must be selected
and tested.
OSHA had proposed that an employee successfully complete three
separate fit
[[Page 1234]]
tests with the same respirator using a QNFT protocol. The proposed
requirement was derived from the fit testing protocols in OSHA's
substance-specific standards, e.g., the Benzene standard (29 CFR
1910.1028). This proposed provision received more than 150 comments.
Many commenters stated that only a single QNFT was needed, and that the
additional tests would only increase the cost of fit testing without a
corresponding improvement in attaining a successful fit (Exs. 54-11,
54-26, 54-35, 54-37, 54-41, 54-44, 54-63, 54-83, 54-114, 54-124, 54-
139, 54-208, 54-289, 54-316, 54-359, 54-363). Some said that requiring
three tests for QNFT would discourage employers from adopting QNFT (Ex.
54-164), or would force employers to use the less protective QLFT,
which requires only one fit test (Exs. 54-316, 54-359, 54-363, 54-434).
One commenter stated that three fit tests for QNFT would only be needed
if OSHA allows higher APFs based on the results (Ex. 54-84). (OSHA
notes that the concept of increasing the APF based on repeated fit
testing, originally contained in the ANSI Z88.2-1980 respirator
standard, was subsequently removed from the Z88.2-1992 revision of that
standard (Ex. 54-443)). The Bath Iron Works (Ex. 54-340) stated that
the variation between separate fit tests is significant, and
recommended that this problem could be resolved by increasing the
safety factor beyond 10. Other commenters suggested that increasing the
fit factor required for passing a single QNFT was an alternative to
requiring three fit tests (Exs. 54-139, 54-154, 54-173, 54-340).
The final standard does not include the requirement to perform
three successful QNFTs because performing three tests has not been
shown in this record to better detect poor respirator fit. Increasing
the safety factor of 10, thereby raising the minimum fit factor
required to pass a QNFT, also has not been adopted by OSHA because
experience indicates a safety factor of ten is sufficient. While many
employers have, on their own, decided to require higher fit factors
during fit testing, data in the record do not support the suggestion
that increasing the safety factor beyond 10 is appropriate. Using a
safety factor of 10 is current practice in fit testing, and is used to
account for the variability in fit testing procedures, as well as other
variables (e.g., differences in respirator fit between the workplace
and during fit testing).
The results of the fit test must be at or above the minimum fit
factor required for that class of tight-fitting air-purifying
respirator. The required fit factors are established by applying a
safety factor of 10 to the APFs for that class of respirator. For
example, quarter and half mask air-purifying respirators with an APF of
10 must achieve at least a fit factor of 100, and full facepiece air-
purifying respirators with an APF of 50 require a minimum fit factor of
500.
Paragraph 3--Condensation Nuclei Counter (CNC) QNFT
A protocol for the ambient aerosol condensation nuclei counter
(CNC) quantitative fit testing protocol (i.e., TSI, Inc. Portacount
TM) has been added to the final standard as an accepted QNFT
method. Many commenters pointed to the need for a CNC QNFT protocol.
Commenters, (Exs. 54-216, 54-326, 54-359) noted that the Portacount is
the most commonly used method, and that sufficient data have been
developed over the past several years to validate its effectiveness.
The use of the Portacount has been allowed by OSHA under a compliance
interpretation published in 1988. Commenters urged that the ambient
aerosol CNC method be included in the list of accepted QNFT methods in
the final standard (Exs. 54-216, 54-326, 54-359). OSHA agrees with
these comments. The written instructions for performing the fit test in
Appendix A are essentially the same as the instructions provided by the
manufacturer.
Paragraph 4--Controlled Negative Pressure (CNP) QNFT
The protocol for the controlled negative pressure (CNP)
quantitative fit test method (Dynatech Nevada FitTester 3000
TM) has also been added to the list of accepted QNFT
methods. This fit test method involves the use of a fit test instrument
to generate a controlled negative pressure inside the facepiece of the
respirator to measure the resulting leak rate.
This fit test protocol is the same protocol allowed by OSHA under a
compliance interpretation letter issued in 1994 and based on various
studies on the performance of the CNP method conducted by its
developer, Dr. Cliff Crutchfield (Exs. 71, 54-436). These studies
reported results that were validated by comparing them to results from
the existing aerosol fit test systems. The data showed that the fit
factors measured with CNP are always lower than the fit factors
measured with an aerosol QNFT. OSHA had reviewed these studies before
issuing its compliance letter. OSHA believes that the CNP method, based
on Dr. Crutchfield's validation data, constitutes adequate support for
the method's reliability in rejecting bad fits. Although no body of
data is available that describes employer experience using the CNP
method in the workplace, OSHA is confident that the extensive
validation data showing consistently conservative results using CNP
means that this method will identify bad fits at least at the same rate
as other accepted fit test protocols.
Several commenters urged OSHA to provide a protocol for the CNP
method and to list it as approved (See, e.g., Exs. 54-167, 54-216). In
addition, NIOSH in its comments and testimony stated that ``NIOSH
recommends that OSHA recognize * * * the following fit test procedures
as acceptable * * * Quantitative fit tests using controlled negative
pressure and appropriate instrumentation to measure the volumetric leak
rate of a facepiece to quantify the respirator fit'' (Tr. 359, Ex. 54-
437). NIOSH further stated in its comment (Ex. 54-437) that ``[o]nly
the controlled negative pressure fit test system, which has been
excluded in the OSHA proposal, has been subjected to limited
validation'' (Decker and Crutchfield, 1993). The State of Washington
Department of Labor and Industries (Ex. 54-173) requested that OSHA
provide performance criteria so that methods such as ``Dynatech test
equipment'' described as ``proven'' and ``accepted'' may more easily be
used.
Penelec/Genco reported favorable experience using the CNP method
(Ex. 54-167). As stated in its comment:
Penelec/Genco recently quantitatively fit tested approximately
1500 employees on both half and full face respirator facepieces
using the Dynatech/Nevada FitTester 3000. For the past 10 years we
have performed fit tests using particle counting equipment. We are
most pleased with the results provided by the FitTester 3000 * * *
We believe that the science is sound, the equipment is reliable, and
the results are valid. When used as part of a complete respiratory
protection program, we believe controlled negative pressure fit
testing is an effective way of matching each person with the best-
fitting, most comfortable facepiece respirator.
All the peer-reviewed studies consistently show that controlled
negative pressure equipment and protocols always produce more
conservative fit test results than particle counting equipment and
protocols. Our experience totally supports this.
We find the Dynatech/Nevada FitTester 3000 to be durable,
reliable and easy to use. Results are always reproducible, with
minimum variation. Employee acceptance is excellent, especially
because they get a direct perception of fit (leaks or lack of) which
corresponds well to the machine's fit results.
Using the FitTester 3000 we are able to select more comfortable,
better fitting respirators for our employees. We believe that
certain respirator brands are far superior to others in terms of fit
and comfort. As a result, we have switched brands. Our
[[Page 1235]]
employees are far more satisfied with the fit and comfort of their
new respirators * * * (Ex. 54-167)
TSI, Inc. (Exs. 54-229, 54-302) stated that OSHA should reject the
CNP method as a valid QNFT, since employees who are tested using this
method must hold their breath and remain motionless during the
measurement, i.e., they cannot perform the required exercises
simultaneously with the measurement. According to TSI (Ex. 171),
dynamic exercises are necessary to simulate the face seal stresses
imposed by workplace conditions. Dr. Crutchfield, in his post-hearing
submission (Ex. 134), responded to statements made by Jeff Weed of TSI
at the hearing and in TSI's submissions to the record regarding the CNP
fit test method. He discussed the ability of aerosol-based fit test
methods to measure transient leaks, stated that leakage occurs with
inhalation, and that the CNP method measured more respirator leakage
than aerosol-based systems, and further, that CNP fit factors ``tend to
align more closely with workplace protection factors than do aerosol-
based fit factors.'' Dr. Crutchfield stressed the importance of being
able to effectively measure fundamental leakage into the respirator,
stating that ``most dynamic exercises do not seem to have a
statistically significant effect on measured fit factors.''
OSHA recognizes the need to perform fit testing exercises to stress
the facepiece seal, and has included a full range of exercises in the
CNP protocol in Appendix A. They differ from the exercises for the CNC
method, since test results are not taken while the test exercise is
being performed, but are taken after the exercise is completed.
However, since the CNP method cannot distinguish changes in facepiece
volume that are related to movement during an exercise from leakage
into the facepiece caused by poor respirator fit, the CNP protocol
requires that the employee remain motionless during the short sampling
period that is required after each exercise. OSHA believes that any
changes in fundamental fit caused by the test exercises should,
consequently, be measured by the CNP method during the 10-second
sampling period following each exercise, and that this does not affect
the test's ability to detect poor fits when the seal is stressed.
In addition to the OSHA-accepted CNP fit test protocol, Dr.
Crutchfield (Tr. 254) testified about a new fit test protocol for the
CNP method. This new protocol is substantially different from the OSHA-
accepted protocol, which requires the performance of test exercises
followed by CNP measurements. The new protocol was also described in
detail in a letter from Senator John McCain of Arizona on behalf of Dr.
Crutchfield (Ex. 54-460). The new protocol submitted after the close of
the post-hearing comment period is described as consisting of three
exercises and two redonnings. The first exercise measured ``fundamental
respirator fit'' with the head facing forward. The second exercise was
a bending exercise, with the respirator parallel to the floor. The
third exercise consisted of vigorously shaking the head from side-to-
side for three seconds, followed by a ``fundamental fit'' measurement.
The respirator user then is required to remove and redon the respirator
twice, with ``fundamental fit'' measured after each redonning. This
protocol results in five CNP measurements, from which a harmonic mean
fit factor is calculated and used to make a pass-fail determination for
the fit test.
The information on the new protocol was not submitted to the
rulemaking docket in time to allow an opportunity for public comment.
OSHA, therefore, cannot include it in this final standard. Appendix A,
Part II establishes procedures by which OSHA will approve new fit
testing protocols after allowing opportunity for public comment. A
proponent of the revised CNP fit test protocol may submit it for
approval in accordance with Appendix A, Part II.
Proposed part (II)(A)(12) of Appendix A required that the employer
maintain a record of the qualitative or quantitative fit test
administered to an employee. This requirement has been moved to
paragraph (m)(2) in the final standard to consolidate the standard's
recordkeeping requirements. The fit test record must include the date
and type of fit test performed, employee information, and type of
respirator. When a QNFT is administered, a record of the test (e.g.,
strip charts, computer integration) must be retained. The fit test
records are to be maintained until the next fit test is administered. A
record is necessary for OSHA to determine compliance by verifying that:
the employee has been fit tested, both prior to starting respirator use
and at least annually thereafter; the tested employee passed the
qualitative fit test or achieved a sufficiently high fit factor to pass
the quantitative fit test for the required assigned protection factor;
the quantitative fit test was correctly performed, and the fit factor
calculated properly; and the model and size of the respirator used
during fit testing are the same as the model and size of the respirator
used by the employee in the workplace.
New Fit Test Protocols
Paragraph (f)(3) of the proposed rule stated that OSHA would
evaluate new fit test protocols under criteria specified in Section I
of Appendix A and would initiate rulemaking under section 6(b)(7) of
the OSH Act if the proponent of a new fit test method submitted the
method and validation testing data to OSHA for evaluation. The section
listed detailed criteria OSHA would apply in determining whether to
approve the new protocol.
Some commenters recommended alternative approaches for approving
new fit test protocols. Mobil Oil (54-234) and the American Petroleum
Institute (Ex. 54-330) suggested that NIOSH should be the reviewer of
alternative fit test methods. Exxon (Ex. 54-266) questioned the role
OSHA would have in the approval of new fit test protocols, stating that
NIOSH or other agencies or laboratories could better review new fit
test methods. The American Association of Occupational Health Nurses
(Ex. 54-213) supported the use of other new fit test methods, provided
that they have been demonstrated to be statistically equivalent to the
existing OSHA-accepted methods, but stated that the administrative
rulemaking procedure OSHA had proposed would result in delays and
paperwork that would discourage the development of new methods. The
Composites Fabricators Association (Ex. 54-295) also stated that
subjecting new fit test methods to rulemaking would discourage an
employer from developing or adopting any fit test method not already
approved by OSHA. The Society of the Plastics Industry (Ex. 54-310)
stated that rulemaking on new methods was unnecessary, and that OSHA
should publish criteria for fit tests and allow employers to adopt new
methods without cumbersome rulemaking. The National Association of
Manufacturers (Ex. 54-313) proposed that publication of a new fit test
method in a peer-reviewed journal should be prima facie evidence that
the method had been validated.
OSHA cannot accept the suggestion by some commenters that it should
accept new fit test protocols without following the OSH Act's
rulemaking procedures. Appendix A was adopted under the OSH Act's
rulemaking procedures and, under section 6(b) of the Act, can only be
modified through the same rulemaking procedures. Modifications to
Appendix A to add new fit test protocols would therefore
[[Page 1236]]
have to undergo the same type of rulemaking scrutiny, including the
opportunity for public comment, that the approved protocols have
received.
In response to comments received, OSHA has modified Appendix A from
the version contained in the proposal. These changes streamline the
process of approving new fit test protocols by assuring that any new
method proposed is supported by data of high quality. As modified,
Appendix A also takes a more performance-oriented approach to the
approval process than did the proposal. Rather than listing the
detailed criteria a new fit test protocol must satisfy, final Appendix
A requires that a proposed new protocol be supported either by test
results obtained by an independent government research laboratory or by
publication in a peer-reviewed industrial hygiene journal.
Both of these options will assure that any new fit test protocol
proposed will have a sound scientific basis before being submitted to
OSHA. Government research laboratories such as Los Alamos National
Laboratory and Lawrence Livermore National Laboratory have considerable
expertise in reviewing new fit test protocols to determine whether they
are safe, accurate, and statistically valid. A favorable recommendation
by such a laboratory, along with the supporting data gathered by the
laboratory, will provide a solid basis on which OSHA can base its
evaluation. Moreover, because the laboratory's report and
recommendation will be in the public record when the OSHA rulemaking
proceeding begins, the public will have the opportunity to examine the
data supporting the proposed new method and to provide any additional
data either in support of or in opposition to the proposed method.
An application for a new test protocol that has been published in a
peer-reviewed industrial hygiene journal will similarly provide a sound
basis for rulemaking on the new method. Like review by a national
research laboratory, the peer-review process assures that the data
supporting the method has been scrutinized and found acceptable by a
neutral party with expertise in evaluating fit test methods. The
published article would be available to the public when the rulemaking
commences, and interested members of the public would therefore be
apprised of all relevant aspects of the proposed method and would be
well-positioned to comment on the method.
OSHA believes that the final rule's approach will streamline the
process of accepting new fit test protocols and avoid discouraging the
development of new methods. A rulemaking on a new protocol would thus
only begin after the protocol's proponent has established a solid basis
for seeking the Agency's approval. At the time the rulemaking begins,
interested members of the public would know the scientific basis on
which approval is sought and would be able to afford OSHA the benefit
of their views. The rulemaking process should therefore be able to
proceed more quickly than if OSHA were to evaluate data that had not
previously been scrutinized by an expert body and were to base the
approval process on the detailed criteria contained in Appendix A of
the proposed rule. And because the rulemaking process can be expected
to proceed expeditiously once a qualifying application has been
submitted, parties interested in developing new protocols should not be
discouraged from doing so.
New fit test methods are to undergo notice and comment rulemaking.
This decision reflects OSHA's long experience in evaluating fit test
methods, which includes, in this rulemaking, such fit test methods as
the ``condensation nuclei counter'' (CNC) method and the ``controlled
negative pressure'' (CNP) method and, in past rulemakings, the
``saccharin QLFT'' method and the ``isoamyl acetate QLFT'' method. In
the past 20 years there have only been a few new methods, but each has
required the evaluation of supporting data, and each new method has
generated wide public interest and comment. New fit test methods,
particularly those that involve new scientific principles and new
techniques for evaluating respirator performance, require full
consideration and public discussion of the issues by the regulated
community, competitive interests, respirator experts, and labor groups.
The notice and comment rulemaking process will ensure that OSHA
receives the necessary public input, as well as data required for open
evaluation, and that all interested parties have a chance to comment
publicly on any new method. Publishing a new fit test method in the
Federal Register should: elicit public comment and debate over the
merits of the method; notify the regulated community of the possible
availability of a new method; and solicit any additional information
that would be relevant for consideration before OSHA makes its final
decision. OSHA does not intend the rulemaking process to be cumbersome
or involved, but such a process will ensure that all information and
comments are available to the public, and that any known problems with
the new method are addressed before final acceptance.
Adopting an approach that allows for the acceptance of new fit test
methods is a fundamental change to this standard. Fit test methods
directly impact a worker's health, since fit tests are designed to
identify poorly fitting respirators. Without the careful evaluation
that a new fit test method will receive during the rulemaking process,
OSHA cannot be sure that a flawed fit test method would not be
developed and marketed to respirator users. If used to select
respirators, a flawed method would lead to unnecessary worker exposure
to hazardous substances, since poorly fitting respirators would not be
detected by the method. Determining the reliability of new fit test
methods requires more evaluation, for example, than do new respirator
cleaning methods or new user seal check methods, which can be developed
by the respirator manufacturer (See Appendix B). New cleaning methods
and user seal checks need not undergo rulemaking to become accepted
methods. The more rigorous evaluation through notice and comment is
required only for new fit testing methods, where OSHA experience has
shown the need for a public review of performance.
Moldex (Ex. 54-153) Mobil Oil (Ex. 54-234), Exxon (Ex. 54-266), and
the American Petroleum Institute (Ex. 54-330), recommended that OSHA
allow interested parties other than employers to submit new fit test
methods for OSHA acceptance. In the past, OSHA has allowed other
interested parties, such as the developers of new fit test equipment,
to submit new test protocols and methods for OSHA approval, and will
continue to do so. To make this explicit, the final rule states that a
proposed new protocol may be submitted by any person.
Paragraph (g)--Use of Respirators
The final rule requires employers to establish and implement
procedures for the proper use of respirators. Paragraph (g)(1) contains
specific requirements for ensuring an adequate facepiece seal each time
a respirator is used. Paragraph (g)(2) requires employers to reevaluate
respirator effectiveness when there are changes in environmental or
user conditions, as well as requiring that employees leave the
respirator use area if they detect any signs that respirator
effectiveness has been compromised or to perform any adjustments.
Paragraphs (g)(3) and (g)(4) address procedures for the use of
respirators in IDLH atmospheres and in interior structural fire
fighting, respectively.
[[Page 1237]]
Paragraph (g) of the proposal addressed the same issues in the
context of requiring employers to develop and implement written
standard operating procedures. As suggested by a number of commenters,
OSHA has deleted the requirement for written procedures in light of the
fact that paragraph (c) already requires a written respiratory
protection program (Exs. 54-38, 54-163, 54-226, 54-428). In addition,
OSHA has moved to paragraph (d), governing respirator selection, the
proposed paragraph (g) requirement that employers ensure that SCBAs are
certified for a minimum service life of 30 minutes if they are to be
used in IDLH atmospheres, for emergency entry, or for fire fighting.
Final paragraph (g) thus contains only those requirements necessary for
the appropriate use of respirators in non-IDLH, IDLH, and interior
structural fire fighting atmospheres.
Paragraph (g)(1)--Facepiece Seal Protection
Paragraphs (g)(1)(i) and (g)(1)(ii) are intended to ensure that
facial hair, other conditions potentially interfering with the
facepiece seal or valve function, and eyewear or other personal
protective equipment does not interfere with the effective functioning
of the respirator. Paragraph (g)(1)(iii) requires employees to perform
a user seal check each time they put on a respirator for use in the
workplace.
Paragraph (g)(1)(i)(A) prohibits an employer from allowing
respirators with tight-fitting facepieces to be worn by employees who
have ``facial hair that comes between the sealing surface of the
facepiece and the face or that interferes with valve function.''
Paragraph (g)(1)(i)(B) prohibits tight-fitting facepieces to be worn by
employees who have any condition that interferes with the face-to-
facepiece seal or with valve function. The prior standard prohibited
the wearing of respirators ``when conditions prevent a good face seal.
Such conditions may be a growth of beard [or] sideburns * * *.'' The
proposed requirement would similarly have prohibited employers from
allowing tight-fitting respirator facepieces to be worn by employees
``with conditions that prevent such fits.'' ``Facial hair that
interferes with the facepiece seal'' was listed as one example of such
a condition. The final rule thus clarifies the language of the NPRM.
OSHA's final standard affords employers more flexibility than the
ANSI Z88.2-1992 standard, Section 7.5.1, which prohibits the use of any
respirator equipped with a facepiece, whether tight or loose-fitting,
if the user has facial hair that comes between the sealing surface of
the facepiece and the face. Although some commenters recommended that
OSHA adopt the language of the ANSI standard (Exs. 54-218, 54-219),
OSHA has determined that it is only necessary to apply the facial hair
prohibition to tight-fitting respirators.
The rulemaking record (Exs. 15-11, 15-26, 15-28, 15-27A, 15-30, 15-
33, 15-35, 15-36, 15-41, 15-52, 15-58, 15-62, 15-73, 15-77) also
contains strong evidence that facial hair can interfere with tight-
fitting facepiece seals. According to the study by Hyatt and Pritchard,
discussed further below, facial hair includes stubble (Ex. 23-5). A
number of studies and comments that were submitted to the record (Exs.
23-5, 36-49, 36-31, 36-45, 36-47, 54-443D, 54-408) addressed the effect
of facial hair on respirator performance. McGee and Oestenstad (Ex. 23-
2) tested eight volunteers on a closed-circuit, pressure-demand, self-
contained breathing apparatus. The volunteers were clean-shaven at the
beginning of the study. They underwent quantitative fit tests at two-
week intervals over an eight-week beard growth period. Beard growth had
a profound, negative effect on the observed fit factors. Most of the
volunteers started with fit factors of 20,000 when first fit tested;
after eight weeks, these same workers achieved fit factors ranging only
from 14 to 1067.
In another study, E.C. Hyatt, J.A. Pritchard and others (Ex. 23-5)
investigated the effect of facial hair on the performance of half-mask
and full-facepiece respirators. Quantitative fit tests were performed
on test volunteers with varying amounts of facial hair, including
stubble, sideburns, and beards. The results showed that facial hair can
have a range of effects on respirator performance, depending on factors
such as the degree to which the hair interferes with the sealing
surface of the respirator, the physical characteristics of the hair,
the type of respirator, and facial characteristics. In general, the
presence of beards and wide sideburns had a detrimental effect on the
performance of the respirators. The authors concluded that:
Individuals with excessive facial hair, including stubble
and wide sideburns, that interfere with the seal cannot expect to
obtain as high a degree of respirator performance as clean shaven
individuals.
The degree of interference depends on many factors (e.g.,
the length, texture, and density of facial hair) and the extent to
which those factors interfere with the respirator's sealing surface.
Short of testing a bearded worker for fit daily, the only
prudent approaches are to require that facial hair not interfere with
the respirator seal surface (e.g., shave where the seal touches the
face) or to prohibit the employee from working in areas requiring
respiratory protection.
Other fit testing studies also show that non-bearded workers have
significantly higher fit factors than bearded workers. Skretvedt and
Loschiavo (Ex. 23-3) tested both half-mask and full facepiece
respirators on 370 male employees who were fit tested both
qualitatively and quantitatively; 67 of the employees had full beards.
The bearded workers consistently failed qualitative fit testing.
Bearded employees using half-masks had a median fit factor of 12, while
clean-shaven employees had a median fit factor of 2950. For full
facepiece respirators, bearded workers had a median fit factor of 30
and clean-shaven employees had a fit factor of greater than 10,000.
Only one study found no significant difference in respirator
performance for employees with or without beards. Fergin (Ex. 23-1)
studied workplace protection factors, but not fit factors, for three
different types of disposable respirators used by carbon setters during
carbon setting and ore bucket filling operations. The study, which
involved a total of 75 samples collected from 38 non-bearded and 22
bearded workers, compared ambient concentrations with ``in-mask''
concentrations. Beard types were classified as light, medium, heavy,
fine, soft, coarse, and curly. Results showed no clear relationship
between type of beard and respirator protection factor. The authors
recommended that, ``* * * where acceptable protection factors can be
demonstrated for subjects with facial hair, the no-beard rule should be
waived.''
OSHA does not find this study a persuasive basis for changing its
position on facial hair. The fact that an acceptable protection factor
can be obtained for a bearded respirator wearer in a workplace
protection factor study does not mean that the worker can achieve the
same protection level each time the respirator is used. First,
protection factor studies are designed to minimize program defects and
are often conducted under very tight supervision, which is generally
not typical of conditions in real workplaces. Second, beards grow and
change daily, resulting in variability of protection from one day to
the next.
Fergin based his conclusion that respirator performance is similar
for
[[Page 1238]]
bearded and non-bearded workers on a statistical comparison of
geometric means, calculated separately for each type of respirator for
bearded and non-bearded workers. OSHA is more concerned about the wide
range of values than the geometric mean values. The protection factors
observed by Fergin varied greatly and ranged from 1-1041 (no beards)
and 4-332 (beards) for a 3M-9910 respirator; 12-36 (no beards) and 7-30
(beards) for a 3M-8706 respirator; and 5-1006 (no beards) and 42-391
(beards) for a 3M-9906 respirator. OSHA notes that the protection
factors of 5 and lower that Fergin achieved for both bearded and clean-
shaven workers are below the NIOSH recommended protection factors for
disposable respirators of the types tested by Fergin (NIOSH Respirator
Decision Logic, 1987, Ex. 9).
There are several other weaknesses in this study that undermine its
use as a counterweight to so much other evidence and expert opinion.
The study did not account for particle size or the differences between
protection factors obtained when the respirators were used in high as
compared to low ambient concentrations. Moreover, two of the three
respirators involved lacked adjustable face straps, which makes any
sort of tightening impossible. Finally, the author himself cautioned
that facial hair can significantly impair respirator seal effectiveness
in atmospheres that are highly toxic or IDLH.
In fact, most rulemaking participants (Exs. 3, 13, 15-50, 23-2, 23-
3, 23-5) agreed that facial hair can be a problem for respirator users,
although they suggested different approaches to address this issue. A
few commenters recommended that OSHA simply prohibit the use of
respirators by bearded workers, based on the ANSI rationale that beards
interfere with the functioning of all respirators (Exs. 54-443, 54-
408). In general, these commenters were opposed to any requirement in
the standard that would have required employers to provide bearded
workers with loose-fitting respirators to accommodate their beards.
Other commenters stated that OSHA should require employers to provide
loose-fitting respirators (e.g., supplied-air hoods, helmets, or suits)
for use by employees with beards (Exs. 15-14, 15-31, 15-34, 15-46, 15-
47, 15-48, 15-54, 15-55, 15-79, 15-81, 54-427, 54-387, 54-363). For
example, NIOSH recommended that, when the situation permits, employers
should be allowed to accommodate bearded workers by providing
respirators that will not be affected by facial hair (Ex. 54-437).
Daniel Shipp of the Industrial Safety Equipment Association (ISEA) also
stated that, in situations where employers do not intend to enforce
policies against facial hair, the ISEA would recommend that employers
provide respirators that do not rely on a tight facepiece fit (Ex. 54-
363).
Richard Uhlar and Michael Sprinker of the International Chemical
Workers Union (ICWU) stated that there should be some provision in the
standard to notify employees that respirators other than tight-fitting
respirators can be used by bearded workers (Ex. 54-427). This comment
is in basic agreement with NIOSH's recommendation that there should be
some provision in the standard to notify employees that other
respirators that can be worn with beards exist (Ex. 54-437).
In contrast, other commenters (Exs. 54-408, 54-443) recommended
that OSHA prohibit the wearing of beards by employees who use
respirators on the grounds that employers should not have to supply
loose-fitting respirators because an employee is unwilling to shave off
his beard. More specifically, George Thomas of Duquesne Light Company
(Ex. 54-408) stated that his company does not support a requirement
that employers should provide workers with loose-fitting respirators
when employees have facial hair. According to Mike Rush of the
Association of American Railroads, requiring employers to provide
respirators other than tight-fitting air-purifying respirators would be
cost-prohibitive, because PAPRs cost 50 times as much as half masks
(Ex. 54-286). A. Gayle Jordan of Norfolk Southern Corporation quoted
the cost of a PAPR as $700 (Ex. 54-267).
This standard does not interfere directly with employer policies
regarding facial hair. Instead, it requires employers to take the
presence or absence of facial hair into consideration in developing
policies for a given workplace; different policies may affect the range
of choices available. However, OSHA notes that several respiratory
protection alternatives, such as loose-fitting hoods or helmets, are
available to accommodate facial hair.
Some commenters focused on the specific language in the proposal.
One commenter said that the term ``any hair growth'' should be
substituted for ``facial hair'' (Ex. 54-69). Another urged OSHA to
specify what acceptable facial hair growth was (Ex. 54-138). OSHA
believes that the term ``facial hair'' is appropriate because the
record shows that any facial hair, including beard stubble, can
interfere with facepiece seal (Exs. 23-5, 54-69). By prohibiting hair
that ``comes between the sealing surface of the facepiece and the
face,'' as well as hair that ``interferes with valve function,'' OSHA
believes it is being as precise as possible. OSHA believes that the
second phrase is necessary because employees with large beards may
shave the skin area where the facepiece of the respirator seals to the
face but the fullness or length of the beard could still block the
valve or cause the valve to malfunction.
In a standard that will apply as broadly as this one will, it is
not possible for OSHA to specify every condition under which respirator
use may be affected by an employee's facial hair. Workplace situations
are variable, as is hair growth. OSHA has instead written the standard
in performance-oriented terms, stressing the importance of the face-to-
facepiece seal and conditions that might interfere with that seal. The
thrust of the entire standard is on making sure that the fit and the
performance of the respirator are not compromised. Employers,
therefore, must ensure that respirators fit and perform properly.
Paragraph (g)(1)(i)(B) prohibits an employer from allowing
respirators with tight-fitting facepieces to be worn by employees who
have any condition that interferes with the face-to-facepiece seal or
valve function. Examples of these conditions include, but are not
limited to, missing dentures, the presence of facial scars, the wearing
of jewelry, or the use of headgear that projects under the facepiece
seal. As with the facial hair requirements, the intent of this
provision is to prevent an employee from wearing a respirator if there
is any factor that could prevent an adequate facepiece-to-face seal.
Therefore, conditions such as missing dentures or facial scars will not
prevent an employee from using a respirator where it can be
demonstrated that those conditions do not prevent an adequate seal.
Paragraph (g)(1)(ii) requires employers to ensure that corrective
glasses or goggles or other personal protective equipment is worn in a
manner that does not interfere with the seal of the facepiece to the
face of the user. The proposal contained a similar provision that
addressed only eyewear. The prior standard contained a similar
provision, but also prohibited the use of contact lenses with
respirators. Final paragraph (g)(1)(ii) is consistent with the 1992
ANSI standard, which allows the use of corrective lenses, spectacles,
and face protection devices, providing that these items do not
interfere with the seal of the respirator; ANSI also allows the use of
contact lenses where the wearer has successfully worn such lenses
before
[[Page 1239]]
and practices wearing them with the respirator.
Most comments supported the proposed provision (Exs. 54-68, 54-266,
54-286, 54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219,
54-222, 54-346, 54-402, 54-408, 54-267, 54-286, 54-361, 54-232, 54-234,
54-244, 54-245, 54-263, 54-265). Some commenters, however, addressed
specific pieces of corrective eyewear. For example, Barbara Price of
the Phillips Petroleum Company recommended, based on the company's
experience with successful quantitative fit testing of employees while
wearing sports goggles, that prescription sports goggles be permitted
with full facepiece respirators (Ex. 54-165). Darrell Mattheis of the
Organization Resources Counselors (ORC) also supported the use of
prescription sports goggles, such as the mask-adaptable goggles (MAG-1)
by Criss Optical, with a full facepiece respirator, based on ORC
companies' successful quantitative fit testing experience (Ex. 54-424).
Again, the standard is written in performance terms so that any
particular piece of equipment may be used as long as it does not
interfere with the facepiece seal. This has consistently been OSHA's
position under the prior standard as well. For example, in a compliance
interpretation letter dated April 7, 1987, OSHA addressed the use of
eyeglass inserts or spectacle kits inside full facepiece respirators.
OSHA stated that eyeglass inserts or spectacle kits are acceptable if
the devices: (1) Do not interfere with the facepiece seal; (2) do not
cause any distortion of vision; and (3) do not cause any physical harm
to the wearer during use (Ex. 64-519).
OSHA again addressed the appropriateness of using the MAG-1 goggles
with full facepiece respirators and SCBAs in a September 20, 1995,
letter to the Excelsior Fire Department. By 1995, OSHA had the benefit
of four quantitative fit testing studies of MAG-1 goggles, two funded
by the goggle manufacturer and the other two funded by OSHA itself. The
letter to Excelsior stated that since the MAG-1 straps project under
the facepiece, use of the MAG-1 could in some cases violate paragraph
(e)(5)(i) of the previous standard. The letter concluded that obtaining
a fit with these goggles is quite complex because the respirator user
may be able in some cases to control the factors determining whether a
seal can be obtained. (For a full discussion, see letter, 9/20/95, Ex.
64-520, Docket H-049a.) In a post hearing comment submitted by the
Exxon Company, Steve Killiany commented about Criss Optical Mag
Spectacles with thin rubber straps (Ex. 183). Mr. Killiany stated that
the spectacles can safely be worn with full facepiece respirators as
long as users are fit tested with the spectacles in place during fit
tests. In its program, Exxon prohibits eyeglasses with temple pieces
for users of full facepiece respirators. Exxon also prohibits hard
contact lenses, but users are allowed to wear soft contact lenses.
The NPRM contained a lengthy explanation of OSHA's proposal not to
include a prohibition against the use of contact lenses with
respirators in the final rule (59 FR 58921, 11/15/94). Although a few
participants requested that OSHA retain the prohibition, or at least
prohibit contact lenses in certain situations (Exs. 54-334, 54-387, 54-
437), most of the commenters agreed with OSHA's conclusion that contact
lenses can be used safely with respirators (Exs. 54-68, 54-266, 54-286,
54-150, 54-155, 54-177, 54-189, 54-196, 54-209, 54-214, 54-219, 54-222,
54-232, 54-234, 54-244, 54-245, 54-263, 54-265, 54-346, 54-402, 54-408,
54-267, 54-286, 54-361). For example, NIOSH specifically recommended
that OSHA allow respirator users to wear contact lenses (Ex. 54-437).
Larry DeCook, President of the American Optometric Association, stated
that the Association was not aware of any reports of injury because of
the use of contact lenses with respirators (Ex. 54-235). Similarly, a
study by the Lawrence Livermore National Laboratory showed that far
fewer firefighters who wore contact lenses with their SCBAs had
problems that necessitated the removal of their facepieces than did
firefighters wearing glasses (Ex. 38-9). Finally, OSHA's review of the
record identified no evidence that the use of contact lenses with
respirators increases safety hazards.
OSHA notes that employers of employees who wear corrective eyewear
must be sure that the respirator selected does not interfere with the
eyewear, make it uncomfortable, or force the employee to remove the
eyewear altogether. Employers should use the respirator selection
process to make accommodations to ensure that their respirator-wearing
employees can see properly when wearing these devices.
In this final rule, OSHA has also expanded the requirements of
paragraph (g)(1)(ii) to cover personal protective equipment other than
goggles and glasses. Other forms of personal protective equipment are
required by OSHA under specific circumstances (See, e.g., Subpart I--
Personal Protective Equipment, and Section 1910.133--Eye and face
protection). Like eyewear, this equipment may interfere with the fit of
respiratory protection equipment. The generic phrase ``other personal
protective equipment'' applies to faceshields, protective clothing, and
helmets, as well as to any other form of personal protective equipment
that an employee may wear that could interfere with safe respirator
use.
Paragraph (g)(1)(iii) requires employers to ensure that their
employees perform user seal checks each time they put on a tight-
fitting respirator, using the ``user seal check'' procedures in
Appendix B-1 or equally effective procedures recommended by the
respirator manufacturer. The proposal would also have given employers
the option of using either the Appendix B-1 procedures or those
recommended by the manufacturer, which is also the approach recommended
by the ANSI standard. Although the prior standard also required a fit
check each time the worker used a respirator, it mandated that the
manufacturer's instructions be followed when performing the check.
OSHA's prior respirator standard referred to respirators being
``fit * * * checked.'' The NPRM used the phrase ``facepiece seal
check,'' and this has been changed in the final standard to ``user seal
check.'' The three phrases are synonymous, and all three were used
interchangeably by rulemaking participants (e.g., Exs. 54-218, 54-219,
who recommended that the term ``fit check'' be used to be consistent
with the ANSI Z88.2-1992 definition). Other commenters (Exs. 54-5, 54-
408) used the term ``seal check'' or ``facepiece seal check.'' The
final standard uses the term ``user seal check'' because OSHA believes
that this phrase best describes the actual procedure to be performed by
the respirator wearer. Also, commenters stated that the similarity
between the terms ``fit check'' and ``fit test'' might lead to
confusion, causing employers erroneously to conclude either that
complete fit testing must be done each time an employee puts on a
respirator or that the fit check can be substituted for a fit test.
In general, commenters (Exs. 54-221, 54-185, 54-321, 54-427, 54-
414, 64-521) agreed with OSHA that user seal checks are necessary.
Although these checks are not as objective a measure of facepiece
leakage as a fit test, they do provide a quick and easy means of
determining that a respirator is seated properly. If a user seal check
cannot be performed on a tight-fitting respirator, the final rule
prohibits that respirator from being used. Appendix B-1, which derives
from the 1992 ANSI standard, contains procedures for user seal checking
of negative pressure and
[[Page 1240]]
positive pressure devices. It states that a check is to be performed
every time the respirator is donned or adjusted to ensure proper
seating of the respirator to the face.
Participants expressed diverse views on whether the negative/
positive fit check procedures in Appendix B-1 should be the exclusive
means of compliance with this requirement or whether procedures
recommended by respirator manufacturers should also be allowed. John
Hale of Respirator Support Services stated that the only way to perform
a fit check is to use the negative/positive fit check methods in
Appendix B-1 (Ex. 54-5). George Notarianni of Logan Associates also
recommended that reference to manufacturers' procedures for fit
checking be deleted, because he was unaware of any effective fit check
methods other than those described in Appendix B (Ex. 54-152). Richard
Miller of the E.D. Bullard Company, however, stated that the manner in
which fit checks are conducted should be left up to the manufacturer
(Ex. 54-221).
The positive/negative user seal checks described in Appendix B-1
cannot be performed on all tight-fitting respirators. William Lambert
of the Mine Safety Appliances Company (MSA) (Ex. 54-414) stated that
respirators for which negative or positive pressure tests cannot be
performed should not be used. He also recommended that OSHA work
cooperatively with NIOSH to develop a testing protocol that would
preclude approval of respirators that cannot be easily checked using a
positive/negative fit check.
The rulemaking record, however, contains evidence that effective
user seal checks can be performed in several ways. OSHA reviewed a
study by Myers (1995) in which the authors described several ANSI fit
check methods, an AIHA/ACGIH negative/positive pressure check, and
manufacturer-recommended check methods (See Myers et al.,
``Effectiveness of Fit Check Methods on Half Mask Respirators,'' in
Applied Occupational Environmental Hygiene, Vol. 10(11), November 1995)
(Ex. 64-521). In addition, the authors briefly explained that
manufacturers of disposable, filtering facepieces recommended covering
the mask with both hands, exhaling, and checking for air flow between
the face and the sealing surface of the respirator. Since it was not
the intent of the authors to evaluate different fit check methods, they
did not present any comparison data; however, they did conclude that
employing the manufacturer's recommended fit check procedure will help
detect and prevent poor respirator donning practices. OSHA is also
aware that some manufacturers make a fit check cup that can be used to
perform a user seal check even with valveless respirators. The final
rule thus allows for the use of the methods in Appendix B-1 as well as
manufacturers' recommended procedures for user seal checks where these
are equivalently effective. This means that respirator manufacturers'
recommended procedures may be used for user seal checking if the
employer demonstrates that the manufacturer's procedures are as
effective as those in Appendix B-1. The intent of the ``equally
effective'' phrase is to ensure that the procedures used have been
demonstrated to be effective in identifying respirators that fit poorly
when donned or adjusted. OSHA believes that the use of performance
language will provide incentives to respirator manufacturers to develop
new user seal check methods and to develop respirators for which user
seal checks can be performed.
There are also respirators for which no user seal checks can be
conducted. A number of rulemaking participants argued that the
inability to seal check a respirator should disqualify these
respirators from use (See, e.g., Exs. 54-152, 54-408, 54-427, 54-321).
For example, William Lambert of MSA (Ex. 54-414) pointed out that,
since respirators are not put on and taken off the same way each time,
the seal check is essential to verify that the user has correctly
donned the respirator.
OSHA agrees with those commenters who stated that OSHA should not
allow the use of respirators that cannot be fit checked. Without the
ability to perform user seal checks, employees may be overexposed to
respiratory hazards as a result of the respirator leakage caused by
multiple redonnings and adjustments. OSHA believes that user seal
checks are important in assuring that respirators are functioning
properly. If no method exists to check how well a respirator performs
during multiple redonnings under actual workplace conditions, OSHA does
not consider the respirator acceptable for use.
Richard Olson of the Dow Chemical Company raised another issue
about paragraph (g)(1)(iii). He stated that use of the word ``ensure''
was inappropriate in this instance, because employers cannot ``ensure''
that user seal checks are performed:
This is impossible for the employer to do in all cases because
the employer is not there. Supervision is not at the work site at
all times, sometimes the employee is the only person in the
facility. The employee can be trained to do this however the
employer can not personally be there to observe and ensure every
time the employee wears a respirator (Ex. 54-278).
OSHA has stated consistently, in connection with the use of the
word ``ensure'' in other standards, that it is not OSHA's intent that
each employee be continually monitored. Further, OSHA case law has held
that employers are required by the use of the word ``ensure'' to take
actions that will result in appropriate employee behavior. These
actions consist of: rules with sanctions, training employees in
behaviors required, and exercising diligence in monitoring the safety
behavior of their employees. The past enforcement history of the use of
the word ``ensure'' in other OSHA standards, including the respirator
provisions in substance specific standards, shows that employers who
demonstrate this level of responsibility are in compliance with
provisions that use the term ``ensure.''
Paragraph (g)(2)--Continuing Respirator Effectiveness
Paragraph (g)(2) contains three sub-paragraphs. Paragraph (g)(2)(i)
requires employers to be aware of conditions in work areas where
employees are using respirators. Paragraph (g)(2)(ii) requires
employers to ensure that their employees leave the respirator use area
to perform any activity that involves removing or adjusting a
respirator facepiece or if there is any indication that a respirator
may not be fully effective. Paragraph (g)(2)(iii) requires employers to
replace, repair, or discard respirators if there is any indication that
they are not functioning properly.
The prior standard did not contain any of these provisions;
however, OSHA proposed them after including similar requirements in a
number of OSHA substance-specific health standards. OSHA believes that
these provisions are important because the effectiveness of even the
best respirator program is diminished if employers do not have
procedures in place to ensure that respirators continue to provide
appropriate protection.
Final paragraph (g)(2)(i), which states, ``Appropriate surveillance
shall be maintained of work area conditions, and degree of employee
exposure or stress,'' reiterates paragraph (b)(8) of the prior
standard. This means that employers are required to evaluate workplace
conditions routinely so that they can provide additional respiratory
protection or different respiratory protection, when necessary. By
observing respirator use under actual workplace conditions, employers
can
[[Page 1241]]
note problems such as changes in the fit of a respirator due to
protective equipment or conditions leading to skin irritation. The
employer can then make adjustments to ensure that employees continue to
receive appropriate respiratory protection.
Paragraph (g)(2)(ii) requires employers to ensure that employees
are allowed to leave the respirator use area in several circumstances.
The intent of this requirement is to ensure that employees leave the
area when necessary. The final standard stipulates that, in these
cases, employees are to leave the ``respirator use'' area, not the work
area or workplace. This language is intended to give employers the
flexibility to establish safe areas in their workplaces that will
minimize interruptions in work flow and production while ensuring that
the area where respirators are removed is free of respiratory hazards
or contamination.
Paragraph (g)(2)(ii)(A) requires employers to ensure that their
employees leave the respirator use area to wash their faces and
respirator facepieces as necessary to prevent eye or skin irritation;
such irritation occurs frequently with the wearing of tight-fitting
respirators. Many of OSHA's substance specific-standards, such as the
cadmium (29 CFR 1910.1027) and arsenic (29 CFR 1910.1018) standards, as
well as the ANSI Z88.2-1992 standard, contain provisions allowing
employees to leave the respirator use area to wash their faces and
respirator facepieces to prevent the skin irritation that is often
associated with the use of respirators. Paragraph (g)(2)(ii) is thus
consistent with these requirements of the Agency's substance-specific
standards, as well as with the ANSI Z88.2-1992 standard.
A number of participants (Exs. 54-6, 36-47, 54-362) questioned the
need for this provision, however. For example, Christopher Seniuk of
Lovell Safety Management Company stated that allowing employees to
leave the area to wash their faces is counterproductive because
allowing frequent breaks increases the chance of contamination while
putting on and removing the respirator (Ex. 54-6). Richard Boggs of ORC
(Ex. 36-47) also recommended that this requirement be dropped, on the
grounds that the frequency with which employees leave their work areas
is a ``labor relations'' issue. Kevin Hayes of ABB Ceno Fuel Operations
(Ex. 54-362) expressed a similar concern; he suggested that employees
be allowed to leave the work area periodically, rather than on an ``as
necessary'' basis, and asked that OSHA quantify the extent of skin
irritation that needed to be present for employees to leave the area
for washing and cleaning. Mr. Hayes was concerned that disgruntled
employees could use this requirement to ``establish a revolving door
from the work area.''
Dr. Franklin Mirer, director of safety and health for the United
Auto Workers, supported this provision, however; he stated that
allowing employees to leave the area to wash would lead to fewer
hygiene problems (Ex. 54-387). OSHA agrees with Dr. Mirer: if employees
are allowed to wash their faces and respirators, the amount of
contamination will be reduced, employees' hands and respirators will be
cleaner, and employees will be donning cleaner respirators. OSHA
believes that, to protect employee health, employees must be able to
wash their faces and facepieces as often as necessary. The skin
irritation caused by dirty respirators can interfere with effective
respirator use (Ex. 64-65). Clearly, any skin irritation that causes
the wearer to move the respirator in a way that breaks the facepiece-
to-face seal is sufficient to warrant an employee leaving the
respirator use area to wash. Whenever eye or skin problems interfere
with respirator performance, the wearer should be able to leave the use
area.
Paragraphs (g)(2)(ii)(B) and (C) require the employer to ensure
that employees leave the respirator use area if they detect vapor or
gas breakthrough, changes in breathing resistance, or leakage of the
facepiece, and to replace the respirator or the filter, cartridge, or
canister elements when these have been exhausted. These requirements
are consistent with the NIOSH Respirator Decision Logic (Ex. 9, page
8), which states that workers who suspect respirator failure should be
instructed to leave the contaminated area immediately to assess and
correct the problem. In addition, employees may need to leave the
respirator use area to change the cartridge or canister when the end-
of-service-life indicator (ESLI) or change schedule demands a change in
canister or cartridge. (See the Summary and Explanation for paragraphs
(c) and (d).) The requirements in paragraph (g)(2)(ii)(B) are essential
to ensure the continuing effectiveness of the protection provided to
the wearer by the respirator. If, for example, the wearer can detect
the odor or taste of a vapor or gas, the cartridge or canister is
clearly no longer providing protection. Similarly, if a filter element
is so loaded with particulates that it increases the work-of-breathing,
it clearly must be changed to continue to be effective. The leakage of
air through the facepiece also requires immediate attention, because it
is a sign that the facepiece-to-face seal has been broken and that the
wearer is breathing contaminated air.
Paragraph (g)(2)(ii)(C) requires employers to ensure that
respirator wearers leave the use area when the filter element,
cartridge, or canister must be changed in order for it to continue to
provide the necessary protection. In the proposal, the term ``filter
elements'' was used instead of the more specific language ``cartridge''
and ``canister,'' and the proposed language generated several comments
requesting the Agency to clarify this terminology (See, e.g., Ex. 54-
173). A representative from Monsanto Company suggested that OSHA should
change the language from ``filter'' to ``cartridge'' or ``canister''
(Ex. 54-219) because filters apply only to particulates, not vapors and
gases. Larry Zobel, Medical Director of 3M, made a similar comment (Ex.
54-218). OSHA has amended the language in final paragraph (g)(2)(ii)(C)
to make it more precise, and the final rule uses the terms
``cartridge,'' ``canister,'' and ``filter'' as these specifically
apply.
Paragraph (g)(2)(iii) requires the employer to replace, repair, or
discard a respirator that is not functioning properly. This requirement
applies in addition to the provisions in paragraphs (d) and (h) of this
section that address the routine replacement of respirators and
respirator parts. The language of this paragraph has been changed from
the proposal to emphasize that a malfunctioning or otherwise defective
respirator must be replaced or repaired before the user returns to the
work area.
Rulemaking participants agreed that respirators should not be used
if they are defective in any way (See, e.g., Ex. 54-362, Kevin Hayes of
ABB Combustion Engineering Nuclear Operations). However, one commenter,
Peter Hernandez of the American Iron and Steel Institute, objected to
the proposal's requirement that defective respirators be repaired
``immediately.'' Mr. Hernandez stated that it is necessary immediately
to replace, but not immediately to repair or discard, a defective
respirator (Ex. 54-307). OSHA agrees that employers can delay repairing
or discarding respirators so long as the affected employees have been
issued proper replacement respirators. This was the intent of paragraph
(g)(8) in the NPRM, and this point has been clarified in the final
regulation by placing the word ``replace'' first and deleting the word
``immediately.'' The intent of final paragraph (g)(2)(iii) is to ensure
that employees receive the necessary protection whenever they are in a
respirator use area. This paragraph
[[Page 1242]]
means that employers must ensure that employees in the respirator use
area are wearing respirators that are in good working order.
The proposed rule would have required disposables to be discarded
at the end of the task or workshift, whichever came first (See
paragraph (g)(9) of the NPRM). A number of commenters (See, e.g., Exs.
54-309, 54-307, 54-442) discussed the use of, and the criteria for
discarding, disposable respirators. OSHA has deleted specific
references to the term ``disposable'' in the final rule and has instead
required, in paragraph (g)(2)(iii), that employers replace, repair, or
discard respirators if employees detect vapor or gas breakthrough, a
change in breathing resistance, or leakage of the facepiece, or
identify any other respirator defect, before allowing the employee to
return to the work area. This requirement thus focuses on the need for
respirators to function properly to provide protection to employees
rather than on a time schedule for discarding particular respirators.
Some commenters stated that disposable respirators should be
allowed to be used until the physical integrity of the respirator is
compromised, which may take longer than one work shift (Exs. 54-190,
54-193, 54-197, 54-205, 54-214, 54-222, 54-241, 54-253, 54-268, 54-271,
54-307, 54-357, 54-171). For example, Peter Hernandez, representing the
American Iron and Steel Institute, stated that employees may perform 20
different tasks in a work day (Ex. 54-307). The implication of Mr.
Hernandez' comment is that workers who perform short duration tasks
would have been required by the proposed requirement to use many
disposable respirators in the course of such a day, which would be
unnecessarily expensive. Suey Howe, representing the Associated
Builders and Contractors, recommended that employees be allowed to keep
their disposable respirators in clean containers on days when the same
task may be performed intermittently (Ex. 54-309). Homer Cole of
Reynolds Metals Company stated that some workplace situations exist
where the environment is clean enough for disposable respirators to be
reused (Ex. 54-222). Randy Sheppard, Battalion Chief of Palm Beach
County Fire-Rescue (Ex. 54-442), stated that disposing of HEPA
disposable respirators after each use would be extremely costly for
large fire departments that respond to many emergency calls. He noted
that these respirators should be discarded, however, when they are no
longer in their original working condition, whether this condition
results from contamination, structural defects, or wear. In a post
hearing comment submitted by the North American Insulation
Manufacturers Association (NAIMA), Kenneth Mentzer, Executive Vice
President, and others stated that OSHA should make it clear that NIOSH-
approved disposable respirators may be used when they provide adequate
protection factors for the exposures encountered. The authors of this
submission also stated that NIOSH-approved disposable respirators
provide protection and have some advantages over reusable respirators
(Ex. 176).
Richard Niemeier of NIOSH (Ex. 54-437) recommended that dust-mist
and dust-mist-fume disposable respirators not be reused, on the grounds
that many of these models degrade in oil mist and humid environments.
He also recommended that only filters approved under 42 CFR Part 84 be
considered for use beyond one shift.
OSHA has considered all of these comments in revising the language
in final paragraph (g)(2)(iii) to reflect a more performance-oriented
approach to the replacement, repair, or discarding of respirators.
Nonetheless, employers still have the responsibility, in paragraph
(a)(2), to ensure that respirators are suitable for each use to which
they are put. [See also discussion in NPRM, 59 FR 58922.]
Paragraphs (g)(3) and (g)(4)--Procedures for IDLH Atmospheres and
Interior Structural Fire Fighting
Paragraphs (g)(3) and (g)(4) of the final rule contain requirements
for respirator use in IDLH atmospheres. Paragraph (g)(3) addresses all
IDLH atmospheres, and paragraph (g)(4) contains three additional
requirements applicable only to the extra-hazardous environments
encountered during interior structural fire fighting. These two
paragraphs, which deal with requirements for standby personnel outside
the IDLH atmosphere and communication between those standby personnel
and the respirator users inside the atmosphere, are intended to ensure
that adequate rescue capability exists in case of respirator failure or
some other emergency inside the IDLH environment.
Paragraphs (g)(3) (i), (ii), and (iii) require that at least one
employee who is trained and equipped to provide effective emergency
rescue be located outside the IDLH respirator use area, and that this
employee maintain communication with the respirator user(s) inside the
area. Paragraphs (g)(3) (iv) and (v) require, respectively, that the
employer or authorized designee be notified before the standby
personnel undertake rescue activity and that the employer or designee
then provide appropriate assistance for the particular situation.
Paragraph (g)(3)(vi) addresses emergency equipment needed by the
standby personnel so that they can perform their duties effectively.
The prior standard, Sec. 1910.134(e), did not distinguish between
types of IDLH atmospheres. Instead, it distinguished between IDLH and
potentially IDLH atmospheres. It stated that only one standby person
was necessary when a respirator failure ``could'' cause its wearer to
be overcome, but that standby ``men'' (plural) with suitable rescue
equipment were required when employees must enter known IDLH
atmospheres wearing SCBA. Under this provision, at least two standby
personnel were required for known IDLH atmospheres (See, e.g., May 1,
1995 memo from James Stanley, Deputy Assistant Secretary, to Regional
Administrators and state-plan designees). In IDLH atmospheres where
airline respirators are used, the prior standard required that users be
equipped with safety harnesses and safety lines to lift or remove them
from the hazardous atmosphere and that ``a standby man or men,''
equipped with suitable SCBA, be available for emergency rescue.
The proposal would have required that, for all IDLH atmospheres, at
least one standby person, able to provide emergency assistance, be
located outside any IDLH atmosphere, and that this person must maintain
communication with the employee(s) in the IDLH atmosphere.
The need for standby personnel when workers use respirators in IDLH
atmospheres is clear. The margin for error in IDLH atmospheres is
slight or nonexistent because an equipment malfunction or employee
mistake can, without warning, expose the employee to an atmosphere
incapable of supporting human life. Such exposure may disable the
employee from exiting the atmosphere without help and require an
immediate rescue if the employee's life is to be saved. Accordingly,
the standard requires that, whenever employees work in an IDLH
atmosphere, at least one standby person must remain outside the
atmosphere in communication with the employee(s) inside the atmosphere.
It also requires that the standby personnel be trained and equipped to
provide effective emergency assistance.
A number of reports from OSHA's investigative files demonstrate the
types of failures that can give rise to the need for immediate rescues
of workers in
[[Page 1243]]
IDLH atmospheres. These cases illustrate that the absence of properly
equipped standby personnel greatly increases the risk to the employees
who enter the IDLH atmosphere. For example, a fire in a cold-rolling
mill triggered a carbon dioxide fire extinguishing system and created
an oxygen deficient atmosphere in the mill's basement. Two security
guards descended a stairway into the basement to reset the system.
Although the employees had been provided SCBAs, they left those
respiratory devices in their vehicle and took only a single self-
rescuer with them. The workers collapsed upon reaching the bottom of
the stairway. No standby personnel were present and, as a result, the
workers were not discovered until 30 minutes had elapsed. Attempts to
revive them failed. This case illustrates that the suddenness with
which workers can be disabled in an IDLH atmosphere can prevent the
workers from leaving the atmosphere under their own power and
underlines the need for employers to provide standby personnel whenever
workers enter such atmospheres. If a properly trained and equipped
standby person had been present, that person could have notified the
employer that help was needed when the two workers collapsed and could
have initiated rescue efforts immediately.
In another case, two mechanics entered a corn starch reactor to
perform routine maintenance and repair. Employee No. 1 detected the
odor of propylene oxide and then observed the chemical running out of
an open vent. Employee No. 1 managed to escape, but employee No. 2 was
overcome and died. A standby person equipped with proper rescue
equipment would have been able to provide immediate, effective
assistance once employee No. 2 was overcome and might have saved that
employee's life.
Some cases from OSHA's investigative files involve fatalities that
occurred when standby personnel were present but were unable to prevent
the fatalities from occurring. These cases illustrate both the types of
failures that can give rise to the need for immediate rescue efforts in
IDLH atmospheres and the importance of standby personnel being trained
and equipped to provide effective rescue capability.
In one case, an employee (No. 1) was working in a confined space
while wearing an SCBA. A standby person (No. 2) advised employee No. 1
that the respirator's air supply was low and that he should leave the
confined space. However, employee No. 1 collapsed and died before he
could exit. Employee No. 2 had no equipment with which to extricate
employee No. 1 from the confined space. This example illustrates,
first, that even an employee who is properly equipped when entering an
IDLH atmosphere may need to be rescued as a result of human error and/
or equipment failure. It also illustrates the need for the standby
person to be equipped to be able to provide effective emergency rescue.
In yet another case, an employee (No. 1) was sandblasting inside a
rail car wearing an airline respirator with an abrasive blasting hood.
A standby person (No. 2) was stationed outside the car. During the
operation, employee No. 1 swallowed a dental appliance and lost
consciousness. Employee No. 2 had not maintained constant communication
with employee No. 1 and only discovered that employee No. 1 had been
overcome too late to save his life. This case shows that the demanding
work often required by a worker constrained by respiratory equipment in
an IDLH atmosphere may lead to accidents that can disable the worker
and require immediate rescue efforts. It also illustrates that the need
for emergency assistance can arise at any time and without warning, and
that standby personnel must therefore maintain constant communication
with the worker(s) inside the IDLH atmosphere.
Standby personnel must also be adequately trained and equipped to
protect themselves against the IDLH atmosphere if an emergency arises.
In a recent case, two employees (Nos. 1 and 2) were installing a blind
flange in a pipeline used to transfer hydrogen sulfide. As the flange
was opened, the hydrogen sulfide alarm sounded. Employee No. 1 tried to
remove his full-facepiece respirator, was overcome, and died. Employee
No. 2 had previously loosened the straps on his respirator to test for
the smell of hydrogen sulfide and was also overcome. A standby person
(No. 3) equipped with an SCBA was on the ground outside the area and
attempted an immediate rescue. Unfortunately, his respirator caught on
an obstruction and tore as he attempted to enter the atmosphere and he,
along with employee No. 2, was overcome and required hospitalization.
The case is another example of the type of human and equipment failures
that can endanger employees who must work in IDLH atmospheres. Although
the rescue effort in this case faltered, the presence of a standby
person equipped with an SCBA increased the chance that the employees in
the IDLH atmosphere could have been rescued before they were killed or
seriously injured, and the availability of appropriate respiratory
equipment reduced the risk to the standby person who attempted the
rescue. It illustrates the benefit of having standby personnel who can
undertake immediate rescue efforts and the need for such personnel to
be trained and equipped properly for their own protection as well as
the protection of the workers in the IDLH atmosphere.
The proposed provision would have required only a single standby
person in most IDLH situations. However, firefighter representatives
urged OSHA (Ex. 75, Tr. 468-469) to retain the prior standard's
requirement for two standby personnel and to expand the provision to
cover all IDLH atmospheres. OSHA has determined, however, that outside
of the fire fighting and emergency response situations, which are
discussed in connection with paragraph (g)(4), environments containing
IDLH atmospheres are frequently well-enough characterized and
controlled that a single standby person is adequate. In most fixed
workplaces, the atmosphere is known, i.e., has been well characterized
either through analysis of monitoring results or through a process
hazard analysis. For example, employers in chemical plants have
conducted comprehensive process hazard analyses as required by OSHA's
Process Safety Management standard, 29 CFR 1910.119, to determine which
of their process units pose potential IDLH hazards. In such situations,
effective communication systems and rescue capabilities have been
established. In addition, in many industrial IDLH situations, only one
respirator user is exposed to the IDLH atmosphere at a time, which
means that a single standby person can easily monitor that employee's
status. Even in situations where more than one respirator user is
inside an IDLH atmosphere, a single standby person can often provide
adequate communication and support. For example, in a small pump room
or shed, even though two or three employees may be inside an IDLH
atmosphere performing routine maintenance activities such as changing
pump seals, one standby person can observe and communicate with all of
them. In this type of situation, one standby person is adequate and
appropriate.
In other cases, however, more than one standby person may be
needed; paragraph (g)(3)(i) of the final standard therefore states the
requirement for standby personnel in performance language: ``one
employee or, when needed, more than one employee * * * [shall be]
located outside the IDLH atmosphere.'' For example, to clean and paint
the inside of a multi-level, multi-
[[Page 1244]]
portal water tower, a process that often generates a deadly atmosphere
as a result of cleaning solution and paint solvent vapors, employees
often enter the tower through different portals to work on different
levels. In such a situation, there will be a need for good
communications at each entry portal, and more than one standby person
would be needed to maintain adequate communication and accessibility.
Several commenters (Exs. 54-6, 54-38, and 54-266) requested
clarification of the proposed requirements that employers ensure that
communication is maintained between the employee(s) in the IDLH
atmosphere and the standby personnel located outside the IDLH
environment. For example, Exxon (Ex. 54-266) requested that OSHA make
clear that, in addition to voice communication, visual contact and hand
signals may be used. In response, paragraph (g)(3)(ii) of the final
rule clarifies that visual, voice, or signal line communication must be
maintained between the employee(s) in the IDLH atmosphere and the
employee(s) located outside the IDLH atmosphere.
Under final paragraph (g)(3)(iv), employers must ensure that before
entering an IDLH environment to provide emergency rescue, standby
personnel notify the employer, or a designee authorized by the employer
to provide necessary assistance, that they are about to enter the IDLH
area. The employer will have determined, in advance, as part of the
written respirator program's worksite-specific procedures, the
procedures standby personnel will follow and whom they must notify in
rescue situations. The employer's emergency response team may provide
the necessary support, or other arrangements may have been made with
local firefighting and emergency rescue personnel. The language used
requires that the employer be notified, which provides the employer
great flexibility in determining who will respond to such emergency
rescue situations.
Paragraph (g)(3)(iv) responds to concerns expressed by several
participants (Exs. 54-6, 54-266, 54-307, 54-330) about the obligation
of standby personnel to provide effective emergency rescue. A number of
comments emphasized that standby personnel should not attempt any
rescue activities without making sure that their own whereabouts are
known and monitored. According to Exxon (Ex. 54 266), ``the ``stand-
by'' person should be able to summon effective emergency assistance and
only then provide the assistance.'' Christopher Seniuk of Lovell Safety
Management Company also stated that a standby employee should have a
telephone or radio to summon help and should not be expected to enter
an IDLH environment for rescue until additional help arrives (Ex. 54-
6). The American Iron and Steel Institute (Ex. 54-307) agreed, stating
that the standby person should be in communication with the employee(s)
in the IDLH atmosphere and be ``able to assist in providing or
obtaining effective emergency assistance.'' The American Petroleum
Institute (Ex. 54-330) also stated that when the employee wears a
respirator in an IDLH atmosphere, the employer must ensure that
adequate provisions have been made for rescue.
OSHA agrees that standby personnel should contact the employer or
employer's designee before undertaking any rescue activities in an IDLH
atmosphere. Accordingly, final paragraph (g)(3)(iv) includes an
employer or designee notification requirement. Although this
requirement was not contained in the NPRM, a similar requirement has
been included in other OSHA standards, e.g., the Permit Required
Confined Spaces standard, 29 CFR 1910.146, and the Hazardous Waste
Operations and Emergency Response standard, 29 CFR 1910.120. By
including this requirement, OSHA is pointing to the need for the
employer or authorized designee to take responsibility for ensuring
that rescue operations are carried out appropriately, that rescuers are
provided with proper respiratory equipment, and that employees are
adequately prepared to facilitate rescue attempts.
On the other hand, the notification provision is not intended to
suggest that standby employees should wait indefinitely for their
employer or designee to respond to notification before entering the
IDLH atmosphere when employees inside are in danger of succumbing and
standby personnel are appropriately trained and equipped to provide
assistance. OSHA is aware that this practice is followed in fire
fighting situations (See paragraph 6-4.4, NFPA 1500 standard, 1997.) In
the majority of cases, however, rescuers should not enter the IDLH
environment until receiving some response to the notification that
rescue is necessary, i.e., the employer or designee should know that
the rescuers are entering, and emergency response units should be on
their way to the incident. OSHA believes that these requirements are
consistent with current industry practice (Exs. 54-266, 54-307, 54-6)
and with other OSHA standards (e.g., the permit-required confined
spaces standard).
This practice is consistent with OSHA's interpretations of other
standards. (See letter of interpretation of the Hazardous Waste and
Emergency Response Standard 29 CFR 1910.120 regarding the number of
standby personnel present when there is a potential emergency); ``* * *
process operators who have (1) informed the incident command * * * of
the emergency * * * (2) [have] adequate PPE (3) [have] adequate
training * * * and (4) employed the buddy system, may take limited
action * * * once the emergency response team arrives, these employees
would be restricted to the action that their training level allows * *
* this has been OSHA's long standing policy for operators responding to
emergencies * * *'' McCully to Olson; July 11, 1996.
Failure to follow such practices can result in employee death. For
example, recently, one employee (No. 1) was working inside a reactor
vessel, attempting to obtain a sample of catalyst. He was wearing a
supplied air respirator with an escape bottle. The standby
``attendant'' informed the employee inside that it was time to exit to
change the air supply cylinder; witnesses said the inside employee (No.
1) did not appear to hear this instruction. When the air supply became
critical, other workers outside ``yelled'' to the inside employee to
hurry outside; by then, the inside employee was moving slowly and then
fell. The attendant tried to check the air pressure while another
employee, a bystander welder (No. 2), entered the vessel without a
breathing apparatus and tried to help the inside employee (No. 1). The
welder also fell down. Other bystanders were partially overcome by the
nitrogen coming out of the vessel. The air hose on the respirator on
the inside employee (No. 1) was disconnected. Neither the first
employee inside (No. 1) nor the welder (No. 2) was wearing a harness or
lifeline. The inside employee later died. [OSHA citation text abstracts
for unscheduled investigations of accidents involving fatalities (one
or more) and catastrophic injuries during calendar years 1994 and
1995].
Once the employer or designee has been notified, paragraph
(g)(3)(v) requires the employer or designee to provide the necessary
assistance appropriate to the situation. Such assistance does not
always require that additional standby personnel enter the hazardous
atmosphere; in some cases, the appropriate assistance could be, for
example, the provision of emergency medical treatment. If standby
employees do need to enter the hazardous environment to perform rescue
[[Page 1245]]
operations, however, the employer must ensure that those rescuers are
fully protected.
Final paragraphs (g)(3)(vi) (A), (B), and (C) require that standby
personnel have appropriate equipment to minimize the danger to these
personnel during rescue efforts. They stipulate that standby employees
be equipped with pressure demand or other positive pressure SCBA, or a
pressure demand or other positive pressure supplied-air respirator with
auxiliary SCBA, according to final paragraph (g)(3)(vi)(A). This
requirement was contained in paragraph (g)(2)(i) of the proposal, and
was not objected to by any participants. It is also consistent with
requirements in clause 7.3.2 of ANSI Z88.2--1992.
The requirements that address appropriate retrieval equipment and
means of rescue in paragraphs (g)(3)(vi)(B)-(C) are written in
performance-based language. Established rescue procedures are well
known, and retrieval equipment is readily available. OSHA therefore
believes that it is necessary merely to state that this equipment must
be used unless its use would increase the overall risk associated with
entry into or rescue from the IDLH environment. OSHA acknowledged in
the Permit-Required Confined Space standard, 58 FR 4530, that
situations exist in which retrieval lines (harnesses, wristlets,
anklets) may pose an entanglement problem, especially in areas in which
air lines or electrical cords are present in the work areas in which
the IDLH atmosphere occurs. Most of the time, however, rescue with
retrieval equipment is effective, and much safer for the rescuers (Ex.
54-428).
Paragraph (g)(4) applies only to respirator use in the ultra-
hazardous context of interior structural fire fighting; the
requirements in this paragraph apply in addition to those in paragraph
(g)(3). OSHA has included this provision in its standard in response to
the record evidence about the extreme hazards of this activity.
Paragraph (g)(4)(i) requires that workers engaged in interior
structural fire fighting work in a buddy system: at least two workers
must enter the building together, so that they can monitor each other's
whereabouts as well as the work environment. In addition, for interior
structural firefighting, paragraph (g)(4)(ii) retains the requirement
that there be at least two standby personnel outside the IDLH
respirator use area, i.e., outside the fire area. Paragraph (g)(4)(iii)
requires that all personnel engaged in interior structural fire
fighting use SCBA respirators. Finally, the notes to paragraph (g)(4)
clarify that these requirements are not intended to interfere with
necessary rescue operations, and the extent to which the standby
personnel can perform other functions.
Paragraph (g)(4) of this Federal standard applies to private sector
workers engaged in firefighting through industrial fire brigades,
private incorporated fire companies, Federal employees through Section
19 of the OSH Act, and other firefighters. It should be noted that
Federal OSHA's jurisdiction does not extend to employees of state and
local governments; therefore, public sector firefighters are covered
only in the 25 states which operate their own OSHA-approved
occupational safety and health state programs and are required to
extend the provisions of their state standards to these workers. These
states and territories are: Alaska, Arizona, California, Connecticut,
Hawaii, Indiana, Iowa, Kentucky, Maryland, Michigan, Minnesota, Nevada,
New Mexico, New York, North Carolina, Oregon, Puerto Rico, South
Carolina, Tennessee, Utah, Vermont, Virginia, Virgin Islands,
Washington, and Wyoming . Eighteen (18) of these states under certain
circumstances also consider ``volunteers'' to be employees and thus may
provide protection to private or public sector volunteer firefighters,
subject to specific interpretation of state law. State and local
government employees, including firefighters, in States which do not
operate OSHA-approved state plans, are not covered by these
requirements, unless voluntarily adopted for local applicability.
Although the proposed rule did not distinguish between interior
structural fire fighting and other IDLH situations, OSHA decided to
include separate requirements for the former activity in the final
standard in response to evidence in the record that safeguards that may
be adequate for well-controlled and well-characterized IDLH situations
are not adequate in the uncontrolled and unpredictable situation
presented by a burning building. The firefighting community already
recognizes that one person alone cannot be sent safely into a structure
to fight a fire that is beyond the incipient stage. The final rule's
staffing requirements for fire fighting are consistent with OSHA's
current enforcement practice for employers subject to federal OSHA
enforcement, and assure that firefighters will not be subject to any
diminution in protection as a result of the more flexible requirements
for IDLH respirator use included in other paragraphs of the final rule.
OSHA has previously recognized that emergency situations analogous
to interior structural fire fighting require additional safeguards for
employees involved in emergency response activities. For example, the
Hazardous Waste Operations and Emergency Response (HAZWOPER) standard,
at 29 CFR 1910.120(q), requires the use of a ``buddy system'' in
responding to IDLH atmospheres. This means that employees involved in
such operations are to be organized into workgroups in such a manner
that each employee of the work group is designated to be observed
continuously by at least one other employee in the work group.
Paragraph (q)(3)(v) of Sec. 1910.120 requires operations in hazardous
areas to be performed using the buddy system in groups of two or more;
paragraph (q)(3)(vi) of that standard specifies that back-up personnel
shall stand by with equipment ready to provide assistance or rescue.
OSHA has made clear that these provisions require more than one standby
person to be present.
The final standard is also consistent with relevant National Fire
Protection Association (NFPA) standards. The NFPA is recognized
internationally as a clearinghouse for information on fire prevention,
fire fighting procedures, and fire protection. A number of NFPA
standards require firefighters using SCBA to operate in a buddy system.
NFPA 1404, ``Fire Department Self-Contained Breathing Apparatus
Program,'' states, in paragraph 3-1.6, that members using SCBA are to
operate in teams of two or more, must be able to communicate with each
other through visual, audible, physical, safety guide rope, electronic,
or other means to coordinate their activities, and are to remain in
close proximity to each other to provide emergency assistance.
The NFPA 600 standard addressing industrial fire brigades requires
in paragraph 5.3.5 that firefighters using SCBA ``operate in teams of
two or more who are in communication with each other * * * and are in
close proximity to each other to provide assistance in case of an
emergency.'' Although this standard, which applies only to industrial
fire brigades where firefighters are working in fixed locations that
are well characterized and have established communications and rescue
systems, requires only one standby person outside the fire area,
another standard, NFPA 1500, ``Standard on Fire Department Occupational
Safety and Health Programs,'' which addresses fire department safety
and health programs
[[Page 1246]]
in the general sense, requires at least two standby personnel. This
provision first appeared in 1992, as a Tentative Interim Amendment to
NFPA 1500 requiring, in paragraph 6-4.1.1, that ``[a]t least four
members shall be assembled before initiating interior fire fighting
operations at a working structural fire.'' In 1997, NFPA finalized the
Amendment. Paragraph 6-4 of the current NFPA 1500 standard, ``Members
Operating at Emergency Incidents,'' addresses the number of persons
required to be present, and requires at least four individuals,
consisting of two persons in the hazard area and two individuals
outside the hazard area, for assistance or rescue (paragraph 6-4.4).
One standby member is permitted to perform other duties, but those
other duties are not allowed to interfere with the member's ability to
provide assistance or rescue to the firefighters working at the
incident (paragraph 6-4.2).
In addition, a 1994 CDC/NIOSH Alert, titled ``Request for
Assistance in Preventing Injuries and Death of Firefighters,'' also
recommends the use of a buddy system whenever firefighters wear SCBAs.
The recommendation states:
Two firefighters should work together and remain in contact with
each other at all times. Two additional firefighters should form a
rescue team that is stationed outside the hazardous area. The rescue
team should be trained and equipped to begin a rescue immediately if
any of the firefighters in the hazardous area require assistance.
Similarly, in testimony on H.R. 1783 before the Subcommittee on
Economic and Educational Opportunities, House of Representatives, 104th
Congress (July 11, 1995, Chairman: Cass Ballenger), Harold A.
Schaitberger, Executive Assistant to the General President of the
International Association of Fire Fighters (IAFF), stated that ``* * *
our organization understood from the outset that the regulation [29 CFR
1910.134(e)] required firefighters wearing self-contained breathing
apparatus and involved in interior structural fire operations to
operate in a `buddy system,' with two firefighters entering a burning
building and two firefighters stationed outside the endangered area for
assistance or rescue, and for accountability purposes * * * The two-in/
two-out rule has been the industry standard in the fire service for
over 25 years.''
The record in this rulemaking provides strong support for including
this requirement in the final standard. Richard Duffy, Director of
Occupational Health and Safety for the International Association of
Fire Fighters (IAFF), argued strongly for provisions similar to those
in the HAZWOPER standard for SCBA users working in IDLH situations. In
his written testimony (Ex. 75), Mr. Duffy stated that the proposed
requirements in paragraph (g)(2)(ii), which would not have required the
buddy system or that two standby personnel be available outside the
IDLH atmosphere, would place workers using respiratory protection in
IDLH situations at considerable risk.
The IAFF recommended that a minimum of 4 individuals be present any
time employees are using SCBA in an IDLH atmosphere: two individuals to
work as a team inside the IDLH atmosphere and two identically trained
and equipped employees to remain outside to account for, and be
available to assist or rescue, the team members working inside the IDLH
atmosphere (Tr. 468-469). The inside employees would use a buddy system
and maintain direct voice or visual contact or be tethered with a
signal line (Tr. 468-469).
According to Mr. Duffy, these changes were necessary:
to save workers'--specifically firefighters'--lives. Since 1970 * *
* 1,416 members of [IAFF] have died in the line of duty. Prohibiting
employers from allowing employees to work alone while working in
IDLH, potentially IDLH or unknown atmospheres * * * would have saved
many of these firefighters' lives * * * [I]f there was a team in
place that accounted for employees while they were working in IDLH *
* * many more firefighters would have been saved and [be] alive
today (Ex. 75).
Mr. Duffy described several incidents in which firefighters had been
injured or killed because of inadequate safety practices, and
particularly the failure to have specific individuals assigned to keep
track of employees in IDLH atmospheres. For example, he referred to a
recent occurrence (Tr. 470) in which three firefighters died inside an
IDLH atmosphere. In this incident, although many firefighters were on
the scene, no one could account for the three firefighters who had been
overcome by the IDLH atmosphere. Their bodies were later discovered
inside the burned building. It appears that more stringent precautions,
such as a buddy system and standby personnel specifically assigned to
keep track of the firefighters' condition, could have prevented these
deaths.
In addition, the Oklahoma Department of Labor submitted comments
stating that it supports a two-in/two-out rule, especially for
firefighters. Specifically, it stated that ``Although we are not a
state plan state, we operate a fully functional OSHA safety and health
program in the public sector * * * it would be unfortunate if the new
respiratory protection standard's interpretation of the `buddy system'
* * * confused this issue (two-out for firefighters) [Ex. 187].''
However, some firefighter services and organizations urged OSHA to
abandon its existing requirement for at least two standby personnel.
For example, Truckee Meadows Fire Protection District in Nevada (Ex.
384) stated that:
there are circumstances where a three person * * * company can
safely and efficiently respond and aggressively attack a fire.
Similarly, there are occasions where additional personnel and
resources may be required before initiating an attack * * * the
emphasis must be practically placed upon assessment of the risk at
the time of arrival and throughout the incident to determine the
resources and precautions needed. The overriding concern should be *
* * safe egress or recovery of personnel should conditions change,
regardless of the standby crew assembled.
A similar opinion was expressed by the fire chief of Sparks, Nevada
(Ex. 54-129).
Even a comment from the County of Rockland Fire Training Center,
Pomona, New York (Ex. 54-155) recommending removing the requirement for
standby personnel from the final rule, noted that ``in operations
during a fire or emergency, it is a standard practice to utilize the
team approach.'' The comment went on to state, however, that ``removing
the restriction of having persons outside the IDLH * * * and allowing
the incident commander the flexibility of moving personnel around as he
or she sees fit at any given situation * * * would actually enhance the
safety of our forces operating at the scene of a fire or emergency.''
As discussed below, OSHA believes that the requirements in the final
standard allow enough flexibility to maximize safety.
OSHA concludes that, for interior structural fire fighting, a buddy
system for workers inside the IDLH atmosphere and at least two standby
personnel outside that atmosphere are necessary. In fact, as noted
above, OSHA has previously explained that under the prior standard and
the OSH Act's general duty clause, there must be more than one person
present outside and at least two firefighters inside when conducting an
interior attack on an interior structural fire. Accordingly, special
provisions have been included in this revised respiratory protection
standard to clarify that firefighters may not enter an IDLH atmosphere
alone during interior structural firefighting, and that two standby
personnel are
[[Page 1247]]
required for all interior structural fire fighting.
As discussed above, however, OSHA does not believe that similar
practices are necessary in better controlled and characterized IDLH
situations, such as those potentially arising in industrial
environments. In those cases, where standby personnel can more easily
track the precise movements of the respirator users and communication
mechanisms are in place, OSHA believes that one standby person will
often be sufficient, although paragraph (g)(3)(i) clearly recognizes
that some nonfirefighting IDLH situations will require multiple standby
personnel.
These additional requirements are necessary because fire fighting
ranks among the most hazardous of all occupations, and interior
structural fire fighting is one of the most dangerous fire fighting
jobs (See, e.g., Jankovic et al. 1991). As the International
Association of Fire Chiefs (Ex. 54-328) pointed out, ``[t]he fire
fighter is usually operating in a hostile environment where normal
systems, facilities, processes and equipment to ensure safety have
already failed.'' A very basic difference between firefighters--
particularly those involved in fighting interior structural fires--and
employees in other occupations is that the work site is always new and
unknown. Firefighters do not report to a fixed location or work in a
familiar environment. Heat stress also affects firefighters differently
than other workers. Petrochemical workers and those in other high heat-
stress occupations, such as highway workers, can deal with issues such
as heat stress through other options, including acclimatization periods
for new employees, scheduling high exertion work at night, and allowing
frequent breaks (Smith 1996). Firefighters do not have these options.
Fire fighting is also extremely stressful mentally because of the
sense of personal danger and urgency inherent in search and rescue
operations. A firefighter regularly steps into situations that others
are fleeing, accepting a level of personal risk that would be
unacceptable to workers in most other occupations. Psychological stress
is caused by the firefighter's need to focus on the protection of lives
and property, as well as the need to maximize his or her own personal
safety and that of his/her coworkers. Tenants and others in the process
of being rescued have also been known to panic and attack firefighters
to obtain air from the firefighter's respirator in an attempt to save
their own lives (1994 NIOSH Alert).
Fire fighting is a high-risk occupation with a very narrow window
of survivability for those who lose their orientation or become
disabled on the job. The terrible toll among firefighters is recorded
in many different national data bases. For example, for the period
1980-1989, the NIOSH National Traumatic Occupational Fatalities (NTOF)
Surveillance System reported 278 deaths among firefighters caused just
by work-related traumatic injuries; NIOSH recognizes that this number
is an underestimate because of the collection and reporting methods
used by NTOF, which limit the kinds of events recorded. Data collected
by the IAFF for the period 1970-1994 report 1,369 firefighter deaths,
and data collected by the NFPA for the period 1990-1992 indicate that
280 firefighters died in this 2-year period alone (1994 NIOSH Alert).
OSHA believes that the requirements of this respirator standard may
prevent a significant number of these deaths and injuries. For example,
in a recent incident, a team of two firefighters was operating inside a
structural fire. Rapidly deteriorating conditions occurred in which
there was dense smoke. Confusion ensued and the team lost contact,
resulting in one firefighter death. (Incident number 2; OSHA
Investigations of Firefighter Fatalities; 10/1/91-3/17/97; IMIS) In
this situation, the need for additional accountability and monitoring
of firefighters during interior structural fire fighting is clear.
Multiple standby personnel and two-person teams inside an IDLH
atmosphere are therefore necessary to check for signs of heat stress,
other illnesses, disorientation, malfunctioning of respiratory and
other protective equipment, and to assist in exit or rescue when needed
(Smith, 1996).
OSHA emphasizes that the requirement for standby personnel does not
preclude the incident commander from relying on his/her professional
judgment to make assignments during a fire emergency. Although the
standard requires at least two standby persons during the attack on an
interior fire, there are obviously situations where more than two
persons will be required both inside and outside the interior
structure, a decision ultimately to be made by the incident commander.
In addition, as is the case under the previous respiratory protection
standard, one of the standby personnel may have other duties and may
even serve as the incident commander. According to OSHA's letter to
Chief Ewell, IFC, Oakland, CA, (J. Dear; 2/27/96), ``* * * one of the
two individuals outside the hazard area may be assigned more than one
role, such as incident commander in charge of the emergency or the
safety officer. However, the assignment of standby personnel of other
roles such as the incident commander, safety officer, or operator of
fire apparatus will not be permitted if by abandoning their critical
task(s) to assist in, or if necessary, perform a rescue clearly
jeopardizes the safety and health of any firefighter working at the
incident.'' OSHA has included specific guidance regarding other duties
of standby personnel under paragraph (g)(4). These duties are
consistent with OSHA's past enforcement policy and NFPA recommendations
(NFPA 1500, 1977 Edition; Section 6-4.4.2).
It is important to have at least two standby people available so
that in the event of an emergency in which both members of the interior
team need rescue or other assistance, adequate personnel are available
for rescue. As Harold A. Schaitberger testified, ``* * * The two-in/
two-out rule has been the industry standard in the fire service for
over 25 years. It is also based on common sense. If there are two
firefighters inside a burning building when a roof caves in, at least
two firefighters are required to assist and/or rescue them (Testimony
on H.R. 1783 before the Subcommittee on Economic and Educational
Opportunities, House of Representatives, 104th Congress (July 11, 1995,
Chairman: Cass Ballenger).'' Whenever possible, the use of the buddy
system should also be maintained during rescue operations.
Moreover, the ``two-in/two-out'' requirement does not take effect
until firefighters begin to perform interior structural fire fighting.
While the fire is in the incipient stage, the incident commander or
other person in charge may conduct an investigation or ``size up'' the
situation to determine whether the fire has progressed beyond the
incipient stage. During this investigative phase, the standard does not
require two-member teams inside and outside the structure. Similarly,
nothing in this rule is meant to preclude firefighters from performing
rescue activities before an entire team has assembled. If there are
fewer than four team members available, and an individual inside the
burning structure must be rescued immediately, this rule does not
prevent the rescue from occurring, as the Note to the regulatory text
makes clear. However, once firefighters begin the interior attack on an
interior structural fire, the atmosphere is assumed to be IDLH and
paragraph (g)(4) applies.
OSHA's requirement in no way is intended to establish staffing
[[Page 1248]]
requirements with regard to, for example, the number of persons on a
fire truck or the size of a fire company. Rather, the 2 in / 2 out
provision specifies only the number of firefighters who must be present
before the interior attack on an interior structural fire is initiated.
Firefighters may be assembled from multiple companies, or arrive at the
scene at various times. All that is intended is that an interior attack
should not be undertaken until sufficient staff are assembled to allow
for both buddy and standby teams.
These requirements are consistent with OSHA's past enforcement
policy. OSHA has relied on the NFPA recommendations as a basis for
determining an appropriate standard of care in fire fighting situations
under the General Duty Clause of the OSH Act, 29 U.S.C. 654(a)(1). In
its interpretative memoranda addressing requirements that are
applicable to firefighters, OSHA noted that occupational exposure to
fire is a well-recognized hazard, and that firefighters using SCBA in
hazardous atmospheres should be operating in a buddy system of two or
more personnel. The Agency explained that even under OSHA's previous
respiratory protection standard, a minimum of four personnel should be
used, with two members inside the hazardous area and two members
outside the hazardous area who are available to enter the area to
provide emergency assistance or rescue if needed. One memorandum also
pointed out that there was no prohibition against the outside standby
personnel having other duties, such as functioning as incident
commander or safety officer, as long as it would not jeopardize the
safety and health of any firefighter working at the incident if the
standby personnel left those duties to perform emergency assistance and
rescue operations.
OSHA notes that the requirements of paragraph (g)(4) apply in
addition to the requirements of OSHA's specific fire protection
standards, subpart L of 29 CFR 1910. OSHA intends to begin negotiated
rulemaking on those fire protection standards in the near future.
Paragraph (h)--Maintenance and Care of Respirators
This final standard for respiratory protection, in paragraph (h),
addresses the elements of respirator maintenance and care that OSHA
believes are essential to the proper functioning of respirators for the
continuing protection of employees. As OSHA stated in the preamble to
the NPRM (59 FR 58923), ``a lax attitude toward this part of the
respiratory protection program will negate successful selection and fit
because the devices will not deliver the assumed protection unless they
are kept in good working order.'' The maintenance and care provisions,
which are divided into cleaning and disinfecting, storage, inspection,
and repair, are essentially unchanged (with the exception of the
cleaning and disinfecting provisions) from paragraph (f) of OSHA's
prior respiratory protection standard. Some rearrangement and
consolidation of the regulatory text and minor language changes have
been made to this paragraph to simplify and clarify the requirements as
a result of comments and concerns that were raised in response to the
proposed rule.
Paragraph (h)(1) of the final standard requires that employers
provide each respirator wearer with a respirator that is clean,
sanitary, and in good working order. It further requires that employers
use the procedures for cleaning and disinfecting respirators described
in mandatory Appendix B-2 or, alternatively, procedures recommended by
the respirator manufacturer, provided such procedures are as effective
as those in Appendix B-2. The prior respiratory protection standard
required that employers clean and disinfect respirators in accordance
with the maintenance and care provision of paragraph (f), but offered
no specific guidance on how to perform these procedures. Mandatory
Appendix B-2 presents a method employers may use to comply with the
cleaning and disinfecting requirements of final paragraph (h)(1). The
procedures listed in Appendix B-2 were compiled from several sources,
including publications of the American Industrial Hygiene Association,
ANSI Z88.2-1992 (clause A.4, Annex A), and NIOSH. Other methods may be
used, including those recommended by the respirator manufacturer, as
long as they are equivalent in effectiveness to the method in Appendix
B-2. Equivalent effectiveness simply means that the procedures used
must accomplish the objectives set forth in Appendix B-2, i.e., must
ensure that the respirator is properly cleaned and disinfected in a
manner that prevents damage to the respirator and does not cause harm
to the user.
Several commenters (Exs. 54-267, 54-300, 54-307) supported the
cleaning and disinfecting provisions in general and the inclusion of
manufacturers' instructions in particular. The American Iron and Steel
Institute (AISI), for example, suggested the following language:
``Respirators must be cleaned and maintained in a sanitary condition.
The cleaning procedures recommended by the respirator manufacturer or
in Appendix B, or a recognized standard-setting organization should be
followed'' (Ex. 54-307).
The need for appropriate cleaning and disinfecting procedures was
also supported during the hearings. For example, James Johnson of
Lawrence Livermore National Laboratories testified:
[P]rocedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, or otherwise maintaining respirators * * *
are elements of the respiratory protection program which are
important and are addressed in the rule * * *. I did some personal
evaluation on the disinfecting procedures recommended by several
U.S. respirator manufacturers. I found that they vary significantly.
If you look in Appendix B of the proposed rule, the hypochlorite or
bleach recommendation and the other disinfectants outlined there are
certainly what is typically recommended and used (Tr. 184).
The Appendix B-2 procedures can be used both with manual and semi-
automated cleaning methods, such as those using specially adapted
domestic dishwashers and washing machines. As with most effective
cleaning procedures, Appendix B-2 divides the cleaning process into
disassembly of components, cleaning and disinfecting, rinsing, drying,
reassembly and testing. Recommended temperatures for washing and
rinsing are given in Appendix B-2, as are instructions for preparing
effective disinfectants.
OSHA has made minor changes to the contents of Appendix B-2 in the
final standard. For example, the cleaning procedures listed in the
final rule are more consistent with the procedures suggested in Clause
A.4, Annex A of the ANSI Z88.2-1992 standard than those proposed,
particularly with regard to the temperatures recommended to prevent
damage to the respirator. Additionally, automated cleaning, which is
now being used by many larger companies, is allowed as long as
effective cleaning and disinfecting solutions are used and recommended
temperatures, which are designed to prevent damage to respirator
components, are not exceeded.
Commenters (Exs. 54-91, 54-187, 54-330, 54-389, 54-309, Tr. 695)
generally supported the need for a respirator maintenance program but
took differing approaches to the provisions proposed in paragraph
(h)(1) (i)-(iii) dealing with the frequency of cleaning and
disinfecting respirators. One commenter (Ex. 54-187) agreed with the
provisions as proposed. Others (Exs. 54-208, 54-67, 54-91, 54-408)
recommended a more performance-oriented approach.
[[Page 1249]]
For example, Darell Bevis of Bevis Associates International objected to
the proposed requirement that respirators that are issued for the
exclusive use of an employee be cleaned and disinfected daily by
stating:
[D]iffering workplace conditions will require that cleaning and
disinfection may be required more frequently or even less frequently
than daily. A requirement for daily cleaning when unnecessary
results in considerable additional respirator program costs with no
benefit. A more realistic and still enforceable requirement would be
routinely used respirators issued for the exclusive use of an
employee shall be cleaned and disinfected as frequently as necessary
to ensure that the user has a clean, sanitary, properly functioning
respirator at all times (Tr. 695).
Other commenters (Exs. 54-67, 54-91, 54-234, 54-271, 54-278, 54-
286, 54-289, 54-293, 54-334, 54-350, 54-374, 54-424, 54-435, Ex. 163)
also objected to cleaning and disinfecting respirators at the end of
each day's use if the respirator is issued for the exclusive use of a
single employee. These comments were in general agreement with the
American Industrial Hygiene Association's statement:
The performance-oriented language of the existing standard is
more reasonable [than the proposed language]. Cleaning and
disinfecting of individually assigned respirators should be done
``as needed'' to assure proper respirator performance and to
preclude skin irritation or toxicity hazards from accumulation of
materials. Disinfecting an individually issued respirator is
probably not necessary at all unless the ``contaminant'' is
biological in nature (Ex. 54-208).
Several other commenters (See, e.g., Exs. 54-330, 54-389, 309) were
in favor of cleaning individually assigned respirators at the end of
each day's use, but recommended disinfecting or sanitizing only after
longer periods or when necessary. Michael Laford, Manager of Industrial
Hygiene and Safety at Cambrex, commented as follows:
It is important to clean all personal protective equipment,
preferably after each use as needed, and not just once a day.
However, is the additional requirement for daily disinfection * * *
where respirators are individually assigned, supported with valid
studies or data? In the absence of data that supports a real benefit
of this requirement, the language should revert to ``periodic''
disinfecting of respirators (Ex. 54-389).
The need for flexibility with respect to maintaining clean and
sanitary respirators was also discussed during the hearings. For
example, in response to a question asked by a member of the OSHA panel
regarding how often a respirator mask should be cleaned, James Centner,
Safety and Health Specialist with the United Steel Workers of America
(USWA), replied that it depended on the length of time the respirator
is worn and the workplace conditions. He stated, ``If you're working in
a smelter where it's hot and dirty and dusty, workers probably need to
take that respirator off about every 30 minutes and do a good, thorough
job of washing the grit and dirt off their face and . . . do a quick
maintenance clean-up job on the sealing surface of the respirator so it
maintains an adequate fit'' (Tr. 1068). Darell Bevis of Bevis
Associates International (Tr. 747-748) responded similarly when asked
this question; he contrasted dusty workplaces, such as fossil fuel
power generation plants where respirators become filthy with hazardous
particulates, to workplaces involving exposure only to gases and vapors
where respirators may remain clean for long periods.
OSHA agrees with these commenters that the necessary frequency for
cleaning a respirator can range from several times a day to less than
daily. Therefore, OSHA has restated paragraph (h)(1)(i) in performance-
based language, which will provide employers with flexibility in
maintaining clean and sanitary respirators when the respirator is used
exclusively by a single employee. Final paragraph (h)(1)(i) now reads
as follows: ``Respirators issued for the exclusive use of an employee
shall be cleaned and disinfected as often as necessary to be maintained
in a sanitary condition.'' Final paragraph (h)(1)(i) is complemented by
the respirator use provision in final paragraph (g)(2)(ii)(A), which
requires that employers ensure that workers leave the respirator use
area to wash their faces as necessary to prevent eye or skin
irritation. OSHA believes that compliance with final paragraphs
(h)(1)(i) and (g)(2)(ii)(A), as well as the training provisions in
paragraph (k) regarding maintenance of the respirator, will provide
effective employee protection against hazardous substances that
accumulate on the respirator, interfere with facepiece seal, and cause
irritation of the user's skin.
Proposed paragraphs (h)(1)(ii)-(iii) specified that respirators
used by more than one employee or respirators issued for emergency use
be cleaned and disinfected after each use and were the subject of a
number of comments (See, e.g., Exs. 54-67, 54-234, 54-361, 54-408, 54-
424 and Tr. 695). For example, the Service Employees International
Union (Ex. 54-455) suggested that OSHA replace the phrase ``after each
use'' with ``before they are worn by another user.'' OSHA agrees with
this suggestion as it applies to the shared use of respirators in non-
emergency situations, and has revised final paragraph (h)(1)(ii) to
require cleaning and disinfecting of respirators prior to their use by
other individuals. OSHA believes that this modification provides
flexibility in those areas where respirators are assigned to more than
one employee. This requirement is also consistent with the parallel
provision of ANSI Z88.2-1992. However, if the respirator is to be used
in an emergency situation, it should be in a clean and sanitary
condition and immediately ready for use at all times. Emergency
personnel cannot waste time cleaning and sanitizing the respirator
prior to responding to an emergency. Thus, if the respirator is one
that is maintained for emergency use, the final standard in paragraph
(h)(1)(iii) retains the requirement to clean and disinfect the
respirator after each use.
Final paragraph (h)(1)(iv) requires the cleaning and disinfecting
of respirators used in fit testing and training exercises. This
provision was added in response to a recommendation made by the Public
Service Company of Colorado (Ex. 54-179) that respirators be cleaned
and disinfected after each fit test. Additionally, representatives of
Electronic and Information Technologies (Ex. 54-161) pointed out that,
although the proposal addressed cleaning and disinfecting procedures
for respirators worn during routine and emergency use, it did not
specify how respirators should be cleaned/disinfected during fit
testing or training activities. Since these conditions involve shared
use, OSHA has emphasized in final paragraph (h)(1)(iv) the need to
properly clean and disinfect or sanitize respirators used for training
and fit testing after each use.
OSHA noted in the proposal that it was not stating who should do
the cleaning and disinfecting, only that it be done (59 FR 58924).
However, as with all other provisions of the standard, the employer is
responsible for satisfying the cleaning and disinfecting requirements.
The final standard requires that the employer ensure that cleaning is
done properly, and that only properly cleaned and disinfected
respirators are used. The employer is allowed to choose the cleaning
and disinfecting program that best meets the requirements of the
standard and the particular circumstances of the workplace. Richard
Uhlar, an industrial hygienist for the International Chemical Workers
Union (ICWU), commented that workers should be given paid time to
clean, disinfect, and inspect respirators; otherwise, in the view of
[[Page 1250]]
this commenter, respirators will not be taken care of properly (Ex. 54-
427). OSHA notes that if the employer elects to have employees clean
their own respirators, the employer must provide the cleaning and
disinfecting equipment, supplies, and facilities, as well as time for
the job to be done.
Commenting on a preproposal draft of the standard, the United
Steelworkers of America (USWA) (Ex. 36-46) recommended that OSHA
require the employer to clean and repair respirators. The USWA stated
that programs in which employers require employees to return their
respirators at the end of each shift to a central facility for
inspection, cleaning, and repairs by trained personnel are more
effective than programs in which employees are responsible for cleaning
their own respirators. OSHA agrees that such a centralized cleaning and
repair operation can ensure that properly cleaned and disinfected
respirators are available for use, but this approach is not the only
way to fulfill this requirement. For example, central facilities may be
inappropriate in workplaces where respirator use is infrequent, or
where the number of respirators in use is small.
Final paragraph (h)(2), which establishes storage requirements for
respirators, does not differ substantively from the corresponding
requirements in the proposal. However, some of the proposed provisions
have been consolidated to simplify understanding and interpretation of
the requirements. Final paragraph (h)(2)(i) sets forth the storage
requirements for all respirators, while final paragraph (h)(2)(ii)
addresses additional requirements for the storage of emergency
respirators. Specifically, final paragraph (h)(2)(i) requires that all
respirators be stored in a manner that protects them from damage,
contamination, harmful environmental conditions and damaging chemicals,
and prevents deformation of the facepiece and exhalation valve.
Respirators maintained for emergency use also must be stored in
accordance with the requirements of final paragraph (h)(2)(i) and, in
addition, must be kept accessible to the work area, be stored in
compartments or covers that are clearly marked as containing emergency
respirators, and be stored in accordance with any applicable
manufacturer's instructions (paragraph (h)(2)(ii)).
There was general support in the record for the performance
approach that OSHA took in the proposal with regard to storage
requirements. For example, the Industrial Safety Equipment Association
(ISEA) commented: ``[B]ecause the degree of severity of an
environmental condition that would cause deterioration would be related
to the tolerance of the particular equipment in question and would thus
vary from model to model, there is no need to specify conditions of
storage in more detail'' (Ex. 54-363). The comment submitted by the
Mobil Oil Corporation (Ex. 54-234) agreed with OSHA's proposed approach
on respirator storage, but went further to state that ``[t]o place
storage requirements in specific language may actually contradict
specific recommendations of the manufacturer.'' Other commenters also
supported OSHA's provisions as proposed (See Exs. 54-172, 54-250, 54-
273, 54-408, 54-424, and 54-455).
There were, however, some suggested changes that commenters
believed would clarify final paragraph (h)(2). One commenter (Ex. 54-
32) suggested that, in addition to requirements for accessibility and
maintenance of emergency respirators, there should be a requirement for
specific `` awareness training'' to remind employees of the location of
such respirators. OSHA agrees that such knowledge is vital. The
training specified in paragraph (k), especially the provisions on how
to use a respirator in emergency situations (final paragraph
(k)(1)(iii)) and procedures for the maintenance and storage of
respirators (final paragraph (k)(1)(v)), are designed to do this. In
addition, paragraph (k) requires that employers retrain employees where
it appears necessary to do so to ensure safe respirator use.
Two commenters recommended that employees, rather than employers,
be held responsible for cleaning, sanitizing, and storing their
respirators. The Grain Elevator and Processing Society (Ex. 54-226)
recommended that, for most operations, the maintenance and care of
respirators should be the responsibility of the employee once the
employee has been trained. In another comment specific to the storage
provision, the American Petroleum Institute (Ex. 54-330) pointed out
that employers generally do not store respirators; instead, respirator
storage is the responsibility of the employee. In response, OSHA notes
that section 5(a)(2) of the OSH Act and case law interpreting that
provision have specifically placed the burden of complying with safety
and health standards on the employer because the employer controls
conditions in the workplace. The employer is, therefore, responsible
for the results of actions taken by others at the direction of the
employer. For example, although an employee may physically store a
respirator, a contractor may perform a fit test, or a physician may
examine an employee at the employer's direction, the employer is
ultimately responsible for ensuring that these actions are taken to
comply with the standard.
Proposed paragraph (h)(2)(ii) would have required that compartments
be built to protect respirators that are stored in locations where
weathering, contamination, or deterioration could occur. The
Westminster, Maryland Fire Department (Ex. 54-68) raised the following
concern about this proposed provision:
This requirement may be appropriate for manufacturing but is not
practical given the operations of the fire service. * * * As OSHA is
aware the fire service maintains its breathing apparatus in a ready
posture on the apparatus. To require the apparatus to be placed in a
compartment would eliminate the precious time saved by donning the
apparatus enroute to the emergency. This operation has been the
backbone of our efficiency at rescue and suppression operations.
Similar concerns were raised by the National Volunteer Fire Council
(Tr. 499) and the Connecticut Fire Chiefs' Association, Inc. (Ex. 180).
In response to these concerns, OSHA has crafted language that the
Agency believes fulfills the purpose of this provision and maintains
the efficiency of emergency response workers such as firefighters.
Instead of requiring emergency respirators to be stored only in
compartments, final paragraph (h)(2)(ii)(B) permits them alternatively
to be stored in covers that are clearly marked as containing emergency
respirators. Walk-out brackets with covers that are mounted on a wall
or to a stable surface (e.g., on a fire truck) may be used so long as
the respirator is covered to prevent damage when not in use. Because a
cover can be removed in seconds, OSHA believes that this change
addresses the needs of firefighters and other emergency responders. It
is important that the walk-out brackets are mounted within the vehicle.
For example, they can be mounted directly to the fire truck to enable
firefighters to rapidly don the respiratory equipment when needed.
However, any means of storage used must be secure. If walk-out brackets
are not mounted, there is a danger that the unsecured respirators could
become damaged as a result of vehicle motion.
Final paragraph (h)(3) requires regular inspections to ensure the
continued reliability of respiratory equipment. The frequency of
inspection and the procedures to be followed depend on whether the
respirator is intended for non-emergency, emergency, or escape-only
use.
[[Page 1251]]
Final paragraph (h)(3)(i)(A) requires respirators for use in non-
emergency situations to be inspected before each use and during
cleaning. For respirators designated for use in an emergency situation,
final paragraph (h)(3)(i)(B) requires that they be inspected at least
monthly and in accordance with the manufacturer's instruction. In
addition, emergency respirators must be examined to ensure that they
are working properly before and after each use. Examining respirator
performance before and after each use is not intended to be as
extensive and thorough a process as respirator inspection. A basic
examination conducted prior to each use will provide assurance to the
wearer that the respirator which he/she is about to don in an emergency
situation will work properly, e.g., that the cylinders on the SCBA are
charged, that air is available and flowing. This examination can be
done fairly quickly, and OSHA believes that this added measure of
employee protection is both necessary and appropriate.
Respirators used for escape only are to be inspected prior to being
carried into the workplace (paragraph (h)(3)(i)(C)). The Dow Chemical
Company (Ex. 54-278) addressed the inspection of emergency escape
respirators, stating, ``Emergency escape respirators such as mouthbit
respirators, usually stored in the box or bag they come in, do not need
to be inspected monthly.'' OSHA agrees with this statement. Mouthbit or
other emergency escape respirators are carried by an individual worker
into the workplace for personal use in an emergency, and must be
inspected for proper condition prior to being carried into the
workplace. Additional monthly inspections of emergency escape
respirators that are stored for future use are unnecessary, since they
will be inspected prior to being carried into the workplace. Final
paragraph (h)(3)(i)(C) therefore specifies that ``escape-only''
respirators need only be inspected before being carried into the
workplace.
Although no commenters were opposed to the inspection requirements,
some participants raised the issues that are discussed below with
respect to inspection frequency and procedures. When respirators are
inspected, the final rule (paragraph (h)(3)(ii)(A)) requires that the
inspection include an examination to ensure that respirators are
working properly, including an examination of the tightness of
connections and the condition of the various components. Two comments
were made with respect to respirator inspection procedures. John Clarke
of Electronic and Information Technologies (Ex. 54-162) stated that
checking for proper function (examination to ensure that respirators
work properly) presents a dilemma if use is to include sanitizing the
facepiece. He pointed out that SCBAs reserved for use by multiple
persons presents a special problem. Likewise, John O'Green of American
Electric Power (Ex. 54-181) asked that ``functional check'' be better
defined and clarified. He stated that requiring the actual activation
of the respirator, including the flow of air to the facepiece, could be
time consuming for all the emergency respirators in their facilities.
OSHA does not intend that the respirator be physically placed on the
employee to examine the respirator to ensure that it is working
properly. Visual inspection can detect factors that would interfere
with proper performance, e.g., distortion in shape (often the result of
improper storage), missing or loose components, blockage, and improper
connections. Alarms can also be examined without actually putting the
respirator on the employee. In addition, examining elastomer parts for
pliability and signs of deterioration, as required by final paragraph
(h)(3)(ii)(B), can be performed without wearing the respirator.
Under paragraph (h)(3)(iii) of the final rule, SCBAs must be
inspected monthly. The employer must ensure that the cylinders are
fully charged. Recharging is required when the pressure falls below 90
percent of the manufacturer's recommended pressure level. The
Westminster, Maryland Fire Department (Ex. 54-68) strongly recommended
that the apparatus be inspected at the beginning of each shift or
workday rather than monthly. OSHA notes that the final rule specifies
only the minimum requirements for an effective respiratory protection
program. Employers, however, are encouraged to exceed these minimum
criteria if, by doing so, employee protection and operating efficiency
are enhanced.
The final provision for recharging air and oxygen cylinders for
SCBAs in paragraph (h)(3)(iii) is unchanged from proposed paragraph
(h)(3)(i)(C). Although no commenters disagreed with this provision as
proposed, a few commenters (Exs. 54-6, 54-220) asked OSHA to clarify
the requirement that SCBA equipment be maintained in a fully charged
state and recharged when the pressure falls to 90% or less of the
manufacturer's recommended pressure level. By way of example, OSHA
notes that if the manufacturer states that the cylinder is fully
charged at 100 psi, the cylinder must be recharged when the pressure
falls to 90 psi (i.e., 90% of the fully charged level). The 90 percent
level was selected to ensure that sufficient air remains in the
cylinder to allow emergency responders to perform their required duties
in a contaminated or oxygen-deficient atmosphere and still have
sufficient air available to escape from these conditions. The 90
percent level, and the requirement that cylinders be recharged once the
pressure falls below 90 percent, was also recommended by the American
Industrial Hygiene Association (Ex. 54-208).
In two separate submissions to the record (Exs. 54-121 and 54-135),
Consolidated Engineering Services asked what type of training is
required for employees who inspect respirators used for emergency
response. OSHA notes that, under final paragraph (k), the specifics of
an appropriate training program are left to the discretion of the
employer. Regarding respirators for emergency use, final paragraph
(k)(1)(iii) requires that employees be trained in how to use the
respirator effectively in emergency situations, while final paragraph
(k)(1)(iv) requires training on how to inspect the respirator. As these
paragraphs make clear, OSHA requires the employer to develop
appropriate training programs for employees who inspect emergency
respirators.
As part of the inspection process for respirators that are
maintained for use in emergencies, paragraph (h)(3)(iv) of the final
standard requires certification of the inspection. Documentation of
certification includes the date of inspection, the name or signature of
the inspector, the findings of the inspection, any required remedial
action, and a serial number or other means of identifying the inspected
respirator. This information must be tagged to the respirator or its
storage compartment, or otherwise stored in the form of inspection
reports (i.e., paper or electronic), and be maintained until replaced
following a subsequent certification.
This requirement was included in the proposal, and several comments
addressed it. Dow Chemical (Ex. 54-278) stated that it supports the
proposed requirement. The American Petroleum Institute (Ex. 54-330)
recommended that OSHA require ``identification of the person that made
the inspection'' in lieu of a signature. However, OSHA believes that
the inspector's name or signature is a clear and precise
identification, and therefore has retained this requirement in the
final rule as proposed.
The final provision of paragraph (h) deals with respirator repairs
and adjustments. Final paragraph (h)(4) provides that respirators that
fail
[[Page 1252]]
inspections, or are otherwise defective, are to be removed from service
and discarded, repaired, or adjusted according to the specified
procedures. In addition, the employer shall ensure that repairs or
adjustments to respirators are made only by persons appropriately
trained to do so, and that they use only the respirator manufacturer's
NIOSH-approved parts that are designed for the particular respirator.
The repairs also must be made in accordance with the manufacturer's
recommendations and specifications. Because components such as reducing
and admission valves, regulators, and alarms are complex and essential
to the safe functioning of the respirator, they are required to be
adjusted and repaired only by the manufacturer or a technician trained
by the manufacturer.
Several comments were submitted to the record regarding this
particular provision. Consolidated Engineering Services (Exs. 54-121
and 54-135) and the Florida Department of Labor and Employment Security
(Ex. 54-79) asked what type of training is required for employees who
repair and adjust respirators. Motorola (Ex. 54-187) also addressed
this point, but added that specialized training for most respirator
repair work was not necessary, and that the training program required
by the standard should provide employees with sufficient expertise to
perform the necessary repair work, or at least to recognize when repair
is beyond their ability. Another commenter (Ex. 54-293) asserted that,
depending on the manufacturer's recommendation, a trained person may or
may not be necessary to make repairs; for example, no training is
required to replace a broken respirator strap.
In response to these concerns, OSHA does not believe that it is
necessary or appropriate to specify in detail in the final rule the
type of training that is required to qualify a person to repair and
adjust respirators. However, because of the important health-related
functions of respirators, the person making the repair needs to be
properly trained. OSHA expects that such repair will often be performed
by the manufacturer, particularly if special expertise is required.
Where this is not the case, the employer must ensure that the employee
or person repairing the respirator has the skills necessary to conduct
the appropriate repair and adjustment functions. The use of the term
``appropriately trained'' refers to an individual who has received
training from the respirator manufacturer or otherwise has demonstrated
that he/she has the skills to return the respirator to its original
state of effectiveness.
The AFL-CIO (Ex. 54-428) and Service Employees International Union
(SEIU) (Ex. 54-455) recommended that OSHA require employers to tag as
``out of service'' those respirators that fail inspections. OSHA agrees
that some means must be available for ensuring that only properly
functioning respirators are introduced into the workplace. However,
OSHA believes that the decision on how to handle respirators that fail
inspection is most appropriately addressed in the employer's respirator
protection program, as required under final paragraph (c).
Specifically, final paragraph (c)(1)(v) would allow such procedures to
be tailored to satisfy the needs of a particular workplace.
The SEIU (Ex. 54-455) recommended that OSHA require employers to
keep an adequate supply of cartridges and other routine replacement
parts in stock and readily accessible to employees so that they can
replace needed parts. OSHA does not believe it is necessary to specify
that employers must maintain an adequate number of spare parts. Final
paragraph (h)(4) requires that defective respirators be removed from
service unless they are repaired or adjusted, and an employer who does
not keep on hand sufficient parts to allow respirators to be repaired
will need to remove those respirators from service until suitable
repairs can be made. Thus, an employer who does not maintain an
adequate inventory of parts will either need to keep extra respirators
on hand or cease operations that require respirator use until parts can
be obtained or installed.
Paragraph (i)--Breathing Air Quality and Use
This paragraph of the respiratory protection standard requires that
breathing air for atmosphere-supplying respirators be of high purity,
meet quality levels for content, and not exceed certain contaminant
levels and moisture requirements. The paragraph sets performance
standards for the operation and maintenance of breathing air
compressors and cylinders, establishes methods for ensuring breathing
air quality, and sets requirements for the quality of purchased
breathing air.
Paragraph (i)(1) of the final standard applies to atmosphere-
supplying respirators that are being used to protect employees, and
requires that breathing air supplied to these respirators be of high
purity. This same requirement for breathing air quality was included in
proposed paragraph (i)(1). Both the prior and final rules refer to a
number of standard references that establish parameters for breathing
air quality. For example, under (i)(1)(i), the final rule requires the
employer to ensure that oxygen used for breathing purposes meets the
requirements of the United States Pharmacopoeia (USP) for medical or
breathing oxygen. This provision is the same as the requirement in
OSHA's prior respiratory protection standard at paragraph (d)(1). The
ANSI Z88.2-1992 respirator standard, in Clause 10.5.1, also requires
that air be of high purity and that oxygen meet the USP requirements.
Inclusion of this requirement in the final rule was strongly supported
by the AFL-CIO (Ex. 54-428), which stated that the employer must ensure
that ``compressed air, compressed oxygen, liquid air, and liquid oxygen
used for respiration is of high purity and in accordance with the
specifications listed in [proposed paragraph] (i)(1).''
Under paragraph (i)(1)(ii) of the final standard, breathing air
must meet at least the requirements for Type I--Grade D breathing air,
as described in the ANSI/CGA G-7.1-1989 standard, which is the latest
revision of that reference standard and the one currently used by OSHA
when determining breathing air quality. Final paragraph (i)(1)(ii)
identifies the specifications for the contents of Grade D breathing
air: oxygen content (volume/volume) of 19.5 to 23.5 percent;
hydrocarbon (condensed) concentration of five milligrams or less per
cubic meter of air; carbon monoxide level of 10 ppm or less; carbon
dioxide level of 1,000 ppm or less; and a lack of noticeable odor.
The OSHA respiratory protection standard adopted in 1971 referenced
the then-current CGA G-7.1-1966 breathing air quality standard. In
1973, and again in 1989, the CGA, in conjunction with ANSI, revised the
G-7.1 standard. The Grade D specification was changed as part of the
1989 ANSI revision, at which time the carbon monoxide level was reduced
from 20 ppm to 10 ppm. The OSHA Directorate of Compliance Programs
subsequently issued letters of interpretation in 1991 and 1992 that
required employers to use the updated Grade D specifications for
breathing air quality.
The proposal requested comments on whether acceptable respirator
breathing air quality should continue to meet the specifications for
Grade D breathing air described in the ANSI/CGA G 7.1-1989 standard.
Commenters supported inclusion of a requirement for use of the 1989
Grade D breathing air values in the final rule (Exs. 54-141, 54-189,
54-267, 54-286, 54-408, 54-443). For example, the Tennessee Valley
Authority (Ex. 54-189) and Norfolk Southern (Ex. 54-267)
[[Page 1253]]
supported the Grade D breathing air requirement, stating that, in their
experience, the Grade D air they have been using is fully adequate and
safe, and that OSHA should not adopt more stringent requirements across
the board.
Modern Safety Techniques, Inc. (Ex. 54-141) supported maintaining
the Grade D breathing air quality requirement but recommended that the
OSHA rule not specify the year of the ANSI/CGA standard, because, for
example, employers were confused when the CGA revised the ANSI/CGA G-
7.1 standard in 1989 and the OSHA standard referred to an earlier
version of that standard. However, the regulations governing the
incorporation of documents by reference (1 CFR 51) require that the
revision date of incorporated references be specified when they are
included in any new or revised standard. Where incorporated references
are used in final paragraph (i), therefore, the latest revision dates
for these references have been used.
The Los Alamos National Laboratory (LANL) (Ex. 36-52) recommended
that Grade E air rather than Grade D air be used since most air that
passes the Grade D requirements will also pass Grade E requirements.
The Grade E specifications narrow the range of permitted oxygen content
from 19.5-23.5 percent to 20 to 22 percent oxygen and lower the
allowable carbon dioxide level from 1000 ppm to 500 ppm. LANL gave no
specific safety or health reason for OSHA to adopt this more stringent
recommendation. The Service Employees International Union (Ex. 54-455),
however, points out that Grade E air of reliable quality may be
difficult for employers to obtain. In addition, OSHA is not aware of
any problems that have occurred as a result of breathing Grade D air,
and believes that the Grade D specifications will fully protect
employees who use atmosphere-supplying respirators. Therefore, OSHA is
not convinced a higher grade of air is required, and the final rule
specifies Grade D air.
OSHA has been informed that NIOSH has been working with the
National Aeronautics and Space Administration (NASA) on a new ``liquid
air SCBA'' that may be submitted for NIOSH certification in the future.
In its revision of the 42 CFR 84 respirator certification standard,
NIOSH incorporated the CGA Commodity Specification for Air in the CGA's
G-7.1-1966 standard to maintain the quality verification category for
Type II liquid compressed air, which had been removed from the updated
ANSI/CGA G-7.1-1989 standard. NIOSH included this specification because
a liquid compressed air quality category is needed for future
evaluations of atmosphere-supplying respirators that use liquefied
compressed air. NIOSH continues to recommend the use of the ANSI/CGA G-
7.1-1989 standard for breathing air quality for currently issued
respirator certifications.
Under paragraph (i)(2) of the final standard, employers are
prohibited from using compressed oxygen in atmosphere-supplying
respirators, including open-circuit SCBAs, that have previously used
compressed air. This prohibition was proposed in the NPRM, and is
intended to prevent the fires and explosions that could result if high
pressure oxygen comes into contact with oil or grease that has been
introduced to the respirator or the air lines during compressed air
operations. Comments to the record (Exs. 10, 54-165, 54-208, 54-218)
support this provision. Additionally, the prohibition is consistent
with Clause 10.5.2 of the ANSI Z88.2-1992 standard.
Proposed paragraph (i)(3) would have prohibited the use of oxygen
with supplied air respirators. This provision was intended to avoid the
possibility of fires and explosions that can result when oxygen is used
in high concentrations. However, some respiratory equipment is
specifically designed to avoid fire and explosion hazards when used
with oxygen in concentrations greater than 23.5%. Therefore, paragraph
(i)(3) of the final standard specifies that oxygen in concentrations
greater than 23.5% is to be used only with equipment designed
specifically for oxygen service or distribution. Several commenters
pointed out the need to specify a maximum oxygen concentration (Exs.
54-165, 54-208, 54-218, 54-219). Clause 10.5.2 of the ANSI Z88.2-1992
standard (Ex. 81) also states, ``Oxygen concentrations greater than
23.5% shall be used only in equipment designed for oxygen service or
distribution.'' OSHA agrees with the recommendations made by the AIHA
(Ex. 54-208), 3M (Ex. 54-218), and Monsanto (Ex. 54-219) that the final
rule adopt the maximum oxygen concentration language from the ANSI
standard, and the final rule reflects this recommendation.
Final paragraph (i)(4) requires that breathing air for respirators
provided from cylinders or air compressors meet certain minimum
standards. Under final paragraph (i)(4)(i), cylinders must be tested
and maintained as prescribed in the Shipping Container Specification
Regulations of the Department of Transportation (DOT) (49 CFR parts 173
and 178); these DOT regulations are also required for NIOSH respirator
certification. The DOT regulations in parts 173 and 178 cover the
construction, maintenance, and testing of these compressed air
cylinders, and are necessary to prevent the explosions that can result
if high pressure breathing air cylinders rupture. The proposal
referenced only 49 CFR part 178, but the AIHA (Ex. 54-208) recommended
that the DOT requirements found in 49 CFR part 173 also be specified in
the final rule because they apply to breathing air cylinders. Final
paragraph (i)(4)(i) therefore includes a reference to part 173 in
addition to part 178.
Paragraph (i)(4)(ii) of the final standard includes a provision
requiring employers to ensure that cylinders of purchased breathing air
are accompanied by a certificate from the supplier stating that the air
meets the requirements for Type 1-Grade D breathing air contained in
paragraph (i)(1)(ii) of the final standard. Employers must obtain a
certificate of analysis of purchased breathing air from the supplier to
ensure that its content and quality meet the requirements for Grade D
breathing air. This will allow the employer to have assurance that the
purchased breathing air being used by employees is safe. The proposal
did not include a requirement for the certification of the quality of
purchased breathing air. There was, however, support in the record
(Exs. 54-234, 54-266, 54-273, 54-330, 54-408) for adding this
requirement. For example, the American Petroleum Institute (Ex. 54-330)
and Duquesne Light Company (Ex. 54-408) recommended that additional
guidance, similar to that in ANSI Z88.2-1992, be provided to ensure the
quality of purchased breathing air. Exxon (Ex. 54-266) stated that OSHA
should not allow the direct blending of compressed nitrogen and oxygen
gases by the employer to produce Grade D air, citing the ``extreme
consequences of having too little oxygen in a cylinder.'' Exxon further
recommended that 100% of the cylinders be tested for oxygen content for
all nitrogen/oxygen mixed cylinders (Ex. 54-266). The requirement that
the employer obtain a certificate of analysis of purchased breathing
air means that every cylinder will have been analyzed for oxygen
content by the supplier and, therefore, the situation feared by Exxon
will not arise.
Final paragraph (i)(4)(iii) requires that the moisture content of
compressed air in air cylinders not exceed a dew point of -50 deg. F
(-45.6 deg. C) at one atmosphere of pressure. This requirement will
prevent respirator valves from freezing, which can occur when excess
moisture accumulates on the valves. This provision has been revised
from the proposed requirement to be consistent
[[Page 1254]]
with the latest versions of the standard references for moisture
content of compressed breathing air, the ANSI Z88.2-1992 and ANSI/CGA
G-7.1-1989 standards. Consistency between the required value and the
standard references will avoid confusion in measuring moisture content
and, consequently, will enhance employee protection. This dew point
value, as the AIHA (Ex. 54-208) recommended, has been taken from the
ANSI/CGA G-7.1-1989 specifications for Grade D air and replaces the 27
ml/m3 value for moisture content specified in the proposal.
Final paragraph (i)(5)(i) requires that compressors that supply
breathing air are to be constructed and situated so that contaminated
air cannot enter the air supply system. This provision from the prior
standard is retained and also reflects the intent of the proposed
requirement. The purity of the air entering the compressor intake is a
major factor in the purity of air delivered to the respirator user. The
location of the intake is most important, and must be in an
uncontaminated area where exhaust gases from nearby vehicles, the
internal combustion motor that is powering the compressor itself (if
applicable), or other exhaust gases being ventilated from the plant
will not be picked up by the compressor air intake. Contaminated air or
exhaust gases from internal combustion engines that are taken into the
compressor are major hazards to the purity of breathing air from
compressors, and these hazards occur with all compressors, not just
oil-lubricated ones. Respirator users have died or been injured when
the air intake was not properly located to avoid contaminants. Final
paragraph (i)(5)(i), therefore, requires that air intakes for all
compressors be located in a way that avoids entry of any contaminated
air into the compressor.
Support for this requirement can be found in the Distler air
compressor study (Ex. 32-1). This study recommended that engine exhaust
gases should be piped upward or downwind from the compressor air
intake, particularly where exhaust gases are not reliably dispersed,
such as in partially enclosed spaces or in turbulent wind areas. The
compressor exhaust piping used in the Distler study had to be
repositioned several times to find a location where the exhaust gases
would not be picked up by the compressor air intake. All of these
findings reinforce the importance of locating the compressor's air
intake in an area that ensures that only high-quality air can be taken
in. No comments were received on the proposed requirement for the
location of compressor air intakes.
Final paragraph (i)(5)(ii) has been slightly modified from proposed
requirement (i)(4)(ii) to require that the moisture content of
compressed air be minimized so that the dew point at one atmosphere of
pressure is 10 degrees Fahrenheit (5.56 degrees Celsius) below the
ambient temperature to prevent water freezing in valves and connections
of the air supply system. Such freezing can block air lines, fittings,
and pressure regulators. This final requirement is similar to the
parallel provision of the previous standard, which required that
breathing air meet the requirements of CGA G-7.1-1966. Two commenters
(Exs. 54-208, 54-218) pointed out that the proposal specified a dew
point of 10 degrees Celsius instead of the 10 degrees Fahrenheit
specified in the ANSI/CGA G-7.1-1989 standard. The value in final
paragraph (i)(5)(ii) has been revised to match the 10 deg. F provision
in the G-7.1-1989 standard for Grade D air, with an equivalent value of
5.56 deg. C added to comply with a Federal government requirement (P.L.
100-418 and E.O. 12770) that scientific and technical measures are
expressed as metric units.
Paragraph (d)(2)(ii) of the prior standard required air compressors
to have a receiver of sufficient capacity to permit the respirator user
to escape from a hazardous atmosphere in the event of compressor
failure. However, under paragraph (d)(2) of the final standard, the
only respirators that can now be used in IDLH atmospheres are either
SCBAs or supplied-air respirators with an auxiliary self-contained air
supply for escape. Consequently, a requirement for an air receiver to
permit escape from IDLH atmospheres is no longer needed in the final
rule. Also, the prior respiratory protection standard, in paragraph
(d)(2)(ii), required compressors to have alarms to indicate compressor
failure and overheating; this requirement was part of the same
provision that specified that a receiver for escape from a contaminated
atmosphere in the event of compressor failure be available. This alarm
requirement was deleted from the proposal and is not part of the final
standard. An alarm to indicate compressor failure or overheating is
unnecessary in non-IDLH atmospheres since, as OSHA stated in the
proposal, the respirator user can readily exit the hazardous area if
the respirator fails.
The deletion from the final standard of the prior standard's
requirement for compressors to be equipped with receivers if they were
to be used in hazardous atmospheres will clarify an enforcement issue
that has arisen in connection with ambient air movers. Ambient air
movers have been developed to provide air to supplied-air respirators.
These units are small electric compressors that are not oil-lubricated
and have no air receiver. Such compressors are used in non-IDLH
atmospheres. The use of ambient air movers has been allowed under an
existing OSHA compliance directive even though such devices do not have
the air receiver required for air compressors by the prior respiratory
protection standard. However, the final standard removes the air
receiver requirement for compressors, and ambient air movers will
therefore be treated like any other air compressor used in non-IDLH
atmospheres.
Under final paragraph (i)(5)(iii), compressors must be equipped
with suitable in-line air-purifying sorbent beds and filters to further
assure breathing air purity. The Associated Builders and Contractors,
Inc. (Ex. 54-309) recommended that the corresponding provision in the
proposal be revised to add the requirement that employers change air-
purifying sorbent bed and filters in accordance with the manufacturer's
instructions. Also, clause 10.5.4.2 of the ANSI Z88.2-1992 standard
recommends that maintenance and replacement or refurbishment of the
air-purifying and filter media be performed periodically by trained
personnel and in accordance with the manufacturer's recommendations and
instructions. OSHA agrees with the Associated Builders and Contractors
that sorbent beds and filters must be maintained properly, and has
added language to paragraph (i)(5)(iii) that is similar to that in ANSI
Z88.2-1992, and requires sorbent beds and filters to be maintained and
replaced or refurbished periodically in accordance with the
manufacturer's recommendations. The Associated Builders and Contractors
also recommended that sorbent bed and filter changes be documented,
that such documentation be retained for one year, and that it be made
available to OSHA on request. However, OSHA is not generally requiring
that records of respirator maintenance performed under this standard be
kept and does not believe such a requirement is necessary here.
Instead, OSHA is requiring in paragraph (i)(5)(iv) that a tag
containing the most recent date of sorbent bed replacement or
refurbishing, along with the signature of the person performing the
change, be kept at the compressor. This tagging requirement is also
consistent with OSHA's efforts, as required by the Paperwork Reduction
[[Page 1255]]
Act of 1995, to reduce paperwork to the extent consistent with employee
safety and health.
Paragraphs (I)(6) and (i)(7) address the control of carbon monoxide
levels in breathing air. Paragraph (i)(6) requires that, for
compressors that are not oil lubricated, the CO levels in the breathing
air may not exceed 10ppm. Paragraph (i)(7) requires monitoring of CO
levels for oil lubricated compressors. OSHA stated in the NPRM that one
method to prevent contaminated air from reaching the breathing air
supply was to require carbon monoxide filters with continuous alarms
for all breathing air compressors. The agency requested comments on the
use of carbon monoxide alarms, high-temperature alarms, and shutoff
devices in the workplace (59 FR 58926). A number of comments were
received that addressed the issue of carbon monoxide monitors and
alarms.
Modern Safety Techniques, Inc. (MST) (Ex. 54-141) noted that in
many workplaces it may be impossible or cost prohibitive to relocate
the air intake to an area that would reduce the likelihood of carbon
monoxide entering the system. In these cases, MST recommended
continuous monitoring as the only method that would ensure breathing
air quality. MST stated that the use of a carbon monoxide alarm or
measuring device is necessary to tell whether carbon monoxide purifiers
(e.g., Hopcalite filters) are functioning properly. MST stated,
``Unless continuous monitoring is being conducted on the breathing air
supply, ``frequent'' monitoring, or proper placement of the breathing
air supply, only assures that the requirements are met at that
particular instance in time.'' [Emphasis in original.] Eugene Satrun,
an industrial hygienist who runs a respirator program in Illinois (Ex.
54-261), supported the need for continuous carbon monoxide monitors,
noting that automatic compressors can be operated with a vehicle
running nearby and may consequently pull significant levels of carbon
monoxide into the intake.
Several commenters were opposed to OSHA adopting a requirement for
continuous carbon monoxide monitoring and alarms (Exs. 54-234, 54-250,
54-408). They stated that the requirements for sorbent bed filtration,
proper air inlet location, and Grade D air quality, confirmed by
periodic sampling, would be sufficient to control the carbon monoxide
hazard. Kodak (Ex. 54-265) stated that it has assessed the purity of
compressed air for breathing use over a period of 18 years at its
plants, collecting and analyzing more than 1200 samples, and that no
incidents of carbon monoxide production involving oil-lubricated
compressors have been reported. Carbon monoxide production, Kodak
stated, is best prevented by adequate procedures, awareness, and
certification. Kodak did not provide specific procedures for
determining air system compliance, nor further clarification of what is
meant by awareness or certification. The Duquesne Light Company (Ex.
54-408) stated that continuous monitoring was unnecessary, and that
requiring filtration or purification of the air supply, proper location
of the air intake, and Grade D air purity should be sufficient to
ensure a safe breathing air supply. Meridian Oil (Ex. 54-206) opposed
continuous monitors because these devices can generate false alarms.
Other commenters proposed alternatives to continuous monitoring.
Niagara Mohawk Power (Ex. 54-177), in comments opposing carbon monoxide
alarms, stated that carbon monoxide filters with color-change
indicators are an appropriate method to monitor carbon monoxide.
Monsanto (Ex. 54-219) stated that OSHA should not require all
compressors to have carbon monoxide filters and alarms. Monsanto stated
that high-temperature alarms or automatic compressor shut downs would
only be needed when there was a reasonable possibility of carbon
monoxide production in the compressor due to equipment problems. TU
Electric (Ex. 54-250) stated that carbon monoxide filters or continuous
monitoring alarms should not be required for all breathing air
compressors, but that regular testing of breathing air prior to use,
and testing in specific locations on a regular basis during compressor
use, should be required. This commenter also recommended against a
requirement for carbon monoxide filters or monitors for oil-free
compressors.
Other commenters (Exs. 54-206, 54-234, 54-250) supported testing
ambient air near the intake on a regular basis, but did not recommend a
testing frequency. General guidance for periodic sampling of air
quality for compressors is specified in Clause 10.5.4.3 and Table 4 of
the ANSI Z88.2-1992 standard. The ANSI procedure was recommended by
several commenters (Exs. 54-234, 54-250, 54-263, 54-273, 54-363). ANSI
Z88.2-1992 recommends acceptance testing prior to initial use and
representative sampling at distribution supply points on a periodic
basis to ensure ``a continued high-quality air supply.'' Norfolk
Southern (Ex. 54-267) stated that OSHA should not require the use of
carbon monoxide filters with compressor-supplied air, and that the
employer should have the option of using a carbon monoxide detector.
This commenter stated also that installing a carbon monoxide filter is
not reasonable for those systems that already have a carbon monoxide
detector and high-temperature alarm. St. Lawrence Gas (Ex. 54-402)
commented that carbon monoxide alarms should not be required and noted
that it has found the use of carbon monoxide-to-carbon dioxide
converters (with color-change indicators) sufficient for detecting the
presence of carbon monoxide. ORC (Ex. 54-424) stated that carbon
monoxide alarms or high-temperature alarms are not needed for all
compressors. ORC recommended that adequate procedures, awareness, and
certification for installation are the best means to ensure that
contaminated air does not enter the compressor. This language is
similar to that used by Kodak (Ex. 54-265), and, like Kodak, ORC (Ex.
54-424) did not provide any elaboration of the phrase ``adequate
procedures, awareness, and certification for installation.''
A carbon monoxide monitor with an alarm can be used to continuously
measure the breathing air and warn respirator users when carbon
monoxide levels exceed the 10 ppm limit set for Grade D breathing air.
However, these alarms need to be properly maintained to function
effectively. MST (Ex. 54-141) stated that the electrochemical type of
sensors used today are specific for carbon monoxide, are relatively
stable during temperature and humidity changes, and are accurate enough
to meet the CGA G-7.1-1989 requirements. These sensors have replaced
the older metal oxide sensors that had problems with false alarms.
However, the electrochemical sensors must be calibrated periodically
(usually on a monthly basis) to perform accurately. The Service
Employees International Union (Ex. 54-455) also recommended that the
final standard address regular replacement of alarm sensors and filter
media.
Carbon monoxide filters with color-change indicators are used to
convert carbon monoxide in breathing air to carbon dioxide, which is
less likely to pose a hazard to the respirator user. The source of the
carbon monoxide can be from contamination of the intake air or from
carbon monoxide generated by the compressor. However, the color change
in the indicator results from moisture in the breathing air that is
trapped in the filter element. The color-change indicator, therefore,
does not indicate the presence of carbon monoxide, but instead signals
only the presence of moisture, which can render the sorbent filters
ineffective. Consequently, the
[[Page 1256]]
color-change indicator cannot be used directly to detect carbon
monoxide. In addition, these carbon monoxide filters, like carbon
monoxide alarms, need periodic maintenance to ensure their continued
effectiveness.
In summary, strong arguments favor a requirement for continuous
carbon monoxide monitoring of compressor-generated breathing air. This
is the case because preventing carbon monoxide contamination by
locating the air intake for compressors in an area that is free of
carbon monoxide contamination is difficult in many cases and impossible
in others. Automatic compressors with poorly located air intakes may
operate when a running vehicle is in the immediate area, thereby
contaminating the air supply with carbon monoxide from the vehicle's
exhaust. In addition, older compressors, which may still be operational
after hundreds, if not thousands of operating hours, may allow
increased oil blow-by due to piston ring and cylinder wear, which
increases the possibility of carbon monoxide contamination.
The most convincing evidence against a requirement for continuous
carbon monoxide monitoring comes from the 18-year collection of
sampling results taken by Kodak (Ex. 54-265). OSHA notes, however, that
Kodak's results are likely to be due to the company's careful
observance of operating procedures, such as procedures ensuring the
proper location of air intakes and regular and thorough maintenance and
repair of all compressors. OSHA notes that Clause 10.5.4.3 of the ANSI
Z88.2-1992 standard calls for periodic, rather than continuous,
sampling of breathing air from the air supply.
The arguments for and against carbon monoxide alarms are less well
defined than the case for carbon monoxide monitoring devices. Several
commenters specifically recommended the use of carbon monoxide alarms
whenever compressed air is being used as breathing air (Exs. 54-337,
54-428, 54-455). The AFL-CIO (Ex. 54-428) recommended the use of carbon
monoxide alarms or monitors on all air supply systems that service
respirators with Grade D breathing air. Both of these recommendations
would assure an air supply uncontaminated by carbon monoxide. The
proponents of carbon monoxide alarms (Exs. 54-141, 54-261, 54-337, 54-
428, 54-455) state that they are needed to alert personnel that
equipment is malfunctioning; the Exxon Company (Ex. 54-266) stated that
gasoline- and diesel-powered compressors should be required to have
carbon monoxide alarms to detect exhaust gases that enter the air
supply, as well as compressor failure and high-temperature alarms;
other commenters (Exs. 54-337, 54-428) would require the use of carbon
monoxide alarms to prevent accidental carbon monoxide contamination
whenever compressed air is being used as breathing air.
The opponents (Exs. 54-177, 54-206, 54-219, 54-234, 54-250, 54-265,
54-402) of carbon monoxide alarms cite the availability of alternate
equipment and procedures that they claim are as effective as alarms in
protecting the purity of breathing air. Examples of these alternatives
are filters with color-change indicators, carbon monoxide-to-carbon
dioxide converters, oil-free compressors, proper air intake placement,
certification of air compressor systems, and periodic monitoring (Exs.
54-177, 54-206, 54-219, 54-250, 54-265, 54-330, 54-402, 54-408, 54-
424).
OSHA believes that it is essential for the employer to ensure that
excessive carbon monoxide is not in the compressed breathing air
supplied to respirators. Final paragraphs (i)(6) and (i)(7), therefore,
require that the employer prevent carbon monoxide levels in the
breathing air from exceeding 10 ppm. For compressors that are not oil-
lubricated, this requirement can be met by several different methods,
including the use of continuous carbon monoxide alarms, carbon monoxide
filters, proper air intake location in an area free of contaminants,
frequent monitoring of air quality, or the use of high-temperature
alarms and automatic shutoff devices, as appropriate. No single method
will be appropriate in all situations, and several methods may need to
be combined, e.g., the use of carbon monoxide alarms with carbon
monoxide filters where conditions are such that a reliable carbon
monoxide-free area for compressor air intakes cannot be found. As the
comments to the record show, there was no agreement on the most
appropriate method for ensuring that carbon monoxide would not
contaminate the breathing air coming from compressors. OSHA has decided
that a performance-based requirement ensuring that carbon monoxide does
not contaminate breathing air will give employers flexibility in
selecting the method(s) most appropriate for conditions in their
workplace.
Oil-lubricated compressors can produce carbon monoxide if the oil
enters the combustion chamber and is ignited. This can be a
particularly severe problem in older compressors whose piston rings and
cylinders are worn. Final paragraph (i)(7) requires that such
compressors have a high-temperature or carbon monoxide alarm, or both.
If only a high-temperature alarm is used, the air from the oil-
lubricated compressor must be monitored at intervals sufficient to
prevent carbon monoxide in the breathing air from exceeding 10 ppm. The
latter requirement ensures that carbon monoxide that enters a poorly
located compressor air intake, as well as carbon monoxide generated by
the compressor itself, is detected.
Final paragraph (i)(7) is similar to a provision in the previous
standard. In the NPRM, OSHA proposed to delete the requirement from the
previous respirator standard that oil-lubricated compressors be
equipped with carbon monoxide alarms and high-temperature shutoff
devices. However, a number of commenters (Exs. 54-144, 54-219, 54-266)
stated that precautions against excessive carbon monoxide were needed
when oil-lubricated compressors were used. Modern Safety Techniques
(Ex. 54-144) stated that oil-lubricated compressors used by industry to
supply breathing air often have hundreds of hours of use, allowing
greater oil blow-by and therefore greater potential for carbon monoxide
production, was reported in the Distler study. That study found that
properly functioning air compressors are unlikely to reach temperatures
at which carbon monoxide production occurs. Exxon (Ex. 54-266)
encouraged OSHA to include a requirement for in-line carbon monoxide
alarms for diesel- or gasoline-powered compressors, since its
experience indicates that the use of these compressors increases the
risk of carbon monoxide contamination from the compressor's exhaust.
Monsanto (Ex. 54-219) stated that high-temperature alarms or automatic
compressor shutoffs would be needed when there was a reasonable
possibility of carbon monoxide production in the compressor due to
equipment problems. The Service Employees International Union (Ex. 54-
455) argued that the requirements specifying Grade D breathing air
purity and location of the compressor air intake in an uncontaminated
atmosphere were not sufficient to ensure that carbon monoxide is not
entrained in the system.
An incident of carbon monoxide production by an oil-lubricated
compressor was described in a MSHA Accident Investigation Report issued
in January 1985 (Ex. 38-12). An oil-cooled, diesel-powered, two-stage,
rotary air compressor overheated during a sandblasting operation at a
limestone quarry. The air compressor thermo-bypass valve, which should
have directed the oil through a cooling
[[Page 1257]]
radiator once the oil had reached a temperature of 185 deg.F, failed,
which allowed the temperature of the cooling oil to rise above its
flashpoint of 420 deg.F. The oil ignited, producing carbon monoxide.
The compressor was equipped with a high-temperature shutoff switch set
for 235 deg.F, but it had been disconnected for at least 30 days prior
to the incident. The compressor was not equipped with a carbon monoxide
filter or alarm. The sandblaster collapsed from carbon monoxide
poisoning. Monsanto (Ex. 54-219) stated that this incident resulted
from a failure to follow the provision in the previous standard
requiring that oil-lubricated compressors have a functional high-
temperature or carbon monoxide alarm, or both. OSHA believes that this
incident, as well as the comments described above, supports carrying
the previous standard's requirement forward in the final rule.
Final paragraph (i)(8) requires that air line couplings be
incompatible with outlets for non-respirable worksite air or other gas
systems to prevent the inadvertent provision of nonrespirable gases to
airline respirators. Breathing air couplings, therefore, are to be made
incompatible with outlets from nonrespirable plant air and other gas
systems. This requirement is similar to the provision in paragraph
(d)(3) of the previous respiratory protection standard and proposed
paragraph (i)(5) of the NPRM. Martin Marietta (Ex. 54-410) stated that
there have been documented cases in which cross-connections have
introduced hazardous contaminants into breathing air lines. To avoid
this problem, Martin Marietta recommended that OSHA add a provision to
the final standard that prohibits connecting breathing air lines to any
nonrespirable gas source or process. Consistent with this
recommendation, OSHA has added a sentence to paragraph (i)(8) requiring
that no asphyxiating substance be introduced into breathing air lines.
This requirement will cover not only the contamination of the breathing
air system from cross-connections, but will also cover other potential
contaminating conditions, e.g., using nitrogen to blow out worksite air
lines where the worksite air source is also used for breathing air.
The final standard also requires that the employer prevent utility
oxygen, i.e., oxygen supplied to meet other manufacturing needs, from
entering the respirator air supply system. As discussed above, the
standard permits oxygen to be used in respirators designed for oxygen
service. The final standard prohibits the introduction of utility
oxygen into breathing air systems that supply respirators that are not
designed for oxygen service; this provision is needed to prevent the
fires and explosions that could result if high-pressure oxygen comes
into contact with oil or grease that has been introduced to the
respirator or the air lines during compressed air operations.
Final rule paragraph (i)(9) requires employers to use breathing gas
containers marked in accordance with the NIOSH respirator certification
standard at 42 CFR part 84. This requirement differs from proposed
paragraph (i)(6), which listed several additional standards for
breathing gas containers. These additional standards have been
incorporated into 42 CFR part 84, making reference to them in the final
rule unnecessary.
Paragraph (j)--Identification of Filters, Cartridges, and Canisters
The final rule provides that the employer only use filter
cartridges and canisters that are labeled and color coded with the
NIOSH approval label and that the label not be removed or made
illegible. This is similar to the parallel requirement in the proposal,
which was supported by commenters (Exs. 54-361, 54-428, 54-455). OSHA
has modified the proposed language in certain respects to add
compliance flexibility while retaining the original objective, i.e.,
assurance that these elements meet NIOSH's stringent requirements.
These comments and modifications are discussed below.
OSHA proposed to eliminate from the previous respiratory protection
standard the language in paragraphs (g)(1) to (g)(6), which described
labeling requirements, and Table I-1, which listed color codes assigned
to canisters and cartridges. These requirements were adopted from the
original national consensus standard (i.e., ANSI K13.1, ``Standard for
Identification of Air-Purifying Respirator Canisters and Cartridges'')
adopted by OSHA in 1971. In place of these requirements, proposed
paragraph (j)(1) would have required employers to ensure that all
filters, cartridges, and canisters bear a NIOSH approval label before
being placed into service.
Proposed paragraph (j)(2) specified that the label not be removed,
obscured, or defaced while the filter, cartridge, or canister was in
service to ensure that the label provided information to the employee
about the protection being afforded by the respirator. In the final
standard, OSHA has combined proposed paragraphs (j)(1) and (j)(2) into
a single paragraph (j). The changes from the previous standard
recognize that employers who use respirators should be able to rely on
labeling and color coding by respirator manufacturers for assurance
that the respirators meet NIOSH requirements.
This position is consistent with that taken by many commenters, who
noted that the labeling and color coding of filters are the
responsibility of the respirator manufacturer (Exs. 54-208, 54-218, 54-
219, 54-278, 54-289) and are required by NIOSH for certification. OSHA
agrees that color coding and the attachment of NIOSH approval labels to
respirators are the responsibility of the manufacturer. However, it is
still the employer's responsibility to use only components bearing a
NIOSH approval label, and to ensure that the NIOSH approval labels are
not removed from the filters, cartridges, and canisters that are used
in the workplace and remain legible.
The NIOSH label serves several purposes. It ensures selection of
appropriate filters for the contaminants encountered in the workplace
and permits the employee using the respirator to check and confirm that
the respirator has the appropriate filters before the respirator is
used. David Lee, a CIH, CSP, and respirator consultant (Ex. 54-304),
commented that, once a filter selection is made and the respirator is
donned, the label becomes meaningless. However, the employee is not the
only one who uses the color coding and label. Color coding and labeling
also allow fellow employees, supervisors, and the respirator program
administrator to readily determine that the appropriate filters are
being used by the employee. Cartridges that are appropriate for one
operation may be inappropriate for another, and color coding and
labeling allow respirator users with inappropriate filters to be
identified in the workplace and potential respiratory hazards to be
avoided.
Proposed paragraph (j)(2) required that the NIOSH approval label
not be ``removed, obscured or defaced'' while respirators are being
used. 3M (Ex. 54-218) and Monsanto (Ex. 54-219) urged OSHA to add the
word ``intentionally'' before ``removed, obscured or defaced,'' since
they believe that an employer would be in violation of this provision
if, for example, a label is covered with paint overspray during use.
Monsanto also stated that some OSHA substance-specific standards
require that cartridges be dated by the employee to indicate when they
were first put into service and that some employers could use this
dating method to control cartridge use even when not required by OSHA.
Accordingly, Monsanto urged OSHA to add the phrase ``except if it is to
record
[[Page 1258]]
initial use information'' to paragraph (j)(2) to clarify that adding a
date to the NIOSH label is allowed and will not be regarded as defacing
the label. David Lee (Ex. 54-304) was concerned that dirt, dust, and
debris can easily obscure the label once the respirator is in use and
that employees would be required by the proposed provision to leave the
area to clean the label to make it legible. Dow (Ex. 54-278) stated
that, because of the small size of the label on some cartridges, the
employer cannot date the cartridges without obscuring some of the
information on the label. To resolve this problem, Dow suggested that
the words ``pertinent information'' be added before ``obscured.''
OSHA has not added the term ``intentional'' to final paragraph (j)
because it would be difficult, if not impossible, to determine if the
removal or obscuring of a NIOSH label was accidental or intentional.
Also, the final provision does not include an exemption for documenting
the initial use date on cartridge and canister labels, since OSHA
already permits this practice. OSHA's experience indicates that the
initial use date can easily be added to a filter, cartridge, or
canister without obscuring the label, and this procedure has not proven
to be a problem in the substance-specific standards that require such
dating. The term ``pertinent information'' has not been included in
final paragraph (j) because OSHA believes that all of the information
on the NIOSH approval label is pertinent. The degree of cleanliness
required of the label while the respirator is in service should not be
an issue because the label only needs to be legible and reasonably
clean to provide the required information. Any dust, dirt, paint
overspray, or other substance that completely obscures the label would
also affect respirator cleanliness and the service life of the filter,
resulting in replacement of the filter with new filters that have
unobscured labels, as required by paragraph (g).
In summary, final paragraph (j) combines into a single provision
the proposed requirements that employers ensure that the manufacturer's
NIOSH approval label is on the cartridge, filter, or canister, and that
employers maintain the labels in legible condition while the cartridge,
filter, or canister is in service. As with the proposed paragraphs,
this provision is a performance-based requirement that permits
employers to adopt whatever procedures are appropriate to ensure that
the label remains on the filter and is not removed, defaced, or
obscured during respirator use.
Paragraph (k)--Training and Information
Paragraphs (k)(1)-(3) of the final standard require employers to
provide effective training for employees required by the employer to
wear respirators. Employees must be trained sufficiently to be able to
demonstrate a knowledge of why the respirator is necessary; how
improper fit, usage, or maintenance can compromise the protective
effect of the respirator; the limitations and capabilities of the
selected respirator; how to deal with emergency situations involving
the use of respirators or with respirator malfunction; how to inspect,
don and remove, and check the seal of the respirator; procedures for
maintenance and storage of the respirator; the medical symptoms and
signs that may limit or prevent the effective use of respirators; and
the general requirements of this standard.
Paragraph (k)(4) allows for the ``portability'' of previous
respirator training, and paragraph (k)(5) specifies the requirement for
at least annual retraining. Also, as discussed earlier under the
Summary and Explanation for paragraph (c), Respiratory Protection
Program, final paragraph (k)(6) requires employers to provide the basic
advisory information presented in Appendix D of this section to
employees who voluntarily use respirators in their workplace.
The final standard requires that training be understandable and be
given to the employee prior to using a respirator in the workplace, and
annually thereafter. Additionally, if the employer has reason to
believe that any employee who has already been trained does not have
sufficient understanding and skill to use the respirator, the employer
must retrain the employee in those areas in which his or her knowledge
or skill is deficient. Retraining is also required when changes in the
workplace or in the type of respirator used render previous training
obsolete.
Section 1910.134(e)(5) of the previous standard required training
in the selection, use, and maintenance of respirators and required
respirator wearers to be provided an opportunity to handle the
respirator, have it fitted properly, test its facepiece seal, and wear
it in normal air for a familiarity period. The final training paragraph
retains many of these provisions. However, the format of the final
training provisions is different, and specific provisions for annual
training and retraining are included in the final standard. Although
the previous standard's requirement for a familiarity period has not
specifically been retained, the final standard requires the respirator
wearer to be trained sufficiently to demonstrate the ability to use the
respirator properly, which may or may not necessitate wearing the
respirator in normal air ``for a long familiarity period.''
The record shows widespread agreement that employee training is a
critical part of a successful respiratory protection program and is
essential for correct respirator use (Exs. 15-13, 15-18, 15-19, 15-22,
15-30, 15-33, 15-41, 15-45, 15-50, 15-53, 15-54, 15-67, 15-79, 54-5,
54-68, 54-91, 54-92, 54-165, 54-172, 54-208, 54-219, 54-278, 54-361,
54-387, 54-428, 54-455, Tr. 186, 387, 595, 1011, 1063, 1083, 1103,
1226).
For example, James Johnson of the Lawrence Livermore National
Laboratory testified:
The training element of the respiratory protection program is
one of the most important elements to assure the respirator is
properly used and is performing as intended * * *. This is the only
time that the worker has a chance to interact with a trained
professional who can properly instruct that person on the correct
use of the respirator, the employee can see what is right, what
doesn't work, and can understand this item that is given to him to
wear throughout a year to help protect his health * * * (Tr. 186)
Dan Faulkner of the United Steelworkers of America concurred,
commenting that: Training must be seen as a critical component of
respiratory protection. This is an area that is grossly ignored
under the current regulation * * *. The very first step in the
education process must be to empower workers to identify the
hazardous substances involved and at what levels they are exposed.
In order for the workers to have confidence that his/her respirator
is providing the necessary protection from the hostile work
environment they must have a thorough knowledge of this entire
process. Once this is understood, the worker can make an informed
decision on what type of respirator to wear. (Tr. 1062)
ASARCO, Inc. (ASARCO) agrees about the importance of training and
reports that its company Respiratory Protection Program Manual states:
``For the safe use of any respirator, it is essential that the user be
properly instructed in the respirator's purpose, selection, fitting,
use, and limitations' (Ex. 163).
OSHA agrees with the many commenters who urged OSHA to mandate a
program that is performance oriented and can be presented informally
(Exs. 15-13, 15-18, 15-22, 15-30, 15-41, 15-47, 15-62, 15-73, 15-75,
54-213, 54-265, 54-275, 54-455). The final standard does not specify
how the training is to be performed nor the format to be used by the
employer. As suggested by commenters (Ex. 15-53, Tr. 837, Tr. 1087),
the employer can use
[[Page 1259]]
whatever training method is effective for the particular worksite,
provided that the method addresses the required topics. Employers can
use prepared materials such as audio-visual and slide presentations,
formal classroom instruction, informal discussions during safety
meetings, training programs developed or conducted by unions or outside
sources such as respirator manufacturers, or a combination of these
methods.
As in the proposal, several categories of training information must
be addressed in the final rule. The final provisions have been
simplified since the proposal, but the information to be covered is
essentially the same as that proposed.
Paragraph (k)(1) requires the employer to ensure that before the
employee uses the respirator in the workplace, the employee
demonstrates that he/she has learned the information communicated under
the training program. The employer can comply with this provision by
reviewing with the employee, either in writing or orally, the
informational part of the training program and by reviewing the
employee's hands-on use of respirators.
OSHA's personal protective equipment standard (Sec. 1910.132(f)(2))
also requires that employees demonstrate effectiveness in using PPE
before workplace use. When that standard was adopted in 1994, OSHA
stated that ``in order for training to be successful, clear and
measurable objectives must be set, and employees must demonstrate that
the training objectives have been reached by showing that they
understand the information provided and that they can use the PPE
properly'' (59 FR 16339). This reasoning applies equally to respiratory
protection. In the NPRM for the respiratory protection standard
(proposed paragraph (k)(1)(iii)), OSHA proposed a similar requirement,
which stated that the training itself was to include ``sufficient
practice to enable the employee to become * * * effective in performing
tasks [relating to inspection, donning and removal, checking the fit
and seals, and in wearing the respirator.]''
The final standard's requirement that employees ``demonstrate''
competence in using respiratory equipment is supported by the
recommendation of commenters that the PPE standard's similar
requirement replace the less direct provision in the respiratory
protection proposal (Exs. 54-213, 54-319). OSHA's enforcement of the
PPE standard has reinforced the Agency's belief that training
effectiveness must be evaluated by demonstrating how well employees use
equipment on-the-job. OSHA believes that adopting a provision in the
respirator standard that is worded similarly to the corresponding
requirement in the PPE standard will promote compliance with both
standards and uniformity of interpretations and enforcement actions.
Moreover, measuring the adequacy of training by evaluating the
employee's knowledge gained from the training is consistent with the
performance orientation of the final standard and with the absence of
specific hourly training requirements in the final standard.
The first category of information to be included in the training
program, specified in final paragraph (k)(1)(i), is a discussion of why
the use of the respirator is necessary. Proposed paragraph (k)(1)(i)
specifically set forth that this discussion was to include information
on the nature, extent, and effects of the respiratory hazards to which
the employee may be exposed while using the respirator. The language of
final paragraph (k)(1)(i) has been simplified; OSHA believes that
training in why the respirator is necessary will include information on
the nature, extent, and effects of the respiratory hazards. For
example, such training would address the identification of the
hazardous chemicals involved, the extent of employee exposures to those
chemicals, and the potential health effects of such exposure. Much of
this information will be available on the Material Safety Data Sheets
that chemical manufacturers provide to employers under the Hazard
Communication standard (29 CFR 1910.1200). Employee training on the
health effects of hazardous chemicals is also required under the Hazard
Communication standard, and the same training could help satisfy this
respirator training requirement. Many commenters agreed that hazard
information is an essential element of training (Exs. 15-10, 15-14, 15-
18, 15-19, 15-27A, 15-41, 15-46, 15-53, 15-62, 15-73, 54-5, 54-68, 54-
91, 54-165, 54-172, 54-208, 54-278, 54-361, 54-428, 54-455).
Information regarding the consequences of improper fit, usage or
maintenance on respirator effectiveness must also be provided to
employees under final paragraph (k)(1)(i). Improper attention to any of
these program elements would obviously defeat the effectiveness of the
respirator. Employees must understand that proper fit, usage and
maintenance of respirators is critical to ensure that they can perform
their protective function.
Under final paragraph (k)(1)(ii), employers are to explain the
limitations and capabilities of the respirator selected for employee
use. A discussion of the limitations and capabilities of the respirator
must address how the respirator operates. This training would include,
for example, an explanation of how the respirator provides protection
by either filtering the air, absorbing the vapor or gas, or providing
clean air from an uncontaminated source. Where appropriate, it also
should include limitations on the use of the equipment, such as
prohibitions against using an air-purifying respirator in IDLH
atmospheres and an explanation of why such a respirator should not be
used in such situations.
Paragraph (k)(1)(iii) requires that employees be provided with
information on respirator use in emergency situations, including those
in which the respirator malfunctions. This training requirement was
included in proposed paragraph (k)(1)(v). Respirators malfunction on
occasion, work routines change, and emergency situations occur that
require a different respirator. The training program must discuss these
possibilities and the procedures the employer has established to deal
with them. Commenters concurred that comprehensive training is
necessary where respirators are to be used in IDLH situations,
including oxygen-deficient atmospheres, such as those that occur in
firefighting, rescue operations and confined area entry (Exs. 15-18,
15-19, 15-26, 15-31, 15-33, 15-37, 15-41, 15-48, 15-50, 15-54, 15-55,
15-56, 15-59, 15-70).
The employee should be able to thoroughly understand the operation
of the respirator as a result of this training and demonstrate the
ability to properly use the respirator selected. Numerous commenters
supported the elements in the training program provided for under final
paragraphs (k)(1) (ii) and (iii) (Exs. 61-3, 15-14, 15-18, 15-27A, 15-
41, 15-46, 15-53, 15-62, 15-73, 54-5, 54-68, 54-91, 54-172, 54-208, 54-
361, 54-428, 54-455). For example, Michael P. Rehfeld, Safety Officer,
Westminster Fire Department, stated that:
In section (k) of the NPRM dealing with training, I strongly
believe OSHA should put the strongest emphasis. It has been my
experience that the stronger the employer training program the less
likely that an employee would become injured or dies from a
respiratory protection failure. OSHA has historically put a strong
emphasis on training (1910.120, 1910.1200, 1910.138, 1910.146). The
same emphasis should appear in this rule (Ex. 54-68).
[[Page 1260]]
Final paragraph (k)(1)(iv) requires the employer to provide
specific instruction on how respirators are inspected, donned, removed,
positive/negative pressure checked, and worn. Although the employer is
required to ensure that respirator inspections are performed, employees
using the equipment may frequently be responsible for inspecting the
respirators assigned to them. In this case it is necessary that
respirator users have this process explained and demonstrated to them
so that they are capable of recognizing any problems that may diminish
the protective capability of the respirator. The training must include
the steps employees are to follow if they discover any problems during
inspection, such as to whom problems should be reported and where
replacement equipment can be obtained if needed. If, however, the
employer routinely has extensive inspections done by separate
personnel, individual respirator wearers are not required to be trained
in how to perform full inspections. Training only in those parts of the
inspection process that may be their responsibility would be
sufficient.
The training under this paragraph must also include the procedures
for donning and removing the respirator, checking the fit and seals,
and using the respirator. Respirator fit in the workplace must be as
close as possible to the fit obtained during fit testing; therefore,
employees must know how to follow procedures that will improve fit in
the workplace. The fit testing procedures can also help in training
employees. For example, employers can use quantitative fit testing
procedures to demonstrate to employees the dramatic improvement in
measured fit when the respirator is adjusted properly (See the
discussion above of paragraph (f) and Ex. 15-44, Tr. 1083).
Final paragraph (k)(1)(iv) requires training in how to check the
respirator seal. Appendix B-1 describes methods for checking the seal
of positive and negative pressure facepieces. Employees must be trained
in the methods set forth in Appendix B-1 or in alternative methods that
are equally effective. The training requirements set forth in paragraph
(k)(1)(iv) were widely supported in the record (Exs. 15-10, 15-14, 15-
22, 15-27A, 15-41, 15-46, 15-50, 15-62, 15-73, 54-5, 54-68, 54-91, 54-
165, 54-172, 54-208, 54-219, 54-278, 54-361, 54-428, 54-455).
Final paragraph (k)(1)(v), like proposed paragraph (k)(1)(iv),
requires the employer to explain the procedures for maintenance and
storage of respirators. The extent of training required under this
provision may vary according to workplace conditions. In some cases,
where employees are responsible for performing some or all respirator
maintenance and for storing respirators while not in use, detailed
training in maintenance and storage procedures may be necessary. In
other facilities where specific personnel or central repair facilities
are assigned to perform these activities, employees may need only to be
informed of the maintenance and storage procedures without having to
learn significant technical maintenance information. The importance of
providing some knowledge to all employees regarding maintenance and
storage of respirators was recognized by a number of commenters. Those
commenters stated that employees must be able to identify respirator
deficiencies that can result from improper maintenance and storage of
respirators so that they will not use improperly functioning
respirators (Exs. 61-3, 61-8, 15-10, 15-14, 15-27A, 15-41, 15-46, 15-
50, 15-62, Tr. 1063).
Final paragraph (k)(1)(vi) requires that employees be instructed in
ways to recognize the medical signs and symptoms that may limit or
prevent the effective use of respirators. This provision was not
included in the proposed standard. However, the Agency agrees with the
AFL-CIO (Ex. 54-428) that employee knowledge of this information is
important to ensure implementation of a successful respirator program.
An employee's knowledge of the medical problems that may preclude the
employee from using some types of respirators or from wearing a
respirator under certain workplace conditions helps assure that the
employee receives the protection intended by the standard. Examples of
medical conditions and signs and symptoms that may affect an employee's
ability to use a respirator are provided in mandatory Appendix C of the
final standard. Training in these signs and symptoms need not be
medically sophisticated or burdensome. Employees must be provided only
with medical information sufficient for them to recognize the signs or
symptoms of medical conditions (e.g., shortness of breath, dizziness)
that may affect their use of respirators. This information will also
enable employees to understand the purpose of the medical assessment
procedures required under paragraph (e) of the final standard, will
improve the ability of employees to recognize and report medical signs
and symptoms, and will give them the knowledge they need to initiate
the follow-up medical evaluations required under paragraph (e) of this
section, if necessary.
Final paragraph (k)(1)(vii) requires the employer to inform
employees of the general requirements of this section. OSHA agrees with
Organization Resources Counselors (Ex. 54-424) that ``general
requirements'' better describes the substantive purpose of this
provision than did the word ``contents,'' which was used in proposed
paragraph (k)(1)(vi). OSHA believes it is necessary to ensure that
employees know, in general, the employer's obligations under the
standard with respect to employee protection. This discussion need not
focus on the details of the standard's provisions but could, for
example, simply inform employees that employers are obligated to
develop a written program, properly select respirators, evaluate
respirator use, correct deficiencies in respirator use, conduct medical
evaluations, provide for the maintenance, storage, and cleaning of
respirators, and retain and provide access to specific records.
Proposed paragraph (k)(1)(vi) would have required that employees be
provided with information on the written respiratory protection
program, as well as the location and availability of the written
program and the standard. These elements are omitted from final
paragraph (k)(1)(vii) because they are addressed in other provisions of
the final standard. For example, employee access to the standard and
written program is required under final paragraph (m)(4), and employee
knowledge about the written respirator program will be imparted to
employees under the training required by final paragraph (k)(1), which
specifies the elements to be included in the written respirator
program.
All of the training elements are important. They are presented in
performance language to give the employer flexibility to adapt the
training to specific workplace conditions and to the respirators used.
Unless the training information is presented in a way that employees
can understand, the training will not be effective. Therefore, final
paragraph (k)(2) requires that training be conducted in a way that is
understandable to employees. Employers should develop training programs
based upon their employees' educational level and language background.
This will ensure that all employees will receive training that will
enable them to maximize the effectiveness of the respirators they use.
Inclusion of a provision addressing training comprehension was
supported in the record (Tr. 166) and is consistent with similar
requirements in other recent OSHA rulemakings (Cadmium, 29 CFR
1910.1027; Bloodborne
[[Page 1261]]
pathogens, 29 CFR 1910.1030; Formaldehyde, 29 CFR 1910.1048).
Final paragraph (k)(3) requires the employer to provide training
before the employee uses a respirator in the workplace. This provision
was included under proposed paragraph (k)(2) and was widely supported
by rulemaking participants (Tr. 1011, Tr. 1986; Exs. 54-91, 54-165, 54-
196, 54-234, 54-267, 54-278, 54-298, 54-319, 54-334, 54-361, 54-387,
54-428, 54-455). No comments opposing this requirement were received.
Final paragraph (k)(4) provides that an employer who can
demonstrate that a new employee has received training within the last
12 months that addressed the elements specified in paragraph (k)(1)(i)
through (vii) is not required to repeat such training provided that, as
required by paragraph (k)(1), the employee can demonstrate knowledge of
the element(s). Employers availing themselves of this provision must,
however, provide subsequent training no later than 12 months from the
date of the previous training, as required by final paragraph (k)(4).
An employee who has been trained in the use of respirators who
moves to another job that involves the use of respirators may not need
to take all of the initial training prescribed in paragraph (k)(4).
Prior training in the topics required by the standard may remain
relevant in the new work setting. Thus, OSHA is permitting limited
``portability'' of training, as noted in the standard. Training in the
elements listed in paragraph (k)(1) that has been provided in the past
12 months by a previous employer may be taken into account by the new
employer when evaluating the training needs of that new employee.
The employer must demonstrate that the employee has received the
prior training and retained the necessary knowledge before the prior
training can be accepted as meeting the requirements of paragraph (k).
Discussions with the employee and with the previous employer may be
used to determine whether the previous training has been sufficient to
enable the employee to wear, use, and care for the respirator
successfully. If the employer cannot demonstrate that the new employee
has been trained in the required elements of the program, and
understands these elements, the new employer is obligated to train the
employee. In cases where training in some elements is lacking or
inadequate, the employer is required by paragraph (k)(4) to provide
training in those elements.
Final paragraph (k)(5) requires retraining annually and when
certain situations occur. The requirement for annual training was
strongly supported by management, labor, and other rulemaking
participants as being necessary to ensure the continuing effectiveness
of the respirator program (Exs. 15-10, 15-18, 15-19, 15-20, 15-37, 15-
44, 15-47, 15-48, 15-50, 15-54, 15-55, 15-71, 54-91, 54-157, 54-165,
54-173, 54-208, 54-222, 54-245, 54-265, 54-292, 54-319, 54-332, 54-361,
54-363, 54-387, 54-424, 54-427, 54-428, 54-442, 54-455, 122, 166; Tr.
187, 443, 547, 614, 1011, 1022, 1226, 1768). For example, the Railway
Labor Executive Association testified:
The training requirements as proposed should be mandated on an
annual basis . . . Such a training schedule will assure continuous
familiarization with the equipment and will serve to negate the
inevitable effects of complacency on the part of both the employer
and the employee. (Tr. 443)
Exxon stated that ``Annual training is good so the employee will
feel comfortable with the respirator they will be using in the future''
(Tr. 547). James Johnson of Lawrence Livermore National Laboratory
testified that annual training is ``. . . necessary to ensure a
reasonable amount of recall and performance . . . `` (Tr. 187). Eastman
Chemical Company (Ex. 54-245) commented that ``Eastman supports [the]
annual training requirement . . . our Company believes this is
necessary to adequately train employees.'' ASARCO and U.S. Steel
require that their employees who wear respirators undergo annual
training, and ASARCO states in its Respiratory Protection Manual that:
All respirator wearing employees shall be given annual training
on routine respirator use. . . . Applicable individuals will also be
thoroughly instructed and trained annually in the use of respiratory
protection and necessary procedures for non-routine or emergency
situations. (Ex. 163)
The Respirator Protection Program training manual for U.S. Steel,
submitted by AISI, requires that: ``Each respirator wearer should be
retrained at least annually. Where necessary, more frequent training
should be performed. The required use of respirators should be
specified in routine training aids such as Safe Job Procedures.'' (Ex.
142)
A number of commenters recommended that training should be required
less frequently than annually (Exs. 15-41, 54-316, 54-324) or should be
required only in response to a change in the respirator program (Exs.
54-168, 54-172, 54-178, 54-187, 54-213, 54-234, 54-267, 54-273, 54-275,
54-278, 54-297, 54-307, 54-316, 54-324, 54-334, 54-352, 54-389, 54-408,
54-434). Other commenters recommended more frequent (than annual)
training for employees required to use SCBAs, or for employees who may
be required to use respirators in emergency situations (Exs. 54-210,
54-290, 54-363, 54-410, 54-424).
OSHA believes that annual training is necessary and appropriate to
ensure that employees know about the respiratory protection program and
that they cooperate and actively participate in the program. Further,
as specifically noted by several witnesses at the hearing, annual
training is necessary so that employees will be confident when using
respirators (Tr. 547, Tr. 595). Annual training will also eliminate
complacency on the part of both the employer and employees with respect
to respirator use (Tr. 443), and annual training will ensure a
reasonable amount of recall and performance on the part of the
respirator user (Tr. 187). In addition, periodic training provides an
opportunity for the employee to interact with trained professionals who
can provide instruction and understanding in the correct use of the
respirator (Tr. 186), which will serve to overcome employee resistance
to proper respirator use (Tr. 1021). OSHA also believes that employee
interaction with respirator instructors on at least an annual basis
will reinforce employee knowledge about the correct use of respirators
and other pertinent elements of the respiratory protection program.
Commenters requesting that training be required less frequently
than annually provided no substantive data demonstrating that training
every two years, for example, would be sufficient for respirator users
to retain information critical to the successful use of respirators on
a continuing basis (Exs. 54-316, 54-324). Less frequent periodic
training would tend to diminish employee attention to proper respirator
use and may result in a long period of poor respirator practice before
problems are identified and corrected. OSHA notes that both the ANSI
Z88.2-1980 and Z88.2-1992 respiratory protection standards provide for
annual retraining. Further, annual periodic training of workers with
respect to the use of respirators is required in other OSHA standards
(i.e., 29 CFR 1910.1001, Asbestos; 29 CFR 1910.1017, Vinyl chloride; 29
CFR 1910.1018, Arsenic; 29 CFR 1910.1025, Lead; 29 CFR 1910.1029, Coke
oven emissions; 29 CFR 1910.1043, Cotton dust; 29 CFR 1910.1044,
Dibromochloropropane (DBCP); 29 CFR 1910.1045, Acrylonitrile; 29 CFR
1910.1047, Ethylene oxide; and 29 CFR 1910.1048, Formaldehyde). In
addition, OSHA's
[[Page 1262]]
compliance experience has demonstrated that inadequate respirator
training is a common problem (Ex. 33-5), and is often associated with
respirator program deficiencies that could lead to employee exposures
to workplace contaminants. Adherence to annual training will minimize
respirator misuse. Thus, the Agency's experience under other
rulemakings, as well as its compliance experience with the previous
respiratory protection standard, serve, in part, as the basis for
concluding that annual training for respirator users under this final
standard is reasonable and appropriate.
As noted above, a number of commenters argued that training should
be required only to inform employees about changes in the respirator
program. This view suggests that regular, periodic training in the use
of respirators is not necessary to ensure the success of a respirator
program. However, as discussed above, evidence provided by management,
labor, and other participants in this and other rulemaking records
demonstrates the importance of reinforcing an employee's knowledge with
respect to the use of respirators on a regular basis to ensure the
successful use of respirators. Accordingly, the final standard in
paragraph (k)(5) includes the requirement for annual training for
respirator users. This provision ensures the successful implementation
of the respiratory protection program by keeping employees thoroughly
and accurately informed on a regular basis regarding the current status
of the program.
Several commenters recommended that training be provided more
frequently than annually to users of SCBAs and to employees who are
required to use respirators during emergency situations (Exs. 54-210,
54-290, 54-363, 54-410, 54-424). OSHA agrees that retraining more
frequently than annually may be appropriate for some users of SCBAs and
emergency responders. This concern is addressed in final paragraph
(k)(5), which contemplates such additional training in circumstances in
which the employer has reason to believe that a previously trained
employee does not have the understanding and skill required to use the
respirator properly on a continuing basis. Although this provision is
performance oriented, it requires that more frequent (than annual)
periodic training be provided if necessary (e.g., because of the
complexity of the respirator or exposure conditions). If respirator
users must be trained more frequently than annually to retain the
knowledge necessary to ensure proper use of the respirator, then the
employer must provide the additional training.
Final paragraphs (k)(5)(i)-(iii) require additional training when
changes in the workplace (process change, increase in exposure, new
hazards) or in the type of respirator used by the employee render
previous training obsolete, when the employee has not retained the
requisite understanding or skill to use the respirator properly, or
when any other situation arises in which retraining appears necessary.
These provisions recognize circumstances that require supplemental
training in addition to full annual training. For example, retraining
with respect to the nature of the hazard may be necessary because of an
increase in the workplace level of a hazardous substance. Retraining
would also be required when an employee does not sufficiently
understand any program element (Ex. 54-387). OSHA believes that the
regulatory burden imposed on employers by final paragraph (k)(5) will
be minimal because this paragraph only requires element-specific
retraining on an as-needed basis to supplement annual training.
Final paragraph (k)(6) provides very basic protection for employees
who use respirators voluntarily. As discussed, in connection with
paragraph (c)(2), such employees are only covered by those provisions
of this standard that are necessary to ensure that respirator use does
not present a health hazard to these employees. Respirator use can
create health and safety problems. For example, an employee who has
chronic obstructive lung disease and who is given a negative pressure
air-purifying respirator to wear may be at risk of hypertension,
overexertion, and dizziness. Employees who voluntarily use some types
of respirators (e.g., air-purifying respirators) are potentially
exposed to the hazards associated with respirator use. Consequently, in
paragraph (k)(6), OSHA requires employers to provide employees who
voluntarily use some types of respirators (e.g., air purifying
respirators) with the informational material in Appendix D so that the
employee will be familiar with basic respirator use procedures.
Paragraph (l)--Program Evaluation
Paragraph (l) requires employers to perform evaluations to
determine whether the respiratory protection program is functioning
effectively. Problems with protection, irritation, breathing
resistance, comfort, and other respirator-related factors occasionally
arise in most respiratory protection programs. Although it is not
possible to eliminate all problems associated with respirator use, the
employer must eliminate as many problems as possible to improve
respiratory protection and encourage employee acceptance and safe use
of respirators. Eliminating problems is accomplished most effectively
when the respiratory protection program is evaluated thoroughly and
revised as necessary. Although the previous respiratory protection
standard requires that the employer perform regular checks of the
effectiveness of the respiratory protection program, it provided little
guidance regarding how these evaluations are to be done. The final
rule, like the proposal, describes the required program evaluation with
greater specificity than OSHA's previous respiratory protection
standard did.
Final paragraph (c) of the respirator standard requires the
employer to establish a written respiratory protection program. The
program must include procedures for evaluating the effectiveness of the
respirator program and must designate a program administrator who is to
monitor conditions in the workplace on a regular basis to ensure that
the provisions of the written respiratory protection program are being
properly implemented. Final paragraph (l) specifies certain steps the
employer must take as part of his/her regular evaluation of the
respiratory protection program.
Paragraph (l) requires the employer to consult employees who use
respirators to ascertain whether they perceive any problems with the
equipment and to obtain their views on program effectiveness. This
assessment must evaluate such factors as difficulty breathing or
fatigue during respirator use, whether the respirator interferes with
hearing and vision, communication, or job performance or restricts
movement, whether the respirator causes discomfort, and whether the
employee has confidence in the respirator's effectiveness. The employer
must correct any problems that are revealed by the evaluation.
The record supports the need to review and evaluate workplace
respirator use to ensure the continuous effectiveness of the respirator
program (Exs. 54-91, 54-153, 54-181, 54-213, 54-219, 54-234, 54-244,
54-252, 54-263, 54-265, 54-54-286, 54-297, 54-330, 54-352, 54-387, 54-
424, 54-428, 54-455, Tr. 387, 1012, 1714, 1733, 1998). Based on the
record, however, the final program evaluation provisions were modified,
as discussed below, from those proposed.
Final paragraph (l)(1) requires the employer to conduct regular
evaluations of the workplace to ensure that the
[[Page 1263]]
provisions of the written program are being properly implemented for
all employees required to use respirators, and to ensure the continued
effectiveness of the program. Proposed paragraph (l)(1) required the
employer to review the written respiratory protection program at least
annually and to conduct frequent random inspections of the workplace to
ensure that the provisions of the program are being properly
implemented for all employees. The review of the written program was to
include an assessment of each written program element specified under
proposed paragraph (c)(1) of the standard.
The final standard under paragraph (l) has deleted the proposed
provisions for annual written program review of each element and
``frequent random'' workplace evaluations in favor of more performance-
oriented requirements. Although a number of commenters supported annual
written program review (Exs. 54-91, 54-153, 54-181, 54-213, 54-244, 54-
265, 54-361, 54-387, 54-424, 54-428), others asserted that program
review was necessary but should only be required on an as-needed,
rather than annual, basis as necessitated by workplace or user
conditions or characteristics (Exs. 54-177, 54-234, 54-263, 54-286, 54-
297, 54-330, 54-352, 54-402, Tr. 1733). The Chemical Manufacturers
Association (CMA) (Ex. 54-263), for example, stated:
For simple programs such as a single air purifying respirator in
use with a single contaminant, assessments might be necessary once
every 3-5 years. For programs with numerous hazards that change
repeatedly such as batch processes, reviews may be needed more
frequently.
The CMA (Ex. 54-263) and Mobil Corporation (Ex. 54-234) support
adoption of the ANSI Z88.2 (1992) recommendation that reads ``The
program shall be periodically audited to ensure that it is implemented
and reflects the written procedures.'' Consumer Power (Ex. 54-297)
argued that program review and revision should be required ``as
necessary to reflect changes in respirator used, training, fit test
methods, and storage or maintenance of the respirator in use at the
facility.''
OSHA agrees with commenters that a more performance-oriented
approach with respect to written program review is appropriate in lieu
of an annual requirement. The Agency believes that the final standard
will ensure the maintenance of an up-to-date written respirator program
without imposing an arbitrary review schedule. Final paragraph (c)(1)
states, in part, that the program shall be updated as necessary to
reflect changes in workplace conditions and respirator use. This
provision requires employers to review the written program and to
revise, as necessary, the written program elements specified in
paragraph (c)(1) when workplace conditions affecting the use of
respirators change.
Accordingly, the final standard does not contain the proposed
requirement for an annual written program review but instead requires
program review and revision as necessary based on workplace changes.
Evaluation frequency to ensure the continued effectiveness of the
program is to be based on program complexity and on factors such as the
nature and extent of workplace hazards, types of respirators in use,
variability of workplace processes and operations, number of respirator
users, and worker experience in the use of respirators. In other words,
the employer must audit respirator use in the workplace with sufficient
frequency to ensure that continuous, successful implementation of all
written respirator program elements prescribed under paragraph (c) is
being achieved.
As noted previously, the proposed requirement for ``frequent
random'' workplace evaluations has been deleted in favor of a
requirement for evaluations conducted on an as-necessary basis. OSHA
agrees with commenters' assertions that the meaning of the term
``frequent random'' was unclear (Exs. 54-181, 54-334), especially with
respect to conditions of infrequent or brief respirator use (Exs. 54-
166, 54-177). In such instances, the commenters indicated that
evaluations would have to be scheduled based on when respirators are
used. The Agency believes that the final standard's evaluation
procedures incorporate a flexible and reasonable approach that will
meet the needs of different workplaces while ensuring continued,
effective implementation of the respirator program. OSHA emphasizes
that the change in language in the final standard is not intended to
deemphasize the importance of conducting evaluations.
Final paragraph (l)(2) requires the employer to consult regularly
with employees who wear respirators to obtain their views on the
effectiveness of the program and to correct any problems that are
identified. This assessment must determine if the respirators are
properly fitted. It must also evaluate whether employees are able to
wear the respirators without interfering with effective workplace
performance, whether respirators are correctly selected for the hazards
encountered, whether respirators are being worn when necessary, and
whether respirators are being maintained properly. Many commenters
(Exs. 54-91, 54-153, 54-181, 54-213, 54-265, 54-361, 54-387, 54-424,
54-488) supported the proposed requirement for the employer
periodically to consult with employees.
This requirement is essentially unchanged from the proposed
provision. Some commenters (Exs. 54-187, 54-278) argued that the
employer's obligations to consult with employees should be limited to
those employees required by OSHA to wear respirators. However, as
explained in detail in the Summary and Explanation for paragraphs (a)
and (c), OSHA believes that all employees who are required to wear
respirators should be covered by the program, regardless of whether
their respirator use is required by OSHA or their employer.
Thus, final paragraph (l)(2) requires the employer to consult with
employees who wear respirators when auditing the effectiveness of the
respirator program. As discussed above in connection with paragraph
(c), OSHA has consistently required employers who provide their
employees with respirators to ensure that those respirators do not pose
a health hazard (e.g., do not increase the work-of-breathing in a way
that threatens health, do not impair vision or hearing). In general,
assessments conducted to comply with paragraph (l) will involve a
technical evaluation of whether respirators are being used properly. If
respirators are not being used properly, the employer is required to
correct any problems found during the assessment. The areas to be
reevaluated include whether the respirator program is providing
employees with properly fitting respirators and whether the appropriate
respirators are being selected, used, and maintained properly.
Proposed paragraph (l)(2)(i), which would have required the
employer to assess whether the program was ``preventing the occurrence
of illness,'' has been deleted from the final rule. Commenters noted
that the individual performing the program evaluation under this
paragraph is not likely to be a health care professional with
sufficient expertise to identify illnesses caused by improper
respirator use, other than skin/eye irritation, which can readily be
observed by the program administrator, supervisor, employer, or
employee. Commenters argued that medical determinations and evaluations
are part of the review of an employee's medical status required by
paragraph (e) of this section (Exs. 54-187, 54-237). OSHA agrees and,
accordingly, has
[[Page 1264]]
omitted this proposed requirement from final paragraph (l)(2). However,
identification of respirator-related medical conditions, such as skin
irritation, would properly be part of the program evaluation. Employees
identified during the evaluation as having skin irritation can either
be referred to the PLHCP or be advised by the program administrator
about the need to leave the respirator use area as necessary to wash
the face and facepiece, as permitted by paragraph (g). It should be
noted that final paragraph (e)(7)(iii) requires medical evaluation if
observations made during the program evaluation indicate that such
evaluation is necessary.
Paragraph (m)--Recordkeeping
The final standard requires the employer to establish and retain
written information regarding medical evaluations, fit testing, and the
respirator program. The final provisions addressing these records
differ in some respects from the proposed requirements. In the proposed
rule, paragraph (c) contained recordkeeping provisions for the written
respiratory program, paragraph (m) required retention of medical
evaluation records, and fit testing records were required to be
maintained under Appendix A. In the final rule, however, all
recordkeeping requirements have been consolidated in paragraph (m), in
response to those commenters who suggested that placing all
recordkeeping provisions in one paragraph will improve understanding of
the rule's recordkeeping obligations (Exs. 54-267, 54-286).
Paragraph (m)(1) of the final standard requires the employer to
retain a medical evaluation record for each employee subject to medical
evaluation under final paragraph (e). Such records are to be kept and
made available as required by 29 CFR 1910.1020, OSHA's Access to
Employee Exposure and Medical Records rule. The record is to include
the result of the medical questionnaire and, if applicable, a copy of
the PLHCP's written opinion and recommendations, including the results
of relevant medical examinations and tests. It is standard medical
practice to make and retain written records of medical examinations and
evaluations. Retention of such records will enable PLHCPs in subsequent
evaluations to determine whether the employee's health has
deteriorated, and will enable employees to obtain copies for their
personal physician or other licensed health care professional to review
as necessary.
Although the format of final paragraph (m)(1) has been simplified
from that of the proposed rule, the substance of the medical evaluation
records to be retained is similar. Several proposed paragraphs referred
specifically to provisions in 29 CFR 1910.1020 that address the
maintenance, availability, and transfer of the medical evaluation
records. As recommended by several commenters, however, only one
reference to 29 CFR 1910.1020 is needed for this purpose, and the final
respiratory protection rule has been revised accordingly (Exs. 54-220,
54-350, 54-362, 54-455, Tr. 1054).
Final paragraph (m)(2) addresses the retention of respirator fit-
testing records. The provisions of this paragraph remain basically
unchanged from the requirements of Appendix A, section II. 12 of the
proposal. The records specified in final paragraphs (m)(2)(i)(A)--(E)
consist of the name or identification of the person tested; the type of
fit test performed (QLFT, QNFT--irritant smoke, saccharin, etc.); the
make, model, and size of the respirator fitted; the date of the fit
test; pass/fail results if a QLFT is used; or the fit factor and strip
chart recording or other record of the test results if quantitative fit
testing was performed.
Under final paragraph (m)(2)(ii), the fit test record must be
maintained until the next fit test is administered. If the employee's
use of a respirator is discontinued (e.g., because of a change of
duties or successful implementation of engineering controls), fit test
records need not be retained for the employee. Fit test records must be
maintained to determine whether annual fit testing has been done, and
whether the employee who was tested passed the QLFT or passed the QNFT
with a fit factor that was appropriate for the type of respirator being
used. OSHA agrees with commenters (Exs. 36-6, 36-17, 36-34, 36-46, 54-
165, 54-210) who stated that fit testing records must be maintained to
ensure that all respirator users have received a fit test, the
respirator selected by fit testing is being used, and retesting is
being performed annually.
Some commenters argued that the employer should only be required to
certify that fit testing has been completed, and that retaining the
other proposed information would provide little additional benefit
(Exs. 54-222, 54-310). OSHA disagrees with this position. The Agency
believes it is essential that fit test records identify the respirator
and employee being fit tested. As noted in the preceding paragraph,
other commenters stated that the information in this record would be
the only means of determining whether the appropriate respirator was
being used by the employee. OSHA believes that the effectiveness of the
respiratory protection program will be substantially improved if these
records are kept. Similar recordkeeping requirements are found in many
OSHA standards: 29 CFR 1910.1027, Cadmium; 29 CFR 1910.1028, Benzene;
29 CFR 1910.1048, Formaldehyde; 29 CFR 1910.1050, Methylenedianiline.
Final paragraph (m)(3) specifically requires employers to maintain
a written copy of the current respiratory protection program prescribed
by final paragraph (c). As discussed under paragraph (c), a written
program is necessary to assure the appropriate use of respirators and
the on-going effectiveness of the program.
Final paragraph (m)(4) provides that written materials required to
be maintained under final paragraph (m) must be made available, upon
request, to employees and to the Assistant Secretary for examination
and copying. This final paragraph replaces, but is consistent with, the
record availability requirement of proposed paragraph (m)(2). Employee
access to these records is necessary to ensure that employees can
assess and verify information describing their exposure to respiratory
hazards in the workplace and the effectiveness of the respirator
program in protecting them from those hazards. Access to these records
by the Assistant Secretary or his or her designees is necessary to
allow OSHA to monitor compliance with the standard and its
effectiveness.
The access provisions in final paragraph (m)(4) are consistent with
provisions found in other OSHA standards: 29 CFR 1910.1001, Asbestos;
29 CFR 1910.1027, Cadmium; 29 CFR 1910.1028, Benzene; 29 CFR 1910.1047,
Ethylene Oxide; 29 CFR 1910.1048, Formaldehyde; and 20 CFR 1910.1050,
Methylenedianiline.
Paragraph (n)--Dates
The final Respiratory Protection standard will become effective on
April 8, 1998. For most requirements of the standard, however,
compliance need not be achieved until the start-up dates specified in
paragraph (n) of the final rule. Unless a different start-up date is
specified for a particular requirement, compliance must be achieved by
the effective date.
The proposal would have required compliance with all provisions of
the standard 90 days after publication of the final standard in the
Federal Register. The Air Conditioning Contractors of America (Ex. 54-
248) stated that a 90-day compliance period should be
[[Page 1265]]
sufficient if OSHA plans to disseminate information to employers in a
``user-friendly'' format, but that additional time would be required if
industry organizations had to analyze and distribute information on the
final standard by themselves. Several commenters recommended a 6-12
month effective date for implementing the final standard (Exs. 54-248,
54-271, 54-283, 54-293, 54-309). The U.S. Enrichment Corporation (Ex.
54-283) wanted the standard phased in over a 12-month period to allow
additional time for the employer to obtain respiratory protection
equipment from manufacturers and to perform fit testing. The American
Subcontractors Association (Ex. 54-293) stated that small contractors
rely on their organization and others for education and training
regarding new standards, and that a 90-day period is too short a period
for transition to a new program. They specifically mentioned training,
updating written programs, changing written standard operating
procedures (SOPs), and medical examinations as provisions in the
standard that may be difficult to comply with in a short time period.
The Associated Building Contractors (Ex. 54-309) also wanted the final
standard to be phased in over 12 months to allow for revising written
SOPs and programs, training, and medical evaluation of respirator
users. Exxon (Ex. 54-266) and the American Petroleum Institute (Ex. 54-
330) stated that employers could not fit test every employee within the
specified 90-day effective date and recommended that employees be fit
tested within one year of the effective date of the standard.
Based on many of these comments, OSHA concludes that additional
time is required for employers to comply with certain provisions of the
final standard. The Agency has therefore included extended start-up
dates for some of the program elements. OSHA does intend, however, to
disseminate information on this standard in a ``user friendly'' format.
Within 150 days of the effective date of the standard, employers
must determine whether respirator use is required under paragraph (a).
This period will afford employers sufficient time to become familiar
with the final standard and to evaluate whether respirator use is
required in their workplaces.
Employers must comply with all the remaining requirements of the
respirator standard no later than 180 days after the effective date of
the standard. OSHA concludes that with the start-up dates provided, all
employers will have adequate time to comply. Paragraph (n)(3) states
that if there is an administrative or judicial delay of the standard,
the respiratory protection provisions of the previous standards (i.e.,
29 CFR 1910.134 and 29 CFR 1926.103) will remain in effect and will be
enforced until the issues have been resolved. Many employers already
have an established respiratory protection program that includes
specific program elements (e.g., fit testing, annual training, medical
evaluations of respirator users, and program evaluation) that comply
with the requirements of the Agency's prior respirator standards.
Program elements that were implemented to meet the prior respirator
standards' requirements may also meet the requirements of this final
respiratory protection standard. Paragraph (n)(4) states that if, in
the 12 month period preceding the effective date of the revised
standard, the employer has conducted annual respirator training, fit
testing, respirator program evaluation, or medical evaluations, the
employer may use the results of these activities to comply with the
corresponding provisions of this section, provided that these
activities were conducted in a manner that meets the requirements of
the revised standard. For example, if the employer has an existing fit
testing program in place on the effective date of the final standard,
the employer may continue that fit testing program if it meets the fit
testing requirements of the final standard. In such cases, employees
would be retested within one year of their last fit test date.
Employers, therefore, can incorporate annual fit testing, training, and
program evaluation into their existing respiratory protection programs
if the appropriate program elements comply with the provisions of the
final standard. This approach should help reduce the impact of the
final rule on employers with effective existing respirator programs.
Paragraph (o)--Appendices
The final paragraph of the standard identifies four appendices that
supplement the requirements specified in the regulatory text.
Appendices A (Fit Testing Procedures), B-1 (User Seal Check
Procedures), B-2 (Cleaning Procedures), and C (Medical Questionnaire)
are mandatory, and contain requirements for performing fit testing,
user seal checks, cleaning, and medical evaluations that supplement the
regulatory requirements in paragraphs (e), (f), (g), and (h) of the
final standard.
Appendix D (Information for Employees Using Respirators When Not
Required Under The Standard) is nonmandatory.
The four appendices are discussed in detail under the Summary and
Explanation sections of the corresponding paragraphs of the final
standard: Appendix A in paragraph (f), ``Fit Testing''; Appendix B-1 in
paragraph (g), ``Use of respirators''; Appendix B-2 in paragraph (h),
``Maintenance and care of respirators''; Appendix C in paragraph (e),
``Medical evaluation''; Appendix D in paragraph (c), ``Written
program'' and paragraph (a), ``Permissible practice.''
Paragraph (p)--Revisions to Specific OSHA Standards
A number of OSHA standards regulating exposure to toxic substance
and harmful physical agents incorporate certain provisions of 29 CFR
1910.134. OSHA proposed to revise these provisions to simplify
compliance for employers by consolidating many of the Agency's
respirator requirements, removing inconsistencies, and deleting
duplicative requirements. The purpose of revising the respirator-
related provisions of OSHA's existing standards was to conform these
standards, to the extent possible, to each other and to revised 29 CFR
1910.134 in general. These standards will be improved by this process,
because they will now refer to the revised respiratory protection
standard, which is based on current respirator use and technology. For
example, revising the respirator-approval references in these standards
from MSHA/NIOSH, Bureau of Mines, and ANSI Z88.2-1969 to the recently
published NIOSH regulation at 42 CFR Part 84 updates these respiratory
protection provisions. The Agency concludes, therefore, that updating
these standards is consistent with the proposed goal of bringing
uniformity to OSHA's respiratory protection requirements. OSHA believes
that regulatory consistency will improve compliance with the
respiratory protection provisions, reduce the compliance burden on the
regulated community, and, consequently, enhance the protection provided
to employees who use respirators. OSHA's review of the rulemaking
record shows that no commenters objected to updating the provisions of
these standards to conform with the requirements of revised 29 CFR
1910.134.
The Agency also notes that revised 29 CFR 1910.134 is intended to
serve as a ``building block'' standard with respect to future standards
that may contain respiratory protection requirements. To the extent
possible, therefore, future standards that regulate respirator use in
[[Page 1266]]
controlling employee exposure to toxic substances and harmful physical
agents will refer to provisions of the final respiratory protection
standard at 29 CFR 1910.134 instead of containing their own respirator
requirements. (However, these standards will continue to have any
respirator requirements, e.g., canister/cartridge change schedules,
that are specific to the substance or agent being regulated.)
In developing the final revision, OSHA also revised the wording
and/or location of some paragraphs to improve the comprehensibility and
uniformity of the requirements; however, the substantive requirements
of the standards addressing respirators have not been revised.
Additionally, the tables in the substance-specific standards specifying
parameters for respirator selection have not been republished because
these tables will remain unchanged and, thus, will continue to be part
of the substance-specific standards until resolution of the reserved
portions of this final standard.
OSHA found that the existing substance-specific standards were
especially in need of revision. Except for a limited number of
respirator provisions unique to each substance-specific standard, the
remaining regulatory text on respirators now reads virtually the same
for each of these standards. For example, all provisions addressing
respirator use, selection, and fit testing were deleted from the
substance-specific standards, making these standards consistent with
the final respiratory protection standard with respect to these
requirements. The Agency believes that revisions to 29 CFR 1910.134 are
sufficiently comprehensive to allow deletion of those provisions in the
substance-specific standards that duplicated provisions of revised 29
CFR 1910.134. A provision was retained only when it addressed
conditions (for example, medical evaluation) that were unique and/or
integral to the substance-specific standard. The Agency concludes,
therefore, that deletion of duplicative provisions from the substance-
specific standards will reduce confusion among members of the regulated
community and decrease the burden of compliance. It will thereby
enhance compliance with the respiratory protection requirements and,
consequently, improve the protection afforded to employees who use
respirators to control exposure to the toxic substances and harmful
physical agents regulated by these standards. The proposed revisions to
the substance-specific standards were widely supported by rulemaking
participants (Exs. 54-187, 54-208, 54-219, 54-220, 54-233, 54-234, 54-
261, 54-263, 54-266, 54-267, 54-273, 54-283, 54-289, 54-327, 54-333,
54-363, 54-424.)
In general, for the substance-specific standards, the incorporated
provisions of revised 29 CFR 1910.134 cover the following requirements:
definitions (paragraph (b)); respiratory protection program (paragraph
(c)); selection of respirators (paragraph (d)); fit testing (paragraph
(f)); use of respirators (paragraph (g)); maintenance and care of
respirators (paragraph (h)); breathing air quality and use (paragraph
(i)); identification of filters, cartridges, and canisters (paragraph
(j)); training and information (paragraph (k)); program evaluation
(paragraph (l)); and recordkeeping (paragraph (m)). Each of these
requirements was addressed by paragraphs (b), (c), (d), (e), and (f) of
the prior respiratory protection standard.
OSHA did not propose to conform the respirator provisions of its
Cadmium, Benzene, Formaldehyde, 1,3-Butadiene, and Methylene chloride
standards with the corresponding requirements of revised 29 CFR
1910.134. Rulemaking participants recommended that the respirator
provisions of the existing Cadmium, Benzene, and Formaldehyde standards
be revised to conform with those provisions of 29 CFR 1910.134 to
improve regulatory consistency and uniformity (Exs. 54-194, 54-195, 54-
208, 54-218, 54-275, 54-294, 54-337, 54-350, 54-387, 54-434). In view
of these comments, the Agency assumes that a consensus exists among the
regulated community to bring these standards (as well as the 1,3-
Butadiene and Methylene chloride standards, which were issued after the
close of the comment period for the respirator rulemaking) into
conformity with the revised respiratory protection standard.
Accordingly, these standards have been revised in the same manner as
the other substance-specific standards for which OSHA proposed
revisions.
In revising the fit-testing provisions (paragraph (f)) of the
substance-specific standards, the frequency of respirator fit testing
was revised from semiannually to annually for the Asbestos (29 CFR
1910.1001 and 1926.1101), Arsenic (29 CFR 1910.1018), Lead (29 CFR
1910.1025 and 1926.62) and Acrylonitrile (29 CFR 1910.1045) standards.
The Agency believes that this revision will not diminish the
effectiveness of respiratory protection provided by these standards.
OSHA's experience in recent rulemakings (Cadmium, 1992;
Methylenedianiline, 1992; Formaldehyde, 1992; Methylene chloride, 1997)
has led the Agency to conclude that annual respirator fit testing,
which is provided for in the recent standards, protects employees
appropriately, and that semi-annual fit testing is not necessary for
employee protection. The basis for adopting a semiannual fit-testing
requirement is not discussed in the preambles to any of the standards
that contain that requirement. For example, there is no discussion in
the preambles of those standards that semiannual fit testing was
adopted because of the toxic properties of the regulated substances or
the particular characteristics of the respirators to be used.
Recent rulemakings, including proposed revisions to the respiratory
protection standard, have provided the Agency with much more scientific
and experiential information on fit testing than was available when the
affected standards were adopted. A number of commenters in the current
rulemaking asserted that provisions for semiannual fit testing in the
existing Asbestos, Arsenic, Lead, and Acrylonitrile standards should be
revised to conform to the annual fit testing requirements of the
recently-adopted standards (Exs. 54-5, 54-179, 54-186, 54-208, 54-218,
54-219, 54-222, 54-242, 54-289, 54-326, 54-330, 54-348, 54-410, 54-424,
54-439, 54-443.) The Agency, therefore, concludes that it is reasonable
and appropriate, for the purpose of regulatory consistency and
uniformity, to require only annual respirator fit testing in its
substance-specific standards.
While the proposal did not incorporate revised paragraph (m)
(recordkeeping) into the existing substance-specific standards, OSHA
incorporated this paragraph in the final rulemaking in the belief that
such action: (1) Will make recordkeeping requirements consistent and
uniform for employers who use respirators to control employee exposures
to the airborne contaminants regulated by the substance-specific
standards; (2) will reduce the regulatory burden on employers because
they are currently required under 29 CFR 1910.1020 to maintain exposure
and medical records; and, (3) it is a prevailing business and
industrial-hygiene practice to retain fit-testing records to
demonstrate that protection was provided to exposed employees.
For the 13 carcinogens addressed by existing 29 CFR 1910.1003 (the
``13 Carcinogens standard''), the provision requiring employers to
ensure that employees use respirators ``in accordance with 29 CFR
1910.134'' was amended to require compliance with paragraphs (b), (c),
(d) (except (d)(1) (iii), (iv), and (d)(3)), and (e)-(m) of the
[[Page 1267]]
final standard. While the proposal did not incorporate revised
paragraph (e) (medical evaluation) into the 13 Carcinogens standard,
OSHA did so in the final rulemaking because such incorporation is
consistent with the requirements of existing 29 CFR 1910.134, conforms
to accepted industry practice, and improves comprehension of, and
compliance with, the respiratory protection requirements of the 13
Carcinogens standard.
Unlike 29 CFR 1910.1003, each of the existing substance-specific
OSHA standards includes unique medical-evaluation requirements for
employees who use respirators. OSHA believes that the medical-
evaluation requirements for respirator use established under its
existing substance-specific standards provide a high degree of medical
protection to employees who are required to use respirators to control
their exposures to the airborne substances regulated by the substance-
specific standards. In addition, the medical-evaluation requirements
for respirator use in the substance-specific standards are part of a
comprehensive, integrated medical-surveillance program designed to
evaluate employees for conditions and risks associated with exposure to
the regulated substances; consequently, OSHA believes that any revision
to the frequency or content of medical evaluations for respirator use
would unnecessarily disrupt ongoing medical-surveillance programs and,
therefore, jeopardize the health of employees who must use respirators
to prevent exposure to hazardous workplace substances.
Paragraph (d)(1)(iii) of the revised respiratory protection
standard, which requires employers to estimate exposure levels in
selecting appropriate respirators, has not been incorporated into
OSHA's substance-specific standards in the final rulemaking. The
existing substance-specific standards, except the 13 Carcinogens
standard, already include exposure assessment provisions that are more
specific than the general exposure-assessment requirement in the final
respiratory protection standard. With respect to the 13 Carcinogens
standard, no PELs or other exposure criteria are specified in that
standard that would be relevant to respirator selection. In the 13
Carcinogens standard, exposure estimates for the substances regulated
by the standard are not necessary for respirator selection because
appropriate respirators have been identified for specific work
activities that occur during employee exposure to each of the 13
carcinogenic substances.
OSHA excepted substance-specific standards that already contain
requirements for cartridge- and canister-change schedules (Vinyl
chloride, Benzene, Acrylonitrile, Formaldehyde, and 1,3-Butadiene) from
paragraphs (d)(3)(iii)(B) (1) and (2) of the revised respiratory
protection standard, which also addresses change schedules, to preclude
regulatory conflict. The Agency finds that information obtained during
the rulemakings for these substance-specific standards resulted in the
development of change schedules that were especially tailored to the
chemistry of the specific substance, documented the exposure conditions
requiring these schedules, and determined the types of respirators
required for employee protection. Consequently, the Agency concludes
that the change schedules adopted during these rulemakings must not be
replaced by the generic change-schedule requirements of revised 29 CFR
1910.134.
As proposed, the Agency also removed a number of appendices from
the substance-specific standards that addressed fit-testing
requirements, replacing them with references to Appendix A of revised
29 CFR 1910.134. In this regard, the Agency proposed to update Section
IV of Appendix B of 29 CFR 1910.1025 (the Lead standard) by citing
Appendix A of 29 CFR 1910.134 as the reference for fit-testing
procedures; the proposed revision has been made in the final
rulemaking. While not proposed, the Agency revised the same information
in Appendix B of 29 CFR 1926.62 (the Lead standard for Construction),
removed the sixth paragraph from Section IV of Appendix B of 29 CFR
1910.1025 and 1926.62 as being outdated, and revised references for
respirator approval in Section IV of Appendix B of 29 CFR 1910.1025,
Section IV of Appendix A to 29 CFR 1910.1045 (the Acrylonitrile
standard), Section IV of Appendix A to 29 CFR 1910.1047 (the Ethylene
Oxide standard), Section III of Appendix A to 29 CFR 1910.1050 (the 4,
4'-Methylenedianiline standard), and Section IV of Appendix B to 29 CFR
1926.62, Lead in Construction. The Agency believes that these revisions
will conform the affected standards with the provisions of the revised
respiratory protection standard; the resulting consistency will,
therefore, reduce confusion and ease compliance.
The following provisions, addressing fit-testing, respirator
selection, and respirator use, have been deleted from OSHA's substance-
specific standards because they duplicate requirements specified in
revised 29 CFR 1910.134:
(1) Fit Testing
This requirement is specified in paragraph (f) of the revised
respiratory protection standard, allowing for the removal of the
following paragraphs:
(a) 29 CFR 1910.1001 Asbestos.
(g)(4) and Appendix C
(b) 29 CFR 1910.1018 Inorganic arsenic.
(h)(3) (i), (ii), and (iii)
(c) 29 CFR 1910.1025 Lead.
(f)(3) (i) and (ii), and Appendix D; Section IV of Appendix B
revised in part
(d) 29 CFR 1910.1027 Cadmium.
(g)(4) and Appendix C
(e) 29 CFR 1910.1028 Benzene.
(g)(5) and Appendix E
(f) 29 CFR 1910.1045 Acrylonitrile.
(h)(3)(iii)
(g) 1910.1048 Formaldehyde.
(g)(3)(ii) and Appendix E
(h) 29 CFR 1910.1050 Methylenedianiline.
(h)(5) and Appendix E
(i) 29 CFR 1910.1051 1,3-Butadiene.
(h)(5) and Appendix E
(j) 29 CFR 1910.1052 Methylene chloride.
(g)(7)
(k) 29 CFR 1926.60 Methylenedianiline. (i)(5) and Appendix E
(l) 29 CFR 1926.62 Lead.
(f)(3) (i) and (ii), and Appendix D; Section IV of Appendix B
revised in part
(m) 29 CFR 1926.1101 Asbestos.
(h)(4) and Appendix C
(n) 29 CFR 1926.1127 Cadmium.
(g)(4) and Appendix C
(2) Respirator-Approval Requirements that Reference MSHA or NIOSH 30
CFR Part 11
The requirement to select respirators approved by NIOSH in 42 CFR
part 84 is specified in paragraph (d)(1)(ii) of the revised respiratory
protection standard. This requirement updates the existing respirator-
approval requirement in the substance-specific standards to select
respirators approved by MSHA or NIOSH under 30 CFR part 11, allowing
for removal of the following paragraphs:
(a) 29 CFR 1910.1001 Asbestos.
(g)(2)(i) [part]
(b) 29 CFR 1910.1017 Vinyl chloride.
(g)(2)
(c) 29 CFR 1910.1018 Inorganic arsenic.
(h)(2)(iii)
(d) 29 CFR 1910.1025 Lead.
(f)(2)(iii); Section IV of Appendix B revised in part
(e) 29 CFR 1910.1027 Cadmium.
(g)(2)(i) [part]
(f) 29 CFR 1910.1028 Benzene
[[Page 1268]]
(g)(2)(ii)
(g) 29 CFR 1910.1029 Coke oven emissions.
(g)(2)(iii)
(h) 29 CFR 1910.1044 1,2-Dibromo-3-chloropropane.
(h)(2)(ii)
(i) 29 CFR 1910.1045 Acrylonitrile.
(h)(2)(ii); Section IV of Appendix A revised in part
(j) 29 CFR 1910.1047 Ethylene oxide.
(g)(2)(ii); Section IV of Appendix A revised in part
(k) 29 CFR 1910.1048 Formaldehyde.
(g)(2)(i) [part]
(l) 29 CFR 1910.1050 Methylenedianiline.
(h)(2)(ii); Section III of Appendix A revised in part
(m) 29 CFR 1910.1051 1,3-Butadiene.
(h)(2)(ii) [part]
(n) 29 CFR 1910.1052 Methylene chloride.
(g)(3) [part]
(o) 29 CFR 1926.60 Methylenedianiline.
(i)(2)(ii)
(p) 29 CFR 1926.62 Lead.
(f)(2)(iii); Section IV of Appendix B revised in part
(q) 29 CFR 1926.1101 Asbestos.
(h)(2)(ii)
(r) 29 CFR 1926.1127 Cadmium.
(g)(2)(i) [part]
(3) Respirator Use
Paragraph (g) of the revised respiratory protection standard
addresses, in part, facepiece seal protection (paragraph (g)(1)), and
employees leaving the work area to wash their faces and respirator
facepieces (paragraph (g)(2)(ii)(A)) and to change filter elements
(paragraph (g)(2)(ii) (B) and (C)), allowing removal of the following
paragraphs:
(a) 29 CFR 1910.1001 Asbestos.
(g)(3) (ii) and (iii)
(b) 29 CFR 1910.1018 Inorganic arsenic.
(h)(4) (ii) and (iii)
(c) 29 CFR 1910.1025 Lead.
(f)(4) (ii) and (iii)
(d) 29 CFR 1910.1027 Cadmium.
(g)(3) (ii) and (iii)
(e) 29 CFR 1910.1028 Benzene.
(g)(4)(iii)
(f) 29 CFR 1910.1029 Coke oven emissions.
(g)(4)
(g) 29 CFR 1910.1043 Cotton dust.
(f)(4)
(h) 29 CFR 1910.1044 1,2-Dibromo-3-chloropropane.
(h)(3)(ii)
(i) 29 CFR 1910.1045 Acrylonitrile.
(h)(3)(iv)
(j) 29 CFR 1910.1048 Formaldehyde.
(g)(3)(v)
(k) 29 CFR 1910.1050 Methylenedianiline.
(h)(4)(ii)
(l) 29 CFR 1910.1051 1,3-Butadiene.
(h)(4)(v)
(m) 29 CFR 1910.1052 Methylene chloride.
(g)(5)
(n) 29 CFR 1926.60 Methylenedianiline. (i)(4)(ii)
(o) 29 CFR 1926.62 Lead.
(f)(4) (ii) and (iii)
(p) 1926.1101 Asbestos.
(h)(3) (ii) and (iii)
(q) 29 CFR 19126.1127 Cadmium.
(g)(3) (ii) and (iii)
The full text, after deletions and revisions, of the paragraphs
dealing with respirators that remain in each of OSHA's existing
substance specific standards has been published in Section XI of this
preamble.
The provisions of the respiratory protection standard found in 29
CFR part 1926 (Construction), specifically 29 CFR 1926.103, are now
identical to the new 29 CFR 1910.134. Following its policy of not
repeating identical health provisions in order to reduce paperwork
burden and to avoid regulatory confusion, OSHA is deleting the
duplicate text in 29 CFR 1926.103 and cross-referencing the text in 29
CFR 1910.134. To implement this action, the title of this section
remains, but a Note is added to read: ``Note: The requirements
applicable to construction work under this section are identical to
those set forth at 29 CFR 1910.134 of this chapter.'' For the
convenience of the Construction industry, OSHA makes available an
indexed manual that includes the full text of all regulations
applicable to construction, including OSHA's respirator requirements.
OSHA is also revising or removing a number of provisions in
addition to safety and health standards, other than the substance-
specific standards, that duplicate provisions now found in the revised
respiratory protection standard. These standards and their revisions
include:
(1) 29 CFR 1910.94 Ventilation.
(a)(1)(i)--Removed the phrase ``continuous flow'' from the
definition of abrasive-blasting respirator consistent with the proposed
requirement to select respirators in accordance with 29 CFR 1910.134.
(a)(5)(i)--Revised the reference from ``30 CFR part 11'' to ``42
CFR Part 84.''
(a)(5)(iii)--Provided the reference ``42 CFR Part 84.''
(a)(5)(iv)--Revised the reference from ``Sec. 1910.134 (a) and
(b)'' to ``Sec. 1910.134.''
(a)(6)--Revised the air-requirement reference for abrasive-blasting
respirators from ``ANSI Z9.2-1960'' to ``29 CFR 1910.134(i).''
(c)(6)(iii)(a)--Revised the reference from ``MSHA/NIOSH/ANSI Z-
88.2-1969'' to ``NIOSH under 42 CFR Part 84.''
(d)(9)(vi)--Revised the reference from ``MSHA/NIOSH'' to ``NIOSH
under 42 CFR Part 84.''
(2) 29 CFR 1910.111 Storage and handling of anhydrous ammonia.
(a)(2)(x)--Revised the reference from ``MSHA'' to ``the National
Institute for Occupational Safety and Health (NIOSH) under 42 CFR Part
84.''
(b)(10)(ii)--Revised the reference from ``Bureau of Mines'' to
``NIOSH under 42 CFR Part 84.''
(3) 29 CFR 1910.156 Fire brigades.
(f)(1)(i) and (v)--Revised the reference from ``MSHA/NIOSH'' to
``NIOSH under 42 CFR Part 84.''
(4) 29 CFR 1910.252 General requirements.
(c)(4)(ii) and (iii), (c)(7)(iii), (c)(9)(i), and (c)(10)--Revised
the references from ``MSHA/NIOSH'' to ``National Institute for
Occupational Safety and Health (NIOSH) under 42 CFR Part 84'' and
``NIOSH under 42 CFR Part 84.''
(5) 29 CFR 1910.261 Pulp, paper, and paperboard mills.
(b)(2) and (g)(10--Revised the reference from ``ANSI Z88.2-1969''
to ``29 CFR 1910.134.''
(h)(2)(iii) and (iv)--Revised the reference from ``ANSI Z-88.2-1969
and K-13.1-1967'' to ``29 CFR 1910.134.''
(6) 29 CFR 1926.57 Ventilation.
(f)(1)(ii)--Removed the phrase ``continuous flow'' from the
definition of abrasive-blasting respirator consistent with the proposed
requirement to select respirators in accordance with 29 CFR 1910.134.
(f)(5)(i)--Revised the reference from ``30 CFR Part 11'' to ``42
CFR Part 84.''
(f)(5)(iii)--Provided the reference ``42 CFR Part 84.''
(f)(6)--Revised the air-requirement reference for abrasive-blasting
respirators from ``ANSI Z9.2-1960'' to ``29 CFR 1910.134(i).''
(h)(6)(iii)(A)--Revised the reference from ``MSHA/NIOSH/ANSI Z-
88.2-1969'' to ``NIOSH under 42 CFR Part 84.''
(i)(9)(vi)--Revised the reference from ``MSHA/NIOSH'' to ``NIOSH
under 42 CFR Part 84.''
(7) 29 CFR 1926.103 Respiratory protection.
Removed paragraphs (a) through (i) and replaced them with a note to
read as follows:
Note: The requirements applicable to construction work under
this section are identical to those set forth at Sec. 1910.134 of
this chapter.
[[Page 1269]]
(8) 29 CFR 1926.800 Underground construction.
(g)(2)--Revised the reference from ``MSHA/NIOSH'' to ``the National
Institute for Occupational Safety and Health under 42 CFR Part 84,''
and from ``Sec. 1926.103 (b) and (c)'' to ``29 CFR 1926.103.''
Appendices
The four appendices are discussed in detail under the Summary and
Explanation sections for the following paragraphs of the final
standard: Appendix A in paragraph (f), ``Fit Testing''; Appendix B-1 in
paragraph (g), ``Use of respirators''; Appendix B-2 in paragraph (h),
``Maintenance and care of respirators'; Appendix C in paragraph (e),
``Medical evaluation''; Appendix D in paragraphs (c), ``Written
program'' and paragraph (a), ``Permissible practice.''
VIII. Authority and Signature
This document was prepared under the direction of Charles N.
Jeffress, Assistant Secretary of Labor for Occupational Safety and
Health, U.S. Department of Labor, 200 Constitution Avenue, NW.,
Washington, DC 20210.
Pursuant to sections 4, 6(b), 8(c), and 8(g) of the Occupational
Safety and Health Act of 1970 (29 U.S.C. 653, 655, 657); Sec. 107 of
the Contract Work Hours and Safety Standards Act (the Construction
Safety Act) (40 U.S.C. 333); Sec. 41, the Longshore and Harbor Worker's
Compensation Act (33 U.S.C. 941); Secretary of Labor's Order Nos. 12-71
(36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90 (55 FR
9033), or 6-96 (62 FR 111), as applicable; and 29 CFR part 1911; 29 CFR
parts 1910 and 1926 are amended as set forth below.
List of Subjects in 29 CFR Parts 1910 and 1926
Health, Occupational safety and health, Reporting and recordkeeping
requirements.
Signed at Washington, DC, this 15th day of December, 1997.
Charles N. Jeffress,
Assistant Secretary of Labor for Occupational Safety and Health.
IX. Amended Standards
Part 1910 of Title 29 of the Code of Federal Regulations is hearby
amended as follows:
PART 1910--[AMENDED]
Subpart G--[Amended]
1. The authority citation for Subpart G of Part 1910 is revised to
read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
part 1911.
2. Section 1910.94 is amended by revising paragraphs (a)(1)(ii),
(a)(5)(i), (a)(5)(iii) introductory text, (a)(5)(iv), (a)(6),
(c)(6)(iii)(a), and (d)(9)(vi) as follows:
Sec. 1910.94 Ventilation.
(a) * * *
(1) * * *
(ii) Abrasive-blasting respirator. A respirator constructed so that
it covers the wearer's head, neck, and shoulders to protect the wearer
from rebounding abrasive.
* * * * *
(5) Personal protective equipment. (i) Employers must use only
respirators approved by the National Institute for Occupational Safety
and Health (NIOSH) under 42 CFR part 84 to protect employees from dusts
produced during abrasive-blasting operations.
* * * * *
(iii) Properly fitted particulate-filter respirators, commonly
referred to as dust-filter respirators, may be used for short,
intermittent, or occasional dust exposures such as cleanup, dumping of
dust collectors, or unloading shipments of sand at a receiving point
when it is not feasible to control the dust by enclosure, exhaust
ventilation, or other means. The respirators used must be approved by
NIOSH under 42 CFR part 84 for protection against the specific type of
dust encountered.
* * * * *
(iv) For employees who use respirators required by this section,
the employer must implement a respiratory protection program in
accordance with 29 CFR 1910.134.
* * * * *
(6) Air supply and air compressors. Air for abrasive-blasting
respirators must be free of harmful quantities of dusts, mists, or
noxious gases, and must meet the requirements for supplied-air quality
and use specified in 29 CFR 1910.134(i).
* * * * *
(c) * * *
(6) * * *
(iii) (a) When an operator is in a booth downstream from the object
being sprayed, an air-supplied respirator or other type of respirator
must be used by employees that has been approved by NIOSH under 42 CFR
part 84 for the material being sprayed.
* * * * *
(d) * * *
(9) * * *
(vi) During the emergencies specified in paragraph (d)(11)(v) of
this section, if employees must be in areas where the concentrations of
air contaminants are greater than the limits set by paragraph
(d)(2)(iii) of this section or the oxygen concentration is less than
19.5 percent, they must use respirators that reduce their exposure to a
level below these limits or that provide adequate oxygen. Such
respirators must also be provided in marked, quickly-accessible storage
compartments built for this purpose when the possibility exists that
hazardous concentrations of air contaminants could be released
accidentally. The respirators must be approved by the NIOSH under 42
CFR part 84, selected by a competent industrial hygienist or other
technically-qualified source, and used in accordance with 29 CFR
1910.134.
* * * * *
Subpart H--[Amended]
3. The authority citation for subpart H of part 1910 is revised to
read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
part 1911.
4. Section 1910.111 is amended by revising paragraphs (a)(2)(x) and
(b)(10)(ii) as follows:
Sec. 1910.111 Storage and handling of anhydrous ammonia.
(a) * * *
(2) * * *
(x) Gas masks. Gas masks must be approved by the National
Institute for Occupational Safety and Health (NIOSH) under 42 CFR part
84 for use with anhydrous ammonia.
* * * * *
(b) * * *
(10) * * *
(ii) Stationary storage installations must have at least two
suitable gas masks in readily-accessible locations. Full-face masks
with ammonia canisters that have been approved by NIOSH under 42 CFR
part 84 are suitable for emergency action involving most anhydrous
ammonia leaks, particularly leaks that occur outdoors. For respiratory
protection in concentrated ammonia atmospheres, a self-contained
breathing apparatus is required.
* * * * *
[[Page 1270]]
Subpart I--[Amended]
5. The authority citation for Subpart I of Part 1910 is revised to
read as follows:
Authority: Sections 4, 6, and 8, Occupational Safety and Health
Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's Order
No. 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736), 1-90
(55 FR 9033), or 6-96 (62 FR 111), as applicable.
Sections 1910.132, 1910.134, and 1910.138 also issued under 29
CFR part 1911.
Sections 1910.133, 1910.135, and 1910.136 also issued under 29
CFR part 1911 and 5 U.S.C. 553.
6. Section 1910.134 is redesignated as Sec. 1910.139 in subpart I
and amended by revising its title and adding introductory text to read
as follows:
Sec. 1910.139 Respiratory protection for M. tuberculosis.
This section applies only to respiratory protection against M.
tuberculosis and applies in lieu of Sec. 1910.134.
* * * * *
7. A new section 1910.134 is added to read as follows:
Sec. 1910.134 Respiratory protection.
This section applies to General Industry (part 1910), Shipyards
(part 1915), Marine Terminals (part 1917), Longshoring (part 1918), and
Construction (part 1926).
(a) Permissible practice. (1) In the control of those occupational
diseases caused by breathing air contaminated with harmful dusts, fogs,
fumes, mists, gases, smokes, sprays, or vapors, the primary objective
shall be to prevent atmospheric contamination. This shall be
accomplished as far as feasible by accepted engineering control
measures (for example, enclosure or confinement of the operation,
general and local ventilation, and substitution of less toxic
materials). When effective engineering controls are not feasible, or
while they are being instituted, appropriate respirators shall be used
pursuant to this section.
(2) Respirators shall be provided by the employer when such
equipment is necessary to protect the health of the employee. The
employer shall provide the respirators which are applicable and
suitable for the purpose intended. The employer shall be responsible
for the establishment and maintenance of a respiratory protection
program which shall include the requirements outlined in paragraph (c)
of this section.
(b) Definitions. The following definitions are important terms used
in the respiratory protection standard in this section.
Air-purifying respirator means a respirator with an air-purifying
filter, cartridge, or canister that removes specific air contaminants
by passing ambient air through the air-purifying element.
Assigned protection factor (APF) [Reserved]
Atmosphere-supplying respirator means a respirator that supplies
the respirator user with breathing air from a source independent of the
ambient atmosphere, and includes supplied-air respirators (SARs) and
self-contained breathing apparatus (SCBA) units.
Canister or cartridge means a container with a filter, sorbent, or
catalyst, or combination of these items, which removes specific
contaminants from the air passed through the container.
Demand respirator means an atmosphere-supplying respirator that
admits breathing air to the facepiece only when a negative pressure is
created inside the facepiece by inhalation.
Emergency situation means any occurrence such as, but not limited
to, equipment failure, rupture of containers, or failure of control
equipment that may or does result in an uncontrolled significant
release of an airborne contaminant.
Employee exposure means exposure to a concentration of an airborne
contaminant that would occur if the employee were not using respiratory
protection.
End-of-service-life indicator (ESLI) means a system that warns the
respirator user of the approach of the end of adequate respiratory
protection, for example, that the sorbent is approaching saturation or
is no longer effective.
Escape-only respirator means a respirator intended to be used only
for emergency exit.
Filter or air purifying element means a component used in
respirators to remove solid or liquid aerosols from the inspired air.
Filtering facepiece (dust mask) means a negative pressure
particulate respirator with a filter as an integral part of the
facepiece or with the entire facepiece composed of the filtering
medium.
Fit factor means a quantitative estimate of the fit of a particular
respirator to a specific individual, and typically estimates the ratio
of the concentration of a substance in ambient air to its concentration
inside the respirator when worn.
Fit test means the use of a protocol to qualitatively or
quantitatively evaluate the fit of a respirator on an individual. (See
also Qualitative fit test QLFT and Quantitative fit test QNFT.)
Helmet means a rigid respiratory inlet covering that also provides
head protection against impact and penetration.
High efficiency particulate air (HEPA) filter means a filter that
is at least 99.97% efficient in removing monodisperse particles of 0.3
micrometers in diameter. The equivalent NIOSH 42 CFR 84 particulate
filters are the N100, R100, and P100 filters.
Hood means a respiratory inlet covering that completely covers the
head and neck and may also cover portions of the shoulders and torso.
Immediately dangerous to life or health (IDLH) means an atmosphere
that poses an immediate threat to life, would cause irreversible
adverse health effects, or would impair an individual's ability to
escape from a dangerous atmosphere.
Interior structural firefighting means the physical activity of
fire suppression, rescue or both, inside of buildings or enclosed
structures which are involved in a fire situation beyond the incipient
stage. (See 29 CFR 1910.155)
Loose-fitting facepiece means a respiratory inlet covering that is
designed to form a partial seal with the face.
Maximum use concentration (MUC) [Reserved].
Negative pressure respirator (tight fitting) means a respirator in
which the air pressure inside the facepiece is negative during
inhalation with respect to the ambient air pressure outside the
respirator.
Oxygen deficient atmosphere means an atmosphere with an oxygen
content below 19.5% by volume.
Physician or other licensed health care professional (PLHCP) means
an individual whose legally permitted scope of practice (i.e., license,
registration, or certification) allows him or her to independently
provide, or be delegated the responsibility to provide, some or all of
the health care services required by paragraph (e) of this section.
Positive pressure respirator means a respirator in which the
pressure inside the respiratory inlet covering exceeds the ambient air
pressure outside the respirator.
Powered air-purifying respirator (PAPR) means an air-purifying
respirator that uses a blower to force the ambient air through air-
purifying elements to the inlet covering.
Pressure demand respirator means a positive pressure atmosphere-
supplying respirator that admits breathing air to the facepiece when
the positive pressure
[[Page 1271]]
is reduced inside the facepiece by inhalation.
Qualitative fit test (QLFT) means a pass/fail fit test to assess
the adequacy of respirator fit that relies on the individual's response
to the test agent.
Quantitative fit test (QNFT) means an assessment of the adequacy of
respirator fit by numerically measuring the amount of leakage into the
respirator.
Respiratory inlet covering means that portion of a respirator that
forms the protective barrier between the user's respiratory tract and
an air-purifying device or breathing air source, or both. It may be a
facepiece, helmet, hood, suit, or a mouthpiece respirator with nose
clamp.
Self-contained breathing apparatus (SCBA) means an atmosphere-
supplying respirator for which the breathing air source is designed to
be carried by the user.
Service life means the period of time that a respirator, filter or
sorbent, or other respiratory equipment provides adequate protection to
the wearer.
Supplied-air respirator (SAR) or airline respirator means an
atmosphere-supplying respirator for which the source of breathing air
is not designed to be carried by the user.
This section means this respiratory protection standard.
Tight-fitting facepiece means a respiratory inlet covering that
forms a complete seal with the face.
User seal check means an action conducted by the respirator user to
determine if the respirator is properly seated to the face.
(c) Respiratory protection program. This paragraph requires the
employer to develop and implement a written respiratory protection
program with required worksite-specific procedures and elements for
required respirator use. The program must be administered by a suitably
trained program administrator. In addition, certain program elements
may be required for voluntary use to prevent potential hazards
associated with the use of the respirator. The Small Entity Compliance
Guide contains criteria for the selection of a program administrator
and a sample program that meets the requirements of this paragraph.
Copies of the Small Entity Compliance Guide will be available on or
about April 8, 1998 from the Occupational Safety and Health
Administration's Office of Publications, Room N 3101, 200 Constitution
Avenue, NW, Washington, DC, 20210 (202-219-4667).
(1) In any workplace where respirators are necessary to protect the
health of the employee or whenever respirators are required by the
employer, the employer shall establish and implement a written
respiratory protection program with worksite-specific procedures. The
program shall be updated as necessary to reflect those changes in
workplace conditions that affect respirator use. The employer shall
include in the program the following provisions of this section, as
applicable:
(i) Procedures for selecting respirators for use in the workplace;
(ii) Medical evaluations of employees required to use respirators;
(iii) Fit testing procedures for tight-fitting respirators;
(iv) Procedures for proper use of respirators in routine and
reasonably foreseeable emergency situations;
(v) Procedures and schedules for cleaning, disinfecting, storing,
inspecting, repairing, discarding, and otherwise maintaining
respirators;
(vi) Procedures to ensure adequate air quality, quantity, and flow
of breathing air for atmosphere-supplying respirators;
(vii) Training of employees in the respiratory hazards to which
they are potentially exposed during routine and emergency situations;
(viii) Training of employees in the proper use of respirators,
including putting on and removing them, any limitations on their use,
and their maintenance; and
(ix) Procedures for regularly evaluating the effectiveness of the
program.
(2) Where respirator use is not required:
(i) An employer may provide respirators at the request of employees
or permit employees to use their own respirators, if the employer
determines that such respirator use will not in itself create a hazard.
If the employer determines that any voluntary respirator use is
permissible, the employer shall provide the respirator users with the
information contained in Appendix D to this section (``Information for
Employees Using Respirators When Not Required Under the Standard'');
and
(ii) In addition, the employer must establish and implement those
elements of a written respiratory protection program necessary to
ensure that any employee using a respirator voluntarily is medically
able to use that respirator, and that the respirator is cleaned,
stored, and maintained so that its use does not present a health hazard
to the user. Exception: Employers are not required to include in a
written respiratory protection program those employees whose only use
of respirators involves the voluntary use of filtering facepieces (dust
masks).
(3) The employer shall designate a program administrator who is
qualified by appropriate training or experience that is commensurate
with the complexity of the program to administer or oversee the
respiratory protection program and conduct the required evaluations of
program effectiveness.
(4) The employer shall provide respirators, training, and medical
evaluations at no cost to the employee.
(d) Selection of respirators. This paragraph requires the employer
to evaluate respiratory hazard(s) in the workplace, identify relevant
workplace and user factors, and base respirator selection on these
factors. The paragraph also specifies appropriately protective
respirators for use in IDLH atmospheres, and limits the selection and
use of air-purifying respirators.
(1) General requirements. (i) The employer shall select and provide
an appropriate respirator based on the respiratory hazard(s) to which
the worker is exposed and workplace and user factors that affect
respirator performance and reliability.
(ii) The employer shall select a NIOSH-certified respirator. The
respirator shall be used in compliance with the conditions of its
certification.
(iii) The employer shall identify and evaluate the respiratory
hazard(s) in the workplace; this evaluation shall include a reasonable
estimate of employee exposures to respiratory hazard(s) and an
identification of the contaminant's chemical state and physical form.
Where the employer cannot identify or reasonably estimate the employee
exposure, the employer shall consider the atmosphere to be IDLH.
(iv) The employer shall select respirators from a sufficient number
of respirator models and sizes so that the respirator is acceptable to,
and correctly fits, the user.
(2) Respirators for IDLH atmospheres. (i) The employer shall
provide the following respirators for employee use in IDLH atmospheres:
(A) A full facepiece pressure demand SCBA certified by NIOSH for a
minimum service life of thirty minutes, or
(B) A combination full facepiece pressure demand supplied-air
respirator (SAR) with auxiliary self-contained air supply.
(ii) Respirators provided only for escape from IDLH atmospheres
shall be NIOSH-certified for escape from the atmosphere in which they
will be used.
(iii) All oxygen-deficient atmospheres shall be considered IDLH.
Exception: If the employer demonstrates that, under all foreseeable
conditions, the oxygen concentration can be maintained within
[[Page 1272]]
the ranges specified in Table II of this section (i.e., for the
altitudes set out in the table), then any atmosphere-supplying
respirator may be used.
(3) Respirators for atmospheres that are not IDLH. (i) The employer
shall provide a respirator that is adequate to protect the health of
the employee and ensure compliance with all other OSHA statutory and
regulatory requirements, under routine and reasonably foreseeable
emergency situations.
(A) Assigned Protection Factors (APFs) [Reserved]
(B) Maximum Use Concentration (MUC) [Reserved]
(ii) The respirator selected shall be appropriate for the chemical
state and physical form of the contaminant.
(iii) For protection against gases and vapors, the employer shall
provide:
(A) An atmosphere-supplying respirator, or
(B) An air-purifying respirator, provided that:
(1) The respirator is equipped with an end-of-service-life
indicator (ESLI) certified by NIOSH for the contaminant; or
(2) If there is no ESLI appropriate for conditions in the
employer's workplace, the employer implements a change schedule for
canisters and cartridges that is based on objective information or data
that will ensure that canisters and cartridges are changed before the
end of their service life. The employer shall describe in the
respirator program the information and data relied upon and the basis
for the canister and cartridge change schedule and the basis for
reliance on the data.
(iv) For protection against particulates, the employer shall
provide:
(A) An atmosphere-supplying respirator; or
(B) An air-purifying respirator equipped with a filter certified by
NIOSH under 30 CFR part 11 as a high efficiency particulate air (HEPA)
filter, or an air-purifying respirator equipped with a filter certified
for particulates by NIOSH under 42 CFR part 84; or
(C) For contaminants consisting primarily of particles with mass
median aerodynamic diameters (MMAD) of at least 2 micrometers, an air-
purifying respirator equipped with any filter certified for
particulates by NIOSH.
Table I.--Assigned Protection Factors [Reserved]
Table II
------------------------------------------------------------------------
Oxygen
deficient
Atmospheres
(% 02) for
which the
Altitude (ft.) employer
may rely on
atmosphere-
supplying
respirators
------------------------------------------------------------------------
Less than 3,001............................................ 16.0-19.5
3,001-4,000................................................ 16.4-19.5
4,001-5,000................................................ 17.1-19.5
5,001-6,000................................................ 17.8-19.5
6,001-7,000................................................ 18.5-19.5
7,001-8,000\1\............................................. 19.3-19.5.
------------------------------------------------------------------------
\1\ Above 8,000 feet the exception does not apply. Oxygen-enriched
breathing air must be supplied above 14,000 feet.
(e) Medical evaluation. Using a respirator may place a
physiological burden on employees that varies with the type of
respirator worn, the job and workplace conditions in which the
respirator is used, and the medical status of the employee.
Accordingly, this paragraph specifies the minimum requirements for
medical evaluation that employers must implement to determine the
employee's ability to use a respirator.
(1) General. The employer shall provide a medical evaluation to
determine the employee's ability to use a respirator, before the
employee is fit tested or required to use the respirator in the
workplace. The employer may discontinue an employee's medical
evaluations when the employee is no longer required to use a
respirator.
(2) Medical evaluation procedures. (i) The employer shall identify
a physician or other licensed health care professional (PLHCP) to
perform medical evaluations using a medical questionnaire or an initial
medical examination that obtains the same information as the medical
questionnaire.
(ii) The medical evaluation shall obtain the information requested
by the questionnaire in Sections 1 and 2, Part A of Appendix C of this
section.
(3) Follow-up medical examination. (i) The employer shall ensure
that a follow-up medical examination is provided for an employee who
gives a positive response to any question among questions 1 through 8
in Section 2, Part A of Appendix C or whose initial medical examination
demonstrates the need for a follow-up medical examination.
(ii) The follow-up medical examination shall include any medical
tests, consultations, or diagnostic procedures that the PLHCP deems
necessary to make a final determination.
(4) Administration of the medical questionnaire and examinations.
(i) The medical questionnaire and examinations shall be administered
confidentially during the employee's normal working hours or at a time
and place convenient to the employee. The medical questionnaire shall
be administered in a manner that ensures that the employee understands
its content.
(ii) The employer shall provide the employee with an opportunity to
discuss the questionnaire and examination results with the PLHCP.
(5) Supplemental information for the PLHCP. (i) The following
information must be provided to the PLHCP before the PLHCP makes a
recommendation concerning an employee's ability to use a respirator:
(A) The type and weight of the respirator to be used by the
employee;
(B) The duration and frequency of respirator use (including use for
rescue and escape);
(C) The expected physical work effort;
(D) Additional protective clothing and equipment to be worn; and
(E) Temperature and humidity extremes that may be encountered.
(ii) Any supplemental information provided previously to the PLHCP
regarding an employee need not be provided for a subsequent medical
evaluation if the information and the PLHCP remain the same.
(iii) The employer shall provide the PLHCP with a copy of the
written respiratory protection program and a copy of this section.
Note to Paragraph (e)(5)(iii): When the employer replaces a
PLHCP, the employer must ensure that the new PLHCP obtains this
information, either by providing the documents directly to the PLHCP
or having the documents transferred from the former PLHCP to the new
PLHCP. However, OSHA does not expect employers to have employees
medically reevaluated solely because a new PLHCP has been selected.
(6) Medical determination. In determining the employee's ability to
use a respirator, the employer shall:
(i) Obtain a written recommendation regarding the employee's
ability to use the respirator from the PLHCP. The recommendation shall
provide only the following information:
(A) Any limitations on respirator use related to the medical
condition of the employee, or relating to the workplace conditions in
which the respirator will be used, including whether or not the
employee is medically able to use the respirator;
(B) The need, if any, for follow-up medical evaluations; and
(C) A statement that the PLHCP has provided the employee with a
copy of the PLHCP's written recommendation.
[[Page 1273]]
(ii) If the respirator is a negative pressure respirator and the
PLHCP finds a medical condition that may place the employee's health at
increased risk if the respirator is used, the employer shall provide a
PAPR if the PLHCP's medical evaluation finds that the employee can use
such a respirator; if a subsequent medical evaluation finds that the
employee is medically able to use a negative pressure respirator, then
the employer is no longer required to provide a PAPR.
(7) Additional medical evaluations. At a minimum, the employer
shall provide additional medical evaluations that comply with the
requirements of this section if:
(i) An employee reports medical signs or symptoms that are related
to ability to use a respirator;
(ii) A PLHCP, supervisor, or the respirator program administrator
informs the employer that an employee needs to be reevaluated;
(iii) Information from the respiratory protection program,
including observations made during fit testing and program evaluation,
indicates a need for employee reevaluation; or
(iv) A change occurs in workplace conditions (e.g., physical work
effort, protective clothing, temperature) that may result in a
substantial increase in the physiological burden placed on an employee.
(f) Fit testing. This paragraph requires that, before an employee
may be required to use any respirator with a negative or positive
pressure tight-fitting facepiece, the employee must be fit tested with
the same make, model, style, and size of respirator that will be used.
This paragraph specifies the kinds of fit tests allowed, the procedures
for conducting them, and how the results of the fit tests must be used.
(1) The employer shall ensure that employees using a tight-fitting
facepiece respirator pass an appropriate qualitative fit test (QLFT) or
quantitative fit test (QNFT) as stated in this paragraph.
(2) The employer shall ensure that an employee using a tight-
fitting facepiece respirator is fit tested prior to initial use of the
respirator, whenever a different respirator facepiece (size, style,
model or make) is used, and at least annually thereafter.
(3) The employer shall conduct an additional fit test whenever the
employee reports, or the employer, PLHCP, supervisor, or program
administrator makes visual observations of, changes in the employee's
physical condition that could affect respirator fit. Such conditions
include, but are not limited to, facial scarring, dental changes,
cosmetic surgery, or an obvious change in body weight.
(4) If after passing a QLFT or QNFT, the employee subsequently
notifies the employer, program administrator, supervisor, or PLHCP that
the fit of the respirator is unacceptable, the employee shall be given
a reasonable opportunity to select a different respirator facepiece and
to be retested.
(5) The fit test shall be administered using an OSHA-accepted QLFT
or QNFT protocol. The OSHA-accepted QLFT and QNFT protocols and
procedures are contained in Appendix A of this section.
(6) QLFT may only be used to fit test negative pressure air-
purifying respirators that must achieve a fit factor of 100 or less.
(7) If the fit factor, as determined through an OSHA-accepted QNFT
protocol, is equal to or greater than 100 for tight-fitting half
facepieces, or equal to or greater than 500 for tight-fitting full
facepieces, the QNFT has been passed with that respirator.
(8) Fit testing of tight-fitting atmosphere-supplying respirators
and tight-fitting powered air-purifying respirators shall be
accomplished by performing quantitative or qualitative fit testing in
the negative pressure mode, regardless of the mode of operation
(negative or positive pressure) that is used for respiratory
protection.
(i) Qualitative fit testing of these respirators shall be
accomplished by temporarily converting the respirator user's actual
facepiece into a negative pressure respirator with appropriate filters,
or by using an identical negative pressure air-purifying respirator
facepiece with the same sealing surfaces as a surrogate for the
atmosphere-supplying or powered air-purifying respirator facepiece.
(ii) Quantitative fit testing of these respirators shall be
accomplished by modifying the facepiece to allow sampling inside the
facepiece in the breathing zone of the user, midway between the nose
and mouth. This requirement shall be accomplished by installing a
permanent sampling probe onto a surrogate facepiece, or by using a
sampling adapter designed to temporarily provide a means of sampling
air from inside the facepiece.
(iii) Any modifications to the respirator facepiece for fit testing
shall be completely removed, and the facepiece restored to NIOSH-
approved configuration, before that facepiece can be used in the
workplace.
(g) Use of respirators. This paragraph requires employers to
establish and implement procedures for the proper use of respirators.
These requirements include prohibiting conditions that may result in
facepiece seal leakage, preventing employees from removing respirators
in hazardous environments, taking actions to ensure continued effective
respirator operation throughout the work shift, and establishing
procedures for the use of respirators in IDLH atmospheres or in
interior structural firefighting situations.
(1) Facepiece seal protection. (i) The employer shall not permit
respirators with tight-fitting facepieces to be worn by employees who
have:
(A) Facial hair that comes between the sealing surface of the
facepiece and the face or that interferes with valve function; or
(B) Any condition that interferes with the face-to-facepiece seal
or valve function.
(ii) If an employee wears corrective glasses or goggles or other
personal protective equipment, the employer shall ensure that such
equipment is worn in a manner that does not interfere with the seal of
the facepiece to the face of the user.
(iii) For all tight-fitting respirators, the employer shall ensure
that employees perform a user seal check each time they put on the
respirator using the procedures in Appendix B-1 or procedures
recommended by the respirator manufacturer that the employer
demonstrates are as effective as those in Appendix B-1 of this section.
(2) Continuing respirator effectiveness. (i) Appropriate
surveillance shall be maintained of work area conditions and degree of
employee exposure or stress. When there is a change in work area
conditions or degree of employee exposure or stress that may affect
respirator effectiveness, the employer shall reevaluate the continued
effectiveness of the respirator.
(ii) The employer shall ensure that employees leave the respirator
use area:
(A) To wash their faces and respirator facepieces as necessary to
prevent eye or skin irritation associated with respirator use; or
(B) If they detect vapor or gas breakthrough, changes in breathing
resistance, or leakage of the facepiece; or
(C) To replace the respirator or the filter, cartridge, or canister
elements.
(iii) If the employee detects vapor or gas breakthrough, changes in
breathing resistance, or leakage of the facepiece, the employer must
replace or repair the respirator before allowing the employee to return
to the work area.
(3) Procedures for IDLH atmospheres. For all IDLH atmospheres, the
employer shall ensure that:
[[Page 1274]]
(i) One employee or, when needed, more than one employee is located
outside the IDLH atmosphere;
(ii) Visual, voice, or signal line communication is maintained
between the employee(s) in the IDLH atmosphere and the employee(s)
located outside the IDLH atmosphere;
(iii) The employee(s) located outside the IDLH atmosphere are
trained and equipped to provide effective emergency rescue;
(iv) The employer or designee is notified before the employee(s)
located outside the IDLH atmosphere enter the IDLH atmosphere to
provide emergency rescue;
(v) The employer or designee authorized to do so by the employer,
once notified, provides necessary assistance appropriate to the
situation;
(vi) Employee(s) located outside the IDLH atmospheres are equipped
with:
(A) Pressure demand or other positive pressure SCBAs, or a pressure
demand or other positive pressure supplied-air respirator with
auxiliary SCBA; and either
(B) Appropriate retrieval equipment for removing the employee(s)
who enter(s) these hazardous atmospheres where retrieval equipment
would contribute to the rescue of the employee(s) and would not
increase the overall risk resulting from entry; or
(C) Equivalent means for rescue where retrieval equipment is not
required under paragraph (g)(3)(vi)(B).
(4) Procedures for interior structural firefighting. In addition to
the requirements set forth under paragraph (g)(3), in interior
structural fires, the employer shall ensure that:
(i) At least two employees enter the IDLH atmosphere and remain in
visual or voice contact with one another at all times;
(ii) At least two employees are located outside the IDLH
atmosphere; and
(iii) All employees engaged in interior structural firefighting use
SCBAs.
Note 1 to paragraph (g): One of the two individuals located
outside the IDLH atmosphere may be assigned to an additional role,
such as incident commander in charge of the emergency or safety
officer, so long as this individual is able to perform assistance or
rescue activities without jeopardizing the safety or health of any
firefighter working at the incident.
Note 2 to paragraph (g): Nothing in this section is meant to
preclude firefighters from performing emergency rescue activities
before an entire team has assembled.
(h) Maintenance and care of respirators. This paragraph requires
the employer to provide for the cleaning and disinfecting, storage,
inspection, and repair of respirators used by employees.
(1) Cleaning and disinfecting. The employer shall provide each
respirator user with a respirator that is clean, sanitary, and in good
working order. The employer shall ensure that respirators are cleaned
and disinfected using the procedures in Appendix B-2 of this section,
or procedures recommended by the respirator manufacturer, provided that
such procedures are of equivalent effectiveness. The respirators shall
be cleaned and disinfected at the following intervals:
(i) Respirators issued for the exclusive use of an employee shall
be cleaned and disinfected as often as necessary to be maintained in a
sanitary condition;
(ii) Respirators issued to more than one employee shall be cleaned
and disinfected before being worn by different individuals;
(iii) Respirators maintained for emergency use shall be cleaned and
disinfected after each use; and
(iv) Respirators used in fit testing and training shall be cleaned
and disinfected after each use.
(2) Storage. The employer shall ensure that respirators are stored
as follows:
(i) All respirators shall be stored to protect them from damage,
contamination, dust, sunlight, extreme temperatures, excessive
moisture, and damaging chemicals, and they shall be packed or stored to
prevent deformation of the facepiece and exhalation valve.
(ii) In addition to the requirements of paragraph (h)(2)(i) of this
section, emergency respirators shall be:
(A) Kept accessible to the work area;
(B) Stored in compartments or in covers that are clearly marked as
containing emergency respirators; and
(C) Stored in accordance with any applicable manufacturer
instructions.
(3) Inspection. (i) The employer shall ensure that respirators are
inspected as follows:
(A) All respirators used in routine situations shall be inspected
before each use and during cleaning;
(B) All respirators maintained for use in emergency situations
shall be inspected at least monthly and in accordance with the
manufacturer's recommendations, and shall be checked for proper
function before and after each use; and
(C) Emergency escape-only respirators shall be inspected before
being carried into the workplace for use.
(ii) The employer shall ensure that respirator inspections include
the following:
(A) A check of respirator function, tightness of connections, and
the condition of the various parts including, but not limited to, the
facepiece, head straps, valves, connecting tube, and cartridges,
canisters or filters; and
(B) A check of elastomeric parts for pliability and signs of
deterioration.
(iii) In addition to the requirements of paragraphs (h)(3)(i) and
(ii) of this section, self-contained breathing apparatus shall be
inspected monthly. Air and oxygen cylinders shall be maintained in a
fully charged state and shall be recharged when the pressure falls to
90% of the manufacturer's recommended pressure level. The employer
shall determine that the regulator and warning devices function
properly.
(iv) For respirators maintained for emergency use, the employer
shall:
(A) Certify the respirator by documenting the date the inspection
was performed, the name (or signature) of the person who made the
inspection, the findings, required remedial action, and a serial number
or other means of identifying the inspected respirator; and
(B) Provide this information on a tag or label that is attached to
the storage compartment for the respirator, is kept with the
respirator, or is included in inspection reports stored as paper or
electronic files. This information shall be maintained until replaced
following a subsequent certification.
(4) Repairs. The employer shall ensure that respirators that fail
an inspection or are otherwise found to be defective are removed from
service, and are discarded or repaired or adjusted in accordance with
the following procedures:
(i) Repairs or adjustments to respirators are to be made only by
persons appropriately trained to perform such operations and shall use
only the respirator manufacturer's NIOSH-approved parts designed for
the respirator;
(ii) Repairs shall be made according to the manufacturer's
recommendations and specifications for the type and extent of repairs
to be performed; and
(iii) Reducing and admission valves, regulators, and alarms shall
be adjusted or repaired only by the manufacturer or a technician
trained by the manufacturer.
(i) Breathing air quality and use. This paragraph requires the
employer to provide employees using atmosphere-supplying respirators
(supplied-air and SCBA) with breathing gases of high purity.
(1) The employer shall ensure that compressed air, compressed
oxygen, liquid air, and liquid oxygen used for respiration accords with
the following specifications:
[[Page 1275]]
(i) Compressed and liquid oxygen shall meet the United States
Pharmacopoeia requirements for medical or breathing oxygen; and
(ii) Compressed breathing air shall meet at least the requirements
for Type 1-Grade D breathing air described in ANSI/Compressed Gas
Association Commodity Specification for Air, G-7.1-1989, to include:
(A) Oxygen content (v/v) of 19.5-23.5%;
(B) Hydrocarbon (condensed) content of 5 milligrams per cubic meter
of air or less;
(C) Carbon monoxide (CO) content of 10 ppm or less;
(D) Carbon dioxide content of 1,000 ppm or less; and
(E) Lack of noticeable odor.
(2) The employer shall ensure that compressed oxygen is not used in
atmosphere-supplying respirators that have previously used compressed
air.
(3) The employer shall ensure that oxygen concentrations greater
than 23.5% are used only in equipment designed for oxygen service or
distribution.
(4) The employer shall ensure that cylinders used to supply
breathing air to respirators meet the following requirements:
(i) Cylinders are tested and maintained as prescribed in the
Shipping Container Specification Regulations of the Department of
Transportation (49 CFR part 173 and part 178);
(ii) Cylinders of purchased breathing air have a certificate of
analysis from the supplier that the breathing air meets the
requirements for Type 1--Grade D breathing air; and
(iii) The moisture content in the cylinder does not exceed a dew
point of -50 deg.F (-45.6 deg.C) at 1 atmosphere pressure.
(5) The employer shall ensure that compressors used to supply
breathing air to respirators are constructed and situated so as to:
(i) Prevent entry of contaminated air into the air-supply system;
(ii) Minimize moisture content so that the dew point at 1
atmosphere pressure is 10 degrees F (5.56 deg.C) below the ambient
temperature;
(iii) Have suitable in-line air-purifying sorbent beds and filters
to further ensure breathing air quality. Sorbent beds and filters shall
be maintained and replaced or refurbished periodically following the
manufacturer's instructions.
(iv) Have a tag containing the most recent change date and the
signature of the person authorized by the employer to perform the
change. The tag shall be maintained at the compressor.
(6) For compressors that are not oil-lubricated, the employer shall
ensure that carbon monoxide levels in the breathing air do not exceed
10 ppm.
(7) For oil-lubricated compressors, the employer shall use a high-
temperature or carbon monoxide alarm, or both, to monitor carbon
monoxide levels. If only high-temperature alarms are used, the air
supply shall be monitored at intervals sufficient to prevent carbon
monoxide in the breathing air from exceeding 10 ppm.
(8) The employer shall ensure that breathing air couplings are
incompatible with outlets for nonrespirable worksite air or other gas
systems. No asphyxiating substance shall be introduced into breathing
air lines.
(9) The employer shall use breathing gas containers marked in
accordance with the NIOSH respirator certification standard, 42 CFR
part 84.
(j) Identification of filters, cartridges, and canisters. The
employer shall ensure that all filters, cartridges and canisters used
in the workplace are labeled and color coded with the NIOSH approval
label and that the label is not removed and remains legible.
(k) Training and information. This paragraph requires the employer
to provide effective training to employees who are required to use
respirators. The training must be comprehensive, understandable, and
recur annually, and more often if necessary. This paragraph also
requires the employer to provide the basic information on respirators
in Appendix D of this section to employees who wear respirators when
not required by this section or by the employer to do so.
(1) The employer shall ensure that each employee can demonstrate
knowledge of at least the following:
(i) Why the respirator is necessary and how improper fit, usage, or
maintenance can compromise the protective effect of the respirator;
(ii) What the limitations and capabilities of the respirator are;
(iii) How to use the respirator effectively in emergency
situations, including situations in which the respirator malfunctions;
(iv) How to inspect, put on and remove, use, and check the seals of
the respirator;
(v) What the procedures are for maintenance and storage of the
respirator;
(vi) How to recognize medical signs and symptoms that may limit or
prevent the effective use of respirators; and
(vii) The general requirements of this section.
(2) The training shall be conducted in a manner that is
understandable to the employee.
(3) The employer shall provide the training prior to requiring the
employee to use a respirator in the workplace.
(4) An employer who is able to demonstrate that a new employee has
received training within the last 12 months that addresses the elements
specified in paragraph (k)(1)(i) through (vii) is not required to
repeat such training provided that, as required by paragraph (k)(1),
the employee can demonstrate knowledge of those element(s). Previous
training not repeated initially by the employer must be provided no
later than 12 months from the date of the previous training.
(5) Retraining shall be administered annually, and when the
following situations occur:
(i) Changes in the workplace or the type of respirator render
previous training obsolete;
(ii) Inadequacies in the employee's knowledge or use of the
respirator indicate that the employee has not retained the requisite
understanding or skill; or
(iii) Any other situation arises in which retraining appears
necessary to ensure safe respirator use.
(6) The basic advisory information on respirators, as presented in
Appendix D of this section, shall be provided by the employer in any
written or oral format, to employees who wear respirators when such use
is not required by this section or by the employer.
(l) Program evaluation. This section requires the employer to
conduct evaluations of the workplace to ensure that the written
respiratory protection program is being properly implemented, and to
consult employees to ensure that they are using the respirators
properly.
(1) The employer shall conduct evaluations of the workplace as
necessary to ensure that the provisions of the current written program
are being effectively implemented and that it continues to be
effective.
(2) The employer shall regularly consult employees required to use
respirators to assess the employees' views on program effectiveness and
to identify any problems. Any problems that are identified during this
assessment shall be corrected. Factors to be assessed include, but are
not limited to:
(i) Respirator fit (including the ability to use the respirator
without interfering with effective workplace performance);
(ii) Appropriate respirator selection for the hazards to which the
employee is exposed;
[[Page 1276]]
(iii) Proper respirator use under the workplace conditions the
employee encounters; and
(iv) Proper respirator maintenance.
(m) Recordkeeping. This section requires the employer to establish
and retain written information regarding medical evaluations, fit
testing, and the respirator program. This information will facilitate
employee involvement in the respirator program, assist the employer in
auditing the adequacy of the program, and provide a record for
compliance determinations by OSHA.
(1) Medical evaluation. Records of medical evaluations required by
this section must be retained and made available in accordance with 29
CFR 1910.1020.
(2) Fit testing. (i) The employer shall establish a record of the
qualitative and quantitative fit tests administered to an employee
including:
(A) The name or identification of the employee tested;
(B) Type of fit test performed;
(C) Specific make, model, style, and size of respirator tested;
(D) Date of test; and
(E) The pass/fail results for QLFTs or the fit factor and strip
chart recording or other recording of the test results for QNFTs.
(ii) Fit test records shall be retained for respirator users until
the next fit test is administered.
(3) A written copy of the current respirator program shall be
retained by the employer.
(4) Written materials required to be retained under this paragraph
shall be made available upon request to affected employees and to the
Assistant Secretary or designee for examination and copying.
(n) Dates. (1) Effective date. This section is effective April 8,
1998. The obligations imposed by this section commence on the effective
date unless otherwise noted in this paragraph. Compliance with
obligations that do not commence on the effective date shall occur no
later than the applicable start-up date.
(2) Compliance dates. All obligations of this section commence on
the effective date except as follows:
(i) The determination that respirator use is required (paragraph
(a)) shall be completed no later than September 8, 1998.
(ii) Compliance with provisions of this section for all other
provisions shall be completed no later than October 5, 1998.
(3) The provisions of 29 CFR 1910.134 and 29 CFR 1926.103,
contained in the 29 CFR parts 1900 to 1910.99 and the 29 CFR part 1926
editions, revised as of July 1, 1997, are in effect and enforceable
until April 8, 1998, or during any administrative or judicial stay of
the provisions of this section.
(4) Existing Respiratory Protection Programs. If, in the 12 month
period preceding April 8, 1998, the employer has conducted annual
respirator training, fit testing, respirator program evaluation, or
medical evaluations, the employer may use the results of those
activities to comply with the corresponding provisions of this section,
providing that these activities were conducted in a manner that meets
the requirements of this section.
(o) Appendices. (1) Compliance with Appendix A, Appendix B-1,
Appendix B-2, and Appendix C of this section is mandatory.
(2) Appendix D of this section is non-mandatory and is not intended
to create any additional obligations not otherwise imposed or to
detract from any existing obligations.
Appendix A to Sec. 1910.134: Fit Testing Procedures (Mandatory)
Part I. OSHA-Accepted Fit Test Protocols
A. Fit Testing Procedures--General Requirements
The employer shall conduct fit testing using the following
procedures. The requirements in this appendix apply to all OSHA-
accepted fit test methods, both QLFT and QNFT.
1. The test subject shall be allowed to pick the most acceptable
respirator from a sufficient number of respirator models and sizes
so that the respirator is acceptable to, and correctly fits, the
user.
2. Prior to the selection process, the test subject shall be
shown how to put on a respirator, how it should be positioned on the
face, how to set strap tension and how to determine an acceptable
fit. A mirror shall be available to assist the subject in evaluating
the fit and positioning of the respirator. This instruction may not
constitute the subject's formal training on respirator use, because
it is only a review.
3. The test subject shall be informed that he/she is being asked
to select the respirator that provides the most acceptable fit. Each
respirator represents a different size and shape, and if fitted and
used properly, will provide adequate protection.
4. The test subject shall be instructed to hold each chosen
facepiece up to the face and eliminate those that obviously do not
give an acceptable fit.
5. The more acceptable facepieces are noted in case the one
selected proves unacceptable; the most comfortable mask is donned
and worn at least five minutes to assess comfort. Assistance in
assessing comfort can be given by discussing the points in the
following item A.6. If the test subject is not familiar with using a
particular respirator, the test subject shall be directed to don the
mask several times and to adjust the straps each time to become
adept at setting proper tension on the straps.
6. Assessment of comfort shall include a review of the following
points with the test subject and allowing the test subject adequate
time to determine the comfort of the respirator:
(a) Position of the mask on the nose
(b) Room for eye protection
(c) Room to talk
(d) Position of mask on face and cheeks
7. The following criteria shall be used to help determine the
adequacy of the respirator fit:
(a) Chin properly placed;
(b) Adequate strap tension, not overly tightened;
(c) Fit across nose bridge;
(d) Respirator of proper size to span distance from nose to
chin;
(e) Tendency of respirator to slip;
(f) Self-observation in mirror to evaluate fit and respirator
position.
8. The test subject shall conduct a user seal check, either the
negative and positive pressure seal checks described in Appendix B-1
of this section or those recommended by the respirator manufacturer
which provide equivalent protection to the procedures in Appendix B-
1. Before conducting the negative and positive pressure checks, the
subject shall be told to seat the mask on the face by moving the
head from side-to-side and up and down slowly while taking in a few
slow deep breaths. Another facepiece shall be selected and retested
if the test subject fails the user seal check tests.
9. The test shall not be conducted if there is any hair growth
between the skin and the facepiece sealing surface, such as stubble
beard growth, beard, mustache or sideburns which cross the
respirator sealing surface. Any type of apparel which interferes
with a satisfactory fit shall be altered or removed.
10. If a test subject exhibits difficulty in breathing during
the tests, she or he shall be referred to a physician or other
licensed health care professional, as appropriate, to determine
whether the test subject can wear a respirator while performing her
or his duties.
11. If the employee finds the fit of the respirator
unacceptable, the test subject shall be given the opportunity to
select a different respirator and to be retested.
12. Exercise regimen. Prior to the commencement of the fit test,
the test subject shall be given a description of the fit test and
the test subject's responsibilities during the test procedure. The
description of the process shall include a description of the test
exercises that the subject will be performing. The respirator to be
tested shall be worn for at least 5 minutes before the start of the
fit test.
13. The fit test shall be performed while the test subject is
wearing any applicable safety equipment that may be worn during
actual respirator use which could interfere with respirator fit.
14. Test Exercises. (a) The following test exercises are to be
performed for all fit testing methods prescribed in this appendix,
except for the CNP method. A separate fit testing exercise regimen
is contained in the CNP protocol. The test subject shall perform
exercises, in the test environment, in the following manner:
[[Page 1277]]
(1) Normal breathing. In a normal standing position, without
talking, the subject shall breathe normally.
(2) Deep breathing. In a normal standing position, the subject
shall breathe slowly and deeply, taking caution so as not to
hyperventilate.
(3) Turning head side to side. Standing in place, the subject
shall slowly turn his/her head from side to side between the extreme
positions on each side. The head shall be held at each extreme
momentarily so the subject can inhale at each side.
(4) Moving head up and down. Standing in place, the subject
shall slowly move his/her head up and down. The subject shall be
instructed to inhale in the up position (i.e., when looking toward
the ceiling).
(5) Talking. The subject shall talk out loud slowly and loud
enough so as to be heard clearly by the test conductor. The subject
can read from a prepared text such as the Rainbow Passage, count
backward from 100, or recite a memorized poem or song.
Rainbow Passage
When the sunlight strikes raindrops in the air, they act like a
prism and form a rainbow. The rainbow is a division of white light
into many beautiful colors. These take the shape of a long round
arch, with its path high above, and its two ends apparently beyond
the horizon. There is, according to legend, a boiling pot of gold at
one end. People look, but no one ever finds it. When a man looks for
something beyond reach, his friends say he is looking for the pot of
gold at the end of the rainbow.
(6) Grimace. The test subject shall grimace by smiling or
frowning. (This applies only to QNFT testing; it is not performed
for QLFT)
(7) Bending over. The test subject shall bend at the waist as if
he/she were to touch his/her toes. Jogging in place shall be
substituted for this exercise in those test environments such as
shroud type QNFT or QLFT units that do not permit bending over at
the waist.
(8) Normal breathing. Same as exercise (1).
(b) Each test exercise shall be performed for one minute except
for the grimace exercise which shall be performed for 15 seconds.
The test subject shall be questioned by the test conductor regarding
the comfort of the respirator upon completion of the protocol. If it
has become unacceptable, another model of respirator shall be tried.
The respirator shall not be adjusted once the fit test exercises
begin. Any adjustment voids the test, and the fit test must be
repeated.
B. Qualitative Fit Test (QLFT) Protocols
1. General
(a) The employer shall ensure that persons administering QLFT
are able to prepare test solutions, calibrate equipment and perform
tests properly, recognize invalid tests, and ensure that test
equipment is in proper working order.
(b) The employer shall ensure that QLFT equipment is kept clean
and well maintained so as to operate within the parameters for which
it was designed.
2. Isoamyl Acetate Protocol
Note: This protocol is not appropriate to use for the fit
testing of particulate respirators. If used to fit test particulate
respirators, the respirator must be equipped with an organic vapor
filter.
(a) Odor Threshold Screening
Odor threshold screening, performed without wearing a
respirator, is intended to determine if the individual tested can
detect the odor of isoamyl acetate at low levels.
(1) Three 1 liter glass jars with metal lids are required.
(2) Odor-free water (e.g., distilled or spring water) at
approximately 25 deg. C (77 deg. F) shall be used for the solutions.
(3) The isoamyl acetate (IAA) (also known at isopentyl acetate)
stock solution is prepared by adding 1 ml of pure IAA to 800 ml of
odor-free water in a 1 liter jar, closing the lid and shaking for 30
seconds. A new solution shall be prepared at least weekly.
(4) The screening test shall be conducted in a room separate
from the room used for actual fit testing. The two rooms shall be
well-ventilated to prevent the odor of IAA from becoming evident in
the general room air where testing takes place.
(5) The odor test solution is prepared in a second jar by
placing 0.4 ml of the stock solution into 500 ml of odor-free water
using a clean dropper or pipette. The solution shall be shaken for
30 seconds and allowed to stand for two to three minutes so that the
IAA concentration above the liquid may reach equilibrium. This
solution shall be used for only one day.
(6) A test blank shall be prepared in a third jar by adding 500
cc of odor-free water.
(7) The odor test and test blank jar lids shall be labeled
(e.g., 1 and 2) for jar identification. Labels shall be placed on
the lids so that they can be peeled off periodically and switched to
maintain the integrity of the test.
(8) The following instruction shall be typed on a card and
placed on the table in front of the two test jars (i.e., 1 and 2):
``The purpose of this test is to determine if you can smell banana
oil at a low concentration. The two bottles in front of you contain
water. One of these bottles also contains a small amount of banana
oil. Be sure the covers are on tight, then shake each bottle for two
seconds. Unscrew the lid of each bottle, one at a time, and sniff at
the mouth of the bottle. Indicate to the test conductor which bottle
contains banana oil.''
(9) The mixtures used in the IAA odor detection test shall be
prepared in an area separate from where the test is performed, in
order to prevent olfactory fatigue in the subject.
(10) If the test subject is unable to correctly identify the jar
containing the odor test solution, the IAA qualitative fit test
shall not be performed.
(11) If the test subject correctly identifies the jar containing
the odor test solution, the test subject may proceed to respirator
selection and fit testing.
(b) Isoamyl Acetate Fit Test
(1) The fit test chamber shall be a clear 55-gallon drum liner
suspended inverted over a 2-foot diameter frame so that the top of
the chamber is about 6 inches above the test subject's head. If no
drum liner is available, a similar chamber shall be constructed
using plastic sheeting. The inside top center of the chamber shall
have a small hook attached.
(2) Each respirator used for the fitting and fit testing shall
be equipped with organic vapor cartridges or offer protection
against organic vapors.
(3) After selecting, donning, and properly adjusting a
respirator, the test subject shall wear it to the fit testing room.
This room shall be separate from the room used for odor threshold
screening and respirator selection, and shall be well-ventilated, as
by an exhaust fan or lab hood, to prevent general room
contamination.
(4) A copy of the test exercises and any prepared text from
which the subject is to read shall be taped to the inside of the
test chamber.
(5) Upon entering the test chamber, the test subject shall be
given a 6-inch by 5-inch piece of paper towel, or other porous,
absorbent, single-ply material, folded in half and wetted with 0.75
ml of pure IAA. The test subject shall hang the wet towel on the
hook at the top of the chamber. An IAA test swab or ampule may be
substituted for the IAA wetted paper towel provided it has been
demonstrated that the alternative IAA source will generate an IAA
test atmosphere with a concentration equivalent to that generated by
the paper towel method.
(6) Allow two minutes for the IAA test concentration to
stabilize before starting the fit test exercises. This would be an
appropriate time to talk with the test subject; to explain the fit
test, the importance of his/her cooperation, and the purpose for the
test exercises; or to demonstrate some of the exercises.
(7) If at any time during the test, the subject detects the
banana-like odor of IAA, the test is failed. The subject shall
quickly exit from the test chamber and leave the test area to avoid
olfactory fatigue.
(8) If the test is failed, the subject shall return to the
selection room and remove the respirator. The test subject shall
repeat the odor sensitivity test, select and put on another
respirator, return to the test area and again begin the fit test
procedure described in (b) (1) through (7) above. The process
continues until a respirator that fits well has been found. Should
the odor sensitivity test be failed, the subject shall wait at least
5 minutes before retesting. Odor sensitivity will usually have
returned by this time.
(9) If the subject passes the test, the efficiency of the test
procedure shall be demonstrated by having the subject break the
respirator face seal and take a breath before exiting the chamber.
(10) When the test subject leaves the chamber, the subject shall
remove the saturated towel and return it to the person conducting
the test, so that there is no significant IAA concentration buildup
in the chamber during subsequent tests. The used towels shall be
kept in a self-sealing plastic bag to keep the test area from being
contaminated.
3. Saccharin Solution Aerosol Protocol
The entire screening and testing procedure shall be explained to
the test subject prior to the conduct of the screening test.
(a) Taste threshold screening. The saccharin taste threshold
screening,
[[Page 1278]]
performed without wearing a respirator, is intended to determine
whether the individual being tested can detect the taste of
saccharin.
(1) During threshold screening as well as during fit testing,
subjects shall wear an enclosure about the head and shoulders that
is approximately 12 inches in diameter by 14 inches tall with at
least the front portion clear and that allows free movements of the
head when a respirator is worn. An enclosure substantially similar
to the 3M hood assembly, parts # FT 14 and # FT 15 combined, is
adequate.
(2) The test enclosure shall have a \3/4\-inch (1.9 cm) hole in
front of the test subject's nose and mouth area to accommodate the
nebulizer nozzle.
(3) The test subject shall don the test enclosure. Throughout
the threshold screening test, the test subject shall breathe through
his/her slightly open mouth with tongue extended. The subject is
instructed to report when he/she detects a sweet taste.
(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer
or equivalent, the test conductor shall spray the threshold check
solution into the enclosure. The nozzle is directed away from the
nose and mouth of the person. This nebulizer shall be clearly marked
to distinguish it from the fit test solution nebulizer.
(5) The threshold check solution is prepared by dissolving 0.83
gram of sodium saccharin USP in 100 ml of warm water. It can be
prepared by putting 1 ml of the fit test solution (see (b)(5) below)
in 100 ml of distilled water.
(6) To produce the aerosol, the nebulizer bulb is firmly
squeezed so that it collapses completely, then released and allowed
to fully expand.
(7) Ten squeezes are repeated rapidly and then the test subject
is asked whether the saccharin can be tasted. If the test subject
reports tasting the sweet taste during the ten squeezes, the
screening test is completed. The taste threshold is noted as ten
regardless of the number of squeezes actually completed.
(8) If the first response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted. If the test subject reports tasting the sweet
taste during the second ten squeezes, the screening test is
completed. The taste threshold is noted as twenty regardless of the
number of squeezes actually completed.
(9) If the second response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
saccharin is tasted. If the test subject reports tasting the sweet
taste during the third set of ten squeezes, the screening test is
completed. The taste threshold is noted as thirty regardless of the
number of squeezes actually completed.
(10) The test conductor will take note of the number of squeezes
required to solicit a taste response.
(11) If the saccharin is not tasted after 30 squeezes (step 10),
the test subject is unable to taste saccharin and may not perform
the saccharin fit test.
Note to paragraph 3. (a): If the test subject eats or drinks
something sweet before the screening test, he/she may be unable to
taste the weak saccharin solution.
(12) If a taste response is elicited, the test subject shall be
asked to take note of the taste for reference in the fit test.
(13) Correct use of the nebulizer means that approximately 1 ml
of liquid is used at a time in the nebulizer body.
(14) The nebulizer shall be thoroughly rinsed in water, shaken
dry, and refilled at least each morning and afternoon or at least
every four hours.
(b) Saccharin solution aerosol fit test procedure.
(1) The test subject may not eat, drink (except plain water),
smoke, or chew gum for 15 minutes before the test.
(2) The fit test uses the same enclosure described in 3. (a)
above.
(3) The test subject shall don the enclosure while wearing the
respirator selected in section I. A. of this appendix. The
respirator shall be properly adjusted and equipped with a
particulate filter(s).
(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer
or equivalent is used to spray the fit test solution into the
enclosure. This nebulizer shall be clearly marked to distinguish it
from the screening test solution nebulizer.
(5) The fit test solution is prepared by adding 83 grams of
sodium saccharin to 100 ml of warm water.
(6) As before, the test subject shall breathe through the
slightly open mouth with tongue extended, and report if he/she
tastes the sweet taste of saccharin.
(7) The nebulizer is inserted into the hole in the front of the
enclosure and an initial concentration of saccharin fit test
solution is sprayed into the enclosure using the same number of
squeezes (either 10, 20 or 30 squeezes) based on the number of
squeezes required to elicit a taste response as noted during the
screening test. A minimum of 10 squeezes is required.
(8) After generating the aerosol, the test subject shall be
instructed to perform the exercises in section I. A. 14. of this
appendix.
(9) Every 30 seconds the aerosol concentration shall be
replenished using one half the original number of squeezes used
initially (e.g., 5, 10 or 15).
(10) The test subject shall indicate to the test conductor if at
any time during the fit test the taste of saccharin is detected. If
the test subject does not report tasting the saccharin, the test is
passed.
(11) If the taste of saccharin is detected, the fit is deemed
unsatisfactory and the test is failed. A different respirator shall
be tried and the entire test procedure is repeated (taste threshold
screening and fit testing).
(12) Since the nebulizer has a tendency to clog during use, the
test operator must make periodic checks of the nebulizer to ensure
that it is not clogged. If clogging is found at the end of the test
session, the test is invalid.
4. BitrexTM (Denatonium Benzoate) Solution Aerosol
Qualitative Fit Test Protocol
The BitrexTM (Denatonium benzoate) solution aerosol
QLFT protocol uses the published saccharin test protocol because
that protocol is widely accepted. Bitrex is routinely used as a
taste aversion agent in household liquids which children should not
be drinking and is endorsed by the American Medical Association, the
National Safety Council, and the American Association of Poison
Control Centers. The entire screening and testing procedure shall be
explained to the test subject prior to the conduct of the screening
test.
(a) Taste Threshold Screening.
The Bitrex taste threshold screening, performed without wearing
a respirator, is intended to determine whether the individual being
tested can detect the taste of Bitrex.
(1) During threshold screening as well as during fit testing,
subjects shall wear an enclosure about the head and shoulders that
is approximately 12 inches (30.5 cm) in diameter by 14 inches (35.6
cm) tall. The front portion of the enclosure shall be clear from the
respirator and allow free movement of the head when a respirator is
worn. An enclosure substantially similar to the 3M hood assembly,
parts #14 and #15 combined, is adequate.
(2) The test enclosure shall have a \3/4\ inch (1.9 cm) hole in
front of the test subject's nose and mouth area to accommodate the
nebulizer nozzle.
(3) The test subject shall don the test enclosure. Throughout
the threshold screening test, the test subject shall breathe through
his or her slightly open mouth with tongue extended. The subject is
instructed to report when he/she detects a bitter taste.
(4) Using a DeVilbiss Model 40 Inhalation Medication Nebulizer
or equivalent, the test conductor shall spray the Threshold Check
Solution into the enclosure. This Nebulizer shall be clearly marked
to distinguish it from the fit test solution nebulizer.
(5) The Threshold Check Solution is prepared by adding 13.5
milligrams of Bitrex to 100 ml of 5% salt (NaCl) solution in
distilled water.
(6) To produce the aerosol, the nebulizer bulb is firmly
squeezed so that the bulb collapses completely, and is then released
and allowed to fully expand.
(7) An initial ten squeezes are repeated rapidly and then the
test subject is asked whether the Bitrex can be tasted. If the test
subject reports tasting the bitter taste during the ten squeezes,
the screening test is completed. The taste threshold is noted as ten
regardless of the number of squeezes actually completed.
(8) If the first response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
Bitrex is tasted. If the test subject reports tasting the bitter
taste during the second ten squeezes, the screening test is
completed. The taste threshold is noted as twenty regardless of the
number of squeezes actually completed.
(9) If the second response is negative, ten more squeezes are
repeated rapidly and the test subject is again asked whether the
Bitrex is tasted. If the test subject reports tasting the bitter
taste during the third set of ten squeezes, the screening test is
completed. The taste threshold is noted as thirty regardless of the
number of squeezes actually completed.
(10) The test conductor will take note of the number of squeezes
required to solicit a taste response.
[[Page 1279]]
(11) If the Bitrex is not tasted after 30 squeezes (step 10),
the test subject is unable to taste Bitrex and may not perform the
Bitrex fit test.
(12) If a taste response is elicited, the test subject shall be
asked to take note of the taste for reference in the fit test.
(13) Correct use of the nebulizer means that approximately 1 ml
of liquid is used at a time in the nebulizer body.
(14) The nebulizer shall be thoroughly rinsed in water, shaken
to dry, and refilled at least each morning and afternoon or at least
every four hours.
(b) Bitrex Solution Aerosol Fit Test Procedure.
(1) The test subject may not eat, drink (except plain water),
smoke, or chew gum for 15 minutes before the test.
(2) The fit test uses the same enclosure as that described in 4.
(a) above.
(3) The test subject shall don the enclosure while wearing the
respirator selected according to section I. A. of this appendix. The
respirator shall be properly adjusted and equipped with any type
particulate filter(s).
(4) A second DeVilbiss Model 40 Inhalation Medication Nebulizer
or equivalent is used to spray the fit test solution into the
enclosure. This nebulizer shall be clearly marked to distinguish it
from the screening test solution nebulizer.
(5) The fit test solution is prepared by adding 337.5 mg of
Bitrex to 200 ml of a 5% salt (NaCl) solution in warm water.
(6) As before, the test subject shall breathe through his or her
slightly open mouth with tongue extended, and be instructed to
report if he/she tastes the bitter taste of Bitrex..
(7) The nebulizer is inserted into the hole in the front of the
enclosure and an initial concentration of the fit test solution is
sprayed into the enclosure using the same number of squeezes (either
10, 20 or 30 squeezes) based on the number of squeezes required to
elicit a taste response as noted during the screening test.
(8) After generating the aerosol, the test subject shall be
instructed to perform the exercises in section I. A. 14. of this
appendix.
(9) Every 30 seconds the aerosol concentration shall be
replenished using one half the number of squeezes used initially
(e.g., 5, 10 or 15).
(10) The test subject shall indicate to the test conductor if at
any time during the fit test the taste of Bitrex is detected. If the
test subject does not report tasting the Bitrex, the test is passed.
(11) If the taste of Bitrex is detected, the fit is deemed
unsatisfactory and the test is failed. A different respirator shall
be tried and the entire test procedure is repeated (taste threshold
screening and fit testing).
5. Irritant Smoke (Stannic Chloride) Protocol
This qualitative fit test uses a person's response to the
irritating chemicals released in the ``smoke'' produced by a stannic
chloride ventilation smoke tube to detect leakage into the
respirator.
(a) General Requirements and Precautions
(1) The respirator to be tested shall be equipped with high
efficiency particulate air (HEPA) or P100 series filter(s).
(2) Only stannic chloride smoke tubes shall be used for this
protocol.
(3) No form of test enclosure or hood for the test subject shall
be used.
(4) The smoke can be irritating to the eyes, lungs, and nasal
passages. The test conductor shall take precautions to minimize the
test subject's exposure to irritant smoke. Sensitivity varies, and
certain individuals may respond to a greater degree to irritant
smoke. Care shall be taken when performing the sensitivity screening
checks that determine whether the test subject can detect irritant
smoke to use only the minimum amount of smoke necessary to elicit a
response from the test subject.
(5) The fit test shall be performed in an area with adequate
ventilation to prevent exposure of the person conducting the fit
test or the build-up of irritant smoke in the general atmosphere.
(b) Sensitivity Screening Check
The person to be tested must demonstrate his or her ability to
detect a weak concentration of the irritant smoke.
(1) The test operator shall break both ends of a ventilation
smoke tube containing stannic chloride, and attach one end of the
smoke tube to a low flow air pump set to deliver 200 milliliters per
minute, or an aspirator squeeze bulb. The test operator shall cover
the other end of the smoke tube with a short piece of tubing to
prevent potential injury from the jagged end of the smoke tube.
(2) The test operator shall advise the test subject that the
smoke can be irritating to the eyes, lungs, and nasal passages and
instruct the subject to keep his/her eyes closed while the test is
performed.
(3) The test subject shall be allowed to smell a weak
concentration of the irritant smoke before the respirator is donned
to become familiar with its irritating properties and to determine
if he/she can detect the irritating properties of the smoke. The
test operator shall carefully direct a small amount of the irritant
smoke in the test subject's direction to determine that he/she can
detect it.
(c) Irritant Smoke Fit Test Procedure
(1) The person being fit tested shall don the respirator without
assistance, and perform the required user seal check(s).
(2) The test subject shall be instructed to keep his/her eyes
closed.
(3) The test operator shall direct the stream of irritant smoke
from the smoke tube toward the faceseal area of the test subject,
using the low flow pump or the squeeze bulb. The test operator shall
begin at least 12 inches from the facepiece and move the smoke
stream around the whole perimeter of the mask. The operator shall
gradually make two more passes around the perimeter of the mask,
moving to within six inches of the respirator.
(4) If the person being tested has not had an involuntary
response and/or detected the irritant smoke, proceed with the test
exercises.
(5) The exercises identified in section I.A. 14. of this
appendix shall be performed by the test subject while the respirator
seal is being continually challenged by the smoke, directed around
the perimeter of the respirator at a distance of six inches.
(6) If the person being fit tested reports detecting the
irritant smoke at any time, the test is failed. The person being
retested must repeat the entire sensitivity check and fit test
procedure.
(7) Each test subject passing the irritant smoke test without
evidence of a response (involuntary cough, irritation) shall be
given a second sensitivity screening check, with the smoke from the
same smoke tube used during the fit test, once the respirator has
been removed, to determine whether he/she still reacts to the smoke.
Failure to evoke a response shall void the fit test.
(8) If a response is produced during this second sensitivity
check, then the fit test is passed.
C. Quantitative Fit Test (QNFT) Protocols
The following quantitative fit testing procedures have been
demonstrated to be acceptable: Quantitative fit testing using a non-
hazardous test aerosol (such as corn oil, polyethylene glycol 400
[PEG 400], di-2-ethyl hexyl sebacate [DEHS], or sodium chloride)
generated in a test chamber, and employing instrumentation to
quantify the fit of the respirator; Quantitative fit testing using
ambient aerosol as the test agent and appropriate instrumentation
(condensation nuclei counter) to quantify the respirator fit;
Quantitative fit testing using controlled negative pressure and
appropriate instrumentation to measure the volumetric leak rate of a
facepiece to quantify the respirator fit.
1. General
(a) The employer shall ensure that persons administering QNFT
are able to calibrate equipment and perform tests properly,
recognize invalid tests, calculate fit factors properly and ensure
that test equipment is in proper working order.
(b) The employer shall ensure that QNFT equipment is kept clean,
and is maintained and calibrated according to the manufacturer's
instructions so as to operate at the parameters for which it was
designed.
2. Generated Aerosol Quantitative Fit Testing Protocol
(a) Apparatus.
(1) Instrumentation. Aerosol generation, dilution, and
measurement systems using particulates (corn oil, polyethylene
glycol 400 [PEG 400], di-2-ethyl hexyl sebacate [DEHS] or sodium
chloride) as test aerosols shall be used for quantitative fit
testing.
(2) Test chamber. The test chamber shall be large enough to
permit all test subjects to perform freely all required exercises
without disturbing the test agent concentration or the measurement
apparatus. The test chamber shall be equipped and constructed so
that the test agent is effectively isolated from the ambient air,
yet uniform in concentration throughout the chamber.
(3) When testing air-purifying respirators, the normal filter or
cartridge element shall be replaced with a high efficiency
particulate air (HEPA) or P100 series filter supplied by the same
manufacturer.
(4) The sampling instrument shall be selected so that a computer
record or strip chart record may be made of the test showing the
rise and fall of the test agent concentration with each inspiration
and expiration at fit factors of at least 2,000.
[[Page 1280]]
Integrators or computers that integrate the amount of test agent
penetration leakage into the respirator for each exercise may be
used provided a record of the readings is made.
(5) The combination of substitute air-purifying elements, test
agent and test agent concentration shall be such that the test
subject is not exposed in excess of an established exposure limit
for the test agent at any time during the testing process, based
upon the length of the exposure and the exposure limit duration.
(6) The sampling port on the test specimen respirator shall be
placed and constructed so that no leakage occurs around the port
(e.g., where the respirator is probed), a free air flow is allowed
into the sampling line at all times, and there is no interference
with the fit or performance of the respirator. The in-mask sampling
device (probe) shall be designed and used so that the air sample is
drawn from the breathing zone of the test subject, midway between
the nose and mouth and with the probe extending into the facepiece
cavity at least 1/4 inch.
(7) The test setup shall permit the person administering the
test to observe the test subject inside the chamber during the test.
(8) The equipment generating the test atmosphere shall maintain
the concentration of test agent constant to within a 10 percent
variation for the duration of the test.
(9) The time lag (interval between an event and the recording of
the event on the strip chart or computer or integrator) shall be
kept to a minimum. There shall be a clear association between the
occurrence of an event and its being recorded.
(10) The sampling line tubing for the test chamber atmosphere
and for the respirator sampling port shall be of equal diameter and
of the same material. The length of the two lines shall be equal.
(11) The exhaust flow from the test chamber shall pass through
an appropriate filter (i.e., high efficiency particulate or P100
series filter) before release.
(12) When sodium chloride aerosol is used, the relative humidity
inside the test chamber shall not exceed 50 percent.
(13) The limitations of instrument detection shall be taken into
account when determining the fit factor.
(14) Test respirators shall be maintained in proper working
order and be inspected regularly for deficiencies such as cracks or
missing valves and gaskets.
(b) Procedural Requirements.
(1) When performing the initial user seal check using a positive
or negative pressure check, the sampling line shall be crimped
closed in order to avoid air pressure leakage during either of these
pressure checks.
(2) The use of an abbreviated screening QLFT test is optional.
Such a test may be utilized in order to quickly identify poor
fitting respirators that passed the positive and/or negative
pressure test and reduce the amount of QNFT time. The use of the CNC
QNFT instrument in the count mode is another optional method to
obtain a quick estimate of fit and eliminate poor fitting
respirators before going on to perform a full QNFT.
(3) A reasonably stable test agent concentration shall be
measured in the test chamber prior to testing. For canopy or shower
curtain types of test units, the determination of the test agent's
stability may be established after the test subject has entered the
test environment.
(4) Immediately after the subject enters the test chamber, the
test agent concentration inside the respirator shall be measured to
ensure that the peak penetration does not exceed 5 percent for a
half mask or 1 percent for a full facepiece respirator.
(5) A stable test agent concentration shall be obtained prior to
the actual start of testing.
(6) Respirator restraining straps shall not be over-tightened
for testing. The straps shall be adjusted by the wearer without
assistance from other persons to give a reasonably comfortable fit
typical of normal use. The respirator shall not be adjusted once the
fit test exercises begin.
(7) The test shall be terminated whenever any single peak
penetration exceeds 5 percent for half masks and 1 percent for full
facepiece respirators. The test subject shall be refitted and
retested.
(8) Calculation of fit factors.
(i) The fit factor shall be determined for the quantitative fit
test by taking the ratio of the average chamber concentration to the
concentration measured inside the respirator for each test exercise
except the grimace exercise.
(ii) The average test chamber concentration shall be calculated
as the arithmetic average of the concentration measured before and
after each test (i.e., 7 exercises) or the arithmetic average of the
concentration measured before and after each exercise or the true
average measured continuously during the respirator sample.
(iii) The concentration of the challenge agent inside the
respirator shall be determined by one of the following methods:
(A) Average peak penetration method means the method of
determining test agent penetration into the respirator utilizing a
strip chart recorder, integrator, or computer. The agent penetration
is determined by an average of the peak heights on the graph or by
computer integration, for each exercise except the grimace exercise.
Integrators or computers that calculate the actual test agent
penetration into the respirator for each exercise will also be
considered to meet the requirements of the average peak penetration
method.
(B) Maximum peak penetration method means the method of
determining test agent penetration in the respirator as determined
by strip chart recordings of the test. The highest peak penetration
for a given exercise is taken to be representative of average
penetration into the respirator for that exercise.
(C) Integration by calculation of the area under the individual
peak for each exercise except the grimace exercise. This includes
computerized integration.
(D) The calculation of the overall fit factor using individual
exercise fit factors involves first converting the exercise fit
factors to penetration values, determining the average, and then
converting that result back to a fit factor. This procedure is
described in the following equation:
[GRAPHIC] [TIFF OMITTED] TR08JA98.006
Where ff1, ff2, ff3, etc. are the
fit factors for exercises 1, 2, 3, etc.
(9) The test subject shall not be permitted to wear a half mask
or quarter facepiece respirator unless a minimum fit factor of 100
is obtained, or a full facepiece respirator unless a minimum fit
factor of 500 is obtained.
(10) Filters used for quantitative fit testing shall be replaced
whenever increased breathing resistance is encountered, or when the
test agent has altered the integrity of the filter media.
3. Ambient aerosol condensation nuclei counter (CNC)
quantitative fit testing protocol.
The ambient aerosol condensation nuclei counter (CNC)
quantitative fit testing (Portacount TM ) protocol
quantitatively fit tests respirators with the use of a probe. The
probed respirator is only used for quantitative fit tests. A probed
respirator has a special sampling device, installed on the
respirator, that allows the probe to sample the air from inside the
mask. A probed respirator is required for each make, style, model,
and size that the employer uses and can be obtained from the
respirator manufacturer or distributor. The CNC instrument
manufacturer, TSI Inc., also provides probe attachments (TSI
sampling adapters) that permit fit testing in an employee's own
respirator. A minimum fit factor pass level of at least 100 is
necessary for a half-mask respirator and a minimum fit factor pass
level of at least 500 is required for a full facepiece negative
pressure respirator. The entire screening and testing procedure
shall be explained to the test subject prior to the conduct of the
screening test.
(a) Portacount Fit Test Requirements.
(1) Check the respirator to make sure the respirator is fitted
with a high-efficiency filter and that the sampling probe and line
are properly attached to the facepiece.
(2) Instruct the person to be tested to don the respirator for
five minutes before the fit test starts. This purges the ambient
particles trapped inside the respirator and permits the wearer to
make certain the respirator is comfortable. This individual shall
already have been trained on how to wear the respirator properly.
[[Page 1281]]
(3) Check the following conditions for the adequacy of the
respirator fit: Chin properly placed; Adequate strap tension, not
overly tightened; Fit across nose bridge; Respirator of proper size
to span distance from nose to chin; Tendency of the respirator to
slip; Self-observation in a mirror to evaluate fit and respirator
position.
(4) Have the person wearing the respirator do a user seal check.
If leakage is detected, determine the cause. If leakage is from a
poorly fitting facepiece, try another size of the same model
respirator, or another model of respirator.
(5) Follow the manufacturer's instructions for operating the
Portacount and proceed with the test.
(6) The test subject shall be instructed to perform the
exercises in section I. A. 14. of this appendix.
(7) After the test exercises, the test subject shall be
questioned by the test conductor regarding the comfort of the
respirator upon completion of the protocol. If it has become
unacceptable, another model of respirator shall be tried.
(b) Portacount Test Instrument.
(1) The Portacount will automatically stop and calculate the
overall fit factor for the entire set of exercises. The overall fit
factor is what counts. The Pass or Fail message will indicate
whether or not the test was successful. If the test was a Pass, the
fit test is over.
(2) Since the pass or fail criterion of the Portacount is user
programmable, the test operator shall ensure that the pass or fail
criterion meet the requirements for minimum respirator performance
in this Appendix.
(3) A record of the test needs to be kept on file, assuming the
fit test was successful. The record must contain the test subject's
name; overall fit factor; make, model, style, and size of respirator
used; and date tested.
4. Controlled negative pressure (CNP) quantitative fit testing
protocol.
The CNP protocol provides an alternative to aerosol fit test
methods. The CNP fit test method technology is based on exhausting
air from a temporarily sealed respirator facepiece to generate and
then maintain a constant negative pressure inside the facepiece. The
rate of air exhaust is controlled so that a constant negative
pressure is maintained in the respirator during the fit test. The
level of pressure is selected to replicate the mean inspiratory
pressure that causes leakage into the respirator under normal use
conditions. With pressure held constant, air flow out of the
respirator is equal to air flow into the respirator. Therefore,
measurement of the exhaust stream that is required to hold the
pressure in the temporarily sealed respirator constant yields a
direct measure of leakage air flow into the respirator. The CNP fit
test method measures leak rates through the facepiece as a method
for determining the facepiece fit for negative pressure respirators.
The CNP instrument manufacturer Dynatech Nevada also provides
attachments (sampling manifolds) that replace the filter cartridges
to permit fit testing in an employee's own respirator. To perform
the test, the test subject closes his or her mouth and holds his/her
breath, after which an air pump removes air from the respirator
facepiece at a pre-selected constant pressure. The facepiece fit is
expressed as the leak rate through the facepiece, expressed as
milliliters per minute. The quality and validity of the CNP fit
tests are determined by the degree to which the in-mask pressure
tracks the test pressure during the system measurement time of
approximately five seconds. Instantaneous feedback in the form of a
real-time pressure trace of the in-mask pressure is provided and
used to determine test validity and quality. A minimum fit factor
pass level of 100 is necessary for a half-mask respirator and a
minimum fit factor of at least 500 is required for a full facepiece
respirator. The entire screening and testing procedure shall be
explained to the test subject prior to the conduct of the screening
test.
(a) CNP Fit Test Requirements.
(1) The instrument shall have a non-adjustable test pressure of
15.0 mm water pressure.
(2) The CNP system defaults selected for test pressure shall be
set at--1.5 mm of water (-0.58 inches of water) and the modeled
inspiratory flow rate shall be 53.8 liters per minute for performing
fit tests.
(Note: CNP systems have built-in capability to conduct fit testing
that is specific to unique work rate, mask, and gender situations
that might apply in a specific workplace. Use of system default
values, which were selected to represent respirator wear with medium
cartridge resistance at a low-moderate work rate, will allow inter-
test comparison of the respirator fit.)
(3) The individual who conducts the CNP fit testing shall be
thoroughly trained to perform the test.
(4) The respirator filter or cartridge needs to be replaced with
the CNP test manifold. The inhalation valve downstream from the
manifold either needs to be temporarily removed or propped open.
(5) The test subject shall be trained to hold his or her breath
for at least 20 seconds.
(6) The test subject shall don the test respirator without any
assistance from the individual who conducts the CNP fit test.
(7) The QNFT protocol shall be followed according to section I.
C. 1. of this appendix with an exception for the CNP test exercises.
(b) CNP Test Exercises.
(1) Normal breathing. In a normal standing position, without
talking, the subject shall breathe normally for 1 minute. After the
normal breathing exercise, the subject needs to hold head straight
ahead and hold his or her breath for 10 seconds during the test
measurement.
(2) Deep breathing. In a normal standing position, the subject
shall breathe slowly and deeply for 1 minute, being careful not to
hyperventilate. After the deep breathing exercise, the subject shall
hold his or her head straight ahead and hold his or her breath for
10 seconds during test measurement.
(3) Turning head side to side. Standing in place, the subject
shall slowly turn his or her head from side to side between the
extreme positions on each side for 1 minute. The head shall be held
at each extreme momentarily so the subject can inhale at each side.
After the turning head side to side exercise, the subject needs to
hold head full left and hold his or her breath for 10 seconds during
test measurement. Next, the subject needs to hold head full right
and hold his or her breath for 10 seconds during test measurement.
(4) Moving head up and down. Standing in place, the subject
shall slowly move his or her head up and down for 1 minute. The
subject shall be instructed to inhale in the up position (i.e., when
looking toward the ceiling). After the moving head up and down
exercise, the subject shall hold his or her head full up and hold
his or her breath for 10 seconds during test measurement. Next, the
subject shall hold his or her head full down and hold his or her
breath for 10 seconds during test measurement.
(5) Talking. The subject shall talk out loud slowly and loud
enough so as to be heard clearly by the test conductor. The subject
can read from a prepared text such as the Rainbow Passage, count
backward from 100, or recite a memorized poem or song for 1 minute.
After the talking exercise, the subject shall hold his or her head
straight ahead and hold his or her breath for 10 seconds during the
test measurement.
(6) Grimace. The test subject shall grimace by smiling or
frowning for 15 seconds.
(7) Bending Over. The test subject shall bend at the waist as if
he or she were to touch his or her toes for 1 minute. Jogging in
place shall be substituted for this exercise in those test
environments such as shroud-type QNFT units that prohibit bending at
the waist. After the bending over exercise, the subject shall hold
his or her head straight ahead and hold his or her breath for 10
seconds during the test measurement.
(8) Normal Breathing. The test subject shall remove and re-don
the respirator within a one-minute period. Then, in a normal
standing position, without talking, the subject shall breathe
normally for 1 minute. After the normal breathing exercise, the
subject shall hold his or her head straight ahead and hold his or
her breath for 10 seconds during the test measurement. After the
test exercises, the test subject shall be questioned by the test
conductor regarding the comfort of the respirator upon completion of
the protocol. If it has become unacceptable, another model of a
respirator shall be tried.
(c) CNP Test Instrument.
(1) The test instrument shall have an effective audio warning
device when the test subject fails to hold his or her breath during
the test. The test shall be terminated whenever the test subject
failed to hold his or her breath. The test subject may be refitted
and retested.
(2) A record of the test shall be kept on file, assuming the fit
test was successful. The record must contain the test subject's
name; overall fit factor; make, model, style and size of respirator
used; and date tested.
Part II. New Fit Test Protocols
A. Any person may submit to OSHA an application for approval of
a new fit test protocol. If the application meets the following
criteria, OSHA will initiate a rulemaking proceeding under section
6(b)(7) of the OSH Act to determine whether to list
[[Page 1282]]
the new protocol as an approved protocol in this Appendix A.
B. The application must include a detailed description of the
proposed new fit test protocol. This application must be supported
by either:
1. A test report prepared by an independent government research
laboratory (e.g., Lawrence Livermore National Laboratory, Los Alamos
National Laboratory, the National Institute for Standards and
Technology) stating that the laboratory has tested the protocol and
had found it to be accurate and reliable; or
2. An article that has been published in a peer-reviewed
industrial hygiene journal describing the protocol and explaining
how test data support the protocol's accuracy and reliability.
C. If OSHA determines that additional information is required
before the Agency commences a rulemaking proceeding under this
section, OSHA will so notify the applicant and afford the applicant
the opportunity to submit the supplemental information. Initiation
of a rulemaking proceeding will be deferred until OSHA has received
and evaluated the supplemental information.
Appendix B-1 to Sec. 1910.134: User Seal Check Procedures (Mandatory)
The individual who uses a tight-fitting respirator is to perform
a user seal check to ensure that an adequate seal is achieved each
time the respirator is put on. Either the positive and negative
pressure checks listed in this appendix, or the respirator
manufacturer's recommended user seal check method shall be used.
User seal checks are not substitutes for qualitative or quantitative
fit tests.
I. Facepiece Positive and/or Negative Pressure Checks
A. Positive pressure check. Close off the exhalation valve and
exhale gently into the facepiece. The face fit is considered
satisfactory if a slight positive pressure can be built up inside
the facepiece without any evidence of outward leakage of air at the
seal. For most respirators this method of leak testing requires the
wearer to first remove the exhalation valve cover before closing off
the exhalation valve and then carefully replacing it after the test.
B. Negative pressure check. Close off the inlet opening of the
canister or cartridge(s) by covering with the palm of the hand(s) or
by replacing the filter seal(s), inhale gently so that the facepiece
collapses slightly, and hold the breath for ten seconds. The design
of the inlet opening of some cartridges cannot be effectively
covered with the palm of the hand. The test can be performed by
covering the inlet opening of the cartridge with a thin latex or
nitrile glove. If the facepiece remains in its slightly collapsed
condition and no inward leakage of air is detected, the tightness of
the respirator is considered satisfactory.
II. Manufacturer's Recommended User Seal Check Procedures
The respirator manufacturer's recommended procedures for
performing a user seal check may be used instead of the positive
and/or negative pressure check procedures provided that the employer
demonstrates that the manufacturer's procedures are equally
effective.
Appendix B-2 to Sec. 1910.134: Respirator Cleaning Procedures
(Mandatory)
These procedures are provided for employer use when cleaning
respirators. They are general in nature, and the employer as an
alternative may use the cleaning recommendations provided by the
manufacturer of the respirators used by their employees, provided
such procedures are as effective as those listed here in Appendix B-
2. Equivalent effectiveness simply means that the procedures used
must accomplish the objectives set forth in Appendix B-2, i.e., must
ensure that the respirator is properly cleaned and disinfected in a
manner that prevents damage to the respirator and does not cause
harm to the user.
I. Procedures for Cleaning Respirators
A. Remove filters, cartridges, or canisters. Disassemble
facepieces by removing speaking diaphragms, demand and pressure-
demand valve assemblies, hoses, or any components recommended by the
manufacturer. Discard or repair any defective parts.
B. Wash components in warm (43 deg. C [110 deg. F] maximum)
water with a mild detergent or with a cleaner recommended by the
manufacturer. A stiff bristle (not wire) brush may be used to
facilitate the removal of dirt.
C. Rinse components thoroughly in clean, warm (43 deg. C
[110 deg. F] maximum), preferably running water. Drain.
D. When the cleaner used does not contain a disinfecting agent,
respirator components should be immersed for two minutes in one of
the following:
1. Hypochlorite solution (50 ppm of chlorine) made by adding
approximately one milliliter of laundry bleach to one liter of water
at 43 deg. C (110 deg. F); or,
2. Aqueous solution of iodine (50 ppm iodine) made by adding
approximately 0.8 milliliters of tincture of iodine (6-8 grams
ammonium and/or potassium iodide/100 cc of 45% alcohol) to one liter
of water at 43 deg. C (110 deg. F); or,
3. Other commercially available cleansers of equivalent
disinfectant quality when used as directed, if their use is
recommended or approved by the respirator manufacturer.
E. Rinse components thoroughly in clean, warm (43 deg. C
[110 deg. F] maximum), preferably running water. Drain. The
importance of thorough rinsing cannot be overemphasized. Detergents
or disinfectants that dry on facepieces may result in dermatitis. In
addition, some disinfectants may cause deterioration of rubber or
corrosion of metal parts if not completely removed.
F. Components should be hand-dried with a clean lint-free cloth
or air-dried.
G. Reassemble facepiece, replacing filters, cartridges, and
canisters where necessary.
H. Test the respirator to ensure that all components work
properly.
Appendix C to Sec. 1910.134: OSHA Respirator Medical Evaluation
Questionnaire (Mandatory)
To the employer: Answers to questions in Section 1, and to
question 9 in Section 2 of Part A, do not require a medical
examination.
To the employee:
Can you read (circle one): Yes/No
Your employer must allow you to answer this questionnaire during
normal working hours, or at a time and place that is convenient to
you. To maintain your confidentiality, your employer or supervisor
must not look at or review your answers, and your employer must tell
you how to deliver or send this questionnaire to the health care
professional who will review it.
Part A. Section 1. (Mandatory) The following information must be
provided by every employee who has been selected to use any type of
respirator (please print).
1. Today's date:-------------------------------------------------------
2. Your name:----------------------------------------------------------
3. Your age (to nearest year):-----------------------------------------
4. Sex (circle one): Male/Female
5. Your height: __________ ft. __________ in.
6. Your weight: ____________ lbs.
7. Your job title:-----------------------------------------------------
8. A phone number where you can be reached by the health care
professional who reviews this questionnaire (include the Area Code):
____________________
9. The best time to phone you at this number: ________________
10. Has your employer told you how to contact the health care
professional who will review this questionnaire (circle one): Yes/No
11. Check the type of respirator you will use (you can check more
than one category):
a. ______ N, R, or P disposable respirator (filter-mask, non-
cartridge type only).
b. ______ Other type (for example, half- or full-facepiece type,
powered-air purifying, supplied-air, self-contained breathing
apparatus).
12. Have you worn a respirator (circle one): Yes/No
If ``yes,'' what type(s):--------------------------------------------
----------------------------------------------------------------------
Part A. Section 2. (Mandatory) Questions 1 through 9 below must
be answered by every employee who has been selected to use any type
of respirator (please circle ``yes'' or ``no'').
1. Do you currently smoke tobacco, or have you smoked tobacco in the
last month: Yes/No
2. Have you ever had any of the following conditions?
a. Seizures (fits): Yes/No
b. Diabetes (sugar disease): Yes/No
c. Allergic reactions that interfere with your breathing: Yes/No
d. Claustrophobia (fear of closed-in places): Yes/No
e. Trouble smelling odors: Yes/No
3. Have you ever had any of the following pulmonary or lung
problems?
a. Asbestosis: Yes/No
b. Asthma: Yes/No
[[Page 1283]]
c. Chronic bronchitis: Yes/No
d. Emphysema: Yes/No
e. Pneumonia: Yes/No
f. Tuberculosis: Yes/No
g. Silicosis: Yes/No
h. Pneumothorax (collapsed lung): Yes/No
i. Lung cancer: Yes/No
j. Broken ribs: Yes/No
k. Any chest injuries or surgeries: Yes/No
l. Any other lung problem that you've been told about: Yes/No
4. Do you currently have any of the following symptoms of pulmonary
or lung illness?
a. Shortness of breath: Yes/No
b. Shortness of breath when walking fast on level ground or
walking up a slight hill or incline: Yes/No
c. Shortness of breath when walking with other people at an
ordinary pace on level ground: Yes/No
d. Have to stop for breath when walking at your own pace on
level ground: Yes/No
e. Shortness of breath when washing or dressing yourself: Yes/No
f. Shortness of breath that interferes with your job: Yes/No
g. Coughing that produces phlegm (thick sputum): Yes/No
h. Coughing that wakes you early in the morning: Yes/No
i. Coughing that occurs mostly when you are lying down: Yes/No
j. Coughing up blood in the last month: Yes/No
k. Wheezing: Yes/No
l. Wheezing that interferes with your job: Yes/No
m. Chest pain when you breathe deeply: Yes/No
n. Any other symptoms that you think may be related to lung
problems: Yes/No
5. Have you ever had any of the following cardiovascular or heart
problems?
a. Heart attack: Yes/No
b. Stroke: Yes/No
c. Angina: Yes/No
d. Heart failure: Yes/No
e. Swelling in your legs or feet (not caused by walking): Yes/No
f. Heart arrhythmia (heart beating irregularly): Yes/No
g. High blood pressure: Yes/No
h. Any other heart problem that you've been told about: Yes/No
6. Have you ever had any of the following cardiovascular or heart
symptoms?
a. Frequent pain or tightness in your chest: Yes/No
b. Pain or tightness in your chest during physical activity:
Yes/No
c. Pain or tightness in your chest that interferes with your
job: Yes/No
d. In the past two years, have you noticed your heart skipping
or missing a beat: Yes/No
e. Heartburn or indigestion that is not related to eating: Yes/
No
f. Any other symptoms that you think may be related to heart or
circulation problems: Yes/No
7. Do you currently take medication for any of the following
problems?
a. Breathing or lung problems: Yes/No
b. Heart trouble: Yes/No
c. Blood pressure: Yes/No
d. Seizures (fits): Yes/No
8. If you've used a respirator, have you ever had any of the
following problems? (If you've never used a respirator, check the
following space and go to question 9:)
a. Eye irritation: Yes/No
b. Skin allergies or rashes: Yes/No
c. Anxiety: Yes/No
d. General weakness or fatigue: Yes/No
e. Any other problem that interferes with your use of a
respirator: Yes/No
9. Would you like to talk to the health care professional who will
review this questionnaire about your answers to this questionnaire:
Yes/No
Questions 10 to 15 below must be answered by every employee who
has been selected to use either a full-facepiece respirator or a
self-contained breathing apparatus (SCBA). For employees who have
been selected to use other types of respirators, answering these
questions is voluntary.
10. Have you ever lost vision in either eye (temporarily or
permanently): Yes/No
11. Do you currently have any of the following vision problems?
a. Wear contact lenses: Yes/No
b. Wear glasses: Yes/No
c. Color blind: Yes/No
e. Any other eye or vision problem: Yes/No
12. Have you ever had an injury to your ears, including a broken ear
drum: Yes/No
13. Do you currently have any of the following hearing problems?
a. Difficulty hearing: Yes/No
b. Wear a hearing aid: Yes/No
c. Any other hearing or ear problem: Yes/No
14. Have you ever had a back injury: Yes/No
15. Do you currently have any of the following musculoskeletal
problems?
a. Weakness in any of your arms, hands, legs, or feet: Yes/No
b. Back pain: Yes/No
c. Difficulty fully moving your arms and legs: Yes/No
d. Pain or stiffness when you lean forward or backward at the
waist: Yes/No
e. Difficulty fully moving your head up or down: Yes/No
f. Difficulty fully moving your head side to side: Yes/No
g. Difficulty bending at your knees: Yes/No
h. Difficulty squatting to the ground: Yes/No
i. Climbing a flight of stairs or a ladder carrying more than 25
lbs: Yes/No
j. Any other muscle or skeletal problem that interferes with
using a respirator: Yes/No
Part B Any of the following questions, and other questions not
listed, may be added to the questionnaire at the discretion of the
health care professional who will review the questionnaire.
1. In your present job, are you working at high altitudes (over
5,000 feet) or in a place that has lower than normal amounts of
oxygen: Yes/No
If ``yes,'' do you have feelings of dizziness, shortness of
breath, pounding in your chest, or other symptoms when you're
working under these conditions: Yes/No
2. At work or at home, have you ever been exposed to hazardous
solvents, hazardous airborne chemicals (e.g., gases, fumes, or
dust), or have you come into skin contact with hazardous chemicals:
Yes/No
If ``yes,'' name the chemicals if you know them:---------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
3. Have you ever worked with any of the materials, or under any of
the conditions, listed below:
a. Asbestos: Yes/No
b. Silica (e.g., in sandblasting): Yes/No
c. Tungsten/cobalt (e.g., grinding or welding this material):
Yes/No
d. Beryllium: Yes/No
e. Aluminum: Yes/No
f. Coal (for example, mining): Yes/No
g. Iron: Yes/No
h. Tin: Yes/No
i. Dusty environments: Yes/No
j. Any other hazardous exposures: Yes/No
If ``yes,'' describe these exposures:--------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
4. List any second jobs or side businesses you have:-------------------
----------------------------------------------------------------------
5. List your previous occupations:-------------------------------------
----------------------------------------------------------------------
6. List your current and previous hobbies:-----------------------------
----------------------------------------------------------------------
7. Have you been in the military services? Yes/No
If ``yes,'' were you exposed to biological or chemical agents
(either in training or combat): Yes/No
8. Have you ever worked on a HAZMAT team? Yes/No
9. Other than medications for breathing and lung problems, heart
trouble, blood pressure, and seizures mentioned earlier in this
questionnaire, are you taking any other medications for any reason
(including over-the-counter medications): Yes/No
If ``yes,'' name the medications if you know them:-------------------
10. Will you be using any of the following items with your
respirator(s)?
a. HEPA Filters: Yes/No
b. Canisters (for example, gas masks): Yes/No
c. Cartridges: Yes/No
11. How often are you expected to use the respirator(s) (circle
``yes'' or ``no'' for all answers that apply to you)?:
a. Escape only (no rescue): Yes/No
b. Emergency rescue only: Yes/No
c. Less than 5 hours per week: Yes/No
d. Less than 2 hours per day: Yes/No
e. 2 to 4 hours per day: Yes/No
[[Page 1284]]
f. Over 4 hours per day: Yes/No
12. During the period you are using the respirator(s), is your work
effort:
a. Light (less than 200 kcal per hour): Yes/No
If ``yes,'' how long does this period last during the average
shift:____________hrs.____________mins.
Examples of a light work effort are sitting while writing,
typing, drafting, or performing light assembly work; or standing
while operating a drill press (1-3 lbs.) or controlling machines.
b. Moderate (200 to 350 kcal per hour): Yes/No
If ``yes,'' how long does this period last during the average
shift:____________hrs.____________mins.
Examples of moderate work effort are sitting while nailing or
filing; driving a truck or bus in urban traffic; standing while
drilling, nailing, performing assembly work, or transferring a
moderate load (about 35 lbs.) at trunk level; walking on a level
surface about 2 mph or down a 5-degree grade about 3 mph; or pushing
a wheelbarrow with a heavy load (about 100 lbs.) on a level surface.
c. Heavy (above 350 kcal per hour): Yes/No
If ``yes,'' how long does this period last during the average
shift:____________hrs.____________mins.
Examples of heavy work are lifting a heavy load (about 50 lbs.)
from the floor to your waist or shoulder; working on a loading dock;
shoveling; standing while bricklaying or chipping castings; walking
up an 8-degree grade about 2 mph; climbing stairs with a heavy load
(about 50 lbs.).
13. Will you be wearing protective clothing and/or equipment (other
than the respirator) when you're using your respirator: Yes/No
If ``yes,'' describe this protective clothing and/or equipment:------
----------------------------------------------------------------------
14. Will you be working under hot conditions (temperature exceeding
77 deg. F): Yes/No
15. Will you be working under humid conditions: Yes/No
16. Describe the work you'll be doing while you're using your
respirator(s):
----------------------------------------------------------------------
----------------------------------------------------------------------
17. Describe any special or hazardous conditions you might encounter
when you're using your respirator(s) (for example, confined spaces,
life-threatening gases):
----------------------------------------------------------------------
----------------------------------------------------------------------
18. Provide the following information, if you know it, for each
toxic substance that you'll be exposed to when you're using your
respirator(s):
Name of the first toxic substance:-----------------------------------
Estimated maximum exposure level per shift:--------------------------
Duration of exposure per shift---------------------------------------
Name of the second toxic substance:----------------------------------
Estimated maximum exposure level per shift:--------------------------
Duration of exposure per shift:--------------------------------------
Name of the third toxic substance:-----------------------------------
Estimated maximum exposure level per shift:--------------------------
Duration of exposure per shift:--------------------------------------
The name of any other toxic substances that you'll be exposed to
while using your respirator:
----------------------------------------------------------------------
----------------------------------------------------------------------
----------------------------------------------------------------------
19. Describe any special responsibilities you'll have while using
your respirator(s) that may affect the safety and well-being of
others (for example, rescue, security):
----------------------------------------------------------------------
Appendix D to Sec. 1910.134 (Non-Mandatory) Information for Employees
Using Respirators When Not Required Under the Standard
Respirators are an effective method of protection against
designated hazards when properly selected and worn. Respirator use
is encouraged, even when exposures are below the exposure limit, to
provide an additional level of comfort and protection for workers.
However, if a respirator is used improperly or not kept clean, the
respirator itself can become a hazard to the worker. Sometimes,
workers may wear respirators to avoid exposures to hazards, even if
the amount of hazardous substance does not exceed the limits set by
OSHA standards. If your employer provides respirators for your
voluntary use, of if you provide your own respirator, you need to
take certain precautions to be sure that the respirator itself does
not present a hazard.
You should do the following:
1. Read and heed all instructions provided by the manufacturer
on use, maintenance, cleaning and care, and warnings regarding the
respirators limitations.
2. Choose respirators certified for use to protect against the
contaminant of concern. NIOSH, the National Institute for
Occupational Safety and Health of the U.S. Department of Health and
Human Services, certifies respirators. A label or statement of
certification should appear on the respirator or respirator
packaging. It will tell you what the respirator is designed for and
how much it will protect you.
3. Do not wear your respirator into atmospheres containing
contaminants for which your respirator is not designed to protect
against. For example, a respirator designed to filter dust particles
will not protect you against gases, vapors, or very small solid
particles of fumes or smoke.
4. Keep track of your respirator so that you do not mistakenly
use someone else's respirator.
Subpart L--[Amended]
8. The authority citation for Subpart L of Part 1910 is revised to
read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable.
9. Section 1910.156 is amended by revising paragraphs (f)(1)(i) and
(f)(1)(v) as follows:
Sec. 1910.156 Fire brigades.
* * * * *
(f) Respiratory protection. (1) General. (i) The employer must
ensure that respirators are provided to, and used by, fire brigade
members, and that the respirators meet the requirements of 29 CFR
1910.134 and this paragraph.
* * * * *
(v) Self-contained breathing apparatuses must have a minimum
service-life rating of 30 minutes in accordance with the methods and
requirements specified by NIOSH under 42 CFR part 84, except for escape
self-contained breathing apparatus (ESCBAs) used only for emergency
escape purposes.
* * * * *
Subpart Q--[Amended]
10. The authority citation for Subpart Q of Part 1910 is revised to
read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
part 1911.
11. Section 1910.252 is amended by revising paragraphs (c)(4)(ii),
(c)(4)(iii), (c)(7)(iii), (c)(9)(i), and (c)(10) as follows:
Sec. 1910.252 General requirements.
* * * * *
(c) * * *
(4) * * *
(ii) Airline respirators. In circumstances for which it is
impossible to provide such ventilation, airline respirators or hose
masks approved for this purpose by the National Institute for
Occupational Safety and Health (NIOSH) under 42 CFR part 84 must be
used.
(iii) Self-contained units. In areas immediately hazardous to life,
a full-facepiece, pressure-demand, self-contained breathing apparatus
or a combination full-facepiece, pressure-demand supplied-air
respirator with an auxiliary, self-contained air supply approved by
NIOSH under 42 CFR part 84 must be used.
* * * * *
(7) * * *
(iii) Local ventilation. In confined spaces or indoors, welding or
cutting operations involving metals containing lead, other than as an
impurity, or
[[Page 1285]]
metals coated with lead-bearing materials, including paint, must be
done using local exhaust ventilation or airline respirators. Such
operations, when done outdoors, must be done using respirators approved
for this purpose by NIOSH under 42 CFR part 84. In all cases, workers
in the immediate vicinity of the cutting operation must be protected by
local exhaust ventilation or airline respirators.
* * * * *
(9) * * *
(i) General. In confined spaces or indoors, welding or cutting
operations involving cadmium-bearing or cadmium-coated base metals must
be done using local exhaust ventilation or airline respirators unless
atmospheric tests under the most adverse conditions show that employee
exposure is within the acceptable concentrations specified by 29 CFR
1910.1000. Such operations, when done outdoors, must be done using
respirators, such as fume respirators, approved for this purpose by
NIOSH under 42 CFR part 84.
* * * * *
(10) Mercury. In confined spaces or indoors, welding or cutting
operations involving metals coated with mercury-bearing materials,
including paint, must be done using local exhaust ventilation or
airline respirators unless atmospheric tests under the most adverse
conditions show that employee exposure is within the acceptable
concentrations specified by 29 CFR 1910.1000. Such operations, when
done outdoors, must be done using respirators approved for this purpose
by NIOSH under 42 CFR part 84.
* * * * *
Subpart R--[Amended]
12. The authority citation for Subpart R of Part 1910 is revised as
follows:
Authority: Sections 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
part 11.
Sections 1910.261, 1910.262, 1910.265 through 1910.269,
1910.274, and 1910.275 also issued under 29 CFR part 1911.
13. Section 1910.261 is amended by revising paragraphs (b)(2),
(g)(10), (h)(2)(iii), and (h)(2)(iv) as follows:
Sec. 1910.261 Pulp, paper, and paperboard mills.
* * * * *
(b) * * *
(2) Personal protective clothing and equipment. Foot protection,
shin guards, hard hats, noise-attenuation devices, and other personal
protective clothing and equipment must be worn when the extent of the
hazard warrants their use. Such equipment must be worn when
specifically required by other paragraphs of this section, and must be
maintained in accordance with applicable American National Standards
Institute standards. Respirators, goggles, protective masks, rubber
gloves, rubber boots, and other such equipment must be cleaned and
disinfected before being used by another employee. Required eye, head,
and ear protection must conform to American National Standards
Institute standards Z24.22-1957, Z87.1-1968, and Z89.1-1969.
Respiratory protection must conform to the requirements of 29 CFR
1910.134.
* * * * *
(g) * * *
(10) Gas masks (digester building). Gas masks must be available,
and they must furnish adequate protection against sulfurous acid and
chlorine gases and be inspected and repaired in accordance with 29 CFR
1910.134.
* * * * *
(h) * * *
(2) * * *
(iii) Gas masks must be provided for emergency use in accordance
with 29 CFR 1910.134.
(iv) For emergency and rescue operations, the employer must provide
employees with self-contained breathing apparatuses or supplied-air
respirators, and ensure that employees use these respirators, in
accordance with the requirements of 29 CFR 1910.134.
* * * * *
Subpart Z--[Amended]
14. The general authority citation for Subpart Z of 29 CFR Part
1910 is revised to read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act (29 U.S.C. 653, 655, and 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
Part 1911.
* * * * *
15. Section 1910.1001 is amended by removing Appendix C and
revising paragraph (g), to read as follows:
Sec. 1910.1001 Asbestos.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activities,
for which engineering and work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the TWA and/or excursion limit.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) The employer must provide a tight-fitting, powered, air-
purifying respirator instead of any negative-pressure respirator
specified in Table 1 of this section when an employee chooses to use
this type of respirator and the respirator provides adequate protection
to the employee.
(iii) No employee must be assigned to tasks requiring the use of
respirators if, based on their most recent medical examination, the
examining physician determines that the employee will be unable to
function normally using a respirator, or that the safety or health of
the employee or other employees will be impaired by the use of a
respirator. Such employees must be assigned to another job or given the
opportunity to transfer to a different position, the duties of which
they can perform. If such a transfer position is available, the
position must be with the same employer, in the same geographical area,
and with the same seniority, status, and rate of pay the employee had
just prior to such transfer.
(3) Respirator selection. The employer must select and provide the
appropriate respirator from Table 1 of this section.
Table 1.--Respiratory Protection for Asbestos Fibers
------------------------------------------------------------------------
Airborne concentration of
asbestos or conditions of use Required respirator
------------------------------------------------------------------------
Not in excess of 1 f/cc (10 X Half-mask air purifying respirator other
PEL). than a disposable respirator, equipped
with high efficiency filters.
[[Page 1286]]
Not in excess of 5 f/cc (50 X Full facepiece air-purifying respirator
PEL). equipped with high efficiency filters.
Not in excess of 10 f/cc (100 Any powered air-purifying respirator
X PEL). equipped with high efficiency filters or
any supplied air respirator operated in
continuous flow mode.
Not in excess of 100 f/cc Full facepiece supplied air respirator
(1,000 X PEL). operated in pressure demand mode.
Greater than 100 f/cc (1,000 Full facepiece supplied air respirator
X PEL) or unknown operated in pressure demand mode,
concentration. equipped with an auxiliary positive
pressure self-contained breathing
apparatus.
------------------------------------------------------------------------
Note: a. Respirators assigned for high environmental concentrations may
be used at lower concentrations, or when required respirator use is
independent of concentration.
b. A high efficiency filter means a filter that is at least 99.97
percent efficient against mono-dispersed particles of 0.3 micrometers
in diameter or larger.
* * * * *
16. Section 1910.1003 is amended by revising paragraphs (c)(4)(iv)
and (d)(1) as follows:
Sec. 1910.1003 13 Carcinogens (4-Nitrobiphenyl, etc.).
* * * * *
(c) * * *
(4) * * *
(iv) Employees engaged in handling operations involving the
carcinogens addressed by this section must be provided with, and
required to wear and use, a half-face filter-type respirator for dusts,
mists, and fumes. A respirator affording higher levels of protection
than this respirator may be substituted.
* * * * *
(d) * * *
(1) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b), (c), (d)
(except (d)(1)(iii) and (iv), and (d)(3)), and (e) through (m).
* * * * *
17. Section 1910.1017 is amended by revising paragraph (g) to read
as follows:
Sec. 1910.1017 Vinyl chloride.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii), and (d)(3)(iii)(B)(1) and (2)), and (f) through
(m).
(3) Respirator selection. (i) Respirators must be selected from the
following table:
------------------------------------------------------------------------
Atmospheric concentration of
vinyl chloride Required apparatus
------------------------------------------------------------------------
(i) Unknown, or above 3,600 p/ Open-circuit, self-contained breathing
m. apparatus, pressure demand type, with
full facepiece.
(ii) Not over 3,600 p/m...... (A) Combination type C supplied air
respirator, pressure demand type, with
full or half facepiece, and auxiliary
self-contained air supply; or
(iii) Not over 1,000 p/m..... (B) Combination type, supplied air
respirator continuous flow type, with
full or half facepiece, and auxiliary
self-contained air supply. Type C,
supplied air respirator, continuous flow
type, with full or half facepiece,
helmet or hood.
(iv) Not over 100 p/m........ (A) Combination type C supplied air
respirator demand type, with full
facepiece, and auxiliary self-contained
air supply; or
(B) Open-circuit self-contained breathing
apparatus with full facepiece, in demand
mode; or
Type (C) supplied air respirator, demand
type, with full facepiece.
(v) Not over 25 p/m.......... (A) A powered air-purifying respirator
with hood, helmet, full or half
facepiece, and a canister which provides
a service life of at least 4 hours for
concentrations of vinyl chloride up to
25 p/m, or
(B) Gas mask, front- or back-mounted
canister which provides a service life
of at least 4 hours for concentrations
of vinyl chloride up to 25 p/m.
(vi) Not over 10 p/m......... (A) Combination type C supplied-air
respirator, demand type, with half
facepiece, and auxiliary self-contained
air supply; or
(B) Type C supplied-air respirator,
demand type, with half facepiece; or
(C) Any chemical cartridge respirator
with an organic vapor cartridge which
provides a service life of at least 1
hour for concentrations of vinyl
chloride up to 10 p/m.
------------------------------------------------------------------------
(ii) When air-purifying respirators are used:
(A) Air-purifying canisters or cartridges must be replaced prior to
the expiration of their service life or the end of the shift in which
they are first used, whichever occurs first.
(B) A continuous-monitoring and alarm system must be provided when
concentrations of vinyl chloride could reasonably exceed the allowable
concentrations for the devices in use. Such a system must be used to
alert employees when vinyl chloride concentrations exceed the allowable
concentrations for the devices in use.
(iii) Respirators specified for higher concentrations may be used
for lower concentrations.
* * * * *
18. Section 1910.1018 is amended by revising paragraph (h) to read
as follows:
Sec. 1910.1018 Inorganic arsenic.
* * * * *
(h) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
or work-practice controls.
(ii) Work operations, such as maintenance and repair activities,
for which the employer establishes that
[[Page 1287]]
engineering and work-practice controls are not feasible.
(iii) Work operations for which engineering and work-practice
controls are not yet sufficient to reduce employee exposures to or
below the permissible exposure limit.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) If an employee exhibits breathing difficulty during fit
testing or respirator use, they must be examined by a physician trained
in pulmonary medicine to determine whether they can use a respirator
while performing the required duty.
(3) Respirator selection. (i) The employer must use Table I of this
section to select the appropriate respirator or combination of
respirators for inorganic arsenic compounds without significant vapor
pressure, and Table II of this section to select the appropriate
respirator or combination of respirators for inorganic arsenic
compounds that have significant vapor pressure.
(ii) When employee exposures exceed the permissible exposure limit
for inorganic arsenic and also exceed the relevant limit for other
gases (for example, sulfur dioxide), an air-purifying respirator
provided to the employee as specified by this section must have a
combination high-efficiency filter with an appropriate gas sorbent.
(See footnote in Table 1 of this section.)
(iii) Employees required to use respirators may choose, and the
employer must provide, a powered air-purifying respirator if it will
provide proper protection. In addition, the employer must provide a
combination dust and acid-gas respirator to employees who are exposed
to gases over the relevant exposure limits.
Table I.--Respiratory Protection for Inorganic Arsenic Particulate
Except for Those With Significant Vapor Pressure
------------------------------------------------------------------------
Concentration of inorganic
arsenic (as As) or condition Required respirator
of use
------------------------------------------------------------------------
(i) Unknown or greater or (A) Any full facepiece self-contained
lesser than 20,000 g/m(3) (20 mg/m(3)) or pressure mode.
firefighting.
(ii) Not greater than 20,000 (A) Supplied air respirator with full
g/m(3) (20 mg/m(3)). facepiece, hood, or helmet or suit and
operated in positive pressure mode.
(iii) Not greater than 10,000 (A) Powered air-purifying respirators in
g/m(3) (10 mg/m(3)). all inlet face coverings with high
efficiency filters \1\.
(B)Half-mask supplied air respirators
operated in positive pressure mode.
(iv) Not greater than 500 (A) Full facepiece air-purifying
g/m(3). respirator equipped with high-efficiency
filter \1\.
(B) Any full facepiece supplied air
respirator.
(C) Any full facepiece self-contained
breathing apparatus.
(v) Not greater than 100 (A) Half-mask air-purifying respirator
g/m(3). equipped with high-efficiency filter
\1\.
(B) Any half-mask supplied air
respirator.
------------------------------------------------------------------------
\1\ High-efficiency filter-99.97 pct efficiency against 0.3 micrometer
monodisperse diethyl-hexyl phthalate (DOP) particles.
Table II.--Respiratory Protection for Inorganic Arsenicals (Such as
Arsenic Trichloride \2\ and Arsenic Phosphide) With Significant Vapor
Pressure
------------------------------------------------------------------------
Concentration of inorganic
arsenic (as As) or condition Required respirator
of use
------------------------------------------------------------------------
(i) Unknown or greater or (A) Any full facepiece self-contained
lesser than 20,000 g/m(3) (20 mg/m(3)) or pressure mode.
firefighting.
(ii) Not greater than 20,000 (A) Supplied air respirator with full
g/m(3) (20 mg/m(3)). facepiece, hood, or helmet or suit and
operated in positive pressure mode.
(iii) Not greater than 10,000 (A) Half-mask \2\ supplied air respirator
g/m(3) (10 mg/m(3)). operated in positive pressure mode.
(iv) Not greater than 500 (A) Front or back mounted gas mask
g/m(3). equipped with high-efficiency filter \1\
and acid gas canister.
(B) Any full facepiece supplied air
respirator.
(C) Any full facepiece self-contained
breathing apparatus.
(v) Not greater than 100 (A) Half-mask air-purifying respirator
g/m(3). equipped with high efficiency filter \1\
and acid gas cartridge.
(B) Any half-mask supplied air
respirator.
------------------------------------------------------------------------
\1\ High-efficiency filter-99.97 pct efficiency against 0.3 micrometer
monodisperse diethyl-hexyl phthalate (DOP) particles.
\2\ Half-mask respirators shall not be used for protection against
arsenic trichloride, as it is rapidly absorbed through the skin.
* * * * *
19. Section 1910.1025 is amended by revising paragraph (f);
revising the second and fourth paragraphs of Section IV to Appendix B;
removing the sixth paragraph of Section IV to Appendix B; and removing
Appendix D, as follows:
Sec. 1910.1025 Lead.
* * * * *
(f) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement engineering or work-
practice controls, except that no employer can require an employee to
use a respirator longer than 4.4 hours per day.
(ii) Work operations for which engineering and work-practice
controls are not sufficient to reduce employee exposures to or below
the permissible exposure limit.
(iii) Periods when an employee requests a respirator.
[[Page 1288]]
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) If an employee has breathing difficulty during fit testing or
respirator use, the employer must provide the employee with a medical
examination in accordance with paragraph (j)(3)(i)(C) of this section
to determine whether or not the employee can use a respirator while
performing the required duty.
Table II.--Respiratory Protection for Lead Aerosols
------------------------------------------------------------------------
Airborne concentration of
lead or condition of use Required respirator
------------------------------------------------------------------------
Not in excess of 0.5 mg/m\3\ Half-mask, air-purifying respirator
(10X PEL). equipped with high efficiency
filters.\2\ \3\
Not in excess of 2.5 mg/m\3\ Full facepiece, air-purifying respirator
(50X PEL). with high efficiency filters.\3\
Not in excess of 50 mg/m\3\ (1) Any powered, air-purifying respirator
(1000X PEL). with high efficiency filters\3\; or (2)
Half-mask supplied-air respirator
operated in positive-pressure mode.\2\
Not in excess of 100 mg/m\3\ Supplied-air respirators with full
(2000XPEL). facepiece, hood, helmet, or suit,
operated in positive pressure mode.
Greater than 100 mg/m\3\, Full facepiece, self-contained breathing
unknown concentration or apparatus operated in positive-pressure
fire fighting. mode.
------------------------------------------------------------------------
\1\ Respirators specified for high concentrations can be used at lower
concentrations of lead.
\2\ Full facepiece is required if the lead aerosols cause eye or skin
irritation at the use concentrations.
\3\ A high efficiency particulate filter means 99.97 percent efficient
against 0.3 micron size particles.
(3) Respirator selection. (i) The employer must select the
appropriate respirator or combination of respirators from Table II of
this section.
(ii) The employer must provide a powered air-purifying respirator
instead of the respirator specified in Table II of this section when an
employee chooses to use this type of respirator and such a respirator
provides adequate protection to the employee.
* * * * *
Appendix B to Sec. 1910.1025--Employee Standard Summary
* * * * *
IV. Respiratory Protection--Paragraph (f)
* * * * *
Your employer is required to select respirators from the seven
types listed in Table II of the Respiratory Protection section of
the standard (Sec. 1910.1025(f)). Any respirator chosen must be
approved by the National Institute for Occupational Safety and
Health (NIOSH) under the provisions of 42 CFR part 84. This
respirator selection table will enable your employer to choose a
type of respirator that will give you a proper amount of protection
based on your airborne lead exposure. Your employer may select a
type of respirator that provides greater protection than that
required by the standard; that is, one recommended for a higher
concentration of lead than is present in your workplace. For
example, a powered air-purifying respirator (PAPR) is much more
protective than a typical negative pressure respirator, and may also
be more comfortable to wear. A PAPR has a filter, cartridge, or
canister to clean the air, and a power source that continuously
blows filtered air into your breathing zone. Your employer might
make a PAPR available to you to ease the burden of having to wear a
respirator for long periods of time. The standard provides that you
can obtain a PAPR upon request.
* * * * *
Your employer must ensure that your respirator facepiece fits
properly. Proper fit of a respirator facepiece is critical to your
protection from airborne lead. Obtaining a proper fit on each
employee may require your employer to make available several
different types of respirator masks. To ensure that your respirator
fits properly and that facepiece leakage is minimal, your employer
must give you either a qualitative or quantitative fit test as
specified in Appendix A of the Respiratory Protection standard
located at 29 CFR 1910.134.
* * * * *
20. Section 1910.1027 is amended by removing and reserving Appendix
C and revising paragraph (g) to read as follows:
Sec. 1910.1027 Cadmium.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls when employee exposure levels exceed the
PEL.
(ii) Maintenance and repair activities, and brief or intermittent
operations, for which employee exposures exceed the PEL and engineering
and work-practice controls are not feasible or are not required.
(iii) Activities in regulated areas specified in paragraph (e) of
this section.
(iv) Work operations for which the employer has implemented all
feasible engineering and work-practice controls and such controls are
not sufficient to reduce employee exposures to or below the PEL.
(v) Work operations for which an employee is exposed to cadmium at
or above the action level, and the employee requests a respirator.
(vi) Work operations for which an employee is exposed to cadmium
above the PEL and engineering controls are not required by paragraph
(f)(1)(ii) of this section.
(vii) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) No employees must use a respirator if, based on their most
recent medical examination, the examining physician determines that
they will be unable to continue to function normally while using a
respirator. If the physician determines that the employee must be
limited in, or removed from, their current job because of their
inability to use a respirator, the limitation or removal must be in
accordance with paragraphs (l) (11) and (12) of this section.
(iii) If an employee has breathing difficulty during fit testing or
respirator use, the employer must provide the employee with a medical
examination in accordance with paragraph (l)(6)(ii) of this section to
determine if the employee can use a respirator while performing the
required duties.
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table 2 of this section.
[[Page 1289]]
Table 2.--Respiratory Protection for Cadmium
------------------------------------------------------------------------
Airborne concentration or
condition of use a Required respirator type b
------------------------------------------------------------------------
10 X or less................. A half mask, air-purifying equipped with
a HEPA c filter.d
25 X or less................. A powered air-purifying respirator
(``PAPR'') with a loose-fitting hood or
helmet equipped with a HEPA filter, or a
supplied-air respirator with a loose-
fitting hood or helmet facepiece
operated in the continuous flow mode.
50 X or less................. A full facepiece air-purifying respirator
equipped with a HEPA filter, or a
powered air-purifying respirator with a
tight-fitting half mask equipped with a
HEPA filter, or a supplied-air
respirator with a tight-fitting half
mask operated in the continuous flow
mode.
250 X or less................ A powered air-purifying respirator with a
tight fitting full facepiece equipped
with a HEPA filter, or a supplied-air
respirator with a tight-fitting full
facepiece operated in the continuous
flow mode.
1000 X or less............... A supplied air respirator with half mask
or full facepiece operated in the
pressure demand or other positive
pressure mode.
>1000 X or unknown A self-contained breathing apparatus with
concentrations. a full facepiece operated in the
pressure demand or other positive
pressure mode, or a supplied-air
respirator with a full facepiece
operated in the pressure demand or other
positive pressure mode and equipped with
an auxiliary escape type self-contained
breathing apparatus operated in the
pressure demand mode.
Fire fighting................ A self-contained breathing apparatus with
full facepiece operated in the pressure
demand or other positive pressure mode.
------------------------------------------------------------------------
a Concentrations expressed as multiple of the PEL.
b Respirators assigned for higher environmental concentrations may be
used at lower exposure levels. Quantitative fit testing is required
for all tight-fitting air purifying respirators where airborne
concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3)
= 50 ug/m(3)). A full facepiece respirator is required when eye
irritation is experienced.
c HEPA means High-efficiency Particulate Air.
d Fit testing, qualitative or quantitative, is required.
SOURCE: Respiratory Decision Logic, NIOSH, 1987.
(ii) The employer must provide an employee with a powered air-
purifying respirator instead of a negative-pressure respirator when an
employee who is entitled to a respirator chooses to use this type of
respirator and such a respirator provides adequate protection to the
employee.
* * * * *
21. Section 1910.1028 is amended by removing Appendix E and
revising paragraph (g) to read as follows:
Sec. 1910.1028 Benzene.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations for which the employer establishes that
compliance with either the TWA or STEL through the use of engineering
and work-practice controls is not feasible; for example, some
maintenance and repair activities, vessel cleaning, or other operations
for which engineering and work-practice controls are infeasible because
exposures are intermittent and limited in duration.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient, or are not required under
paragraph (f)(1)(iii) of this section, to reduce employee exposure to
or below the PELs.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f)
through (m).
(ii) For air-purifying respirators, the employer must replace the
air-purifying element at the expiration of its service life or at the
beginning of each shift in which such elements are used, whichever
comes first.
(iii) If NIOSH approves an air-purifying element with an end-of-
service-life indicator for benzene, such an element may be used until
the indicator shows no further useful life.
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table 1 of this section.
(ii) Any employee who cannot use a negative-pressure respirator
must be allowed to use a respirator with less breathing resistance,
such as a powered air-purifying respirator or supplied-air respirator.
Table 1.--Respiratory Protection for Benzene
------------------------------------------------------------------------
Airborne concentration of
benzene or condition of use Respirator type
------------------------------------------------------------------------
(a) Less than or equal to 10 (1) Half-mask air-purifying respirator
ppm. with organic vapor cartridge.
(b) Less than or equal to 50 (1) Full facepiece respirator with
ppm. organic vapor cartridges.
(1) Full facepiece gas mask with chin
style canister.1
(c) Less than or equal to 100 (1) Full facepiece powered air-purifying
ppm. respirator with organic vapor canister.1
(d) Less than or equal to (1) Supplied air respirator with full
1,000 ppm. facepiece in positive-pressure mode.
(e) Greater than 1,000 ppm or (1) Self-contained breathing apparatus
unknown concentration. with full facepiece in positive pressure
mode.
(2) Full facepiece positive-pressure
supplied-air respirator with auxiliary
self-contained air supply.
(f) Escape................... (1) Any organic vapor gas mask; or
(2) Any self-contained breathing
apparatus with full facepiece.
[[Page 1290]]
(g) Firefighting............. (1) Full facepiece self-contained
breathing apparatus in positive pressure
mode.
------------------------------------------------------------------------
\1\ Canisters must have a minimum service life of four (4) hours when
tested at 150 ppm benzene, at a flow rate of 64 LPM, 25 deg. C, and
85% relative humidity for non-powered air purifying respirators. The
flow rate shall be 115 LPM and 170 LPM respectively for tight fitting
and loose fitting powered air-purifying respirators.
* * * * *
22. Section 1910.1029 is amended by revising paragraph (g) to read
as follows:
Sec. 1910.1029 Coke oven emissions.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Compliance with the permissible exposure limit may not be achieved by
the use of respirators except during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activity, for
which engineering and work-practice controls are technologically not
feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the permissible exposure limit.
(iv) Emergencies.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii)), and (f) through (m).
(3) Respirator selection. The employer must select appropriate
respirators or combination of respirators from Table I of this section.
TABLE I.--Respiratory Protection for Coke Oven Emissions
------------------------------------------------------------------------
Airborne concentration of
coke oven emissions Required respirator
------------------------------------------------------------------------
(a) Any concentration........ (1) A Type C supplied air respirator
operated in pressure demand or other
positive pressure or continuous flow
mode; or
(2) A powered air-purifying particulate
filter respirator for dust and mist or
(3) A powered air-purifying particulate
filter respirator or combination
chemical cartridge and particulate
filter respirator for coke oven
emissions.
(b) Concentrations not (1) Any particulate filter respirator for
greater than 1500 ug/m \3\. dust and mist except single-use
respirator; or
(2) Any particulate filter respirator or
combination chemical cartridge and
particulate filter respirator for coke
oven emissions; or
(3) Any respirator listed in paragraph
(g)(3)(a) of this section.
------------------------------------------------------------------------
* * * * *
23. Section 1910.1043 is amended by revising paragraph (f) to read
as follows:
Sec. 1910.1043 Cotton dust.
* * * * *
(f) Respiratory protection. (1) General. For employees who are
required to use respirators by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Maintenance and repair activities for which engineering and
work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the permissible exposure limits.
(iv) Work operations specified under paragraph (g)(1) of this
section.
(v) Periods for which an employee requests a respirator.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) Whenever a physician determines that an employee who works in
an area in which the cotton-dust concentration exceeds the PEL is
unable to use a respirator, including a powered air-purifying
respirator, the employee must be given the opportunity to transfer to
an available position, or to a position that becomes available later,
that has a cotton-dust concentration at or below the PEL. The employer
must ensure that such employees retain their current wage rate or other
benefits as a result of the transfer.
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table I of this section.
Table I
------------------------------------------------------------------------
Cotton dust concentration Required respirator
------------------------------------------------------------------------
Not greater than:
(a) 5 x the applicable A disposable respirator with a
permissible exposure particulate filter.
limit (PEL).
(b) 10 x the applicable A quarter or half-mask respirator, other
PEL. than a disposable respirator, equipped
with particulate filters.
(c) 100 x the A full facepiece respirator equipped with
applicable PEL. high-efficiency particulate filters.
(d) Greater than 100 x A powered air-purifying respirator
the applicable PEL. equipped with high-efficiency
particulate filters.
------------------------------------------------------------------------
Notes:
1. A disposable respirator means the filter element is an inseparable
part of the respirator.
2. Any respirators permitted at higher environmental concentrations can
be used at lower concentrations.
[[Page 1291]]
3. Self-contained breathing apparatus are not required respirators but
are permitted respirators.
4. Supplied air respirators are not required but are permitted under
the following conditions: Cotton dust concentration not greater than
10X the PEL--Any supplied air respirator; not greater than 100X the
PEL--Any supplied air respirator with full facepiece, helmet or hood;
greater than 100X the PEL--A supplied air respirator operated in
positive pressure mode.
(ii) Whenever respirators are required by this section for cotton-
dust concentrations that do not exceed the applicable permissible
exposure limit by a multiple of 100 (100 X), the employer must, when
requested by an employee, provide a powered air-purifying respirator
with a high-efficiency particulate filter instead of the respirator
specified in paragraphs (a), (b), or (c) of Table I of this section.
* * * * *
24. Section 1910.1044 is amended by revising paragraph (h) to read
as follows:
Sec. 1910.1044 1,2-Dibromo-3-chloropropane.
* * * * *
(h) Respiratory protection. (1) General. For employees who are
required to use respirators by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Maintenance and repair activities for which engineering and
work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the permissible exposure limit.
(iv) Emergencies.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii)), and (f) through (m).
(3) Respirator selection. The employer must select the appropriate
respirator from Table 1 of this section.
Table 1.--Respiratory Protection for DBCP
------------------------------------------------------------------------
Airborne concentration of
DBCP or condition of use Respirator type
------------------------------------------------------------------------
(a) Less than or equal to 10 (1) Any supplied-air respirator; or (2)
ppb. any self-contained breathing apparatus.
(b) Less than or equal to 50 (1) Any supplied-air respirator with full
ppb. facepiece, helmet, or hood; or (2) any
self-contained breathing apparatus with
full facepiece.
(c) Less than or equal to (1) A Type C supplied-air respirator
1,000 ppb. operated in pressure-demand or other
positive pressure or continuous flow
mode.
(d) Less than or equal to (1) A Type C supplied-air respirator with
2,000 ppb. full facepiece operated in pressure-
demand or other positive pressure mode,
or with full facepiece, helmet, or hood
operated in continuous flow mode.
(e) Greater than 2,000 ppb or (1) A combination respirator which
entry and escape from includes a Type C supplied-air
unknown concentrations. respirator with full facepiece operated
in pressure-demand or other positive
pressure or continuous flow mode and an
auxiliary self-contained breathing
apparatus operated in pressure-demand or
positive pressure mode; or (2) a self-
contained breathing apparatus with full
facepiece operated in pressure-demand or
other positive pressure mode.
(f) Firefighting............. (1) A self-contained breathing apparatus
with full facepiece operated in pressure-
demand or other positive pressure mode.
------------------------------------------------------------------------
* * * * *
25. Section 1910.1045 is amended by revising paragraph (h) and the
first paragraph of Section IV to Appendix A to read as follows:
Sec. 1910.1045 Acrylonitrile.
* * * * *
(h) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activities or
reactor cleaning, for which the employer establishes that engineering
and work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the permissible exposure limits.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f)
through (m).
(ii) If air-purifying respirators (chemical-cartridge or chemical-
canister types) are used:
(A) The air-purifying canister or cartridge must be replaced prior
to the expiration of its service life or at the completion of each
shift, whichever occurs first.
(B) A label must be attached to the cartridge or canister to
indicate the date and time at which it is first installed on the
respirator.
(3) Respirator selection. The employer must select the appropriate
respirator from Table I of this section.
Table I.--Respiratory Protection for Acrylonitrile (AN)
------------------------------------------------------------------------
Concentration of AN or
condition of use Respirator type
------------------------------------------------------------------------
(a) Less than or equal to 20 (1) Chemical cartridge respirator with
ppm. organic vapor cartridge(s) and half-mask
facepiece; or
(2) Supplied air respirator with half-
mask facepiece.
(b) Less than or equal to 100 (1) Full facepiece respirator with (A)
ppm or maximum use organic vapor cartridges, (B) organic
concentration (MUC) of vapor gas mask chin-style, or (C)
cartridges or canisters, organic vapor gas mask canister, front-
whichever is lower. or back-mounted;
[[Page 1292]]
(2) Supplied air respirator with full
facepiece; or
(3) Self-contained breathing apparatus
with full facepiece.
(c) Less than or equal to (1) Supplied air respirator operated in
4,000 ppm. the positive pressure mode with full
facepiece, helmet, suit, or hood.
(d) Greater than 4,000 ppm or (1) Supplied air and auxiliary self-
unknown concentration. contained breathing apparatus with full
facepiece in positive pressure mode; or
(2) Self-contained breathing apparatus
with full facepiece in positive pressure
mode.
(e) Firefighting............. Self-contained breathing apparatus with
full facepiece in positive pressure
mode.
(f) Escape................... (1) Any organic vapor respirator, or
(2) Any self-contained breathing
apparatus.
------------------------------------------------------------------------
* * * * *
Appendix A to Sec. 1910.1045--Substance Safety Data Sheet for
Acrylonitrile
* * * * *
IV. Respirators and Protective Clothing
A. Respirators. You may be required to wear a respirator for
nonroutine activities, in emergencies, while your employer is in the
process of reducing acrylonitrile exposures through engineering
controls, and in areas where engineering controls are not feasible.
If respirators are worn, they must have a label issued by the
National Institute for Occupational Safety and Health under the
provisions of 42 CFR part 84 stating that the respirators have been
approved for use with organic vapors. For effective protection,
respirators must fit your face and head snugly. Respirators must not
be loosened or removed in work situations where their use is
required.
* * * * *
26. Section 1910.1047 is amended by removing table 1 following
paragraph (h)(2) and revising paragraph (g) and the first paragraph of
Section IV to Appendix A to read as follows:
Sec. 1910.1047 Ethylene oxide.
* * * * *
(g) Respiratory protection and personal protective equipment. (1)
General. For employees who use respirators required by this section,
the employer must provide respirators that comply with the requirements
of this paragraph. Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activities and
vessel cleaning, for which engineering and work-practice controls are
not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the TWA.
(iv) Emergencies.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii)), and (f) through (m).
(3) Respirator selection. The employer must select the appropriate
respirator from Table 1 of this section.
Table 1.--Minimum Requirements for Respiratory Protection for Airborne
EtO
------------------------------------------------------------------------
Condition of use or
concentration of airborne EtO Minimum required respirator
(ppm)
------------------------------------------------------------------------
Equal to or less than 50..... (a) Full facepiece respirator with EtO
approved canister, front-or back-
mounted.
Equal to or less than 2,000.. (a) Positive-pressure supplied air
respirator, equipped with full
facepiece, hood, or helmet, or
(b) Continuous-flow supplied air
respirator (positive pressure) equipped
with hood, helmet or suit.
Concentration above 2,000 or (a) Positive-pressure self-contained
unknown concentration (such breathing apparatus (SCBA), equipped
as in emergencies). with full facepiece, or
(b) Positive-pressure full facepiece
supplied air respirator equipped with an
auxiliary positive-pressure self-
contained breathing apparatus.
Firefighting................. (a) Positive pressure self-contained
breathing apparatus equipped with full
facepiece.
Escape....................... (a) Any respirator described above.
------------------------------------------------------------------------
Note. Respirators approved for use in higher concentrations are
permitted to be used in lower concentrations.
(4) Protective clothing and equipment. When employees could have
eye or skin contact with EtO or EtO solutions, the employer must select
and provide, at no cost to the employee, appropriate protective
clothing or other equipment in accordance with 29 CFR 1910.132 and
1910.133 to protect any area of the employee's body that may come in
contact with the EtO or EtO solution, and must ensure that the employee
wears the protective clothing and equipment provided.
* * * * *
Appendix A to Sec. 1910.1047--Substance Safety Data Sheet for Ethylene
Oxide (Non-mandatory)
* * * * *
IV. Respirators and Protective Clothing
A. Respirators. You may be required to wear a respirator for
nonroutine activities, in emergencies, while your employer is in the
process of reducing EtO exposures through engineering controls, and
in areas where engineering controls are not feasible. As of the
effective date of this standard, only air-supplied, positive-
pressure, full-facepiece respirators are approved for protection
against EtO. If air-purifying respirators are worn in the future,
they must have a label issued by the National Institute for
Occupational Safety and Health under the provisions of 42 CFR part
84 stating that the respirators have been approved for use with
ethylene oxide. For effective protection, respirators must fit your
face and head snugly. Respirators must not be loosened or removed in
work situations where their use is required.
* * * * *
27. Section 1910.1048 is amended by removing Appendix E and
revising paragraph (g) to read as follows:
[[Page 1293]]
Sec. 1910.1048 Formaldehyde.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activities or
vessel cleaning, for which the employer establishes that engineering
and work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the PELs.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii), (d)(3)(iii)(b)(1), and (2)), and (f)
through (m).
(ii) If air-purifying chemical-cartridge respirators are used, the
employer must:
(A) Replace the cartridge after three (3) hours of use or at the
end of the workshift, whichever occurs first, unless the cartridge
contains a NIOSH-approved end-of-service-life indicator (ESLI) to show
when breakthrough occurs.
(B) Unless the canister contains a NIOSH-approved ESLI to show when
breakthrough occurs, replace canisters used in atmospheres up to 7.5
ppm (10xPEL) every four (4) hours and industrial-sized canisters used
in atmospheres up to 75 ppm (100xPEL) every two (2) hours, or at the
end of the workshift, whichever occurs first.
(3) Respirator selection. (i) The employer must select appropriate
respirators from Table 1 in this section.
Table 1.--Minimum Requirements for Respiratory Protection Against
Formaldehyde
------------------------------------------------------------------------
Condition of use or
formaldehyde concentration Minimum respirator required \1\
(ppm)
------------------------------------------------------------------------
Up to 7.5 ppm. (10 x PEL).... Full facepiece with cartridges or
canisters specifically approved for
protection against formaldehyde.\2\
Up to 75 ppm. (100 x PEL).... Full-face mask with chin style or chest
or back mounted type, with industrial
size canister specifically approved for
protection against formaldehyde. Type C
supplied air respirator, demand type, or
continuous flow type, with full
facepiece, hood, or helmet.
Above 75 ppm or unknown. Self-contained breathing apparatus (SCBA)
(emergencies). (100 x PEL). with positive pressure full facepiece.
Combination supplied-air, full facepiece
positive pressure respirator with
auxiliary self-contained air supply.
Firefighting................. SCBA with positive pressure in full face-
piece.
Escape....................... SCBA in demand or pressure demand mode.
Full-face mask with chin style or front
or back mounted type industrial size
canister specifically approved for
protection against formaldehyde.
------------------------------------------------------------------------
\1\ Respirators specified for use at higher concentrations may be used
at lower concentrations.
\2\ A half-mask respirator with cartridges specifically approved for
protection against formaldehyde can be substituted for the full
facepiece respirator providing that effective gas-proof goggles are
provided and used in combination with the half-mask respirator.
(ii) The employer must provide a powered air-purifying respirator
adequate to protect against formaldehyde exposure to any employee who
has difficulty using a negative-pressure respirator.
* * * * *
28. Section 1910.1050 is amended by revising paragraph (h) and the
first paragraph of Section III to Appendix A to read as follows:
Sec. 1910.1050 Methylenedianiline.
* * * * *
(h) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations for which the employer establishes that
engineering and work-practice controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the PEL.
(iv) Emergencies.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii)), and (f) through (m).
(3) Respirator selection. (i) The employer must select, and ensure
that employees use, the appropriate respirator from Table 1 in this
section.
Table 1.--Respiratory Protection for MDA
------------------------------------------------------------------------
Airborne concentration of MDA
or condition of use Respirator type
------------------------------------------------------------------------
a. Less than or equal to 10 (1) Half-Mask Respirator with HEPA \1\
x PEL. Cartridge.\2\
b. Less than or equal to 50 (1) Full facepiece Respirator with HEPA
x PEL. \1\ Cartridge or Canister.\2\
c. Less than or equal to 1000 (1) Full facepiece powered air-purifying
x PEL. respirator with HEPA \1\ cartridges.\2\
d. Greater than 1000 x PEL (1) Self-contained breathing apparatus
or unknown concentrations. with full facepiece in positive pressure
mode.
(2) Full facepiece positive pressure
demand supplied-air respirator with
auxiliary self-contained air supply.
e. Escape.................... (1) Any full facepiece air-purifying
respirator with HEPA \1\ cartridges; \2\
(2) Any positive pressure or continuous
flow self-contained breathing apparatus
with full facepiece or hood.
f. Firefighting.............. (1) Full facepiece self-contained
breathing apparatus in positive pressure
demand mode.
------------------------------------------------------------------------
Note: Respirators assigned for higher environmental concentrations may
be used at lower concentrations.
[[Page 1294]]
\1\ High Efficiency Particulate in Air filter (HEPA) means a filter that
is at least 99.97 percent efficient against mono-dispersed particles
of 0.3 micrometers or larger.
\2\ Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA
in liquid form or a process requiring heat is used.
(ii) Any employee who cannot use a negative-pressure respirator
must be given the option of using a positive-pressure respirator, or a
supplied-air respirator operated in the continuous-flow or pressure-
demand mode.
* * * * *
Appendix A to Sec. 1910.1050--Substance Safety Data Sheet for 4,4'-
Methylenedianiline
* * * * *
III. Protective Clothing and Equipment
A. Respirators. Respirators are required for those operations in
which engineering controls or work-practice controls are not
adequate or feasible to reduce exposure to the permissible limit. If
respirators are worn, they must have a label issued by the National
Institute for Occupational Safety and Health under the provisions of
42 CFR part 84 stating that the respirators have been approved for
this purpose, and cartridges and canisters must be replaced in
accordance with the requirements of 29 CFR 1910.134. If you
experience difficulty breathing while wearing a respirator, you can
request a positive-pressure respirator from your employer. You must
be thoroughly trained to use the assigned respirator, and the
training must be provided by your employer.
* * * * *
29. Section 1910.1051 is amended by removing and reserving Appendix
E and revising paragraph (h) to read as follows:
Sec. 1910.1051 1,3-Butadiene.
* * * * *
(h) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Non-routine work operations that are performed infrequently
and for which employee exposures are limited in duration.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposures
to or below the PELs.
(iv) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii), (d)(3)(iii)(B)(1), and (2)), and (f)
through (m).
(ii) If air-purifying respirators are used, the employer must
replace the air-purifying filter elements according to the replacement
schedule set for the class of respirators listed in Table 1 of this
section, and at the beginning of each work shift.
(iii) Instead of using the replacement schedule listed in Table 1
of this section, the employer may replace cartridges or canisters at
90% of their expiration service life, provided the employer:
(A) Demonstrates that employees will be adequately protected by
this procedure.
(B) Uses BD breakthrough data for this purpose that have been
derived from tests conducted under worst-case conditions of humidity,
temperature, and air-flow rate through the filter element, and the
employer also describes the data supporting the cartridge-or canister-
change schedule, as well as the basis for using the data in the
employer's respirator program.
(iv) A label must be attached to each filter element to indicate
the date and time it is first installed on the respirator.
(v) If NIOSH approves an end-of-service-life indicator (ESLI) for
an air-purifying filter element, the element may be used until the ESLI
shows no further useful service life or until the element is replaced
at the beginning of the next work shift, whichever occurs first.
(vi) Regardless of the air-purifying element used, if an employee
detects the odor of BD, the employer must replace the air-purifying
element immediately.
(3) Respirator selection. (i) The employer must select appropriate
respirators from Table 1 of this section.
Table 1.--Minimum Requirements for Respiratory Protection for Airborne
BD
------------------------------------------------------------------------
Concentration of airborne BD
(ppm) or condition of use Minimum required respirator
------------------------------------------------------------------------
Less than or equal to 5 ppm (a) Air-purifying half mask or full
(5 times PEL). facepiece respirator equipped with
approved BD or organic vapor cartridges
or canisters. Cartridges or canisters
shall be replaced every 4 hours.
Less than or equal to 10 ppm (a) Air-purifying half mask or full
(10 times PEL). facepiece respirator equipped with
approved BD or organic vapor cartridges
or canisters. Cartridges or canisters
shall be replaced every 3 hours.
Less than or equal to 25 ppm (a) Air-purifying full facepiece
(25 times PEL). respirator equipped with approved BD or
organic vapor cartridges or canisters.
Cartridges or canisters shall be
replaced every 2 hours.
(b) Any powered air-purifying respirator
equipped with approved BD or organic
vapor cartridges. PAPR cartridges shall
be replaced every 2 hours.
(c) Continuous flow supplied air
respirator equipped with a hood or
helmet.
Less than or equal to 50 ppm (a) Air-purifying full facepiece
(50 times PEL). respirator equipped with approved BD or
organic vapor cartridges or canisters.
Cartridges or canisters shall be
replaced every (1) hour.
(b) Powered air-purifying respirator
equipped with a tight-fitting facepiece
and an approved BD or organic vapor
cartridges. PAPR cartridges shall be
replaced every (1) hour.
Less than or equal to 1,000 (a) Supplied air respirator equipped with
ppm (1,000 times PEL). a half mask of full facepiece and
operated in a pressure demand or other
positive pressure mode.
Greater than 1000 ppm unknown (a) Self-contained breathing apparatus
concentration, or equipped with a full facepiece and
firefighting. operated in a pressure demand or other
positive pressure mode.
(b) Any supplied air respirator equipped
with a full facepiece and operated in a
pressure demand or other positive
pressure mode in combination with an
auxiliary self-contained breathing
apparatus operated in a pressure demand
or other positive pressure mode.
Escape from IDLH conditions.. (a) Any positive pressure self-contained
breathing apparatus with an appropriate
service life.
[[Page 1295]]
(b) A air-purifying full facepiece
respirator equipped with a front or back
mounted BD or organic vapor canister.
------------------------------------------------------------------------
Notes: Respirators approved for use in higher concentrations are
permitted to be used in lower concentrations. Full facepiece is
required when eye irritation is anticipated.
(ii) Air-purifying respirators must have filter elements approved
by NIOSH for organic vapors or BD.
(iii) When an employee whose job requires the use of a respirator
cannot use a negative-pressure respirator, the employer must provide
the employee with a respirator that has less breathing resistance than
the negative-pressure respirator, such as a powered air-purifying
respirator or supplied-air respirator, when the employee is able to use
it and if it provides the employee adequate protection.
* * * * *
30. Section 1910.1052 is amended by revising paragraph (g) to read
as follows:
Sec. 1910.1052 Methylene chloride.
* * * * *
(g) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods when an employee's exposure to MC exceeds the 8-hour
TWA, PEL, or STEL (for example, when an employee is using MC in a
regulated area).
(ii) Periods necessary to install or implement feasible engineering
and work-practice controls.
(iii) A few work operations, such as some maintenance operations
and repair activities, for which the employer demonstrates that
engineering and work-practice controls are infeasible.
(iv) Work operations for which feasible engineering and work-
practice controls are not sufficient to reduce employee exposures to or
below the PELs.
(v) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (m) (except (d)(1)(iii)).
(ii) Employers who provide employees with gas masks with organic-
vapor canisters for the purpose of emergency escape must replace the
canisters after any emergency use and before the gas masks are returned
to service.
(3) Respirator selection. The employer must select appropriate
atmosphere-supplying respirators from Table 2 of this section.
Table 2.--Minimum Requirements for Respiratory Protection for Airborne
Methylene Chloride
------------------------------------------------------------------------
Methylene chloride airborne
concentration (ppm) or Minimum respirator required \1\
condition of use
------------------------------------------------------------------------
Up to 625 ppm (25 X PEL)..... (1) Continuous flow supplied-air
respirator, hood or helmet.
Up to 1250 ppm (50 X 8-TWA (1) Full facepiece supplied-air
PEL). respirator operated in negative pressure
(demand) mode.
(2) Full facepiece self-contained
breathing apparatus (SCBA) operated in
negative pressure (demand) mode.
Up to 5000 ppm (200 X 8-TWA (1) Continuous flow supplied-air
PEL). respirator, full facepiece.
(2) Pressure demand supplied-air
respirator, full facepiece.
(3) Positive pressure full facepiece
SCBA.
Unknown concentration, or (1) Positive pressure full facepiece
above 5000 ppm (Greater than SCBA.
200 X 8-TWA PEL).
(2) Full facepiece pressure demand
supplied-air respirator with an
auxiliary self-contained air supply.
Fire fighting................ Positive pressure full facepiece SCBA.
Emergency escape............. (1) Any continuous flow or pressure
demand SCBA.
(2) Gas mask with organic vapor canister.
------------------------------------------------------------------------
\1\ Respirators assigned for higher airborne concentrations may be used
at lower concentrations.
(4) Medical evaluation. Before having an employee use a supplied-
air respirator in the negative-pressure mode, or a gas mask with an
organic-vapor canister for emergency escape, the employer must:
(i) Have a physician or other licensed health-care professional
(PLHCP) evaluate the employee's ability to use such respiratory
protection.
(ii) Ensure that the PLHCP provides their findings in a written
opinion to the employee and the employer.
* * * * *
PART 1926--[AMENDED]
Subpart D--[Amended]
31. The authority citation for Subpart D of Part 1926 is revised to
read as follows:
Authority: Sec. 107, Contract Work Hours and Safety Standards
Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8 of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655,
657); Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111),
as applicable; and 29 CFR Part 11.
Secs. 1926.58, 1926.59, 1926.60, and 1926.65 of 29 CFR, also
issued under 5 U.S.C. 553, and 29 CFR Part 1911.
Sec. 1926.62 of 29 CFR, also issued under sec. 1031 of the
Housing and Community Development Act of 1992 (42 U.S.C. 4853).
Sec. 1926.65 of 29 CFR, also issued under sec. 126 of the
Superfund Amendments and Reauthorization Act of 1986, as amended (29
U.S.C. 655 note), and 5 U.S.C. 553.
32. Section 1926.57 is amended by revising paragraphs (f)(1)(ii),
(f)(5)(i) and (iii), (f)(6), (h)(6)(iii)(A), and (i)(9)(vi) to read as
follows:
Sec. 1926.57 Ventilation.
* * * * *
[[Page 1296]]
(f) * * *
(1) * * *
(ii) Abrasive-blasting respirator. A respirator constructed so that
it covers the wearer's head, neck, and shoulders to protect the wearer
from rebounding abrasive.
* * * * *
(5) Personal protective equipment. (i) Employers must use only
respirators approved by NIOSH under 42 CFR part 84 for protecting
employees from dusts produced during abrasive-blasting operations.
* * * * *
(iii) Properly fitted particulate-filter respirators, commonly
referred to as dust-filter respirators, may be used for short,
intermittent, or occasional dust exposures such as cleanup, dumping of
dust collectors, or unloading shipments of sand at a receiving point
when it is not feasible to control the dust by enclosure, exhaust
ventilation, or other means. The respirators used must be approved by
NIOSH under 42 CFR part 84 for protection against the specific type of
dust encountered.
* * * * *
(6) Air supply and air compressors. Air for abrasive-blasting
respirators must be free of harmful quantities of dusts, mists, or
noxious gases, and must meet the requirements for supplied-air quality
and use specified in 29 CFR 1910.134(i).
* * * * *
(h) * * *
(6) * * *
(iii)(A) When an operator is in a booth downstream of the object
being sprayed, an air-supplied respirator or other type of respirator
approved by NIOSH under 42 CFR Part 84 for the material being sprayed
should be used by the operator.
* * * * *
(i) * * *
(9) * * *
(vi) When, during the emergencies specified in paragraph (i)(11)(v)
of this section, employees must be in areas where concentrations of air
contaminants are greater than the limits set by paragraph (i)(2)(iii)
of this section or oxygen concentrations are less than 19.5 percent,
they must use respirators that reduce their exposure to a level below
these limits or that provide adequate oxygen. Such respirators must
also be provided in marked, quickly-accessible storage compartments
built for this purpose when the possibility exists of accidental
release of hazardous concentrations of air contaminants. Respirators
must be approved by NIOSH under 42 CFR part 84, selected by a competent
industrial hygienist or other technically-qualified source, and used in
accordance with 29 CFR 1926.103.
* * * * *
33. Section 1926.60 is amended by removing Appendix E and revising
paragraph (i) to read as follows:
Sec. 1926.60 Methylenedianiline.
* * * * *
(i) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls.
(ii) Work operations, such as maintenance and repair activities and
spray-application processes, for which engineering and work-practice
controls are not feasible.
(iii) Work operations for which feasible engineering and work-
practice controls are not yet sufficient to reduce employee exposure to
or below the PELs.
(iv) Emergencies.
(2) Respirator program. The employer must implement a respiratory
protection program in accordance with 29 CFR 1910.134 (b) through (d)
(except (d)(1)(iii), and (f) through (m).
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table 1 of this section.
Table 1.--Respiratory Protection for MDA
------------------------------------------------------------------------
Airborne concentration of MDA
or condition of use Respirator type
------------------------------------------------------------------------
a. Less than or equal to 10 (1) Half-Mask Respirator with HEPA\1\
x PEL. Cartridge.\2\
b. Less than or equal to 50 (1) Full facepiece Respirator with
x PEL. HEPA\1\ Cartridge or Canister.\2\
c. Less than or equal to 1000 (1) Full facepiece powered air-purifying
x PEL. respirator with HEPA\1\ cartridge.\2\
d. Greater than 1000 x PEL (1) Self-contained breathing apparatus
or unknown concentration. with full facepiece in positive pressure
mode.
(2) Full facepiece positive pressure
demand supplied-air respirator with
auxiliary self-contained air supply.
e. Escape.................... (1) Any full facepiece air-purifying
respirator with HEPA\1\ cartridges.\2\
(2) Any positive pressure or continuous
flow self-contained breathing apparatus
with full facepiece or hood.
f. Firefighting.............. (1) Full facepiece self-contained
breathing apparatus in positive pressure
demand mode.
------------------------------------------------------------------------
Note: Respirators assigned for higher environmental concentrations may
be used at lower concentrations.
\1\ High Efficiency Particulate in Air filter (HEPA) means a filter that
is at least 99.97 percent efficient against mono-dispersed particles
of 0.3 micrometers or larger.
\2\ Combination HEPA/Organic Vapor Cartridges shall be used whenever MDA
in liquid form or a process requiring heat is used.
(ii) An employee who cannot use a negative-pressure respirator must
be given the option of using a positive-pressure respirator, or a
supplied-air respirator operated in the continuous-flow or pressure-
demand mode.
* * * * *
34. Section 1926.62 is amended by revising paragraph (f); revising
the second and fourth paragraphs of Section IV to Appendix B; removing
the sixth paragraph of Section IV to Appendix B; and removing Appendix
D, as follows:
Sec. 1926.62 Lead.
* * * * *
(f) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods when an employee's exposure to lead exceeds the PEL.
(ii) Work operations for which engineering and work-practice
controls are not sufficient to reduce employee exposures to or below
the PEL.
(iii) Periods when an employee requests a respirator.
(iv) Periods when respirators are required to provide interim
protection of employees while they perform the
[[Page 1297]]
operations specified in paragraph (d)(2) of this section.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) If an employee has breathing difficulty during fit testing or
respirator use, the employer must provide the employee with a medical
examination in accordance with paragraph (j)(3)(i)(B) of this section
to determine whether or not the employee can use a respirator while
performing the required duty.
(3) Respirator selection. (i) The employer must select the
appropriate respirator or combination of respirators from Table I of
this section.
(ii) The employer must provide a powered air-purifying respirator
when an employee chooses to use such a respirator and it will provide
adequate protection to the employee.
Table 1.--Respiratory Protection for Lead Aerosols
------------------------------------------------------------------------
Airborne concentration of
lead or condition of use Required respirator 1
------------------------------------------------------------------------
Not in excess of 500 ug/m3... \1/2\ mask air purifying respirator with
high efficiency filters.2 3
\1/2\ mask supplied air respirator
operated in demand (negative pressure)
mode.
Not in excess of 1,250 ug/m3. Loose fitting hood or helmet powered air
purifying respirator with high
efficiency filters.3
Hood or helmet supplied air respirator
operated in a continuous-flow mode--
e.g., type CE abrasive blasting
respirators operated in a continuous-
flow mode.
Not in excess of 2,500 ug/m3. Full facepiece air purifying respirator
with high efficiency filters.3
Tight fitting powered air purifying
respirator with high efficiency
filters.3
Full facepiece supplied air respirator
operated in demand mode.
\1/2\ mask or full facepiece supplied air
respirator operated in a continuous-flow
mode.
Full facepiece self-contained breathing
apparatus (SCBA) operated in demand
mode.
Not in excess of 50,000 ug/m3 \1/2\ mask supplied air respirator
operated in pressure demand or other
positive-pressure mode.
Not in excess of 100,000 ug/ Full facepiece supplied air respirator
m3. operated in pressure demand or other
positive-pressure mode--e.g., type CE
abrasive blasting respirators operated
in a positive-pressure mode.
Greater than 100,000 ug/m3 Full facepiece SCBA operated in pressure
unknown concentration, or demand or other positive-pressure mode.
fire fighting.
------------------------------------------------------------------------
\1\ Respirators specified for higher concentrations can be used at lower
concentrations of lead.
\2\ Full facepiece is required if the lead aerosols cause eye or skin
irritation at the use concentrations.
\3\ A high efficiency particulate filter (HEPA) means a filter that is a
99.97 percent efficient against particles of 0.3 micron size or
larger.
* * * * *
Appendix B to Sec. 1926.62--Employee Standard Summary
* * * * *
IV. Respiratory Protection--Paragraph (f)
* * * * *
Your employer is required to select respirators from the types
listed in Table I of the Respiratory Protection section of the standard
(Sec. 1926.62 (f)). Any respirator chosen must be approved by the
National Institute for Occupational Safety and Health (NIOSH) under the
provisions of 42 CFR part 84. This respirator selection table will
enable your employer to choose a type of respirator that will give you
a proper amount of protection based on your airborne lead exposure.
Your employer may select a type of respirator that provides greater
protection than that required by the standard; that is, one recommended
for a higher concentration of lead than is present in your workplace.
For example, a powered air-purifying respirator (PAPR) is much more
protective than a typical negative pressure respirator, and may also be
more comfortable to wear. A PAPR has a filter, cartridge, or canister
to clean the air, and a power source that continuously blows filtered
air into your breathing zone. Your employer might make a PAPR available
to you to ease the burden of having to wear a respirator for long
periods of time. The standard provides that you can obtain a PAPR upon
request.
* * * * *
Your employer must ensure that your respirator facepiece fits
properly. Proper fit of a respirator facepiece is critical to your
protection from airborne lead. Obtaining a proper fit on each
employee may require your employer to make available several
different types of respirator masks. To ensure that your respirator
fits properly and that facepiece leakage is minimal, your employer
must give you either a qualitative or quantitative fit test as
specified in Appendix A of the Respiratory Protection standard
located at 29 CFR 1910.134.
* * * * *
Subpart E--[Amended]
35. The authority citation for Subpart E of Part 1926 is revised to
read as follows:
Authority: Sec. 107, Contract Work Hours and Safety Standards
Act (Construction Safety Act) (40 U.S.C. 333); secs. 4, 6, and 8 of
the Occupational Safety and Health Act of 1970 (29 U.S.C. 653, 655,
657); Secretary of Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR
25059), 9-83 (48 FR 35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111),
as applicable; and 29 CFR part 11.
36. Section 1926.103 is revised to read as follows:
Sec. 1926.103 Respiratory protection.
Note: The requirements applicable to construction work under
this section are identical to those set forth at 29 CFR 1910.134 of
this chapter.
Subpart S--[Amended]
37. The authority citation for Subpart S of Part 1926 is revised to
read as follows:
Authority: Sec. 107, Contract Work Hours and Safety Standards
Act (40 U.S.C. 333); secs. 4, 6, and 8 of the Occupational Safety
and Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of
Labor's Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR
35736), 1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable.
38. Section 1926.800 is amended by revising paragraph (g)(2) as
follows:
Sec. 1926.800 Underground construction.
* * * * *
(g) * * *
(2) Self-rescuers. The employer must provide self-rescuers approved
by the National Institute for Occupational Safety and Health under 42
CFR part 84. The respirators must be immediately available to all
employees at work stations in underground areas where employees might
be trapped by smoke or gas. The selection, issuance, use, and care of
respirators must be in accordance with 29 CFR 1926.103.
* * * * *
[[Page 1298]]
Subpart Z--[Amended]
39. The authority citation for Subpart Z of Part 1926 is revised to
read as follows:
Authority: Secs. 4, 6, and 8 of the Occupational Safety and
Health Act of 1970 (29 U.S.C. 653, 655, 657); Secretary of Labor's
Orders 12-71 (36 FR 8754), 8-76 (41 FR 25059), 9-83 (48 FR 35736),
1-90 (55 FR 9033), or 6-96 (62 FR 111), as applicable; and 29 CFR
part 11.
Section 1926.1102 of 29 CFR not issued under 29 U.S.C. 655 or 29
CFR part 1911; also issued under 5 U.S.C. 553.
40. Section 1926.1101 is amended by removing and reserving Appendix
C and revising paragraph (h) to read as follows:
Sec. 1926.1101 Asbestos.
* * * * *
(h) Respiratory protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Class I asbestos work.
(ii) Class II asbestos work when ACM is not removed in a
substantially intact state.
(iii) Class II and III asbestos work that is not performed using
wet methods, except for removal of ACM from sloped roofs when a
negative-exposure assessment has been conducted and ACM is removed in
an intact state.
(iv) Class II and III asbestos work for which a negative-exposure
assessment has not been conducted.
(v) Class III asbestos work when TSI or surfacing ACM or PACM is
being disturbed.
(vi) Class IV asbestos work performed within regulated areas where
employees who are performing other work are required to use
respirators.
(vii) Work operations covered by this section for which employees
are exposed above the TWA or excursion limit.
(viii) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) No employee shall be assigned to asbestos work that requires
respirator use if, based on their most recent medical examination, the
examining physician determines that the employee will be unable to
function normally while using a respirator, or that the safety or
health of the employee or other employees will be impaired by the
employee's respirator use. Such employees must be assigned to another
job or given the opportunity to transfer to a different position that
they can perform. If such a transfer position is available, it must be
with the same employer, in the same geographical area, and with the
same seniority, status, rate of pay, and other job benefits the
employee had just prior to such transfer.
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table 1 of this section.
Table 1.--Respiratory Protection for Asbestos Fibers
------------------------------------------------------------------------
Airborne concentrations of
asbestos or conditions of use Required respirator
------------------------------------------------------------------------
Not in excess of 1 f/cc (10 X Half-mask air purifying respirator other
PEL), or otherwise as than a disposable respirator, equipped
required independent of with high efficiency filters.
exposure pursuant to
paragraph (h)(2)(iv) of this
section.
Not in excess of 5 f/cc (50 X Full facepiece air-purifying respirator
PEL). equipped with high efficiency filters.
Not in excess of 10 f/cc (100 Any powered air-purifying respirator
X PEL). equipped with high efficiency filter or
any supplied air respirator operated in
continuous flow mode.
Not in excess of 100 f/cc Full facepiece supplied air respirator
(1,000 X PEL) or unknown operated in pressure demand mode.
concentration.
Greater than 100 f/cc (1,000 Full facepiece supplied air respirator
X PEL) or unknown operated in pressure demand mode,
concentration. equipped with an auxiliary positive
pressure self-contained breathing
apparatus.
------------------------------------------------------------------------
Note: a. Respirators assigned for high environmental concentrations may
be used at lower concentrations, or when required respirator use is
independent of concentration.
b. A high efficiency filter means a filter that is at least 99.97
percent efficient against mono-dispersed particles of 0.3 micrometers
in diameters in diameter or larger.
(ii) The employer must provide an employee with a tight-fitting,
powered air-purifying respirator instead of a negative-pressure
respirator from Table 1 when the employee chooses to use this type of
respirator and such a respirator will provide adequate protection to
the employee.
(iii) The employer must provide a half-mask air-purifying
respirator, other than a disposable respirator, that is equipped with
high-efficiency filters when the employee performs:
(A) Class II and III asbestos work and a negative-exposure
assessment has not been conducted by the employer.
(B) Class III asbestos work when TSI or surfacing ACM or PACM is
being disturbed.
(iv) The employer must provide employees with a full-facepiece
supplied-air respirator operated in the pressure-demand mode and
equipped with an auxiliary, positive-pressure self-contained breathing
apparatus when the employees are in a regulated area where Class I work
is being performed and the employer has not conducted a negative-
exposure assessment.
* * * * *
41. Section 1926.1127 is amended by removing and reserving Appendix
C and revising paragraph (g) to read as follows:
Sec. 1926.1127 Cadmium.
* * * * *
(g) Respirator protection. (1) General. For employees who use
respirators required by this section, the employer must provide
respirators that comply with the requirements of this paragraph.
Respirators must be used during:
(i) Periods necessary to install or implement feasible engineering
and work-practice controls when employee exposures exceed the PEL.
(ii) Maintenance and repair activities, and brief or intermittent
work operations, for which employee exposures exceed the PEL and
engineering and work-practice controls are not feasible or are not
required.
(iii) Work operations in the regulated areas specified in paragraph
(e) of this section.
(iv) Work operations for which the employer has implemented all
feasible engineering and work-practice controls, and such controls are
not sufficient to reduce employee exposures to or below the PEL.
[[Page 1299]]
(v) Work operations for which an employee, who is exposed to
cadmium at or above the action level, requests a respirator.
(vi) Work operations for which engineering controls are not
required by paragraph (f)(1)(ii) of this section to reduce employee
exposures that exceed the PEL.
(vii) Emergencies.
(2) Respirator program. (i) The employer must implement a
respiratory protection program in accordance with 29 CFR 1910.134 (b)
through (d) (except (d)(1)(iii)), and (f) through (m).
(ii) If an employee exhibits breathing difficulty during fit
testing or respirator use, the employer must provide the employee with
a medical examination in accordance with paragraph (l)(6)(ii) of this
section to determine if the employee can use a respirator while
performing the required duties.
(iii) No employee must use a respirator when, based on their most
recent medical examination, the examining physician determines that the
employee will be unable to continue to function normally while using a
respirator. If the physician determines the employee must be limited
in, or removed from, their current job because of the employee's
inability to use a respirator, the job limitation or removal must be
conducted in accordance with paragraphs (l) (11) and (12) of this
section.
(3) Respirator selection. (i) The employer must select the
appropriate respirator from Table 1 of this section.
Table 1.--Respiratory Protection for Cadmium
------------------------------------------------------------------------
Required respirator
Airborne concentration or condition of use a type b
------------------------------------------------------------------------
10 X or less...................................... A half mask, air-
purifying equipped
with a HEPA c
filter.d
25 X or less...................................... A powered air-
purifying
respirator
(``PAPR'') with a
loose-fitting hood
or helmet equipped
with a HEPA filter,
or a supplied-air
respirator with a
loose-fitting hood
or helmet facepiece
operated in the
continuous flow
mode.
50 X or less...................................... A full facepiece air-
purifying
respirator equipped
with a HEPA filter,
or a powered air-
purifying
respirator with a
tight-fitting half
mask equipped with
a HEPA filter, or a
supplied-air
respirator with a
tight-fitting half
mask operated in
the continuous flow
mode.
250 X or less..................................... A powered air-
purifying
respirator with a
tight fitting full
facepiece equipped
with a HEPA filter,
or a supplied-air
respirator with a
tight-fitting full
facepiece operated
in the continuous
flow mode.
1000 X or less.................................... A supplied air
respirator with
half mask or full
facepiece operated
in the pressure
demand or other
positive pressure
mode.
>1000 X or unknown concentrations................. A self-contained
breathing apparatus
with a full
facepiece operated
in the pressure
demand or other
positive pressure
mode, or a supplied-
air respirator with
a full facepiece
operated in the
pressure demand or
other positive
pressure mode and
equipped with an
auxiliary escape
type self-contained
breathing apparatus
operated in the
pressure demand
mode.
Firefighting...................................... A self-contained
breathing apparatus
with full facepiece
operated in the
pressure demand or
other positive
pressure mode.
------------------------------------------------------------------------
a Concentrations expressed as multiple of the PEL.
b Respirators assigned for higher environmental concentrations may be
used at lower exposure levels. Quantitative fit testing is required
for all tight-fitting air purifying respirators where airborne
concentration of cadmium exceeds 10 times the TWA PEL (10 X 5 ug/m(3)
= 50 ug/m(3)). A full facepiece respirator is required when eye
irritation is experienced.
c HEPA means High-efficiency Particulate Air.
d Fit testing, qualitative or quantitative, is required.
SOURCE: Respiratory Decision Logic, NIOSH, 1987.
(ii) The employer must provide a powered air-purifying respirator
instead of a negative-pressure respirator when an employee entitled to
a respirator chooses to use this type of respirator and such a
respirator will provide adequate protection to the employee.
* * * * *
Note: The following table will not appear in the Code of Federal
Regulations.
Redesignation Table for Actions on Specific Standards
------------------------------------------------------------------------
Old section New section
------------------------------------------------------------------------
1910.94:
(a)(1)(ii).............................. Revised.
(a)(5)(i)............................... Revised.
(a)(5)(iii)............................. Revised.
(a)(5)(iv).............................. Revised.
(a)(6).................................. Revised.
(c)(6)(iii)(a).......................... Revised.
(d)(9)(vi).............................. Revised.
1910.111:
(a)(2)(x)............................... Revised.
(b)(10)(ii)............................. Revised.
1910.156:
(f)(1)(i)............................... Revised.
(f)(1)(v)............................... Revised.
1910.252:
(c)(4)(ii).............................. Revised.
(c)(4)(iii)............................. Revised.
(c)(7)(iii)............................. Revised.
(c)(9)(i)............................... Revised.
(c)(10)................................. Revised.
1910.261:
(b)(2).................................. Revised.
(g)(10)................................. Revised.
(h)(2)(iii)............................. Revised.
(h)(2)(iv).............................. Revised.
1910.1001:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (g)(3).
(g)(2)(ii).............................. Revised; (g)(2)(ii).
(g)(3)(i)............................... Revised; (g)(2)(i).
(g)(3)(ii).............................. Removed.
(g)(3)(iii)............................. Removed.
(g)(3)(iv).............................. Revised; (g)(2)(iii).
(g)(4).................................. Removed.
Appendix C.............................. Removed.
1910.1003:
(c)(4)(iv).............................. Revised.
(d)(1) [Reserved]....................... Revised.
1910.1017:
(g)(1).................................. Revised.
(g)(2).................................. Removed.
(g)(3).................................. Revised; (g)(2).
(g)(4).................................. Revised; (g)(3)(i).
(g)(5).................................. Removed.
(g)(6) (i) and (ii)..................... Revised; (g)(3)(ii).
(g)(7).................................. Revised; (g)(3)(iii).
1910.1018:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3)(i).
(h)(2)(ii).............................. Revised; (h)(3)(ii).
(h)(2)(iii)............................. Removed.
(h)(3)(i), (ii), and (iii).............. Removed.
(h)(3)(iv).............................. Revised; (h)(2)(ii).
(h)(4)(i)............................... Revised; (h)(2)(i).
(h)(4) (ii) and (iii)................... Removed.
(h)(5) (i) and (ii)..................... Removed.
[[Page 1300]]
(h)(5)(iii)............................. Revised; (h)(4)(iii).
1910.1025:
(f)(1) and (f)(1)(i).................... Revised.
(f)(2)(i)............................... Revised; (f)(3)(i).
(f)(2)(ii).............................. Revised; (f)(3)(ii).
(f)(2)(iii)............................. Removed.
(f)(3)(i) and (ii)...................... Removed.
(f)(3)(iii)............................. Revised; (f)(2)(ii).
(f)(4)(i)............................... Revised; (f)(2)(i).
(f)(4) (ii) and (iii)................... Removed.
Appendix B, Section IV.................. Revised second and fourth
paragraphs; removed sixth
paragraph.
Appendix D.............................. Removed.
1910.1027:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (f)(3)(i).
(g)(2)(ii).............................. Revised; (f)(3)(ii).
(g)(3)(i)............................... Revised; (f)(2)(i).
(g)(3) (ii) and (iii)................... Removed.
(g)(3)(iv).............................. Revised; (g)(2)(iii).
(g)(3)(v)............................... Revised; (g)(2)(ii).
(g)(4).................................. Removed.
Appendix C................................ Removed.
1910.1028:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (g)(3)(i).
(g)(2)(ii).............................. Removed.
(g)(2)(iii)............................. Revised; (g)(3)(ii).
(g)(3).................................. Revised; (g)(2).
(g)(4)(i)............................... Revised; (g)(2)(ii).
(g)(4)(ii).............................. Revised; (g)(2)(iii).
(g)(4)(iii)............................. Removed.
(g)(5).................................. Removed.
Appendix E.............................. Removed.
1910.1029:
(g)(1)(i)............................... Revised.
(g)(1)(ii).............................. Removed.
(g)(2)(i)............................... Revised; (g)(3).
(g)(2)(ii) and (iii).................... Removed.
(g)(3).................................. Revised; (g)(2).
(g)(4).................................. Removed.
1910.1043:
(f)(1).................................. Revised.
(f)(2)(i)............................... Revised; (f)(3)(i).
(f)(2)(ii).............................. Removed.
(f)(2)(iii)............................. Revised; (f)(3)(ii).
(f)(2)(iv).............................. Revised; (f)(2)(ii).
(f)(3).................................. Revised; (f)(2)(i).
(f)(4).................................. Removed.
1910.1044:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3).
(h)(2)(ii).............................. Removed.
(h)(3)(i)............................... Revised; (h)(3).
(h)(3)(ii).............................. Removed.
1910.1045:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3).
(h)(2)(ii).............................. Removed.
(h)(3)(i)............................... Revised; (h)(2)(i).
(h)(3)(ii).............................. Revised; (h)(2)(ii).
(h)(3)(iii)............................. Removed.
(h)(3)(iv).............................. Removed.
Appendix A, Section IV.................. Revised first paragraph.
1910.1047:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (g)(3).
(g)(2)(ii).............................. Removed.
(g)(3).................................. Revised; (g)(2).
(g)(4).................................. Revised; (g)(4).
Appendix A, Section IV.................. Revised first paragraph.
1910.1048:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (g)(3)(i).
(g)(2)(ii).............................. Revised; (g)(3)(ii).
(g)(3)(i)............................... Revised; (g)(2)(i).
(g)(3)(ii).............................. Removed.
(g)(3)(iii)............................. Revised; (g)(2)(ii)(A).
(g)(3)(iv).............................. Revised; (g)(2)(ii)(B).
(g)(3)(v)............................... Removed.
Appendix E.............................. Removed.
1910.1050:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3)(i).
(h)(2)(ii).............................. Removed.
(h)(2)(iii)............................. Revised; (h)(3)(ii).
(h)(3).................................. Revised; (h)(2).
(h)(4).................................. Removed.
(h)(5).................................. Removed.
Appendix A, Section III................. Revised first paragraph.
Appendix E.............................. Removed.
1910.1051:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3)(i).
(h)(2)(ii).............................. Revised; (h)(3)(ii).
(h)(2)(iii)............................. Revised; (h)(3)(iii).
(h)(3).................................. Revised; (h)(2)(i).
(h)(4)(i)............................... Revised; (h)(2)(ii).
(h)(4)(ii).............................. Revised; (h)(2)(iii).
(h)(4)(iii)............................. Revised; (h)(2) (iv) and
(vi).
(h)(4)(iv).............................. Revised; (h)(2) (vi) and
(vi).
(h)(4)(v)............................... Removed.
(h)(5).................................. Removed.
Appendix E.............................. Removed.
1910.1052:
(g)(1).................................. Revised.
(g)(2).................................. Revised; (g)(4).
(g)(3).................................. Revised; (g)(3).
(g)(4).................................. Revised; (g)(2)(i).
(g)(5).................................. Removed.
(g)(6).................................. Revised; (g)(2)(ii).
(g)(7).................................. Removed.
1926.57:
(f)(1)(ii).............................. Revised.
(f)(5)(i)............................... Revised.
(f)(5)(iii)............................. Revised.
(f)(6).................................. Revised.
(f)(6)(i), (ii), and (iii).............. Removed.
(h)(6)(iii)(A).......................... Revised.
(i)(9)(vi).............................. Revised.
1926.60:
(i)(1).................................. Revised.
(i)(2)(i)............................... Revised; (i)(3)(i).
(i)(2)(ii).............................. Removed.
(i)(2)(iii)............................. Revised; (i)(3)(ii).
(i)(3).................................. Revised; (i)(2).
(i)(4).................................. Removed.
(i)(5).................................. Removed.
Appendix E.............................. Removed.
1926.62:
(f)(1).................................. Revised.
(f)(2)(i)............................... Revised; (f)(3)(i).
(f)(2)(ii).............................. Revised; (f)(3)(ii).
(f)(2)(iii)............................. Removed.
(f)(3)(i)............................... Removed.
(f)(3)(ii).............................. Removed.
(f)(3)(iii)............................. Revised; (f)(2)(ii).
(f)(4)(i)............................... Revised; (f)(2)(i).
(f)(4) (ii) and (iii)................... Removed.
Appendix B, Section IV.................. Revised second and fourth
paragraphs; removed sixth
paragraph.
Appendix D.............................. Removed.
1926.103:
All..................................... Revised to a single
provision.
1926.800:
(g)(2).................................. Revised.
1926.1101:
(h)(1).................................. Revised.
(h)(2)(i)............................... Revised; (h)(3)(i).
(h)(2)(ii).............................. Removed.
(h)(2)(iii)............................. Revised; (h)(3)(ii).
(h)(2)(iv).............................. Revised; (h)(3)(iii).
(h)(2)(v)............................... Revised; (h)(3)(iv).
(h)(3)(i)............................... Revised; (h)(2)(i).
(h)(3)(ii).............................. Removed.
(h)(3)(iii)............................. Removed.
(h)(3)(iv).............................. Revised; (h)(2)(ii).
(h)(4).................................. Removed.
Appendix C.............................. Removed.
1926.1127:
(g)(1).................................. Revised.
(g)(2)(i)............................... Revised; (g)(3)(i).
(g)(2)(ii).............................. Revised; (g)(3)(ii).
(g)(3)(i)............................... Revised; (g)(2)(i).
(g)(3)(ii) and (iii).................... Removed.
(g)(3)(iv).............................. Revised; (g)(2)(ii).
(g)(3)(v)............................... Revised; (g)(2)(iii).
(g)(4).................................. Removed.
Appendix C.............................. Removed.
------------------------------------------------------------------------
[FR Doc. 97-33843 Filed 12-31-97; 8:45 am]
BILLING CODE 4510-26-P