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August 24, 2006

Part II

Department of Labor
Occupational Safety and Health

29 CFR Parts 1910, 1915, and 1926

Assigned Protection Factors; Final Rule
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50122 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

DEPARTMENT OF LABOR 693–2289 or fax (202) 693–1678. For E. MUCs for Mixtures and Hazard Ratios
general inquiries regarding this final F. MUC Provisions
Occupational Safety and Health standard contact Kevin Ropp, OSHA G. Superseding the Respirator Selection
Administration Office of Public Affairs, Room N–3647, Provisions of Substance-Specific
Standards in Parts 1910, 1925, and 1926
U.S. Department of Labor, 200 VII. Procedural Determinations
29 CFR Parts 1910, 1915, and 1926 Constitution Ave., NW., Washington, A. Legal Considerations
DC 20210 (telephone (202) 693–1999). B. Paperwork Reduction Act
[Docket No. H049C]
Copies of this Federal Register notice C. Federalism
RIN 1218–AA05 are available from the OSHA Office of D. State Plans
Publications, Room N–3101, U.S. E. Unfunded Mandates
Assigned Protection Factors Department of Labor, 200 Constitution F. Applicability of Existing Consensus
Ave., NW., Washington, DC 20210 Standards
AGENCY: Occupational Safety and Health (telephone (202) 693–1888). For an List of Subjects in 29 CFR Parts 1910, 1915,
Administration (OSHA), Department of electronic copy of this notice, as well as and 1926
Labor. news releases and other relevant
Authority and Signature
ACTION: Final rule. Amendments to Standards
documents, go to OSHA’s Web site
(, and select B. Glossary
SUMMARY: In this final rule, OSHA is This glossary specifies the terms
‘‘Federal Register,’’ ‘‘Date of
revising its existing Respiratory represented by acronyms, and provides
Publication,’’ and then ‘‘2006’’.
Protection Standard to add definitions definitions of other terms, used
and requirements for Assigned SUPPLEMENTARY INFORMATION:
frequently in the preamble to the final
Protection Factors (APFs) and I. General rule. This glossary does not change the
Maximum Use Concentrations (MUCs). legal requirements in this final rule, nor
The revisions also supersede the A. Table of Contents
is it intended to impose new regulatory
respirator selection provisions of The following Table of Contents requirements on the regulated
existing substance-specific standards identifies the major preamble sections of community.
with these new APFs (except for the this final rule and the order in which
respirator selection provisions of the they are presented: 1. Acronyms
1,3-Butadiene Standard). I. General ACGIH: American Conference of
The Agency developed the final APFs A. Table of Contents Governmental Industrial Hygienists
after thoroughly reviewing the available B. Glossary AIHA: American Industrial Hygiene
literature, including chamber- II. Events Leading to the Final Standard Association
simulation studies and workplace A. Regulatory History of APFs ANSI: American National Standards
protection factor studies, comments B. Non-Regulatory History of APFs
C. Need for APFs Institute
submitted to the record, and hearing III. Methodology for Developing APFs for APF: Assigned Protection Factor
testimony. The final APFs provide Respirators APR: Air-purifying respirator
employers with critical information to A. Introduction Ci: Concentration measured inside the
use when selecting respirators for B. Background respirator facepiece
employees exposed to atmospheric C. Methodology, Data, and Studies on Co: Concentration measured outside the
contaminants found in general industry, Filtering Facepieces and Elastomerics respirator
construction, shipyards, longshoring, D. Alternative Approaches DOP: Dioctylphthalate (see definition
E. Updated Analyses
and marine terminal workplaces. Proper F. Summary of Studies Submitted During
respirator selection using APFs is an the Rulemaking DFM: Dust, fume, and mist filter
important component of an effective IV. Health Effects EPF: Effective Protection Factor (see
respiratory protection program. V. Summary of the Final Economic Analysis definition below under ‘‘Protection
Accordingly, OSHA concludes that the and Initial Regulatory Flexibility factor study’’)
final APFs are necessary to protect Analysis HEPA: High efficiency particulate air
employees who must use respirators to A. Introduction filter (see definition below)
B. The Rule and Affected Respirator Users IDLH: Immediately dangerous to life or
protect them from airborne C. Compliance Costs
contaminants. D. Benefits
health (see definition below)
E. Economic Feasibility LANL: Los Alamos National Laboratory
DATES: The final rule becomes effective
F. Economic Impacts to Small Entities LASL: Los Alamos Scientific Laboratory
November 22, 2006.
VI. Summary and Explanation of the Final LLNL: Lawrence Livermore National
ADDRESSES: In compliance with 28 Standard Laboratory
U.S.C. 2212(a), the Agency designates A. Definition of Assigned Protection Factor MSHA: Mine Safety and Health
Joseph M. Woodward, the Associate B. APF Provisions Administration
Solicitor for Occupational Safety and C. Assigned Protection Factors for Specific MUC: Maximum Use Concentration
Health, Office of the Solicitor, Room S– Respirator Types
1. APF for Quarter Mask Air-Purifying NFPA: National Fire Protection
4004, U.S. Department of Labor, 200 Association
Constitution Avenue, NW., Washington, 2. APF for Half Mask Air-Purifying NIOSH: National Institute for
DC 20210, as the recipient of petitions Respirators Occupational Safety and Health
for review of this rulemaking. 3. APF for Full Facepiece Air-Purifying NRC: Nuclear Regulatory Commission
FOR FURTHER INFORMATION CONTACT: For Respirators OSHA: Occupational Health and Safety
technical inquiries regarding this final 4. APF for Powered Air-Purifying Administration
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rule, contact Mr. John E. Steelnack, Respirators (PAPRs)

OSH Act: The Occupational Safety and
5. APF for Supplied-Air Respirators (SARs)
Directorate of Standards and Guidance, 6. APF for Self-Contained Breathing Health Act of 1970 (29 U.S.C. 655,
Room N–3718, OSHA, U.S. Department Apparatuses (SCBAs) 657, 665).
of Labor, 200 Constitution Ave., NW., D. Definition of Maximum Use PAPR: Powered air-purifying respirator
Washington, DC 20210; telephone (202) Concentration (see definition below)

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PEL: Permissible Exposure Limit with a filter as an integral part of the outside the respirator (Co) to the
PPF: Program Protection Factor (see facepiece or with the entire facepiece concentration inside the respirator (Ci)
definition below under ‘‘Protection composed of the filtering medium. (i.e., Co/Ci). Therefore, as the ratio
factor study’’) Fit factor*: A quantitative estimate of between Co and Ci increases, the
QLFT: Qualitative fit test (see definition the fit of a particular respirator to a protection factor increases, indicating
below) specific individual and typically an increase in the level of protection
QNFT: Quantitative fit test (see estimates the ratio of the concentration provided to employees by the respirator.
definition below) of a substance in ambient air to its Four types of protection factor studies
RDL: Respirator Decision Logic (see concentration inside the respirator are:
definition below) when worn. Effective Protection Factor (EPF)
REL: Recommended Exposure Limit (see Fit test*: The use of a protocol to study: A study, conducted in the
definition below) qualitatively or quantitatively evaluate workplace, that measures the protection
SAR: Supplied-air (or airline) respirator the fit of a respirator on an individual. provided by a properly selected, fit-
(see definition below) Helmet*: A rigid respiratory inlet tested, and functioning respirator when
SCBA: Self-contained breathing covering that also provides head used intermittently for only some
apparatus (see definition below) protection against impact and fraction of the total workplace exposure
WPF: Workplace Protection Factor (see penetration. time (i.e., sampling is conducted during
definition below under ‘‘Protection High-efficiency particulate air filter periods when respirators are worn and
factor study’’) (HEPA)*: A filter that is at least 99.97% not worn). EPFs are not directly
TLV: Threshold Limit Value (see efficient in removing monodisperse comparable to WPF values because the
definition below) particles of 0.3 micrometers in diameter. determinations include both the time
SWPF: Simulated Workplace Protection The equivalent NIOSH 42 CFR part 84 spent in contaminated atmospheres
Factor (see definition below under particulate filters are the N100, R100, with and without respiratory protection;
‘‘Protection factor study’’) and P100 filters. therefore, EPFs usually underestimate
2. Definitions Hood*: A respiratory inlet covering the protection afforded by a respirator
that completely covers the head and that is used continuously in the
Terms followed by an asterisk (*) refer neck and may also cover portions of the workplace.
to definitions that can be found in shoulders and torso. Program Protection Factor (PPF)
paragraph (b) (‘‘Definitions’’) of OSHA’s Immediately dangerous to life or study: A study that estimates the
Respiratory Protection Standard (29 CFR health (IDLH)*: An atmosphere that protection provided by a respirator
1910.134). poses an immediate threat to life, would within a specific respirator program.
Air-purifying respirator*: A respirator cause irreversible adverse health effects, Like the EPF, it is focused not only on
with an air-purifying filter, cartridge, or or would impair an individual’s ability the respirator’s performance, but also
canister that removes specific air to escape from a dangerous atmosphere. the effectiveness of the complete
contaminants by passing ambient air Loose-fitting facepiece*: A respiratory respirator program. PPFs are affected by
through the air-purifying element. inlet covering that is designed to form all factors of the program, including
Atmosphere-supplying respirator*: A a partial seal with the face. respirator selection and maintenance,
respirator that supplies the respirator Negative pressure respirator (tight- user training and motivation, work
user with breathing air from a source fitting)*: A respirator in which the air activities, and program administration.
independent of the ambient atmosphere, pressure inside the facepiece is negative Workplace Protection Factor (WPF)
and includes SARs and SCBA units. during inhalation with respect to the study: A study, conducted under actual
Canister or cartridge*: A container ambient air pressure outside the conditions of use in the workplace, that
with a filter, sorbent, or catalyst, or respirator. measures the protection provided by a
combination of these items, which Permissible Exposure Limit (PEL): An properly selected, fit-tested, and
removes specific contaminants from the occupational exposure limit specified functioning respirator, when the
air passed through the container. by OSHA. respirator is worn correctly and used as
Continuous flow respirator: An Positive pressure respirator*: A part of a comprehensive respirator
atmosphere-supplying respirator that respirator in which the pressure inside program that is in compliance with
provides a continuous flow of the respiratory inlet covering exceeds OSHA’s Respiratory Protection Standard
breathable air to the respirator the ambient air pressure outside the at 29 CFR 1910.134. Measurements of
facepiece. respirator. Co and Ci are obtained only while the
Demand respirator*: An atmosphere- Powered air-purifying respirator respirator is being worn during
supplying respirator that admits (PAPR)*: An air-purifying respirator that performance of normal work tasks (i.e.,
breathing air to the facepiece only when uses a blower to force the ambient air samples are not collected when the
a negative pressure is created inside the through air-purifying elements to the respirator is not being worn). As the
facepiece by inhalation. inlet covering. degree of protection afforded by the
Dioctylphthalate (DOP): An Pressure demand respirator*: A respirator increases, the WPF increases.
aerosolized agent used for quantitative positive pressure atmosphere-supplying Simulated Workplace Protection
fit testing. respirator that admits breathing air to Factor (SWPF) study: A study,
Elastomeric: A respirator facepiece the facepiece when the positive pressure conducted in a controlled laboratory
made of a natural or synthetic elastic is reduced inside the facepiece by setting and in which Co and Ci
material such as natural rubber, inhalation. sampling is performed while the
silicone, or EPDM rubber. Protection factor study: A study that respirator user performs a series of set
Filter or air-purifying element*: A determines the protection provided by a exercises. The laboratory setting is used
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component used in respirators to respirator during use. This to control many of the variables found
remove solid or liquid aerosols from the determination generally is in workplace studies, while the
inspired air. accomplished by measuring the ratio of exercises simulate the work activities of
Filtering facepiece (or dust mask)*: A the concentration of an airborne respirator users. This type of study is
negative pressure particulate respirator contaminant (e.g., hazardous substance) designed to determine the optimum

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performance of respirators by reducing preceded OSHA developed the original report by Ed Hyatt from LASL titled
the impact of sources of variability maritime respiratory protection ‘‘Respiratory Protection Factors’’ (Ex. 2),
through maintenance of tightly standards in the 1960s (e.g., Section 41 and the RDL developed jointly by OSHA
controlled study conditions. of the Longshore and Harbor Worker and NIOSH, as revised in 1978 (Ex. 9,
Qualitative fit test (QLFT)*: A pass/ Compensation Act). The section Docket No. H049). The 1982 ANPR
fail fit test to assess the adequacy of designations adopted by OSHA for these asked for comments on how OSHA
respirator fit that relies on the standards, and their original should use protection factors. The
individual’s response to the test agent. promulgation dates, are: Shipyards—29 Agency received 81 responses to this
Quantitative fit test (QNFT)*: An CFR 1915.82, February 20, 1960 (25 FR inquiry. The commenters generally
assessment of the adequacy of respirator 1543); Marine Terminals—29 CFR supported revising OSHA’s Respiratory
fit by numerically measuring the 1917.82, March 27, 1964 (29 FR 4052); Protection Standard, and provided
amount of leakage into the respirator. and Longshoring—29 CFR 1918.102, recommendations regarding approaches
Recommended Exposure Limit (REL): February 20, 1960 (25 FR 1565). OSHA for including a table of protection
An occupational exposure level incorporated 29 CFR 1910.134 by factors (Ex. 15).
recommended by NIOSH. reference into its Marine Terminal On September 17, 1985, OSHA
Respirator Decision Logic (RDL): standards (Part 1917) on July 5, 1983 (48 announced the availability of a
Respirator selection guidance developed FR 30909). The Agency updated and preliminary draft of the proposed
by NIOSH that contains a set of strengthened its Longshoring and Respiratory Protection Standard. This
respirator protection factors. Marine Terminal standards in 1996 and preproposal draft standard included a
Self-contained breathing apparatus 2000, and these standards now discussion of the public comments
(SCBA)*: An atmosphere-supplying incorporate 29 CFR 1910.134 by received in response to the 1982 ANPR,
respirator for which the breathing air reference. and OSHA’s analysis of revisions
source is designed to be carried by the Under the Respiratory Protection needed in the Respiratory Protection
user. Standard that OSHA initially adopted, Standard to address up-to-date
Supplied-air respirator (or airline) employers were required to follow the respiratory protection. The Agency
respirator (SAR)*: An atmosphere- guidance of the Z88.2–1969 ANSI received 56 responses from interested
supplying respirator for which the standard to ensure proper selection of parties (Ex. 36), which OSHA carefully
source of breathing air is not designed respirators. Subsequently, OSHA reviewed in developing the proposed
to be carried by the user. published an Advance Notice of rule.
Threshold Limit Value (TLV): An Proposed Rulemaking (‘‘ANPR’’) to On November 15, 1994, OSHA
occupational exposure level revise the Respiratory Protection published the proposed rule to revise 29
recommended by ACGIH. Standard on May 14, 1982 (47 FR CFR 1910.134, and provided notice of
Tight-fitting facepiece*: A respiratory 20803). Part of the impetus for this an informal public hearing on the
inlet covering that forms a complete seal notice was the Agency’s inclusion of proposal (59 FR 58884). The Agency
with the face. new respirator requirements in the convened the informal public hearing
comprehensive substance-specific on June 6, 1995. In response to the
II. Events Leading to the Final Standard standards promulgated under section comments OSHA received on the
A. Regulatory History of APFs (6)(b) of the OSH Act, e.g., fit testing proposal, the Agency proceeded to
protocols, respirator selection tables develop APFs. On June 15, 1995, as part
Congress established the with assigned protection factors, use of of the public hearing, OSHA held a one-
Occupational Safety and Health PAPRs, changing filter elements day panel discussion by respirator
Administration (OSHA) in 1970, and whenever an employee detected an experts on APFs. The discussion
gave it the responsibility for increase in breathing resistance, and included measuring respirator
promulgating standards to protect the referring employees with breathing performance in WPF and SWPF studies,
health and safety of American workers. difficulties, either at fit testing or during the variability of data from these
As directed by the OSH Act, the Agency routine respirator use, to a physician studies, and setting APFs for various
adopted existing Federal standards and trained in pulmonary medicine (see, types of respirators that protect
national consensus standards developed e.g., 29 CFR 1910.1025 (OSHA’s Lead employees across a wide variety of
by various organizations such as the Standard)). The respirator provisions in workplaces and exposure conditions.
NFPA and ANSI. The ANSI standard these substance-specific standards OSHA also reopened the rulemaking
Z88.2–1969, ‘‘Practices for Respiratory reflected advances in respirator record for the revised Respiratory
Protection,’’ was the basis of the first six technology and changes in related Protection Standard on November 7,
sections (permissible practice, minimal guidance documents that were state-of- 1995 (60 FR 56127), requesting
respirator program, selection of the-art information at the time when comments on a study performed for
respirators, air quality, use, OSHA published these substance- OSHA by Dr. Mark Nicas titled ‘‘The
maintenance and care) of OSHA’s specific standards. These standards Analysis of Workplace Protection Factor
Respiratory Protection Standard (29 CFR recognized that effective respirator use Data and Derivation of Assigned
1910.134) adopted in 1971. The seventh depends on a comprehensive respiratory Protection Factors’’ (Ex. 1–156). This
section was a direct, complete protection program that includes the use study, which the Agency placed in the
incorporation of ANSI Standard K13.1– of APFs. rulemaking docket on September 20,
1969, ‘‘Identification of Gas Mask In the 1982 ANPR, OSHA sought 1995, addressed the use of statistical
Canisters.’’ information on the effectiveness of its modeling for determining respirator
The Agency promulgated an initial current Respiratory Protection Standard, APFs. OSHA received 12 comments on
respiratory protection standard for the the need to revise the standard, and the Nicas report. This report, and the
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construction industry (29 CFR 1926.103) recommendations regarding what comments received in response to it,
in April 1971. On February 9, 1979, revisions should be made. The 1982 convinced OSHA that more information
OSHA formally applied 29 CFR ANPR referenced the ANSI Z88.2–1980 would be necessary before the Agency
1910.134 to the construction industry standard on respiratory protection with could resolve the complex issues
(44 FR 8577). Federal agencies that its table of protection factors, the 1976 regarding how to establish APFs,

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including what methodology to use in comments, exhibits, hearing transcript, of LASL researchers, as well as
analyzing existing protection factor and post-hearing submissions that extrapolations from available facepiece
studies. (See Section IV. Methodology OSHA has prepared these final APF and leakage data for similar respirators. For
for Developing Assigned Protection MUC provisions and revisions to example, Hyatt assumed that
Factors in the June 6, 2003 NPRM, 68 substance-specific standards. performance data for SCBAs operated in
FR 34044, for a detailed discussion of the pressure-demand mode could be
B. Non-Regulatory History of APFs
the Nicas report and the comments used to represent other (non-tested)
OSHA received.) In 1965, the Bureau of Mines respirators that maintain positive
OSHA published the final, revised published ‘‘Respirator Approval pressure in the facepiece, hood, helmet,
Respiratory Protection Standard, 29 CFR Schedule 21B,’’ which contained the or suit during inhalation. In addition,
1910.134, on January 8, 1998 (63 FR term ‘‘protection factor’’ as part of its Hyatt recommended in his report that
1152). The standard contains worksite- approval process for half mask NIOSH continue testing the
specific requirements for program respirators (for protection up to 10 times performance of respirators that lacked
administration, procedures for the TLV) and full facepiece respirators adequate fit test data. To increase the
respirator selection, employee training, (for protection up to 100 times the TLV). database, Hyatt used a representative
fit testing, medical evaluation, respirator The Bureau of Mines based these 35-person test panel to conduct
use, and other provisions. However, protection factors on quantitative fit quantitative fit tests from 1974 to 1978
OSHA reserved the sections of the final tests, using DOP, that were conducted on all air-purifying particulate
standard related to APFs and MUCs on six male test subjects performing respirators approved by the Bureau of
pending further rulemaking (see 63 FR simulated work exercises. Mines and NIOSH.
1182 and 1203). The Agency stated that, The Atomic Energy Commission In August 1975, the Joint NIOSH–
until a future rulemaking on APFs is (AEC) published proposed protection OSHA Standards Completion Program
completed: factors for respirators in 1967, but later published the RDL (Ex. 25–4, Appendix
withdrew them because quantitative fit F, Docket No. H049). The RDL
[Employers must] take the best available
information into account in selecting testing studies, which the AEC used to contained a table of protection factors
respirators. As it did under the previous determine APFs, were available for that were based on quantitative fit
[Respiratory Protection] standard, OSHA some, but not all, types of respirators. testing performed at LASL and
itself will continue to refer to the [APFs in To address this shortcoming, the AEC
the 1987 NIOSH RDL] in cases where it has
elsewhere, as well as the expert
sponsored respirator performance
not made a different determination in a judgment of the RDL authors. In 1978,
studies at LASL, starting in 1969.
substance specific standard. (63 FR 1163) ANSI standard Z88.2–1969, which NIOSH updated the RDL specifying the
OSHA adopted by reference in 1971, did following protection factors:
The Agency subsequently established a
separate docket (i.e., H049C) for the APF not contain APFs for respirator 5 for single-use respirators;
rulemaking. This docket includes copies selection. Nevertheless, this ANSI 10 for half mask respirators with DFM
of material related to APFs that standard recommended that ‘‘due or HEPA filters;
previously were placed in the docket consideration be given to potential 50 for full facepiece air-purifying
(H049) for the revised Respiratory inward leakage in selecting devices,’’ respirators with HEPA filters or
Protection Standard. The APF and contained a list of the various chemical cartridges;
rulemaking docket also contains other respirators grouped according to the 1,000 for PAPRs with HEPA filters;
expected quantity of leakage into the 1,000 for half mask SARs operated in
APF-related materials, studies, and data
facepiece during routine use. the pressure-demand mode;
that OSHA obtained after it promulgated
In 1972, NIOSH and the Bureau of 2,000 for full facepiece SARs operated
the final Respiratory Protection
Mines published new approval in the pressure-demand mode; and
Standard in 1998.
On June 6, 2003, the Agency schedules for respiratory protection 10,000 for full facepiece SCBAs
published in the Federal Register an under 30 CFR 11. However, these new operated in the pressure-demand
NPRM titled ‘‘Assigned Protection approval schedules did not include mode.
Factors; Proposed Rule’’ (68 FR 34036) provisions for determining facepiece ANSI’s Respiratory Protection
that contained proposed definitions for leakage as part of the respirator Subcommittee (‘‘Subcommittee’’)
APFs and MUCs, a proposed Table 1 certification process. decided to revise Z88.2–1969 in the late
with APFs for the various respirator NIOSH sponsored additional 1970s. During its deliberations, the
classes, and proposed revisions to the respirator studies at LASL, beginning in Subcommittee conducted an extensive
APF provisions and tables in OSHA’s 1971, that used quantitative test systems discussion regarding the role of
substance-specific standards. The to measure the overall performance of respirator protection factors in an
NPRM announced that OSHA would be respirators. In a 1976 report titled effective respiratory protection program.
holding an informal public hearing in ‘‘Respirator Protection Factors’’, Edwin As a result, the Subcommittee decided
Washington, DC on the proposal. The C. Hyatt of LASL included a table of to add an APF table to the revised
public hearings were held over three protection factors for: single-use dust standard. In May 1980, ANSI published
days, from January 28–30, 2004. OSHA respirators; quarter mask, half mask, and the revision as Z88.2–1980 which
received extensive pre-hearing full facepiece air-purifying respirators; contained the first ANSI Z88.2
comments (Exs. 9–1 through 9–43 and and SCBAs (Ex. 2). Hyatt based these respirator protection factor table (Ex. 10,
10–1 through 10–60), written hearing protection factors on data from DOP and Docket H049). The ANSI Subcommittee
testimony (Exs. 16–1 through 16–25), sodium chloride quantitative fit test based the table on Hyatt’s protection
post-hearing comments (Exs. 17–1 studies performed at LASL on these factors, which it updated using results
through 17–12), and post-hearing briefs respirators between 1970 and 1973. The from fit testing studies performed at
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(Exs. 18–1 through 18–9 and 19–1 table also contained recommended LANL and elsewhere since 1973. For
through 19–8). Transcripts of the public protection factors for respirators that example, the protection factor for full
hearings also were made and added to had no performance test data. Hyatt facepiece air-purifying particulate
the APF Docket (Exs. 16–23–1, 16–23– based these recommended protection respirators was 100 when qualitatively
2, and 16–23–3). It is from these public factors on the judgment and experience fit tested, or 1,000 when equipped with

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HEPA filters and quantitatively fit other information [were] used to decide what respirators. Therefore, the APFs for
tested. The table consistently gave value to place in the table. In all cases where these respirators were based on
higher protection factors to tight-fitting the assigned protection factor changed when analogies with other similarly designed
compared to the 1980 standard, the assigned
facepiece respirators when employers number is lower in the 1992 standard.
respirators (Ex. 135). The ANSI
performed quantitative fit testing rather Subcommittee based the APF of 50 for
than qualitative fit testing. The ANSI In addition, the 1992 ANSI Z.88.2 half mask continuous flow atmosphere-
Subcommittee concluded that PAPRs standard abandoned ANSI’s 1980 supplying respirators, and the APF of 25
(with any respiratory inlet covering), practice of giving increased protection for loose-fitting continuous flow
atmosphere-supplied respirators (in factors to some respirators when atmosphere-supplying respirators, on
either a continuous flow or pressure- quantitative fit testing was performed. the similarities between these
demand mode), and pressure-demand Thomas Nelson, the co-chair of the respirators and PAPRs with the same
SCBAs required no fit testing because ANSI Z88.2–1992 Subcommittee, airflow rates. Nelson noted that the
they operated in a positive-pressure published a second report entitled ‘‘The ANSI Subcommittee set the APF of
mode. ANSI assigned high protection Assigned Protection Factor According to 1,000 for full facepiece continuous flow
factors to these respirators, but limited ANSI’’ (Ex. 135) four years after the atmosphere-supplying respirators
their use to concentrations below the Z88.2 Subcommittee completed the consistent with the APF for SARs with
IDLH values. Pressure-demand SCBAs revised 1992 standard. In the report, helmets or hoods using the results of
and combination continuous flow or Nelson reviewed the reasoning used by two earlier studies: a WPF study by
pressure-demand airline respirators the ANSI Subcommittee in setting the Johnson (Ex. 1–64–36) and a SWPF
with escape provisions for use in IDLH 1992 ANSI APFs. Nelson noted that the study by Skaggs (Ex. 1–38–3). The
atmospheres were assigned protection Z88.2 Subcommittee gave an APF of 10 Subcommittee used the design analogy
factors of 10,000 plus. to all half mask air-purifying respirators, between PAPRs and continuous flow
In response to a complaint to NIOSH including quarter mask, elastomeric,
supplied-air respirators to select the
that the PAPRs used in a workplace did and disposable respirators. The
APF of 50 for half mask pressure-
not appear to provide the expected Subcommittee also recommended that
demand SARs and an APF of 1,000 for
protection factor of 1,000, Myers and full facepiece air-purifying respirators
full facepiece pressure-demand SARs.
Peach of NIOSH conducted a WPF study retain an APF of 100 (from the 1980
Nelson stated, ‘‘The committee believed
during silica-bagging operations. Myers ANSI standard) because no new data
that setting a higher APF because of the
and Peach tested half mask and full were available to justify another value.
pressure-demand feature was not
facepiece PAPRs under these Nelson noted that the Z88.2
warranted, but rather that the total
conditions, and found protection factors Subcommittee approved the RDL’s
airflow was critical’’ (Ex. 135).
that ranged from 16 to 215. They reduction to an APF of 25 for loose-
Nelson noted in the report that the
published the results of their study in fitting facepieces and PAPRs with
Subcommittee selected no APF for
1983 (Ex.1–64–46). The results of this helmets or hoods based on their
SCBAs. In explaining the committee’s
study led NIOSH and other researchers, performance in WPF studies. For half
decision, he stated that ‘‘the
as well as respirator manufacturers, to mask PAPRs, the ANSI Subcommittee
performance of this type of respirator
perform additional WPF studies on set an APF of 50 based on a WPF study
may not be as good as previously
PAPRs and other respirators. by Lenhart (Ex. 1–64–42). The ANSI
measured in quantitative fit test
NIOSH revised its RDL in 1987 (Ex. Subcommittee had no WPF data
chambers.’’ Nelson also observed that
1–54–437Q) to address advances in available for full facepiece PAPRs, so
Nelson indicated that the Subcommittee the ANSI Z88.2–1992 standard justified
respirator technology and testing. The this approach in a footnote to the APF
revision retained many of the provisions selected an APF of 1,000 to be
consistent with the APF for PAPRs with table. The footnote states:
of the 1978 RDL, but also lowered the
APFs for other respirators based on helmets or hoods. The Subcommittee, in A limited number of recent simulated
NIOSH’s WPF studies. For example, the turn, based its APF of 1,000 for PAPRs workplace studies concluded that all users
with helmets or hoods on design may not achieve protection factors of 10,000.
APFs were lowered for the following Based on [these] limited data, a definitive
respirator classes: PAPRs with a loose- similarities (i.e., same facepiece designs, assigned protection factor could not be listed
fitting hood or helmet (reduced to 25); operation at the same airflow rates) for positive pressure SCBAs. For emergency
PAPRs with a tight-fitting facepiece and between these respirators and airline planning purposes where hazardous
a HEPA filter (lowered to 50); supplied- respirators. Nelson noted that the results concentrations can be estimated, an assigned
air continuous flow hoods or helmets from a subsequent WPF report by Keys protection factor of no higher than 10,000
(decreased to 25); and supplied-air (Ex. 1–64–40) on PAPRs with helmets or should be used.
continuous flow tight-fitting facepiece hoods were consistent with an APF of A new ANSI Z88.2 Subcommittee
respirators (reduced to 50). 1,000. According to Nelson, the recently finished revising the ANSI
In August 1992, ANSI again revised Subcommittee used WPF studies by Z88.2–1992 standard, in accordance
its Z88.2 Respiratory Protection Myers (Exs. 1–64–47 and 1–64–48), with the ANSI policy specifying that
Standard (Ex. 1–50). The ANSI Z88.2– Gosselink (Ex. 1–64–23), and Que Hee each standard receive a periodic review.
1992 standard contained a revised APF and Lawrence (Ex. 1–64–60) to set an This revised ANSI Z88.2 standard is
table, based on the Z88.2 APF of 25 for PAPRs with loose-fitting currently under appeal to the ANSI
Subcommittee’s review of available facepieces. Nelson stated that two WPF Board.
protection factor studies. In a report studies, conducted by Gaboury and
describing the revised standard (Ex. 1– Burd (Ex. 1–64–24) and Stokes (Ex. 1– C. Need for APFs
64–423), Nelson, Wilmes, and daRoza 64–66) subsequent to publication of When OSHA published the final
described the rationale used by the ANSI Z88.2–1992, supported the APF of Respiratory Protection Standard in
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ANSI Subcommittee in setting APFs: 25 selected by the Subcommittee for January 1998, it noted that the revised
If WPF studies were available, they formed PAPRs with loose-fitting facepieces. standard was to ‘‘serve as a ‘building
the basis for the [APF] number assigned. If Nelson also stated in his report that block’ standard with respect to future
no such studies were available, then the ANSI Subcommittee had no new standards that may contain respiratory
laboratory studies, design analogies, and information on atmosphere-supplying protection requirements’’ (63 FR 1265).

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50127

OSHA’s final Respiratory Protection Integration of the final APF and MUC mask respirators and the establishment
Standard established the minimum provisions into the reserved provisions of the APFs for higher performing
elements of a comprehensive program of paragraph (d) completes that respirators is included in Section VI,
that are necessary to ensure effective standard. With the addition of these Summary and Explanation of the Final
performance of a respirator. The only provisions, appropriate implementation Standard.
parts missing from this building block of the Respiratory Protection Standard B. Background
standard are the APF and MUC by employers in their workplaces
provisions that are being finalized in should afford each affected employee The Occupational Safety and Health
this rulemaking. In the standard the the maximum level of respiratory Act of 1970 (‘‘OSH Act’’), 29 U.S.C.
Agency recommended that employers in protection. 651–678, enacted to ensure safe and
the interim ‘‘take the best information healthy working conditions for
into account in selecting respirators. As III. Methodology for Developing APFs employees, empowers OSHA to
it did under the previous standard, for Respirators promulgate standards and provides
OSHA itself will continue to refer to the A. Introduction overall guidance on how these
NIOSH APFs in cases where it has not standards are to be developed. It states:
In the proposed rule for Assigned
made specific compliance Protection Factors (APFs), OSHA raised (5) The Secretary, in promulgating
interpretations’’ (63 FR 1203). a number of issues or questions about its standards dealing with toxic materials or
In October 2004, NIOSH published its harmful physical agents under this
proposed methodology for deriving subsection, shall set the standard which most
Respirator Selection Logic (RSL), an
APFs (68 FR 34112–34113). OSHA adequately assures, to the extent feasible, on
update of the 1987 RDL. The APF tables
asked for information on: (1) The the basis of the best available evidence, that
in the new RSL have not changed from
those in the 1987 RDL. However, NIOSH evidence-based method used by OSHA no employee will suffer material impairment
in developing the proposed APFs; (2) of health or functional capacity even if such
stated in the forward to the 2004 RSL: employee has regular exposure to the hazard
‘‘[w]hen the OSHA standard on APFs is any additional studies that may be
useful in determining APFs that were dealt with by such standard for the period of
finalized NIOSH intends to consider his working life. Development of standards
revisions to this RSL.’’ (Ex. 20–4.) not already identified by OSHA in the under this subsection shall be based upon
The ANSI Z88.2–1992 APF table also proposal; and, (3) statistical analyses, research, demonstrations, experiments, and
has been a source for interim APFs treatments, or approaches, other than such other information as may be
while OSHA completed its APF those described in the proposal, appropriate. In addition to the attainment of
rulemaking. However, the ANSI Z88.2– available for differentiating between, or the highest degree of health and safety
comparing, the respirator performance protection for the employee, other
1992 respiratory protection standard considerations shall be the latest available
was withdrawn by ANSI in 2003. While data. The vast majority of the comments
scientific data in the field, the feasibility of
a revised ANSI Z88.2 standard has been in response to the NPRM addressed the the standards, and experience gained under
written, the final ANSI standard has yet use of WPF studies for establishing the this and other health and safety laws.
to be published since it is currently APF for filtering facepiece half mask Whenever practicable, the standard
under appeal. Therefore, no ANSI respirators. OSHA also received promulgated shall be expressed in terms of
respiratory protection standard with comments on the methodology and data objective criteria and of the performance
recommended APFs is available at this it used for determining the filtering desired. 29 U.S.C. 655(b)(5) [emphasis
facepiece APF, and was provided with added].
time. The draft APF table from the ANSI
Z88.2 revision was submitted to the new studies on these respirators for A reviewing court will uphold
OSHA rulemaking docket (Ex.13–7–2), consideration. OSHA’s quantitative standards set under this section when
and was the subject of discussion during analyses for establishing the APFs for they are supported by substantial
the public hearings on APFs. OSHA other classes of higher performing evidence in the record considered as a
considered the draft ANSI table during respirators drew little comment, and no whole (29 U.S.C. 655(f)). In searching
its deliberations in this rulemaking. new studies on these respirators were for the ‘‘best available evidence’’ upon
Throughout the Respiratory submitted. This section, therefore, which to base its rulemaking, OSHA is
Protection Standard rulemaking, OSHA focuses on methodology and new required to ‘‘identify the relevant factual
has emphasized that the APF and MUC information relative to the APF for half evidence, * * * to state candidly any
definitions and the APF table are an mask air-purifying respirators. assumptions on which it relies, and to
integral part of the overall standard. A More specifically, Part C of this present its reasons for rejecting any
careful review of the submitted section contains a discussion of the significant contrary evidence or
comments and information supports the comments about OSHA’s proposed argument.’’ Public Citizen Health
Agency’s conclusion that this final methodology for determining APFs for Research Group v. Tyson, 796 F.2d
standard is necessary to guide filtering facepiece half mask respirators, 1479, 1495 (D.C. Cir. 1986).
employers in selecting the appropriate including comments on data analysis OSHA has retained the multifaceted
class of respirator needed to reduce and study selection. In addition, OSHA approach it used in the proposal to
hazardous exposures to acceptable is providing an overview of Dr. Kenny determine the APFs for classes of
levels. The final APF for a class of Crump’s statistical analyses (Ex. 20–1) respirators. That is, the Agency
respirators specifies the workplace level of the updated half mask database (Ex. reviewed all of the available literature,
of protection that a class of respirator 20–2). Comments about alternative including the various analyses by
should provide under an effective approaches are discussed in Part D respirator authorities, as well as
respiratory protection program. In (‘‘Methodology, Data, and Studies on quantitative analyses of data from WPF
addition, the APFs can be utilized by Filtering Facepieces and Elastomerics’’). and SWPF studies. During revision of
employers to determine a respirator’s The Agency’s overall conclusions on the overall Respiratory Protection
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MUC for a particular chemical exposure methodology, and summaries of new Standard, the Agency used a similar
situation. studies submitted during the public approach when reviewing protection
The final APFs must be used in comment process, are presented under factor studies related to the effectiveness
conjunction with the existing provisions Part E. Discussion of the comments and and necessity of a comprehensive
of the Respiratory Protection Standard. opinions regarding the APF for half respiratory protection program.

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50128 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

The Agency did not use Effective regarding the appropriate APF for half The available data are not ideal because
Protection Factor (EPF) and Program mask respirators. The Agency believes there can be considerable model-to-model
Protection Factor (PPF) studies in its that the database it constructed variation and only a few models in each class
have been evaluated. Given that lack of
APF analyses since these measure represents the best available data on complete data, the approach taken by OSHA
deficiencies in respirator program APFs, and that its conclusions are based is the most appropriate currently possible.
practices. More specifically, EPFs are on substantial evidence. See Texas (Ex. 9–13.)
not directly comparable to WPF values Independent Ginners’ Association v.
because the determinations include the The United States Army Center for
Marshall, 630 F.2d 398, 413 n. 48 (5th
time spent in contaminated atmospheres Health Promotion and Preventive
Cir. 1980), citing Industrial Union Dept.,
both with and without respiratory Medicine commented:
AFL–CIO–CIC v. American petroleum
protection. PPFs are affected by any Institute, 448 U.S. 607, 661 (1980). The method of APF development used by
deficient elements of a respirator In past rulemakings, OSHA’s OSHA is appropriate. OSHA reviewed
program, including inadequate available data, both published and
conclusions as to the best available
unpublished; utilized technical reviews and
respirator selection and maintenance, evidence have been upheld as based on summaries from subject matter experts
poor user training and motivation, work substantial evidence when it has relied outside-OSHA; weighed study findings and
activities, and inadequate program on a body of reputable scientific conclusions based on study shortfalls, as
administration. Therefore, OSHA relied evidence. See ASARCO v. Occupational then state-of-the-art technical bias and
on WPF and SWPF studies, since they Safety and Health Administration, 746 procedural omissions; and used a
focus on the performance characteristics F.2d 483, 494 (9th Cir. 1984). OSHA conservative approach to maintain
of the respirator only. need not accept all data presented to it confidence that minimal risk of respirator
During the APF rulemaking, OSHA selection and use errors will exist in worker
as long it considers the data and rejects protection from proposed APF use. (Ex. 9–
reviewed the extensive literature on it on reasonable grounds. See id. 42–1.)
APFs and developed selection criteria Furthermore, each study relied upon by
for including studies and data in its the Agency need not be a model of Nevertheless, some commenters did
quantitative analysis of respirator textbook scientific inquiry, and OSHA not agree with OSHA’s approach. These
performance. This procedure ensured need not find one definitive study participants included several labor
that only carefully designed and organizations (Exs. 9–27, 9–29, 9–34, 9–
supporting its decision. Public Citizen
executed WPF and SWPF studies were 40, and 10–37), trade associations (Exs.
Health Research Group, 796 F.2d at
included in the analysis. The Agency 9–24 and 10–27), and individuals (e.g.,
1489, 1495. Rather, the Agency is
then used these studies to compile the Exs. 9–17, 9–25, 9–33, 9–41, 10–33, and
justified in adopting a conclusion when
NPRM’s original database. The database 10–42). Criticisms of OSHA’s approach
the cumulative evidence is compelling.
was comprised of 917 data points from focused on the Agency’s selection of
Id. at 1489, 1491, 1495. OSHA’s
16 WPF studies for half mask respirators WPF studies for its determination of the
conclusions are strongest when it has
(Matrix 1) and 443 data points from 13 proposed APFs. Reasons given to
relied on multiple data sources that
studies for PAPRs and SARs (Matrix 2), support these criticisms included: The
support each other, as it has in this
conducted in a variety of American differences between the studies do not
workplaces. OSHA made the studies, its permit comparison of the studies; the
selection criteria, the data, and its C. Methodology, Data, and Studies on study conditions are not representative
analyses available to the public Filtering Facepieces and Elastomerics of typical workplaces; the study data are
electronically and through the too old; the data do not cover all
1. Comments on the Methodology
rulemaking docket. In addition, the configurations of filtering facepieces
Agency encouraged the public to access OSHA developed the proposed APFs available; and, the analytical method
this information and to reanalyze the through a multi-faceted approach. As it employed by some studies was too
data using methods of their choice. The stated in the preamble to the proposal, sensitive.
Agency also sought submissions from ‘‘The Agency reviewed the various A few commenters (Exs. 10–34 and
the public of any additional studies for analyses of respirator authorities, 10–47) recommended that certain
inclusion in its database. Four available WPF and SWPF studies, and criteria should be met before a WPF
additional WPF studies of half masks other APF literature.’’ It later concluded study is deemed acceptable for analysis.
were submitted during the public that ‘‘the APFs proposed by OSHA in These criteria include: Exposures to
comment period following publication this rulemaking represent the Agency’s small particle sizes; work time of at least
of the NPRM. Dr. Kenny Crump updated evaluation of all available data and four hours; moderate to heavy work rate;
the Matrix 1 half mask database with research literature i.e., a composite and, high temperature and humidity.
these additional studies (Ex. 20–2) and evaluation of all relevant quantitative Still others believed that OSHA should
reanalyzed the resulting 1,339 data and qualitative information’’ (68 FR develop and perform SWPFs on a
points for half mask respirators (Ex. 20– 34050). OSHA then asked the public if representative subset of all filtering
1). this method was appropriate to facepieces or all configurations of
Dr. Crump also performed a second determine APFs. The methodology was filtering facepiece respirators and all
quantitative analysis in which the 1,339 supported by a number of commenters, respirator models, and establish APFs
accepted data points (original NPRM including NIOSH (Ex. 9–13), the for all classes of respirators based on the
database updated with data from the Department of the Army (Ex. 9–42), SWPF study results (Exs. 9–41 and 10–
four new studies) for half mask ALCOA (Ex. 10–31), and others (e.g., 27). A more detailed discussion of data
respirators were combined with 403 Exs. 9–1, 9–4, 9–14, 9–16, 9–22, 10–2, issues is presented below.
data points from 12 studies that the 10–17, 10–18, and 10–59). NIOSH
Agency originally excluded from the stated: 2. Comments on Data and Study
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analysis. This second analysis Problems

NIOSH agrees that the APF values resulting
corroborated the original findings to the from this multi-faceted approach are Selection bias in WPF studies. Several
extent practicable. The results of both of reasonable indications of the level of commenters stated that the authors of
these analyses provide compelling protection that should be expected for each WPF studies ‘‘cherry-picked’’ either the
support of OSHA’s conclusions class of respirators. * * * workplaces in which the studies were

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50129

conducted or the individual tasks that concern to identify specific studies in grinding, torch cutting, pouring molten
were performed by workers chosen for which the observer effect may have been metal, handling concrete blocks, and
monitoring (Pascarella, Tr. at 464; involved, they could not do so (i.e., in spray painting. Work rates for these
Faulkner, Tr. at 549 and 564–565). no case did the commenters provide any studies, when provided, ranged from
‘‘Cherry-picking’’ is a common term for example to support their allegations). In low to heavy.
‘‘selection bias.’’ Selection bias is a its own analysis of the WPF studies, the The purpose of a WPF study is to
matter of concern when either Agency was also unable to find any evaluate a respirator’s effectiveness
workplace study participants or job evidence of an observer bias. under actual workplace use conditions.
tasks are selected for inclusion in the Representativeness of the data. A Consequently, the contaminant
study in a manner that skews the results number of commenters expressed concentrations and particle sizes
of the study away from the true value. concern that the study data analyzed by contained in the analyzed studies were
Selection bias is a matter of concern OSHA were not representative of generated while the workers performed
for all scientific studies, not just WPF conditions found in the construction their normal job duties. With regard to
studies, and peer reviewers typically industry (Ex. 9–29, Building concerns about particle size, Myers et al.
evaluate its effects before a study is Construction Trades Department), or of (Ex.1–64–51) found particles larger than
accepted for publication in a peer- workplace conditions in general (e.g., 10 microns inside the respirator
reviewed journal. Most of the studies Exs. 9–34, International Union facepiece. The Agency believes that
included in OSHA’s analysis of WPF Operating Engineers; 9–35, Melissa accepting only WPF studies that are
studies were either published in peer- Rich; 9–40, United Steel Workers of conducted at exposure levels close to 10
reviewed journals or were presented at America; and 10–60, Paul Hewett). The times the PEL, with particulates of two
the AIHCE, and met the criteria for bulk of these concerns are represented microns in size or less, would not be
respirator research studies accepted by in the comments of Melissa Rich, a representative of the conditions found
the industrial hygiene community. The Department of Energy respirator in the workplace. Studies based on such
half mask database consists of 16 program manager, who stated: selective criteria would be more akin to
studies performed in a variety of a SWPF, rather than a WPF, study.
The selection of the test sites for the cited
workplaces over a range of years (from APF proposed rulemaking WPF studies are
OSHA has concluded that the data used
1976 to 2004) by many different not representative of the worksite for in its analyses are applicable to other
researchers. Therefore, it is highly American workers. Many test sites chosen for American work settings because a range
improbable that these studies were these studies were selected on availability of work rates and environmental
subject to selection bias. OSHA could only. Moreover, key study attributes such as conditions were represented, and many
find no instance of selection bias either hot humid conditions, long work hours, and of the tasks performed by the test
in its review of the scientific studies or heavy workload were the exception, not the subjects are performed in a variety of
its analysis of the data. Finally, OSHA norm for most of the cited studies. Most test workplaces, including construction.
repeatedly asked commenters who sites had ambient concentrations less than Accordingly, the Agency is not
the OSHA half mask respirator maximum use
raised concerns about ‘‘cherry-picking’’ limit (i.e., ten times the PEL).
persuaded by comments suggesting that
for specific studies in which selection the studies were so narrowly focused
bias occurred. In no case did the * * * * * that the data cannot be applied to other
The various particle sizes, a critical issue
commenters provide any details to in a WPF, cited in many of the APF proposed
work settings.
support their allegations. rule Workplace Protection Factor studies are Sensitive analytical method. Several
Observer effect in WPF studies. so large that they do not penetrate the commenters questioned the use of
Several commenters (Shine, Tr. at 644 faceseal. Many respiratory protection studies sensitive analytical methods for the
and Macaluso, Tr. at 652) stated that have indicated that particles larger than two analyses of workplace exposures,
data from the WPF studies considered microns are less likely to penetrate the most sometimes accompanied by a
by OSHA were the result of a condition important attribute of a respirator, the recommendation to test respirators
known as the ‘‘observer effect.’’ The faceseal. Most of the APF proposed rule under controlled laboratory settings,
observer effect occurs when the act of Workplace Protection Factor studies have a and at sufficiently high concentrations
particle size greater than two microns. (Ex. 9–
observing or monitoring test subjects to obtain inside-the-facepiece
causes their responses to differ from measurements (Ci) that can be assessed
their usual (nonobserved) responses. In The studies analyzed by OSHA by less sensitive methods (e.g., Exs. 9–
some of the WPF studies used by OSHA, consisted of a varied cross-section of 32, 9–35, 10–6, 10–37, and 10–49). The
the researchers stated that during the workplaces and conditions. For commenters believed that sensitive
study, they were present to monitor the example, workplaces included ship analytical methods (particularly PIXEA,
test equipment to ensure that the breaking, asbestos removal, aluminum proton-induced x-ray emission analysis)
sampling equipment functioned and lead smelters, brass foundries, and permit the determination of low Ci
properly, thereby increasing the aircraft painting and manufacturing. concentrations, resulting in high
usefulness of the results. In other WPF Two of the four new studies analyzed by protection factors.
studies, the researchers did not indicate OSHA involved concrete-block In response to these comments, OSHA
their presence during the study. manufacturing. The authors of an reviewed the seven half mask studies
The mere presence of an observer aluminum smelter study (Ex. 1–64–24) that used the PIXEA analytical method
does not, in and of itself, presume that noted that employees were required to (Exs. 1–64–19, 1–64–51, 1–64–52, 1–64–
there will be an observer effect. For rest in a cool area for 50% of each hour 15, 1–64–16, and 1–64–34) and found
example, if the observer is a researcher due to high heat, and a steel mill study that six of the studies used the method
who is monitoring the test equipment (Ex. 1–64–50) and a primary lead to measure both the Ci and Co
instead of a supervisor who is smelter study (Ex. 1–64–42) both were concentrations. The seventh study (Ex.
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monitoring the workers’ practices, the conducted in the sinter plant and blast 3–12) used PIXEA to measure the Ci
workers are unlikely to change their furnace areas. The asbestos study (Ex. concentration but used atomic
practices. 1–64–54) was conducted under high absorption (AA) to assess Co
Although the Agency repeatedly humidity conditions. Tasks performed concentrations because the respirator
asked the commenters who raised this by test subjects included welding and filters were overloaded. However, the

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50130 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

Agency does not believe that this study study, the higher sensitivity of PIXE[A] is contaminants in the various WPF
provided inaccurate results. Under necessary to get the best data. (Ex. 19–3–1.) studies in the docket range from [about]
conditions of high Co concentrations, Tom Nelson commented that ‘‘[t]he 0.5 [microns] to 14 [microns] MMAD,’’
the AA method must be used because analytical method must be sensitive for and that ‘‘particles much larger than
the PIXEA method would exceed its a WPF study. For a half facepiece those that would be predicted from
maximum measurement limits. respirator[,] the detection limit should laboratory studies have been found
Therefore, the PIXEA method would be be at least 1⁄100 of the ambient inside the facepiece in WPF studies’’
unable to provide accurate Co data. concentration’’ (Ex. 18–9). Later in these (Ex. 18–9). At the hearing, Nelson
Based on its review of these seven comments, Nelson stated, ‘‘The [low- presented data showing that large
studies, the Agency found that the concentration Ci] samples are part of the particles enter half mask respirators,
sensitive analytical method (i.e., PIXEA) distribution of WPF samples collected probably through breaks in the faceseal;
allowed the investigators to quantify during a study. These represent true moreover, these data demonstrate that
small amounts of contaminant that measures of performance.’’ no relationship exists between particle
penetrate a respirator. This method Based on the evidence in the record, size and the WPF obtained for the
permitted accurate assessment of Ci OSHA concludes that using sensitive respirator (Tr. at 146–148). The 3M
concentrations under conditions of low analytic methods for assessing Ci Company addressed this point further,
ambient concentrations, thereby samples is both necessary and stating in its comments:
permitting the use of actual Ci values in appropriate. Specifically, the Agency Laboratory studies have shown that
determining WPFs. Less sensitive sees no scientific basis for excluding particle losses occur through fixed leaks. A
methods would result in penetration WPF studies that used PIXEA, faceseal leak is not accurately represented by
values that are nondetectable or less particularly when using the method to a fixed leak, however. To perform these
than the limit of detection (LOD) for the determine both Ci and Co. The Agency’s studies[,] assumptions were made regarding
analytic method, thereby requiring the leak size, shape, and the particle size
review of the record evidence shows penetrating those leaks. These assumptions
study to discard these data or to correct that a leading national organization have been shown to be wrong. Myers has
for nondetected values using representing industrial hygienists (i.e., shown that large particles can be found
unvalidated statistical techniques. On the AIHA) recommends using sensitive inside the facepiece[,] much larger than
the other hand, the sensitive analytical analytic methods for assessing Ci could have occurred with the fixed leaks
method was able to quantify low Ci samples. Furthermore, using sensitive used by several researchers.[] As shown in
concentrations, thereby enhancing the analytic methods improves significantly Figure 1 [of the Myers et al. study], an
validity of the subsequent analysis by analysis of particle size and the geometric
the validity of data analyses by allowing mean WPF from a number of studies does not
retaining the actual data and avoiding studies to retain low Ci values, and by show any relationship between particle size
unvalidated statistical corrections. reducing substantially the need to use and WPF. If the size of the particle played
Craig Colton of 3M provided the unvalidated techniques to correct low Ci a role in faceseal leaks, a relationship would
following testimony in support of values. Therefore, OSHA concludes that be evident. (Ex. 9–16.)
OSHA’s conclusions: the data from the WPF studies used in Based on the evidence in the record,
Some commenters also asserted that the its analyses are accurate, and that the OSHA concludes that the data in its
use of analytical methods with low detection availability of data with low Ci values APF analyses for half masks were the
limits are a reason to invalidate some of the improved the validity of the APFs
WPF studies. The claim is erroneously made
same as particle sizes found in the
derived from these analyses. workplaces represented in the WPF
that the analytical sensitivity affects the
results from WPF studies. However, the
Large particles. Several commenters studies. Therefore, eliminating the study
actual amount of contaminant on the Ci (e.g., Exs. 9–33, 9–35, 10–6, 10–37, and data from the Agency’s analyses would
sample is not changed by the analytical 10–41) postulated that larger particles be unnecessary and inappropriate.
method. (greater than one or two microns) do not Probe bias. Probe bias refers to the
* * * Because the [Ci levels are] typically penetrate a respirator’s faceseal. They misplacement of the sampling probe
very small in a WPF study, the higher believed that WPF studies having large when taking measurements inside the
sensitivity of [the PIXEA method] is particles in the Co concentration should
necessary to get the best data.
respirator facepiece. Some commenters
* * * The WPF protocol from the AIHA
be excluded from OSHA’s analyses. expressed concern that probe bias may
Respirator Committee recommended the use They reasoned that these large particles have underestimated Ci in the half mask
of analytical methods with sensitive were being measured as part of the Co WPF studies analyzed by Dr. Brown
detection limits. * * * Use of less sensitive but had no chance of being measured in (e.g., Exs. 9–17, 9–30, 9–35, and 10–42).
analytical methods for * * * [Ci] sample[s] the Ci, and consequently were inflating These commenters suggested that OSHA
that result in nondetect values are not the WPF values. reanalyze its database after applying a
meaningful for determining true exposure. These commenters appear to be
(Tr. at 413–414.)
correction factor to account for probe
ignoring the possibility that half masks bias. Tim Roberts provided a specific
In its post-hearing comments, 3M (both elastomerics and filtering description of this concern when he
illustrated the value of sensitive facepieces) with faceseals that testified:
analytical methods using the following selectively filter large particles still are
Respirator probe error is an issue. It’s been
example: capable of providing an adequate level better characterized for elastomeric type
[C]onsider three filters ‘‘spiked with 1 µg of protection. Nevertheless, OSHA notes respirators than it has for filtering facepiece
of silicon each and analyzed by three that in one of the WPF studies used in respirators, and we think that this needs
different methods [gravimetric, atomic OSHA’s data analyses, Myers et al. some additional work as well, to characterize
absorption (AA), and PIXEA]. In the case of found large particles (i.e., 10 microns in what that means when we put probes in
gravimetric and AA analyses, it is certain diameter) inside the facepiece, different locations in elastomeric facepieces
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only that the silicon mass on the filter is indicating that large particles are (Tr. at 208).
between 0 µg and 10 [µg] or 0 µg and 5 µg
respectively. However, PIXE[A] has sufficient capable of penetrating a respirator Later in the hearings, Ching-tsen Bien
analytical sensitivity to ‘‘find’’ the true value faceseal (Ex. 1–64–51). Consistent with questioned Craig Colton of 3M on
of 1 µg. Because the mass of contaminants on these results, Tom Nelson stated in his Colton’s experiences with probe
a Ci filter is typically very small in a WPF comments that ‘‘[t]he particle size of location while conducting filtering

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facepiece WPF studies. Colton studies, whether corrected for probe al. (Ex. 27–11; 63 FR 1167) substantiates
responded: bias or excluded altogether, would have these conclusions.
[S]treamlining that you see is similar to resulted in APFs that differed from the Ching-tsen Bien of LAO Consulting,
that in the elastomeric half-facepieces. You final APFs derived from this Inc. (Ex. 18–5) wanted OSHA to enter
see it streamlining from the leak up to the rulemaking. into the record any available
mouth and nose. And so what Dr. Myers independent assessment reports (and
indicated in his sampling bias—not really
3. Summary and Conclusion
probe bias, but the sampling bias—was that
applicable check lists) for the year prior
OSHA considered the comments to, and for the year of, each WPF study.
location becomes important because if your
probe is flushed with the facepiece, you can
addressing the data and study problems Bien noted that the reports would have
miss the streamlines. So his recommendation identified by commenters, but does not covered applicable program elements,
was that the probe needs to be ideally on the find that these comments merit rejection and ensure that OSHA selected studies
midline, between the mouth and the nose, of the data or analyses. The studies for its analyses that were in compliance
and as close to the face as possible. And so OSHA analyzed were conducted on with appropriate respiratory protection
that’s what we attempt to do as best as you employees in actual workplaces who standards. He also requested that OSHA
can with the products you end up testing to were performing their normal job duties. enter the ‘‘selection criteria, decision
meet his recommendations. (Tr. at 455–456.) Consequently, the particle sizes, work matrix for each study, and the review
Colton also noted that, although some rates, work times, and environmental report for these studies to the H–049C
of his studies may show probes entering conditions varied among these studies. Docket’’ (Ex. 18–5.)
the side of the filtering facepiece, a The Agency has concluded that using
data collected under these various As stated in the NPRM at 68 FR
probe extension was used to place the
sampling inlet in the nose-mouth area conditions presents a more accurate 34046, the Agency evaluated all studies
(Tr. at 455–456). Tom Nelson explained picture of workplace use of these used in its analyses for compliance with
the purpose of the probe location when respirators and is a better measure of the the requirements of OSHA’s Respiratory
he commented, ‘‘The sampling probe is protection provided by half mask Protection Standard (29 CFR 1910.134),
placed so that it is close to the nose and respirators than data collected only from as well as for completeness of the data.
mouth. This minimizes sampling bias’’ SWPF or other highly controlled The Agency also compiled a list of
(Ex. 18–9). Warren Myers testified that, studies. criteria (Ex. 5–5) for evaluating each
in unusual circumstances, the study. Accordingly, OSHA evaluated
D. Alternative Approaches each published article or each written
configuration of a half mask (including
some elastomerics) requires placing the 1. Alternatives Based on Non-Compliant study report to determine whether the
sampling probe on the side of the mask Respirator Programs test subjects were trained properly, fit
instead of the centerline between the tested, medically evaluated, and in
nose and the mouth; in these cases, a Several commenters suggested compliance with the requirements of the
study can control for sampling bias by alternative means for ascertaining APFs. OSHA Respiratory Protection Standard.
randomly alternating the location of the While not completely disagreeing with The researchers performing these WPF
probe on the right and left side of the OSHA’s approach, Paul Hewett of studies ensured that fit testing was
mask (Tr. at 77). Exposure Assessment Solutions performed on the test subjects, trained
OSHA also reviewed the 13 half mask Incorporated (Ex. 10–60) stated that them on doffing and donning the
studies analyzed by Dr. Brown. The OSHA should include EPF studies in its respirator, as well as the performance of
authors of nine of these studies APF deliberations. He commented that user seal checks, on the selection of
specifically state that the probe was EPF studies account for actual use proper-sized respirators, and on the
located in the area of the nose and conditions in that they factor in the time other elements of a complete OSHA-
mouth. While the remaining four that the employee does not wear the compliant respirator program. These
studies do not specify the probe’s respirator but is still exposed to researchers did not rely on the existing
location, no evidence from this atmospheric contaminants. He also workplace respirator program, but
rulemaking indicates that the sampling believed that determination of an instead performed the necessary actions
probes were inappropriately placed. appropriate APF should represent to ensure that the test subjects in their
Therefore, the majority of the WPF respirator use in hot, strenuous jobs. WPF studies met the respirator program
studies, along with the new studies Therefore, he recommended that requirements.
included in the updated database, ‘‘OSHA should factor in real world The WPF studies the Agency
located the sampling probe in the nose- conditions and not rely exclusively on evaluated were either WPF studies that
mouth area. Of the 1,339 data points in WPF and particularly SWPF studies’’ had been published previously, or were
the updated database, approximately (Ex. 10–60.) newly performed studies that were
220 of these points (about 16%) are from OSHA noted in the proposal that the submitted during the rulemaking for
the four studies in which no Agency would analyze only WPF and inclusion in the OSHA database. OSHA
information on probe placement was SWPF studies since they address did not perform these studies, and was
available. OSHA believes the sampling respirator performance exclusively (68 not involved in the selection of the
methodology that was used in these FR 34045). This alternative approach worksites being tested. Therefore, the
studies was consistent with comments already has been addressed above by the Agency could not gather additional
indicating that the optimum location for Agency in its discussion of the information on a worksite’s respirator
a probe is at the centerline between the usefulness of WPF data. The Agency has program that was in effect when a WPF
nose and the mouth. At this location, no data in the record showing that EPF study was performed, as Bien requested.
the probe will sample any streamlining studies would improve, or even Additionally, such information is
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that occurs between a faceseal leak and complement, its analyses. Therefore, irrelevant to the results of a WPF study
the nose-mouth area, thereby detecting OSHA is not convinced that EPF data since the researchers had to demonstrate
the maximum Ci exposure level. In would increase the validity of the APFs compliance with the required respirator
addition, no analysis was submitted derived in this final rule. The program before OSHA included the
indicating that the data from these discussion of an EPF study by Harris et study in its database.

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2. Alternatives Based on SWPF Studies concluded that its approach in using class using information from existing
The American Chemistry Council (Ex. both WPF and SWPF studies is well WPF and SWPF studies.
10–25) stated that OSHA’s APFs should supported by the rulemaking record and
4. Nicas-Neuhaus Model
be based on SWPF studies, and that the is appropriate for determining APFs
specified in this final rule. Several commenters (Paul Hewett, Ex.
APFs derived from this rulemaking
10–60; Bill Kojola, AFL–CIO, Ex. 17–2;
should be used only as interim values 3. Model-Specific APFs and NIOSH, Ex. 17–7–1) asked OSHA to
until SWPF studies could be performed.
consider a February 2004 article by
OSHA notes that basing APFs on SWPF The Organization Resources
Nicas and Neuhaus (Ex. 17–7–2) that
studies, rather than on WPF studies, Counselors Worldwide (Ex. 10–27), the
applies a model for analyzing WPF data
was recommended by a number of American Chemistry Council (Ex. 10–
to establish APFs. The Nicas-Neuhaus
commenters including Organizational 25), and the Pharmaceutical Research
article is based on the variability of
Resource Counselors Worldwide (ORC) and Manufacturers of America (Ex. 9–
WPFs (i.e., the variability between
(Ex. 10–27), Paper, Allied-Industrial, 24) urged OSHA to develop model-
different test subjects, as well as the
Chemical & Energy Workers specific APFs. Under this
variability within a test subject resulting
International Union (PACE) (Ex. 10–37), recommendation, each respirator model from repeated donnings of the
and others (e.g., Exs. 9–32, 9–41, 10–6, would undergo testing and be assigned respirator). APFs based on this Nicas-
10–49, 9–33, 9–35, and 18–5). These a unique APF. NIOSH did not support Neuhaus model require that WPFs for
commenters expressed various concerns this approach. In response to 95% of all workers be above the APF
about the WPF studies, and stated that questioning by OSHA, NIOSH stated: 95% of the time. However, the
SWPF studies permit investigators to This morning’s expert witnesses and the established method for deriving APFs
control a number of variables (e.g., questions I think clearly identified that there used by OSHA, NIOSH, and ANSI sets
particle size, contaminant is variability, and because of this variability, the APFs at the 95% percentile of the
concentration, environmental we believe that class APFs are more between-subject WPFs. By controlling
conditions) that cannot be controlled in appropriate and consistent with the state of for within-subject variability, APFs
WPF studies. the art today. In order to achieve more
precise data, much, much larger data sets,
based on the Nicas-Neuhaus model will
SWPF studies use sensitive analytical always be smaller than APFs derived
methods, such as PIXEA, to obtain including the numbers of test subjects that
would have to be involved to eliminate this using the established method.
measurable Ci information. SWPF To account for within-subject
variability, seems impractical based upon the
studies safely test a respirator in a high- variability, the Nicas-Neuhaus model
state of the art today. So we are for these
concentration atmosphere (i.e., at the reasons supporting class APFs, not model- requires repeated measurements on each
respirator’s limit of protection) to specific APFs. (Tr. at 120.) test subject which is not required by the
generate enough penetration for the established method. Consequently, most
analytical method to quantify Ci results. OSHA considered the use of SWPF available WPF studies did not include
OSHA agrees that SWPF testing permits studies in developing model-specific multiple measures on individual test
an investigator to control factors such as APFs. The Agency’s review of the ORC subjects, resulting in an extremely
particle size, contaminant SWPF study of PAPRs and SARs in the limited database for applying the Nicas-
concentration, temperature, and proposal (68 FR 34069) stated that ORC Neuhaus model. Nicas and Neuhaus
humidity. Accordingly, the Agency used had recommended that ‘‘the [ORC were able to analyze only seven half
data generated from all available SWPF SWPF] study methodology should be mask respirator studies, comprising a
studies in determining APFs. However, the basis for determining APFs for all total of 310 data pairs. In comparison,
OSHA concluded that controlled SWPF respiratory protective equipment the database established and analyzed
studies alone are not representative of, regulated by OSHA’’ (68 FR 34070). by OSHA for determining the final APFs
nor can they be extrapolated readily to, However, only a few SWPF studies are contains 1,339 data pairs from 16 half
typical workplaces. Standardized available that measured the performance mask respirator studies. Also, OSHA
protocols for conducting such testing, or of a few PAPRs and SARs. Model- had rejected for its analyses several of
a methodology for extrapolating SWPF specific SWPF studies for the remaining the WPF studies used by Nicas and
results to protection levels expected in respirator classes have not been Neuhaus in developing their model
the workplace, are not available. ORC performed. In addition, the respirator because these studies did not meet the
stated, ‘‘We advocate development of a protection community has not agreed on Agency’s selection criteria.
protocol based on a combination of a standard protocol for conducting The Nicas-Neuhaus model is a
laboratory testing and field trials for SWPF studies, or how the results relate significant departure from established
determining expected respirator to APFs. These issues would have to be and accepted practices used by the
performance’’ (Ex. 10–27). NIOSH also addressed before it would be possible to respirator research community, The
supported the use of both SWPF and use model-specific APFs. Also, Agency has concluded that there are
WPF studies, noting, ‘‘NIOSH agrees insufficient data are available to set insufficient data to fully evaluate the
that the APF values resulting from model-specific APFs, and developing proposed model, and to incorporate it in
OSHA’s multifaceted approach to the methodology and conducting the setting APFs.
analysis of existing data provide testing could take years. OSHA believes
reasonable values for the level of that completing the APF rulemaking 5. Other Alternative Approaches
protection that should be expected for with the information available now is Sheldon Coleman recommended that
each class of respirators’’ (Tr. at 102). necessary. Delaying this rulemaking to OSHA select a panel from AIHA
NIOSH continued, ‘‘Given this lack of develop model-specific APFs will result members to review the APF data and
complete data, the noted model-to- in employers not knowing what OSHA’s APF determinations (Ex.10–40).
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model variation and the imperfection in respirators to select and, consequently, OSHA believes this rulemaking has
protection level measurements, the employees will not receive adequate provided ample opportunity for
approach taken by OSHA is the best protection. Based on the rulemaking comment from the public and
currently possible based upon available record, the Agency has concluded it will professional associations. Further
data’’ (Tr. at 103). The Agency has determine an APF for each respirator analysis would delay the development

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of the final APFs, and is unnecessary as submitted for higher-performing measurements. The data submitted to
the rulemaking record is sufficient to respirators. OSHA from this study are provided in
determine APFs. In the NPRM, Dr. Brown initially Appendix A of Dr. Crump’s report on
divided negative pressure half mask air- the reanalysis of the half mask database
6. Summary and Conclusion
purifying respirators (APRs) into five (Ex. 20–1).
OSHA is relying on science, data, and classes. Four classes of filtering The second set of WPF data provided
established quantitative analyses to facepiece half masks were derived based by 3M Company was from a study by
establish the final APFs for filtering on whether a respirator had adjustable Bidwell and Janssen (Ex. 9–16) on the
facepiece and elastomeric half mask head straps, an exhalation valve, a performance of a ‘‘flat-fold’’ filtering
respirators, and is limiting its statistical double-shell construction, or a foam- facepiece respirator conducted at a
analyses to those procedures that use ring faceseal. Elastomeric half masks concrete-block manufacturing facility.
the selected data to the fullest extent were grouped together in a single fifth Repeated measurements of WPFs were
possible. Reliance on alternative class. (See Ex. 5–1 for details on made on 19 workers, and each sample
approaches is not supported by the respirator class definitions.) In his
evidence in the record. The data to use was analyzed for both silicon and
analyses, Dr. Brown found no clear calcium. A total of 73 Co and 73 Ci air
such approaches are not currently evidence of a difference in WPFs across
available, and require either a different samples were collected, for a total of
these different classes. In particular, he 146 WPF measurements. Eleven of the
set of data or a standardized testing found that elastomeric half masks
protocol that requires testing every 146 Ci measurements were non-
performed substantially the same as detectable (all coming from silicon
respirator model. OSHA concludes that filtering facepieces. From the original
the available data and analytic methods exposures).
database of 917 WPF measurements for
used in determining the final APFs are negative pressure half mask APRs, 36 The third study added to the database
appropriate. WPF measurements (3.9%) were found was a WPF study by Colton (Ex. 4–10–
to have an APF less than 10, and 96.1% 4) on the performance of an elastomeric
E. Updated Analyses half mask respirator. This study had
at 10 and above.
1. Review of the Original WPF and been submitted earlier to OSHA, but
SWPF Databases 2. Updated OSHA Database on APRs was not included in the NPRM database
In developing its proposed rule In the NPRM, OSHA asked if any since it was received too late for
regarding APFs for respirators, OSHA more WPF or SWPF studies should be inclusion in Dr. Brown’s original
contracted with Dr. Kenneth Brown to considered in setting APFs. Data from analysis. The data from this study,
investigate possible approaches for four additional studies were submitted conducted in the battery-pasting and
evaluating respirator performance data for OSHA’s evaluation during the assembly areas of a battery
from WPF and SWPF studies. To assist comment period, and an updated half manufacturing plant, have now been
Dr. Brown in this evaluation, the mask database was compiled using added to OSHA’s updated database.
Agency reviewed the available studies these studies (Ex. 20–2). During the Also, three additional data points from
and created a database from these post-hearing comment period, the 3M a study by Myers and Zhuang (Exs. 1–
studies. In deciding which WPF studies Company provided OSHA with data 64–50 and 3–14) were added to the
to include in this database, OSHA from two additional WPF studies of updated database. These data were
evaluated studies with respect to filtering facepiece respirators. One study collected in a concrete-block facility
compliance with the requirements of its (Colton and Bidwell, Ex. 9–16–1–1) while elastomeric half mask respirators
Respiratory Protection Standard (29 CFR measured the performance of three were worn as protection against calcium
1910.134) and the completeness of the different types of filtering facepiece and silicon particulates.
data. In doing so, the Agency excluded respirators used by 21 workers at a lead- The updated OSHA half mask
WPF studies of gas or vapor battery manufacturing plant. One database (Ex. 20–2), summarized in
contaminants due to the limited number respirator (3M 8710) was approved Table III–1, contains 1,339 WPF
of these studies and the difficulties in under 30 CFR part 11, and two measurements—760 collected from
conducting and interpreting data from respirators were N95 particulate filtering facepiece respirators, and 579
such studies (68 FR 34046). During the respirators (3M 8210 and 3M 8510) from elastomeric respirators. The
rulemaking, OSHA received new WPF approved under 42 CFR part 84. Up to database originally analyzed by Dr.
data on half mask respirators. No new three WPF measurements were made Brown contained 917 WPF
SWPF data were submitted for half with each worker on each respirator measurements—471 from filtering
masks, and no new WPF data were type, for a total of 143 WPF facepieces, and 446 from elastomerics.


Number Number
Respirator Figure 1 No. Constituent sampled Author Exhibit No. samples per samples per
class study class

Filtering Facepiece Respirators

1 ................................... 1 Asbestos ............................ Dixon ................................. 1–64–54 26 474

1 ................................... 2 Fe ...................................... Myers ................................. 1–64–50, 3–14 21 ....................
1 ................................... 3 Mn ...................................... Wallis ................................. 1–64–70 69 ....................
1 ................................... 4 Al ....................................... Colton ................................ 1–64–15 23 ....................
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1 ................................... 5 Al ....................................... Johnston ............................ 1–64–34 13 ....................

1 ................................... 6 Si ....................................... Johnston ............................ 1–64–34 15 ....................
1 ................................... 7 Ti ........................................ Johnston ............................ 1–64–34 18 ....................
1 ................................... 8 Pb ...................................... Colton & Bidwell ................ 9–16–1–1 143 ....................
1 ................................... 9 Si ....................................... Bidwell & Janssen ............. 9–16 73 ....................

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Number Number
Respirator Figure 1 No. Constituent sampled Author Exhibit No. samples per samples per
class study class

1 ................................... 10 Ca ...................................... Bidwell & Janssen ............. 9–16 73 ....................

3 ................................... 11 Pb ...................................... Myers ................................. 1–64–51, 3–12 19 162
3 ................................... 12 Zn ...................................... Myers ................................. 1–64–51, 3–12 20 ....................
3 ................................... 13 Fe ...................................... Colton ................................ 1–146 31 ....................
3 ................................... 14 Mn ...................................... Colton ................................ 1–146 32 ....................
3 ................................... 15 Ti ........................................ Colton ................................ 1–146 28 ....................
3 ................................... 16 Zn ...................................... Colton ................................ 1–146 32 ....................
4 ................................... 17 Pb ...................................... Colton ................................ 1–64–16 62 124
4 ................................... 18 Zn ...................................... Colton ................................ 1–64–16 62 ....................

Elastomeric Respirators

5 ................................... 19 Asbestos ............................ Dixon ................................. 1–64–54 46 579

5 ................................... 20 B(a)Pyrene ........................ Gaboury ............................. 1–64–24 18 ....................
5 ................................... 21 Pb ...................................... Lenhart .............................. 1–64–42 25 ....................
5 ................................... 22 Pb ...................................... Myers ................................. 1–64–51, 3–12 46 ....................
5 ................................... 23 Zn ...................................... Myers ................................. 1–64–51, 3–12 46 ....................
5 ................................... 24 Fe ...................................... Myers ................................. 1–64–50, 3–14 30 ....................
5 ................................... 25 Cr ....................................... Myers ................................. 1–64–52, 4–5 35 ....................
5 ................................... 26 Ti ........................................ Myers ................................. 1–64–52, 4–5 33 ....................
5 ................................... 27 Cd ...................................... Colton ................................ 1–64–13 68 ....................
5 ................................... 28 Pb ...................................... Colton ................................ 1–64–13 57 ....................
5 ................................... 29 Pb ...................................... Dixon & Nelson ................. 1–64–19 42 ....................
5 ................................... 30 Pb ...................................... Colton ................................ 4–10–4 130 ....................
5 ................................... 31 Calcium .............................. Myers ................................. 1–64–50, 3–14 3 ....................

Grand Total ........... .................... ............................................ ............................................ ........................ .................... 1339

3. Variability of the APF Data who wear respirators. It is reasonable to a skewed distribution and extreme
expect variability because respirator outliers, both of which are common
Several commenters (Faulkner, Ex. 9– performance is determined by many with ratio-based data. As Figure III–1
40 and Kojola, Ex. 9–27) criticized WPF factors, including: Respirator type, the shows, when a logarithmic
studies because the studies workers’ face shapes, work practices transformation is applied to OSHA’s
demonstrated what they considered to and effort levels, and workplace WPF database, the data closely follow a
be a high degree of variability of the conditions such as temperature and standard normal distribution. Therefore,
data. However, it is inappropriate to humidity. Thus, the key issue is not OSHA’s analysis of the data, which
describe the variability of the data with whether the data have too much or too assumes that WPFs are log-normally
terms such as ‘‘high’’ or ‘‘low’’ because little variability, but whether the distributed with a geometric mean of
no recognized standard exists by which variability in the data reflects the true
to characterize variability. The 307 and a geometric standard deviation
variability in respirator performance
variability of the data should reflect the of 7.1, appropriately accounts for the
under actual workplace conditions.
true variability in respirator fit and A logarithmic transformation was variability in the WPF data.
performance experienced by workers applied to the WPF data set to adjust for
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4. Analysis of Updated Database on focuses on estimating this APF, a row number listed in column 2 of
APRs particularly the percent of WPFs that are Table III–1. This figure shows that more
OSHA proposed an APF of 10 for less than 10. WPFs for elastomerics are less than 10
negative pressure half mask APRs, Figure III–2 displays the 1,339 WPF than was the case for filtering
including both filtering facepieces and values, grouped by respirator class,1 facepieces, even though a much larger
elastomerics (68 FR 34096). study, and contaminant. Each column of proportion of these WPFs are from
Accordingly, the present analysis data points in the figure corresponds to filtering facepieces.
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1 Includes four of the five classes originally design characteristics: (1) Adjustable head straps, characteristics (1) through (3). Class 4 has all four
determined in the analysis conducted for OSHA by (2) presence of an exhalation valve, (3) double shell of the design characteristics. Class 5 consists of all
Dr. Ken Brown; no data were available for Class 2. construction, and (4) foam ring liner. Class 1 has elastomeric half masks.
Dr. Brown characterized disposable half marks none of the four design characteristics. Class 2 has

according to combinations of the following four design characteristics (1) and (3). Class 3 has design

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50136 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

Figure III–2 also shows that study evaluated respirators approved confidence interval, 3.7%, is equivalent
differences exist between WPFs under 42 CFR part 84. to a one-sided 95% upper statistical
measured in different studies, even Table III–2 shows the percentages of confidence bound on the true
among respirators of the same type. For WPFs less than 10 by respirator class, proportion of WPFs less than 10. This
example, both the Colton (Ex. 1–64–15, along with the 90% statistical bound may be interpreted as follows:
#4 in Figure 2) and the Colton and confidence intervals on these assuming the database is representative
Bidwell (Ex. 9–16–1–1, #8 in Figure 2) percentages. The exact confidence of workplace WPFs in general (more
studies were conducted by some of the intervals are based on a binomial specifically, that the data approximate a
distribution for counts. The percentage
same investigators, and both studies random sample of WPFs from all
of WPFs less than 10 is less than 5% for
used Class 1 filtering facepieces. workers who use respirators), when the
all four classes, and the 90% statistical
Nevertheless, all but one of the 23 WPFs confidence interval on this percentage true proportion of WPFs less than 10 is
in the Colton study (Ex. 1–64–15) are excludes 5% for every class except 3.7%, the probability of observing 2.8%
less than 40, while all 143 of the WPFs elastomerics. Also, elastomerics had the or less (the observed percentage) would
from the Colton and Bidwell study (Ex. highest percentage of WPFs less than 10 be 1 ¥ 0.95 = 0.05. Thus, under these
9–16–1–1) are at least 58 or higher. (4.5%). Over all classes, 38/1339, or assumptions, it is unlikely that the true
However, the Colton study evaluated 2.8%, of WPFs were less than 10 (90% proportion of WPFs less than 10 is as
respirators approved under 30 CFR part confidence interval: 2.1%, 3.7%). The high as 3.7% (and extremely unlikely to
11, whereas the Colton and Bidwell upper bound of this two-sided 90% be as high as 5%).


Total n n < 10 Percent (90% Cl)

Class 1 ..................................................................................................................... 474 11 2.3 (1.3%, 3.8%)

Class 3 ..................................................................................................................... 162 0 0.0 (0.0%, 1.8%)
Class 4 ..................................................................................................................... 124 1 0.8 (0.0%, 3.8%)
Class 1–4 (Filtering Facepieces) ............................................................................. 760 12 1.6 (0.9%, 2.5%)
Class 5 (Elastomerics) ............................................................................................. 579 26 4.5 (3.2%, 6.2%)
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Total .................................................................................................................. 1339 38 2.8 (2.1%, 3.7%)


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In the earlier database analyzed by Dr. analyzed by Dr. Brown. These data were III–2, the 403 WPFs were added to the
Brown, 3.9% of the WPFs were less than omitted for various reasons, including updated data base of 1,339 WPFs (for a
10. By comparison, among the 422 too few WPF measurements in a study total of 1,742 WPFs), and the overall
WPFs added to the database, only 2⁄422 and problems with the quality of the fraction of WPFs less than 10 was
(0.5%) were less than 10. Thus, the new studies (i.e., study did not meet computed (Table III–3). The percent of
data indicate a higher level of protection requirements of OSHA’s Respiratory WPFs less than 10 was 4.0% (90%
by APRs. Protection Standard). In addition, as confidence interval: 3.2%, 4.8%). Thus,
In addition to the 1,339 WPFs in the noted earlier, OSHA did not include even with no data exclusions, the
updated OSHA database, an additional data from studies in which exposures overall percent of WPFs smaller than 10
403 WPFs from 12 studies were coded were predominantly to a gas or vapor. is less than 5%, and the 95% statistical
by OSHA but were not included in To determine the effect that excluding upper confidence bound is also less
either the present database or the one these data had on the results in Table than 5% (i.e., 4.8%).

Total n n < 10 Percent (90% Cl)

Used ......................................................................................................................... 1339 38 2.8 (2.1%, 3.7%)

Unused ..................................................................................................................... 403 31 7.7 (5.6%, 10.2%)
Both Used and Unused ........................................................................................... 1742 69 4.0 (3.2%, 4.8%)

Consistent with the WPF studies used OSHA. Since several commenters exceeded 10 for all classes combined,
in its analysis, OSHA adopted the point expressed concern about whether and, with the exception of elastomerics,
estimate of the lower 5th percentile of sufficient evidence is available to for each individual class. The
WPF or SWPF data to establish APFs. support an APF of 10 for filtering confidence limits for the 5th percentiles
Table III–4 shows the point estimate of facepieces, OSHA also calculated 90% were computed using the method for
the 5th percentiles of WPFs for different confidence intervals for each point distribution-free confidence intervals of
categories of respirators using the estimate. (As noted earlier, the lower Hahn and Meeker (1991), as
updated database. The 5th percentile of limit estimate of a two-sided 90% implemented in SAS (2001). Therefore,
WPFs for filtering facepieces as a whole confidence interval is equivalent to a OSHA concludes that sufficient
was 18.1, and for elastomerics it was one-sided 95% lower confidence statistical evidence is available to justify
12.0. In both cases, the point estimate bound.) The lower 95% confidence an APF of at least 10 for filtering
was above the APF of 10 proposed by bounds for the 5th percentile of WPFs facepieces.


5th per- (90% Cl)

Class 1 ............................................................................................................................................................................. 14.8 (12, 18)

Class 3 ............................................................................................................................................................................. 19.7 (15, 24)
Class 4 ............................................................................................................................................................................. 27.0 (22, 49)
Class 1–4 (Filtering Facepieces) ..................................................................................................................................... 18.1 (15, 22)
Class 5 (Elastomerics) ..................................................................................................................................................... 12.0 (7, 14)

Total .......................................................................................................................................................................... 14.7 (13, 18)

5. Comparison of Respirators Approved the performance of 42 CFR 84-approved performance of respirators approved
Under 30 CFR Part 11 Versus 42 CFR respirators. The 3M study by Colton and under the two standards. Table III–5
Part 84 Bidwell (Ex. 9–16–1–1) evaluated one shows the performance of these three
respirator approved under 30 CFR 11, respirators using three methods: the
Several commenters expressed and two respirators approved under 42 proportion of samples with Ci non-
concern that the majority of WPF and CFR 84. In this study, WPFs were detects, the distribution of the 30
SWPF studies were conducted on measured on up to nine different smallest WPF values among the three
respirators certified by NIOSH under occasions for 21 workers (143 total respirators, and the geometric mean of
requirements in 30 CFR 11, instead of measurements), 17 of whom used each WPFs. The two 42 CFR 84-approved
the newer NIOSH certification type of respirator on at least one
respirators performed similarly with
procedure described in 42 CFR 84. occasion, with none of them using the
each of these methods, and they both
While these commenters did not explain same type respirator on more than three
the basis of their concern, two major performed better than the 30 CFR 11-
occasions. Thus, this study provides an
studies were submitted that examined opportunity for comparing the approved respirator (see Table III–5).
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50138 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

RESPIRATORS (3M 8511 AND 3M 8210)
Inside-the- Dist. of 30 WPF
mask smallest geometric
non-detects WPF means 1

3M 8710 ................................................................................................................................................... 5/49 15 792

3M 8511 ................................................................................................................................................... 23/47 7 2506
3M 8210 ................................................................................................................................................... 19/47 8 2405
1 Modeled assuming log-normal distribution with non-detects set at detectin limit.

The geometric means of WPFs of the provide useful information on filtering respirators with cartridge filters (579
42 CFR 84 respirators were similar facepiece and elastomeric half mask WPFs). This database also contains Co
(2506 and 2405), and were significantly respirators. and Ci measurements (expressed in µg/
(p < 0.0001) higher than the geometric Two major studies (Exs. 9–16–1–9 m3), with asbestos fiber counts
mean of the 30 CFR 11 respirator (792). and 4–21) address the likelihood that converted as follows: 1 fiber/cm3 = 30
This comparison was made using a half mask respirators will not µg/m3); these measurements permit
repeated measures analysis that sufficiently reduce occupational binomial analysis of overexposure
accounted for dependence among exposures to airborne contaminants. In through calculation of hazard ratios
different samples collected from the the first of these two studies (Nelson et (HR).
same worker, assumed log-normally al., Ex. 9–16–1–9), the authors evaluated The following 8-hour TWA PELs were
distributed WPFs, and set non-detects at the risk of overexposure for selected used to calculate HR = Co/PEL for this
the detection limit (which should APFs using Monte Carlo simulation study (see Table III–6).
minimize differences between the two modeling. For a half mask respirator
respirator types). All three respirators with an APF of 10, the calculations TABLE III–6.—8-HOUR TWA PELS
performed well in this study, with the indicated a low risk of being exposed
smallest of the 143 WPFs being 52, well
above an occupational exposure limit RATIOS
above the APF of 10 proposed by OSHA. (OEL), with mean exposures being
When the 146 WPF measurements controlled well below an OEL. In the
from the Bidwell and Janssen study (Ex. PEL
second article by Drs. Myers and Analyte (mg/m3)
9–16) (that assessed the 3M 9211 Zhuang (Ex. 4–21), ambient (Co) and in-
respirator approved under 42 CFR 84) facepiece exposure monitoring data (Ci) Benzo(a)pyrene ..................... 0.2
are added to the 94 WPFs from the from studies of worker exposures in Lead ...................................... 0.05
Colton and Bidwell study (Ex. 9–16–1– foundry, aircraft-painting, and steel- Zinc ........................................ 15
1), 240 WPFs in the OSHA database are Iron ........................................ 10
manufacturing industries were Chromium .............................. 0.5
from 42 CFR 84 respirators. None of
compared with the OSHA PEL for Titanium ................................. 15
these WPFs was less than 10 (0/240).
single-substance exposures. The 5th Manganese ............................ 5
This finding, along with the evidence
percentiles of the protection factor (Co/ Aluminum .............................. 15
that 42 CFR 84 respirators performed
Ci) data from each study were Asbestos ................................ 0.003 (0.1
better than 30 CFR 11 respirators in the fiber/cm3)
calculated. The authors used a new
same study, suggests that the new Silica ...................................... 10
binomial analysis of likelihood of
filtering facepiece respirators certified Cadmium ............................... 0.005
successes (no overexposure) and failures
under 42 CFR 84 may perform better Calcium ................................. 15
(overexposures). Their calculations
than the respirators relied on by OSHA
for its analyses, which consisted mainly indicate, for both half mask elastomeric
and filtering facepiece respirators, that Values for individual WPFs then were
of respirators approved under 30 CFR plotted against HR as illustrated in the
11. Because the respirators approved the <5% of workers who fail to achieve
an APF of 10 are still being protected. figures of the Myers and Zhuang
under 42 CFR 84 outperformed those reference (Ex. 4–21, Figure 1, page 798,
respirators approved under 30 CFR 11, OSHA considered Nelson’s analysis
along with the findings of Myers and and Figure 2, page 799). The same
which were adequately protective, reference lines and labels were used, but
OSHA is confident current workers will Zhuang when it conducted its own
analysis. Accordingly, the Agency was the scales were expanded to include all
be well protected by the respirators data in the OSHA database.
approved under 42 CFR 84. persuaded to quantify the probability of
overexposure by applying the Myers Figure 1 below shows the plot of all
6. Methodology of Evaluating and Zhuang binomial analysis to data for both filtering facepieces and
Overexposure OSHA’s updated database. OSHA’s elastomerics. The line labeled CD
Another method to assess the expert, Dr. Gerry Wood, performed the represents WPF = 10; 38 (2.8%) of the
appropriateness of an APF is to analysis and presented his results in a 1,339 data points fell below this line
determine whether an overexposure report (Ex. 20–3) described below. The and five data points (0.37%) fell within
occurs (Ex. 10–17). The Agency updated OSHA half mask database (Ex. the triangle defined by the letters ABK;
reviewed relevant studies on this 20–2) used in this analysis contains Myers and Zhuang (Ex. 4–21) label this
subject cited by several commenters 1,339 WPFs from studies with both triangle as ‘‘Inadequate Protection,
Overexposure,’’ which corresponds to
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(Exs. 9–16, 9–22, and 10–17–1) to filtering facepiece half mask respirators
determine if such an analysis would (760 WPFs) and elastomeric half mask the region in which Ci exceeds the PEL.

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Figure 2 shows the same plot for ABK overexposure region. The data the-mask exposure just barely higher
studies using filtering facepieces only. point in the A corner (from a study by than the PEL. The only other data point
Twelve data points (1.6%) are below the Colton (Ex. 1–64–16, CL4.15.Pb)) in the over-exposure region is from the
WPF = 10 line. Two of these twelve data represents a Co just above the lead PEL asbestos (PEL–0.1 fiber/cm3) study by
points equal WPF = 10 when rounded (HR = 1.20) that, with a WPF = 1.15 Dixon (Ex. 1–64–54, CL1.2.Asb) which
off to the nearest whole number. Only (almost no protection), gave a Ci = 1.04 corresponds to HR = 77, WPF = 47, and
2 (0.26%) of the points are within the * PEL; this value represents an inside- a Ci = 1.6 * PEL, (or 0.16 fiber/cm3).

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50140 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

If the MUC is defined as MUC = APF data points in the AGFE area, with an overexposure triangle are from an
× PEL, and an APF = 10 is assumed, HR ranging from 1 to 10, are outside the asbestos study by Dixon (Ex. 1–64–54,
then data points in the triangle labeled triangle (AHE) that represents CL5.2.Abs). However, no data points of
AHE represent overexposures. With one diminished protection). 265 in the AGFE area fall within the
data point in this triangle, filtering Figure 3 shows the same plot for the AHE triangle, indicating that all of these
facepieces are 99.4% effective in elastomerics. Of these 579 data points, respirators provided protection at APF =
protecting employees at an APF = 10 26 (4.5%) fall below WPF = 10. Three 10 × PEL.
and an MUC = 10 × PEL (i.e., 160 of 161 data points (0.5%) in the ABK

Figures 4 and 5 demonstrate that both (pre-April 1993). The combined data for 5 and Figures 2 and 3 demonstrate that
filtering facepiece and elastomeric both Figures 4 and 5 show that filtering both filtering facepiece and elastomeric
respirators maintain the level of facepieces had only one data point of respirators afford employees effective
employee protection found in Figures 2 160 (with an HR ratio of 1 to 10) in the protection against two different
and 3, even when the data are plotted overexposure area (i.e., the AHE exposure levels of asbestos and
using the higher PELs specified by the triangle), while none of the 241 data cadmium.
older OSHA asbestos standard (pre- points for elastomeric respirators fell BILLING CODE 4510–26–P
August 1994) and cadmium standard into this area. Therefore, Figures 4 and
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collected from numerous scientific process, called on participants to
7. Summary of Quantitative Analyses of studies related to APFs. OSHA identify additional studies to augment
the Updated Database established criteria that were used to the dataset or to discuss alternative
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evaluate each study’s design and data methods of analysis. In response, a

First, OSHA’s database includes the
quality to assure that the database number of commenters expressed these
best available data. As part of the APF
included only the most valid data. The concerns about the data analysis: The
rulemaking process, the Agency
Agency, at each step in the rulemaking statistical treatment minimized the true

conducted a metaanalysis of data

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50142 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

differences between elastomeric and Based on this risk analysis, OSHA on-one basis throughout the sampling
filtering facepieces, and there was too concluded that workers participating in periods.
much variability in the data. In all cases, effective respirator programs had an The inside-the-facepiece sampling
concerns raised by commenters about extremely low risk of overexposure. train consisted of a 25-mm three-piece
the composition of the dataset used in In conclusion, the extensive cassette with a 0.8-micron pore-size
the metaanalysis, or the statistical quantitative analyses of the databases polycarbonate filter with porous plastic
methods used to conduct the analyses, clearly indicate that both filtering back-up pads for collecting the inside
were unsubstantiated by evidence facepieces and elastomeric respirators samples. For sampling purposes, a Liu
submitted to the record despite repeated are capable of achieving an APF of 10. probe was inserted opposite the mouth
requests by OSHA for either specific The results demonstrate that no near the midline of the respirator. It
examples or additional evidence. statistical justification exists for projected one centimeter into the
Second, the best available data assigning an APF of less than 10 to facepiece. The sampling cassette was
support an APF of 10 for half mask attached directly to the probe, and a
either of these two types of respirators.
elastomerics and filtering facepieces. cassette heater was used to prevent
Finally, the results show that an APF of
The final APF half mask database condensation of moisture from exhaled
10 is an underestimate of the true
consists of 1,339 data points from 16 breath. Outside-the-facepiece samples
protection provided by both types of
different studies, which represents a used a 25-mm three-piece cassette with
respirators. Therefore, the final APF of
data increase of 46% over the 917 data a 0.8-micron pore-size mixed cellulose-
10 determined by this rulemaking
points initially available for analysis in ester filter. The outside sample cassette
provides employees who use respirators
the proposal. The full data set indicates: also was connected to a Liu probe, and
with an extra margin of safety against
(a) The precise APF for filtering this combination was attached in the
airborne contaminants.
facepieces is 18.1, with a 90% worker’s breathing zone. Inside samples
confidence interval between 15 and 22; F. Summary of Studies Submitted and outside samples were collected at a
(b) the precise APF for elastomerics is During the Rulemaking flow rate of two liters per minute.
12.0, with a 90% confidence interval Respirators were donned and doffed,
between 7 and 14; and (c) that a greater 1. Additional Studies Used in the and sampling trains started and
percentage of elastomerics failed to Updated Analyses stopped, in a clean area. Field blanks
achieve an APF of 10 (4.5%) than OSHA found the studies discussed in were used to evaluate for sample-
filtering facepieces (1.6%). In both this section to be of sufficient quality for handling contamination, and
cases, fewer than 5% of the respirators inclusion in its APF analyses. manufacturer blanks were collected to
failed to achieve an APF of 10, which determine background contamination
is the maximum failure rate historically Bidwell and Janssen study (Exs. 9–16– on the filters.
allowed by both OSHA and other 1–1 and 9–16). J. O. Bidwell and L. The inside samples were analyzed
standards-setting bodies. Janssen of 3M gave a presentation at the using proton-induced X-ray emission
Third, OSHA substantiated its May 2003 American Industrial Hygiene analysis (PIXEA), and the outside
previous analysis by adding to its Conference and Exposition (AIHCE) on samples were analyzed by inductively
updated database 403 data points that a workplace protection factor study they coupled plasma (ICP) spectroscopy. For
were excluded originally because they performed in a concrete-block both calcium and silicon, the authors
did not meet OSHA’s selection criteria manufacturing plant with workers using presented the range of Co, Ci, and the
and reanalyzing the database. This a NIOSH-approved N95 flatfold filtering associated geometric means and
additional analysis also supports an facepiece respirator. The filtering standard deviations. Three sets of WPF
APF of 10 for both types of respirators, facepiece respirator tested was the 3M results were determined: One for
with the results being highly similar to Particulate Respirator 9211, approved calcium, a second for silicon, and a
the analysis based on the best-available by NIOSH under the 42 CFR 84 harmonic mean for the combined
data. respirator certification standards. The calcium and silicon samples. Silicon
Fourth, new studies submitted during authors measured silicon and calcium was not detected on eleven of the Ci
the rulemaking allowed OSHA to exposures to 19 workers in the bagging samples. However, by using 70% of the
compare the performance of similar and block-handling areas of the plant. In limit of detection as the inside mass, the
respirators that were certified under the bagging area, workers placed bags authors were able to include these
both NIOSH’s old (30 CFR 11) and new over cement-dust chutes for filling, and samples in the statistical analysis. No
(42 CFR 84) certification standards. The then transferred the bags to pallets. In field-blank adjustments were made (i.e.,
42 CFR 84 respirators achieved a WPF the other areas of the plant sampled by no calcium or silicon detected), and no
that was better than the 30 CFR 11 the authors, workers handled concrete mention is made of adjusting the data
respirators. This finding is significant blocks, swept and shoveled dust and for pulmonary retention of particles. In
because the majority of the WPF studies, block pieces into containers, and addition, three sample sets were
and the only studies in OSHA’s original cleaned out mullers with chipping tools. invalidated as a result of equipment and
data set, were conducted on respirators The workers were informed of the procedural problems. The authors
certified under 30 CFR 11. Thus, the purpose and procedures of, and their reported a mean WPF of 152, with a 5th
improved performance of 42 CFR 84 role in, the study, and were provided percentile of 13, for the calcium
respirators indicates that these with instructions on proper donning, samples; a mean WPF of 394, with a 5th
respirators are likely to be even more fitting, and user seal check procedures, percentile of 34, for the silicon samples;
protective of worker health than an APF as well as respirator operation. In and a harmonic mean of the calcium
of 10 as provided for in the final rule. addition, the workers had to pass a and silicon samples of 206, with a 5th
OSHA also addressed the issue of Bitrex qualitative fit test that followed percentile of 20. The authors noted a
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overexposure among workers. In doing the fit test protocol described in OSHA’s difference in the WPFs measured for
so, it reviewed the respirator literature Respiratory Protection Standard prior to calcium and silicon (using the same
and performed an analysis of study participation. They also had to be respirator), and discussed a number of
overexposure risk using filtering clean shaven. They were observed by possible reasons for the difference (e.g.,
facepiece or elastomeric respirators. the authors in the workplace on a one- random sampling and analytical errors,

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possible non-uniformity of the challenge the first day and the second filter type approved by NIOSH under the 30 CFR
aerosol over time). The authors on the second day. 11 respirator certification standards.
concluded, ‘‘The estimated WPF for this The inside- and outside-the-facepiece The authors measured lead exposures
respirator model based on this study samples were analyzed for lead by ICP for 21 workers in the battery-
exceeds the APF of 10 assigned to this spectroscopy. The authors presented the manufacturing and assembly areas of
respirator class by ANSI Z88.2–1992 range of outside and inside lead the plant. The worker job classifications
and proposed by OSHA.’’ They also concentrations, and the associated tested were stackers, heat sealers,
stated, ‘‘The respirator provided an geometric means and standard burners, and assemblers. The workers
adequate level of protection and reliably deviations. Two sets of WPF results were informed of the purpose and
provided workplace protection factors were determined: One for the 3M 2040 procedures of, and their role in, the
of at least 10 when properly fitted, filter and a second for the 3M 7255. A study, and were provided with
worn, and used’’ (Ex. 9–16, page 40). total of 140 samples were collected— instructions on proper donning, fitting,
Colton and Bidwell study (Ex. 4–10– one sample was eliminated due to low and user seal check procedures, as well
4). C. Colton and J. Bidwell of 3M made mass loading, 10 samples were lost due as respirator operation. In addition, the
a presentation on May 25, 1995 at the to equipment problems, and 85 samples workers had to pass a Bitrex
AIHCE comparing the workplace had inside-sample mass values that qualitative fit test with all three
performance of two different types of were non-detectable. Of the remaining respirators, and they had to be clean
HEPA filters on an elastomeric half 44 samples, one outlier was identified shaven. They were observed in the
mask respirator in a battery in the electret filter data set, leaving 22 workplace by the authors on a one-on-
manufacturing plant. The HEPA filters sets for the 3M 2040 filter and 21 sets one basis throughout the sampling
and the respirator model tested were for the 3M 7255 filter. No field blank periods.
approved under the 30 CFR 11 adjustments were reported (i.e., no lead The sampling probe was a Liu probe
respirator certification standards. The was detected on the field blanks). The that was inserted opposite the mouth
half facepiece respirator tested was the authors reported a mean WPF of 562 near the midline of the respirator. It
3M 7000, available in three sizes. The and a 5th percentile of 71 for the 3M projected one centimeter into the
HEPA filters tested were the 3M 7255 2040 filter-respirator combination, and a facepiece. The sampling cassette was
high-efficiency (mechanical) filter and mean WPF of 1006 and a 5th percentile attached directly to the probe, and a
the 3M 2040 high efficiency (electret) of 80 for the 3M 7255 filter-respirator cassette heater was used to prevent
filter. The authors measured lead combination. condensation of moisture from exhaled
exposures for 19 workers in the battery- When no lead was detected for the
breath. Inside and outside samples were
pasting and assembly areas of the plant inside samples, the WPF results were
collected at a flow rate of two liters per
because these areas had the highest lead recalculated using the detection limit to
represent the mass for these samples. minute for 79 to 159 minutes. Three
exposures. The workers were informed
From these recalculations, the authors samples were collected per day for each
of the purpose and procedures of, and
identified one outlier in the electret worker. Field blanks were used, and
their role in, the study, and were
filter data set and two outliers in the care was taken to avoid handling
provided with instructions on proper
mechanical filter data set. They then contamination.
donning and fitting procedures, as well
as respirator operation. In addition, the calculated geometric means, geometric The inside samples were analyzed for
workers had to pass a saccharin standard deviations, and 5th percentile lead using PIXEA. Outside samples
qualitative fit test performed using the WPFs for the 67 samples for the 3M were analyzed by ICP spectroscopy. The
fit test protocol described in OSHA’s 2040 filter and for the 59 samples for the authors presented the range of outside
Lead Standard. Workers had to be clean 3M 7255 filter. The authors reported a and inside sample lead concentrations,
shaven. They were observed in the mean WPF of 420 and a 5th percentile and the associated geometric means and
workplace by the authors on a one-on- of 101 for the 3M 2040 filter-respirator standard deviations for each respirator
one basis throughout the sampling combination, and a mean WPF of 549 model tested. Three sets of WPF results
periods. and a 5th percentile of 138 for the 3M were determined: One for the 3M 8710,
For sampling purposes, a Liu probe 7255 filter-respirator combination. a second for the 3M 8210, and a third
was inserted opposite the mouth near The authors concluded that the for the 3M 8511. Lead was not detected
the midline of the respirator. It performance differences between the on five of the inside samples for the 3M
projected one centimeter into the two filter types were not statistically 8710, 19 for the 3M 8210, and 23 for the
facepiece. The sampling cassette was significant. Both filters provided 5th 3M 8511. No field blank adjustments
attached directly to the probe, and a percentile protection factors above 10. were reported (i.e., no lead was detected
cassette heater was used to prevent No WPFs were less than 30. Under these on the field blanks). The authors
condensation of moisture from exhaled workplace conditions, no difference was reported a mean WPF of 730, with a 5th
breath. A Liu probe was also attached to found in the level of protection percentile of 105, for the 3M 8710
the outside sample to ensure that provided by the electrostatic HEPA filter respirator; a mean WPF of 955, with a
particle loss for the outside samples compared to a mechanical HEPA filter. 5th percentile of 73, for the 3M 8210;
would be similar to that with the inside Colton and Bidwell study (Ex. 9–16). and a mean WPF of 673, with a 5th
samples. Inside samples and outside C. Colton and J. Bidwell of 3M percentile WPF of 169, for the 3M 8511
samples were collected at a flow rate of presented a research paper at the May using test samples with detectable lead
two liters per minute, and sampling 1999 AIHCE on a WPF study they levels. When no lead was detected on
times ranged from 56 to 200 minutes. performed in a battery manufacturing the inside samples, the WPF results
Up to four samples were collected per plant with workers using three NIOSH- were calculated by using 70% of the
day on each worker, each worker was approved filtering facepiece respirators. limit of detection as the mass for inside
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sampled for two days, field blanks were The filtering facepiece respirators tested samples. The authors reported a mean
used, and care was taken to avoid were the 3M 8210 and 3M 8511, WPF of 804, with a 5th percentile of
handling contamination. The filter for approved by NIOSH under the 42 CFR 111, for the 3M 8710 respirator; a mean
the first day was assigned randomly, 84 respirator certification standards, and WPF of 2210, with a 5th percentile of
with a worker using one filter type on the 3M 8710 filtering facepiece, 133, for the 3M 8210; and a mean WPF

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50144 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

of 1970, with a 5th percentile WPF of MSA Affinity foldable FR 200, and the analyses because it is not a WPF or
223, for the 3M 8511. Willson N95 10FL produced by Dalloz SWPF study, and addresses only fit
The authors stated, ‘‘All respirator Safety in response to OSHA’s request in testing issues.
models provided an equivalent level of the NPRM for additional studies that Coffey, et al. study (Ex. 17–7–4).
protection,’’ and that ‘‘[a]ll the may be useful in determining APFs. The NIOSH submitted to the record a
respirators tested reliably provided author of the study permitted workers publication by Coffey et al. (Ex. 17–7–
workplace protection factors of 10 when who did not pass a fit test with a 4). In this study, 18 N95 filtering
properly fitted, worn, and used.’’ No minimum fit factor of 100, as required facepiece respirators were evaluated.
reported WPFs were less than 51, and by OSHA’s Respiratory Protection The authors determined the following
no difference in workplace protection Standard, to participate in the study. measurements from the results: 5th
was found between workers using 30 OSHA reviewed this study and did not percentile SWPF value; the average
CFR part 11-approved respirators and add the data set to its quantitative SWPF per shift; the h-value; and the
workers using 42 CFR 84-approved analyses because it was a PPF study that assignment error. A SWPF test was used
respirators. The authors concluded that, is not directly comparable with WFP to determine respirator performance,
using the 5th percentile WPFs as an studies used by OSHA in its APF which was assessed using a Portacount
indicator of performance, the APFs determinations. However, the study Plus with test subjects performing six
should not differ between these results confirmed that when a worker’s standard fit test exercises. However, the
respirators. filtering facepiece respirator is fit tested generally accepted format for a SWPF
properly, it is capable of achieving a study involves test subjects performing
2. Additional Studies Not Used in the
protection factor of at least 10. simulated workplace exercises (e.g.,
Updated Analyses
Peacock study (Ex. 9–13–4). This fit shoveling pebbles, moving blocks,
The Agency received a number of test research report was submitted to the pounding nails).
comments on the relationship between record by NIOSH. In this study, a liquid- Using this procedure, the authors
fit testing and APFs. OSHA regulations aerosol QNFT (Large Particle QNFT found that when properly fit tested, over
require that when a respirator user (LPQNFT)) was developed and used to 80% of the poorly performing
cannot pass a fit test with a particular evaluate filter penetration of a regular respirators achieved a protection factor
respirator model, it cannot be used. N95 respirator. Protection factors of more than 10. However, OSHA did
OSHA does not believe that it is determined by the LPQNFT were not use this study in its APF
appropriate to assign a lower protection compared to fit factors obtained using determinations since this was not a
factor to a respirator (e.g., half the APF) the saccharin QLFT. The sensitivity and WPF or SWPF study. Nevertheless, the
when the respirator doesn’t fit. specificity of the saccharin QLFT were study supports the requirement that
However, a number of fit test studies, evaluated. The results for the specifity APFs apply only when used within the
and one study on farm worker of the LPQNFT indicated that workers context of a comprehensive respirator
exposures to bioaerosols, were who failed the saccharin QLFT also program.
submitted to the record for the Agency failed the LPQNFT when using a Reponen et al. study (Exs. 19–8–3 and
to evaluate in terms of APFs. OSHA has protection factor ≥ 100. The sensitivity 19–8–4). The purpose of this study was
evaluated these studies and determined was low. Twelve (12) subjects passed to further develop a prototype personal-
that they do not meet the criteria that both the LPQNFT and the saccharin sampling system for use with N95
data must meet to be included in the QLFT (out of 28 subjects), but another filtering facepiece respirators. The study
database. These criteria have been 16 subjects failed the saccharin test results were calculated from 30–60
described above. while passing the LPQNFT. Peacock minute Co and Ci measurements taken
NIOSH agreed (Tr. at 102) that the concluded that the LPQNFT may be across multiple agricultural settings,
APF values resulting from OSHA’s subject to particle deposition at leakage tasks, and simulated exposures. The
multifaceted approach provide sites, as well as conditions inside the data were combined to calculate dust,
reasonable values for the level of facepiece that would lead to sampling microorganism, and cultured
protection expected for each respirator bias. OSHA did not rely on these fit test microorganism exposures. Descriptions
class. Proposed Table 1 (‘‘Assigned data for setting APFs because, as of tasks in several workplaces were
Protection Factors’’) represents the state Peacock noted, further studies should be provided.
of the art for each class or respirator. conducted to identify the cause of these The N95 respirators in this study
However, NIOSH stated that designating problems. performed at or above a WPF of 10
a specific APF for a respirator class will Lee and Nicas study (Ex. 17–7–3). when evaluated using dust
not ensure that a respirator will perform NIOSH submitted this study of N95 measurements. However, the dust-
as expected. The protection afforded by respirators used against Mycobacterium exposure measurements counted both
a respirator is contingent on: The tuberculosis (TB). In this study, Lee and dust particles and microorganisms
respirator user adhering to the respirator Nicas (Ex. 17–7–3) computed risks of TB because the optical-particle counter
program requirements of OSHA’s infection using five medium- or regular- used for this purpose does not
Respiratory Protection Standard; the use size N95 filtering facepiece respirators. differentiate between organic and
of NIOSH-certified respirators in their Five NIOSH-approved respirators were nonorganic particles. When they
approved configuration; and fit testing selected for evaluation after reviewing calculated WPFs for the microorganism
for each employee that ensures selection manufacturer-provided fit test, comfort, samples alone, the WPFs decreased
of a properly fitting respirator. The and cost data. After extensive somewhat. The authors concluded that
following studies, which OSHA did not evaluation, the original five brands were the geometric mean WPF increased with
include in its updated analyses, rank ordered from highest to lowest fit increasing particle size, and that the
typically violated one or more of these test pass rates, and the authors WPFs were smaller for biological
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three conditions. calculated the risk of TB transmission. particles than for dust. The authors
Don-Hee Han study (Ex. 9–13–2). The authors concluded that fit testing is speculated that differences in WPFs
NIOSH (Ex. 9–13) submitted a study by necessary to ensure that respirators may result from the measurement effects
Don-Hee Han (Ex. 9–13–2) of the 3M perform as expected. However, OSHA of particle size or density. They also
8511 cup-shaped filtering facepiece, the did not accept this study for its APF said that even a small variation in the

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density of particles can have a APF table requirements in its substance- which an employee can use a respirator
pronounced effect on the loss of dust specific standards. By superceding the safely. The APFs would apply to
particles through faceseal leaks due to APF tables, the Agency estimates that respirator use for protection against
impaction. The authors concluded that the benefits for the final APFs under the overexposure to any substance regulated
their findings deserve further research. Respiratory Protection Standard will be under 29 CFR 1910.1000. In addition,
OSHA agrees with the authors that available as well to employers who must OSHA rules for specific substances
further research is needed to select respirators for employee use under subpart Z (regulated under the
substantiate and explore these findings. under the substance-specific standards. authority of section 6(b)(5) of the OSH
Also, the Agency has significant In addition, the Agency believes that Act of 1970, 29 U.S.C. 655) specify APFs
concern regarding the measurement harmonizing the APFs of the substance- for respirators used for protection
methodology used in this prototype specific standards with the APFs in the against these chemicals (hereafter
study. For example, it is not clear Respiratory Protection Standard will referred to as § 6(b)(5) substances). The
whether the WPF differences are valid reduce confusion among the regulated rule would supercede most of these
or are simply the result of using community and aids in uniform protection factors, and harmonize APFs
different measurement methods. application of APFs, while maintaining for these substances with those for
Therefore, the Agency decided not to employee protection at levels at least as general respirator use.
use this study for developing APFs. protective as the existing APF
Summary and conclusions for studies requirements. OSHA based estimates of the number
not used in the updated database. of employees using respirators and the
OSHA reviewed the studies submitted V. Summary of the Final Economic corresponding number of respirator-
to the APF rulemaking docket and Analysis and Regulatory Flexibility using establishments on the NIOSH-BLS
determined that five of them were Analysis survey of respirator use and practices 2
unsuitable for the database used to A. Introduction (Ex. 6–3). The NIOSH-BLS survey
develop APFs. OSHA established a set OSHA’s Final Economic and provides up-to-date use estimates by
of criteria in the proposal for evaluating Regulatory Flexibility Screening two-digit industry sector and respirator
new studies for inclusion in the APF Analysis (FEA) addresses issues related type for establishments in which
database. The studies by Han (Ex. 9–13– to the costs, benefits, technological and employees used respirators during the
4), Peacock (Ex. 9–13–4), Lee and Nicas economic feasibility, and economic previous 12 months.3 As shown in
(Ex. 17–7–3), Coffey et al. (Ex 17–7–4), impacts (including small business Table V–1, an estimated 291,085
and Reponen et al. (Exs. 19–8–3 and 19– impacts) of the Agency’s Assigned establishments reported respirator use
8–4) were not used by OSHA in setting Protection Factors (APF) rule. The in industries covered by OSHA’s
the final APFs because these studies did Agency has determined that this rule is regulation. Most of these establishments
not follow established WPF or SWPF not an economically significant rule (208,528 or 71.6 percent) reported use of
protocols, or required further research to under Executive Order 12866. The filtering facepieces. Substantial
substantiate or explore the results. economic analysis meets the percentages of establishments also
IV. Health Effects requirements of both Executive Order reported the use of half-mask and full
12866 and the Regulatory Flexibility Act facepiece non-powered air-purifying
American workers use respirators as a
(RFA; as amended in 1996). The FEA respirators (49.0 and 21.4 percent,
means of protection against a multitude
presents OSHA’s full economic analysis respectively). A smaller number of
of respiratory hazards that include
and methodology. The Agency entered establishments reported use of powered
chemical, biological, and radiological
the complete FEA into the docket as air-purifying respirators (PAPRs) and
agents. Respirators provide protection
Exhibit 11. The remainder of this supplied-air respirators (SARs). Fifteen
from hazards that are immediately life-
section summarizes the results of that percent of establishments with
threatening, as well as hazards
analysis. respirators (43,154) reported using
associated with routine operations for The purpose of this FEA is to:
which engineering controls and work PAPRs and 19 percent (56,022) reported
• Evaluate the costs employers would using SARs. Table V–2 presents
practices do not protect employees incur to meet the requirements of the
sufficiently. When respirators fail, or do estimates of the number of respirator
APF rule; users by two-digit industry sector. An
not provide the degree of protection • Estimate the benefits of the rule;
expected by the user, the user is placed estimated 2.3 million employees used
• Assess the economic feasibility of
at an increased risk of adverse health filtering facepiece respirators in the last
the rule for affected industries; and
effects that result from exposure to the • Determine the impacts of the rule 12 months, while 1.5 million used half
respiratory hazards present. Therefore, on small entities and the need for a masks, and 0.7 million used full
it is critical that respirators perform Regulatory Flexibility Analysis. facepiece non-powered air-purifying
properly to ensure that users are not at respirators. Fewer employees reported
an increased risk of experiencing B. The Rule and Affected Respirator using PAPRs (0.3 million) and SARs (0.4
adverse effects caused by exposure to Users million). The industry-specific estimates
respiratory hazards. OSHA’s APF rule would amend 29 show substantial respirator use in
In this final rulemaking, OSHA CFR 1910.134(d)(3)(i)(A) of the several industries, including the
defined the minimal level of protection Respiratory Protection Standard by construction sector, several
a respirator is expected to achieve (i.e., specifying a set of APFs for each class manufacturing industries (SICs 28, 33,
the APFs in Table 1), as well as the of respirators. These APFs specify the 34, and 37), and Health services (SIC
MUCs for the respirators. The Agency highest multiple of a contaminant’s 80).
also is superseding most of the existing permissible exposure limit (PEL) at BILLING CODE 4510–26–P
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2 Preliminary results from the 2001 NIOSH–BLS by BLS, who also tabulated the data after 12 months, how many of your current employees
‘‘Survey of Respirator Use and Practices’’ in press. completing the survey. used respirators at your establishment?’’ It excluded
NIOSH commissioned the survey to be conducted 3 The survey was conducted between August voluntary use of respirators from detailed followup
2001 and January 2002. It asked: ‘‘During the past respirator use questions (Ex. 6–3).

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50148 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

The standard would have different requires only that employers use under the existing Respiratory
impacts on employers using respirators respirators already on the market. Protection Standard. However, in the
to comply with OSHA substance- Further, these respirators are already in case of full facepiece negative pressure
specific standards than for employers use and have proven feasible in a wide respirators, the Agency has established
using respirators for other purposes. variety of industrial settings. However, that an APF of 50, as opposed to ANSI’s
Therefore, OSHA used findings from the costs for the APF standard result from APF of 100, is currently acceptable. In
NIOSH–BLS survey of establishments requiring some users to switch to more this regard, all but one of the substance-
that reported respirator use, by general protective respirators than they specific standards with APFs for full
respirator class, for protection against currently use. When the APF is lower facepiece negative pressure respirators
specific substances (see Table V–3). than the baseline (current) APF, set an APF of 50. In addition, the
OSHA applied these numbers to all respirator users must upgrade to a more existing respirator rule and its
respirator users and establishments protective model. Both the 1992 ANSI supporting preamble require that
within the industries that make up each Z88.2 Respiratory Protection Standard
quantitative fit testing of full facepiece
sector to derive substance-specific and the 1987 NIOSH RDL specify APFs
negative pressure respirators must
estimates of respirator use. For those for certain classes of respirators. The
Agency assumed that employers achieve a fit factor of 500 when
§ 6(b)(5) substances not reported by
currently use the ANSI or NIOSH APFs, employees use them in atmospheres in
NIOSH, OSHA used expert judgments of
or the APFs in the OSHA substance- excess of 10 times the PEL; this
a consultant with experience in the
specific standards, as applicable, to requirement assumes a safety factor of
respirator industry to estimate the
percentage of establishments and select respirators. While the Agency 10. Therefore, based on a fit factor of
employees that use respirators for currently refers to the NIOSH RDL as its 500, such respirators are safe to wear in
protection against these chemicals (Ex. primary reference for APFs, in the atmospheres up to 50 times the PEL,
6–2) (see Table V–3). absence of an applicable OSHA consistent with similar requirements
standard, this analysis assumes that, in regarding respirator use found in
C. Compliance Costs most cases, adhering to the existing existing standards for § 6(b)(5)
The standard does not raise issues of ANSI APFs fulfills employers’ legal chemicals.
technological feasibility because it obligation for proper respirator selection BILLING CODE 4510–26–P
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BILLING CODE 4510–26–C respirator to a more protective respirator overall compliance costs associated
For each respirator type, OSHA (e.g., a PAPR). with the proposal, as currently written,
compared the new and existing Because of the absence of data on this will likely be even lower than OSHA
standards and, where these new APFs issue, OSHA made several assumptions has estimated.’’
were lower, identified an incrementally regarding the requirement to upgrade The Agency estimated distributions of
more protective respirator model. To be respirators. First, OSHA assumed that exposures above the PELs based on
adequate, the more protective respirator employers use respirators only when reports from its Integrated Management
must have an APF greater than the their employees have exposures above Information System describing
current APF. the PEL. Second, OSHA assumed workplace monitoring of § 6(b)(5) toxic
1. Number of Users Required To employers use the most inexpensive substances performed during OSHA
Upgrade Respirator Models respirator permitted, taking into health inspections. Of the 9,095 samples
consideration the employees’ safety and reported above the PELs, 68.0 percent
For a given respirator type, the compliance with regulatory reported exposures between one and
number of users required to shift to a requirements. These assumptions most five times the PEL, 13.1 percent found
more protective respirator depends on likely overestimate the cost of exposures between five and 10 times the
two factors: the total number of users of compliance because many employers PEL, and 9.5 percent documented
that type, and the percentage of those require their employees to use exposures between 10 and 25 times the
users for whom the ambient exposure respirators when OSHA does not require PEL. Exposures for the remaining 9.4
level is greater than the APF. While such use, or they require respirators percent of the samples were greater than
survey data are available to estimate the with higher APFs than OSHA currently 25 times the PEL. Based on these data,
number of users, virtually no requires. As a result, this analysis OSHA modeled the current exposure
information is available in the literature assumes shifts in respirators that distribution for each respirator type.
that provides a basis for estimating the employers may have implemented 2. Incremental Costs of Upgrading
percentage of users required to upgrade already. Two commenters on this issue Respirator Models
respirators. The percentage of workers agreed that these assumptions
switching respirators would depend on overestimate the number of employers OSHA also analyzed the costs of
the profile or frequency distribution of that would need to change respirators as upgrading from the current respirator to
users’ exposure to contaminants relative a result of this rule (see Exs. 9–16 and a more protective alternative. In doing
to the PEL. For example, the Agency is 13–8). One commenter (Ex. 9–16) noted so, OSHA estimated the annualized unit
lowering the APFs for full facepiece that ‘‘For about twenty years, 3M has costs for each respirator type, including
respirators used to protect against cotton looked for worksites where employers equipment and accessory costs, and the
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dust from 100 to 50; accordingly, when were using respirators at concentrations costs for training and fit testing. One
workers have ambient exposures that at the upper end of the APF range. We commenter (Ex. 17–9) noted the
are greater than 50 times the PEL, have not been able to find these importance of not just considering the
employers must upgrade the respirator worksites.’’ This commenter went on to initial costs of a respirator, but all

from a full facepiece negative pressure note, as a result ‘‘we believe that the associated costs. OSHA has considered

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50150 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

all of these costs, including training, fit associated with each respirator type. training, contributing substantially to
testing, program development, and Table V–4 shows estimated compliance greater worker protection. Estimates of
medical evaluation, as this commenter costs for OSHA’s APF rule. The rule benefits are difficult to calculate
suggested. OSHA then calculated the would require 1,918 users of non- because of uncertainties regarding the
incremental cost for each combination powered air-purifying respirators to existing state of employer respirator-
of upgrades from an existing model to upgrade to some respirator more selection practices and the number of
a more protective one, taking into expensive than they are now using at a covered work-related illnesses. At the
account the effect of replacement before cost of $1.8 million. The Agency time of the 1998 revisions to the
the end of the respirator’s useful life. estimates that 22,848 PAPR users would Respiratory Protection Standard, the
These annualized costs range from upgrade their respirators at a cost of Agency estimated that the standard
$49.98 (for upgrading from a supplied- $2.3 million. A relatively small number would avert between 843 and 9,282
air, demand mode, full facepiece of SAR users (5,110) would upgrade to work-related injuries and illnesses
respirator to a supplied-air, continuous more expensive respirators at a cost of annually, with a best estimate (expected
flow, half-mask respirator) to $963.73 $0.4 million. Industry-specific value) of 4,046 averted illnesses and
(for upgrading from a non-powered, air- compliance costs vary according to the injuries annually (63 FR 1173). In
purifying full facepiece respirator to a number of respirator users and the addition, OSHA estimated that the
full facepiece PAPR). proportion of these users affected by the standard would prevent between 351
In certain instances, workers who use rule. Industries with relatively large and 1,626 deaths annually from cancer
respirators under the substance-specific compliance costs include SIC 17, and many other chronic diseases,
standards may have to upgrade to a SAR Special trade contractors ($0.8 million), including cardiovascular disease, with a
with an auxiliary escape SCBA. Several and SIC 80, Health services ($0.8 best estimate (expected value) of 932
substance-specific standards currently million).
specify SARs for exposures that exceed averted deaths from these causes. The
As discussed previously, the Agency APFs in this rulemaking will help
1,000 times the PEL.4 OSHA believes believes the actual costs of the standard
that workers are unlikely to regularly ensure that these benefits are achieved,
almost certainly are overestimated. The as well as provide an additional degree
use respirators at such extreme exposure cost analysis assumes all respirator
levels, i.e., they are most likely to use of protection. These APFs also will
wearers have levels of exposures that reduce employee exposures to several
them only in exceptional, possibly require the particular respirator they are
emergency-related situations. § 6(b)(5) chemicals covered by standards
using. Under this assumption, 15,000 with outdated APF criteria, thereby
Furthermore, exposures at levels more employees would be allowed to safely
than 1,000 times the PEL would reducing exposures to chemicals such as
shift to a less expensive respirator, asbestos, lead, cotton dust, and arsenic.6
generally be at or above levels deemed which could lead to cost savings for the
immediately dangerous to life or health While the Agency did not quantify these
employer. Such potential cost savings benefits, it estimates that 29,655
(IDLH), so employers already are are not accounted for in this cost
required by the Respiratory Protection employees would have a higher degree
analysis. of respiratory protection under this APF
Standard to provide each worker with a In many cases, employers use
respirator that has SCBA capability. For standard. Of these employees, an
respirators when respirators are not
these reasons, this PERFSA estimated estimated 8,384 have exposure to lead,
required by OSHA, or use respirators
no impacts for these situations.5 7,287 to asbestos, and 3,747 to cotton
more protective than required by OSHA.
dust, all substances with substantial
3. Aggregate Compliance Costs As a result, OSHA’s cost analysis
health risks.
For each respirator type affected by overestimates the number of employees
the regulation, OSHA combined the who are affected by the standard, and
incremental costs of upgrading to a therefore overestimates costs associated
6 In the 1998 rulemaking revising the Respiratory
more protective respirator, the estimated with the standard.
Protection Standard, the Final Economic Analysis
share of users forecast to upgrade, and D. Benefits noted that the standard would not directly affect the
the number of users involved to benefits for the estimated 5% of employees who use
The benefits that would accrue to respirators under OSHA’s substance-specific health
estimate the compliance costs standards (except to the extent that uniformity of
respirator users and their employers
provisions improve compliance). Therefore, the
4 These standards regulate cotton dust, coke oven take several forms. The standard would Agency likely over-estimated the benefits of that
emissions, acrylonitrile, arsenic, DBCP, ethylene benefit workers by reducing their rulemaking since the standard did not affect
oxide, and lead. exposures to respiratory hazards. directly the type of respirator used by those
5 Paragraph (d)(2) of the Respiratory Protection
Improved respirator selection would employees (63 FR 1173). Conversely, this rule
Standard requires employers to provide either a directly addresses the APF provisions of the
pressure demand SCBA or a pressure demand SAR
augment previous improvements to the substance-specific standards; therefore, this rule
with auxiliary SCBA to any employee who works Respiratory Protection Standard, such as would affect directly the respirators used by
in IDLH atmospheres. better fit-test procedures and improved employees covered by these standards.
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In addition to health benefits, OSHA other potential stresses, because of the ability The analysis of the potential impacts
believes other benefits result from the to select a filtering facepiece respirator. of this standard on before-tax profits
harmonization of APF specifications, E. Economic Feasibility and sales shown in Table V–5 is a
thereby making compliance with the ‘‘screening analysis,’’ so called because
respirator rule easier for employers. OSHA is required to set standards that
it simply measures costs as a percentage
Employers also benefit from greater are feasible. To demonstrate that a
of pre-tax profits and sales under the
administrative ease in proper respirator standard is feasible, the courts have
held that OSHA must ‘‘construct a worst-case assumptions discussed
selection. Employers would no longer above, but does not predict impacts on
reasonable estimate of compliance costs
have to consult several sources and these before-tax profits or sales. OSHA
and demonstrate a reasonable likelihood
several OSHA standards to determine used the screening analysis to determine
that these costs will not threaten the
the best choice of respirator, but could whether the compliance costs
existence or competitive structure of an
make their choices based on a single, potentially associated with the standard
industry’’ (United Steelworkers of
easily found regulation. Some could lead to significant impacts on all
America, AFL–CIO–CLC v. Marshall (the
employers who now hire consultants to affected establishments. The actual
‘‘Lead’’ decision), 647 F.2d 1189 (DC
aid in choosing the proper respirator impact of the standard on the profit and
Cir. 1980)).
should be able to make this choice on OSHA conducted its analysis of sales of establishments in a specific
their own with the aid of this rule. In economic feasibility on an industry would depend on the price
addition to having only one set of establishment basis. Accordingly, for elasticity of demand for the products or
numbers (i.e., APFs) to assist them with each affected industry, the Agency services of these establishments.
respirator selection for nearly all compared estimates of per-
substances, some employers may be able Table V–5 shows the economic
establishment annualized compliance impacts of these costs. For each
to streamline their respirator stock by costs with per-establishment estimates
using one respirator class to meet their industry, OSHA constructed the average
of revenues and per-establishment compliance cost per affected
respirator needs instead of several estimates of profits. It used two worst-
respirator classes. The increased ease of establishment and compared it to
case assumptions regarding the ability average revenues and average profits.7
compliance would also yield additional of employers to pass the costs of
health benefits to employees using These costs are quite small, i.e., less
compliance through to their customers: than 0.005 percent of revenues; the one
respirators. The no-cost-pass-through assumption,
Alternatively, these APFs would major exception is SIC 44 (Water
and the full-cost-pass-through transportation), for which OSHA
clarify when employers can safely place assumption. Based on the results of
employees in respirators that impose estimated the costs impacts to be 0.16
these comparisons, which define the percent of revenues. When the Agency
less stress on the cardiovascular system universe of potential impacts of the
(e.g., filtering facepiece respirators). compared average compliance costs
APFs, OSHA then assessed the
Many of these alternative respirators with profits, the costs also are small,
economic feasibility for all affected
may have the additional benefit of being i.e., less than 0.17 percent; again, the
establishments, i.e., those covered by
less expensive to purchase and operate. major exception was SIC 44, which had
this rule.
As previously discussed, OSHA The Agency assumed that an estimated impact of 2.12 percent of
estimates that over 15,000 employees establishments falling within the scope profits.8 Based on the very small
currently use respirators that fall in this of the standard would have the same impacts for establishments in all
group (i.e., shift to a less expensive average sales and profits as other industries shown in Table V–5, OSHA
respirator). establishments in their industries. concludes that the APF standard is
One commenter (Ex. 9–16) agreed that OSHA believes this assumption is economically feasible, in the sense of
the standard would have significant reasonable because no evidence is being unlikely to close or alter the
benefits, saying: available showing that the financial competitive structure of the affected
characteristics of those firms with industries, for the affected
3M concurs with OSHA’s conclusion that
significant health benefits will accrue to employees who use respirators are establishments.
workers as a result of this rulemaking. 3M different from firms that do not use BILLING CODE 4510–26–P
believes that the majority of these benefits respirators. In the absence of such
will be the result of simplification of the evidence, OSHA relied on the best 7 OSHA defines ‘‘affected establishment’’ as any

respirator selection process for employers. available financial data (those from the facility that uses respirators, as represented in the
This will in turn lead to greater compliance NIOSH–BLS survey data.
Bureau of the Census (Ex. 6–4) and 8 For some industries, such as SIC 44, data from
with OSHA’s various standards regarding Robert Morris Associates (Ex. 6–5)),
exposure to toxic and harmful substances. the NIOSH–BLS survey were suppressed due to low
* * *
used a commonly accepted response rates. In these cases, the Agency, for the
In addition to these benefits from increased methodology to calculate industry purposes of assessing economic feasibility, imputed
averages, and based its analysis of the broader sector-level data from the survey to form an
compliance, 3M also concurs with OSHA’s estimate of respirator use. This procedure may
determination that the simplification and significance of the projected economic result in overestimating the impact of the standard
clarification of the APF tables will result in impacts and the feasibility of (proposal) in some industries. See the full FEA (Ex.
lessening of cardiovascular stress, as well as compliance on these data. 11) for further details.
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F. Economic Impacts to Small Entities economic impacts for small entities firms, average compliance costs are less
with fewer than 20 employees: average than 0.005 percent of average revenues
OSHA also estimated the economic compliance costs by industry are less and less than 0.03 percent of average
impacts of the rule on affected entities than 0.005 percent of average revenues, profits. Thus, the Agency projects no
with fewer than 20 employees, and for and less than 0.19 percent of profits, in significant impacts from the rule on
affected small entities as defined by the all industries. Table V–7 presents the small entities.
Small Business Administration (SBA). economic impacts for small entities as a BILLING CODE 4510–26–P
Table V–6 shows the estimated whole, as defined by SBA. For these
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When costs exceed one percent of developed a definition for an APF in its The major revision the Agency made
revenues or five percent of profits, Z88.2–1992 Respiratory Protection to the ANSI APF definition in
OSHA considers the impact on small Standard that reads, ‘‘The expected developing the proposed APF definition
entities significant for the purposes of workplace level of respiratory included adding the phrase ‘‘when the
complying with the RFA. For all classes protection that would be provided by a employer implements a continuing,
of affected small entities, the Agency properly functioning respirator or class effective respiratory protection program
found that the costs were less than one of respirators to properly fitted and as specified by 29 CFR 1910.134.’’ The
percent of revenues and five percent of trained users’’ (Ex. 1–50). The ANSI Agency added this phrase to emphasize
profits. Therefore, OSHA certifies that Z88.2 subcommittee that developed the the already existing requirement that
this regulation would not have a 1992 standard used the NIOSH employers must select a respirator in the
significant impact on a substantial definition of an APF as a template for context of a comprehensive respiratory
number of small entities. its APF definition. However, the Z88.2 protection program. Also, the Agency
VI. Summary and Explanation of the subcommittee revised the phrase revised the phrase ‘‘as specified by 29
Final Standard ‘‘minimum anticipated protection’’ in CFR 1910.134’’ at the end of the
the NIOSH definition to ‘‘expected proposed APF definition to read ‘‘as
This section of the preamble provides workplace level of respiratory specified by this section’’ to conform to
a summary and explanation of each protection.’’ It also removed the NIOSH style conventions for referencing an
revision made to OSHA’s Respiratory phrase ‘‘to a given percentage’’ from its entire standard. Therefore, the Agency
Protection Standard involving APFs. definition. is adopting the APF definition that was
A. Definition of Assigned Protection The phrase ‘‘a given percentage’’ proposed in the NPRM except for this
Factor implies that some respirator users will minor revision. OSHA’s final definition
As part of its 1994 proposed not achieve the full APF under for APF reads as follows:
rulemaking for the Respiratory workplace conditions. The ‘‘given Assigned protection factor (APF) means the
Protection Standard, OSHA proposed a percentage’’ usually is about five workplace level of respiratory protection that
definition for APFs that read as follows: percent, which is a percentage derived a respirator or class of respirators is expected
from statistical analyses of results from to provide to employees when the employer
‘‘[T]he number assigned by NIOSH [the implements a continuing, effective
National Institute for Occupational WPF studies. In this regard, five percent
respiratory protection program as specified
Safety and Health] to indicate the represents the 5th percentile of the
by this section.
capability of a respirator to afford a geometric distribution of individual
certain degree of protection in terms of protection factors in a WPF study. B. APF Provisions
fit and filter/cartridge penetration’’ (59 Therefore, the 5th percentile is the 1. Paragraph (d)(3)(i)(A)—APF
FR 58938). OSHA proposed this threshold for specifying the APF for the Provisions
definition on the assumption that respirator tested under those workplace
conditions. Using the 5th percentile Paragraph (d)(3)(i)(A) is the provision
NIOSH would develop APFs for the
means that about five percent of the in OSHA’s Respiratory Protection
various respirator classes, building on
employees who use the respirator under Standard that requires employers to use
the APFs in the 1987 NIOSH RDL (59
these workplace conditions may not the APFs in Table 1 of this final
FR 58901–58903). However, NIOSH
achieve the level of protection assigned standard to select respirators. The
subsequently decided not to publish a
to the respirator (or class of respirators), language of the final provision is the
list of APFs as part of its 42 CFR 84
even after they receive proper fit testing same as the language in the proposal.
Respirator Certification Standards (60
and use the respirator correctly under a Therefore, paragraph (d)(3)(i)(A) in the
FR 30338), and reserved APFs for a
comprehensive respiratory protection final rule reads as follows:
future NIOSH rulemaking.
During his opening statement on June program. However, ANSI dropped the (A) Assigned Protection Factors (APFs).
15, 1995, at an OSHA-sponsored expert- phrase ‘‘to a given percentage’’ to reduce Employers must use the assigned protection
panel discussion on APFs, Adam confusion (i.e., the phrase did not factors listed in Table 1 to select a respirator
specify a percentage), and to emphasize that meets or exceeds the required level of
Finkel, then Director of the Agency’s employee protection. When using a
Directorate of Health Standards the level of protection needed by the combination respirator (e.g., airline
Programs, noted that OSHA would vast majority of employees who use respirators with an air-purifying filter),
explore developing its own list of APFs respirators in the workplace. See also employers must ensure that the assigned
(H–049, Ex. 707–X). The Agency then subsection E.4 (‘‘Analysis of Updated protection factor is appropriate to the mode
announced in the preamble to the final Database on APRs’’) of Section III of operation in which the respirator is being
Respiratory Protection Standard (63 FR (‘‘Methodology for Developing APFs for used.
1182) that it would propose an APF Respirators’’) of this preamble. The proposed language in paragraph
table ‘‘based on a thorough review and The Agency’s review of the available (d)(3)(i)(A) also contained the following
analysis of all relevant evidence’’ in a data on respirator performance, as well note that addressed two issues related to
subsequent rulemaking. In the final as findings from surveys of personal APFs:
Respiratory Protection Standard, OSHA protective equipment (Exs. 6–1 and 6– Note to paragraph (d)(3)(i)(A): The
reserved space for a table for APFs, a 2), indicate that existing APF definitions assigned protection factors listed in Table 1
paragraph ((d)(3)(i)(A)) for APF are confusing to the respirator-using are effective only when the employer has a
requirements, and a definition of APF public. Accordingly, OSHA has continuing, effective respiratory protection
under paragraph (b). developed its own definition in this program as specified by 29 CFR 1910.134,
In its 1987 RDL, NIOSH defined an final rule that will reduce confusion including training, fit testing, maintenance
APF as ‘‘[t]he minimum anticipated among employers and employees and use requirements. These assigned
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protection factors do not apply to respirators

protection provided by a properly regarding APFs, thereby assisting
used solely for escape.
functioning respirator or class of employers in providing their employees
respirators to a given percentage of with effective respirator protection, The first sentence of the note was
properly fitted and trained users’’ (Ex. consistent with its Respiratory proposed to remind employers that the
1–54–437Q). ANSI subsequently Protection Standard. APFs in Table 1 are effective only when

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50158 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

they have a complete respirator program that, when test subjects used pressure- C. Assigned Protection Factors for
that meets the requirements of OSHA’s demand SCBAs under high work rates, Specific Respirator Types
Respiratory Protection Standard. Table 1 a few of the study results indicated that
of the final rule already contains a note the respirators may not achieve an APF OSHA received comments on APFs
(footnote 2) that essentially repeats this of 10,000. Consequently, the proposed during the public comment period
language. Therefore, to avoid footnote cautioned employers not to use following publication of the NPRM, and
unnecessary duplication, the Agency these respirators under conditions that at the public hearing. These comments
decided to remove this language for the would require protection above this and hearing testimony are addressed in
final rule. However, the Agency is level. In discussing this footnote in the the following sections.
retaining the last part of the note as a proposal, OSHA stated that, ‘‘the 1. APF for Quarter Mask Air-Purifying
footnote in Table 1 of the final rule (see employer must restrict [pressure- Respirators
discussion of footnote 5 in the following demand SCBA] use to conditions in
subsection). which the required level of employee Introduction. OSHA proposed an APF
protection is at or below an APF of of 10 for quarter mask air-purifying
2. Table 1—APF Table respirators (i.e., quarter masks/quarter
10,000’’ (68 FR 34105). While the
The NPRM contained Table 1 Agency received no comments on the mask respirators), including them in the
(‘‘Assigned Protection Factors’’), which proposed footnote, it believes that, same category as filtering facepieces and
listed the APFs for the various respirator when employers use these respirators, half mask air-purifying respirators (68
classes. The final APFs for these they must assess the exposure FR 43115). However, the Agency
respirators are discussed in detail in conditions prior to such use as required specifically requested comment on
subsection C (‘‘Assigned Protection by paragraph (d)(1)(iii) of OSHA’s whether this action was appropriate (see
Factors for Specific Respirator Types’’) Respiratory Protection Standard. In 68 FR 34112).
of this section. view of the already existing The following recommendations
The proposed APF Table also requirement, the Agency decided that include all of the issues raised by
contained a set of footnotes that the information in proposed footnote 5 commenters regarding quarter mask
informed users regarding the was unnecessary, and, therefore, respirators: assign them an APF of 10;
application of APFs in the table. In the assign them an APF of 5; prohibit their
removed it from the final rule.
final rule, footnote 1 remains essentially As noted previously under subsection use altogether; or refrain from assigning
unchanged from the proposal. Footnote B (‘‘Paragraph (d)(3)(i)(A)—APF an APF to them until more studies
2 has been clarified to explain when Provisions’’) of this section, OSHA is become available. In general, those
APFs are effective, rather than when adding a new footnote 5 to Table 1 in commenters who recommended an APF
APFs apply. All employers who use the final rule. The new footnote will of 10 for quarter mask respirators based
respirators need to comply with the remind employers that they cannot their recommendations on the
Respiratory Protection Standard. The apply the APFs specified in Table 1 to analogous structural characteristics (i.e.,
language in footnote 3 of the proposed similarities in design) of quarter mask
emergency-escape conditions. OSHA
table was revised from the proposal. and half mask respirators. Commenters
believes this footnote is important
Proposed footnote 3 stated ‘‘This APF who recommended an APF of 5 pointed
because precise exposures levels, which
category includes quarter masks, out that the only available APF data for
serve as the basis for determining APFs,
filtering facepieces, and half-masks.’’ quarter mask respirators were in the
cannot be assessed accurately for
The reference to quarter masks has been 1976 study by Edwin C. Hyatt entitled
emergency-escape conditions. Under
removed from this footnote since ‘‘Respiratory Protection Factors’’ (i.e.,
these conditions, the only appropriate
quarter mask respirators have been the ‘‘Hyatt Study’’ (Ex. 2)). Based on this
respirators for employee use are
assigned a separate APF in Table 1. study, Hyatt assigned quarter masks an
respirators designated for escape (i.e.,
Also, the phrase ‘‘with elastomeric APF of 5.
escape respirators), consistent with the
facepieces’’ has been added to the
requirements specified by OSHA’s Comments regarding quarter mask
description of half masks to clarify that
Respiratory Protection Standard at 29 respirators. The commenters who
elastomeric facepieces are included in
CFR 1910.134(d)(2)(ii). New footnote 5 advised OSHA to give quarter mask
the half mask respirator class. Final
is similar to the APF provisions of the respirators an APF of 10 believed that
footnote 3 reads as follows in the final
Agency’s substance-specific standards when these respirators are used in a
rule: ‘‘This APF category includes
that designate appropriate respirators workplace where the employer has
filtering facepieces, and half masks with
for use under emergency-escape implemented a complete respirator
elastomeric facepieces.’’
Footnote 4 relates to the testing of conditions. Because both the substance- program as required by 29 CFR
PAPRs with helmets or hoods to specific standards and 29 CFR 1910.134, their performance should be
demonstrate that these respirators can 1910.134(d)(2)(ii) contain requirements the same as that of half mask respirators.
perform at the required APF of 1,000 or for selecting escape respirators, the For example, Thomas Nelson of Nelson
greater for this class. The proposed Agency is revising the note slightly to Industrial Hygiene Systems, Inc.
footnote and the changes made to it in ensure that employers refer to the testified,
the final standard are discussed in appropriate provisions. Therefore, There is no unique property of a quarter
subsection C (‘‘Assigned Protection footnote 5 to Table 1 in the final rule mask respirator that makes it[s] use different
Factors for Specific Respirator Types’’) will read as follows: from half facepiece respirators provided the
in item 4 (‘‘APF for Powered Air- These APFs do not apply to respirators person using the respirator is trained, fitted
used solely for escape. For escape respirators and maintains the respirator. OSHA should
Purifying Respirators (PAPRs)’’) of this
used in association with specific substances include quarter masks in the half facepiece
section. category. (Ex. 10–17.)
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Footnote 5 in the proposal described covered by 29 CFR part 1910 subpart Z,

employers must refer to the appropriate
limitations for the APF of 10,000 substance-specific standard in that subpart. Michael Runge of 3M Corporation
(maximum) for pressure-demand Escape respirators for other IDLH recommended that both half mask and
SCBAs. The proposed footnote 5 atmospheres are specified by 29 CFR quarter mask respirators should receive
described an SWPF study demonstrating 1910.134(d)(2)(ii). an APF of 10 because of their similarity

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in performance, which he described as because it was a fit test protocol, not an structural analogies between quarter
follows: experimental study. masks and half masks, and not on the
[L]eakage into a respirator can occur The International Brotherhood of functional characteristics of these
through three pathways[:] defects, filter Teamsters and the AFL–CIO Building respirators. Accordingly, the rulemaking
penetration or faceseal leakage. Leakage and Construction Trades Department record contains no quantitative or
through defects is controlled by the respirator supported an APF of 5 for quarter mask qualitative data or other convincing
maintenance program. Quarter facepiece respirators because they believed that evidence confirming that quarter mask
respirators are no harder to maintain than quarter mask respirators were more and half mask respirators function in a
half facepiece respirators; they have many of likely than half mask respirators to similar fashion to provide employees
the same parts * * * Filter leakage is move around on workers’ faces when with equal levels of respiratory
controlled by the NIOSH certification process protection. No WPF or SWPF studies
the workers communicate, or because of
* * * Faceseal leakage is controlled through
fit testing. The same fit tests can be used with movement, exertion, or perspiration. conducted on quarter mask respirators
either type of respirator, hence the same These commenters stated: were submitted to the record. The Hyatt
maximum face seal leakage would be Since the lower seal of the facepiece in Study, which consisted of testing
expected for the quarter and half facepiece quarter mask respirators is on the chin, rather quarter masks using a fit testing
respirator. (See Ex. 9–16.) than below the chin, the seal is much more protocol, provides the only data
likely to be compromised than the seal on a available for quarter mask respirators,
Daniel Shipp and Janice Bradley of half face respirator. Additionally, in use and it supports an APF of 5. Therefore,
the International Safety Equipment factors such as movement, exertion, and OSHA has decided to separate quarter
Association and Kenneth V. Bobetich of perspiration add to the likelihood that the mask respirators into their own category
MSA made similar statements (Exs. 9– seal of these masks will be compromised in
the work place. (Exs. 9–12 and 9–29.)
and assign them an APF of 5.
22, 9–37, and 16–14). It is possible that the facepieces of
Thomas Nelson asserted that the The Nuclear Regulatory Commission quarter masks and half masks are not
Hyatt Study may have underestimated commented that its regulations prohibit functionally analogous. Some
the APF for quarter mask respirators the use of quarter masks because of ‘‘the commenters noted that half masks rest
because the study did not control potential lack of stability of fit and the under the chin while quarter masks rest
adequately for respirator leakage. His availability of acceptable alternatives on the chin. Consequently, quarter
comment was based on the fact that the (half-face respirators)’’ (Ex. 10–7). Tracy masks are more prone than half masks
authors of the study: (1) Did not Fletcher of Parsons-Oderbrecht JV to slip and compromise the face seal
administer a proper fit test to the test recommended that OSHA prohibit the when a worker talks or performs heavy
subjects prior to measuring particle use of both quarter and half masks, work. While the record contains no
contamination inside the respirator, and stating, ‘‘Employees are required to wear quantitative evidence supporting such
(2) used a fine particle (sodium eye protection with the respirator, and assertions, there is ample qualitative
chloride) as a test aerosol, that may have use of the two together is difficult as the evidence, and OSHA is entitled under
penetrated both the faceseal and filter, wearer will find that the glasses rest on these circumstances to take a
thereby artificially increasing the nose piece of the respirator creating conservative approach in weighing the
concentrations inside the respirator (Tr. an entry point for an overspray, splash available evidence (see, e.g., 29 U.S.C.
at 163 and Ex. 18–9). or whatever.’’ (Ex. 10–1.) 655(b)(5) and United Steelworkers of
A small number of commenters America, AFL–CIO–CLC v. Marshall,
The commenters who recommended expressed the opinion that, because the 647 F.2d 1189, 1248 (D.C. Cir. 1980)).
that OSHA assign quarter mask Hyatt Study provides the only data on Moreover, OSHA believes that these
respirators an APF of 5 stressed that no the protection afforded by quarter mask respirators can be used safely at an APF
studies, including WPF and SWPF respirators, OSHA should reserve its of 5 because properly administered fit
studies, on quarter mask respirators decision on the APF for these testing protocols (including
have been performed since the Hyatt respirators until more studies can be administering the fit test with glasses
Study. Few quantitative data are thus completed. ORC Worldwide commented and other protective equipment worn
available on which OSHA can rely to set that ‘‘[q]uarter masks should be during respirator use),9 as well as
an APF for quarter mask respirators. evaluated as individual respirator appropriate respirator training, will
These commenters, who include models. In the absence of inform employees of this problem and
NIOSH, pointed out that NIOSH used comprehensive testing data over the last the procedures they can use to prevent
the Hyatt Study to set the APF for 27 years, there is no valid basis for it.
quarter mask respirators at 5 in its 1987 giving them an APF of any kind’’ (Ex. In further response to those
RDL. NIOSH commented further that, 10–27). David Spence, an industrial commenters who advised OSHA to
‘‘quarter mask respirators should be hygienist, stated: prohibit quarter masks, OSHA does not
separated from half mask respirators believe that this approach is reasonable.
We recommend that SWPF studies be
into a class of their own with an APF As discussed at the public hearing,
performed on quarter masks respirators in a
of 5. The data from Hyatt’s study [1976] manner analogous to the ORC SWPF studies quarter mask respirators are not widely
do not support an APF of 10’’ (Ex. 17– performed on powered air-purifying used, but they do have some popularity
7–1). Similarly, James S. Johnson stated, respirators and supplied-air respirators. To in particular industries (Tr. at 558). All
‘‘We object to the agency’s proposed not delay publishing APFs for the other existing quarter mask respirators have
APF of 10 for quarter mask respirators. classes of respirators, the section on APF of received an N95 rating under NIOSH’s
There is no evidence in the record, from quarter masks could be reserved pending
completion of SWPF studies. (Ex. 10–6.)
certification program, indicating that the
either WPF or simulated workplace respirators are designed to prevent at
protection factor (SWPF) studies that Summary and conclusions. In light of least 95% of the challenge agent from
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support this conclusion’’ (Ex. 16–9–1). these comments, the Agency has penetrating the filter. Therefore, these
Johnson’s comments were echoed by the reconsidered the proposed APF of 10 for certification results, along with the
AFL–CIO (Exs. 9–27 and 19–1–1). These quarter masks. The comments
comments indicate that the Hyatt Study recommending an APF of 10 for quarter 9 As required under Appendix A (Part IA,

was not a valid WPF or SWPF study mask respirators are based solely on paragraph 13) of 29 CFR 1910.134.

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other evidence in the rulemaking APF of 10. Consequently, these to or greater than 10. (A detailed
record, have convinced OSHA that commenters argued that the entire class discussion of Dr. Crump’s analyses can
employees can use these quarter mask of respirators should receive an APF of be found in section III (Methodology) of
respirators safely at an APF of 5 in 5 (Exs. 9–29, 9–27, and 10–54). The this preamble.) Therefore, OSHA does
workplaces that implement a respirator AFL–CIO stated: not agree that the evidence in the record
program that complies with 29 CFR An examination of the summary table of supports an APF for filtering facepieces
1910.134. WPF studies for filtering facepieces and half- of 5 as suggested by these commenters.
Regarding those commenters who mask elastomeric respirators at 68 FR 30495 Respirator configuration and
advised OSHA to delay the APF of OSHA’s preamble to this proposed rule certification issues. Commenters also
decision for quarter mask respirators justifies our position. Of the seven respirators stated that not all configurations (e.g.,
until WPF or SWPF studies are that had a 5th percentile WPF less than 9, cups, duckbills, fold flats) of filtering
available, OSHA notes that in the five of [the] respirators that failed consisted facepiece respirators have been studied
intervening 29 years following the Hyatt of the filtering facepiece style of respirator.
Thus [of] the overwhelming majority of the
(e.g., Exs. 9–17, 9–34, 9–40, 10–33, and
Study, no WPF or SWPF studies have 10–34; Tr. at 204–205). In addition,
been conducted on quarter mask half mask respirators that failed, five of the
seven or 71%, were filtering facepieces. At some commenters mentioned that none
respirators. If OSHA was to delay setting the qualitative level then, this data clearly of the respirators in the studies
an APF for quarter mask respirators indicates that most of the problem with evaluated by the Agency for the
pending further study, it could in effect failing to provide adequate protection rests proposal were certified under NIOSH’s
be deciding to delay setting an APF for with filtering facepieces and not with half- new 42 CFR 84 requirements (Exs. 9–33,
these respirators indefinitely. OSHA has mask elastomerics. (Ex. 9–27.) 9–34, 10–22, and 10–38). The focus of
not been persuaded by the record to these comments was that OSHA should
The summary table in the proposal at
delay setting an APF for quarter mask not assume that all filtering facepieces
68 FR 34095 contains several studies
respirators. Moreover, as noted in the perform the same as those filtering
that were reviewed by OSHA, but did
previous paragraph, OSHA has facepieces that were tested. These
not meet the selection criteria and were
concluded that the record evidence commenters believed that filtering
excluded from the quantitative analyses.
supports an APF of 5 for quarter mask facepiece half masks should be given an
The two filtering facepiece respirators
respirators. APF of 5 because, in their view, there
(one model in each study) evaluated in
2. APF for Half Mask Air-Purifying these excluded studies had WPFs less is a lack of information on 42 CFR 84
Respirators than 9 (Cohen, Ex. 1–64–11; and Reed, filtering facepieces.
Introduction. OSHA proposed an APF Ex. 1–64–61), while five of the OSHA recognizes that its analyses do
of 10 for both elastomeric and filtering respirators included in OSHA’s analyses not encompass all configurations or
facepiece half mask respirators. During failed to achieve a WPF of 9. Three of models of filtering facepiece half masks.
the public comment period, interested these five respirators were filtering However, this is true for all types of
parties expressed two divergent views facepiece respirators and the remaining respirators, not just filtering facepiece
on this proposed APF. The healthcare two respirators were elastomeric half half masks. Since filter efficiency is
industry (Ex. 9–18 to 9–21), NIOSH (Tr. masks. As noted at the hearing, OSHA certified by NIOSH, the filter media of
107 and 112) and other commenters conducted a Chi-square analysis to all filtering facepiece (and elastomeric)
(e.g., Exs. 9–11, 9–22, 9–26, 9–42, and determine if the proportion of filtering half mask configurations are equivalent.
10–18) agreed to an APF of 10 for both facepieces having a WPF less than 9 Therefore, any differences in
types of respirators, while a number of differed from the proportion of performance would arise from
commenters stated that filtering elastomerics with a WPF less than 9 variations in faceseal leakage among the
facepieces should be assigned a (Trans. at 135–136). This statistical different configurations. OSHA’s
protection factor of 5 (e.g., Exs. 9–8, 9– comparison showed that these Respiratory Protection Standard
12, 9–29, and 10–6; AFL–CIO Tr. at proportions did not differ significantly requires that all respirator users pass a
122–126). The following sections from each other, indicating that similar respirator fit test to ensure that a
discuss this issue in detail. proportions of filtering facepiece and minimum acceptable faceseal
A number of reasons were presented elastomeric respirators performed at this performance is achieved. Therefore,
for limiting filtering facepiece half level—i.e., that the filtering facepiece because all respirators must be used in
masks to an APF of 5. These reasons can respirators did not perform more poorly accordance with the Respiratory
be categorized generally into concerns than the elastomeric respirators. Protection Standard, the Agency sees no
related to: (1) WPF studies and After updating the proposal’s half reason to conclude that differences in
associated data; (2) design of filtering mask WPF database (Ex. 20–2) with new configuration will result in performance
facepiece respirators; (3) respirator use and additional data, Dr. Crump variations. In addition, Section III of this
in the workplace; and (4) ANSI reanalyzed the database (Ex. 20–1). preamble discusses two studies that
standards. As discussed in Section III Plotting the observed protection factors compare the workplace performance of
above, some commenters believed that for both the elastomeric and the filtering 42 CFR 84 and 30 CFR 11 filtering
the WPF studies evaluated by OSHA facepiece half masks shows that over facepiece half masks. The 42 CFR 84
suffered from multiple problems (e.g., 95% of each type of half mask attained respirators demonstrated superior
old data, studies not representative of an APF of at least 10. Moreover, a performance when compared to the 30
typical workplaces). While these points review of these updated analyses reveals CFR 11 respirators. OSHA concludes
are addressed in detail in Section III of that more elastomeric than filtering that, based on the more stringent filter
this preamble, some of these concerns facepiece respirators failed to achieve an efficiency certification requirements and
warrant further discussion here. APF of 10 (see Table 2 in Ex. 20–1). these study results, 42 CFR 84
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Some filtering facepieces do not Even when the data from studies respirators provide performance at least
achieve an APF of 10. Comment was excluded from these analyses were equal to 30 CFR 11 respirators.
made that the data presented in the added to the database, over 95% of the Therefore, the record evidence does not
studies analyzed by OSHA indicate that WPFs for both types of half mask support lowering the APF for filtering
not all filtering facepieces achieved an (separately and combined) are still equal facepieces to 5.

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Determining faceseal leakage. Several in this area. However, employers and study data to 42 CFR 84 respirators. For
commenters mentioned that NIOSH had respirator users should note that using example, Mark Haskew testified:
eliminated the fit test portion of its a respirator certified by NIOSH through The other problem with the old data is that
certification procedures. They believed performance tests would not preclude the 30 CFR 11 respirators are significantly
that as a result of this NIOSH action, individual fit testing as required by different in performance, or at least we
one could not be sure if a filtering OSHA’s Respiratory Protection would anticipate that they may be different
facepiece respirator achieves an Standard. in the performance that they provide. Based
adequate faceseal and provides the Filtering facepiece design problems. on the newer filter media with the 95, 99 and
expected protection (Exs. 9–8, 9–27, 9– Several commenters urged an APF of 5 100 series, there’s an allowance for increased
29, 9–34, 9–35, 9–40, 9–41, 10–22, 10– for filtering facepiece half masks based breathing resistance. And because the
on the design characteristics of these efficiency has to be greater, the filter media
33, 10–38, 10–50, and 10–55). During itself tends to be stiffer. And the concern we
the public hearing, NIOSH indicated respirators. Some commenters
have, of course, which is untested in the
that it would establish a new respirator expressed concern that, in comparison research as far as we know, is that it may not
certification testing procedure, stating: to elastomeric half masks, filtering conform as well to a wearer’s face. (Tr. at
facepieces are poorly constructed (e.g., 203.)
Such changes would result in additional
certification tests to assure or assess the
non-adjustable head straps, prone to
overall performance of every respirator crushing or denting, facepiece too stiff Based on their opinion that
model, and thus assure that every model is or too soft) (e.g., Exs. 9–34, 10–37, 10– manufacturers would have to produce
capable of providing a level of protection 38, 10–54, and 12–7–1). For example, thicker, stiffer filter media to meet the
consistent with the class APF. (Tr. at 103.) T.C. Lefford of Fluor Hanford stated: new filter efficiency requirements, these
Several commenters supported this Elastomeric half-mask respirators provide a commenters concluded that the data for
approach, and indicated that better face seal that filtering facepieces 42 CFR 84 filtering facepieces would
implementing such a procedure would (Disposable respirators or maintenance-free show a decrease in performance
be beneficial. For example, Tim Roberts masks). Most elastomeric half-mask compared to the older 30 CFR 11
respirators are made of more pliable silicone respirators. These commenters, based on
(Exs. 17–8 and 18–4) stated that the rubber that provides a much better seal on
procedure would help to identify this assumption, concluded that it
the face. Elastomeric half-mask respirators would be inappropriate to set the APF
respirators that may not have adequate have three sizes with adjustable head straps
workplace performance. The AFL–CIO and a head cradle to improve stability while for filtering facepieces based on WPF
(Ex. 19–1) believed that while the the majority of filtering facepieces have one studies of the older 30 CFR 11
procedure would help assure certified or two sizes and the head straps are non- respirators. However, they presented no
filtering facepieces are capable of fitting adjustable. (Ex. 9–32.) data to substantiate this claim.
an employee properly, these respirators OSHA believes that concerns about When NIOSH published the 42 CFR
should still be given an APF of 5. loose, dented, or crushed filtering 84 respiratory protective devices final
Two respirator manufacturers also facepieces are addressed adequately by rule (60 FR 30336), Section 84.180 of
addressed this issue. The 3M Company compliance with existing program this rule increased the maximum
commented that no evidence exists requirements under 29 CFR 1910.134(d) allowable breathing resistance levels
showing that employee protection and (g). during inhalation to 35 mm (of water
would be enhanced by adding a fit test In addition, comment was received pressure), and during exhalation, to 25
requirement to NIOSH’s certification alleging that the 42 CFR 84 mm. NIOSH explained this increase as
procedures, and added that proper requirements for increased filter follows:
respirator fit must be determined by fit efficiency result in respirators with stiff [It will] enable manufacturers to produce
testing each wearer (Ex. 18–7). When facepieces, poor face seals, and high respirators meeting the new requirements
asked by OSHA about the proposed breathing resistance, thereby producing more expeditiously and at lower cost. * * *
NIOSH testing, Jay Parker of Bullard filtering facepieces with increased This small increase in maximum allowable
responded that he believed such testing faceseal leakage (e.g., Exs. 9–34, 9–41– breathing resistance for particulate
would be an improvement over the 1, 10–46, and 10–50). Mark Haskew, respirators does not add substantially to
current procedures (Tr. at 497). Tim Roberts, and Ching-tsen Bien (Exs. physiologic burden for respirator users, and
OSHA has reviewed this information 12–7–1, 16–12, 16–20–3, and 17–5) also will be compensated for by increased worker
protection provided by the new filter
and supports NIOSH’s plans to add expressed concern about the increased efficiency tests and classification system. (60
performance testing to its respirator filter efficiency requirements of the new FR 30346.)
certification procedures. The Agency 42 CFR 84 certification standards and
agrees with the 3M Company that their effect on the performance of However, when respirator
proper facepiece fit can only be assured filtering facepiece respirators. In their manufacturers developed new
through individual fit testing. However, written comments, Mark Haskew and particulate filters to meet the 42 CFR 84
OSHA also agrees with Tim Roberts that Tim Roberts stated that the 42 CFR 84 performance requirements, they were
performance testing will assist in filter efficiency requirements ‘‘would able to meet them without increasing
identifying respirators with poor fitting increase the breathing resistance and in the breathing resistance levels. For
characteristics that may not provide turn cause an increase in faceseal example, the 3M Company submitted
protection consistent with the leakage when compared to 30 CFR part the following table of breathing
respirator’s APF. Thus, OSHA 11 filtering facepieces’’ (Ex. 12–7–1). resistance values for several classes of
concludes that performance testing will Haskew, Roberts and Bien also 42 CFR 84 filters made by different
enhance the information needed for questioned the ability of 42 CFR 84 manufacturers (Ex. 17–9–1, page 6;
selecting appropriate respirators, and filtering facepieces to fit the user’s face, derived from a paper submitted by 3M
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encourages NIOSH to expedite its efforts and the applicability of 30 CFR part 11 to the OSHA docket (Ex. 9–16–1–3)).

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50162 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

Manufacturer A Manufacturer B
Filter Class (DP mmH2O) (DP mmH2O)

N95 .................................................................... 11.5 ................................................................... 9.7

R95 .................................................................... No Product ....................................................... 13.6
P95 .................................................................... 14.9 ................................................................... No Product
P100 .................................................................. 23.9 ................................................................... 17.3

No measurement in this table exceeds increased leakage as pressure drop to support his experience that filtering
the 30 CFR 11 limit of 30 mm of water increases’’ (Ex. 18–7, page 49). Janssen, facepieces demonstrate a difference in
pressure. As the 3M Company stated, in a summary of this study that he user seal check performance compared
‘‘Breathing resistance of 42 CFR 84 presented at the May 2004 AIHCE to elastomerics.
respirators are contained within the stated, ‘‘Results of this study do not Similar concerns were voiced by Mark
range of breathing resistances allowed support the concept of increased Haskew (Exs. 17–5 and 18–3), Tim
for 30 CFR 11 respirators, rather than faceseal leakage with increased pressure Roberts (Exs. 9–8, 10–55, and 17–8), and
being significantly higher’’ (Ex. 16–25– drop.’’ Ching-tsen Bien (Exs. 9–43–2 and 18–5).
2, page 17). While concern was expressed by some In addition, Mark Haskew stated that
OSHA also received comments that commenters about increased filter filtering facepieces with adjustable nose
higher breathing resistance leads to efficiency requirements resulting in pieces cannot normally obtain
increased faceseal leakage (Exs. 9–34, 9– increased breathing resistance and repeatable fit factors. However, these
35, 9–41, 10–38, and 10–50). During the faceseal leakage, no data were submitted commenters did not submit any
public hearings, 3M submitted two new to support this viewpoint. However, supporting data for this contention. In
studies of filtering facepiece respirators studies were submitted that his post-hearing submission, Tim
certified under 42 CFR 84 (Ex. 16–25– demonstrated that 42 CFR 84 filtering Roberts (Ex. 18–4) stated that data
3). The 42 CFR 84 certified filtering facepiece respirators perform at least as demonstrating this difference in
facepieces used in these studies well as 30 CFR 11 filtering facepieces, performance are not available.
performed better, overall, than and that increased filter efficiency does James Johnson (Exs. 10–33, 16–9–1,
comparable filtering facepieces certified not result in increased faceseal leakage. and 17–10) also stated that filtering
under 30 CFR 11 (see discussion above After reviewing this information, OSHA facepieces cannot be fit checked
under Section III (‘‘Methodology, etc.’’)). is persuaded that 42 CFR 84 half masks effectively, and presented results from a
These results indicate that faceseal are as protective as 30 CFR 11 half series of fit tests he performed on
leakage, if it existed, did not impair the masks and that increased face seal himself with filtering facepieces and
performance of these filtering leakage in such respirators has not been elastomeric half masks. Three of the
facepieces. demonstrated by evidence in the record. four elastomeric half masks that he
At the 2004 AIHCE in Atlanta, Therefore, these arguments do not tested passed a positive or negative user
Georgia, Larry Janssen of the 3M support an APF for filtering facepieces seal check, and consistently achieved a
Company presented the results of a of 5. fit factor of 1500 or more using the
recently completed study (Ex. 17–9–1) The efficacy of user seal checks Portacount fit test instrument. One
using the OHD FitTester 3000 controlled provided by respirator manufacturers elastomeric half mask did poorly (fit
negative pressure (CNP) fit testing also was questioned by several factor of less than 100), and it was
instrument to measure faceseal leak rate commenters. These commenters stated identified clearly as a failure by a user
(i.e., a drop in pressure inside the that user seal checks for filtering seal check and a subsequent fit test. He
mask). Leak-rate measurements first facepieces either could not be found that it was difficult to achieve a
were made using the negative pressure performed or were more difficult than minimum fit factor of 100 or greater
and flow-rate settings listed for the CNP user seal checks with elastomeric with filtering facepieces using the
fit test in Appendix A of 29 CFR facepieces (e.g., Exs. 9–27, 9–31, 9–34, Portacount Companion fit test
1910.134. Without disturbing the fit of 9–35, 9–40–1, 9–41–1, and 10–54). In instrument. However, two of the eight
the respirator, four additional leak-rate general, their opinion was that the filtering facepiece models he tested
measurements then were made at four inability to perform an adequate user achieved fit factors of 100 or greater. He
different negative pressures and flow seal check on filtering facepiece stated that he was able to identify
rates ranging from 5.6 through 20.1 mm respirators would lead to decreased obvious leaks with the filtering
of water pressure, followed by a final protection, thereby warranting a facepieces he tested by exhaling heavily
measurement at the CNP fit test rates. reduced APF for this type of respirator. and sensing the airflow, but that
Janssen found that test subjects with a Bill Kojola of the AFL–CIO (Exs. 9–27 cupping his hands over the facepiece
fit equal to or greater than a fit factor of and 19–1) stated that ‘‘user seal checks was not an effective user seal check for
100: are rarely performed on filtering him. He stated further that these
facepieces in the field and * * * it is preliminary fit test results demonstrated
[D]id not show any increase in leak rate as
pressure drop increased. Subjects with a fit
extremely difficult, if not impossible, to a significant difference in performance
factor below 100 * * * showed significant perform effective user seal checks on between elastomeric and filtering
variability in leakage as the settings were filtering facepieces.’’ He stated that it facepiece half masks, and that OSHA
changed, but the amount of leakage did not was ‘‘easy for wearers to perform should give filtering facepieces an APF
correlate with increasing pressure drop, i.e., effective user seal checks on of 5 based on these results.
sometimes the leakage was higher and elastomerics.’’ Kojola cited this The numerical differences in fit
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sometimes lower. (Ex. 18–7, page 49.) difficulty in performing user seal checks factors between filtering facepieces and
The 3M Company concluded that the as a reason for separating filtering elastomeric half masks reported by
study ‘‘demonstrates the value of fit facepieces from elastomerics, and giving Johnson may not be significant.
testing: respirators that fit well enough filtering facepieces an APF of 5. Achieving a fit factor of 170, as Johnson
to be assigned to a worker do not exhibit However, he did not provide any data did with the 3M 9211 foldable filtering

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facepiece using the Portacount that the use of seal checks improved the asserted that user seal checks that
Companion, is not necessarily worse overall quality of respirator fit. involve cupping the hands over the
than achieving a fit factor of 2200 with The 3M Company also stated that the facepiece were not effective, and that
a MSA Comfo elastomeric half mask ease or difficulty in performing user seal the use of fit check cups should be
using the Portacount alone. In this checks is based on many factors. These required by OSHA. They implied that fit
regard, the fit test instruments identified factors include difficulty in performing check cups are a generic device for
the elastomeric half masks and filtering a user seal check on some elastomeric doing user seal checks, and that one
facepieces that provided adequate fits respirators when the exhalation valve manufacturer’s fit check cup can be
on Johnson (i.e., they met their required cover must be removed without used with other types of filtering
fit factor of 100), and he was able to disturbing the fit. Also, it can be facepieces. On the other hand, Ken
perform user seal checks with both difficult to perform a user seal check on Wilson of the Ohio Board of Water
respirators. Therefore, OSHA finds that elastomerics by blocking off the filter Quality, Division of Safety and Hygiene
these fit test measurement differences when a respirator user has small hands. (Ex. 10–3) stated that he has not seen fit
are not a convincing argument for an In addition, 3M cited an analysis from check cups used in the field, and
APF for filtering facepiece respirators of its report at the 2001 AIHCE (Ex. 4–10– doubted that their use would allow a
5. The Agency believes that Johnson’s 7) that showed no significant differences respirator user to achieve a successful fit
pilot study proves only that some makes in WPF results for filtering facepieces check.
and models of filtering facepieces are measured in the morning and afternoon, OSHA has considered carefully the
not suitable for his face size and shape. with repeated redonnings of the opinions presented about fit check cups
When he wore a filtering facepiece or respirators performed during each of and user seal checks. The Agency
elastomeric respirator that fit him, an these periods. These results indicate recognizes that the use of a fit check cup
APF of at least 10 was achieved. that the user seal check conducted after is one way of performing a user seal
In response to these concerns, the 3M each redonning was effective in check. However, these cups can be
Company (Ex. 17–9–2) and the Aearo ensuring proper respirator fit. inconvenient when used in the
Company (Ex. 17–3–1) submitted to the During the rulemaking, several workplace on a daily basis. In this
record instructions for conducting user commenters referred to the use of fit regard, each respirator user would need
seal checks on their filtering facepiece check cups to perform user seal checks. ready access to a fit check cup, not only
respirators. The Aearo Company These devices are designed to assist the to perform the required user seal checks
instructs users to cup their hands over respirator user in performing a positive when initially donning the respirator,
and negative pressure seal check by but for any repeated respirator donnings
the respirator to test the seal, stating: ‘‘If
covering the surface of a filtering that occur throughout the workday. The
air flows around your nose, tighten the
facepiece respirator. For example, Tim fit check cup would be another piece of
nosepiece; if air leaks around the edges,
Roberts stated: equipment for respirator users to carry
reposition the straps to fit better (Ex.
with them, and it can be misplaced.
17–3–1).’’ User seal check instructions One of the manufacturers did recognize
that there was difficulty in doing these types However, most respirator manufacturers
for 3M filtering facepieces read, ‘‘If air
of fit checks, and they designed, and have not adopted the use of fit check
leaks between the face and faceseal of
constructed, and sold a fit-check cup that cups, and these manufacturers
the respirator, reposition it and readjust
actually fit over the facepiece of a respirator, recommend cupping the hands over the
the nose clip for a more secure seal’’ a filtering facepiece respirator, so that it filtering facepiece to perform a user seal
(Ex. 17–9–2). would actually check the seal in a more check. As the 3M Company stated in
In their post-hearing comments (Exs. conventional manner. We think that that may describing the use of fit check cups,
9–16, 17–9–1, 18–7, and 19–3), 3M be another alternative approach to assuring
that these respirators fit properly if there was
‘‘Based on our experience, user seal
responded to the comments raised at the checks without cups are effective, more
public hearing regarding the difficulty a requirement to do that. (Tr. at 216.)
convenient, and easier to perform’’ (Ex.
or impossibility of performing user seal Another commenter who discussed 17–9–1, page 4).
checks on filtering facepiece respirators. the use of fit check cups was Donald Since only a few respirator
The 3M Company pointed out that no Faulkner of the United Steelworkers, manufacturers have fit check cups, it is
data were offered to support this who stated during his questioning of not surprising that they are seldom used
position, nor was recognition given to Warren Myers: in the workplace. The fit check cups
the methods contained in both the 1980 [W]e don’t see a real good fit with the that exist are designed by the respirator
and 1992 editions of the ANSI Z88.2 hands-over filtering facepiece. That’s why the manufacturer to work with a specific
respirator standard for performing user cups were developed by many facepiece configuration and respirator
seal checks. The 3M Company also cited manufacturers, but we don’t see them being model, and the cups do not necessarily
a study in the docket by Myers et al. (Ex. utilized, bought, or anything else. (Tr. at 95.) work with other models of respirators,
9–16–1–13), which concluded that no He elaborated in his post-hearing even models made by the same
difference was found in the comment: ‘‘Filtering facepieces do not manufacturer. OSHA knows of only one
effectiveness of performing user seal allow seal checks to be performed series of 42 CFR part 84 filtering
checks on filtering facepiece respirators without the assistance of additional facepiece respirators that have fit check
or elastomeric respirators. This study equipment [i.e., fit check cups] that is cups available.
also referenced a comment by Daniel K. never provided by the employers, as OSHA does not find merit in the
Shipp of the ISEA (Ex. 9–22) that user being cost prohibitive.’’ (Ex. 19–2.) comments that fit check cups are
seal checks can be performed with Bill Kojola of the AFL–CIO (Tr. at necessary to perform user seal checks
filtering facepieces. A second evaluation 132) and George Macaluso of the with filtering facepieces. While a fit
of user seal checks submitted by 3M (Ex. Building Construction Trades check cup designed to work with a
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17–9–10) involved the use of a 3M flat- Department of the AFL–CIO (Tr. at 654) particular model of respirator can be
fold filtering facepiece by novice made similar statements regarding the used to perform a user seal check, it is
respirator users. It showed that novice infrequent use of fit check cups, i.e., not the only way to perform this
respirator users can be trained to that they are generally not used in the function. Accordingly, the Agency
effectively perform user seal checks, and workplaces their unions represent. They believes that respirator users can follow

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50164 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

a respirator manufacturer’s instructions and find that these respirators can be to both elastomeric and filtering
to perform a user seal check, e.g., reliably fit tested and fit checked. facepiece half masks will result in an
whether the seal check involves The WPF studies provide further economic incentive for employers to
cupping the hands over the facepiece or support for this conclusion. In fact, provide filtering facepiece respirators to
the use of a fit check cup. every WPF study of filtering facepieces employees rather than elastomeric half
The OSHA Respiratory Protection in the OSHA APF database involved fit masks. These commenters assumed that
Standard requires that an employee testing the respirator, using the new and the less expensive filtering facepiece
perform a user seal check to use a refined methods, prior to the worker respirators were less protective than the
respirator. The WPF database that using the respirator in the study. more expensive elastomerics (e.g., Exs.
OSHA developed contains over 1,000 Researchers used the available fit testing 9–29, 10–38, and 10–54; Tr. at 212–213
WPF data points for half mask and checking technologies and and 659–660). The USWA expressed
respirators collected from workers using methodologies in the studies to be this concern, stating, ‘‘If OSHA gives the
respirators in programs that included assured that employees would be filtering face piece type of respirator an
user seal checks. Analyses of these data protected during the study by the APF of 10, employers would interpret
showed that the filtering facepiece respirators when exposed to airborne this as ‘let’s take the cheap way out.’ It
respirators achieved an APF of 10. contaminants up to 10 times the PEL, will be a dis-incentive to issue to
These data are derived from WPF and so that they could determine the workers the proven protection of the
studies in which user seal checks were results of the study would be accurate. elastomeric face piece respirator’’ (Ex.
performed on filtering facepiece Non-compliance and economic 9–40–1). Responding to an OSHA
respirators by 100s of workers. In incentive issues. Several commenters question about this issue, Thomas
addition, 3M’s analysis (Ex. 4–10–7) asserted that filtering facepiece half O’Connor of the National Grain and
indicates that user seal checks masks should be given an APF less than Feed Association stated:
performed on filtering facepieces ensure 10 because employers do not comply
Well, clearly, if [you] had two respirators
proper redonning of these respirators. with the Respiratory Protection that provided the comfort and fit to the
When a respirator user cannot perform Standard (e.g., by not performing fit employee that’s needed and one was half the
a user seal check with a particular testing) (e.g., Exs. 9–40–1, 10–33, and cost of the other one, obviously anybody
respirator model, then that respirator 10–52; Tr. at 663). In this regard, Donald would select the lower cost respirator. But as
cannot be used by that employee, and Faulkner of the United Steelworkers of I noted, that’s not the primary motivation,
the employer must find another America (USWA) stated: cost. The primary motivation is complying
respirator model on which a user seal with the standard, making sure that the
We observe in many worksites that the employee[s] wear it and it fits properly and
check can be performed. This employers are issuing filtering masks as if
requirement applies to all tight-fitting it’s comfortable. * * * If an employee’s
they were candies. They don’t have
facepieces, including filtering facepieces wearing a respirator that’s not comfortable,
respiratory protection programs,
there’s going to be an incentive for them
and elastomeric half masks. How easy or requirements to be clean shaven, and no
possibly not to wear that respirator * * *
difficult it is for an employee to perform medical or no idea of the MUC of the
when they should be wearing it. So from our
a user seal check on a particular type of contaminant that the worker needs to be
protected from. (Ex. 9–40–1.) perspective, comfort is one of the primary
respirator is not an issue that precludes considerations in selecting a respirator for an
other employees from using that However, the 3M Company employee. (Tr. at 684–685.)
respirator. Therefore, the comments on commented that non-compliance with
OSHA considered these comments
user seal checks do not provide the Respiratory Protection Standard
and concludes that neither cost nor non-
convincing evidence that would support should not be a factor in determining
compliance with the Respiratory
decreasing the APF for filtering APFs, noting:
Protection Standard is an appropriate
facepieces to 5. OSHA has appropriately made the
OSHA argued previously in National basis for determining the final APF for
proposed APFs contingent upon the half masks. Employers are required to
Cottonseed Products Association v. existence of an effective and well-managed
Brock, 825 F.2d 482 (D.C. Cir. 1987) that comply with all the provisions of the
respiratory protection program. This is the
filtering facepieces used to protect only circumstance under which APFs can be Respiratory Protection Standard. Non-
employees against exposure to cotton used. Setting APFs on assumptions of poor compliance is not an option for
dust should have an APF of 5 based on fit and lack of training is impossible because employers. Thus, there is no compliance
the difficulty of fit testing, particularly of the countless variables that exist in the reason to reduce the APF for half masks.
workplace and workforce. APFs can only As to whether assigning a protection
fit checking on a daily basis. However, apply under properly managed respiratory
the Agency now believes that the record factor of 10 to filtering facepiece half
protection programs. This is supported by masks will provide an economic
evidence for this rulemaking shows that following the American Industrial Hygiene
the industrial-hygiene research Association Respiratory Protection
incentive to use these respirators, OSHA
community has developed and refined Committee definition of APFs: An APF is the concludes that so long as a respirator
qualitative and quantitative fit tests, as level of respiratory protection that a properly achieves an APF of 10, it doesn’t matter
well as developed sophisticated functioning respirator or class of respirators what respirator an employer uses. Once
techniques for determining respirator would be expected to provide to properly again, OSHA’s data analyses, as well as
fitted and trained users in the workplace. The consensus standards, show that filtering
leakage. Several commenters (Exs. 16–
APF takes into account all expected sources facepieces can attain an APF of 10.
25–3 and 17–9–1) provided evidence of facepiece penetration (e.g., face seal
that filtering facepieces could be fit ANSI’s updated APF of 5. Several
penetration, filter penetration, valve leakage).
tested and then used effectively. Seal- It is not intended to take into account factors
commenters noted that the recent draft
check techniques and procedures (e.g., that degrade performance such as poor of the ANSI Z88.2 respirator standard
fit-test cups, manual testing) also have maintenance, failure to follow manufacturers’ gave filtering facepieces an APF of 5
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been developed to help ensure that instructions, and failure to wear the (e.g., Exs. 9–8, 10–51, and 10–54; Tr. at
filtering facepieces maintain their fit respirator during the entire exposure period. 124–125 and 197–201). For example,
while being worn in the workplace. (Ex. 9–16.) Bill Kojola of the AFL–CIO testified:
These new developments allowed the Several commenters voiced concern The AFL–CIO’s position that filtering
Agency to reassess filtering facepieces that assigning a protection factor of 10 facepieces should be given an APF of 5 is

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50165

also provided by other organizations with agreed that a subcommittee composed of factor of at least 100 for 95% of the
considerable expertise on respiratory other members may have reached a respirator users. The sixth respirator
protection. Indeed, the ANSI Z88.2 different conclusion regarding the APF attained this level of protection for 70%
Committee, charged with the responsibility
for the American standard for respiratory
for filtering facepiece half masks (Tr. at of the users. Based on the results for the
protection, has recently proposed an APF of 354–355). He also stated: sixth respirator, Hyatt recommended an
5 for filtering facepiece respirators. We There’s nothing in the consensus process APF of 50 for the respirator class as a
believe that OSHA should give serious that says every part of the standard has to whole.
consideration to this ANSI position as well have an absolute defendable, scientific, The 1980 ANSI respirator standard
when it issues its final rule. (Tr. at 124–125.) technically traceable base. It doesn’t exist. It’s listed an APF of 100 for full facepiece
OSHA considered the draft ANSI not there. We have tremendous numbers of air-purifying respirators with DFM
standard during this APF rulemaking. standards that are out there that the filters (Ex. 7–3). ANSI increased the
professionals develop with the best
However, this draft standard currently is APF for this respirator class from 50 to
knowledge and experience that they have,
under appeal, and has not been and this is the process. (Tr. at 363.) 100 because the poorly performing
designated by ANSI as a final standard respirator in Hyatt’s study was no longer
(Ex. 17–9–10–2). Jill Snyder, Standards Summary and conclusions. In this in production. Using the 1976 LANL
Coordinator for the AIHA secretariat of section, OSHA considered the issue of quantitative fit testing results, the 1980
the ANSI Z88 committee, addressed the the appropriate APF for filtering ANSI standard increased this APF to a
status of the draft ANSI Z88.2 revised facepieces. OSHA’s data analyses in the maximum of 1,000 when the respirator
respiratory protection standard in an e- record support an APF of 10 for filtering used HEPA filters and respirator users
mail sent to participants in Roundtable facepiece respirators. Moreover, a received quantitative fit testing (Ex. 7–
228 held at the 2004 AIHCE. This e-mail number of commenters supported the 3).
stated: APF of 10. Some commenters
Based on Hyatt’s 1976 data, the 1987
recommended a lower APF for filtering
Until a standard is approved by ANSI, it NIOSH RDL recommended that this
facepieces than proposed based on the
is not an ANSI standard. Therefore, we respirator class receive an APF of 50
should not say things like ‘ANSI completed poor structural integrity of the mask, the
when equipped with a HEPA filter.
drafting * * *’ etc. It is actually the availability of additional models of
However, the RDL gave these respirators
Accredited Standards Committee (ASC) Z88 respirator protection, poor compliance
an APF of 10 when using DFM filters.
or Z88.2 that put together what is still the with the respirator program
DRAFT standard. We also have to make sure NIOSH gave these respirators an APF of
requirements, difficulty performing user
we call it a draft standard, not a standard at 10 when equipped with DFM filters
seal checks, increased breathing
this point. (Ex. 17–9–10–2.) because testing that it conducted
resistance among filtering facepieces
The method used by ANSI to showed that the filters had relatively
approved under 42 CFR part 84, and the
determine the draft APFs also differs low efficiency.
recent ANSI draft APF for filtering
from OSHA’s approach, which used facepieces. As discussed in the previous The 1992 ANSI respirator standard
data analyses and expert opinion to sections, the evidence in the record with retained the 1980 ANSI standard’s APF
arrive at the final APF for half masks. regard to these issues justifies retaining of 100 for full facepiece air-purifying
James Johnson, representing the ANSI in this final rulemaking the proposed respirators, but required that respirator
Z88.2 subcommittee, stated that the APF of 10 for filtering facepieces. users perform quantitative fit testing
subcommittee did not perform an and achieve a minimum fit factor of
extensive quantitative analyses similar 3. APF for Full Facepiece Air-Purifying 1,000 prior to using the respirators.
to OSHA’s in determining the draft Respirators QNFTs were necessary because no
APFs (Tr. at 357). In response to Introduction. In a 1976 report, Ed QLFTs could achieve a fit factor of
questions from Thomas Nelson, ANSI Hyatt of LANL developed an APF table 1,000. The ANSI standard kept this APF
subcommittee member George Macaluso that included this respirator class (Ex. because the ANSI committee found, as
confirmed that an overall tabulation and 2). In this report, Hyatt used the results it did in 1980, that no WPF or SWPF
review of available WPF data was not from quantitative fit testing to assess six studies had been performed for this
conducted by the ANSI subcommittee in models of full facepiece negative respirator class.
determining APFs (Tr. at 663–666). pressure air-purifying respirators The following table summarizes the
With regard to the decision of the equipped with HEPA filters. Five of previous APFs assigned to full facepiece
ANSI subcommittee, James Johnson these respirators achieved a protection air-purifying respirators.

Fully facepiece air-purifying
respirators LANL 1980 ANSI NIOSH RDL 1992 ANSI
(1976) standard (1987) standard

All respirators in the class ....... 50 (with HEPA filter) ............... 10 (with QLFT) ........................ 10 (with DFM filter) ................. 100
100 maximum (with QNFT) .... 50 (with HEPA filter) ...............

In the proposal, OSHA also discussed but concluded that the respirator only 5,300. However, 23 of the 60
a WPF study that Colton, Johnston, provided reliable protection at a measurements reported were less than
Mullins, and Rhoe (Ex. 1–64–14) protection factor of 50. In addition, a 1,000, seven were less than 100, and
conducted in a lead smelter. The LANL SWPF study by Skaggs, Loibl, three were less than 50. Based on a
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respirator used in this study was a 3M Carter, and Hyatt (Ex. 1–38–3) measured careful review of these studies, OSHA
7800 full facepiece air-purifying the protection afforded by the MSA proposed an APF of 50 for full facepiece
respirator equipped with HEPA filters. Ultra Twin respirator with HEPA filters. air-purifying respirators.
The authors found a 5th percentile The authors reported fit factors with OSHA requested comment in question
protection factor of 95 for the sample, geometric means ranging from 1,000 to #7 of the proposal on whether it should

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50166 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

limit full facepiece negative pressure filter, but did not have any WPF or submitted. After carefully evaluating the
respirators to an APF of 20 when N95 SWPF data on the performance of full original studies reviewed in the
filters are used. The NIOSH certification facepiece respirators certified under 42 proposal, the Agency is setting an APF
tests for 42 CFR part 84 filters are CFR part 84 using N, R, or P95 filters. of 50 for full facepiece air-purifying
conducted using monodisperse aerosols NIOSH stated that because the filters are respirators. The final APF agrees with
of the most penetrating particle size (0.3 tested at the most penetrating particle the conclusion of Colton, Johnston,
µm) delivered at a high flow rate of 85 size, filter efficiency in the workplace Mullins, and Rhoe (Ex. 1–64–14) cited
liters per minute. Also, the 42 CFR part should exceed certification efficiency. earlier in this discussion that this class
84 certification standards allow up to However, NIOSH noted that some of respirators provides reliable
5% filter leakage with an N95 filter. If workplace tasks, such as welding and protection at an APF of 50. Importantly,
this level of leakage were to occur in the grinding, may result in high leakage an APF of 50 corresponds with the APF
workplace, an APF of 20 would be rates through the N95 filter because the previously assigned to full facepiece air-
appropriate for a full facepiece tasks produce fine or ultra fine particles. purifying respirators by OSHA in its
respirator using N95 filters. However, as Loraine Krupa-Greshman of the substance-specific standards, and by
several commenters noted (Exs. 9–16, 9– American Chemistry Council (Ex. 10– NIOSH in its 1987 RDL. Therefore,
22, 9–23, 9–37, 10–6, 10–17, 10–27, 10– 25) stated that OSHA could not justify OSHA is assigning an APF of 50 to full
59, and 10–60), workplace filter using a simplistic, generalized treatment facepiece air-purifying respirators based
penetration is always much less than of N95 filter efficiency to limit the APF on: the results of WPF and SWPF
filter penetration estimated from to 20. She noted that using N95 or N100 studies (which used N95 filters at
certification testing. Kenneth Bobetich filters is a matter of professional moderate to high contaminant levels);
of MSA (Ex. 9–37) stated that while 5% judgment, based on the type and The APFs given previously to this
leakage is the worst case, such leakage concentration of the contaminant. Frank respirator class by NIOSH and ANSI;
does not occur in the workplace. White of ORC Worldwide (Ex. 10–27) comments in the record indicating that
Compared to the aerosols used in stated that reducing the APF to 20 was N95 filters function effectively under
certification testing, workplace aerosols unnecessary because protection factors the workplace exposure conditions in
are not monodisperse, are many times and filter performance need to be which they are used; and years of
larger, and are delivered through the considered separately as part of the experience showing that these
filters at a lower flow rate. In addition, respirator selection process. Ted respirators, when equipped with an N95
the 3M Company (Ex. 9–16) cited Steichen of the American Petroleum filter, are safe when used in the manner
studies performed by Janssen (Exs. 9– Institute (API) (Ex. 9–23) mentioned that prescribed by OSHA’s respiratory
16–1–3 and 9–16–1–4) that compared API believes that OSHA should further protection standards. However, as with
the performance of N95 and P100 filters evaluate the data before assigning, based any respirator, if a full facepiece air-
made by two manufacturers and used on worst-case assumptions, an APF of purifying respirator is unsuitable for the
during grinding operations in a steel 20 to these respirators. Thomas exposure conditions, paragraph (d)(1) of
plant. Workplace performance of both O’Connor of the National Grain & Feed OSHA’s Respiratory Protection Standard
filters was equivalent statistically, and Association (Ex. 10–13) commented that requires that employers select a
the study showed that N95 filter he was not aware of any scientific respirator that will protect employees
performance was adequate under these information that refuted assigning an from the exposure hazards.
conditions. Lisa Brosseau of the APF of 50 to full facepiece respirators or
justified lowering the APF for N95 4. APF for Powered Air-Purifying
University of Minnesota (Ex. 10–59)
stated that it was entirely inappropriate filters to 20. He supported retaining the Respirators (PAPRs)
for OSHA to consider a 5% leakage proposed APF of 50 for this class of Half mask tight-fitting PAPRs. In the
effect for N95 filters because such respirators. Sheldon Coleman of the proposal, OSHA assigned an APF of 50
leakage would only occur when the Hanford Site Respiratory Protection to tight-fitting half mask PAPRs (68 FR
aerosol is monodisperse and of a small Committee (Ex. 10–40) stated that, based 34098 and 34115) based on the 1987
size, conditions that she said are on fit testing data, an APF of 50 for NIOSH RDL and the Z88.2–1992 ANSI
unlikely to occur in most workplaces. these respirators already is conservative. respirator standard. In arriving at a
Bill Kojola of the AFL–CIO (Ex. 9–27), OSHA agrees with these commenters proposed APF of 50 for these
Pete Stafford of the Building that full facepiece respirators with N95 respirators, the Agency relied heavily on
Construction Trades Department of the filters provide sufficient protection to the WPF study conducted by Lenhart
AFL–CIO (Ex. 9–29), and Michael maintain an APF of 50, and Table 1 of and Campbell (Ex. 1–64–42), instead of
Watson of the International Brotherhood the final standard reflects this decision. the WPF study performed by Myers and
of Teamsters (Ex. 9–7) supported Any effect of filter penetration on Peach (Ex. 1–64–46) and the SWPF
limiting the APF for full facepieces to 20 respiratory protection is best addressed studies of Skaggs et al. (Ex. 1–38–3) and
when N95 filters are used. Watson during respirator selection, which also da Roza et al. (Ex. 1–64–94). In
stated that if OSHA gave these is the case for half masks and other explaining its position, OSHA stated:
respirators an APF higher than 20, respirator classes using particulate
[The Lenhart and Campbell] study was
employees would likely be exposed to filters. In rare cases, when workplace well controlled and collected data under
hazardous levels of workplace exposures consist of a large percentage actual workplace conditions; these
contaminants. Kojola stated further that of particles of the most penetrating size, conditions ensure that the results are reliable
OSHA should take into account both this information must be taken into and represent the protection employees
sources of leakage (filter and faceseal), account by the employer when selecting likely would receive under conditions of
and lower the APF accordingly. the appropriate class of particulate filter normal respirator use. The Agency did not
However, neither Watson nor Kojola for any respirator, not just for full consider the Myers and Peach WPF study
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* * * for this purpose because of problems

provided any evidence to support these facepieces. involving filter assembly leakage and poor
misgivings about the performance of Summary and conclusions. In the facepiece fit reported by the authors;
these respirators. proposal, OSHA asked for any consequently, the abnormally high levels of
NIOSH (Ex. 9–13) recommended that additional studies of full facepiece air- silica measured inside the mask would most
OSHA consider the limitations of the purifying respirators, but none was likely underestimate the true protection

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50167

afforded by the respirator. The two SWPF According to James Johnson of LLNL, echoed this concern (Exs. 9–11 and 10–
studies * * * reported much higher simple and effective equipment and 32).
geometric mean protection factors than did procedures are available for detecting
the WPF study performed by Lenhart and
Other comments focused either on the
Campbell. However, OSHA believes that the
leaks in these respirators. In this regard, need for a protocol to determine if the
higher protection factors reported for these Johnson noted that LLNL developed respirators could perform at an APF
SWPF studies are consistent with the equipment that monitors and records level of 1,000, or on design
proposed APF of 50 based on data obtained positive pressure in these respirators characteristics that would permit
for this respirator class in the Lenhart and using a commercially available device. respirator users to select appropriate
Campbell WPF study because SWPF studies As he stated at the hearing: respirators. In advocating the testing
typically report significantly higher approach, Stephan Graham of the U.S.
protection factors than WPF studies of the [T]his is the one we chose, a data logging
same respirator. (68 FR 34098.) micro manometer, the TSI–DP Calc, with a Army Center for Health Promotion and
range of –5 to +15 inches of water gauge, and Preventative Medicine noted that
During this rulemaking, OSHA data recording intervals of one second and respirators that have high APFs should
received no substantive comments or longer were chosen. * * * We plan on using receive credit for their design and
other information regarding the this technique periodically to monitor actual performance. Graham recommended
proposed APF of 50 for these high-contamination work activities to assure that manufacturers test their hooded
respirators. Nevertheless, OSHA this PAPR maintains a positive pressure. (Ex.
and helmeted respirators, and set the
believes that the existing WPF and maximum APF (to a maximum of 1,000)
SWPF studies on this class proved A number of commenters provided based on the results (Ex. 9–42–1). The
adequate support for OSHA’s additional support for using positive 3M Company stated that if OSHA
conclusion that an APF of 50 is an pressure inside the facepiece as the retains a testing requirement in the final
appropriate level to predict the rule, it must specify the testing
criterion for protection. For example,
protection capabilities of this class of conditions. The 3M Company
Rick Givens of the Atlanta, GA Utilities
respirators. recommended testing at a work rate of
Full facepiece PAPRs and PAPRs with Department stated that ‘‘the
maintenance of positive pressure is an 40 liters per minute, ensuring that
hoods or helmets. In the proposal,
appropriate method for distinguishing pressure inside the hood or helmet is
OSHA assigned an APF of 1,000 to tight-
high-performing hood/helmet maintained at a minimum level of one
fitting full facepiece PAPRs (68 FR
respirators from others’’ (Ex. 10–2), atmosphere at this work rate, measuring
34099). In support of the proposed APF,
OSHA cited a WPF study by Colton and while Sheldon Coleman of the Hanford, this pressure at the flow rate
Mullins that found a corrected 5th Washington DOE site asserted: recommended by the manufacturer, and
percentile protection factor of 1,335 for In the last three years, our program has maintaining the maximum static
these respirators. OSHA received no used approximately 10,000 PAPR hoods. We pressure inside the hood or helmet at 38
substantive comments or other have conducted some limited fit testing using mm of water pressure (Ex. 18–7).
information regarding the proposed APF particulate fit testers (although the hood Similarly, Jay Parker of the Bullard Co.
of 1,000 for these respirators. However, manufacturer does not recommend using a stated that ‘‘without oversight and
particulate tester due to the extensive dead guidance, testing performed may not
the ANSI Z88.2–1992 respirator space in the hood). All of our information
standard and the 2004 draft revision to achieve such goals. This may lead to the
suggests that an APF of 1,000 is appropriate use of respirators and an APF of 1,000
the ANSI standard both assign an APF for a PAPR hood that maintains positive
of 1,000 to this respirator class. Based that actually should not be used at that
pressure inside of the hood. (Ex. 10–40.)
on its review of these consensus level because the testing performed was
standards and the existing WPF research Several commenters took exception to not really capable of ensuring that level
literature (see Exs. 1–64–12 and 1–64– the positive pressure criterion. Craig of performance’’ (Tr. at 492).
40), and SWPF research studies (Ex. 3– Colton of 3M stated that ‘‘3M disagrees ORC Worldwide stated that ‘‘the
4), OSHA concludes that this respirator with OSHA’s proposed requirement that approach proposed by OSHA would
class warrants an APF of 1,000. hoods and helmets demonstrate that hold hood/helmet or loose-fitting
In proposing an APF of 1,000 for they maintain positive pressure at all facepiece PAPRs and SARs to a higher
PAPRs with helmets or hoods, the times of use to receive an APF of 1,000’’ standard than that required of other
Agency stated in footnote 4 of proposed (Tr. at 390). In this regard, Colton respirator classes, based simply on the
Table 1 that ‘‘only helmet/hood argued that the recent study conducted results of one model’’ (Ex. 10–27), a
respirators that ensure the maintenance on PAPRs with hoods/helmets by ORC point made as well by Alice E. Till of
of a positive pressure inside the and LLNL showed that every respirator the Pharmaceutical Research and
facepiece during use, consistent with tested in the study ‘‘had two or more Manufacturers Association (PhRMA)
performance at a level of protection of brief negative pressure spikes within the (Ex. 9–24). Nevertheless, ORC
1,000 or greater, receive an APF of respiratory inlet covering. Under the concluded that, ‘‘[s]hould OSHA retain
1,000’’ and that ‘‘[a]ll other helmet/hood current proposal, all of these respirators, this requirement, the final rule should
respirators are treated as loose-fitting except the poorest performing supplied- clearly specify acceptable testing criteria
facepiece respirators and receive an APF air respirator would have received an to which respirator manufacturers must
of 25.’’ (See 68 FR 34115.) OSHA APF of 25, even though the 5th conform’’ (Ex. 10–27). PhRMA believed
proposed this condition because percentile SWPFs found in the study that OSHA should consider the
available WPF and SWPF studies found ranged from 86,000 to 250,000’’ (Tr. at proposed APF table to be an interim
that some of these hood/helmet 391). Colton then added, ‘‘This study step in a transition toward the
respirators achieved protection factors indicates that pressure within the development of a certification protocol
well below 1,000 (Exs. 3–4 and 3–5). respiratory inlet covering is only one of by NIOSH that provides APFs for each
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Under the proposed condition, the a complex set of factors that determine respirator model (Ex. 9–24). Thomas
burden of conducting any testing likely the protection provided by PAPRs and Nelson of NIHS, Inc. agreed, stating,
would fall on respirator manufacturers, supplied-air respirators, and should not ‘‘Specific test conditions and
but the employer would be responsible be considered by itself’’ (Tr. at 391). performance criteria must be identified’’
for selecting a properly tested respirator. John P. Farris of Safe Bridge Consultants (Ex. 10–17).

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50168 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

NIOSH provided the following that limits a hood or helmet to a certain APF of 1,000 only when they have
information that addressed the concerns design, then that would limit the appropriate test results provided by the
of these commenters: manufacturer’s ability to innovate with new respirator manufacturer demonstrating
designs. (Tr. at 480.)
Respirator models should not be assigned that the respirator performs at a
to the higher APF level following After reviewing the comments on protection level of 1,000 or greater.
promulgation of the proposed APF rule proposed footnote 4, OSHA concludes Evidence in the rulemaking record
unless the respirator manufacturer provides that: no single parameter (e.g., positive indicates that the technology exists to
evidence that testing of that model pressure inside the facepiece) will measure any leakage into the facepiece
demonstrates performance at the higher APF identify respirators that consistently from the ambient atmosphere that could
level. A standard test protocol is needed to perform at a high APF level; no lessen the protection afforded by a
assure reliable and reproducible results when agreement exists on how to determine PAPR or SAR with a helmet or hood
determining if a hood/helmet PAPR * * * APFs for these respirators based on (Ex. 16–9–1). This evidence also shows
can consistently achieve a protection factor
of 1000. NIOSH will assist in developing this
design characteristics alone; no uniform that small amounts of leakage measured
protocol. With implementation of new testing criteria are available to use in by this technology during testing did
NIOSH certification criteria, every respirator determining APFs for these respirators; not reduce the performance of the
model could be evaluated using this protocol and ample evidence demonstrates that respirator below a level that was
as a condition of certification to assure WPF or SWPF studies conducted under consistent with an APF of at least 1,000
overall performance consistent with the a variety of conditions reliably (Exs. 3–4–1, 1–38–3, 1–64–12, and 1–
established APF. Thus, NIOSH will assure determine reliable and safe protection 64–40) Based on this evidence, OSHA
that approved respirators are capable of factors for these respirators. Therefore, believes that it is important for
providing this assigned level of protection so OSHA is revising footnote 4 to Table 1 respirator manufacturers to determine,
that employers have appropriate guidance
and APF values when selecting respirators
in the final standard to read as follows: using available technology, that leakage
for their workers. (Ex. 16–4.) The employer must have evidence into a respirator does not compromise
provided by the respirator manufacturer that the respirator’s capability to maintain a
Proponents of using design criteria, testing of these respirators demonstrates level of performance throughout testing
instead of testing, to assess the performance at a level of protection of 1,000 that is consistent with an APF of at least
protection afforded by these respirators or greater to receive an APF of 1,000. This 1,000. Therefore, the Agency removed
recommended that poorer performing level of performance can best be from footnote 4 in the final rule the
respirators should be identifiable by demonstrated by performing a WPF or SWPF language in proposed footnote 4 stating
either their appearance or technical study or equivalent testing. Absent such
testing, all other PAPRs and SARs with
that ‘‘only helmet/hood respirators that
specifications. For example, John Ferris ensure the maintenance of positive
of Safe Bridge Consultants, stated: helmets/hoods are to be treated as loose-
fitting facepiece respirators, and receive an pressure inside the respirator during use
In my experience, the most important APF of 25. * * * receive an APF of 1000.’’
factor in achieving workplace protection Loose-fitting facepiece PAPRs with
factors of 1,000 or greater with these devices The Agency is setting an APF of 1,000
hoods or helmets. OSHA proposed an
is the ability to tuck the inner bib (or shroud) for tight-fitting facepiece PAPRs with
APF of 25 for loose-fitting PAPRs with
into the outer work garment with the outer hoods and helmets when the
hoods or helmets based on WPF studies
shroud placed over the shoulders on the manufacturers of these respirators
described in the proposal (68 FR 34100),
outside of the garment. I support the use of conduct testing that demonstrates that
a 1000-fold APF for helmet hood PAPRs the NIOSH RDL, and the Z88.2–1992
the respirators provide a level of
without the footnote. (Ex. 9–11.) ANSI respirator standard. In supporting
protection of at least 1,000(e.g.,
the proposed APF, ISEA commented
Robert Barr of Alcoa noted that design demonstrating WPFs of at least 10,000
that ‘‘as the reports of many WPF
flaws need to be identified, stating, ‘‘For or greater divided by a safety factor of
studies have shown, the performance of
example, flip-front types could be 10, or lower fifth percentile SWPFs of at
loose-fitting PAPRs with loose-fitting
designated 25; and helmets with least 25,000 divided by a safety factor of
facepieces warrants a lower APF than
shrouds at 1000’’ (Exs. 9–26 and 10–31). 25). Based on its review of the record
for loose-fitting hoods and helmets’’ (Ex.
PhRMA, ORC, and the American regarding these respirators, the Agency
9–24). Additional support came from
Chemistry Council argued that OSHA believes that tight-fitting facepiece
Warren Myers, OSHA’s expert witness
should base the APFs for these PAPRs with hoods and helmets tested in
at the rulemaking hearing, who stated:
respirators on design and construction a manner that is consistent with the
characteristics that would ‘‘enable a SWPF testing performed previously Our summary conclusion was that PAPRs
under the ORC–LLNL study of were incorrectly considered as positive
more exacting selection process, and pressure devices by the respirator community
* * * would be conducive to eventually respirators in this class (Ex. 3–4–1) will and that a minimum certification air flow of
assigning protection factors based on provide the required level of protection 170 liters a minute, at least for the loose-
individual model performance’’ (Exs. 9– for employees who use these respirators. fitting class of devices, does not necessarily
24 and 10–27). However, Jay Parker of While proposed footnote 4 provide a positive pressure operational
the Bullard Co. noted that the latest emphasized that respirator characteristic with the respirator. And then
ANSI Z88.2 subcommittee ‘‘was unable manufacturers have responsibility for finally, that the assigned protection factor for
to agree on the design characteristics of testing these respirators, it did not these devices with those types of air flows
address who is responsible for selecting would be 25. (Tr. at 69.)
a hood or helmet that would lead to a
performance level equivalent to an APF properly tested respirators. Consistent The WPF studies previously cited (68
of 25’’ (Tr. at 480). Continuing, Jay with Section 5 of the OSH Act (29 FR 34100) demonstrate that OSHA
Parker stated: U.S.C. 654), which places the based the proposed APF on valid data
responsibility for employee protection that were substantiated by the Myers
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I don’t see that we will ever be able to

define the performance of a respirator by its
on employers, footnote 4 in the final study. OSHA concludes that an APF of
design. We don’t want to stifle innovation. rule now clearly places the 25 is appropriate for loose-fitting
We want to be able to allow respirator responsibility for proper respirator facepiece PAPRs with hoods or helmets,
manufacturers to develop new hoods and selection on employers. Accordingly, and therefore is retaining this APF for
helmets. If OSHA comes up with a definition employers may use a respirator at an this respirator class in the final rule. No

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50169

adverse comments regarding the SWPF study (Ex. 1–38–3) in which the response to the proposal, OSHA is
proposed APF were submitted. results for these respirators showed assigning these respirators an APF of
geometric mean protection factors 1,000 in the final rule only when the
5. APFs for Supplied-Air Respirators
ranging from 8,500 to 20,000. Further employer can provide evidence from the
justification for the proposed APF came respirator manufacturers that
Half mask SARs. The Agency based from the similarity in operational demonstrates the respirators perform at
its proposed APF of 10 for this characteristics between these respirators that level; absent such testing, these
respirator class on the analogous and tight-fitting full facepiece respirators must receive an APF of 25.
performance between these respirators continuous flow PAPRs, which had a Loose-fitting facepiece SARs. OSHA
and negative pressure half mask air- proposed APF of 1,000. The proposed proposed an APF of 25 for this class of
purifying respirators tested in WPF and APF for these respirators also was respirators based on analogous
SWPF studies (68 FR 34100). consistent with the APFs of 1,000 performance between these respirators
Furthermore, the Agency proposed to assigned to them under the Z.88.2–1992 and loose-fitting facepiece PAPRs (68
give half mask SARs that function in ANSI respirator standard, and was FR 34104). Additional support cited in
continuous flow or pressure-demand substantially lower than the APF of the proposal included data from NIOSH
modes an APF of 50, consistent with the 2,000 recommended for these showing that the two types of
analogous performance between these respirators by the 1987 NIOSH RDL. respirators (i.e., loose-fitting facepiece
respirators and half mask PAPRs OSHA received no comments on full SARs and PAPRs) have the same
operated in a continuous flow mode facepiece SARs operated in a demand, minimum airflow rates when evaluated
during WPF and SWPF studies. pressure-demand, or other positive- under 42 CFR part 84. The proposed
Additional support for the proposed pressure mode. The Agency believes APF also is consistent with the APF
APFs came from the Z88.2–1992 ANSI that the evidence in the proposal is specified for respirators in the 1987
respirator standard that assigned an APF sufficient to support an APF of 50 for NIOSH RDL and the Z88.2–1992 ANSI
of 10 to half mask airline SARs operated these respirators when operated in the respirator standard.
in the demand mode, and an APF of 50 demand mode, and an APF of 1,000 Commenters agreed with OSHA’s
to these respirators when operated in when the respirators function in a proposed APF of 25 (Exs. 9–22 and 10–
the continuous flow or pressure-demand pressure-demand or other positive- 39; Tr. at 75 and 546). For example,
modes. The 1987 NIOSH RDL also gave pressure mode, and has included these Warren Myers stated, ‘‘I believe it is
half mask demand SARs an APF of 10, APFs in the final standard. reasonable for OSHA to use analogous
but recommended an APF of 1,000 for SARs with hoods or helmets. Based on operational characteristics between
these respirators when functioning in a number of WPF studies, OSHA PAPRs and SARs equipped with loose-
the pressure-demand or other positive- proposed an APF of 1,000 for fitting hoods or helmets to set the APF
pressure modes. continuous flow SARs with hoods or for the SARs devices at 25’’ (Tr. at 75).
OSHA received no comments or other helmets, contingent on the ISEA noted that WPF studies conducted
information during this rulemaking manufacturers’ demonstration that the on loose-fitting facepieces justify an
regarding these proposed APFs. respirators meet the criteria specified in APF of 25 for these respirators (Ex. 9–
However, the Agency is confident that Table 1 of the proposed standard (68 FR 22). Based on these comments, the
the available WPF and SWPF studies for 34103). In responding to the proposed analogous performance with loose-
half mask air-purifying respirators cited APF, Paul Schulte of NIOSH noted that fitting PAPRS, NIOSH certification
in the proposal provide sufficient data an APF of 1,000 is appropriate for these testing at the same minimum flow rates,
to retain an APF of 10 for half mask respirators only when the manufacturer and the APFs given these respirators in
SARs when operated in the demand demonstrates that the models performed the 1987 NIOSH RDL and the ANSI
mode, and an APF of 50 for these at this level (Ex. 9–13). ORC Worldwide Z88.2–1992 respirator standard, OSHA
respirators when operated in the stated that only SWPF data would give has concluded that an APF of 25 is
continuous flow or pressure-demand employers the assurance that the SAR appropriate for this respirator class.
modes. Therefore, OSHA is retaining offers the necessary protection for their Therefore, the final rule will list an APF
these APFs in Table 1 of the final rule. workers (Ex. 10–27). ISEA of 25 for SARs with loose-fitting
Full facepiece SARs. OSHA stated in recommended that further testing be facepieces.
the proposal that ‘‘[n]o WPF or SWPF performed before assigning an APF of
studies were available involving tight- 6. APF for Self-Contained Breathing
1,000 for continuous flow SARs with
fitting full facepiece SARs operated in Apparatuses (SCBAs)
hoods and helmets (Ex. 9–22). MSA
the demand mode. Therefore, in the concluded that an APF of 1,000 is Ed Hyatt, in 1976, assigned a
absence of any such quantitative data, appropriate (Ex. 16–10) because, it protection factor of 50 to a full facepiece
the Agency assigned this respirator class asserted, every credible WPF study SCBA operated in the demand mode,
an APF of 50’’ (68 FR 34102). OSHA demonstrates that continuous flow the same protection factor he assigned
based the proposed APF on the SARs with hoods and helmets perform to full facepiece SARs used in this
analogous operational characteristics of at an APF of 1,000. mode. Based on results from a panel of
these respirators and negative pressure These commenters generally agree 31 respirator users tested at LANL, he
full facepiece air-purifying respirators that continuous flow SARs with hoods gave full facepiece SCBAs used in the
tested under WPF conditions in the or helmets should be assigned an APF pressure demand mode an APF of
demand mode. Also, the proposed APF of 1,000 only after manufacturers 10,000+ (Ex. 2). The 1980 ANSI
is the same as the APF recommended demonstrate through appropriate WPF respirator standard listed half mask and
for this respirator class by the 1987 or SWPF studies that the respirators are full facepiece SCBAs operated in the
NIOSH RDL. capable of performing at an APF of demand mode with APFs of 10 and 100,
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The Agency proposed an APF of 1,000 1000. Therefore, based on the evidence respectively, when qualitatively fit
for full facepiece SARs operated in cited in the proposal, the comments tested. The APFs for half mask or full
continuous flow, pressure-demand, or from ORC Worldwide, NIOSH, and facepiece SCBAs functioning in the
other positive-pressure mode (68 FR ISEA, and the absence of any new demand mode were the protection
34102). It based the proposed APF on a studies or evidence submitted in factors obtained during quantitative fit

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50170 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

testing, with this APF limited to the cup and a tight-fitting seal at the neck, NIOSH subsequently certified the
sub-IDLH value. Full facepiece SCBAs and an air cylinder that supplies Survivair Puma respirator, which has a
used in the pressure-demand mode breathing air to the facepiece. NIOSH tight-fitting hood supplied by an air
received an APF of 10,000+. The 1987 reviewed this respirator in accordance cylinder, as a pressure-demand SCBA
NIOSH RDL recommended that half with its 42 CFR part 84 certification with a tight-fitting facepiece. As part of
mask and full facepiece SCBAs operated requirements, and in January 2001 the 42 CFR part 84 certification process,
in the demand mode receive APFs of 10 certified the respirator as a tight-fitting NIOSH specified that the fit testing
and 50, respectively, and that the APF full facepiece demand SCBA when requirement for tight-fitting SCBAs
for full facepiece SCBAs operated in the equipped with a cylinder having a 30- would apply to this respirator. However,
pressure-demand or other positive minute service life. NIOSH also Steve Weinstein of Survivair (Ex. 7–2)
pressure mode be 10,000. approved the respirator for use in stated that the hood totally encapsulates
The Z88.2 subcommittee responsible entering and escaping from hazardous the respirator user’s hair, making
for the 1992 ANSI respirator standard
atmospheres. In a May 16, 2001 letter to quantitative fit testing (e.g., with a
could not reach a consensus on an APF
OSHA’s Directorate of Enforcement Portacount) impossible. In such cases,
for full facepiece pressure-demand
SCBAs. Available WPF and SWPF Programs (Ex. 7–1), Richard Metzler of the fit testing instrument treats dander
studies reported that, in some cases, the NIOSH justified the classification of the and other material shed by the hair as
respirators did not achieve an APF of Draeger respirator as an SCBA on the particulates originating from outside the
10,000 (Ex. 1–50). Nevertheless, the basis that the neck seal, which is respirator, causing the fit factor to be
subcommittee found that a maximum integral to the facepiece, forms a gas- artificially low. Nevertheless, qualitative
APF of 10,000 was appropriate when tight or dust-tight fit with the face fit testing with the hood is possible
employers use the respirators for consistent with the definition of a tight- because Survivair provides an adapter
emergency-planning purposes and fitting facepiece specified by 42 CFR and P100 filters for this purpose. Such
could estimate levels of hazardous 84.2(k). This letter also noted that the fit fit testing meets the fit-testing
substances in the workplace. testing procedures used for full requirements for tight-fitting SCBAs
Two respirators equipped with hoods, facepiece demand SCBAs apply to the specified in paragraph (f)(8) of OSHA’s
Draeger’s Air Boss Guardian and Draeger SCBA, and that, as a full Respiratory Protection Standard.
Survivair’s Puma, have operational facepiece demand SCBA, NIOSH
characteristics similar to SCBAs. The recommended that the respirator receive The table below provides a summary
facepiece of the Draeger respirator an APF of 50 in accordance with its of APFs given to the half mask and full
consists of a hood with an inner nose 1987 RDL. facepiece SCBAs by different groups.

1992 ANSI
(1976) standard (1987)

Tight-fitting half mask 10 (demand) .............. 10 (demand; with QLFT) Same as QNFT 10 (demand).
factor (demand; sub-IDLH value max.).
Tight-fitting Full face- 50 (demand) .............. 100 (demand; with QLFT) Same as QNFT 50 (demand).
piece. factor (demand; sub-IDLH value max.).
Tight-fitting Full face- 10,000 (pressure de- 10,000+ (pressure demand) .......................... 10,000 (pressure de- 10,000 maximum
piece. mand). mand). (emergency plan-
ning purposes only).

OSHA received no new WPF or SWPF of the 57 test subjects (i.e., firefighters) the second study, Johnson, da Roza, and
studies for tight-fitting half mask SCBAs experienced one or more negative McCormack of LLNL (Ex. 1–64–98)
and tight-fitting full facepiece SCBAs pressure incursions inside the facepiece tested the Survivair Mark 2 SCBA that
operated in the demand mode in while performing firefighting tasks. met NFPA 1981 air-flow requirements.
response to the proposal. In the only After analyzing the data for these During testing, a panel of 27 test
WPF study conducted on full facepiece firefighters using two different methods, subjects exercised on a treadmill at 80%
positive-pressure SCBAs, Campbell, the authors estimated that the overall of their cardiac reserve capacity.
Noonan, Merinar, and Stobbe of NIOSH protection factor exceeded 10,000. Although the authors found negative
assessed the performance of two In the first of two SWPF studies pressure incursions inside the facepiece
different models of full facepiece performed on full facepiece SCBAs used at high work rates, they concluded that
pressure-demand SCBAs that met the in the pressure-demand mode, McGee the respirator ‘‘provided [a minimum]
NFPA 1981 air-flow requirements for and Oestenstad determined the average fit factor of 10,000 [for any
respirators used by firefighters (Ex. 1– protection afforded to members of a single subject], with no single subject
64–7). While the authors could not respirator test panel who used the
having a fit factor less than 5,000 at a
determine protection factors for these Biopack 60 closed-circuit SCBA (Ex. 1–
high work rate.’’ The tables below
respirators because contaminant levels 64–86). Three members of the panel had
measured inside the facepiece were too summarize the results of the WPF and
protection factors of 4,889, 7,038, and
low, pressure measurements taken 18,900, with the remaining members SWPF studies performed on full
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inside the facepiece proved more useful. having protection factors over 20,000. In facepiece pressure-demand SCBAs.
These measurements showed that four

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WPF studies for tight-fitting full facepiece pressure demand Geometric
Sample size standard 5th percentile WPF
SCBAs (by name of authors and model of respirator tested) mean deviation

Campbell et al. (Ex. 1–64–7) Unspecified model (with NFPA-com- 57 .................... .................... >10,000 (estimated).
pliant airflow).

SWPF studies for ight-fitting full facepiece pressure demand SCBAs (by name of Geometric 5th per-
Sample size standard
authors & mode of respirator tested) mean centile WPF

McGee and Oestenstad (Ex. 1–64–86) Biopack 60 (closed circuit) ............................... 23 >20,000 .................... ....................
Johnson et al. (Ex. 1–64–98) Survivair mark 2 with NFPA-compliant airflow) ............... 27 29,000 1.63 ....................

Janice Bradley (Ex. 9–22) of the 10,000. While four respirator wearers In 1974, NIOSH and OSHA started the
International Safety Equipment experienced momentary negative- Standards Completion Program to
Association and Kenneth Bobetich of pressure spikes inside their facepieces, develop standards for substances with
the MSA Company (Ex. 9–37) both which indicates possible leakage into existing PELs. As part of this process,
stated that footnote 5 in the proposed the facepiece under some workplace the initial respirator decision logic was
OSHA APF Table 1 was not necessary conditions, these spikes did not impair developed and the concept of MUCs
because most SCBA models now meet overall respirator performance. The began to be used. NIOSH Criteria
the increased air-flow requirements in Agency concludes that these study Documents also recommended MUCs
the NFPA 1981 standard. They further results justify an unrestricted APF of for different types of respirators. The
noted that the study that served as the 10,000 for tight-fitting full facepiece information for these MUCs were
basis of the footnote was more than 15 SCBAs. obtained from various sources,
years old, and that OSHA should For the class of respirators designated including NIOSH Current Intelligence
remove the footnote. They as pressure-demand SCBAs with tight- Bulletins and recognized industrial
recommended that the APF should be hygiene references. NIOSH later
fitting hoods or helmets, including the
10,000 for pressure-demand SCBAs that published this information in its Pocket
Survivair Puma, OSHA is setting an
meet the air-flow requirements of NFPA Guide to Chemical Hazards. Other
APF of 10,000. The basis for this final
1981. Janice Bradley (Tr. at 531) cited source documents for MUC definitions
APF is the analogous operational
the WPF study NIOSH performed with and regulations include the 1987 NIOSH
characteristics between these respirators
firefighters (Ex. 1–64–7) as supporting RDL, and the ANSI Z88.2–1980 and
and tight-fitting full facepiece pressure-
the conclusion that SCBAs meeting the ANSI Z88.2–1992 respiratory protection
demand SCBAs.
NFPR 1981 requirements would provide standards.
APFs of 10,000. D. Definition of Maximum Use OSHA’s 1994 proposed Respiratory
Summary and conclusions. OSHA is Concentration Protection Standard contained the
setting APFs of 10 and 50, respectively, following definition of MUC:
for tight-fitting half mask SCBAs and Employers use MUCs to select Maximum use concentration (MUC) means
tight-fitting full facepiece SCBAs appropriate respirators, especially for the maximum concentration of an air
operated in the demand mode. In the use against organic vapors and gases. contaminant in which a particular respirator
absence of any new WPF and SWPF MUCs specify the maximum can be used, based on the respirator’s
studies on these respirators, the Agency atmospheric concentration that an assigned protection factor. The MUC cannot
employee can experience while wearing exceed the use limitations specified on the
is basing the final APFs on analogous NIOSH approval label for the cartridge,
operational characteristics between a specific respirator or class of
respirators. MUCs are a function of the canister, or filter. The MUC can be
these respirators and half mask determined by multiplying the assigned
facepiece and full facepiece air- APF determined for a respirator (or class protection factor for the respirator by the
purifying respirators, that have APF of respirators), and the exposure limit of permissible exposure limit for the air
values of 10 and 50, respectively. In the hazardous substance in the contaminant for which the respirator will be
addition, the final APFs are consistent workplace. used. (59 FR 58884.)
with the APFs recommended by the 1. Introduction Several commenters to this 1994
1987 NIOSH RDL for these respirators. proposal recommended alternatives to
(Note that the 1992 ANSI standard did Ed Hyatt, in the 1976 LASL report on this definition. Reynolds Metal
not assign APFs for these respirator respiratory protection factors (Ex. 2, Company recommended defining MUC
classes.) Docket H049), recounted the early as ‘‘the maximum concentration of an
For tight-fitting full facepiece SCBAs history of MUCs, starting with the MUC air contaminant in which a particular
used in the pressure-demand or other recommendations of the joint AIHA– respirator can be used, based on the
positive pressure modes, OSHA is ACGIH committee in 1961. This respirator’s assigned protection factor’’
setting an APF of 10,000 in the final committee recommended that, for (Ex. 1–54–222). The American
standard, which is consistent with the highly toxic compounds, full facepiece Petroleum Institute (API) noted NIOSH
1987 NIOSH RDL and the 1992 ANSI respirators with HEPA filters use a developed the term ‘‘MUC,’’ and that, to
respirator standard. Empirical support maximum limit of 100 times the TLV. avoid confusion, OSHA should not use
for the final APF comes from the WPF Hyatt noted that Dr. Letts in 1961 in the the term (Ex. 1–54–330). API proposed
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study conducted by Campbell, Noonan, United Kingdom, recommended that using the term ‘‘assigned use
Merinar, and Stobbe (Ex. 1–64–7). This half mask dust respirators provided concentration’’ to replace MUC. API
study showed that protection factors for effective protection against airborne defined ‘‘assigned use concentration’’ as
these respirators, when operating at contaminant levels no greater than 10 ‘‘the maximum concentration of an air
NFPA-compliant air flows, far exceed times the TLV. contaminant in which a particular

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50172 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

respirator can be used, based on the method used by safety and health employers in the preamble to the
respirator’s assigned protection factor’’ professionals for calculating MUCs. Respiratory Protection Standard for
(Ex. 1–54–330). However, when the Absent any other accepted method, the determining APFs in the absence of a
Agency published the final Respiratory term ‘‘usually’’ is confusing and final APF standard (see, e.g., 63 FR
Protection Standard in 1998, it reserved unnecessary. 1203). OSHA believes this language
the definition of MUC in paragraph (b), The second revision to the proposed gives employers maximum flexibility to
and the MUC requirements in paragraph MUC definition involves the last part of develop MUCs that protect their
(d)(3)(i)(B), for future rulemaking the second sentence, which required employees from hazardous airborne
because it reserved the APF provisions employers to consider an ‘‘exposure contaminants, including the use of other
of the respirator selection section of the limit’’ when determining an MUC. exposure limits when appropriate.
standard (i.e., MUCs could not be OSHA is making two changes to this In the proposal to this final rule,
determined without knowing the APF proposed language to make clear its OSHA requested comments on the
values). intent regarding the information development of the MUC for substances
In the June 6, 2003 proposal, OSHA employers need to consider when with no OSHA PEL, limiting factors
defined MUC as follows: making this calculation. First, OSHA is such as eye irritation, LELs and IDLHs,
Maximum use concentration (MUC) means
clarifying the language to require and mixtures of substances (68 FR
the maximum atmospheric concentration of a employers to calculate an MUC using an 34112). OSHA received numerous
hazardous substance from which an OSHA exposure limit in those instances comments on these issues, as well as on
employee can be expected to be protected where one exists. OSHA was concerned hazard ratios, an issue raised by several
when wearing a respirator, and is determined that employers could have commenters. These issues are discussed
by the assigned protection factor of the misinterpreted the language in the in the following sections.
respirator or class of respirators and the proposed MUC definition as meaning
exposure limit of the hazardous substance. that they could use any available 2. MUCs for Substances With No OSHA
The MUC usually can be determined exposure limit for calculating an MUC PEL or Other Limiting Factors
mathematically by multiplying the assigned (and, by implication, for protecting
protection factor specified for a respirator by OSHA received many comments on
the permissible exposure limit, short-term
employees from hazardous airborne this issue. Some commenters believed
exposure limit, ceiling limit, peak limit, or contaminants). This revision that in the absence of a PEL it is
any other exposure limit used for the emphasizes the priority that OSHA appropriate for the Agency to require
hazardous substance. (68 FR 34036.) exposure limits have in regulating calculation of MUCs based on other
hazardous airborne contaminants. information (Exs. 10–54, 9–27, and 10–
Under this definition, MUC represents Second, OSHA is changing the
the maximum atmospheric 3). Other commenters supported using
language to make clear the information any occupational exposure limit for this
concentration of a hazardous substance employers need to consider to
against which a specific respirator or purpose, but some of these commenters
determine an MUC in the absence of an specified that no other limiting factors
class of respirators with a known APF OSHA exposure limit. The Agency
can protect employees who use these should be used (Exs. 9–26, 9–42, 10–27).
revised the language to require Others specified that additional limiting
respirators. Accordingly, MUCs are a employers to use relevant available
function of the APF determined for a factors were needed (Exs. 9–13, 9–15, 9–
information and informed professional 29, 10–6, and 10–60). Several
respirator (or class of respirators) and judgment when determining an MUC
the exposure limit of the hazardous commenters recommended using only
when no OSHA exposure limit exists. the OSHA PELs with limiting factors
substance in the workplace. This language more clearly states
The last sentence in the definition (Ex. 10–17, 10–25, and 9–16) or without
OSHA’s intent that employers can limiting factors (Exs. 9–22 and 9–23). A
describes the MUC in terms of a utilize a wide range of available
mathematical calculation, i.e., that few commenters addressed limiting
information in calculating an MUC factors only, either supporting specific
employers can ‘‘usually’’ determine the when OSHA has not yet promulgated an
MUC by multiplying the APF for the factors (Exs. 9–12 and 10–1) or stating
exposure limit for a hazardous airborne that no limiting factors were needed
respirator by the exposure limit used for contaminant. While not required, some
the hazardous substance.10 The last when determining MUCs (Ex. 9–37).
employers may choose to conduct These comments are discussed in the
sentence of the proposed definition also individualized risk assessments of
specifies the exposure limits as following paragraphs.
hazards. Others may consult W.M. Parris of Alabama Power (Ex. 9–
‘‘permissible exposure limit (PEL), information from manufacturers or other
short-term exposure limit (STEL), 15) proposed the following generic
published exposure limits (e.g., the
ceiling limit (CL), peak limit, or any definition of MUC that would include
NIOSH RELs or the AIHA WEELs) for
other exposure limit used for the all possible MUCs:
making MUC determinations. However,
hazardous substance.’’ Although OSHA whatever approach employers choose to Maximum use concentration (MUC) means
received no comments on the proposed take, the MUC must provide adequate the maximum atmospheric concentration of a
definition, it nevertheless is making protection for their employees. OSHA hazardous substance from which an
several minor revisions to the definition employee can be expected to be protected
believes this approach provides when wearing a respirator. The MUC will be
in the final rule. First, the Agency is employers with greater flexibility than the lowest of the following: (1) IDLH value
removing the term ‘‘usually’’ from the the proposed MUC definition while still for the substance, (2) the LEL value, (3)
definition because multiplying the maintaining employee protection. limitations set by manufacturer, or (4)
assigned protection factor by the The Agency also broadened the mathematically determined by multiplying
exposure limit for a hazardous language in this second sentence by the assigned protection factor specified for
substance is the currently accepted requiring employers to ‘‘take the best the respirator by the permissible exposure
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available information into account’’ limit, short term exposure limit, ceiling limit,
10 For example, when the hazardous substance is
when determining an MUC in the peak, or another occupational exposure limit
lead (with a PEL of 50 µg/m3), and the respirator used for the hazardous substance.
used by employees has an APF of 10, then the
absence of an OSHA exposure limit.
calculated MUC is 500 µg/m3 or 0.5 mg/m3 (i.e., 50 This language is consistent with the Paul Schulte of NIOSH (Exs. 9–13,
µg/m3 × 10). guidance that the Agency provided to 13–11–1, and 16–4) recommended that

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employers use the RELs, or in the OSHA rules. The Alcoa representatives OSHA PEL because many of these
absence of a REL, another appropriate said that employers should be free to substances can harm employees.
exposure limit. Schulte also stated that, select the criteria for calculating MUCs David L. Spelce (Ex. 10–6) stated that
for both regulated and non-regulated based on their own risk assessments. the PELs in 29 CFR 1910.1000 were
substances, the MUC for any respirator Also, they did not want the lower adopted by OSHA in 1971 and came
other than a pressure-demand SCBA NIOSH RELs to replace OSHA PELs in mostly from the 1968 ACGIH TLVs. He
should never exceed the IDLH value. calculating MUCs. They did not believe recommended that OSHA require
Schulte noted further that NIOSH did that OSHA should specify the LEL or employers to use the ACGIH TLVs and
not agree with the use of the LEL as an 10% of the LEL as a limiting factor AIHA Workplace Environmental
appropriate respirator-selection factor because LEL is an independent Exposure Levels when no OSHA PEL
for MUCs unless the respirator is the indicator of a physical hazard. They exists. He indicated that these
source of an ignition hazard (e.g., asserted that respirator users who could alternative values also should be used
respirators with communication be exposed to an explosive level of a when they are more stringent than the
systems). Accordingly, Schulte (Ex. 9– substance must not enter such an area OSHA PELs. He agreed with OSHA that
13) proposed revising the MUC because of the physical hazard—the when the IDLH level is lower than the
definition to read as follows: characteristics of their respirators are calculated MUC, the IDLH
Maximum use concentration (MUC) means irrelevant in such situations. Similarly, concentration must take precedence. In
the maximum atmospheric concentration of a Daniel P. Adley and William L. Shoup such circumstances, only the most
hazardous substance from which an of the Society for Protective Coatings protective atmosphere-supplying
employee can be expected to be protected (Ex. 9–10) did not agree with the ‘‘or respirators should be used. He also
when wearing a respirator, and is determined any other exposure limit’’ in the stated that IDLH limits should be
by the lesser of definition of MUC, which would give established based on toxicological data,
• APF times (x) exposure limit
regulatory authority to TLVs, RELs, and but, in the absence of toxicological data,
• The respirator manufacturer’s maximum
use concentration for a hazardous substance other industry—established exposure 10% of the LEL should be used as the
(if any) limits. limiting factor (i.e., having the same
• The IDLH, unless the respirator is a Bill Kojola of the AFL–CIO (Exs. 9–27 weight as the IDLH for flammable
positive-pressure, full facepiece SCBA and 16–5) believed that OSHA should substances).
Daniel K. Shipp of the International expand the definition and application of Thomas C. O’Connor of the National
Safety Equipment Association (ISEA) MUC to include substances it does not Grain and Feed Association (NGFA)
(Ex. 9–22) commented that ISEA regulate, and that the exposure limits (Exs.10–13 and 16–19) recommended a
believed that OSHA should not expand issued by NIOSH, ACGIH, EPA, or the revised MUC definition that would read
the MUC definition to include MUCs for manufacturer should be used when as follows:
hazardous substances not regulated by available. Pete Stafford of the Building
Maximum use concentration (MUC) * * *
OSHA, and that the definition should and Construction Trades Department, usually can be determined mathematically by
not involve limiting factors. He AFL–CIO (Ex. 9–29) recommended that multiplying the assigned protection factor
indicated that employers should have OSHA expand the definition of MUC to specified for a respirator by the permissible
the flexibility to determine what to do include appropriate exposure values exposure limit or ceiling value as
in these situations. Shipp also stated because thousands of harmful and appropriate. In a situation when such
that the NIOSH approval labels on potentially harmful chemicals used in regulatory limits have not been set by OSHA,
the workplace are not regulated by the employer may rely on limits established
chemical cartridges already read ‘‘Do by non-regulatory organizations based on
not exceed maximum use OSHA. He indicated that alternative
professional judgment and the working
concentrations established by regulatory MUCs calculated for chemicals using a
standards.’’ In this regard, he suggested non-OSHA exposure limit should be
that OSHA rewrite the MUC definition used when these MUCs are lower than However, he (Ex. 10–13) said that
to require that MUCs used to select the MUCs determined from using PELs. NGFA strongly opposes requiring
respirators shall not be exceeded. He also recommended that OSHA employers to determine MUCs for
Michael Sprinker of the International specify 10% of the LEL as a limiting substances for which no OSHA PELs are
Chemical Workers Union Council of the factor for MUCs. available. The NGFA also opposed any
United Food and Commercial Workers Stephan C. Graham of the United requirement that employers rely on
Union (Ex. 10–54) believed that OSHA’s States Army Center for Health MUCs developed by NIOSH, but
definition of MUC should be revised Promotion and Preventive Medicine supported the use of non-OSHA
because it is unclear whether the MUC (Exs. 9–42, 9–42–1, and 9–42–2) exposure limits as aids employers can
is a concentration never to be exceeded indicated that OSHA should expand the use in establishing MUCs.
or a time weighted average. He also MUC definition to include hazardous Thomas Nelson of NIHS, Inc. (Ex. 10–
stated that OSHA should require substances it does not regulate. 17) indicated that OSHA should not
employers to determine MUCs for However, he did not believe that NIOSH require employers to determine MUCs
substances for which no OSHA PEL is MUCs should be used when they are for substances that have no OSHA PELs.
available, and that these MUCs can be lower than the MUCs calculated using Nelson said that OSHA first must
derived from occupational exposure OSHA PELs. Rick N. Givens of Augusta determine when a need for such
limits issued by NIOSH, ACGIH, EPA, Utilities Department (Ex. 10–2) also exposure limits exists, and then issue
or the manufacturer. agreed that OSHA should require new PELs. Furthermore, Nelson stated
Robert W. Barr and Linda M. Maillet employers to calculate MUCs for that OSHA cannot rely on other groups
of Alcoa, Inc. (Exs. 9–26 and 10–31) said substances that do not have OSHA to establish limits for OSHA’s use. He
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that OSHA should not expand the PELs. Ken M. Wilson of the Division of also said that the only limiting factors
definition and application of MUCs to Safety & Hygiene, Ohio Board of Water that should be used in calculating MUCs
hazardous substances it does not Control (Ex. 10–3) stated that OSHA are APFs and IDLHs, and that the
regulate because that would constitute should require employers to determine Agency should specify the LEL, or a
adoption of these exposure limits as MUCs for substances that have no value close to the LEL (e.g., 90% of the

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50174 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

LEL), when no IDLH exists for a protection provided by a respirator, but factor. Accordingly, when the
substance. is an essential factor to consider when atmosphere reaches 10% of the LEL, the
Lorraine Krupa-Greshman of the working with flammable or combustible employee should be removed and steps
American Chemistry Council (ACC) (Ex. materials. taken to make the work area safe (e.g.,
10–25) indicated that NIOSH MUCs Paul Hewett of Exposure Assessment ventilate the area). When the area
should not be adopted as a specific Solutions, Inc. (Ex. 10–60) believed that cannot be made safe, the employer
requirement, but should remain OSHA should require employers to should provide the employee with a
available for guidance. The ACC also determine MUCs for those substances fire-retardant suit and supplied air.
does not support requiring compliance that have no OSHA PEL. He pointed out
with NIOSH MUCs when they are lower that employers already are required to 3. Summary and Conclusions
than OSHA’s MUCs. The ACC consider all hazardous substances, As noted above in the discussion of
recommends a requirement for including those substances without an the MUC definition, the final standard
employers to determine the appropriate OSHA PEL, under the ‘‘recognized will require employers to use an OSHA
MUCs for substances that do not have hazards’’ provision of the general-duty exposure limit when available.
an OSHA PEL. However, employers clause of the OSH Act. He However, absent an OSHA exposure
should be allowed to designate and recommended that OSHA indicate, limit, employers must use relevant
document the basis for these MUCs either by regulation or by repeated available information combined with
using either the OSHA formula or other emphasis in the preamble of this final informed professional judgment to
criteria. She stated that the IDLH is a standard and in all respirator determine MUCs. The purpose of this
reasonable limit on the MUC for some guidelines, that these requirements also approach is to permit employers to rely
types of respirators, and that an IDLH apply to overexposures involving on existing data sources and
should be based on health effects. She unregulated substances. Hewett also professional judgment when
noted that using the LEL or a percentage stated that OSHA should not require determining an MUC that will provide
of the LEL to limit MUCs is confusing employers to comply with MUCs adequate protection for their employees
and inappropriate because an LEL is calculated using NIOSH RELs when from hazardous airborne contaminants
used to determine whether an employee these MUCs are lower than the MUCs that have no OSHA exposure limit.
can safely enter an area with a fire calculated using OSHA PELs. He
hazard, not for selecting respirators. recommended as well that OSHA E. MUCs for Mixtures and Hazard Ratios
Frank A. White of ORC Worldwide should specify an upper bound on 1. MUCs for Mixtures
(Ex. 10–27) stated that OSHA should not MUCs that is a percentage of the IDLH
require employers to calculate MUCs for for a substance, e.g., the MUC is no Paragraph (d)(3)(i)(B)(1) requires
substances that have no OSHA PEL, but more than 25% of the IDLH. employers to select respirators for
that employers should have the freedom Michael Watson of the International employee use that maintains the
to select the occupational exposure Brotherhood of Teamsters, AFL–CIO employees exposure to the hazardous
limits used for calculating MUCs based (Ex. 9–12), Pete Stafford of the Building substance at or below the MUC.
on their own risk assessments. He and Construction Trades Department, However, a question arises regarding
emphasized that it is important that AFL–CIO (Ex. 9–29), and Rick N. Givens how to make these calculations for
employers be able to show the of the Augusta Utilities Department (Ex. mixtures. Question 12 in Section VIII.
documented evidence used to support 10–2) agreed with using the IDLH as a (‘‘Issues’’) of the proposal addressed this
their MUC decisions. ORC Worldwide limiting factor for MUCs. Givens also issue by requesting comments on the
also indicated that OSHA should not recommended that OSHA specify 10% proposed MUC for mixtures., About half
expand the application of MUCs to of the LEL as an additional limiting of the commenters supported the MUC
hazardous substances it does not factor for MUCs. provisions as proposed, but believed
regulate because these exposure limits Michael Runge of the 3M Company that insufficient data were available to
(e.g., developed by chemical (Exs. 9–16, 16–25, and 16–25–2) said perform the calculations for mixtures
manufacturers, ACGIH, NIOSH, EPA) that only APFs and IDLHs should be (Exs. 9–23, 9–37, 10–17, 10–25, and 10–
would become OSHA regulations. He used to calculate MUCs. The LEL and 59). Another group of commenters
also stated that OSHA should not eye irritation, as well as all other supported performing the calculations
enforce the 1994 NIOSH IDLHs, but limitations, already are considered in based on information that each
instead should continue to rely on those the respirator selection process, and do component of a mixture has a non-
IDLHs that NIOSH developed in 1990. not necessarily need to be considered additive effect on independent organ
OSHA should not use either the LEL or when establishing specific MUCs. He systems. In this case, the commenters
10% of the LEL as a limiting factor did not support use of 10% of the LEL suggested either a separate MUC for
because these factors are not health- as a limiting factor, but stated that each component, or lowering the MUC
based, and are used as indicators of a OSHA should specify the LEL when no according to the proportion of each
physical hazard. IDLH is available for a chemical. He also component in the mixture (Exs. 9–12, 9–
Ted Steichen of the American stated that when employers use the REL 13, 9–22, 9–29, and 9–37). Still others
Petroleum Institute (Ex. 9–23) believed for an unregulated contaminant to select recommended lowering the MUC by an
that the determination of MUCs for a respirator, the APF and MUC unspecified proportion when individual
substances with no OSHA PELs should principles specified in the proposal components of the mixture have
be left to the good practices of the should apply. synergistic effects on organ systems (Ex.
employer. He stated that OSHA would Kenneth Bobetich of Mine Safety 9–42), or simply requiring employers to
be exceeding its authority if it expanded Appliances (Ex. 9–37) believed that use supplied-air respirators when
the definition and application of MUC OSHA’s definition of MUC is sufficient employees are exposed to mixtures (Ex.
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to hazardous substances that it does not to cover the limitations, and that MUCs 10–1).
regulate. Steichen said that the use of should not be based on eye irritation. Daniel K. Shipp of the International
the LEL to limit the MUC is confusing Tracy C. Fletcher of Parsons-Odebrecht Safety Equipment Association (Ex. 9–
and inappropriate. He stated that the JV (Ex. 10–1) recommended that OSHA 22) pointed out that the effect of the
LEL has no relationship to the use 10% of the LEL as an MUC-limiting mixture on canister/cartridge service life

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must be evaluated, and an appropriate contaminants have additive health Lisa M. Brosseau of the University of
change schedule established for a effects, and they should use the additive Minnesota (Ex. 10–59) believed that the
mixture of gases or vapors. Shipp mixture formula set by ACGIH and issue of mixtures, as addressed in the
indicated that no MUC equation is OSHA to calculate the MUC. proposal, is confusing and incorrect.
available for mixtures. He suggested that Michael Watson of International She stated that the only requirements
when the health effects of a mixture’s Brotherhood of Teamsters, AFL-CIO (Ex. needed are to assure that respirators
components are not additive, then each 9–12) and Pete Stafford of the Building have the required filters and that gases
component should be evaluated and Construction Trades Department, A and vapors have appropriate cartridges.
separately, and the respirator must be FL-CIO (Ex. 9–29) stated:
2. Use of Hazard Ratios
appropriate for the sum of the The presence of multiple contaminants in
individual chemical concentrations. the workplace should be taken into Michael Runge of the 3M Company
Kenneth Bobetich of Mine Safety consideration when the employer determines (Ex. 9–16), Daniel K. Shipp of the
Appliances (Ex. 9–37) noted that no the MUC and respirator change schedules for International Safety Equipment
evidence exists to indicate that gases and vapors. Mixtures may have similar Association (Ex. 9–22), and Lisa M.
respirator performance is different when effects on chemical cartridge loading, so the Brosseau of the University of Minnesota
the exposure is to a mixture of MUC of each component of a mixture should (Ex. 10’59) supported another method
be lowered in proportion to its percentage of for selecting respirators, the hazard ratio
particulates versus a single particulate. the total concentration of contaminants in
However, the effect of a mixture of gases air. (HR). The HR is defined as the ratio of
or vapors on canister/cartridge service the workplace concentration of an
life must be evaluated, and an Paul Schulte of NIOSH (Exs. 9–13, airborne contaminant divided by the
appropriate change schedule 13–11–1, and 16–4) recommended that occupational exposure limit (e.g., PEL).
established. He further mentioned that the equation C1/MUC1 + C2/MUC2 + Any respirator that has an APF equal to
Dr. Gerry Wood of LANL is conducting * * * + Cn/MUCn = 1 should be used to or greater than the HR may be selected.
a study to evaluate the effect of mixtures determine MUCs for mixtures. He They stated that the HR is more useful
on service life, and is developing a asserted that the MUC would be safe to employers than MUCs because
model to predict cartridge service life. only when the result is ≥1. Schulte also employers likely will have information
Bobetich indicated that when the health stated that the rated service life of the on airborne concentrations and
effects of the mixture components are cartridge may be shortened during occupational exposure limits when
on the same organ system and these exposure to a mixture (i.e., one or more selecting respirators. Both Runge and
effects are additive, an additive formula of the mixture’s components may break Shipp said that the HR is similar to the
can be used to establish the PEL for the through before the rated end-of-service- MUC. Brosseau noted that it makes
mixture. However, when the health life). more sense to use the HR rather than the
effects are not additive, then each Ted Steichen of American Petroleum MUC to select respirators, and she
component should be evaluated Institute (Ex. 9–23) indicated that no recommended that OSHA require the
individually and the respirator must be data are available comparing respirator HR method, and use the MUC as
appropriate for the sum of the performance during exposure to guidance.
individual chemical concentrations. multiple contaminants and exposure to OSHA is not adopting hazard ratios
Thomas Nelson of NIHS, Inc. (Ex. 10– single contaminants, and that it is under this final rulemaking because it
17) said that, because exposures to impractical to discuss establishing was not addressed in the notice of
multiple organic vapors will affect the different MUCs for mixtures. Stephan C. proposed rulemaking. Accordingly,
service life of a cartridge, the employer Graham of the United States Army OSHA would have to provide the public
already is required to consider multiple Center for Health Promotion and with notice and an opportunity for
contaminants in setting a cartridge Preventive Medicine (Exs. 9–42, 9–42– comment on this issue before taking
change schedule. He recommended that, 1, and 9–42–2) stated that MUCs for such action.
to determine the MUC for a mixture that mixtures should differ from MUCs for
single compounds depending on 3. Summary and Conclusions
affects the same organ system,
employers should assume that the whether the health effects are additive OSHA agrees with the commenters
health effects of each component are or synergistic. who stated that the data on mixtures are
additive. Tracy C. Fletcher of Parsons- limited, and that no revision is needed
Frank A. White of ORC Worldwide Odebrecht JV (Ex. 10–1) believed that for OSHA’s proposed single-
(Ex. 10–27) indicated that exposure to supplied-air respirators should be used contaminant MUC definition (Exs. 9–23,
multiple gas or vapor contaminants may to eliminate the risk of filter failure 9–37, 10–17, 10–25, and 10–59). The
affect the service life of respirator filters caused by chemical reactions that may existing requirement for setting change
and cartridges differently than exposure occur among the components of a schedules for respirator cartridges and
to a single contaminant. He, too, mixture. Lorraine Krupa-Greshman of canisters specified in 29 CFR 1910.134
mentioned that Dr. Gerry Wood is the American Chemistry Council (ACC) (d)(3)(iii)(B)(2) already requires that
working on this issue with NIOSH, and (Ex. 10–25) indicated that by addressing employers consider the effects of each
that a service life calculation model for contaminants with additive effects, 29 component in organic vapor mixtures
multiple contaminants will soon be CFR 1910.1000(d)(2)(i) and the proposal when they develop change schedules.
available. He emphasized that the more provide adequate means of achieving The Agency recognizes that reliable
important consideration in determining suitable protection. Also, she said that methods are not available to develop
MUCs for mixtures is the health effects MUCs can be developed for multiple MUCs for mixtures based on whether
of multiple contaminants. He stated that contaminants that have independent the components of the mixture act
the employers are in the best position to health effects by using the change additively or synergistically, and
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apply recommendations from chemical schedule provisions of whether they affect the same organ or
manufacturers and information on 1910.134(d)(3)(iii)(B)(2). The ACC does different organs. Therefore, OSHA will
health effects to their specific not believe that adequate information rely on the provisions at 29 CFR
workplaces. He noted that industrial and data are available to develop MUCs 1910.1000(d)(2)(i) to assist employers in
hygienists should determine if the for mixtures with synergistic effects. calculating MUCs.

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50176 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

While the determination of MUCs and APF. Accordingly, this provision pressure-demand supplied-air respirator
service life are both necessary for ensures that employers maintain with an auxiliary self-contained air
respirator selection, they should not be employees’ direct exposure to supply. In the preamble to the final
confused. MUCs can be used to decide hazardous substances (i.e., inside the Respiratory Protection Standard, the
if a certain type of respirator even respirator) below levels specified by Agency justified selecting these
qualifies for consideration for use in OSHA’s Z tables and substance-specific respirators as follows: ‘‘In [IDLH]
defined workplace concentrations. standards, and, when OSHA has no atmospheres there is no tolerance for
Service life estimation identifies how standards, below exposure levels respirator failure. This record supported
long a properly selected respirator can determined by the employer. Therefore, OSHA’s preamble statement that IDLH
be expected to provide worker this provision provides employee atmospheres ‘require the most
protection and, therefore, is useful for protection consistent with existing protective types of respirators for
setting change schedules. regulatory requirements and prevailing workers’ ’’ (59 FR 58896). Commenters
OSHA has established at 29 CFR industrial-hygiene practice. to the APF proposal, including NIOSH,
1910.1000(d)(2)(i) an equivalent In the MUC provision following ANSI, and representatives of both labor
exposure requirement for mixtures of air paragraph (d)(3)(i)(B)(1) in the proposal, and management, agreed that employees
contaminants. Accordingly, MUCs for OSHA had incorporated a note that should use these respirators, which are
respirators used in a mixture of stated: ‘‘MUCs are effective only when the most protective respirators available,
contaminants must satisfy the following the employer has a continuing, effective when exposed to IDLH atmospheres.
equation: respiratory protection program as (See 63 FR 1201 for a more complete
specified by 29 CFR 1910.134, including discussion of these comments.)
Em = (C1 ÷ L1 + C2 ÷ L2) + * * * + (Cn
training, fit testing, maintenance and Ted Steichen of the American
÷ Ln)
use requirements.’’ The Agency is Petroleum Institute (Ex. 9–23) requested
Where: removing this note because the program that OSHA clarify that a pressure-
Em is the equivalent exposure for the already is required under its Respiratory demand full facepiece SAR with
mixture Protection Standard for all employers auxiliary SCBA can be used at an APF
C is the concentration of a particular using respirators, and OSHA believes higher than 1,000. He said that positive-
contaminant that duplicating this information in a pressure SARs with auxiliary SCBAs
L is the exposure limit for that note is unnecessary. often are used by the petroleum
substance The second MUC provision in the industry for non-emergency work in
The value of Em shall not exceed unity proposal, paragraph (d)(3)(i)(B)(2), high-hazard operations (e.g., cleaning
(1). required employers to use MUCs refinery flare systems) that may involve
OSHA is maintaining the MUC as a determined by respirator manufacturers potential exposures greater than 1,000
requirement in the final standard for when those MUCs were lower than the times the PEL. Under proposed Table 1,
determining the maximum MUCs determined using the general he questioned whether OSHA would
concentration of an airborne calculation (i.e., MUC = APF × PEL). consider this use of SARs with auxiliary
contaminant from which a respirator Several commenters objected to the SCBAs to be acceptable. The Agency
will protect an employee. In addition, proposed provision, stating that it gave notes that paragraph (d)(2)(i)(B) of its
the Agency cannot revise the final rule regulatory status to manufacturer’s Respiratory Protection Standard already
to mandate the use of hazard ratios MUCs (e.g., Exs. 9–10, 9–22, 9–23, 9–24, permits employers to use a combination
because the regulated community must 9–26, and 10–13). However, the Agency full facepiece pressure-demand
have adequate notice of, and an often defers in its rules to instructions supplied-air respirator (SAR) with
opportunity to comment on, any such and other documents published by auxiliary self-contained air supply in
revision to the standard. manufacturers (e.g., no fewer than seven IDLH atmospheres. Also, paragraph
provisions of OSHA’s Respiratory (d)(3)(i)(A) of this final standard states,
F. MUC Provisions Protection Standard refer to ‘‘When using a combination respirator
1. Paragraph (d)(3)(i)(B)—MUC manufacturers’ instructions or * * * employers must ensure that the
Provisions recommendations). Nevertheless, the assigned protection factor is appropriate
Agency believes that the proposed to the mode of operation in which the
These final requirements consist of provision is unnecessary because using respirator is being used.’’ In this case,
three separate paragraphs ((d)(3)(i)(B)(1) the general calculation specified in the the combination pressure-demand full
through (d)(3)(i)(B)(3)). Paragraph MUC definition is an accepted safe facepiece SAR with auxiliary SCBA
(d)(3)(i)(B)(1), which sets the practice in the industrial-hygiene respirator is equivalent to an SCBA,
requirements for the use and application community. and, therefore, the APF for an SCBA
of MUCs, reads, ‘‘The employer must Paragraph (d)(3)(i)(B)(2) of the final applies.
select a respirator for employee use that MUC provisions (which was designated The last MUC provision, proposed
maintains the employee’s exposure to as paragraph (d)(3)(i)(B)(3) in the paragraph (d)(3)(i)(B)(4), would have
the hazardous substance, when proposal) specifies that employers must required that ‘‘[w]hen the calculated
measured outside the respirator, at or not use MUCs to select respirators for MUC exceeds another limiting factor
below the MUC.’’ This paragraph, which employees who are entering an IDLH such as the IDLH level for a hazardous
has the same designation in the atmosphere. OSHA previously specified substance, the lower explosive limit
proposal, requires employers to select the requirements for selecting (LEL), or the performance limits of the
respirators for employee protection that respirators for use in IDLH atmospheres cartridge or canister, then employers
are appropriate to the ambient levels of in paragraph (d)(2) of its Respiratory must set the maximum MUC at that
the hazardous substance found in the Protection Standard. Paragraph (d)(2) lower limit.’’ Accordingly, the IDLH
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workplace, i.e., that the ambient level of requires employers to select for this limits for hazardous substances would
the hazardous substance must never purpose a full facepiece pressure- take precedence over the calculated
exceed the MUC, which is the exposure demand SCBA certified by NIOSH to MUC when the IDLH limits result in
limit specified for the hazardous have a service life of at least 30 minutes, lower employee exposures to the
substance multiplied by the respirator’s or a combination full facepiece hazardous substances. Consequently,

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this provision increases employee G. Superseding the Respirator Selection substance-specific standards is
protection against these hazardous Provisions of Substance-Specific consistent with OSHA’s goal of bringing
substances. OSHA is retaining a revised Standards in Parts 1910, 1915, and 1926 uniformity to its respiratory protection
version of this proposed provision in requirements. Moreover, protection for
1. Introduction
the final rule (redesignated as paragraph workers likely will be increased because
(d)(3)(i)(B)(3)). The remaining OSHA proposed to revise the
the final APFs result in regulatory
paragraphs of this subsection discuss provisions in its substance-specific
standards under 29 CFR parts 1910, consistency, enhanced employer
the revisions. compliance, and reduced the
The previous discussion of MUCs for 1915, and 1926 that regulate APFs
substances with no OSHA PEL or other (except the APF requirements for the compliance burden on the regulated
limiting factors (see subsection 2 1,3-Butadiene Standard at 29 CFR community, and, consequently, further
(‘‘MUCs for Substances with No OSHA 1910.1051). These substance-specific increases the protection afforded to
PEL or Other Limiting Factor’’) of this standards specify numerous employees who use respirators.
section) addressed the use of the LEL as requirements for regulating employee In its Respiratory Protection Standard,
a limiting factor to be considered when exposure to toxic substances. The OSHA noted that the revised standard
calculating the MUC. NIOSH did not proposed revisions would have removed was to ‘‘serve as a ‘‘building block’’
agree with the use of the LEL as a the APF tables from these standards, as standard with respect to future
limiting factor for MUCs in respirator well as any references to these tables, standards that may contain respiratory
selection unless the respirator is the and would have replaced them with a protection requirements.’’ (See 63 FR
source of an ignition hazard (Ex. 9–13). reference to the APF and MUC 1265, 1998.) However, in the proposed
Alcoa, Inc. did not believe OSHA provisions specified by proposed APF rulemaking that would provide
should use the LEL as a limiting factor paragraphs (d)(3)(i)(A) and (d)(3)(i)(B) of
generic APFs and MUCs as part of the
for MUCs since the LEL ‘‘is not health- the Respiratory Protection Standard at
Respiratory Protection Standard, the
based, rather it is an independent 29 CFR 1910.134. In justifying these
proposed revisions, the Agency stated Agency decided to retain former
indicator of a physical hazard’’ (Ex. 10–
that the proposed revisions would respirator selection provisions in the
31). The American Chemical Council
simplify compliance for employers by existing substance-specific standards
commented using the LEL to set MUCs
was confusing and inappropriate, removing many APF requirements that it found supplemented or
because the LEL is used to determine across its substance-specific standards. supplanted the proposed APFs and
whether an employee can safely enter The proposed revisions would enhance MUCs (e.g., organic vapor cartridge and
an area with a fire hazard, not for consolidation and uniformity of these canister procedures, prohibiting use of
selecting respirators (Ex. 10–25). The requirements, and conform them to each filtering facepieces or half mask
American Petroleum Institute also other and to the general APF and MUC respirators). OSHA did so because these
questioned the use of the LEL to limit requirements specified by 29 CFR provisions enhance the respirator
the MUC because the LEL has no 1910.134 (68 FR 34107). protection afforded to employees.
relationship to the protection provided As noted elsewhere in this preamble
to the final APF rule, OSHA developed 2. Comments Regarding the Respirator
by a respirator, but is a factor to
the final APFs using the best available Selection Provisions of the 1,3-
consider when working with flammable
evidence. The development of these Butadiene Standard
or combustible substances (Ex. 9–23).
The 3M Company stated that the LEL final APFs included a careful review of The former respirator selection
already is required under the the comments, testimony, data, and
provisions being retained in this final
Respiratory Protection Standard when other evidence submitted to the
rule include those provisions in the 1,3-
selecting respirators, and does not need rulemaking record, a quantitative (i.e.,
statistical) analysis of the results from Butadiene (BD) Standard. In issue 13 of
to be taken into account when the proposed APF rule (68 FR 34112),
establishing specific MUCs (Ex. 9–16). WPF studies performed among workers
wearing air-purifying half mask OSHA asked if exclusion of this
The Agency agrees with these
commenters that the LEL is not respirators (both filtering facepieces and standard was warranted. The responses
appropriate as a limiting factor in elastomerics) discussed above in this to this question addressed only the
setting MUCs. Therefore, OSHA preamble, and a thorough quantitative service life requirement for cartridges
removed from paragraph (d)(3)(i)(B)(3) and qualitative review of existing WPF used to absorb atmospheric BD. Typical
in the final rule the language that and SWPF studies performed with other of these responses is the following
identified the LEL as a limiting factor in types of respirators. Using the best data comment from the 3M Company:
setting MUCs. The Agency made this and analytic techniques available, as A short service life does not affect the
revision to the proposal because the LEL well as the extensive comments and ability of a specific respirator to reduce a
is not related to the performance of the testimony provided to the rulemaking concentration of a contaminant below the
respirator, but is an independent record, lends a high degree of reliability PEL. * * * [W]ith the cartridge change
indicator of a physical hazard (i.e., the and validity to the final APF requirements in 1910.134 there is no need to
flammability or combustibility of a determinations. limit the use of organic vapor cartridges or
substance) that already must be The Agency believes that the final canisters to specific levels of BD. The
considered when determining whether APFs developed under this rulemaking employer is required to determine a useful
an employee can safely enter a will improve the substance-specific service life. If that service life is very short,
hazardous area. standards. The final APFs will provide the employer will need to determine if the
The revised and redesignated final employers with confidence that their replacement schedule is realistic. (Ex. 18–7.)
paragraph (d)(3)(i)(B)(3) now reads as employees will receive the level of
follows: protection from airborne contaminants However, two other commenters
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signified by these APFs when they made important observations. First, the
(3) When the calculated MUC exceeds the American Chemistry Council
IDLH level for a hazardous substance, or the implement a respiratory protection
performance limits of the cartridge or program that complies with the representative noted that ‘‘[E]xclusion of
canister, then employers must set the requirements of 29 CFR 1910.134. In [the BD] standard is reasonable since
maximum MUC at that lower limit. addition, applying the final APFs to the this standard has a more comprehensive

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respirator section that includes end of Allowing for a reasonable margin of testimony, a representative from 3M
service life specifications’ (Ex. 10–25). protection, and given that test data were stated, ‘‘We contend that requiring
Second, ORC Worldwide stated, available only for a few makes of cartridges separate respirator APFs and selection
and canisters, OSHA believes that air-
‘‘Excluding [BD] is warranted. requirements in the substance-specific
purifying devices should not be used for
Additional verbiage relative to service protection against BD present in standards as proposed would only add
lives developed under a negotiated concentrations greater than 50 ppm, or 50 confusion to the respirator selection
rulemaking process should not be times the 1 ppm PEL. Thus, OSHA finds that process, and is not justified by any
changed’’ (Ex. 10–27). the ANSI APFs of 100 for full facepiece, air- scientific or practical evidence’’ (Tr. at
Commenters who recommended purifying respirators and 1,000 for PAPRs 394). Thomas Nelson of NIHS, Inc.,
adopting the change-out schedule equipped with tight-fitting facepieces are provided similar rationale in support of
inappropriate for selecting respirators for BD. standardizing these provisions, stating:
provisions of 29 CFR 1910.134 provided
no compelling rationale for disturbing Accordingly, OSHA is retaining the The proposal would retain information
the extensive change-out schedules respirator selection provisions of the BD [on] cartridge change schedules, filter
developed for the BD Standard on the Standard to avoid imposing on selection and some specific respirator
recommendation of industry and labor employers the new burden of selection requirements in the substance
representatives . Substituting the developing their own change-out specific standards. None of these
schedules, and to ensure maximum requirements are necessary in the substance
performance-based provisions that specific standard[s]. The current 1910.134
regulate change schedules under 29 CFR protection for employees exposed to BD.
with the addition of an assigned protection
1910.134 for the existing BD Standard’s 3. Comments Regarding the Respirator factor table contains requirements that are
change schedule provisions for the sake Selection Provisions of Other protective. (Ex. 18–9.)
of convenience is insufficient Substance-Specific Standards Many of these comments addressed
justification for revisiting these issues involving single substance-
relatively recently promulgated The Agency proposed to retain a
number of special respirator selection specific standards, including their
provisions. In this regard, the latter two cartridge, canister, and filter
provisions in the existing substance-
commenters clearly recognized the requirements. The following paragraphs
specific standards. In this regard, OSHA
importance of the process that resulted provide a summary of the comments
noted that the respirator selection
in the existing change schedule that pertain to individual substance-
requirements proposed for retention
requirements. specific standards, as well as OSHA’s
were developed in rulemakings to
In the preamble to the final BD provide protection against a hazardous response to these comments.
Standard, the Agency reviewed test data characteristic or condition that is • Inorganic Arsenic (29 CFR
that demonstrated short breakthrough unique to the regulated substance. 1910.1018). A commenter wanted
times for BD concentrations above 50 Additionally, the Agency stated that OSHA to ‘‘[c]larify if filtering facepieces
ppm. Accordingly, these short retaining these requirements would not will be acceptable [under this
breakthrough times justified setting at increase the existing employer burden standard],’’ and asserted that requiring
50 ppm the upper limit at which because they already must comply with ‘‘gas masks or SARs for exposures above
employees can use air-purifying these requirements. Consequently, the PEL is unnecessary (Ex. 9–5). Two
respirators for protection against BD retaining these provisions would commenters, the Mine Safety
exposures. The Agency used these data maintain the level of respiratory Appliances Co., and the 3M Company,
to develop change schedules for protection currently afforded to questioned the need to require a HEPA
cartridges and canisters that are unique employees. These provisions were in filter when using a cartridge or canister
for BD exposures (see Table 1 of the BD the substance-specific standards for exposures above a specified limit
Standard). OSHA reviewed the test data regulating employee exposure to vinyl (Exs. 9–37, 18–7), while one of these
when it published the final standard in chloride, inorganic arsenic, asbestos, commenters claimed that any filter
1996 and found that these conclusions benzene, coke oven emissions, cotton approved by NIOSH under 42 CFR part
remain valid. The Agency believes that dust, ethylene oxide, and formaldehyde. 84 would provide the required level of
it would impose an unnecessary burden Under issue 13 in the proposal, OSHA filter efficiency (Ex. 18–7).
on employers who are subject to the BD requested comments on the need to The Agency did not address, as part
Standard to require them to repeat the standardize the respirator selection of this rulemaking, the use of filtering
review already conducted by OSHA on provisions being proposed for retention. facepieces during inorganic arsenic
BD breakthrough times, and then The Agency received numerous exposures. This question deals with
develop their own change-out schedules comments and hearing testimony on compliance. The other two commenters
under 29 CFR 1910.134. Moreover, this issue. Most of these comments and provided no basis for questioning the
employee protection from exposure to testimony encouraged OSHA not to requirement for HEPA filters, while the
BD is unlikely to be increased. retain these provisions in their existing issue of filters approved under 42 CFR
The Agency acknowledged in the form, but instead to subsume these part 84 is addressed below (see section
preamble to the final BD Standard that provisions under the Respiratory entitled ‘‘Substituting N95 Filters for
it took a conservative approach to Protection Standard at 29 CFR 1910.134. HEPA Filters’’).
employee protection. In this regard, An example of such a recommendation • Asbestos (29 CFR 1910.1001 and 29
OSHA noted that its ‘‘decision to rely on was provided by the 3M Company (3M) CFR 1926.1101). The 3M Company (3M)
the more protective NIOSH APFs is when it stated, in its hearing testimony, objected to the provision in this
based on evidence showing that organic ‘‘It is neither necessary nor justified to standard that prohibits the use of
vapor cartridges and canisters have retain any of the specific requirements disposable half masks, but permits the
limited capacity for adsorbing BD and in the substance-specific standards. use of elastomeric respirators, at
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may have too short a service life when * * * They do not reflect the changes asbestos concentrations that are 10
used in environments containing greater in science and technology, respirator times the PEL (Ex. 18–7). In these
than 50 ppm BD.’’ (See 61 FR 56816.) design, respirator certification, or comments 3M stated that this disparity
With regard to the change-out respirator regulation under 29 CFR ‘‘is counter to OSHA’s analysis of WPF
schedules, the Agency concluded: 1910.134’’ (Tr. at 393). In subsequent data that does not show a difference

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between filtering facepieces and part of the facepiece or that constitutes Several commenters responded
elastomeric facepieces.’’ The 3M the entire facepiece. These negatively to the recommendations to
Company continued by noting that characteristics also describe single-use raise the APF from 5 to 10 for filtering
NIOSH stated that the aerosol size used respirators. This definition does not facepieces used for protection against
in its respirator certification test ensures specify the functional characteristics of cotton dust (Exs. 12–7–1 and 18–5; Tr.
that filter performance will be at least as filtering facepieces, only their structural at 41–43). However, these commenters
efficient ‘‘for essentially all other features. In this regard, both filtering provided no technical or safety-and-
aerosol sizes’’ (see 60 FR 30344). While facepiece and single-use respirators health rationale for their position.
this comment implies that NIOSH generally are considered disposable, Typical of these comments was the
would accept filtering facepieces for with the period of effectiveness following statement made at the
protection against asbestos, another determined by the functional rulemaking hearing by one of the
commenter observed that the 1997 characteristics of either respirator. participants: ‘‘If OSHA goes ahead and
NIOSH Pocket Guide to Chemical Therefore, because single-use and assigns a 10 * * * for [filtering
Hazards expressly prohibits such use filtering facepiece respirators are facepieces] for the cotton dust standard
(Ex. 18–5). identical with regard to their structural * * *, you’re going against what was
The rebuttal made by the last characteristics, OSHA is retaining the established way back when and settled
commenter indicates that 3M’s concerns proposed terminology in the final APF by the court [at] an APF of 5.’’ (Tr. at
regarding the use of disposable standard. However, while paragraph 43.)
respirators are controversial. (b)(1) of the Table I in the Coke Oven The first set of commenters
Consequently, revision would require a Emissions Standard prohibits using a recommended revising this standard to
new rulemaking. single-use, filtering facepiece respirator, raise the APF for filtering facepieces
• Coke Oven Emissions (29 CFR paragraph (b)(2) of this table permits its from 5 to 10, consistent with the APF
1910.1029). A 3M representative use when it functions as a ‘‘particulate for filtering facepieces proposed for 29
asserted that OSHA made an error when filter respirator.’’ Accordingly, CFR 1910.134. However, the Agency did
it proposed to revise the term ‘‘single- employers may select filtering facepiece not propose to raise the APF for filtering
use respirator’’ to ‘‘filtering facepiece respirators when employees are exposed facepieces used against cotton dust, and
respirators’’ in item (b)(1) of Table 1 in to coke oven emissions and those the record is inadequate to make that
paragraph (g)(3) of this standard (Ex. emissions (1) consist solely of decision at this time. The second set of
18–7). This commenter supported this particulates, and (2) the exposure comments noted that revising the APF
assertion by noting that ‘‘[t]he ‘single conditions are no more than 10 times from 5 to 10 for filtering facepieces used
use type’ respirator was a term that the PEL for coke oven emissions. during exposures to cotton dust would
NIOSH started after promulgation of the Finally, OSHA simply cannot adopt the be foreclosed by the court’s decision in
coke oven emission standard,’’ and that Minnesota Mining and Manufacturing
recommendation of the second
‘‘[d]isposable dust/mist respirators are Co. v. OSHA, 825 F.2d 482 (D.C. Cir.
commenter to use only P100 filtering
not prohibited from use under the * * * 1987); this decision upheld the Cotton
facepieces under these conditions as
standard.’’ In conclusion, this Dust Standard’s assignment of an APF
this issue was not part of this
commenter remarked that, by revising of 5 for disposable respirators. While
the term ‘‘single-use respirator’’ to OSHA is not revising the APF for
‘‘filtering facepiece respirators,’’ the • Cotton Dust (29 CFR 1910.1043). filtering facepieces used against cotton
Agency is ‘‘prohibiting disposable The comments concerning this standard dust at this time, the Agency notes that
particulate respirators from being used, addressed whether filtering facepieces the court’s decision in this case does not
which was not the intent of the original used to protect employees against cotton preclude it from revising the Cotton
standard.’’ However, another dust exposure should retain the current Dust Standard in the future based on an
commenter took exception to removing APF of 5 or be upgraded to an APF of appropriate rulemaking record.
the proposed prohibition against all 10. In this regard, one commenter
filtering facepiece respirators (Ex. 18–5), believed that revising this standard to 4. Change-Out Schedules for Vinyl
claiming that the particle size of coke upgrade the APF of filtering facepieces Chloride (29 CFR 1910.1017), Benzene
oven emissions is unknown, and that to 10 would be consistent with the (29 CFR 1910.1028), Formaldehyde (29
coke oven fumes may degrade the results of OSHA’s statistical analysis of CFR 1910.1048), and Ethylene Oxide (29
electrostatic filters used in filtering WPF studies for filtering facepiece CFR 1910.1047)
facepieces. This commenter asserted respirators (Ex. 18–7). This commenter The International Safety Equipment
that employers should use only HEPA stated, ‘‘[F]iltering facepieces should Association (ISEA), the Mine Safety
filter cartridges, or P100 filtering have the same APF of 10 for cotton dust Appliances Co., and the 3M Company
facepieces that respirator manufacturers as they would for all other dusts. (3M) requested OSHA to remove the
demonstrate will not degrade when Filtering facepieces do not show existing cartridge change-out schedules
exposed to coke oven fumes. selective performance to cotton dust under the Vinyl Chloride Standard and
The Agency agrees with the first versus other aerosols.’’ Three additional replace them with the change-out
commenter that the term ‘‘single-use commenters echoed a similar concern schedule provisions of 29 CFR 1910.134
respirator’’ is outdated. It believes that with regard to filtering facepieces used (Exs. 9–22, 9–37, and 18–7). In its
the regulated community now against cotton dust. Two of these comments on this issue, 3M stated that
designates these respirators as filtering commenters noted that no technical ‘‘the nature of toxicity of any analyte
facepiece respirators. Accordingly, the reason exists ‘‘to reduce the APF to 5 for does not affect the service life of a
definition of filtering facepiece filtering facepieces’’ (Exs. 9–22 and 9– chemical cartridge’’ (Ex. 18–7). ISEA
respirators in paragraph (b) of 29 CFR 37), while the third commenter stated and 3M submitted similar comments
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1910.134 consists of three key that ‘‘[n]ot allowing filtering facepieces regarding the existing cartridge change-
characteristics—they function under for greater than 5 times the PEL is out schedules in the Benzene Standard
negative pressure, are used against inconsistent with an APF of 10 (Exs. 9–22 and 18–7). Accordingly, 3M
particulates and vapors, and consist of indicated in [proposed] Table 1’’ (Ex. 9– noted that the Agency should not limit
a filtering medium that is an integral 42). cartridge selection to only organic vapor

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50180 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

cartridges specified for benzene not identify any specific substances (Ex. Agency remove references to HEPA
absorption, but should expand the 9–59). One of these commenters asked, filters from a number of its substance-
permitted cartridges to organic vapor ‘‘Why make it a requirement to wear eye specific standards because ‘‘[p]article
cartridges for acid gas or formaldehyde protection unless the concentrations are properties such as size and form are no
absorption, as well as multi-gas at irritant levels?’’ (See Ex. 9–42.) This longer needed in filter selection’’ (Ex. 9–
cartridges (Ex. 18–7). The three commenter also noted that OSHA does 37). Another commenter stated that
commenters also recommended that not permit the use of half mask P100 filters were equivalent to HEPA
OSHA remove the requirements for respirators during exposure to arsenic filters, and that OSHA should
cartridges, filters, and the cartridge trichloride, but did not apply this ‘‘[p]rovide clear generic guidance on
change-out schedules in the Ethylene prohibition to other chemicals that when HEPA or P100 filters should be
Oxide Standard, as well as the employees may absorb rapidly through used, as opposed to another less
specifications for cartridges/canisters the skin. This commenter recommended efficient filter’’(Ex. 9–42).
and change-out schedules in the that the Agency ‘‘[p]rovide consistent In addressing other issues, one
Formaldehyde Standard, asserting that recommendations that involve commenter stated that OSHA would be
employers could refer to 29 CFR chemicals that can be absorbed through breaching an earlier decision if it
1910.134 to obtain the necessary the skin in significant amounts (e.g., superseded dust-mist-fume respirators
information (Exs. 9–22, 9–37, and 18–7). chemicals with PEL or TLV with ‘skin’ with respirators using HEPA filters at
In response to these commenters, the notations).’’ Another commenter took a lead levels that are equal to or below 0.5
Agency notes that it believes that the different approach to this issue, mg/m3 (Ex. 10–4).11 Another commenter
minimum change-out schedules proposing that OSHA should ‘‘[r]emove recommended limiting the use of all
specified by these standards ensure that all references to [the] use of respirators electrostatic (fiber) filters (Ex. 18–5).
employers use the designated for protection from substances that can This commenter based this
respirators at appropriate concentration be absorbed through the skin or irritate recommendation on evidence presented
levels of the regulated substance. OSHA the skin or eyes. There are other ways at the 1994 NIOSH hearing on the
also recognizes that retaining these that the skin can be protected’’ (Ex. 10– proposed filter certification
specifications may limit employers’ 59). requirements of 42 CFR 84. This
flexibility in adopting change-out The purpose of this rulemaking was to commenter stated that the evidence
schedules. However, it considers this provide the regulated community with showed, when tested with a heated
limitation justified because the specified notice of, and an opportunity to DEHP aerosol challenge agent, the
change-out schedules provide a high comment on, specific respirator average filter efficiency for electrostatic
level of protection for employees against selection provisions that the Agency P100 filters was less than the average
the dangerous properties of these proposed for revision. In this regard, filter efficiency for respirators that used
substances. In addition, adopting the OSHA proposed no revisions to any a mechanical filter media. In one of
change-out schedule provisions of 29 requirements in the substance-specific these tests, the average filter efficiency
CFR 1910.134 for current OSHA health standards that addressed protection for a P100 electrostatic filter was as low
standards is beyond the scope of this against eye or skin irritants. as 84.5%.
APF rulemaking. The Agency cannot Accordingly, these provisions will While it is beyond the scope of this
make revisions to this final rule based remain intact. The Agency believes that rulemaking to make the revisions
on these comments because the the requirements of existing substance- recommended by these commenters, the
regulated community must have specific standards that specify the use of Agency notes that the definition of
adequate notice of, and an opportunity protective clothing and the other HEPA filters in paragraph (b) of 29 CFR
to comment on, any proposed revisions. personal protective equipment 1910.134 equates these filters with high-
requirements of 29 CFR 1910 subpart D end filters tested under the NIOSH
5. Miscellaneous Comments Regarding
will prevent serious skin absorption of certification scheme specified by 42
Superseding Other Substance-Specific
toxic substances. Moreover, provisions CFR 84. In this regard, the definition
in the substance-specific standards that notes that, under 42 CFR 84, HEPA
A number of comments were general, require the use of full facepiece filters are equivalent to the N100, R100,
and did not address a single substance- respirators and other high-end and P100 particulate filters certified by
specific standard. These comments respirators for eye protection will NIOSH. Therefore, the Respiratory
centered on respirator selection issues provide employees with an integrated Protection Standard already describes
that involved two or more of the protection system that assures HEPA filters in language that equates
substance-specific standards, such as maximum respiratory and eye them to N100, R100, and P100 filters
HEPA filters and training. The following protection. certified by NIOSH (i.e., the terms are
paragraphs identify the issues addressed • HEPA Filters. Several commenters interchangeable). OSHA Directive No.
in these comments, and provide a took exception to requirements in many CPL 2–0.120 of September 25, 1998
summary of the comments that address substance-specific standards that some (‘‘Inspection Procedures for the
these general issues, including OSHA s respirators use HEPA filters. For Respiratory Protection Standard’’) also
response to them. example, one commenter stated that states, ‘‘When HEPA filters are required
• Skin absorption and eye irritation. NIOSH’s updated respirator testing by an OSHA standard, N100, R100, and
Three commenters argued that it was protocol in 42 CFR 84 eliminated the P100 filters can be used to replace
unnecessary to preclude the use of half need for HEPA filters (Ex. 9–22). them.’’ In addition, an Agency letter of
masks against eye irritants in the Similarly, a second commenter noted interpretation to Neoterik Health
Ethylene Oxide, Methylene Chloride, that HEPA filters were no longer listed Technologies, Inc. dated March 18, 1996
and Formaldehyde standards when in the NIOSH certification categories, concludes that, ‘‘when any OSHA
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employees wear appropriate eye and that OSHA should update the standard requires the use of HEPA
protection with half masks (Exs. 9–22, language in the Respiratory Protection filters[,] then the employer may satisfy
9–37, and 9–42). A fourth commenter Standard to be consistent with these
made a similar statement regarding categories (Ex. 10–59). A third 11 OSHA published this decision at 44 FR 5446

protection against eye irritants, but did commenter recommended that the (January 26, 1979).

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the requirement by choosing to use a shown by high airflow rates through the performance requirements. NIOSH does
P100, N100, or R100 filter certified filters) and exposure to an iron aerosol. not certify that they will perform any
under 42 CFR 84, since such filters The 3M Company claimed that under better than these criteria.’’
would exhibit minimum leakage.’’ these conditions, no significant Revising the existing respirator
Therefore, for over eight years, OSHA difference existed between P95 and selection requirements for HEPA filters,
has consistently equated HEPA filters to P100 particulate filters used by these or for filters certified by NIOSH as
the high-end filters certified by NIOSH employees with regard to the percentage N100, R100, and P100 under 42 CFR
under 42 CFR 84. of workplace iron penetration inside the part 84, is beyond the scope of the
OSHA believes that this definition is filter. In addition, they asserted that present rulemaking. Additionally, the
sufficient to meet the recommendations neither type of filter permitted any commenters did not provide any
of these commenters regarding the need detectable oil mist penetration (Ex. 18– evidence demonstrating that 95-level
to update the description of HEPA 7; Tr. at 397). filters would protect employees when
filters consistent with the NIOSH Later in the hearing, when asked used under the worst-case conditions
certification program, including the about the test conditions under which simulated during the NIOSH
need to provide the ‘‘clear generic NIOSH certifies filter efficiency, the 3M certification tests. However, from the
guidance’’ requested by one of the representative stated: evidence presented here, OSHA believes
commenters (Ex. 9–42). As noted by that NIOSH’s filter certification program
NIOSH’s testimony yesterday, which I
another commenter (Ex. 9–37), the agree with, is that they’ve got a worst case, provides a substantial margin of
definition of HEPA filters contained in or close to worst case, testing, and, as they’ve protection to employees who use
the Respiratory Protection Standard also stated, * * * they expect performance in the respirators. In addition, it is unclear
specifies the filtering criterion that these workplace to be better than that rating. * * * from the study discussed by these
filters must meet in terms of particulate So I believe that in the N95 filter[s], while commenters whether the results are
size. The definition recognizes that the you see a difference in their performance in applicable to the extreme range of
N100, R100, and P100 filters meet this the laboratory, when they’re used against exposure conditions used by NIOSH in
criterion, thereby updating the HEPA workplace aerosols, there is no difference.
(Tr. at 429.)
its filter certification testing.
definition as recommended by this Consequently, the Agency believes that
commenter. In his testimony the previous day, the adopting the recommendations made by
Contrary to the assertions made by NIOSH representative made the these commenters may enable
one of the commenters (Ex. 10–4), the following statement: employers to purchase respirators that
Agency is not breaching its earlier do not perform at the designated level
Well, NIOSH does not accept the premise
decision to permit the use of dust-mist- that efficiency levels for filters that we test of efficiency under extreme workplace
fume respirators (instead of respirators should be considered at higher efficiency exposure conditions, thereby
configured with HEPA filters) when levels. The approval program designates an jeopardizing seriously the health of their
employees are exposed to lead levels efficiency level for the filters, which is well employees. Absent data demonstrating
that are equal to or below 0.5 mg/m3. known to be tested with a near-worst case that 95-level filters perform effectively
Although this commenter mentioned aerosol. However, this is done so that every
workplace does not have to conduct sizing
under near worst-case experienced
that the decision covered N95
tests before they selected proper filters in the conditions, OSHA is retaining its
respirators as well, N95 respirators were
workplace. We think that this is a proper way existing HEPA filter requirements.
not even available in 1979 when the
to go, and we also do not think that assuming • Mixed-Versus Single-Substance
Agency published the decision and,
particle sizes and greater efficiencies on the Contaminants. Several commenters
therefore, were never part of the filters is a very wise approach for protecting recommended superseding the
decision. The remarks of the last workers. (Tr. at 121.)
commenter (Ex. 18–5) described special individualized canister/cartridge
testing conditions (using a heated DEHP The 3M Company also mentioned that change-out schedules in the substance-
aerosol challenge agent) that appeared another justification for substituting specific standards with the
to degrade specific types of filters. N95 filters for N100 filters is that performance-based provisions for
While this information may be of ‘‘increased breathing resistance caused developing change-out schedules
interest to NIOSH in determining the by use of a 100 filter may decrease described in OSHA’s Respiratory
efficacy of its filter certification overall respirator effectiveness by Protection Standard. Their rationale for
program, it is unclear how useful this reducing user comfort and thereby this recommendation is that schedules
information would be in selecting reducing the time the respirator is developed using the Respiratory
respirators for use in workplaces that worn’’ (Ex. 18–7). Protection Standard provisions are
vary substantially from these In its post-hearing comments, NIOSH capable of accommodating employee
specialized testing conditions. acknowledged, ‘‘It is possible that a exposure to multiple contaminants,
• Substituting N95 Filters for HEPA specific NIOSH certified 95-level filter while the schedules provided in the
Filters. A representative for the 3M may have filter penetration less than 5% substance-specific standards are limited
Company (3M) argued strongly that in a specific workplace. However, this to a single atmospheric contaminant.
OSHA should require only N95 type of workplace-specific result may For example, 3M noted that:
particulate filters for respirators, noting not be generalized to all 95-level filters [T]he benzene standard requires the
that OSHA based the existing in all workplace settings’’’ (Ex. 17–7–1). cartridges be changed before the beginning of
requirement to use HEPA filters under Later in these comments it stated, the next shift. In a refinery, workers may be
some exposure conditions on NIOSH’s ‘‘NIOSH has included rigorous exposed to benzene along with [toluene] and
outdated filter certification process certification tests to help assure that [x]ylene. The change schedule should be
specified in 30 CFR 11 (Tr. at 396). The filter performance in the workplace will based on the exposure to the mixture as
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required by 29 CFR 1910.134, not just the

3M Company then described a WPF be maintained at least at the benzene, because the mixture may result in
study conducted by Jensen et al. in a certification level even under severe requiring the cartridge to be changed sooner
steel foundry on employees who conditions,’’ and ‘‘the NIOSH than eight hours. By following the
performed a grinding operation certification criteria are designed to requirements of 134, a change schedule
involving a heavy work load (i.e., as assure that filters meet minimum would be established resulting in changing

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50182 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations

the cartridge before loss of service life, testimony, stating, ‘‘Calculations to available information in the revised
thereby, increasing worker protection. (Tr. at determine appropriate respirator add [a] substance-specific standards and the
396.) barrier to compliance * * *’’ (Ex. 9–29). Respiratory Protection Standard.
The International Safety Equipment A representative of the Insulators and • Upgrading Respirator Type at
Association and Thomas Nelson of Asbestos Workers International Employee Request. At the hearing, the
NIHS, Inc., made similar statements (Tr. (‘‘IAWI’’) found the tables to be BCTD representative mentioned that
at 518 and Ex. 18–9). In further invaluable as a teaching aid, and added several of the substance-specific
justification, 3M remarked that that: standards required employers to
‘‘[r]espirator program administrators I am asked by all types of people, upgrade respirators when requested to
may not be aware that the cartridge regulators, legislators, facility engineers, do so by employees. The representative
change schedules contained in the owners of companies, [and] consultants encouraged the Agency to include such
substance specific [standards] may not where to find the information [about APFs]. a requirement in current and future
be protective if multiple contaminants I just tell them [to] look in the tables. * * * substance-specific standards (Tr. at
are present’’ (Ex. 18–7). The common worker knows where to find 616). The IAWI representative
These comments are a variation of the this. It is where it should be. There are no
OSHA libraries on the job sites. * * * I am
comments cited earlier in this section asked by a lot of people in charge of sites [S]ome of our members, for a variety of
that recommended removing the where these [APFs] are in writing. If it is reasons, like working in PAPRs. * * * Some
change-out schedules specified for taken out of the rules, if it is not written, it people work in them, feel comfortable in
substance-specific standards and will not be adhered to. (Tr. at 623.) them. They want them. And it makes them
replacing them with the provisions of 29 However, this representative later more at ease at doing their work. * * * It
CFR 1910.134 governing change-out makes the person more productive, cools
admitted that ‘‘[e]very one of our them down; there’s a variety of reasons. (Tr.
schedules. This recommendation supervisors gets a copy of an updated
involves a major revision to these at 648.)
[construction] standard,’’ and ‘‘[h]e gets
standards, and, therefore, is beyond the the 1910.134 [i.e., the Respiratory When asked how often employers
scope of this rulemaking. However, such Protection Standard]’’ (Tr. at 645.) upgrade respirators when doing so is
a revision likely is unnecessary because Similarly, another commenter remarked discretionary, this representative
change-out schedules involving that ‘‘[e]mployers covered by replied, ‘‘I wouldn’t say it’s 100 percent.
multiple-contaminant exposures would [substance-]specific standards are I’d say a portion of them would allow
not be covered under the substance- already required to refer to 29 CFR somebody that activity’’ (Tr. at 649).
specific standards. Instead, employers 1910.134 for most respirator program Placing a burden on employers to
must develop these change-out elements including fit testing, upgrade respirators at an employee’s
schedules for air-purifying respirators inspection and cleaning, and program request is beyond the scope of this
not equipped with an end-of-service-life evaluation,’’ and that ‘‘[i]f some rulemaking. However, the Agency
indicator according to the requirements employers would not bother to consult recognizes the advantages, as well as
of the Respiratory Protection Standard, 29 CFR 1910.134 for APFs, these same disadvantages, to upgrading a respirator
notably paragraph (d)(3)(iii)(B)(2). employers are most likely not at an employee’s request. As it stated in
• Retaining APF Tables for Lead and the preamble to the Respiratory
complying with other necessary
Asbestos. Several unions requested that Protection Standard with regard to
program elements’’(Ex. 18–7).
OSHA retain the revised APF tables in The Agency believes that employers PAPRs:
the construction standards for lead and know they are required to use the OSHA continues to believe that under
asbestos. During the hearing, a Respiratory Protection Standard. some circumstances PAPRs provide superior
representative from the Building Retaining the APF tables in the acceptability. These include situations where
Construction Trades Department of the construction standards for lead and employees wear respirators for full shifts,
AFL–CIO (BCTD) stated that union- asbestos is unlikely to result in any where employees frequently readjust their
management training centers ‘‘conduct a negative pressure respirators to achieve what
savings or convenience to employers or they consider a more comfortable or tighter
great deal of worker training on lead and other parties because these tables cannot
asbestos,’’ and that ‘‘these tables * * * fit, and where the air flow provided by a
be used safely and effectively without PAPR reduces the employee’s psychological
greatly facilitate the understanding of consulting the requirements of 29 CFR and physiological discomfort. However,
appropriate respirator selection’’ (Tr. at 1910.134. Even one of the union where ambient temperatures are extremely
615). This representative stated further: representatives recognized this high or low, PAPRs are often unacceptable
It is much more usable for these parties to necessity when stating that supervisors because of the temperature of the airstream
go directly to the substance-specific standard must have access to both the in the facepiece. * * * (63 FR 1201.)
with the air-monitoring results and choose construction standards and the
the appropriate type of respirator. If
OSHA noted further, ‘‘The Agency
Respiratory Protection Standard at the continues to believe that it is good
employers had to do calculations to
determine the appropriate type of respirator job site (Tr. at 646). In addition, OSHA industrial hygiene practice to provide a
to select, that is simply an added barrier to believes that any respirator selection respirator that the employee considers
compliance. Additionally, the tables are of requirements that are unique to a acceptable’’ (63 FR 1201). Therefore,
great help when communicating the need for substance-specific standard (i.e., not employers are free to upgrade
respirators to employers who may not subsumed by this rulemaking under the respirators voluntarily at an employee’s
normally be engaged in lead and asbestos Respirator Protection Standard) will request when the employee meets the
work. (Tr. at 615.) remain available for easy access under medical qualifications for using the
The BCTD representative later noted the particular standard. In this regard, respirator and receives the necessary
that ‘‘[i]t’s the idea of jumping from [the the Agency concludes that it is training.
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respiratory protection] standard to [the unnecessary to retain the APF tables for
lead/asbestos construction] standard, the lead and asbestos standards in the 5. Summary of Superseding Actions
that’s why we don’t want the table construction standards because the The following table summarizes final
[removed]’’ (Tr. at 647). The BCTD post- required APF tables can be assembled revisions to the existing respirator
hearing comments expanded on this readily for training purposes from the selection provisions of OSHA’s

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Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Rules and Regulations 50183

substance-specific standards. Section plain-language regulatory text of these

VIII (‘‘Amendments to Standards’’) of final revisions.
this rulemaking notice provides the full,


Existing provisions Final action

29 CFR 1910.1001(g)(2)(ii) ....................................................................... Revise.

.1001(g)(3) ................................................................................................ Remove Table 1 and revise.
.1001(l)(3)(ii) .............................................................................................. Redesignate Table 2 as Table 1.
.1017(g)(3)(i) ............................................................................................. Remove table and revise.
.1017(g)(3)(iii) ............................................................................................ Remove.
.1018 (Tables I and II) .............................................................................. Remove.
.1018(h)(3)(i) ............................................................................................. Revise.
.1018(h)(3)(ii) ............................................................................................ Remove.
.1018(h)(3)(iii) ............................................................................................ Redesignate as .1018 (h)(3)(ii).
.1025(f)(2)(ii) ............................................................................................. Remove Table II.
.1025(f)(3)(i) .............................................................................................. Revise.
.1027(g)(3)(i) ............................................................................................. Remove Table 2 and revise.
.1028(g)(3)(ii) ............................................................................................ Remove Table 1.
.1028(g)(2)(i) ............................................................................................. Revise.
.1028(g)(3)(i) ............................................................................................. Revise.
.1029(g)(3) ................................................................................................ Remove Table I and revise.
.1043(f)(3)(i) .............................................................................................. Remove Table I and revise.
.1043(f)(3)(ii) ............................................................................................. Revise.
.1044(h)(3) ................................................................................................ Remove Table 1 and revise.
.1045(h)(2)(i) ............................................................................................. Revise.
.1045(h)(3) ................................................................................................ Remove Table I and revise.
.1047(g)(3) ................................................................................................ Remove Table 1 and revise.
.1048(g)(2) ................................................................................................ Revise.
.1048(g)(3) ................................................................................................ Remove Table 1 and revise.
.1050(h)(3)(i) ............................................................................................. Remove Table 1 and revise.
.1052(g)(3) ................................................................................................ Remove Table 2 and revise.
29 CFR 1915.1001(h)(2)(i) through (h)(2)(v) ............................................ Remove Table 1 and revise.
29 CFR 1926.60(i)(3)(i) ............................................................................. Remove Table 1 and revise.
.62 (f)(3)(i) ................................................................................................. Remove Table 1 and revise.
.1101(h)(3)(i) through (h)(3)(iv) ................................................................. Remove Table 1 and revise.
.1127(g)(3)(i) ............................................................................................. Remove Table 1 and revise.

6. Use of Plain Language uniformity and comprehensibility of language provisions did not alter the
these provisions. These improvements substantive requirements of the existing
In the proposal, OSHA rewrote into will, in turn, enhance employer provisions. (The following table lists the
plain language the respirator-selection compliance with the provisions and, plain-language provisions in the final
provisions of the substance-specific concomitantly, increase the protection rule and the corresponding provisions
standards retained in this final rule. The afforded to employees. The Agency also in the existing standards.) Therefore,
Agency received no comments on these found that rewriting the respirator- OSHA is retaining these plain-language
proposed revisions. OSHA believes that selection provisions of the existing revisions in the final rule.
using plain language will improve the substance-specific standards into plain-

Plain-language provisions Existing provisions

§ 1910.1001(g)(2)(ii) .................................................................................. § 1910.1001(g)(2)(ii).

§ 1910.1001(g)(3)(i) ................................................................................... § 1910.1001(g)(3); Table 1.
§ 1910.1001(g)(3)(ii) .................................................................................. § 1910.1001(g)(3); Table 1.
§ 1910.1017(g)(3)(i)(B) .............................................................................. § 1910.1017(g)(3)(i); undesignated table.
§ 1910.1017(g)(3)(i)(C) .............................................................................. § 1910.1017(g)(3)(i); undesignated table.
§ 1910.1018(h)(3)(i)(B) .............................................................................. § 1910.1018(h)(3)(i); Table II (footnote 2).
§ 1910.1018(h)(3)(i)(C) .............................................................................. § 1910.1018(h)(3)(i); Table I and Table II.
§ 1910.1018(h)(3)(i)(D)(1) ......................................................................... § 1910.1018(h)(3)(ii).
§ 1910.1018(h)(3)(i)(D)(2) ......................................................................... § 1910.1018(h)(3)(i); Table II.
§ 1910.1025(f)(3)(i)(B) ............................................................................... § 1910.1025(f)(3)(i); Table II (footnote 2).
§ 1910.1025(f)(3)(i)(C) ............................................................................... § 1910.1025(f)(3)(i); Table II.
§ 1910.1025(f)(3)(ii) ................................................................................... § 1910.1025(f)(3)(ii).
§ 1910.1027(g)(3)(i)(B) .............................................................................. § 1910.1027(g)(3)(i)(B); Table 2 (footnote b).
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§ 1910.1027(g)(3)(i)(C) .............................................................................. § 1910.1027(g)(3)(i)(B); Table 2.

§ 1910.1028(g)(3)(i)(B) .............................................................................. § 1910.1028(g)(3)(i); Table 1.
§ 1910.1028(g)(3)(i)(C) .............................................................................. § 1910.1028(g)(3)(i); Table 1.
§ 1910.1028(g)(3)(i)(D) ......................................................................