Friday, June 6, 2003

Part II

Department of Labor Occupational Safety and Health Administration

29 CFR Parts 1910, 1915, and 1926 Assigned Protection Factors; Proposed Rule

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DEPARTMENT OF LABOR the discretion of the presiding Hearing testimony and documentary administrative law judge. If an evidence. Interested parties who will be Occupational Safety and Health additional hearing is held, the Agency requesting more than 10 minutes to Administration will announce the date, time, and present their testimony, or who will be location of this hearing later in the submitting documentary evidence at the 29 CFR Parts 1910, 1915, and 1926 subsequent Federal Register notice. informal public hearing must mail three [Docket No. H049C] Notice of intention to appear to copies of the testimony and the provide testimony at the informal public documentary evidence to the Docket RIN 1218–AA05 hearing. Interested parties who intend Office, Docket No. H049C, Room N– to present testimony at the informal 2625, OSHA, U.S. Department of Labor, Assigned Protection Factors public hearing in Washington, DC, must 200 Constitution Avenue, NW., AGENCY: Occupational Safety and Health notify OSHA of their intention to do so Washington DC 20210. Additional Administration (OSHA), Department of no later than September 4, 2003. information for submitting testimony Labor. Hearing testimony and documentary and evidence is found under ACTION: Proposed rule; request for evidence. Interested parties who will be SUPPLEMENTARY INFORMATION. comments and scheduling of informal requesting more than 10 minutes to FOR FURTHER INFORMATION CONTACT: For public hearings. present their testimony, or who will be technical inquiries, contact Mr. John E. submitting documentary evidence at the Steelnack, Directorate of Standards and SUMMARY: OSHA is proposing to revise hearing, must provide the Agency with Guidance, Room N–3718, OSHA, U.S. its existing Respiratory Protection copies of their full testimony and all Department of Labor, 200 Constitution Standard to add definitions and specific documentary evidence they plan to Ave., NW., Washington, DC 20210; requirements for assigned protection present by September 4, 2003. telephone (202) 693–2289 or fax (202) factors (APFs) and maximum use ADDRESSES: Written comments. You may 693–1678. For hearing information concentrations (MUCs). The proposed submit three copies of written contact Ms. Veneta Chatmon, OSHA revisions also would supersede the comments to the Docket Office, Docket Office of Information, Docket No. H– respirator selection provisions of No. H049C, Technical Data Center, 49C, Room N–3649, U.S. Department of existing substance-specific standards Room N–2625, OSHA, U.S. Department Labor, 200 Constitution Ave., NW., with these new APFs (except the APFs of Labor, 200 Constitution Ave., NW., Washington, DC 20210 (telephone (202) for the 1,3-Butadiene Standard). Washington, DC 20210; telephone (202) 693–1999). For additional copies of this The Agency developed the proposed 693–2350. If your written comments are Federal Register notice, contact the APFs after thoroughly reviewing the 10 pages or fewer, you may fax them to Office of Publications, Room N–3103, available literature, including chamber the OSHA Docket Office, telephone OSHA, U.S. Department of Labor, 200 simulation studies and workplace number (202) 693–1648. You do not Constitution Ave., NW., Washington, protection factor studies. The proposed have to send OSHA a hard copy of your DC 20210 (telephone (202) 693–1888). APFs would provide employers with faxed comments. You may submit Electronic copies of this Federal critical information to use when comments electronically through Register notice, as well as news releases selecting respirators for employees OSHA’s Home page at http:// and other relevant documents, are exposed to atmospheric contaminants ecomments.osha.gov/. If you would like available at OSHA’s Home page at found in general industry, construction, to submit additional studies or journal http://www.osha.gov. shipyard, longshoring, and marine articles, you must submit three copies of SUPPLEMENTARY INFORMATION: terminal workplaces. Proper respirator them to the OSHA Docket Office at the selection using APFs is an important address above. These materials must OMB Review Under the Paperwork component of an effective respirator clearly identify your electronic Reduction Act protection program. Accordingly, OSHA comments by name, date, subject, and After a thorough analysis of the has made a preliminary conclusion that docket number so we can attach them to proposed provisions, OSHA believes the proposed APFs are necessary to your comments. that these provisions would not add to protect employees who use respirators Informal public hearings. The the existing collection-of-information against atmospheric contaminants. informal public hearing to be held in (i.e., paperwork) requirements regarding DATES: Written comments. The Agency Washington, DC will be located in the respirator selection. OSHA determined invites interested parties to submit Auditorium on the plaza level of the that its existing Respiratory Protection written comments regarding the Frances Perkins Building, U.S. Standard at 29 CFR 1910.134 has two proposed rule, including comments to Department of Labor, 200 Constitution provisions that involve APFs and also the information-collection Ave., NW., Washington, DC. impose paperwork requirements on determination under the Supplementary Notice of intention to appear to employers. These provisions require Information section of this Federal provide testimony at the informal public employers to: Include respirator Register notice, by mail, facsimile, or hearing. Notices of intention to appear selection in their written respiratory electronically. You must send all at the informal public hearing should be protection program (29 CFR comments, whether submitted by mail, submitted in triplicate to the Docket 1910.134(c)(1)(i)); and inform facsimile, or electronically through Office, Docket No. H049C, Room N– employees regarding proper respirator OSHA’s Web site, by September 4, 2003. 2625, OSHA, U.S. Department of Labor, selection (29 CFR 1910.(k)(ii)). The Informal public hearings. The Agency 200 Constitution Avenue, NW., information on respirator selection plans to hold an informal public hearing Washington, DC 20210. Notices may addressed by these two provisions must in Washington, DC in late summer or also be faxed to the Docket Office at include a brief discussion of the early fall of 2003. OSHA expects the DC (202) 693–1648 or submitted purpose of APFs, and how to use them hearing to last from 9:30 a.m. to 5:30 electronically at http:// in selecting a respirator that affords an p.m. on the first day, and from 8:30 a.m. ecomments.osha.gov. OSHA Docket employee protection from airborne to 5:30 p.m. on subsequent days; Office and Department of Labor hours of contaminants. The burden imposed by however, the exact daily schedule is at operation are 8:15 a.m. to 4:45 p.m. this requirement remains the same

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whether employers currently use the Federalism employees from the risks of exposure to APFs published in the 1987 NIOSH RDL The Agency reviewed the proposed airborne contaminants. However, while or the ANSI Z88.2–1992 Respiratory APF provisions according to the most OSHA drafted the proposed APF and Protection Standard, or implement the recent Executive Order on Federalism MUC requirements to protect employees APFs proposed in this rulemaking. (Executive Order 13132, 64 FR 43225, in every state, section 18(c)(2) of the Act Therefore, the proposed use of APFs in August 10, 1999). This Executive Order permits state-plan states to develop their the context of these two existing requires that federal agencies, to the own requirements to deal with any respirator-selection provisions does not extent possible, refrain from limiting special workplace problems or require an additional paperwork-burden state policy options, consult with states conditions, provided these requirements determination because OSHA already before taking actions that restrict their are at least as effective as the final accounted for this burden under its policy options, and take such actions requirements that result from this existing Respiratory Protection Standard only when clear constitutional authority proposal. (see 63 FR 1152–1154; OMB Control exists and the problem is of national State Plans Number 1218–0099). scope. The Executive Order allows Both OSHA’s existing Respiratory The 26 states and territories with their federal agencies to preempt state law Protection Standard and the proposed own OSHA-approved occupational APF provisions require employers to only with the expressed consent of safety and health plans must adopt use APFs as part of the respirator- Congress; in such cases, federal agencies comparable provisions within six selection process. This process includes must limit preemption of state law to months after the Agency publishes the obtaining information about the the extent possible. final APF and MUC requirements. These Under section 18 of the Occupational workplace exposure level to an airborne states and territories are: Alaska, Safety and Health Act (the ‘‘Act’’ or contaminant, identifying the exposure Arizona, California, Hawaii, Indiana, ‘‘OSH Act’’), Congress expressly limit (e.g., permissible exposure limit) Iowa, Kentucky, Maryland, Michigan, for the contaminant, using this provides OSHA with authority to Minnesota, Nevada, New Mexico, North information to calculate the required preempt state occupational safety and Carolina, Oregon, Puerto Rico, South level of protection (i.e., the APF), and health standards to the extent that the Carolina, Tennessee, Utah, Vermont, referring to an APF table to determine Agency promulgates a federal standard Virginia, Virgin Islands, Washington, which respirator to select. Admittedly, under section 6 of the Act. Accordingly, and Wyoming. Connecticut, New Jersey this process involves the collection and section 18 of the Act authorizes the and New York have OSHA approved use of information, but it does not Agency to preempt state promulgation State Plans that apply to state and local require employers to inform others, and enforcement of requirements government employees only. Until a either orally or in writing, about the dealing with occupational safety and state-plan state promulgates its own process they use to select respirators for health issues covered by OSHA comparable provisions, Federal OSHA individual employees, or the outcomes standards unless the state has an OSHA- will provide the state with interim of this process; by not requiring approved occupational safety and health enforcement assistance, as appropriate. plan (i.e., is a state-plan state) [see Gade employers to communicate this Unfunded Mandates information to others, OSHA removed v. National Solid Wastes Management this process from the ambit of the Association, 112 S. Ct. 2374 (1992)]. The Agency reviewed the proposed Paperwork Reduction Act of 1995 Therefore, with respect to states that do APF and MUC provisions according to (PRA–95) (44 U.S.C. 3506(c)(2)(A)). In not have OSHA-approved plans, the the Unfunded Mandates Reform Act of the alternative, even if PRA–95 applies, Agency concludes that this proposal 1995 (UMRA) (2 U.S.C. 1501 et seq.) and the proposal involves the same conforms to the preemption provisions Executive Order 12875. As discussed in information-collection and -use of the Act. Additionally, section 18 of section VI (‘‘Summary of the requirements with regard to APFs as the the Act prohibits states without Preliminary Economic Analysis and existing standard (see paragraphs (d)(1) approved plans from issuing citations Initial Regulatory Flexibility Analysis’’) and (d)(3)(i) of 29 CFR 1910.134, and for violations of OSHA standards; the of this preamble, OSHA estimates that the rationale for the existing APF Agency finds that the proposed compliance with this proposal would requirements in the preamble to the rulemaking does not expand this require private-sector employers to final Respiratory Protection Standard, limitation. expend about $4.5 million each year. 63 FR 1163 and 1203–1204); OSHA asserts that it has authority However, while this proposal accordingly, the paperwork burden under Executive Order 13132 to propose establishes a federal mandate in the imposed by the proposal would be APF requirements because the problems private sector, it is not a significant equivalent to the burden already addressed by these requirements are regulatory action within the meaning of imposed under the existing standard. national in scope. As noted in section VI section 202 of the UMRA (2 U.S.C. Interested parties who want to (‘‘Summary of the Preliminary 1532). comment on OSHA’s determination that Economic Analysis and Initial OSHA standards do not apply to state the proposed provisions contain no Regulatory Flexibility Analysis’’) of this and local governments, except in states additional paperwork burden compared preamble, hundreds of thousands of that have voluntarily elected to adopt an to the existing paperwork requirements employers must select appropriate OSHA-approved state occupational must send their written comments to the respirators for millions of employees. safety and health plan. Consequently, Office of Information and Regulatory These employees are exposed to many the proposed provisions do not meet the Affairs, Attn: OMB Desk Officer for different types and levels of airborne definition of a ‘‘Federal OSHA, Office of Management and contaminants found in general industry, intergovernmental mandate’’ [see Budget, Room 10235, 725 17th Street construction, shipyard, longshoring, and section 421(5) of the UMRA (2 U.S.C. NW., Washington, DC 20503. The marine terminal workplaces. 658(5)]. Therefore, based on a review of Agency also encourages commenters to Accordingly, the proposed requirements the rulemaking record to date, the submit their comments on this would provide employers in every state Agency believes that few, if any, of the paperwork determination to OSHA with critical information to use when affected employers are state, local, and along with their other comments. selecting respirators to protect their tribal governments. Therefore, the

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proposed APF requirements do not extent to which the respirators provide State Plans impose unfunded mandates on state, them with adequate protection. Based Unfunded Mandates local, and tribal governments. on this discussion, OSHA believes that Protecting Children from Environmental the APF and MUC requirements Health and Safety Risks Protecting Children From Applicability of Existing Consensus proposed in this rulemaking do not Environmental Health and Safety Risks Standards constitute a covered regulatory action as Environmental Impact Assessment Executive Order 13045 requires that defined by Executive Order 13045. I. General Federal agencies submitting covered Table of contents regulatory actions to OMB’s Office of Applicability of Existing Consensus Glossary Information and Regulatory Affairs Standards II. Pertinent Legal Authority (OIRA) for review pursuant to Executive Section 6(b)(8) of the OSH Act III. Events Leading to the Proposed Standard Order 12866 must provide OIRA with requires OSHA to explain ‘‘why a rule A. Regulatory History (1) an evaluation of the environmental B. Need for Assigned Protection Factors promulgated by the Secretary differs C. Review of the Proposed Standard by the health or safety effects that the planned substantially from an existing national Advisory Committee for Construction regulation may have on children, and consensus standard,’’ by publishing ‘‘a Safety and Health (ACCSH) (2) an explanation of why the planned statement of the reasons why the rule as IV. Methodology for Developing Assigned regulation is preferable to other adopted will better effectuate the Protection Factors potentially effective and reasonably purposes of the Act than the national A. Dr. Nicas’ Proposal and Response from feasible alternatives considered by the consensus standard.’’ [see 29 U.S.C. Commenters agency. Executive Order 13045 defines 655(b)(8)]. Accordingly, the Agency B. Analyses of WPF Studies ‘‘covered regulatory actions’’ as rules C. Analyses of SWPF Studies compared the proposed APF D. OSHA’s Overall Summary Conclusions that may (1) be economically significant requirements with the APF provisions E. Summaries of Studies under Executive Order 12866 (i.e., a of ANSI Z88.2–1992 (‘‘Respiratory V. Health Effects rulemaking that has an annual affect on Protection’’). This consensus standard, VI. Summary of the Preliminary Economic the economy of $100 million or more, or published by the American National Analysis and Initial Regulatory would adversely affect in a material way Standards Institute in 1992, is the only Flexibility Screening Analysis the economy, a sector of the economy, publicly available consensus standard VII. Summary and Explanation of the Proposed Standard productivity, competition, jobs, the that includes APFs. In most instances, environment, public health or safety, or A. Revisions to the Respiratory Protection the APFs being proposed by the Agency Standard state, local, or tribal governments or are identical to ANSI’s APFs, however, B. Superseding the Respirator Selection communities), and (2) concern an some differences exist. Where OSHA Provisions of Substance-Specific environmental health risk or safety risk has proposed an APF that differs from Standards in Parts 1910, 1915, and 1926 that an agency has reason to believe may ANSI’s, the Summary and Explanation VIII. Issues disproportionately affect children. In provides the basis for that decision. IX. Public Participation—Comments and this context, the term ‘‘environmental Hearings health risks and safety risks’’ means Environmental Impact Assessment X. Proposed Amendments to Standards risks to health or safety that are The Agency reviewed the proposed Glossary attributable to products or substances provisions according to the National that children are likely to come in This glossary specifies the terms Environmental Policy Act (NEPA) of represented by acronyms, and provides contact with or ingest (e.g., through air, 1969 (42 U.S.C. 4321 et seq.), the food, water, soil, product use). definitions of other terms, used regulations of the Council of frequently in this proposal. This The proposed provisions are not Environmental Quality (40 CFR part economically significant under glossary does not change the legal 1500), and the Department of Labor’s requirements as proposed in this notice Executive Order 12866 (see section VI NEPA procedures (29 CFR part 11). (‘‘Summary of the Preliminary of proposed rulemaking, nor is it OSHA estimates that this proposed rule intended to propose new regulatory Economic Analysis and Initial would have a direct impact on a Regulatory Flexibility Analysis’’) of this requirements or definitions. It is relatively small number of respirator presented simply to assist the reader. preamble). In addition, after reviewing users and, in so doing , merely alter the the proposed APF provisions, OSHA type of respirator they are using. The A. Acronyms has determined that these provisions do Agency does not anticipate that this will ACGIH: American Conference of not impose environmental health or significantly alter solid waste patterns, safety risks to children as set forth in Governmental Industrial Hygienists. water quality, or ambient air quality. As AIHA: American Industrial Hygiene Executive Order 13045. The proposed a result of this review, OSHA concludes Association. provisions would require employers to that the proposed provisions would ANSI: American National Standards use APFs in selecting proper respirators have no significant environmental Institute. for employee use, with the objective of impact. APF: Assigned Protection Factor (see limiting employee exposures to airborne definition in proposed regulatory I. General contaminants. To the best of OSHA’s text). knowledge, no employees under 18 Table of Contents DOP: Dioctylphthalate (an aerosolized years of age work under conditions that agent used for quantitative fit The following Table of Contents identifies require respirator use. However, if such testing). conditions exist, children who use the major preamble sections of this proposal and the order in which they are presented: DFM: Dust/Fume/Mist filter. respirators selected according to these EPF: Effective Protection Factor (see Introductory Material proposed provisions would receive definition below under ‘‘Protection adequate protection from the airborne Notice and Comment Dates for Hearings factor study’’). contaminants. In this regard, the Agency Supplementary Information HEPA: High efficiency particulate air is requesting public comment on OMB Review Under the Paperwork [filter] (see definition below). whether employees under the age of 18 Reduction Act IDLH: Immediately dangerous to life or years use respirators, and, if they do, the Federalism health (see definition below).

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

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sampling is performed while the subject reasoned justification for departing from standards must also meet the performs a series of set exercises. The prior Agency action, and supported by ‘‘feasibility mandate’’ of section 6(b)(5) laboratory setting is used to control substantial evidence; it must also of the OSH Act, 29 U.S.C. 655(b)(5). many of the variables found in effectuate the Act’s purposes better than Section 6(b)(5) of the Act requires workplace studies, while the exercises any national consensus standard it OSHA to select ‘‘the most protective simulate the work activities of respirator supersedes [see International Union, standard consistent with feasibility’’ users. This type of study is designed to UAW v. OSHA (LOTO II), 37 F.3d 665 needed to reduce significant risk when determine the optimum performance of (DC Cir. 1994; and 58 FR 16612–16616 regulating health hazards [see Cotton respirators by reducing the impact of (March 30, 1993)]. Dust, 452 U.S. at 509]. Section 6(b)(5) sources of variability through OSHA has discussed the nature of also directs OSHA to base health maintenance of tightly controlled study adverse health effects caused by standards on ‘‘the best available conditions. exposure to airborne chemical hazards evidence,’’ including research, Qualitative fit test*: A pass/fail fit test many times in previous rulemaking demonstrations, and experiments [see to assess the adequacy of respirator fit activities [see, for example, the 29 U.S.C. 655(b)(5)]. In this regard, that relies on the individual’s response preambles to any of OSHA’s substance- OSHA must consider ‘‘in addition to the to the test agent. specific standards codified in 29 CFR attainment of the highest degree of Quantitative fit test*: An assessment 1910.1001 to 1910.1052]. As discussed health and safety protection * * * the of the adequacy of respirator fit by in the Significance of Risk section of the latest scientific data * * * feasibility numerically measuring the amount of Respiratory Protection Standard, the and experience gained under this and leakage into the respirator. health risk presented to workers can be other health and safety laws.’’ (Id.). Self-contained breathing apparatus*: represented by the risk that a respirator Furthermore, section 6(b)(5) of the Act An atmosphere-supplying respirator for will not be properly selected or used, specifies that standards must ‘‘be which the breathing air source is which increases the possibility that the expressed in terms of objective criteria designed to be carried by the user. user will be overexposed to a harmful and of the performance desired’’ [see 29 Supplied-air respirator (or airline) air contaminant. The risks that are U.S.C. 655(b)(7)]. respirator*: An atmosphere-supplying addressed by the Respiratory Protection The proposed APF and MUC respirator for which the source of Standard are not characterized as provisions are integral components of breathing air is not designed to be illness-specific risks but, instead, relate an effective respiratory protection carried by the user. to a more general probability that when Tight-fitting facepiece*: A respiratory a respirator provides insufficient program. Respiratory protection is a inlet covering that forms a complete seal protection, the wearer may be exposed supplemental method used by with the face. to a level of air contaminant that is employers to protect employees against airborne contaminants in workplaces II. Pertinent Legal Authority associated with material impairment of the worker’s health. where feasible engineering controls and The purpose of the Occupational The Agency believes that a standard work practices are not available, have Safety and Health Act, 29 U.S.C. 651 et is technologically feasible when the not yet been implemented, or are not in seq. (the ‘‘OSHA Act’’ or ‘‘Act’’) is to protective measures it requires already themselves sufficient to protect ‘‘assure so far as possible every working exist, can be brought into existence with employee health. Employers also use man and woman in the Nation safe and available technology, or can be created respiratory protection under emergency healthful working conditions and to with technology that can reasonably be conditions involving the accidental preserve our human resources.’’ [29 expected to be developed [see American release of airborne contaminants. The U.S.C. 651(b)]. To achieve this goal, Textile Mfrs. Institute v. OSHA (Cotton proposed amendments to OSHA’s Congress authorized the Secretary of Dust), 452 U.S. 490, 513 (1981); Respiratory Protection Standard, and Labor to promulgate and enforce American Iron and Steel Institute v. the Agency’s substance-specific occupational safety and health OSHA (Lead II), 939 F.2d 975, 980 (DC standards, would provide employers standards [see 29 U.S.C. 654(b) Cir. 1991)]. A standard is economically with critical information to use when (requiring employers to comply with feasible when industry can absorb or selecting respirators for employees OSHA standards), 29 U.S.C. 655(a) pass on the costs of compliance without exposed to airborne contaminants found (authorizing summary adoption of threatening the industry’s long-term in general industry, construction, existing consensus and federal profitability or competitive structure shipyard, longshoring, and marine standards within two years of the Act’s [see Cotton Dust, 452 U.S. at 530 n. 55; terminal workplaces. Since it is enactment), and 29 U.S.C. 655(b) Lead II, 939 F.2d at 980], and a standard generally recognized that different types (authorizing promulgation of standards is cost effective when the protective of respiratory protective equipment pursuant to notice and comment)]. measures it requires are the least costly provide different degrees of protection A safety or health standard is a of the available alternatives that achieve against hazardous exposures, proper standard ‘‘which requires conditions, or the same level of protection [see Cotton respirator selection is of critical the adoption or use of one or more Dust, 453 U.S. at 514 n. 32; importance. The proposed APF and practices, means, methods, operations, International Union, UAW v. OSHA MUC provisions provide additional or processes, reasonably necessary or (LOTO III), 37 F.3d 665, 668 (DC Cir. guidance on the point at which an appropriate to provide safe or healthful 1994)]. increase in the level of respiratory employment or places of employment.’’ All standards must be highly protection is necessary. The APF and [29 U.S.C. 652(8)]. A standard is protective [see 58 FR 16612, 16614–15 MUC provisions will greatly enhance an reasonably necessary or appropriate (March 30, 1993); LOTO III, 37 F.3d at employer’s ability to select a respirator within the meaning of section 652(8) of 669]. Accordingly, section 8(g)(2) of the that will adequately protect employees. the Act when it substantially reduces or Act authorizes OSHA ‘‘to prescribe such OSHA believes that in the absence of eliminates significant risk, and is rules and regulations as [it] may deem these proposed provisions, employers technologically and economically necessary to carry out its will be less certain about which feasible, cost effective, consistent with responsibilities under the Act’’ [see 29 respirators to select for adequate prior Agency action or supported by a U.S.C. 657(g)(2)]. However, health employee protection.

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The Agency also developed the 29 CFR 1918.102, February 20, 1960 (25 for including a table of protection proposed provisions to be feasible and FR 1565). OSHA incorporated 29 CFR factors (Ex. 15). cost effective, and is specifying them in 1910.134 by reference into its Marine On September 17, 1985, OSHA terms of objective criteria and the level Terminal standards (Part 1917) on July announced the availability of a of performance desired. In this regard, 5, 1983 (48 FR 30909). The Agency preliminary draft of the proposed section VI (‘‘Summary of the updated and strengthened its Respiratory Protection Standard. This Preliminary Economic Analysis and Longshoring and Marine Terminal preproposal draft standard included the Initial Regulatory Flexibility Analysis’’) standards in 1996 and 2000, and these public comments received in response of this preamble provides the benefits standards now incorporate 29 CFR to 1982 ANPR, and OSHA’s own and costs of this proposal, and describes 1910.134 by reference. analysis of revisions needed in the several other alternatives as required by Under the Respiratory Protection Respiratory Protection Standard to section 205 of the UMRA (2 U.S.C. Standard that OSHA initially adopted, account for state-of-the-art respiratory 1535). Based on this information, OSHA employers needed to follow the protection. The Agency received 56 preliminarily concludes that the guidance of the Z88.2–1969 ANSI responses from interested parties (Ex. proposed APF and MUC provisions standard to ensure proper selection of 36) which OSHA carefully reviewed in constitute the most cost-effective respirators. Subsequently, OSHA developing the proposal. alternative for meeting its statutory published an Advance Notice of On November 15, 1994, OSHA objective of reducing risk of adverse Proposed Rulemaking (‘‘ANPR’’) to published the proposed rule to revise 29 health effects to the extent feasible. revise the Respiratory Protection CFR 1910.134, and provided public notice of an informal public hearing on III. Events Leading to the Proposed Standard on May 14, 1982 (47 FR 20803). Part of the impetus for this the proposal (59 FR 58884). The Agency Standard convened the informal public hearing notice was the Agency’s inclusion of on June 6, 1995. On June 15, 1995, as A. Regulatory History new respirator requirements in the part of the public hearing, OSHA held comprehensive substance-specific Congress created the Occupational a one-day panel discussion by respirator standards promulgated under Section Safety and Health Administration experts of APFs. Areas discussed (6)(b) of the OSH Act, e.g., fit testing (OSHA) in 1970, and gave it the included difficulties in measuring protocols, respirator selection tables, responsibility for promulgating performance of respiratory protection in use of PAPRs, changing filter elements standards to protect the health and WPF and SWPF studies, statistical whenever an employee detected an safety of American workers. As directed uncertainties regarding the distribution increase in breathing resistance, and by the OSH Act, the Agency adopted of data from these studies, and the existing Federal standards and national requirements referring employees with problems associated with setting APFs consensus standards developed by breathing difficulties to a physician for all respirators that protect all various organizations such as the trained in pulmonary medicine, either potential respirator users across a wide American Conference of Governmental at fit testing or during routine respirator variety of workplaces and exposure Industrial Hygienists (ACGIH), the use [see, e.g, 29 CFR 1910.1025 (OSHA’s conditions. National Fire Protection Association Lead Standard)]. The respirator OSHA reopened the rulemaking (NFPA), and the American National provisions in these substance-specific record for the revised Respiratory Standards Institute (ANSI). The ANSI standards took into account advances in Protection Standard on November 7, standard Z88.2–1969, ‘‘Practices for respirator technology and changes in 1995 (60 FR 56127), requesting Respiratory Protection,’’ was the basis of related guidance documents that were comments on a study performed for the first six sections (permissible state-of-the-art when OSHA published OSHA by Dr. Mark Nicas titled ‘‘The practice, minimal respirator program, these substance specific standards and, Analysis of Workplace Protection Factor selection of respirators, air quality, use, in particular, recognized that effective Data and Derivation of Assigned maintenance and care) of OSHA’s respirator use depends on a Protection Factors’ (Ex. 1–156). That Respiratory Protection Standard (29 CFR comprehensive respiratory protection study, which the Agency placed in the 1910.134) adopted in 1971. The seventh program that includes use of APFs. rulemaking docket on September 20, section was a direct, complete OSHA’s 1982 ANPR sought 1995, addressed the use of statistical incorporation of ANSI Standard K13.1– information on the effectiveness of its modeling for determining respirator 1969, ‘‘Identification of Gas Mask current Respiratory Protection Standard, APFs. OSHA received 12 comments on Canisters.’’ the need to revise this standard, and the Nicas report. This report, and the The Agency promulgated an initial suggestions on the nature of the comments received in response to it, Respiratory Protection Standard for the revisions. The 1982 ANPR referenced convinced OSHA that more information construction industry (29 CFR 1926.103) the ANSI Z88.2–1980 standard on would be necessary before it could in April 1971. On February 9, 1979, respiratory protection with its table of resolve the complex issues regarding OSHA formally applied 29 CFR protection factors, the 1976 report by Dr. how to establish APFs, including what 1910.134 to the construction industry Ed Hyatt from the LASL titled methodology to use in analyzing (44 FR 8577). Agencies that preceded ‘‘Respiratory Protection Factors’’ (Ex. 2), existing protection factor studies (see OSHA developed the original maritime and the RDL developed jointly by OSHA Section IV below for a more detailed respiratory protection standards in the and NIOSH, as revised in 1978 (Ex. 9, explanation of the Nicas report and the 1960s (e.g., section 41 of the Longshore Docket No. H049). Questions #2, #3, and comments made on it). and Harbor Worker Compensation Act). #4 in the 1982 ANPR asked for OSHA published the final, revised The section designations adopted by comments on how OSHA should use Respiratory Protection Standard, 29 CFR OSHA for these standards, and their protection factors. The Agency received 1910.134, on January 8, 1998 (63 FR original promulgation dates, are: responses from 81 interested parties. 1152). The standard contains worksite- Shipyards—29 CFR 1915.82, February The commenters generally supported specific requirements for program 20, 1960 (25 FR 1543); Marine revising OSHA’s Respiratory Protection administration, procedures for Terminals—29 CFR 1917.82, March 27, Standard, and provided respirator selection, employee training, 1964 (29 FR 4052); and Longshoring— recommendations regarding approaches fit testing, medical evaluation, respirator

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use, and other provisions. However, fit testing provisions as part of the deliberations, the Subcommittee OSHA reserved the sections of the final respirator certification process. conducted an extensive discussion standard related to APFs and maximum NIOSH sponsored additional regarding the role of respirator use concentration (MUC) pending respirator studies at LASL, beginning in protection factors in an effective further rulemaking (see 63 FR 1182 and 1971, that used quantitative test systems respiratory protection program. As a 1203). The Agency stated that, until a to measure the overall performance of result, the Subcommittee decided to add future rulemaking on APFs is respirators. Dr. Edwin C. Hyatt of LASL an APF table to the revised standard. In completed: included a table of protection factors May 1980, ANSI published the revision [Employers must] take the best available for, single-use dust respirators; quarter- as Z88.2–1980 (Ex. 10, Docket No. information into account in selecting mask, half-mask, and full facepiece air- H049) and it contained the first ANSI respirators. As it did under the previous purifying respirators; and SCBAs in a Z88.2 respiratory protection factor table. [Respiratory Protection] standard, OSHA 1976 report titled ‘‘Respirator Protection The ANSI Subcommittee based the table itself will continue to refer to the [APFs in Factors’’ (Ex. 2). The protection factors on Hyatt’s protection factors, which it the 1987 NIOSH RDL] in cases where it has were based on data from DOP and updated using results from fit testing not made a different determination in a sodium chloride quantitative fit test studies performed at LANL and substance specific standard. (see 63 FR 1163) studies performed on these respirators elsewhere since 1973. For example, the The Agency subsequently established at LASL between 1970 and 1973. The protection factor for full facepiece air- a separate docket (i.e., H049C) for the table also contained recommended purifying particulate respirators was 100 APF rulemaking. This docket includes protection factors for respirators that when qualitatively fit tested, or 1,000 copies of material related to APFs that had no performance test data. Dr. Hyatt when equipped with high efficiency it previously placed in the docket based these recommended protection filters and quantitatively fit tested. The (H049) for the revised Respiratory factors on the judgment and experience table consistently gave higher protection Protection Standard. The APF of LASL researchers, as well as factors to tight-fitting facepiece rulemaking docket also contains other extrapolations from available facepiece respirators when employers performed APF-related materials, studies, and data leakage data for similar respirators. For quantitative fit testing rather than that OSHA obtained after it promulgated example, he assumed that performance qualitative fit testing. The ANSI the final Respiratory Protection data for SCBAs operated in the pressure Subcommittee concluded that PAPRs Standard in 1998. demand mode could be used to (with any respiratory inlet covering), History of Assigned Protection Factors represent other (non-tested) respirators atmosphere-supplied respirators (in that maintain positive pressure in the continuous flow or pressure demand In 1965, the Bureau of Mines facepiece, hood, helmet, or suit during mode), and pressure demand SCBAs published ‘‘Respirator Approval inhalation. In addition, he required no fit testing because they Schedule 21B,’’ which contained the recommended in his report that NIOSH operated in a positive pressure mode. term ‘‘protection factor’’ as part of its continue testing the performance of Accordingly, it gave these respirators approval process for half-mask respirators that lacked adequate fit test high protection factors, limited only by respirators (for protection up to 10 times data. Relative to this, staff members at IDLH values. The Subcommittee the TLV) and full facepiece respirators LASL (from 1974 to 1978) used a assigned protection factors of 10,000 (for protection up to 100 times the TLV). representative 35-person test panel to and over to respirators used in IDLH The Bureau of Mines based these conduct quantitative fit tests on all air- atmospheres. protection factors on quantitative fit purifying particulate respirators In response to a complaint to NIOSH tests, using dioctyl pthalate (DOP), that approved by the Bureau of Mines and that the PAPRs used in a plant did not were conducted on six male test NIOSH. appear to provide the expected subjects performing simulated work In August 1975, the Joint NIOSH- protection factor of 1,000, Myers and exercises. OSHA Standards Completion Program Peach of NIOSH conducted a WPF study The Atomic Energy Commission published the RDL (Ex. 25–4, Appendix during silica bagging operations. Myers (AEC) published proposed protection F, Docket No. H049). The RDL and Peach tested half-mask and full factors for respirators in 1967, but later contained a table of protection factors facepiece PAPRs and found protection withdrew them because quantitative fit that were based on quantitative fit factors that ranged from 16 to 215. They testing studies were available for some, testing performed at LASL and published the results of the study in but not all, types of respirators. To elsewhere, as well as the expert 1983 (Ex. 1–64–46). The results of this address this shortcoming, the AEC judgment of the RDL authors. The 1978 study led NIOSH and other researchers, subsequently sponsored respirator NIOSH update of the RDL contained the as well as respirator manufacturers, to studies at LASL, starting in 1969. perform additional WPF studies on ANSI standard Z88.2–1969, which following protection factors: 5 for single-use respirators; PAPRs and other respirators. OSHA adopted by reference in 1971, did 10 for half-mask respirators with DFM NIOSH revised its RDL in 1987 (Ex. not contain APFs for respirator or HEPA filters; 1–54–437Q). While the revision retained selection. Nevertheless, this ANSI 50 for full facepiece air-purifying many of the provisions of the 1978 RDL, standard recommended that ‘‘due respirators with HEPA filters or it recognized the problems involved in consideration be given to potential chemical cartridges; developing APFs. The 1987 RDL also inward leakage in selecting devices,’’ 1,000 for PAPRs with HEPA filters; revised the APFs for some respirators, and contained a list of the various 1,000 for half-mask SARs operated in based on NIOSH’s WPF studies. For respirators grouped according to the the pressure demand mode; example, the APFs were lowered for the quantity of leakage into the facepiece 2,000 for full facepiece SARs operated following respirator classes: PAPRs with expected during routine use. in the pressure demand mode; and a loose-fitting hood or helmet to 25; In 1972, NIOSH and the Bureau of 10,000 for full facepiece SCBAs PAPRs with a tight-fitting facepiece and Mines published new approval operated in the pressure demand mode. a HEPA filter to 50; supplied-air schedules for respiratory protection ANSI’s respiratory protection continuous flow hoods or helmets to 25; under 30 CFR Part 11. However, these Subcommittee decided to revise Z88.2– and supplied-air continuous flow tight- new approval schedules did not include 1969 in the late 1970s. During its fitting facepiece respirators to 50.

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NIOSH stated that it may revise the was consistent with an APF of 1,000. A new ANSI Z88.2 Subcommittee 1987 RDL if warranted by subsequent According to Nelson, the Subcommittee currently is reviewing the ANSI Z88.2– WPF studies. used WPF studies by Myers (Ex. 1–64– 1992 standard, in accordance with ANSI In August 1992, ANSI again revised 48), Gosselink (Ex. 1–64–23), Myers (Ex. policy specifying that each standard its Z88.2 Respiratory Protection 1–64–47), and Que Hee and Lawrence receive a periodic review. This review Standard (Ex. 1–50). The ANSI Z88.2– (Ex. 1–64–60) to set an APF of 25 for likely will result in revisions to the 1992 standard contained a revised APF PAPRs with loose-fitting facepieces. Z88.2 APF table based on WPF and table, based on the Z88.2 Nelson stated that two WPF studies, SWPF respirator performance studies Subcommittee’s review of the available conducted by Gaboury and Burd (Ex. 1– conducted since publication of the protection factor studies. In a report 64–24) and Stokes (Ex. 1–64–66) current standard in 1992. describing the revised standard (Ex. 1– subsequent to publication of ANSI B. Need for APFs 64–423), Nelson, Wilmes, and daRoza Z88.2–1992, supported the APF of 25 described the rationale used by the selected by the Subcommittee for PAPRs The proposed APF definition and ANSI Subcommittee in setting APFs: with loose-fitting facepieces. regulatory text are important additions If WPF studies were available, they formed to, and an integral part of, OSHA’s Tom Nelson stated in his report that Respiratory Protection Standard because the basis for the [APF] number assigned. If the ANSI Subcommittee had no new no such studies were available, then employers need this information to laboratory studies, design analogies, and information on atmosphere-supplying select appropriate respirators for other information was used to decide what respirators. Therefore, the APFs for employee use when engineering and value to place in the table. In all cases where these respirators were based on work-practice controls are insufficient the assigned protection factor changed when analogies with other similarly designed to maintain hazardous substances at safe compared to the 1980 standard, the assigned respirators (Ex. 135). The ANSI levels in the workplace. Employers need number is lower in the 1992 standard. Subcommittee based the APF of 50 for the consistent and valid information In addition, the 1992 ANSI Z88.2 half-mask continuous flow atmosphere- contained in the proposed APF standard abandoned the 1980 standard’s supplying respirators, and the APF of 25 provisions to select respirators for practice of giving increased protection for loose-fitting facepiece continuous employee protection, based on the type factors to some respirators if flow atmosphere-supplying respirators, of hazardous substance and the level of quantitative fit testing was performed. on the similarities between these employee exposure to that substance. Tom Nelson, the co-chair of the ANSI respirators and PAPRs with the same As noted in Table I of the proposed Z88.2–1992 Subcommittee, published a airflow rates. Nelson noted that the regulatory text, the proposed APFs second report, entitled ‘‘The Assigned ANSI Subcommittee set the APF of differ for each class of respirator. In this Protection Factor According to ANSI’’ 1,000 for full facepiece continuous flow regard, the proposed APF for a class of (Ex. 135), four years after the Z88.2 atmosphere-supplying respirators to be respirators specifies the workplace level Subcommittee completed the revised consistent with the APF for SARs with of protection that class of respirator 1992 standard. In the report, he helmets or hoods found in two earlier should provide under an effective reviewed the reasoning used by the studies—a WPF study by Johnson (Ex. respiratory protection program. ANSI Subcommittee in setting the 1992 1–64–36) and a SWPF study by Skaggs Therefore, when the concentration of a ANSI APFs. He noted that the Z88.2 (Ex. 1–3803). The Subcommittee used hazardous substance in the workplace is Subcommittee gave an APF of 10 to all the analogy between PAPRs and less than 10 times the PEL, the employer half-mask air-purifying respirators, continuous flow supplied-air respirators must select a respirator from a respirator including quarter-mask, elastomeric, to select the APF of 50 for half-mask class with an APF of at least 10 for use and disposable respirators. The pressure demand SARs and 1,000 for by employees exposed to that substance. Subcommittee also recommended that full facepiece pressure demand SARs. However, when the concentration of the full facepiece air-purifying respirators Nelson stated: ‘‘The committee believed hazardous substance is greater than 10 retain an APF of 100 (from the 1980 that setting a higher APF because of the times the PEL, the employer must select ANSI standard) because no new data pressure demand feature was not a respirator that has an APF greater than were available to justify another value. warranted, but rather that the total 10 for this purpose. In addition, The Z88.2 Subcommittee also reviewed airflow was critical.’’ employers would derive MUCs from the the 1987 NIOSH RDL values, Nelson noted in the report that the APFs proposed for the different particularly the RDL’s reduction of Subcommittee selected no APF for respirator classes. These MUCs loose-fitting facepiece and PAPRs with SCBAs. In explaining the committee’s determine the maximum atmospheric helmets or hoods to an APF of 25 based decision, he stated that ‘‘the concentration of toxic gasses and vapors on their performance in WPF studies. performance of this type of respirator at which respirators equipped with For half-mask PAPRs, the ANSI may not be as good as previously cartridges and canisters can be used to Subcommittee set an APF of 50 based measured in quantitative fit test protect employees. on a WPF study by Lenhart (Ex. 1–64– chambers.’’ Nelson also observed that In summary, when used in 42). The ANSI Subcommittee had no the ANSI 88.2–1992 standard justified conjunction with the existing provisions WPF data available for full facepiece this approach in a footnote to the APF of the Respiratory Protection Standard, PAPRs, so it decided to select an APF table. The footnote states: especially the respirator selection of 1,000 to be consistent with the APF requirements specified in paragraph (d), for PAPRs with helmets or hoods. The A limited number of recent simulated the proposed APF definition and Subcommittee, in turn, based its APF of workplace studies concluded that all users regulatory text would provide 1,000 for PAPRs with helmets or hoods may not achieve protection factors of 10,000. employers with the information they Based on [these] limited data, a definitive on design analogies (i.e., same facepiece need to select the appropriate assigned protection factor could not be listed designs, operation at the same airflow for positive pressure SCBAs. For emergency respirators for reducing employee rates) between these respirators and planning purposes where hazardous exposures to hazardous substances to airline respirators. Nelson noted that a concentrations can be estimated, an assigned safe levels. Accordingly, integrating the subsequent WPF report by Keys (Ex. 1– protection factor of no higher than 10,000 proposed APF provisions into the 64–40) on PAPRs with helmets or hoods should be used. Respiratory Protection Standard will

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ensure that employees receive the A. Dr. Nicas’ Proposal and Response performance is both bad science and optimum level of protection afforded by From Commenters bad policy’’ (Ex. 1–182–10). that standard. During the June 1995 APF hearings, 2. Inappropriate Use of ANOVA Model C. Review of the Proposed Standard by OSHA devoted a full day to a panel Three commenters believed that using the Advisory Committee for discussion on the uncertainties Nicas’ lognormal ANOVA model to Construction Safety and Health associated with sample statistics and analyze existing data was inappropriate (ACCSH) their use for deriving APFs. Based on (Exs. 1–174, 1–182–5, 1–182–1). Two of The proposed provisions would this discussion, OSHA contracted with these commenters advocated using a replace the existing respirator-selection Dr. Mark Nicas to develop a statistical simple analysis of the aggregate data requirements specified by the method for deriving APFs. Nicas used instead (Exs. 1–174, 1–182–5). Thomas Respiratory Protection Standard for the two approaches to account for within- Nelson (Ex. 1–174) and 3M (1–182–5) construction industry (29 CFR wearer and between-wearer variabilities. expressed concern that the ANOVA 1926.103). Accordingly, OSHA’s For penetration data collected from a model focuses primarily on within- regulation governing the Advisory specific cohort of respirator wearers, he wearer and between-wearer variability, Committee on Construction Safety and used a one-factor lognormal analysis of while ignoring the potential variability Health (ACCSH) at 29 CFR 1912.3 variance. He used a two-factor contributed by other sources such as requires OSHA to consult with the lognormal analysis of variance to work site, respirator model, filter, and contaminant. Nelson stated: ‘‘A simple ACCSH whenever the Agency proposes perform a meta-analysis of the data from analysis of the entire data (i.e., a rulemaking that involves the studies of different cohorts of respirator geometric mean, estimates of percentiles occupational safety and health of wearers. Using these approaches, Nicas and confidence intervals) includes these construction employees. On December proposed assigning two different and other possible sources of variation 5, 2002, OSHA briefed the ACCSH protection factors; he recommended one and the within-person variability in the membership on the proposed provisions for chronic toxicants (i.e., substances model.’’ Two other commenters, Drs. and responded to their questions. On regulated by an 8-hour PEL), and the Rappaport and Kupper [contractors for March 27, 2003, the APF proposal was other for acute toxicants (i.e., substances the Industrial Safety Equipment distributed to the ACCSH membership regulated by a STEL). Nicas also made Association (ISEA)] believed that using for their review prior to their next recommendations regarding sampling data management and inclusion of an ANOVA model provided some regular meeting on May 22, 2003. OSHA benefits; however, they had concerns staff discussed the APF proposal and studies in statistical analyses of respirator performance. regarding the assumption of log- answered questions from the ACCSH normality of penetration values, the lack OSHA reopened the rulemaking members during their meeting on May of validation of the model, and errors record on November 7, 1995 (60 FR 22, 2003. The ACCSH then that appeared in some of the equations. 56127) to request comment on Dr. Nicas’ recommended that OSHA proceed with Therefore, they regarded report titled ‘‘The Analysis of publishing the proposal. ‘‘implementation of Dr. Nicas’ ideas as Workplace Protection Factor Data and being problematic at this time,’’ and IV. Methodology for Developing Derivation of Assigned Protection Assigned Protection Factors encouraged the industry to develop Factors’’ (Ex. 1–156). OSHA received 12 improved methods and data for deriving This section contains an overview of comments on the report. While some APFs (Ex. 1–182–1). the analyses performed for OSHA and commenters expressed general support summaries of the studies used in these for Nicas’ approach (e.g., Ex. 1–182–4, 3. ANOVA Model Fails To Account for analyses. OSHA entered the complete American College of Occupational and Differences Between WPF Studies analyses and studies into Docket H049C Environmental Medicine), others had Five commenters stated that the as Exhibits 3, 4, and 5 and Exhibit 1– serious reservations about establishing proposed analysis fails to account for 156 (Dr. Nicas’ report). Studies and APFs using this approach. The issues important differences between studies information supporting the APF for each raised by these commenters are that could affect WPF values. Thomas class of respirator are discussed in described below. Nelson and 3M believed that the Section VII of this document. The 1. Lack of Valid and Reliable WPF Data ANOVA model does not account for analyses discussed below assisted other sources of variability (Exs 1–174, OSHA in determining its proposed Two commenters stated that the 1–182–5). NIOSH stated that Nicas’ approach to deriving APFs. Commenters available WPF data were of insufficient report did not address the effect of the expressed appreciation for the approach quality to permit a sophisticated test subjects’ work rates and other suggested by Dr. Nicas, but nearly all statistical analysis. The 3M Company activities on a respirator’s performance did not support implementation of his (3M) commended OSHA for ‘‘attempting (Ex. 1–182–3), and did not account for methods. However, his to use science to evaluate workplace employee training and program recommendations provided guidance to studies for determining Assigned surveillance (Ex. 1–182–9). The the Agency regarding the types of Protection Factors,’’ but stated that Chemical Manufacturers Association studies and data needed for determining insufficient valid data were available for (CMA) also commented on factors not APFs. Dr. Brown’s complex statistical such an evaluation, and that the data considered in the Nicas report, analyses demonstrated the widespread that were available were too variable ‘‘including differences in training, variability inherent in current (Ex. 1–182–5). In addition, Organization experience, work site, work rate and workplace protection factor studies. Resource Counselors, Inc. (ORC) stated: sample collection’’ (Ex. 1–182–7). ORC However, he found in his final analysis ‘‘The use of existing, often flawed, noted: ‘‘ The results of a WPF study are that the performance of filtering workplace protection factor studies, is based on at least the following facepiece and elastomeric half-mask not a solution to the problem. * * * A components: quality of the respirator respirators could not be differentiated, reliance on sophisticated statistics in an chosen; quality of the training program; thereby supporting grouping of these attempt to compensate for a lack of quality of the fit testing and selection two types of respirator under one APF. reliable scientific data on respirator program; nature of the work and ability

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to challenge the fit of a respirator regarded the question of how to deal 182–5, 1–182–10, 1–182–6, 1–182–8) (sedentary versus high exercise work)’’ with acutely toxic substances as noted that the ANSI Z88.2–1992 (Ex. 1–182–10). unresolved (Ex. 1–182–1). standard does not explicitly account for several factors in assigning APF values 4. Using a Conservative Criterion for 6. Distribution of Contaminant to different respirator classes, or the use Setting APFs Concentrations of a respirator in different situations, Five commenters stated that Nicas’ Two participants believed that it was which they indicated were necessary criterion for setting APF values was necessary to incorporate information on considerations. Moreover, some overly conservative. The Dow Chemical the variability of ambient exposure commenters (Exs. 1–182–11,1–182–12) Company (Dow) stated that the Nicas concentrations, as well as the maximum recommended APFs that differ from approach ‘‘would result in protection anticipated concentration, when those published by the ANSI Z88.2 factors which are very conservative’’ discussing respirator selection. CMA Committee. Other commenters believed (Ex. 1–182–2), while 3M believed that stated that since an employee’s that it was OSHA’s responsibility to OSHA’s use of Nicas’s recommendation exposures will vary from day to day, show that the commonly used ANSI would result in a major change in the employers should select respirators with Z88.2 1992 APFs were erroneous (Ex. 1– pattern of respirator use (Ex. 1–182–5). maximum use limits well above the 182–2), and that the Agency should not NIOSH commented that the approach mean exposure levels to ensure ‘‘that use SWPF studies to derive APFs (Ex. may result in very low APF estimates there is less than 5% probability of 1–182–5). Several participants at the because of high WPF variability, and exposures above the maximum use limit hearing for the final Respiratory that while the approach would derive of the respirator’’ (Ex. 1–182–7). In a Protection Standard stated that OSHA more conservative (i.e., more protective) related comment, ORC stated that many should issue a second NPRM to address APFs, its use for ‘‘WPF studies with industrial applications typically have the development of APFs (Exs. 1–182– small sample sizes * * * could result in exposures only 2–3 times the acceptable 1, 1–182–5, 1–182–10). APF estimates less than or equal to 1.0 exposure limit; therefore, ‘‘selecting a After carefully considering Dr. Nicas’ (APF values less than 1.0 are respirator with an APF of 10 may mean model and the comments received in meaningless)’’ (Ex. 1–182–3). Drs. there is only a remote chance of response to his report of the model, the Rappaport and Kupper stated that only overexposure to a contaminant due to Agency concluded that other possible weak precedence existed for Nicas’ use fit/wear variability’’ (Ex. 1–182–10). approaches to deriving APFs should be of 95th percentiles to define APFs, and 7. Other Concerns With Nicas’ Method investigated. Accordingly, the Agency suggested that other percentiles (e.g., the identified and collected available data 90th percentile) would be more The commenters raised several other for this purpose. Of particular interest practical to implement (ISEA, Ex. 1– issues with Dr. Nicas’ methodology. For were data that OSHA could use to 182–1). Finally, CMA believed that the example, 3M (Ex. 1–182–5) and CMA discriminate between the performance proposed criterion rated ‘‘all respirators (Ex. 1–182–7) believed that the of different respirator classes. The on the lowest protection achieved by the relationship between outside Agency gathered information from both lowest performing person’’ (Ex. 1–182– concentration and WPF (i.e., WPF published and non-published papers 7). increases with increasing Co) was and reports, and included WPF, SWPF, poorly understood; therefore, a 5. APFs Based on a Contaminant’s PPF, and EPF studies; Health Hazard sophisticated analysis of the data is Evaluations conducted by NIOSH; Toxicity (Acute Versus Chronic questionable. Other commenters noted respirator performance data from Toxicants) errors in the equations of the proposed manufacturers, such as SWPF data Dr. Nicas proposed that two APFs be model (e.g., Ex. 1–182–1) and with the submitted to OSHA by Bullard (Ex. 3– assigned to a respirator, depending on distribution of the respirator penetration 8); and other material related to its use against either a chronic toxicant values (Ex. 1–182–1). assessing respirator performance. This or an acute toxicant. Four commenters information is in Docket H049 as remarked on the feasibility and effects 8. Miscellaneous Comments (e.g., ANSI APFs) Exhibits 2, 3, and 4. of this approach. NIOSH commented To assist in evaluating the data, that ‘‘defining acceptable protection In addition to responding to the Nicas OSHA employed Dr. Kenneth Brown (a against short-term exposures is very report, a number of commenters statistician) and several respirator complex * * *.’’ (Ex. 1–182–3). 3M supported using the APFs authorities: Mr. Harry Ettinger, Dr. Gerry commented that dual APFs would be recommended in the ANSI Z88.2–1992 Wood of LANL, and Drs. James Johnson, confusing to the user community and respiratory protection standard (Exs. 1– Kenneth Foote, and Arthur Bierman of workers, and would make program 182–1, 1–182–2, 1–182–5, 1–182–7, 1– LLNL. After the Agency reviewed all of management difficult (Ex. 1–182–5). 182–10). These commenters stated that the studies and information, it decided CMA provided similar comments, and the members of the ANSI Z88.2 to attempt to analyze only WPF and noted that many materials have both committee were ‘‘respected industrial SWPF studies since they address chronic and acute effects (Ex. 1–182–7). hygiene and respirator experts’’ (Ex. 1– respirator performance exclusively. ORC believed that: 182–5), that the ANSI Z88.2–1992 APFs OSHA discusses the work and findings * * * different APFs for different were ‘‘the appropriate values’’ (Ex. 1– of these individuals below. 182–7), and that the ANSI APFs ‘‘have contaminants or types of exposure is not B. Analyses of WPF Studies appropriate. Occupational exposure been through the ANSI peer review standards should have adequate safety factors process’’ (Ex. 1–182–5). In advocating OSHA contracted with Dr. Brown to which are based on the health outcome (e.g., use of the ANSI APFs, none of the investigate possible approaches, other irritation, systemic toxicity, carcinogenicity) commenters described the process by than those approaches proposed by of exposure. (Ex. 1–182–10) which the ANSI Z88.2 committee Nicas, to evaluate respirator While Drs. Rappaport and Kupper derived its APFs, or identified the performance data from WPF studies. stated that Nicas’ argument about studies and other information on which The following discussion is a general respiratory protection for substances that committee relied. Furthermore, description of the analyses performed with chronic effects was logical, they several commenters (Exs. 1–182–7, 1– by Brown, as well as his overall

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conclusions. For a detailed explanation elimination differs between gases/ for analysis. OSHA placed a list of these of the methodology and rationale used vapors and particulates. Therefore, studies, and their respective respirators, in the analyses, refer to Brown’s reports OSHA decided to analyze only WPF in the docket (Ex. 7–4). Brown in the docket (Exs. 5–1, 5–2). studies using particulate challenge subsequently identified 14 APR studies OSHA reviewed the available WPF agents. The Agency evaluated those and 13 PAPR/SAR studies for further studies for possible inclusion in studies initially selected for further analysis (see Exs. 5–1 and 5–2 for more Brown’s analyses. Early in this review analysis for compliance with the information on the evaluation criteria). process, the Agency decided to exclude requirements of OSHA’s Respiratory WPF studies with a gas or vapor Protection Standard (29 CFR 1910.134), Brown’s analyses divided the workplace challenge agent because: The as well as completeness of the data. The respirators used in these studies into preponderance of studies were Agency compiled a list of review items separate respirator classes. The analyses conducted in workplaces with to use in evaluating each study (Ex. 5– divided APRs into 5 classes, listed particulate challenges; gas/vapor studies 5). below in Table 1. As this table shows, did not provide any further insight or OSHA then divided the remaining Brown’s analyses separated filtering clarification regarding sources of studies into two categories: Half-mask facepieces into four classes based on the variability in WPF studies (most likely, negative-pressure air-purifying characteristics listed under the gas/vapor studies add variability to the respirators (APRs) and atmosphere- Description column heading, with the data such as the effects of humidity on supplying respirators (PAPRs and fifth class comprised of elastomeric sampling media collection and SARs). This procedure resulted in 22 facepiece APRs. desorption efficiencies); and pulmonary APR studies and 16 PAPR/SAR studies

TABLE 1.—HALF-MASK APR CLASSES

Description Class Type Adjustable Exhalation Double shell Foam ring head straps valve construction liner

1 ...... Filtering facepiece ...... 2 ...... Filtering facepiece ...... X ...... X ...... 3 ...... Filtering facepiece ...... X X X ...... 4 ...... Filtering facepiece ...... XXXX 5 ...... Elastomeric facepiece.

In addition, Brown’s analyses divided penetration of the contaminant into the data from each study as a homogeneous PAPRs into five classes and SARs into respirator (PEN = Ci/Co = 1/WPF). The sample arising from the same parent two classes, as shown in Table 2. APR studies had a total of 917 data distribution. Then he examined the data pairs, while the PAPR/SAR studies in each study for a Co effect, and TABLE 2.—PAPR AND SAR CLASSES provided 443 data pairs. constructed a scatterplot of ln(WPF) versus ln(Co) for each respirator class. 1. Half-Mask APRs Class Type Description In doing so, he treated extreme or poorly In the first phase of his analysis, fitting data as outliers and removed 1 ...... PAPR Loose-fitting facepiece. Brown statistically analyzed the data for them from the analysis. He subsequently 2 ...... PAPR Loose-fitting facepiece with half-mask negative pressure APRs, both derived a linear regression of ln(WPF) hood and/or helmet. filtering facepiece and elastomeric 3 ...... PAPR Hood and/or helmets—not on ln(Co) for each study, and loose-fitting. APRs, using the following three extrapolated from the observed range to 4 ...... PAPR Tight-fitting half-mask face- approaches: (1) Pooled the data within the entire range of Co values in all of the piece. classes, corrected the data for the data. The positive slopes, which he 5 ...... PAPR Tight-fitting full facepiece. positive relationship found between found for most classes, showed that 6 ...... SAR Loose-fitting. WPF values and increasing Co, and ln(WPF) increased as ln(Co) increased. 7 ...... SAR Hood or helmet. compared the differences in WPF In addition, the regression lines were statistics between classes; (2) conducted well mixed, indicating that studies Later in the analyses, Brown further an intra-study analysis of the within the same respirator class varied divided these classes according to class performance of two different classes of more than anticipated. This result of respirator, study, and challenge agent respirator used against the same indicated that variability occurring (CLSA). This division resulted in 26 contaminant under similar workplace within respirator classes could obscure CLSAs for the APRs and 14 CLSAs for conditions; and (3) divided the data into differences between respirator classes. the PAPRs/SARs. class-study-agent combinations, and These studies collected data over The data from the WPF studies evaluated WPF as a function of Co. The different ranges of Co. Therefore, to consisted of simultaneous following sections discuss these compare the WPFs observed in the measurements of the challenge agent approaches in detail. studies, Brown corrected the WPF concentration inside the respirator Approach 1. Brown’s initial approach values for all studies, using a common facepiece (i.e., concentration inside or was to determine if he could pool the Co adjustment factor. He pooled the Ci) and outside the respirator facepiece data within each respirator class and adjusted WPFs by class, and then (i.e., concentration outside or Co) in the estimate the fifth percentile WPF for plotted the cumulative distributions to ambient workplace atmosphere. that respirator class; he then tested for determine if he could identify Corresponding Co and Ci measurements differences in WPFs between the differences between respirator classes, can be used to calculate the workplace respirator classes. He divided and despite intra- and inter-study protection factor (WPF = Co/Ci) or analyzed the data by study, treating the differences. Finding no differences

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between respirator classes using the Co into units smaller than respirator class, effect), taken in conjunction with other adjustment factor, he concluded that: i.e., units based on class of respirator, poorly described factors (e.g., particle Observed 5th percentiles for WPFs, and study, and workplace challenge agent size, temperature, humidity) that may their lower confidence intervals when (class-study-agent or CLSA). This affect the relationship of Ci and Co; (3) adjusted for the Co effect, showed no clear procedure resulted in 42 CLSA characteristics of the ambient agent evidence that any class was preferable to combinations. After removing deficient itself (e.g., possible effects of the agent another. In particular, there was no data (e.g., no data on Co), he narrowed occurring in a mixture with other indication that Class 5 (elastomerics) the data set to 26 combinations. Again, agents); and (4) variations in data among performed better than four disposable he tested the data for each CLSA to studies related to using different study classes. (Ex. 5–1, p. 8) determine if WPF increases with Co procedures (e.g., repeated measurements The results of these analyses and, if so, whether the effect held for all on the same worker in some studies prompted a more detailed examination respirator classes. Data analyses of the versus single measurements on each of the data. To control for study-related 26 CLSAs indicated that WPF increased worker in other studies, random versus and agent-related factors that may with Co; Brown then derived a common non-random selection of study contribute to variability, Brown estimate (across all CLSAs) of the Co participants). He also commented that performed an intra-study analysis on effect. He subsequently estimated the the analyses assumed that the data were two different respirator classes used means for the CLSAs within each class representative of workplace conditions; against the same workplace challenge of respirator, both with and without however, the data may not represent agent under similar workplace adjustment for Co effect. Brown either current or future workplaces in conditions (Approach 2). compared the means of these CLSAs which employees use respirators. Approach 2. The second approach within and between respirator classes. Finally, Brown observed that studies attempted to determine respirator For each respirator class, he grouped the with high Ci values, relative to Co, may performance after controlling for study- CLSAs that had no significant difference have influenced his findings. He to-study and agent-to-agent sources of between their means into common believed that these studies should be variability. Among the half-mask APRs, subclasses, and plotted both the closely reviewed because some study the chance of detecting performance adjusted and non-adjusted means [i.e., weakness, unrelated to respirator differences appeared to be greatest for mean of ln(PEN)] of the subclasses, as performance, could be the reason for the comparisons between elastomeric and well as their associated confidence high Ci values. filtering facepiece respirators. In intervals. The results of the comparisons Brown also made some general implementing this approach, Brown showed that: the estimated means of observations about WPF studies. First, assumed that controlling for study and CLSAs vary so much within a class that he believed that the role of WPF studies agent sources of variability would result the mean of one CLSA is likely to be a in assessing and comparing respirator in WPF differences attributable, in large poor predictor of the mean of another effectiveness, and influencing APFs, part, to variability in respirator CLSA within the same class; and it was should be reevaluated. He believed that performance. not visually apparent from the plots that a more refined instrument that is Four of the studies compared the one class of respirator performed better amenable to experimental design and performance of elastomeric and filtering than another class. In general, the control, such as chamber studies, is facepiece respirators against the same comparison indicated that study better suited for providing information challenge agent in the same workplace. outcomes, even within the same class of during determination of assigned After reviewing these studies, a study by respirator, are highly heterogeneous. protection factors. Brown noted that the Meyers and Zhuang (Ex. 1–64–51) was Final analysis. Since the three use of high concentrations of a selected for further analysis because it approaches discussed above could not challenge agent in chamber studies may was recent, followed a protocol distinguish between respirator minimize the uncertainty of patterned after other published WPF effectiveness within or across classes, extrapolating test results obtained at low study protocols, and was well the data were viewed, as a whole, from outside concentrations to levels well documented. Brown’s statistical the relationship of Ci and Co. Brown above the observed range. Therefore, analyses of this study (see Ex. 5–1, pooled the data for all 26 CLSAs and WPF studies would serve as a Appendix C) indicated large sources of derived several functional relationships counterpart to chamber studies, i.e., variability within the study, making from the pooled data. This approach WPF studies would provide data on the comparison of the two respirator classes showed that the majority of the respirator during actual use in the difficult and tenuous. Based on plots of observed data pairs achieved a WPF of workplace, and identify workplace the data and the occurrence of several 10. (See Ex. 5–1 for more details.) conditions in which a respirator may outliers, it appeared that even data on After performing the above analyses, perform poorly. To improve the same agent, obtained under similar Brown made a number of observations comparability of results, he advocated workplace conditions, may not have and conclusions. He noted that the using uniform procedures to: select the come from the same parent distribution. range of WPF values within a CLSA was challenge agent; collect samples; record In addition, the variability of WPFs typically wide, and that the the data; and measure and interpret Ci within the study (regardless of observations were highly variable. In and Co (Ex. 5–1, pp. 42–44). adjustment for the Co effect) was large. addition, he believed that variability in Overall, the analyses led Brown to Therefore, the results of this second WPF studies can affect the accuracy, several conclusions. First, workplace approach led Brown to state that, at validity, and reliability of study results, studies have limitations for comparing least in this analysis, ‘‘workplace as well as the ability to compare study respirator performance because of studies may have too much intra-study results. Brown noted several possible uncontrolled sources of variability. variability for reasonably valid/ sources of variability in WPF studies, Support for this conclusion comes from accurate/reliable assessments and including: (1) Study characteristics the wide confidence intervals for the comparisons of respirator related to study design, execution, means of the CLSAs, and the wide range effectiveness.’’ (Ex. 5–1, p. C–17) sample analysis, and data management of those confidence intervals within the Approach 3. Brown began the third and reporting; (2) measurements of Ci at same respirator class. Second, Brown statistical approach by dividing the data different outside concentrations (Co believed that the WPF has limits as a

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measure of respirator effectiveness for trends of WPFs, either upward or Fifth percentiles are commonly used because, in general, it tends to increase downward, as Co increases, and for as a benchmark for respirator as Co increases. This relationship homogeneity. Brown plotted all of the performance. Brown’s analyses showed complicates comparisons of WPF values data, fitted lines to these plots, made that fifth percentile estimates differed measured at different Co levels. Third, comparisons of study results within considerably within respirator classes he found no clear evidence that one each respirator class, and developed that contained more than one CLSA. class of respirator is better than any functions from the fitted lines. (For The range of the fifth percentile other class, particularly between additional details on these statistical estimates was 28–389 for the five CLSAs elastomeric half-mask and filtering analyses and the data plots, see Ex. 5– in Class 2, 17–107 for the two CLSAs in facepiece respirators. In addition, the 2.) Class 4, 29–1779 for two CLSAs in Class differing results between CLSAs within On reviewing the data plots, Brown 5, and 74–188 for the two CLSAs in the same class of respirators indicated concluded that the data were consistent Class 7. The fifth percentile estimates in that the outcome of one CLSA may be with a linear relationship between ln(Ci) Classes 3 and 6 were large, while the a poor predictor for another CLSA in the fifth percentile estimates were small in same class. and ln(Co). Also, the presence of outliers and/or an imbalanced Classes 1, 4, and 7. Brown believed that, 2. PAPRs and SARs distribution of the observations while some of these differences may be Dr. Brown analyzed 13 studies to influenced the results. He recommended attributed to a real difference in evaluate and compare the effectiveness further investigation of the outliers, respirator performance between classes, of PAPRs and SARs. Ten of the studies particularly those with unusually high the sample sizes were too small and/or were conducted with PAPRs, and three Ci values, to determine if they resulted the sampling variability too large to with SARs. Brown’s analyses divided from characteristics of the respirator or obtain reliable estimates at low these ‘‘high-performance’’ respirators other variables. He also recommended percentile levels. He noted that the fifth into seven classes (i.e., five types of studying the imbalanced distributions to percentile estimates were variable, and PAPR and two types of SAR) based on determine if they represented individual were not predictable from one CLSA to their design features (see Table 2), with study biases caused, for example, by another CLSA within the same subsequent separation of these collecting data at different work sites or respirator class. Thus, he concluded that respirator classes into 14 CLSAs. on different work shifts. Finally, Brown the fifth percentile estimates of WPFs Brown used the CLSAs to determine noted that the robust least trimmed have limited utility for setting assigned whether any differences in respirator squares line may be useful for protection factors. Table 3 lists the effectiveness existed among the estimating the relationship between descriptive statistics for WPFs, for each respirator classes. He analyzed the data ln(Ci) and ln(Co). class-study-agent combination.

TABLE 3.—DESCRIPTIVE STATISTICS FOR WPF, BY CLASS, STUDY AGENT

CL1.26.Cd CL2.22.Pb CL2.23.Pb CL2.24.Si CL2.3.BAP CL2.5.Asb CL3.27.EBZ

Curve Label ...... 1 2a 2b 2c 2d No curves 3 Median ...... 2,972.97 127.88 155.29 3,553.72 1,788.32 156.00 11,935.87 Range ...... 25,186.05 1,040.75 6,131.76 95,518.07 8,203.89 537.00 4,746,673.83 Minimum ...... 53.70 22.58 28.24 36.31 371.49 66.00 1,152.26 Maximum ...... 25,239.75 1,063.33 6,160.00 95,554.38 8,575.38 603.00 4,747,826.09 No. Observations (N) ...... 33 46 43 59 20 7 58 5th Percentile ...... 280.25 27.82 35.03 92.07 388.70 70.50 1,797.79 10th Percentile ...... 581.87 53.04 43.08 267.60 407.51 75.00 2,365.29 Reject Lognormality?...... No No No No No No Yes Geometric Mean ...... 2,523.49 126.85 184.69 2,765.75 1,408.10 151.95 15,623.81 Geometric Stan. Dev ...... 3.56 2.28 3.21 6.33 2.50 2.54 5.56

CL4.21.Si CL4.6.Pb CL5.18.Pb CL5.21.Si CL6.19.Si CL7.25.Sr CL7.28.Si

Curve Label ...... 4a 4b 5 No curves 6 7a 7b Median ...... 48.67 438.60 7,948.14 85.44 9,178.81 3,827.16 2,480.55 Range ...... 176.27 2,310.33 73,081.90 189.92 34,735.48 87,137.82 33,384.67 Minimum ...... 16.40 23.00 579.04 24.75 668.34 41.67 43.33 Maximum ...... 192.67 2,333.33 73,660.94 214.67 35,403.82 87,179.49 33,428.00 No. Observations (N) ...... 7 25 53 4 15 21 52 5th Percentile ...... 17.20 107.06 1,779.12 29.10 1,407.60 74.07 188.14 10th Percentile ...... 18.00 160.95 2,300.18 33.50 2,229.66 79.37 383.47 Reject Lognormality? ...... No No No N too small No No No Geometric Mean ...... 49.20 400.34 8,319.09 76.10 7,389.62 2,315.04 2,066.00 Geometric Stan. Dev ...... 23.60 2.81 3.03 25.60 2.92 9.99 4.02

The objective of the review of these 13 how Ci changes as Co changes, and noted that study outcomes for the same WPF studies was to see what can be what factors affected this relationship. class of respirator may differ learned about the performance of each Brown found too much unexplained significantly, which raised concerns respirator class, and its relative variability between study outcomes, about interpreting the outcome for a effectiveness, based on the data for Co even within the same respirator class class from a single study. More and Ci. He also attempted to determine and within similar ranges of Co, to make specifically, he questioned whether the valid and reliable comparisons. He results from one study would be similar

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to another study. He concluded that it respirators satisfied the established the breathing background and the is not possible to know to what extent criteria of fit factors that exhibited only challenge aerosol penetrating the the outcome of a study is attributable to brief negative pressure spikes. He respirator. The LLNL researchers characteristics of the respirator used. believed these results indicated that if believed that the breathing background Brown believed that the variability these devices are used and maintained can limit fit factor measurements to identified in this analysis was probably properly, they appear to have fit factors 1,000 and less when the challenge due to uncontrolled parameters in the of at least 20,000. He believed that, concentration is below 2,000 particles/ workplace test situations, such as using a safety factor of 20, a protection cc (Ex. 4–15). They concluded that aerosol particle size distributions and factor of 1,000 is attainable, assuming challenge aerosol concentrations can be densities, and work activities. Based on that the testing protocol is adequate. better controlled in chamber studies the data from these studies, he found Ettinger stated that he could not than under this protocol. that WPF tends to increase as Co define clearly a relationship between When calculating faceseal leakage, the increases (equivalently, penetration, or the older and more recent study results. NIOSH authors assumed that all study PEN., tends to decrease). He believed For example, he suggested that the participants have the same constant that the probability of a Co dependence additional exercises in the more recent volumetric flow rate through the for WPFs seemed to be established by study (ORC, 2001; Ex. 3–4–2) did not respirator. Using a filtration model his analyses. adequately represent normal or extreme developed by Rubow (Ex. 3–7–3), the work situations. Ettinger cautioned LLNL reviewers determined media C. Analyses of SWPF Studies against assuming that all blasting penetration that was approximately 5% 1. Bullard Models 77 and 88, Clemco helmets would achieve the high fit less than the media penetration Apollo Models 20 and 60, and 3M factors measured in the recent studies calculated by the NIOSH authors using Whitecap II because performance is device specific, the constant flow rate assumption. Since and indicated that older respirator the method used by the NIOSH authors In the mid-1980s, SWPF studies designs may need to be reevaluated. results in only a 5% error, and gives a provided OSHA with information on the Furthermore, he believed that quality conservative estimate of the filter effects of temperature, relative control, human factors, minimum flow penetration, the LLNL reviewers humidity, airflow, and facial hair on rate, and the sturdiness of respirator believed that the constant flow rate respirator performance (LANL, 1988; Ex. construction are important variables assumption is reasonable. The LLNL 1–64–101, LLNL, 1986; Ex. 1–64–94). that should be evaluated in the testing reviewers also discussed other More recent SWPF studies provided protocol. considerations, including fluctuations additional information on the in peak flows under various exercise 2. NIOSH N95 Study performance of the following abrasive conditions, and the correction factor for blasting respirators: the Bullard Models In 1999, NIOSH conducted a chamber filter media penetration used by the 77 and 88 (Ex. 3–8–3), the Clemco study of 21 N95 respirators (20 filtering NIOSH authors. Apollo Models 20 and 60 (Ex. 3–7–3), facepiece, and 1 elastomeric, Investigating the possible effect of and the 3M Whitecap II (Ex. 3–9–2). respirators) and statistically analyzed breathing background on the PortaCount OSHA contracted with Mr. Harry the respirators’ performance (Ex. 4–14). fit factor measurement, the LLNL Ettinger to review and comment on the At the request of OSHA, Drs. Johnson, reviewers applied an estimated worst- study principles and protocols Foote, and Bierman of LLNL undertook case scenario to the data. The scenario described in the five reports (Bullard, a review of this study to assist the consisted of the following two Clemco, 3M Whitecap, the LLNL study, Agency in evaluating APFs of half-mask assumptions: (1) A challenge aerosol and the LANL study). His report (Ex. 3– respirators (Ex. 3–2). OSHA provided concentration of 3,000 particles/cc, and 3) contained the following observations the raw data files from the study to (2) a breathing background of 5 and conclusions. LLNL for independent evaluation. particles/cc. Applying these Mr. Ettinger noted that while the The NIOSH investigators used assumptions to the NIOSH data, the reports do not satisfy the typical criteria ambient (i.e., room) aerosol as the LLNL reviewers recalculated total for defining peer-reviewed publications, challenge agent, and a PortaCount to penetrations, and adjusted the results this was not a serious problem because measure respirator penetration. Use of for breathing background. They found the studies were conducted in national ambient aerosol does not require aerosol that, when compared to the NIOSH laboratories by knowledgeable and generation equipment, thereby results, 14 of the 21 respirators had experienced investigators. Furthermore, circumventing use of a possibly more tests passing the 0.01 penetration the review procedures generally used by hazardous chemical. However, if this criteria than before. The LLNL reviewers these national laboratories most likely technique generates a low ambient also calculated the 50th and 95th provide a sufficient peer-review process. particle concentration it is difficult to percentiles for the penetration data, He noted that none of the reports detect the reduced number of particles both with and without applying the provided sufficient detail to permit a that penetrate the respirator; this effect breathing background assumption. In statistical re-analysis of the data by results in an artificially low protection view of their results, they believed that OSHA. In addition, he observed that the factor. In addition, an ambient aerosol the original NIOSH analysis and studies of the Bullard, Clemco, and 3M that is varying in concentration during findings result in a conservative respirators reported considerably higher testing can cause error in the estimate of the respirators’ performance. fit factors than the 1986 and 1988 penetration measurements. Study The LLNL reviewers also used the national laboratory studies. However, he participants can also produce aerosols NIOSH raw data to reproduce values, believed that it was not appropriate to ranging from 0.1 to 3 particles/cc geometric standard deviations, and the compare the results of recent studies through their breathing (i.e., ‘‘breathing’’ 95th percentile for total penetration, with the older studies, but he noted that background). Whenever the amount of filter penetration, and face seal leakage. older respirators may not perform as challenge agent that penetrates the They then compared these results to well as newer designs. respirator is low (i.e., on the order of total penetration and face seal leakage Mr. Ettinger also noted that the tests particles/cc or less), the PortaCount penetrations summarized in the NIOSH of the Bullard, Clemco, and 3M cannot distinguish between particles in study (Exs. 4–1, Table 2; 4–14, Table I).

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The few discrepancies were small, and Wood calculated 95% confidence Rappaport and Kupper, who indicated could be attributed, for example, to limits for the average and maximum that, while some modeling may be rounding off values. The 95th penetration values during each exercise. useful, concerns remain regarding the percentiles in the NIOSH study were In doing so, he assumed that pre-test lack of model validation (Ex. 1–182–1). based on a formula using the geometric and post-test background, and chamber Furthermore, OSHA finds merit in mean and geometric standard deviation, aerosol measurements were distributed Thomas Nelson’s comment that a simple and assumed that the distribution was normally, since no movement variables analysis of the entire data may log normal. For comparison, the were present. He then calculated aerosol sufficiently cover the relevant sources of reviewers calculated the 50th and 95th penetration. Wood found that the variation in these data (Ex. 1–174). percentiles based on the raw data alone photometer reading averages and Databases of the information used by the (i.e., assuming no distribution). Using standard deviations that he analyzed for Agency in its analyses have been placed this approach, the LLNL reviewers all 144 data sets were in agreement with in the docket for review by interested noted that, for many respirator models, the LLNL figures, and that rounding off parties (Exs. 5–3, 5–4, 5–5). the 50th percentile differed markedly figures accounted for any minor The Agency also recognizes that WPF from the geometric mean. They also saw differences in average penetrations that and SWPF studies have their strengths differences between the 95th percentile he calculated. and weaknesses. SWPF studies can calculated using a log normal In summary, Dr. Wood believed that control for a number of variables, thus distribution and the corresponding the quality of the data, experimental providing less variable results across percentile determined directly from the protocol, measurements and data, and respirators classes than WPF studies. data. LLNL reviewers stated that the calculations applied to the data in the Also, SWPF studies can test respirators NIOSH study demonstrated the ORC–LLNL study were excellent. He safely at the limits of their effectiveness. advantages of SWPF studies for half- agreed with the authors’ conclusions However, WPF studies evaluate mask respirators. Their results confirm that SWPF studies are useful for respirators during use in the workplace. the quality of this important SWPF comparing respirators, and that the Therefore, the Agency believes that study of filtering facepiece and study protocol was reproducible. WPF or SWPF studies provide elastomeric half-mask respirators. complementary information. D. OSHA’s Overall Summary OSHA developed the proposed APFs 3. ORC Study of PAPRs and SARs Conclusions using a multi-faceted approach. The Prior to this current rulemaking, Agency reviewed the various analyses of In 1997, ORC and a group of its OSHA explored several procedures to respirator authorities, available WPF member companies sponsored a study evaluate and compare respirator and SWPF studies, and other APF of 11 powered air-purifying and performance across models, studies, literature. For example, OSHA reviewed supplied-air respirators (PAPRs and agents, and testing protocols. The Brown’s analyses and noted no SARs) to evaluate the protection that Agency thoroughly reviewed the difference in performance between these respirators afforded to workers in available data on respirator performance filtering facepiece and elastomeric half- the pharmaceutical industry. The study, to determine the current concepts, and mask APRs, and that few data pairs from ‘‘Simulated Workplace Protection Factor possible methodologies, for deriving the combined data sets analysis failed to Study of Powered Air Purifying and APFs. To evaluate the data, OSHA had achieve a WPF of 10. In addition, the Supplied Air Respirators’ (Ex. 3–4–1) to make several decisions. data from WPF and SWPF studies, as was completed in 1998 by researchers at For example, while OSHA was aware well as a qualitative review of the LLNL. OSHA requested Dr. Gerry Wood that particle size can affect available APF literature, supported an of LANL to evaluate ORC’s LLNL study. concentration values, the Agency was APF of 10 for all half-mask APRs. He evaluated the study using the data unable to quantify this factor based on Therefore, OSHA is proposing an APF received from ORC, as well as available information. Consequently, of 10 for half-mask APRs. The Agency information on the study published in OSHA did not attempt to adjust for used a similar approach in developing the American Industrial Hygiene differences in particle size in the the remaining proposed APFs. Association Journal (Exs. 3–1, 3–4–2). analyses. Furthermore, the Agency had In conclusion, the APFs proposed by The raw data files from the study to decide how to address sampling OSHA in this rulemaking represent the consisted of instantaneous (0.1 second) results that were below the limit of Agency’s evaluation of all the available photometer aerosol measurements detection (LOD). Accordingly, whenever data and research literature; i.e., a obtained before, during, and after 12 sampling results were below the limit of composite evaluation of all the relevant exercise periods (including four periods detection, OSHA set the Ci at a quantitative and qualitative information. of normal breathing) performed by each percentage of the LOD reported in the The Agency seeks comment on this study participant. The instantaneous study. When the study reported approach, as well as the proposed APFs penetration results for the 144 tests were extremely low Ci results as a percentage developed using this approach. plotted against time. Wood examined of the LOD, the Agency used the values patterns of aerosol penetration into the provided by the authors. E. Summaries of Studies respirator that occurred throughout OSHA was concerned that the Researchers often determine the testing, noting that certain exercises analyses be those best able to account protection afforded by a respirator by often exhibited penetration spikes. He for parameter uncertainty, and be a conducting Workplace Protection Factor found that running in place produced measure of respirator effectiveness that (WPF) studies and Simulated Workplace the most penetration spikes. However, is valid over a plausible range of Protection Factor (SWPF) studies. A he also noted other respirator/subject concentrations for each of the agents WPF study measures the effectiveness of combinations result in spikes. Wood against which the respirator is to be respirators under workplace conditions. indicated that such non-random used. As discussed above, the Agency Workers participating in a WPF study distributions of readings was not contracted with Drs. Nicas and Brown to wear respirators while performing their surprising, as different movements independently evaluate the raw WPF usual job tasks. The WPF is a measure during an exercise should affect data. As a result of these analyses, of the reduction in exposure achieved instantaneous penetrations differently. OSHA preliminarily agrees with Drs. while using respiratory protection and

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is the ratio of the concentration of the facility used torches to cut an aircraft cadmium or lead detected), and no contaminant found in the workplace air carrier into large sections that were then mention is made of adjusting the data to the concentration found inside the cut into smaller pieces on shore. for pulmonary retention of particles. In respirator facepiece. Similarly, a SWPF Burners and firemen, on the ship and on addition, samples were invalidated as a study measures the ratio of a shore, were sampled for lead. Work rate result of equipment and procedural contaminant’s concentration both at the colorant facility was judged to be problems, and if the outside filter outside and inside the facepiece. low, while the work rate of the ship weights were less than 100 times the However, researchers obtain these breaking workers was assessed as being limit of detection (or 101 times the field measurements in test chambers, which moderate. The respirator used in the blank value). The authors reported a allows them to control some important study was a 3M 6000 series elastomeric mean WPF of 353, with a fifth percentile variables (e.g., outside concentration of half-mask equipped with either 3M of 34, for the cadmium samples, and a the challenge agent). Rather than 2040 or 3M 2047 HEPA filters (the 2047 mean WPF of 135, with a fifth percentile performing the actual job tasks found in HEPA filter has some activated charcoal of 15, for the lead fume samples. The a particular work setting, the study for removal of nuisance levels of organic authors noted a sizable difference in participants perform a series of vapors). Employees normally wore the WPFs for cadmium and lead (using the exercises in the test chamber that study respirator and were provided with same respirator), and discussed a simulate the actions of workers in training in its proper donning, fitting, number of possible reasons for the general. and operation. In addition, the difference (e.g., differences in particle In developing the proposed APFs employees had to pass a saccharin size, work environment, work rate). The listed in Table 1 of the proposed qualitative fit test prior to study authors concluded that the ANSI Z88.2– amendments to the standards (Section participation; they also had to be clean- 1992 recommended APF of 10 for half- XII). OSHA reviewed data from properly shaven. The study was explained to the facepieces was appropriate. conducted WPF studies and SWPF participants and they were observed on Study 1C. In a poster presentation at studies. In addition, the Agency a one-on-one basis throughout the the 1992 AIHCE, C.E. Coulton and H.E. reviewed published APF tables. These sampling periods. Mullins provided results of a study of data formed the basis for OSHA’s The inside-the-facepiece sampling several contaminants (Ex. 1–146). proposed APFs. OSHA also reviewed train consisted of a 25 mm three-piece Exposure to iron (Fe), manganese (Mn), other types of studies, such as Effective cassette with a 0.8 micron pore size titanium(Ti), and zinc (Zn) were Protection Factors (EPF) and Program mixed cellulose ester filter. Respirators determined for shipyard workers Protection Factor (PPF) studies, along were probed with a Liu probe inserted involved with welding and grinding. with respirator performance studies that opposite the mouth and projecting one The respirators studied were 3M 9920 lacked raw data. A review of those cm into the facepiece. The sampling and 3M 9925 dust/fume/mist disposable studies can be found in the Docket (Exs. cassette was attached directly to the respirators. 3–10, 3–11). However, EPF and PPF probe, and a cassette heater was utilized At the Agency’s request, 3M provided studies account for aspects of respirator to prevent condensation of moisture the raw data from the study, but the use other than effectiveness of the from exhaled breath. Outside-the- information provided had no discussion respirator while it is being worn, while facepiece samples used a 25 mm three- of sampling or analytical methodologies. studies that lack raw data give little piece cassette with a 0.8 micron pore However, in a brief abstract, the authors information for in-depth statistical size mixed cellulose ester filter. The mention using blank samples and analysis. Therefore, OSHA relied on outside sample cassette was also observing participants during sampling WPF and SWPF studies, since they connected to a Liu probe, and this (in the context of discarding particular attempt to account for actual use combination was attached in the sample sets). Outside- and inside-the- conditions and focus on the worker’s breathing zone. Inside samples facepiece concentrations, and associated performance characteristics of the and outside samples were collected at a WPFs, were provided for the four respirator only. flow rate of 2 Lpm. Respirators were analytes: Fe (31 data sets), Mn (32 data donned and doffed, and sampling trains sets), Ti (28 data sets), and Zn (32 data 1. WPF Studies—Filtering Facepiece started and stopped, in a clean area. sets). Calculated WPFs ranged as and Elastomeric Half-Mask Respirators Field blanks were used for follows: 24 to 1010 for Fe, 10.21 to 715 Study 1B. C.E. Coulton, H.E. Mullins, contamination evaluation. Particle size for Mn, 50.38 to 2545 for Ti, and 27.41 and J.O. Bidwell gave a presentation at distribution was ascertained with a six- to 854.89 for Zn. Tom Nelson (Ex. 135) the May 1994 American Industrial stage single-jet cascade impactor that calculated a geometric mean (GM) of Hygiene Conference and Exposition sampled all day at 1 Lpm. 147, a geometric standard deviation (AIHCE) on worker protection afforded Samples were analyzed by (GSD) of 2.5, and a best estimate fifth by the same respirator in two different inductively coupled plasma (ICP) percentile of 33 for the 32 sample sets environments and against two different spectroscopy. For both cadmium and he used in evaluating this study. The contaminants (Ex. 1–64–13). At the first lead, the authors presented the range of information he provided contained no site, the authors determined exposure to outside concentrations, inside additional discussion of the results or cadmium dust for 18 workers in a concentrations, and the associated study conclusions. plastic colorant manufacturing facility. geometric means and standard Study 1D. Workplace performance of They determined exposure to lead fume deviations. Three sets of WPFs were an elastomeric half-mask against for 18 workers during ship breaking and determined for cadmium and lead, exposure to lead was reported in 1984 recycling at the second site. At the based on three different methods for by S.W. Dixon and T.J. Nelson for 11 colorant facility, cadmium-containing reporting inside samples that were workers in an unidentified work pigments were weighed, mixed with below the limit of detection (LOD) (i.e., environment (Ex. 1–64–19). The plastic resin, and fed into extruders for calculating WPF using 70% of the LOD; participants’ work rate was judged to be production of concentrated colorant. calculating WPF using the LOD; or moderate to heavy. Workers viewed a Samples were obtained from workers in eliminating these samples from the WPF training program and selected from the weighing, mixing, and extruding calculation database). No field blank three mask sizes of a Survivair 2000 areas. Workers at the ship breaking adjustments were made (i.e., no elastomeric half-mask respirator,

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equipped with organic vapor/high- concentrations versus blood lead levels filters; they noticed a slight trend for efficiency particulate filters. (a table and graph of this data was heavier deposition at the filter center Participants were qualitatively fit tested provided). They concluded that the half- using both methods. They also with isoamyl acetate. Prior to mask respirator they tested provided computed the precision of sample participation, employees were WPFs that exceeded an APF of 10, and gathering using open- versus closed-face quantitatively fit tested with a Dynatec/ provided program protection factors cassettes and found no difference Frontier FE250A portable unit while (PPFs) that exceeded 10. between the methods. wearing the Survivair with high- Study 2. Workplace protection against Asbestos analysis was based on efficiency filters and performing six exposure to asbestos fibers (chrysotile NIOSH method P&CAM 239 and NIOSH ANSI-recommended exercises. In and amosite) was reported at the 1985 method 7400 (i.e., the filter mounting addition, paired (before and after) AIHCE by T.J. Nelson and S.W. Dixon and ‘‘A’’ counting rules). To increase quantitative fit tests were performed for for 17 workers who removed asbestos- analytical sensitivity, the methodology about half of the WPF determinations to containing materials at two sites (Ex. 1– was modified by counting fibers in a ascertain if quantitative fit tests can 64–54). Six of these workers were minimum of 500 fields per inside-the- predict WPFs. Participants were removing asbestos fireproofing from a facepiece filter when less than 100 instructed not to break the faceseal ceiling at the first site, while eleven fibers were counted. The actual number during sampling, and were observed workers at the second site were of fibers counted in each sample was throughout the sampling period. removing asbestos-containing pipe used to compute the airborne Samples were collected on 25 mm 0.8 insulation. The participants’ work rate concentration. In addition, one micron pore size polycarbonate filters, was judged to be moderate, site microscopist performed all fiber for 30 to 120 minutes (a complete job temperatures ranged from 65–85 degrees counting. The distributions of fiber cycle) at a flow rate of 2 Lpm. Sampling Fahrenheit, and humidity was very length and diameter were determined by trains were calibrated before and after high. transmission electron microscopy using each day’s sampling, and respirators The following six brands of half-mask lapel sample filters. The GM and GSD were disassembled, cleaned, and respirators were studied: 3M 8710 values for the fiber length, fiber reassembled at the end of each day. The disposable dust/mist respirator; 3M diameter, and equivalent aerodynamic authors do not provide a more detailed 9910 disposable dust/mist respirator; diameter at each worksite and the discussion of the inside or outside American Optical R1050 disposable combined data from both sites were sampling trains (e.g., type of respirator dust/mist respirator; Survivair 2000 reported, but the values for fiber density probe, placement of outside sampling elastomeric respirator with high- and the length-diameter correlation apparatus). Particle size analysis was efficiency filters or DFM filters; MSA coefficient were not provided. A total of performed using light microscopy and Comfo II elastomeric respirator with 84 pairs of inside and outside fiber scanning electron microscopy. high-efficiency filters or DFM filters; concentrations, and corresponding Proton induced x-ray emission and a North 7000 elastomeric respirator WPFs, were provided by participant, analysis (PIXEA) was used to analyze with high-efficiency filters. Participants respirator brand, and sampling period in the samples. This method’s limit of were trained in respirator use by the supplemental data tables. However, the detection was 2 nanograms per sample. investigators and were qualitatively fit authors considered seven WPF values The authors provide an approximate tested using the saccharin fit test. measured for the American Optical particle aerodynamic diameter based on Supplemental data indicate that respirator as suspect because the inside- the particle size analyses. Inside-the- participants wore one or more respirator the-facepiece filter samples contained facepiece results were corrected for brands. No mention is made of glass fibers, originating from the losses caused by the sample probe but respirator donning and doffing respirator’s filter matrix. These glass were not corrected for lung deposition procedures, or starting sampling trains fibers have the same appearance as (which the authors believed caused only in a clean area; however, the sampling asbestos fibers under light microscopy. a small bias). Thirty-seven WPFs were procedures state pumps were stopped The authors did not adjust measured determined; however, the individual and cassettes removed in a dust-free values for field blank values (i.e., blanks data sets (i.e., inside concentration, area. Participants were observed by the were below the limit of quantification) outside concentration, and associated researchers throughout the sampling or fiber retention in the respiratory tract WPF) were not provided. During the period. (i.e., the authors believed that study, some participants were observed The inside-the-facepiece sampling pulmonary fiber retention resulted in to break the faceseal to talk. The authors train was a 25 mm closed-face three- only a slight change in concentration provide an overall range of WPFs piece cassette with a 1⁄2-inch extender, inside the facepiece). achieved, GM, and GSD, for undisturbed containing a 0.8 micron pore size mixed The 3M 8710 results showed a GM facepiece samples and pooled disturbed cellulose ester filter. The cassette was WPF of 310, a GSD of 5.3, and a best and undisturbed facepiece samples. The attached directly to a tapered probe estimate of the fifth percentile of 20. authors reported a GM WPF of 3,400, inserted into the respirator midway The 3M 9910 had a GM WPF of 580, a and a best estimate of the fifth between the nose and mouth. In-mask GSD of 4.2, and a best estimate of the percentile of 390 when the facepiece samples were collected at a flow rate of fifth percentile of 55. The AO R1050 was not disturbed, and a GM WPF of 2.0 Lpm. The outside-the-facepiece had a GM WPF of 52, a GSD of 4.2, and 2,400, and a best estimate of the fifth sampling cassettes and probes were a best estimate of the fifth percentile of percentile of 160 when the facepiece identical to the inside-the-facepiece 5. The Survivair 2000 or MSA Comfo II was disturbed. The authors also found sampling train and were fastened to the equipped with DFM filters had a GM no correlation (at the 5% level) between lapel of the subject. Outside samples WPF of 240, a GSD of 6.3, and a best WPF and outside concentration, or the were gathered at 0.5 to 1.0 Lpm. estimate of the fifth percentile of 12. relationship between WPF and Sampling times ranged from 30 to 120 With high-efficiency filters, the GM quantitative fit factors for predicting minutes, and the pumps were calibrated WPF was 94, the GSD was 3, and the workplace protection. The authors also before and after each sampling period. best estimate of the fifth percentile was estimated the program protection factor The authors investigated uniform 16. For the North 7700 equipped with based on historical measures of air lead deposition of asbestos fibers across the high-efficiency filters, the GM WPF was

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250, the GSD was 6.9, and the best The inside-the-facepiece sampling intervals were 30 and 74 for the dual estimate of the fifth percentile was 11. train consisted of a closed-face three- cartridge respirators. The fifth percentile Since the WPFs for respirators piece cassette with a 25 mm organic was 9. The authors found no significant equipped with DFM and high-efficiency binder free glass fiber filter, backed with relationship between B(a)P filters were similar, and were well a cellulose ester pad. The sampling concentrations inside and outside the below the protection expected if filter cassettes were connected to a tapered facepiece. Also, while the data were efficiency alone was the determining Liu probe inserted into the respirator limited, the authors believed no performance factor, the authors between the nose and mouth. The correlation existed between WPF and concluded that ‘‘* * * filter efficiency outside-the-facepiece sampling train quantitative fit factor. The authors was not as significant a factor in was identical to the inside-the-facepiece concluded that the fifth percentile for determining the relative workplace sampling train; however, no mention is the half-masks they tested were in performance against asbestos as the face made of connecting the cassette to a Liu agreement with the APF of 10 fit’’. The authors also noted comparable probe. All filters were pre-calcined at recommended by the NIOSH RDL. performance between disposable and 400 degrees Centigrade for 24 hours. Study 6. S.W. Lenhart and D.L. elastomeric respirators. With regard to Both inside and outside samples were Campbell reported in 1984 on a WPF this, the authors noted that perspiration collected at a flow rate of 2 Lpm for study in which they measured and wetting solutions led to the approximately 300 minutes, or one-half protection against exposure to elastomeric facepieces slipping on the of the 10-hour work shift. Respirators particulate lead (Pb) for 25 primary lead participants’ faces, something that was and sampling trains were worn and smelter workers; seven of whom worked not noted with the fibrous disposable operated until the employee entered the in the sinter plant and eighteen of respirators. The authors postulate that rest area; they were donned and started whom were in the blast furnace area the effect of this slippage could be a prior to leaving the rest area for the next (Ex. 1–64–42). The predominant aerosol reason why the two types of respirators work cycle. Sampling cassettes were forms of lead were dust in the sinter had similar performance. plugged when not in use and the plant and fume in the blast furnace. In Study 3. In 1993, A. Gaboury and D.H. respirators were cleaned after each work both areas, lead comprised about 50% of Burd performed a WPF study by cycle. Field blanks were used to identify the total aerosol particulate with measuring exposure to benzo(a)pyrene possible contamination due to handling. composition of the remaining 50% [B(a)P] on particles among 22 workers in Sampling train airflow rates were being unknown. All participants wore a primary aluminum smelter (Ex. 1–64– checked at the beginning, middle (i.e., an MSA elastomeric half-mask with 24). The participants were rack raisers, after lunch), and end of the work day; high-efficiency filters. (Note: No stud pullers, and rod raisers on anode on changing the cassettes; and when a respirator model number was provided) crews. The following three brands of problem was suspected. Sampling The study also examined the elastomeric half-mask respirator devices occurred over a five-day period. Only performance of an MSA PAPR, but only were studied: Willson, Survivair, and stud pullers and rod raisers used the data for the negative-pressure, air- American Optical. (Note: Respirator elastomeric half-mask respirators. purifying half-mask respirator are model numbers were not provided) The presented here (the PAPR results are respirators were equipped with B(a)P analysis followed the Alcan discussed below). The employees combination organic vapor/acid gas Method #1223–84. The ambient B(a)P routinely used respirators; however, no cartridges and DFM pre-filters, with the particle size distribution was mention is made of them with respirator exception that dust/mist pre-filters were determined by collecting four samples, training. Participants were used on the American Optical as close as possible to the workers, quantitatively fit tested using an respirator. The study also examined the using an 8-stage Anderson cascade unspecified method, and had to achieve performance of a powered air-purifying impactor (Model 296). Impactor samples the employer’s required fit factor of 250. respirator (PAPR), but only the negative- were collected for two to five hours at Workers were instructed not to remove pressure, air-purifying half-mask a flow rate of 2 Lpm. The average or manipulate the respirator during respirator data are presented here (the percent of B(a)P mass (across four sampling, and were observed by the PAPR results are discussed below). The samples) per impactor stage (defined by researchers throughout the sampling participants had used respirators for an aerodynamic diameter cut point, in period. several years, had been previously micrometers) was reported. About 93% The inside-the-facepiece sampler trained in the use of the particular of the B(a)P mass was associated with consisted of a closed-face 37 mm respirator under study, and had used it particles having diameters of less than cassette containing an AA filter and for more than six months. All 9.8 micrometers. A total of 18 pairs of AP10 support pad. This cassette was participants in half-mask respirators inside and outside sample connected to a tapered Liu probe that were clean-shaven and were concentrations, with associated WPFs, was inserted into the respirator between quantitatively fit tested using the TSI were provided by brand of respirator the nose and upper lip. In-mask samples Portacount. The minimum acceptable fit and job category, but were not linked to were collected at 2 Lpm. The outside- factor was 100. Industrial hygiene specific participants. Overall GM, GSD, the-facepiece sampling train was a technologists assisted participants with and 95% confidence interval on the closed-face 37 mm cassette containing donning and doffing respirators, cleaned mean were also provided for the inside an AA filter and AP 10 support pad; no and maintained the respirators at the and outside concentrations and WPF, tapered Liu probe was used. The outside end of each work cycle, and observed along with an overall fifth percentile sample cassette was attached to the participants on a one-to-one basis WPF. The authors stated that some worker’s lapel. Outside samples were throughout the sampling period. employees participated more than once gathered at 2 Lpm. The authors Participants were directed not to tamper during the study. No mention is made collected samples for as much of each with the respirator or sampling of adjusting inside-the-facepiece 8-hr work shift as possible. Respirators equipment. Due to the high heat in the concentrations for particle retention in and sampling trains were donned and work area, the employer required that the respiratory tract. The half-masks had doffed, and samplers were started and employees rest in a cool environment WPF ranging from 13 to 410, with a GM stopped, in a lead-free area. Respirator for one-half hour during each hour. of 47. The two-sided 95% confidence facepieces were wiped clean inside

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prior to donning after each break and brands of half-mask devices were monitoring times of approximately one cleaned and sanitized after each shift. studied: 3M 9920 disposable DFM to four hours. Respirators were donned One WPF was measured for each respirator; American Optical 5-Star and doffed, and sampling trains were employee. The ambient particle size elastomeric respirator with DFM filters started and stopped, in a clean area. distribution was determined using 19 (R56A); MSA Comfo II elastomeric Elastomeric facepieces were cleaned Marple cascade impactor samples (11 in respirator with DFM filters (Type S); and inspected at the end of each shift, the sinter plant; 8 in the blast furnace and Scott Model 65 elastomeric but were not wiped out during the shift area). respirator with DFM filters (642–F). unless such wiping was a standard Lead analysis was by flame atomic Participants were selected from practice before the study (the authors absorption spectroscopy according to volunteers who normally wore noted that most of the time workers did NIOSH Method S–341. Inside-the- respirators, were clean-shaven, and not wipe out facepieces). Air-purifying facepiece samples that contained less passed a fit test. Their work rate was filters (cartridges) and disposable than l0ug of lead were reanalyzed by subjectively determined by observing respirators were changed at the end of graphite furnace atomic absorption their work activities. Respirators were each shift unless the employer’s policy (limit of detection = 0.2 µg). The ranges worn for the usual period. For the dictated more frequent changing. In for the mass median aerodynamic elastomeric half-mask respirators, the addition, the mouth of the in-mask diameters (in micrometers) and for the participants were quantitatively fit probe was plugged whenever the GSD values were reported. A total of 25 tested using a TSI Portacount; a fit factor respirator was not being worn. Working pairs of inside and outside half-mask of 100 or more constituted a pass. (field) blanks and manufacturer’s values, and the corresponding WPFs, Disposable respirators were fit tested (media) blanks were used to determine were provided by employee, job title, using the saccharin qualitative fit test. possible contamination of filters due to and job location. An overall GM and The investigators trained the handling or manufacturing. The GSD of the WPFs, and various participants in the proper donning and investigators also washed the interior of percentile WPFs, were provided. When adjustment of the respirators, and the sampling cassettes to ascertain samples contained lead below the level instructed them not to remove or lift the retention of sample particles on the of detection, the authors reported respirator from their face in the work cassette wall. The ambient particle size concentration values ‘‘*** area. Readjustment of the respirator had distribution was determined by PIXE 8- determined from the least amount of to be accomplished by sliding the stage cascade impactor samples at lead detectable by the analytical method facepiece on their face. Workers were several work locations in each foundry. and the sampled volume of air.’’ observed throughout the sampling These area samples were collected at In-mask values were not adjusted for period. Each participant wore two or roughly mid-chest to shoulder level of particle retention in the respiratory tract more respirator brands, and one WPF workers for approximately 1 hour, to (the authors imply retention probably was measured per employee for each prevent impactor overloading. had a non-significant effect on results, brand worn. but could result in overestimated The inside-the-facepiece sampling All samples were analyzed by proton WPFs). No mention is made of the train was a 25 mm closed-face cassette induced X-ray emission analysis investigators using field blanks. They attached directly to a flared mouth (PIXEA). The mass distribution of Pb, reported that approximately 98% of the probe, inserted into the respirator Zn, and TAM by particle aerodynamic WPFs would be expected to be at or opposite the mouth. The cassette diameter was graphically presented for above 10, 90% above 30, and 75% contained a 0.5 micron pore size all cascade impactor samples. Across would be expected to be above 100. polyethylene filter and polypropylene the three foundries, 66 pairs of inside- They concluded that an APF of 10 was backup pad. A 4.5 mm ring under the the-facepiece and outside-the-facepiece appropriate for the half-mask negative filter restricted airflow to an 18 mm concentrations, and the corresponding pressure air-purifying respirator circle in the center of the filter to keep WPFs, were provided by job task, evaluated in this study. The authors also deposition in an area that could be employee, brand of respirator, and discussed two proportional methods of entirely covered by the proton beam analyte (Pb, Zn, and TAM). The authors defining an APF. used for sample analysis. A heating did not adjust measured values for Study 7. W.R. Meyers and Z. Zhuang bonnet was slid over the outside of the particle retention on sampling cassette conducted a 3-part workplace protection cassette to minimize condensation of walls since these losses appeared to be factor study in three different work moisture from exhaled breath. Sampled random, independent of collected mass, environments. In addition to presenting air was then drawn through a moisture and of a negligible amount. No mention the study findings, the authors also trap using a personal sampling pump is made of correcting measured in-mask discuss their rationale for selecting operating at 2 Lpm. The outside-the- values for pulmonary particle retention. exposure agents, study facilities, and facepiece sampling train was a 10 mm A foundry-specific average of the field workers; study procedures followed at nylon cyclone attached to 25 mm blank loadings was used as a correction the sites; and analytical methods. W.R. closed-face cassette (the cassette was not factor for estimating background and Meyers and Z. Zhuang in January, 1993 connected to a flared mouth probe). The handling contamination for each (Ex. 1–64–51) and W.R. Meyers, Z. cassette contained a 0.5 micron pore foundry. Outside-the-facepiece samples Zhuang, and T.J. Nelson in 1996 (Ex. 3– size polyethylene filter and were collected as respirable particulate, 12) reported on the first part of the polypropylene backup pad. A 4.5 mm thereby providing respirable mass study in which the authors determined ring under the filter restricted airflow to levels, while in-mask samples were protection against exposure to an 18 mm circle in the center of the collected as total particulate mass. The particulate lead (Pb), zinc (Zn), and total filter. This sampling train was attached authors initially assumed that particles airborne mass (TAM) for 25 workers, on in the lapel area and samples were larger than 10 microns did not penetrate day and evening shifts, in three brass collected at a flow rate of 1.7 Lpm. respirator faceseals; however, this was foundries (3, 9, and 13 participants, Two separate samples were gathered found to be incorrect after analyzing in- respectively). (Note: The reports during the shift, one during the first half mask particle size. Therefore, to avoid mention 26 participants, but data were and another during the second half. comparison of dissimilar measurements, presented for only 25 participants.) Four Individual WPFs were based on the investigators used particle size data

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obtained by ambient sampling to study and sampling protocols were donned and doffed, and sampling trains convert the respirable mass levels to discussed by the authors in the foundry were started and stopped, in a clean total mass levels (using Chimera/TSI portion of the investigation (see Study 7 area. New cassettes were used for each Disfit software). The reported levels discussion above). While not sampling period. Working (i.e., field) represent these total mass values, and specifically discussed, it is assumed that blanks and manufacturer’s (media) form the basis of the reported WPF the same sampling parameters used in blanks were used to determine possible values. The authors also provide data the foundry study were in place during contamination of filters due to handling and discussion on a number of sampling this particular study, unless the authors or manufacturing. The investigators also analyses, including GM concentration of stated otherwise. These assumptions washed the interior of the sampling analyte by job task, GM concentration of include: composition of the sampling cassettes to determine retention of analyte for in-mask and ambient trains was unchanged; individual WPFs sample particles on the cassette wall. concentrations, particle size distribution were based on monitoring times of one The ambient particle size distribution by job category, GM WPF estimates by to four hours; elastomeric facepieces was determined by PIXE cascade job category, GM WPF by respirator were cleaned and inspected at the end impactor samples. Personal impactor type, within shift sampling variation, of each shift but the insides were not samples, rather than area samples, were and variation between foundries. For wiped during the shift such wiping was collected at the steel mill sites (see the pooled data from the three the employer’s standard practice before foundry sampling procedures discussed foundries, the 3M 9920 filtering the study; air-purifying filter cartridges above in Study 7). facepiece had a 50% WPF of 108, a GSD and disposable respirators were changed Analysis for Fe and Ca on inside-the- of 5.2, and a fifth percentile estimate of at the end of each shift unless the facepiece filters was by proton induced 7. The AO half-mask had a 50% WPF employer’s policy dictated more X-ray emission analysis (PIXEA). Due to estimate of 98, a geometric standard frequent changing; and the in-mask filter overloading, analysis for Fe and Ca deviation (GSD) of 5.8, and a fifth probe mouth was plugged whenever the on outside-the-facepiece filters was by percentile WPF of 5. The MSA Comfo II respirator was not being worn. In atomic absorption spectroscopy. The half-mask had a 50% WPF of 163, a GSD addition, it is assumed that the mass distribution of Fe by particle of 3.1, and a fifth percentile WPF of 26. participants were clean shaven, aerodynamic diameter was tabulated for The Scott half-mask had a 50% WPF of normally used respirators, were trained all cascade impactor samples. A total of 94, a GSD of 4.8, and a fifth percentile in the proper donning and adjustment of 54 individual pairs of inside- and WPF of 7. For all respirators a 50% WPF the respirators, were instructed not to outside-the-facepiece concentrations, of 114, a GSD of 4.6, and a fifth remove or lift the respirator from their and the corresponding WPFs, were percentile estimate of 9 was reported. face in the work area, and were provided by shift and date, job category, The authors concluded that ‘‘*** observed throughout the sampling employee, and brand of respirator. For dust-fume-mist (DFM) half-facepiece period. 16 workers, the WPFs reported were respirators, when conscientiously used, based on the Fe data, while Ca data The inside-the-facepiece sampling worn, and maintained, provided were used to calculate the WPF for one train was a closed-face 25 mm cassette effective worker protection.’’ worker (flux unloader) in the BOP Study 8. W.R. Meyers and Z. Zhuang containing a 0.5 micron pore size facility. Based on analytical in January, 1993 (Ex. 1–64–51) and W.R. polyethylene filter and polypropylene information, the authors did not adjust Myers, Z. Zhuang, and T.J. Nelson in backup pad. A reducing ring under the measured values for particle retention 1996 (Ex. 3–12) reported on the second filter restricted airflow to an 18 mm on the walls of the sampling cassette. part of the three-part study, which circle in the center of the filter to aid in No mention is made of adjusting inside- evaluated protection against exposure to PIXE analysis. A heating bonnet was the-facepiece values for particle particulate iron (Fe) for 16 workers in slid over the outside of the cassette to retention in the respiratory tract. The the sinter plant and basic oxygen minimize condensation of moisture average field blank mass loading was process (BOP) facility of a steel from exhaled breath. This cassette was used as a correction factor for estimating manufacturing plant. In addition, attached directly to a flared mouth background contamination. The 3M exposure to particulate calcium (Ca) in probe, inserted into the respirator 8710 had a reported GM WPF of 377, a the BOP facility was determined for one opposite the mouth. Sampled air was GSD of 3.7, and a fifth percentile WPF worker. The five brands of half-mask drawn through a moisture trap using a of 44. The Gerson 1710 had a reported respirators studied were: 3M 8710 personal sampling pump operating at GM WPF of 123, a GSD of 2.7, and a disposable dust/mist respirator; Gerson 1.5 Lpm. The outside-the-facepiece fifth percentile WPF of 24. The 1710 disposable dust/mist respirator; sampling train was a closed-face 25 mm American Optical elastomeric half-mask American Optical 5-Star elastomeric cassette containing a 0.5 micron pore had a reported GM WPF of 280, a GSD respirator with dust/mist filters (R30); size polyethylene filter and of 2.7, and a fifth percentile WPF of 56. MSA Comfo II elastomeric respirator polypropylene backup pad. A reducing The MSA Comfo II had a reported GM with dust/mist filters (Type F); and ring under the filter restricted airflow to WPF of 427, a GSD of 4.3, and a fifth Scott, Model 65 elastomeric respirator an 18 mm circle in the center of the percentile WPF of 39. The Scott with dust/mist filters (642–D). filter. The cassette was not connected to elastomeric half-mask had a reported In general, each participant wore two a flared mouth probe. This sampling GM WPF of 252, a GSD of 2.9, and a or more brands, and one WPF was train was attached in the lapel area and fifth percentile WPF of 45. The authors measured per employee per brand worn. samples were collected at a flow rate of concluded that ‘‘The 5th percentiles for One employee had one WPF determined 1.5 Lpm. (Note: Unlike the foundry the WPF distributions for each for only one respirator brand. For the portion of the study, outside samples respirator or pooled data were greater elastomeric half-mask respirators, the were collected as total mass rather than than 20.’’ participants were quantitatively fit respirable mass samples.) Sampling The authors also provided data and tested. A fit factor of 100 or more pump flows were calibrated before and discussion on a number of sampling constituted a pass. Disposable after each sampling period and pumps analyses, including GM concentration of respirators were fit tested using the were monitored at approximately 15–20 analyte and GM WPF by job task, GM saccharin qualitative fit test. The overall minute intervals. Respirators were concentration of Fe inside the facepiece

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and ambient and GM WPF by respirator polyethylene filter and polypropylene respirator brand; of the original 38 data brand, and particle size distribution by backup pad. A reducing ring under the sets, two sets were eliminated as job category. The authors stated that filter restricted airflow to an 18 mm outliers. For primer spraying, the ‘‘* * * half-facepiece respirators circle in the center of the filter to aid in reported WPFs were based on Cr data, (maximum use concentration 10 times sample analysis. A heating bonnet was while WPFs for spraying topcoat were the PEL) were a suitable selection for slid over the outside of the cassette to based on Ti data. WPFs were not the tasks included in this study.’’ minimize condensation of moisture calculated for total airborne mass. The Study 9. In January 1993, W.R. Meyers from exhaled breath. This cassette was authors also provided data and and Z. Zhuang reported on the third attached directly to a flared mouth discussion on a number of sampling part of their investigation, in which they probe, inserted into the respirator analyses, including GM concentration of determined protection against exposure opposite the mouth. Sampled air was analyte (TAM, Ti, Cr) for both in-mask to particulate titanium (Ti), chromium then drawn through a moisture trap and ambient measurements by task (Cr), strontium (Sr) and total ambient using a personal sampling pump location on the plane; GM WPF as a mass (TAM) for 22 workers who spray operating at approximately 2 Lpm. The function of painting location on plane painted aircraft on day, evening, and outside-the-facepiece sampling train and paint type, and respirator brand; night shifts (Ex. 1–64–52). The three was a closed-face 25 mm cassette and GM WPF by respirator brand. The brands of half-mask elastomeric containing a 0.5 micron pore size fifth percentile estimates for all WPF respirators studied were the: American polyethylene filter and polypropylene data were reported to be much greater Optical 5-Star, MSA Comfo II, and Scott backup pad. A reducing ring under the than 10. The authors concluded that Model 65. All respirators were equipped filter restricted airflow to an 18 mm these half-facepiece elastomeric with combination high-efficiency filter/ circle in the center of the filter. The respirators, when properly worn and organic vapor cartridges. cassette was not connected to a flared used in conjunction with existing Twelve participants each wore two mouth probe. This sampling train was controls provided effective worker brands of respirator with a WPF attached in the lapel area, and samples protection. determined for each brand worn; nine were collected at a flow rate of 1 Lpm. Study 13. G. Wallis, R. Menke, and C. participants wore one brand of (Note: Unlike the foundry portion of the Chelton reported in 1993 on a WPF respirator and had one WPF study, outside samples were collected as study in which they evaluated exposure determined; and one employee had one total mass rather than respirable mass to manganese dioxide dust for an WPF determined for one respirator samples.) Sampling pump flows were unknown number of participants in brand and two WPFs determined for calibrated before and after each several alkaline battery manufacturing another brand. The participants were sampling period and pumps were plants (number of plants not provided) quantitatively fit tested and a fit factor monitored at approximately 15–20 (Ex. 1–64–70). All participants wore the of 100 or more constituted a pass. The minute intervals. Respirators were disposable 3M 8710 dust/mist respirator overall study and sampling protocol was donned and doffed, and sampling trains and performed their normal work discussed by the authors in the foundry were started and stopped, in a clean activities. The participants were not portion of the studies, summarized in area. New cassettes were used for each trained by the investigators, but had Study 7 above (Ex. 1–64–51). While not sampling period. Working (i.e., field) been previously trained and routinely specifically discussed, it is assumed that blanks and manufacturer’s (media) used respirators. It was not stated the same sampling parameters were in whether the participants had ever been blanks were used to determine possible place during this particular study as in fit tested for the 3M 8710 respirators. contamination of filters due to handling the foundry study, unless the authors Prior to sampling, the participants or manufacturing. The investigators did stated otherwise. These assumptions washed their faces and were taken to a not wash the interior of the sampling include: composition of the sampling clean area, where the study was cassettes to determine retention of trains was unchanged; individual WPFs explained. The participants were particles on the cassette wall, since a were based on monitoring times of one observed throughout the sampling simple alcohol wash would not have to four hours; elastomeric facepieces period. were cleaned and inspected at the end removed dried paint spray. Ambient The inside-the-facepiece sampling of each shift but were not the inside was particle size distributions were not train was a closed-face 37 mm cassette not wiped during the shift, unless such characterized. containing a 0.8 micron pore size mixed wiping was the employer’s standard Analysis of all filters was by proton cellulose ester filter. The cassette was practice before the study; filters and induced X-ray emission analysis connected to a tapered Liu probe (made disposable respirators were changed at (PIXEA). The average field blank mass of nylon) which was inserted into the the end of each shift unless the loading was used as a correction factor respirator midway between the nose and employer’s policy dictated more for estimating background mouth. The outside-the-facepiece frequent changing; and the mouth of the contamination. The authors did not sampling train was a closed-face 37 mm in-mask probe was plugged whenever mention adjusting inside-the-facepiece cassette containing a 0.8 micron pore the respirator was not being worn. In measured values for particle retention in size mixed cellulose ester filter. The addition, it is assumed that the the respiratory tract. A total of 36 outside sampling cassette was attached participants were clean-shaven, individual pairs of inside-the-facepiece to the employee’s lapel. No mention is normally used respirators, were trained and outside-the-facepiece made of connection of the outside in the proper donning and adjustment of concentrations of each analyte (total cassette to a tapered Liu probe. Inside- the respirators, were instructed not to airborne mass, titanium, chromium, and outside-the-facepiece samples were remove or lift the respirator from their strontium) were provided by shift and collected at an airflow rate of 1.5 Lpm face in the work area, and were date, painting location on the plane (i.e., for 30 to 40 minutes. The authors chose observed by the researchers throughout top, side, or underside of the aircraft), a short sampling interval to prevent the sampling period. employee, brand of respirator, and paint resistance across the inside-the- The inside-the-facepiece sampling type (i.e., top coat, primer). A total of 36 facepiece sampling filter due to a train was a closed-face 25 mm cassette WPFs were reported by shift, task buildup of moisture from exhaled containing a 0.5 micron pore size location on the plane, employee, and breath. Sampling pump flows were

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calibrated before, and rechecked after, a WPF study in which they measured report concluded that the respirator each sampling period. Respirators were protection against exposure to provided reliable WPFs of 10. donned and doffed, and the sampling aluminum dust for five participants Cumulative probability of achieving a trains started (and assumed stopped), in working as carbon changers in an particular WPF, and the effect of filter the clean area. Field blanks were used aluminum smelter (Ex. 1–64–15). All weight on WPF, were also graphically to identify possible contamination of participants wore the disposable 3M presented. The authors stated that the filters due to handling. The number of 9906 dust/mist respirator. The WPFs represented conservative sample pairs collected per subject was investigators trained the participants in estimates of protection since outside not specified. The ambient manganese donning the respirator and the concentrations were measured as particle size distribution was participants were qualitatively fit tested, respirable dust. In the summary of this determined by 6-stage Marple Cascade although the fit test method was not study (Ex. 1–146), submitted to OSHA impactor equipped with an inlet cowl to described. The total number of samples along with the raw sampling data, the prevent debris from entering the collected per employee was not authors recommended that the study not impactor. Samples were collected for specified, although it is stated that the be used to assess the ultimate APF for several hours at a flow rate of 2 Lpm, five employees were sampled daily for this class of respirator since they felt and flows were calibrated before and five days. Participants were observed that the real WPF of the respirator was after each sampling interval. Four throughout the sampling period. significantly underestimated. samples were gathered: One in the The inside-the-facepiece sampling Study 15. C.E. Colton, H.E. Mullins, powder drop area (Plant A) and three at train was a closed-face 25 mm cassette and C.R. Rhoe presented a WPF study the bag slitting operations (one in Plant containing a 0.8 micron pore size at the 1990 AIHCE in which they A, two in Plant B). polycarbonate filter. The cassette was determined exposure to particulate Pb Samples were analyzed for Mn by connected to a tapered Liu probe, and Zn for 17 participants working in atomic absorption (AA) spectroscopy inserted into the facepiece in an core making, mold making, pouring, and according to NIOSH Method 7300. The unspecified location. In-mask samples cleaning areas of a brass foundry (Ex. 1– mass distribution of Mn by particle were collected at an airflow rate of 2.0 64–16). All participants wore the aerodynamic diameter was tabulated for Lpm. The outside-the-facepiece disposable 3M 9970 high-efficiency all cascade impactor samples. Less than sampling train was a closed-face 25 mm respirator. The investigators trained the 30% of the mass was associated with cassette containing a 0.8 micron pore participants in the proper donning and respirable particles. A total of 70 size polycarbonate filter. Outside fitting of the respirator, and participants individual pairs of inside-the-facepiece samples were gathered as respirable were fit tested using the saccharin and outside-the-facepiece dust samples with the cassette being qualitative fit test method described in concentrations, and the corresponding connected downstream from a cyclone Appendix D of OSHA’s Lead Standard WPFs, were provided by job activity apparatus. Sampling airflow rate was (29 CFR 1910.1025). Sampling took (but not by employee or plant). No 1.7 Lpm. Sampler airflow rates were place over five days. mention is made of adjusting measured calibrated before and after each sample The inside-the-facepiece sampling values for particle retention in the period. No mention is made of donning train was a 25 mm three-piece cassette respiratory tract or results of field blank and doffing procedures. Field blanks containing a 0.8 micron pore size analysis. A GM of 50 and a GSD of 3.5 were used to identify possible filter polycarbonate filter (open- versus was reported for all the WPF values contamination caused by handling. The closed-face was not specified). The measured. A calculated fifth percentile ambient aluminum particle size cassette was directly connected to a protection factor of 7.5 was also distribution was determined through 12 tapered nylon Liu probe, inserted into reported. The authors reported that their area samples (unspecified locations) the facepiece midway between the nose data indicated a systematic dependence collected by Marple personal cascade and mouth. The inside-the-facepiece of WPF on the concentration outside the impactors. In addition, particulates that samples were collected at a flow rate of respirator. In their discussion of this passed a cyclone selector were sized by 2.0 Lpm. The outside-the-facepiece observation, the investigators refer to optical microscopy. sampling train was a 25 mm three-piece three possible causes presented by Aluminum was determined by proton cassette containing a 0.8 micron pore authors of other studies: Program induced x-ray emission analysis size polycarbonate filter. Outside protection factors tend to be low in low (PIXEA). The mass distribution of samples were gathered as respirable exposure settings since the workers, aluminum by particle diameter and dust samples, with the cassette being aware of the low exposure, exercise less percent penetration to the collector was connected downstream from a 10 mm care; low outside concentrations result graphically presented. Final nylon cyclone. Samples were collected in inside-the-facepiece concentrations calculations used only those outside at a flow rate of 1.7 Lpm, and sampling so small that reliable quantification is filter weights that were greater that 11 pumps were calibrated before and after difficult; and filter efficiency increases times the detection limit. A total of 24 each sample. The authors do not with loading, and low concentrations do time-weighted-average (TWA) inside- mention using of field or manufacturer’s not adequately load the filter. The the-facepiece and outside-the-facepiece blanks, respirator donning and doffing authors discuss these causes relative to concentrations, with corresponding procedures, or methods of starting and their study results, and postulate that TWA WPFs, are provided in stopping sampling trains in a clean area. another cause may be particle size supplemental data (Ex. 1–146). The The ambient Pb and Zn particle size selectivity (i.e., smaller particles have a sample pairs are not linked to specific distributions were determined by an higher probability of entering the participants. No mention is made of unspecified number of Marple personal respirator). They conclude that it is adjusting sample results for particle cascade impactor (Model 2401) samples. important to characterize respirator retention in the respiratory tract. The Pb and Zn were determined by performance in the environment where mean blank value was zero, so no proton-induced x-ray emission analysis the respirator will be used. adjustment to measured values was (PIXEA). The particle size data were not Study 14. At the 1990 AIHCE, C.E. made. The authors reported a GM of 27, presented; however, the report stated Colton, A.R. Johnston, H.E. Mullins, a GSD of 1.5, and a fifth percentile of that the Pb and Zn aerosols were present C.R. Rhoe, and W.R. Meyers presented 13 for the 23 sample sets used. The as both dust and fume. The range of

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outside-the-facepiece and inside-the- from a tapered Liu probe. Outside higher concentrations. In a summary of facepiece concentrations for Pb and Zn samples were collected at a flow rate this study submitted to OSHA (Ex. 1– were provided. For the purpose of WPF between 1.5 and 2 Lpm. Sampling times 146) the authors stated that: calculation, inside-the-facepiece ranged from 35 to 235 minutes. * * * the mass outside the respirator was samples with non-detected Sampling pumps were calibrated three very low. For this reason, the ability of the concentrations were treated as times a day—at the beginning of the respirator to provide protection was not containing analyte at the detection limit shift, lunch, and the end of the shift. challenged. Therefore, this study should not (This situation only arose with lead, not Sampling equipment was removed for be used for direct comparison to others in zinc). For the 62 sample sets taken for breaks, which occurred multiple times assigning protection factors as they are lead, the GM WPF was 415, the GSD in some instances. While no mention is artificially low. was 4.4, and the fifth percentile WPF made of using a clean area to don and The authors also discussed sampling was 36. For zinc, the GM WPF was 681, doff respirators, and start and stop and analytical considerations for WPF the GSD was 5.6, and the fifth percentile sampling trains, the authors noted that studies, such as calibration reliability, WPF was 40. The authors believe they cassettes had to be removed in the work sample cassette integrity, analytical handled their results conservatively area. Field blanks were used to identify sensitivity, and sample handling since outside concentrations were possible filter contamination due to procedures. collected as respirable particulate, handling. The ambient particle size 2. WPF Study—Full Facepiece APR rather than total mass, and inside-the- distribution was not characterized. facepiece samples with non-detected Study 2A. C.E. Colton, A.R. Johnston, Samples were analyzed by proton H.E. Mullins and C.R. Rhoe of the 3M concentrations were given values of the induced x-ray emission analysis analytical detection limit when Occupational Health and Environmental (PIXEA). Sample results were adjusted Safety Division in May,1989 gave a calculating WPF. In the study summary, for field blank values, but no mention the authors concluded that when the presentation at the AIHCE on their WPF was made of adjustments for particle study (Ex.1–64–14) performed with full respirator is properly selected, fit tested, retention in the respiratory tract. The and used, their results supported its use facepiece air-purifying respirators worn authors rejected sample sets in which: in a secondary lead smelter. Air for concentrations up to 10 times the the outside filter weight was less than PEL. sampling for lead was conducted over 5 11 times the mean blank value; the Study 16. A.R. Johnston and H.E. days in four areas of the plant; the blast inside filter weight was non-detectable, Mullins reported at the 1987 AIHCE on furnace, reverberatory furnace, casting, a WPF study in which they measured or less than the mean field blank value; and warehouse areas. exposure to particulate aluminum (Al), or the measured WPF was determined to The respirator evaluated was the 3M titanium (Ti) and silicon (Si) for three be an outlier (i.e., too far above or below 7800 Easi-Air full facepiece respirator participants working in the polishing the geometric mean WPF using 5% used with 3M 7255 high efficiency and grinding area of an aircraft confidence intervals). A total of 38 filters. The respirator was equipped components manufacturing facility (Exs. sample sets were accepted for Al (10), with a nosecup inside the facepiece. 1–64–34, 1–146, 1–133). Although Ti (14), and Si (14). Pairs of inside-the- The sampling probe was inserted into WPFs were also measured for two other facepiece and outside-the-facepiece the respirator in place of the speaking participants, one in the blasting area concentrations, and the corresponding diaphragm to assure a gas tight seal and and one in the coating area, no data WPFs, are provided in supplemental consistent probe location close to the were presented for these employees. All data (Exs. 1–146, 1–133), but were not breathing zone of the wearer. The participants wore the disposable 3M linked to specific participants. Also, a respirators were equipped with 8715 dust/mist respirator. Prior to table of GM WPF, GSD, and fifth sampling probes using a design by Dr. testing, the investigators trained the percentile WPF, by analyte, was Ben Liu to minimize particle entry participants in the proper fitting of the presented. The authors calculated WPF losses. Both the inside and outside respirator, fit tested the employees using values for the 10 sample sets of Al, sampling trains used the Liu designed the OSHA Lead Standard’s saccharin reporting a GM of 145, a GSD of 2.3, and probe for consistency. qualitative fit test method, and a fifth percentile of 32. For the 14 Thirteen workers who normally wore explained the study to them. sample sets measured for Ti, the GM full facepiece respirators in the plant Participants had previously worn was 59, the GSD was 1.7, and the fifth qualified to participate in the study. respirators, but on an ‘‘as needed’’ or percentile was 24. For Si, using 14 They were trained in proper respirator elective basis only. Employees were sample sets, the GM was 172, the GSD use, the procedures to be followed for observed one-on-one throughout the was 3.1, and the fifth percentile was 24. the study, and how to don and fit the sampling period. The number of WPFs The authors concluded that their study 3M respirator. Quantitative fit testing measured per subject was not specified, supports using this respirator for was performed using the Portacount although it appears that about six WPFs concentrations up to 10 times the PEL. QNFT instrument and fit test operators were measured per subject. In addition, the authors noted a positive followed the OSHA Lead standard The inside-the-facepiece sampling correlation between filter weight and exercise protocol for fit testing. The train was a closed 25 mm three-piece WPF. Two explanations put forth for workers were fit tested wearing their cassette containing a polycarbonate this effect were that respirators work normally required personal protective filter. The cassette was connected to a better with higher dust loadings, and equipment (PPE), and care was taken to tapered nylon Liu probe that was that WPF measurements are more assure that this additional PPE did not inserted into the facepiece at an accurate at higher dust loadings. The interfere with facepiece fit. The criterion unspecified location. Inside-the- authors favored the latter explanation, the authors used for passing the QNFT facepiece samples were collected at a and believed that to assess true was a minimum fit factor of 500; 10 flow rate between 1.5 and 2 Lpm. The respirator performance capabilities, times the assigned protection factor of outside-the-facepiece sampling train testing should be conducted at or near 50 given in the lead standard for a full was a closed 25 mm three-piece cassette the respirator’s APF, or a filter weight facepiece negative pressure respirator. containing a polycarbonate filter. The versus protection factor curve should be The 13 qualified workers were cassette was connected downstream defined for predicting performance at measured for face length and width, and

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all the workers except 1 were in Grids The authors stated that the data contamination after each removal (gross 1–4 of the Los Alamos Test Panel. The appeared to be close to the plateau contamination was not observed), and one remaining worker’s his face was region. The authors also stated that the the facepieces were cleaned by the wider than those accommodated by the quantitative fit factors measured during investigators after each shift. In Los Alamos Test Panel. worker fit testing did not correlate with addition, each PAPR’s volumetric air Samples were analyzed by proton the WPFs measured in this study. output (with the facepiece removed) induced x-ray emission analysis The authors concluded that ‘‘ *** was measured with a dry gas meter. (PIXEA) for lead. The authors reported the results of this study indicate that Filters and batteries were changed that for PIXEA the sensitivity is good, this full facepiece respirator with high according to the manufacturer’s typically 10 nanograms per sample. efficiency filters reliably provides instructions. While no mention is made Area samples for particle size analysis workplace protection factors in excess of fit testing the participants, the were also collected, using Marple of 50 against lead dust and fume investigators instructed them not to cascade impactors, in the reverberatory aerosol.’’ The authors stated that they manipulate, lift, or remove the facepiece furnace, casting, and warehouse areas. would expect 95% of the workplace during sampling. Participants were Three particle size ranges were found; protection factors to be above 95. They observed 100% of the time during less than 1 µm (15% of the total also stated that ‘‘The ANSI Z88.2 donning and doffing, and about 80% of aerosol), between 1 to 10 µm (20% of proposed Standard for Practices for the time at their workstations. The the total aerosol), and greater that 10 µm Respiratory Protection has assigned a authors used field blanks to assess (65% of the total aerosol). The particle protection factor of 100 to this type contamination caused by handling. size distribution showed that both lead respirator. These data support that The sampling train for the inside-the- dust and lead fume were present. recommendation.’’ facepiece samples consisted of a 37 mm The authors had pre-established that two-piece cassette containing a 5 micron 3. WPF Studies—Powered Air-Purifying if the outside filter weights were less pore size FWS–B polyvinyl chloride and Supplied-Air Respirators Half-Mask than 51 times the field blank value, the filter. The cassette was attached directly PAPRs sample set would be rejected. The to a modified Luer adaptor sampling authors stated, ‘‘You need at least this Study 21. In 1983, W.R. Meyers and probe, inserted into the facepiece much differential between inside and M.J. Peach of NIOSH reported half and between the nose and upper lip of the outside samples if you want to prove or full facepiece PAPR performance employee. The flow rate of the pump disprove that a respirator provides a PF measurements for four workers during was 1.5 Lpm. The outside-the-facepiece of 50.’’ None of the workplace samples bagging of micro-crystalline silica (Si) in samples were collected with a 37 mm were rejected for being less than 51x the a silica processing plant (Ex. 1–64–46). two-piece cassette and a 5 micron pore field blank value. However, several The study examined several aspects of size FWS–B polyvinyl chloride filter. sample sets were rejected for other the respirator’s performance. Prior to the The sampling airflow rate was 1.5 Lpm, reasons such as the inside sample workplace evaluation, dioctyl phthalate and the cassette was attached to the coming loose from the probe, sample (DOP) was used to determine filter subject’s lapel. Outside samples were pump failure, etc. Field blanks were efficiency. A 4-hour Si dust chamber collected as total dust since previous used, and were handled the same as study was performed by mounting the sampling revealed 70% or more of the other samples. Detectable amounts of PAPR on an anthropomorphic head, dust particles to be 10 microns or less lead were found on the field blanks. The simulating worker breathing, and in size (i.e., respirable). Sample times mean value of the field blanks was used gathering inside- and outside-the- ranged from 84 to 320 minutes, with to correct the sample values by facepiece silica samples. Workers were cassettes being changed during the subtracting the mean field blank value provided with an unspecified brand of employees’ lunch break. Overall PAPR from the inside and outside sample PAPR, with either a tight-fitting half- performance (leakage) was determined weights. WPFs were calculated by mask or full facepiece, and equipped by replacing the facepiece of two dividing the outside concentration (Co) with high-efficiency filters. Both styles respirators with an air-filtering head by its corresponding inside of facepiece were made of natural containing a pre-weighed 76 mm glass concentration (Ci), and checked for rubber and had two exhalation valves. fiber filter. The respirators were outliers. The authors reported that for The sealing edge of the facepiece was mounted in a free-standing stationary the 20 samples collected the geometric either an internal roll (half-mask) or a position, and run for 6–7 hours (with a mean WPF was 3929 and the GSD was flat edge with an inner flap (full battery change at 4 hours). The air 9.6, and the 5th percentile WPF estimate facepiece). The filters were located output was measured, the filter was 95. The outside concentrations downstream of the respirator’s blower weighed, and the ambient Si ranged from 150 to 8380 µg/m3, and the unit. concentration estimated. Area samples inside concentrations ranged from 0.03 The PAPRs used in the study were were collected to determine particle µg/m3 to 3.0 µg/m3. Sampling periods identical to those already being used by size. An Anderson impactor was placed ranged from 30 minutes to 3 hours. The the employees; the authors did not 4–8 feet from the participants and workers were under constant mention training the participants in collected samples for about 3 hours at observation to ensure proper respirator proper use of the respirator. Respirators a flow rate of 1 cfm. use and wear and to ensure sample were placed on and removed from the Samples were analyzed for free Si validity. participants by the investigators, as according to NIOSH P&CAM 259 (i.e., The authors looked at subsets of the needed (e.g., start of shift, lunch break, gravimetric weight and x-ray powder data using multiples of the field blank personal breaks, end of shift). Donning diffraction for Si). Results were mean values ranging from 1,000 times and doffing the respirator, and sampling corrected for the average blank filter the field blank to 25,000 times the field train starting and stopping, occurred in weight gain, but not for pulmonary blank value. The authors found a strong a clean area. Samplers were started after retention (which the authors believed correlation between filter weight and the PAPR was donned and turned on, was negligible). Ten individual inside- workplace protection factor when they and were stopped before the PAPR was and outside-the-facepiece looked at the log of the mean filter turned off for doffing. Facepiece concentrations, with associated WPFs, weight and the log of the mean WPF. interiors were examined for dust are tabulated by sample period, worker,

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type of facepiece, and sample time. The cassette containing an AA filter and limit above which we may predict with study reported that the half-mask PAPR AP10 support pad. This cassette was a specific confidence level that 95% of did not provide the protection factor of connected to a tapered Liu probe that the workplace protection factors lie.’’ 1,000 previously expected; instead, the was inserted into the respirator between The WPF for the PAPR had a GM of protection factors ranging from 16 to the nose and upper lip. In-mask samples 380 and a GSD of 2.6, and the 193. The authors also provided results were collected at 2 Lpm. The outside- individual WPFs ranged from 23 to for DOP filter penetration, aerodynamic the-facepiece sampling train was a 1,600. Approximately 98% of the WPFs mass median particle size and GSD, x- closed-face 37 mm cassette containing for the half-mask PAPR were above 50, ray powder diffraction tests, and free- an AA filter and AP 10 support pad 90% above 110, 75% above 200, 40% standing PAPR leakage measurements. (with no tapered Liu probe used). The above 500, and only 25% above 1,000. The researchers discussed several outside sample cassette was attached to The authors concluded that an APF of parameters that could have affected the worker’s lapel. Outside samples 50 was appropriate for the PAPR they results, including poor respirator use were gathered at 2 Lpm. Samples were tested, and that an APF of 500 was practices of the participants (which the collected for ‘‘as much of the 8-hr work inappropriately high for the half-mask authors believed they controlled and shift as possible.’’ Respirators and PAPR. A protection factor not in excess maintained at a minimal level); inside- sampling trains were donned and of 50 was recommended for half-mask the-facepiece sampling flow rate (which doffed, and started and stopped, in a PAPRs. The authors noted that the the authors believed was not a major lead-free area. The inside of the WPFs may be too high because the source of error); and inherent PAPR respirator facepieces were wiped clean workers did not routinely undergo a leakage (however, the free standing prior to donning after each break, and quantitative fit test screen with negative PAPR results indicated minimal were cleaned and sanitized after each pressure respirators before receiving leakage). Also discussed as reasons for shift. The PAPR batteries were replaced their PAPR. the low protection factors were possible after four hours of use (i.e., according to 4. WPF Studies—Full Facepiece PAPRs leakage of Si past the blower housing manufacturer’s instructions). Battery Study 21. W.R. Myers and M.J. Peach grommet when employees bumped the voltage was checked, and airflow rates of NIOSH reported in 1983 on the PAPR during work (the effect of this was were verified to exceed 15 Lpm before performance of an unspecified brand of unknown) and leakage from inadequate use. One WPF was measured for each PAPR equipped with a tight-fitting facepiece fit (which the authors participant. The ambient particle size elastomeric full facepiece and HEPA considered could be significant at distribution was determined by 19 filters; four employees used the moderate to heavy work rates). Marple cascade impactor samples (11 in Study 6. S.W. Lenhart and D.L. respirator in a silica bagging operation the sinter plant; 8 in the blast furnace (A detailed description of the work Campbell of NIOSH reported in 1984 on area). a WPF study in which they measured setting, sampling methodology, and protection against exposure to Analysis of Pb was by flame atomic study protocol for this study is particulate lead (Pb) for 25 primary lead absorption spectroscopy according to presented in the discussion of Study 21 smelter workers; 7 of the employees NIOSH Method S–341. Inside-the- in the section on half-mask PAPRs facepiece samples that contained less above) (Ex. 1–64–46). The full facepiece worked in the sinter plant, and 18 µ worked in the blast furnace area (Ex. 1– than 10 g of lead were reanalyzed by PAPR had a sealing edge consisting of graphite furnace atomic absorption a flat edge with an inner flap. The 64–42). The predominant aerosol forms µ of Pb were dust in the sinter plant and (limit of detection = 0.2 g). The report participants routinely used this PAPR fume in the blast furnace. In both areas, provided ranges of the mass median and, therefore, the investigators did not Pb comprised about 50% of the total aerodynamic diameters (in train them in its use. Fit testing was not aerosol particulate, with composition of micrometers), as well as the GSD values. performed. the remaining 50% of particulates being The authors provided a total of 25 pairs The investigators calculated WPFs for unknown. All participants wore an of inside- and outside-the-facepiece only three of the four employees MSA half-mask PAPR with high- concentrations, and the corresponding because the sample for the fourth efficiency filters (the authors provided WPFs, by employee, job title, and job employee had an inside-the-facepiece no respirator model number in the location, as well as the overall GM and concentration less than the limit of report). The study also examined the GSD of the PAPR WPFs and several detection, making it unsuitable for WPF performance of an MSA negative- percentile values. For samples determination. The samples were pressure air-purifying respirator, which containing Pb below the level of evaluated for crystalline Si by x-ray is discussed above in the half-mask air- detection, the authors determined diffraction. The full facepiece WPFs purifying respirator study summaries. concentration values ‘‘* * * from the ranged from 25 to 215, which are low The participants routinely used least amount of lead detectable by the for a PAPR. In this regard, the authors respirators, but the investigators do not analytical method and the sampled reported that the employees routinely mention respirator training for the volume of air.’’ In-mask measured bumped and rubbed the belt-mounted employees. The participants were not values were not adjusted for particle motor blower housing and filter normally fit tested with the half-mask retention in the respiratory tract (the assembly during the bagging operation. PAPR facepiece; however, for this study, authors imply that retention had a non- They believed such action may have they had to achieve a fit factor of at least significant effect on the results, but caused movement between the neck of 250 while wearing a negative pressure could cause WPF to be overestimated). the filter and the blower housing air-purifying respirator with the same No mention is made of using field grommet; thereby resulting in the seal half facepiece as the PAPR. Employees blanks. Two approaches to defining an failing and allowing unfiltered air to were instructed not to remove or assigned protection factor (APF) were bypass the filter. They reported some manipulate the respirator during also discussed. These approaches are: evidence to support this conclusion, but sampling, and were observed Defining the APF in terms of a specific could not determine the contribution of throughout the sampling period. proportion of WPFs expected to exceed this problem to the overall leakage into The inside-the-facepiece sampler the APF, and defining the APF ‘‘in the facepiece. Although the blowers consisted of a closed-face 37 mm terms of a one-sided lower tolerance were checked to ensure each PAPR

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delivered a minimum 115 Lpm (4 cfm) presented, individual inside and outside gathered for 1⁄2–3 hours at a flow rate of airflow to the facepiece, the authors concentrations or results by employee or 2.5–3.5 Lpm. Pumps were calibrated in- concluded that ‘‘* * * migration of job classification were not provided. line before and after each sampling contaminant into the facepiece of the Similarly, the report presented an period. PAPR system could be a significant overall GM WPF, GSD, and fifth The authors used radioimmunoassay source of leakage when the respirator is percentile WPF, but not individual (RIA), a very sensitive analytical exposed to the wide ranging conditions WPFs. Of the 55 sample measurements, technique, to analyze inside-the- that exist in the work environment.’’ 34 of the inside-the-facepiece results facepiece samples, and HPLC to analyze While the WPFs measured in this study were below the analytical limit of outside samples; they rejected inside were well below the level expected of a detection. In these instances, the samples with weights below the limit of PAPR, the authors stated that these authors used a conservative WPF quantification. Also, the investigators results ‘‘* * * represent a more calculation by setting the values at the rinsed the outside sample probes with accurate measure of the level of worker limit of detection. No lead was methanol and analyzed the rinsate by protection that can be expected from detectable on the field blanks so no HPLC to determine sample loss due to this type of PAPR system.’’ adjustments were made to sample probe use. The authors did not provide Study 18. At the 1990 AIHCE, C.E. weights. The authors do not mention any further analytical information. Colton and H.E. Mullins presented a adjusting inside-the-facepiece values for Sixty valid sample sets were obtained WPF study in which they assessed pulmonary particle retention. Final from the study. Results were not protection against exposure to lead fume calculations used only those sample adjusted for blank value (i.e., all blank and dust for 20 employees working in pairs with outside sample weights values were below 1 nanogram per the blast furnace, reverberatory furnace, greater than 1,000 times the detection filter) or probe loss (i.e., the GM of 1% casting, and baghouse areas of a limit. The authors believed this was not statistically significant). secondary lead smelter (Ex. 1–64–12). procedure was necessary to determine Individual inside and outside The employees were provided with a that the respirator was capable of concentrations or WPFs were not 3M Whitecap PAPR with a high- providing a protection factor of 1,000. reported. Instead, the authors presented efficiency filter (TC–21C–456). The The authors also analyzed the data for the range of inside- and outside-the- investigators trained the employees in outliers (at the 99% confidence level). facepiece concentrations. They the proper donning, fitting, and The overall data analysis resulted in a determined an overall fifth percentile operation of the respirators. Using a TSI GM WPF of 8,843, a GSD 3.2, and a fifth WPF for each respirator, along with the Portacount, the investigators conducted percentile WPF of 1,335. The authors number of samples, the minimum and fit testing while the participants concluded that the data supported maximum WPF achieved, a GM WPF, performed the exercise sequence ANSI’s proposed APF of 1,000 for full and the GSD. In addition, the authors contained in Appendix D of OSHA’s facepiece PAPRs. They also determined the percentage of WPFs that Lead Standard; the required fit factor recommended that fit testing be fell in selected ranges (e.g., <1,000, was 500. Participants were observed performed on all tight-fitting respirators. 1,000–10,000) for each PAPR, and they continuously throughout the sampling. briefly discussed the correlation The inside-the-facepiece sampling 5. WPF Study—Helmet/Hood PAPRs between WPF and outside concentration train consisted of a 25 mm three-piece Study 27. At the 1990 AIHCE, D.R. (i.e., they found WPF to be independent cassette containing a 0.8 micron pore Keys, H.P. Guy, and M. Axon reported of outside filter loading in this study). size polycarbonate filter. The authors on a 3-month WPF study in which they The Racal Breathe Easy 10, with 29 mounted the sampling cassette directly evaluated exposure to estradiol benzoate sample pairs, had a GM WPF of 11,137, to an ABS Liu probe and inserted the (a steroid) for an unspecified number of a GSD of 3.9, and a fifth percentile WPF probe into the facepiece in place of the workers in a pharmaceutical facility (Ex. of 1,197. The Bullard Quantum, with 9 speaking diaphragm. The outside-the- 64–40). They included three loose- sample pairs, had a GM WPF of 9,574, facepiece sampling train was a 25 mm fitting hood/helmet type PAPRs in the a GSD of 3.1, and a fifth percentile WPF three-piece cassette containing a 0.8 study: Racal Breathe Easy 10, Bullard of 1,470. The 3M Whitecap II helmet, micron pore size polycarbonate filter. Quantum, and 3M Whitecap II. All three with 22 sample pairs, had a GM WPF of The authors did not mention attaching PAPRs had double-bibbed capes, were 42,260, a GSD of 9.8, and a fifth the outside cassette to a probe or the equipped with HEPA filters, and did not percentile WPF of 997. The authors location of the sampling cassette on the have lift-up visors. A Tyvek hood was stated that they obtained WPFs above employee. Airflow rates of the sampling part of the Racal and Bullard PAPRs 10,000 for the three PAPRs at least 44% pumps were calibrated in-line before while the 3M had a hard helmet. PAPRs of the time, and that the three and after each sampling interval, but no were previously used at the facility, so respirators provided WPFs above 1,000 sampling airflow rate was provided. workers were already properly trained throughout the study. The authors Sampling was conducted for as much of in their use and were familiar with concluded that the results of their study the 8-hour shift as possible, with wearing them. The investigators agreed with the then-proposed ANSI sampling intervals ranging from 1 to 4 observed the participants continuously, Z88.2–1992 APF of 1,000 for PAPRs hours. Field blanks were used, and area one-on-one, during sampling. While the with hoods or helmets. samples for particle size analysis were authors used field blanks, they did not gathered with a Marple personal mention determining particle size or 6. WPF Studies—Loose-Fitting Helmet/ cascade impactor (Model 2401). using a clean area for donning and Hood PAPRs & Loose-Fitting Facepiece Sample and field blank analyses were doffing or for starting and stopping the PAPRs performed using proton induced x-ray sampling train. Study 23. W.R. Meyers, M.J. Peach, K. emission (PIXE) analysis. Particle size The inside- and outside-the-facepiece Cutright, and W. Iskander reported in analysis by inductively-coupled sampling trains consisted of a 37 mm 1984 on a study in which they plasma—mass spectrometry indicated two-piece cassette with a glass fiber examined lead (Pb) exposure of 12 particles in the dust and fume range. filter, attached to a nylon Liu probe. workers in a secondary lead smelter (Ex. While the range of inside- and outside- Location of the inside-the-facepiece 1–64–47). The job classifications the-facepiece concentrations were probe was not specified. Samples were studied were furnace operator, helper,

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and pig caster. They selected two data and a probability of 0.95 the counted per inside sample filter and 100 employees from each classification on assigned protection factor calculated by fields counted per outside sample filter. two shifts. The PAPRs used in the study this method for these PAPRs would be The distributions of fiber length and were the 3M W–344 and the Racal AH3; 26.’’ They recommended a reduction in fiber diameter were not characterized. each employee wore both respirators the RDL’s APF of 1,000 for loose-fitting The authors stated that blanks were twice. Pre-shift quantitative fit testing PAPRs with helmets and HEPA filters. submitted for fiber counting; however, was performed each day. The Study 5. W.H. Albrecht, G.R. Carter, no further mention is made of the blank investigators trained the participants, D.W. Gosselink, H.E. Mullins, and D.P. results or how they were addressed. but did not describe the training; they Wilmes reported at the 1986 AIHCE on None of the PAPR samples were monitored the employees continuously a study they conducted that evaluated comparison counted by Phase Contrast during sampling. protection against exposure to asbestos Microscopy (PCM) and Scanning The authors referred to a companion fibers for 12 workers who manufactured Electron Microscopy (SCM). A total of paper for a description of the sampling asbestos-containing brake shoes for seven PAPR WPFs were reported (5 protocol used in this study; therefore, trucks (Ex. 1–64–23). The employees employees). Individual pairs of inside they provided no information is performed six operations at the facility: and outside concentration values were provided on sampling or analytical mixing brake shoe components, not provided. Individual WPFs were methodologies in this report. Eight weighing mixed formulation, pre- reported for each of the seven sampling impactor samples were collected at each forming molding press charges, molding intervals, but were not linked to specific work activity to determine particle size the shoe, grinding the brake shoe participants or jobs. The authors distribution. Samples were collected for surface, and drilling shoe mounting provided an overall GM, GSD, and fifth the full shift, but the investigators did holes. The investigators sampled at each percentile for the Airhat PAPR; a range not provide specific sampling times. operation. The PAPR studied was the of asbestos concentrations and the The authors also provided the range of 3M Airhat with high-efficiency (HEPA) associated GM and GSD were also inside-the-facepiece concentrations, filters. The participants and supervisory reported by job. An inside-the-facepiece with associated GM and GSD, for both staff were shown an audio slide fiber count of 1,000 was used in brands of respirator; they measured presentation explaining how to fit calculating the WPF when the sampling these concentrations with the PAPRs respirators and the procedures for result was at or below the limit of placed on manikins which were located saccharin fit testing; they then received detection (i.e., 1,000 fibers per filter). at the worksites where employees in the the saccharin qualitative fit test (since The investigators did not mention three job classifications worked. the authors do not specifically mention adjusting inside-the-facepiece values for For each respirator, the study fit testing the PAPR, it is assumed that fiber retention in the respiratory tract. In provided 24 individual inside- and only the half-mask respirators studied addition, the authors determined that outside-the-facepiece (front and rear) were fit tested). Fit testing was not sampling results were not affected, at concentrations, along with associated conducted prior to each study test. The the 95% confidence level, by sampling WPFs and each employee’s fit factor. It PAPR was fitted and worn according to flow rate or open-versus closed-face also provided the overall GM, GSD, and the manufacturer’s instructions. Each sampling cassette. The mean breathing 95% confidence level on the mean for employee was observed on a one-on-one zone concentration of asbestos for the the inside-the-facepiece concentrations, basis during testing to assure that they Airhat PAPR was 4.14 fibers/cc, with a WPFs, and fit factors. The authors properly donned and used the respirator mean breathing zone concentration tabulated the data by day, shift and and that sampling train integrity was range of 1.23 to 8.05 fibers/cc. The work activity. For both respirators, two maintained. authors reported a GM WPF for the samples were discarded due to sampling The inside-the-facepiece sampling pump failure, giving 22 usable train was a closed-face filter cassette PAPR of 199, with a GSD of 2.36 and a measurements for each respirator. The connected to a tapered Liu probe, fifth percentile of 42. Five employees WPFs measured on the Racal AH3 inserted into the respirator between the tested the PAPR, resulting in a total of ranged from 42 to 2,323, with a GM of nose and mouth. The outside-the- nine sample sets, including two 205 and a GSD of 2.83. The 3M W–344 facepiece sampling train was a closed- unusable sets of data. The authors noted had WPFs that ranged from 28 to 5,500, face filter cassette connected to a Liu that respirators that had the highest GM with a GM of 165 and a GSD of 3.57. probe attached in the employee’s lapel and fifth percentile WPFs (i.e., the 3M The two-sided 95% confidence limits area; the authors do not mention Airhat and 3M 9920 DFM respirators) around the mean of the WPFs were 128 cassette size. Samples were collected for were also tested at higher breathing and 325 for the Racal AH3, and 94 and 30 minutes, but other sampling times zone fiber concentrations. They believed 292 for the 3M W–344. The authors were occasionally used; sampling pump that this factor probably led to these provided a detailed discussion of their flow rates were 2 Lpm (inside-the- respirators’ increased performance statistical analyses of the data; they also facepiece) and 0.5 Lpm (outside-the- measurements. discussed several potential sources of facepiece). The report does not mention Study 22. In 1986, W.R. Meyers, M.J. variation in the workplace performance modifying the inside-the-facepiece Peach, K. Cutright, and W. Iskander of PAPRs, including: a possible probe location (midway between the reported on a study in which they relationship between fit factor and WPF; nose and mouth) or the sampling flow evaluated exposure to lead (Pb) dust and a possible relationship between fit factor rate for the PAPR versus that used for mist for 12 workers on two lead acid and inside-the-facepiece concentration; the half-mask respirators studied. plate production lines of a battery day of the week; shift; leakage into the Sampling trains were calibrated manufacturer (Ex. 1–64–48). They facepiece due to ambient air currents; before the shift, at lunch, and at the end sampled the pasting operator and two and worker activity. The only sources of the shift; average airflow rate was slitter operators on each line for two found to be potentially significant were used to calculate sampled air volume. different shifts. The respirators studied leakage into the facepiece due to The investigators did not mention were the Racal Airstream AH5 and the ambient air currents and worker determining the PAPR’s airflow rate. 3M W–3316, equipped with a helmet, activity. The authors stated that ‘‘*** Asbestos analysis was based on visor enclosure, and dust/mist filters. using the pooled 3M and Racal WPF NIOSH method 7400, with 500 fields Participants were clean-shaven, and

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each employee wore both types of (without simulated breathing), located and HEPA filters. (The authors also respirator twice. The AH5 provided a about 4 feet from the subjects. Two filter tested the performance of several seal between the employee’s face and blanks were used for each shift. Particle negative-pressure, air-purifying half- the face shield by using two flexible face size distribution was determined mask respirators; see Study 7 above). seals; air was exhausted at the chin. The through using a Marple cascade The employees previously received size of the faceseal (i.e., large or small) impactor operating at a flow rate of 3 training on this PAPR, and used it for was selected based on the appearance of Lpm. more than six months prior to the study. best fit and wearer comfort. The 3M’s Inside-the-facepiece samples were Forty percent of the employees had soft flexible face seal gave a loose-fitting analyzed by graphite furnace using a beards (i.e., more than two weeks seal between the face and face shield, modified NIOSH P&CAM 214 method, growth), but the investigators did not with air exhausted at the temples. Prior with perchloric acid in the wet ashing find a significant difference between to field testing, randomly-selected filters step. Outside-the-facepiece samples bearded and non-bearded participants. underwent silica dust penetration were analyzed by atomic absorption No fit testing was performed on the testing. The investigators put on and spectroscopy (NIOSH Method S–341 employees, but previous quantitative fit removed the respirators from the with the perchloric acid wet ashing step testing showed fit factors ‘‘greater than employees in a clean area, except when modification). Forty-seven individual 1000 in all cases.’’ Industrial hygiene the employees took personal breaks (in inside- and outside-the-facepiece (i.e., technologists assisted participants with which case, the employees donned and front and rear) time-weighted-average donning and doffing respirators, cleaned doffed the respirator in the work area). (TWA) measurements, with associated and maintained the respirators at the Employees were not fit tested, but were TWA WPFs, were provided (AH5 = 24; end of each work cycle, and observed instructed in the proper use of the PAPR W–316 = 23). These results were participants on a one-to-one basis and directed not to remove the helmet, tabulated by day, shift, and work throughout the sampling period. The lift the face shield, or tamper with the activity. Overall GM and GSD were also investigators directed the employees not sampling equipment without notifying given for the concentration to tamper with the respirator or the investigators. The investigators measurements and WPFs. All blanks sampling equipment. Due to high heat continuously monitored donning and were below the analytical limit of levels in the work area, the employer doffing and work activities. Respirator detection; the authors did not mention required employees to rest in a cool helmets and visors were cleaned adjustments for pulmonary retention. environment for one-half hour during between each use, and volumetric air Particle size (large) and stationary each work hour. output was periodically checked manikin filter efficiency (98%–99.9%) were briefly discussed. The WPFs for The inside-the-facepiece sampling (usually at the beginning of the shift, train consisted of a closed-face three- lunch, and shift’s end). The authors the Racal AH 5 ranged from 23 to 1,063, with a GM of 120 and a GSD of 2.64. piece cassette with a 25 mm organic- replaced the batteries according to binder-free glass fiber filter, backed with manufacturer’s instructions, and when The WPFs for the 3M W–316 ranged from 31 to 392, with a GM of 135 and a cellulose ester pad. Inside sampling low airflow occurred. They also cassettes were connected to a tapered installed new filters at the beginning of a GSD of 1.89. Since the authors found no statistical difference between the Liu probe, which was inserted through each shift. The investigators started the the PAPR’s visor and into the sampling pumps after the employees performance of the respirators, they pooled the data for both respirators; employee’s breathing zone. The outside- donned the respirators and the PAPR they then graphically plotted the the-facepiece sampling train was blower was functioning; they stopped percent of WPFs less than specific identical to the above; however, the the pumps before turning off the PAPR values. The pooled data for the two investigators did not mention blower. PAPRs resulted in a distribution with a connecting the cassette to a Liu probe. Sampling trains were identical and GM of 127 and a GSD of 2.28. The The outside cassette was mounted on a consisted of a closed-face 37 mm two- authors stated that, at a 0.95 probability bracket at the top of the visor. All filters piece cassette, containing a 0.45 micron level, this class of PAPRs would receive were pre-calcined at 400 degrees pore size cellulose ester filter and back- an assigned protection factor of 25. The Centigrade for 24 hours. Both inside and up pad. Inside-the-facepiece sample authors also stated that the results outside samples were collected at a flow cassettes were attached directly to a ‘‘* * * strongly suggest that the rate of 2 Lpm for approximately 300 modified Luer adapter sampling probe, respirator user community not view minutes, or one-half of the 10-hour work inserted through the face shield about current generation powered air- shift. Respirators and sampling trains one to two inches in front of the purifying respirators equipped with were worn and operated until the employee’s mouth. Outside-the- helmets as positive pressure respiratory employee entered the rest area; they facepiece sample cassettes were located devices.’’ donned and turned on the respirators at the front lower right side of the Study 3. A. Gaboury and D.H. Burd prior to leaving the rest area for the next facepiece, away from the PAPR’s (Ex. 1–64–24) and A. Gaboury, D.H. work cycle. The authors plugged the exhaust airflow; they located a second Burd, and R.S. Friar (Ex. 1–64–348) sampling cassettes when not in use, and cassette located the employee near the reported in 1993 on the WPF study they cleaned the respirators after each work PAPR’s filter, to determine the filter’s performed in a primary aluminum cycle. Field blanks were used to identify contaminant challenge. All samples smelter. Exposure to benzo(a)pyrene contamination due to handling. were collected as total dust at a flow [B(a)P] on particles was measured for 22 Sampling train airflow rates were rate of approximately 2 Lpm over the employees who worked as rack raisers, checked at the beginning, middle (i.e., full shift (The report did not provide stud pullers, and rod raisers on anode after lunch), and end of the work day; actual sample times). Sampling pumps crews. The employees used a Racal upon changing cassettes; and when a were calibrated in the laboratory, and Breathe-Easy 1 (BE1/AP3), a loose- problem was suspected. PAPR turbo- the flow rates confirmed at the worksite. fitting helmeted PAPR. The PAPR came unit flow rate was checked every two Performance of the PAPR filtration equipped with one-piece non-woven hours to assure flow was greater than six system was checked by placing flame-retardant face seals, visor locking cubic feet per minute (cfm). Sampling operating respirators on manikins clips, and combination organic vapor occurred over a five-day period.

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B(a)P analysis followed Alcan Method was the 3M Breathe-Easy 12 (BE–12), a fifth percentile of 280; and the Monte #1223–84. The ambient B(a)P particle loose-fitting facepiece PAPR equipped Carlo simulation model approach size distribution was determined by with high-efficiency filters; the resulted in a fifth percentile of 220 collecting four samples, as close as employees were using this PAPR prior when the non-detected inside values possible to the workers, using an 8-stage to the study. During a preliminary visit, had a value of 0.002, a fifth percentile Anderson cascade impactor (Model the investigators discussed the study of 303 with the non-detected values 296). Impactor samples were collected with the union, management and excluded, and a fifth percentile of 103 for two to five hours at a flow rate of 2 workers. The authors also evaluated the with Employee C excluded. The authors Lpm. The average percent of B(a)P mass worksite and took area samples to concluded that the BE–12 PAPR (across four samples) per impactor stage identify areas with the highest provided a level of protection consistent (defined by an aerodynamic diameter exposures. Prior to sampling, they with an APF of 25. cut point, in micrometers) was reported. informed the employees about their role Study 24. D.W. Stokes, A.R. Johnston, About 93% of the B(a)P mass was in the study, as well as the study’s and H.E. Mullins determined exposure associated with particles having purpose and procedures. The to silica (Si) dust for five workers in a diameters of ≤9.8 micrometers. A total investigators continuously observed the roofing granule production plant (Ex. 1– of 20 pairs of inside and outside sample employees during sampling, and used 64–66). The participants were involved concentrations, with associated WPFs, field blanks to identify contamination in cleanup of silica dust byproduct by were provided by job category (but not from handling. The study contained no sweeping, brushing walls, and for individual employees), and whether additional information on sampling shoveling. The respirator studied was the employee had a beard. An overall protocols (e.g., donning and doffing the 3M Airhat, a loose-fitting PAPR with GM, GSD, and 95% confidence interval procedures). helmet, equipped with dust/mist or on the mean were also provided for the Inside-the-facepiece samples were high-efficiency filters, and worn with inside and outside concentrations and gathered using 25 mm three-piece and without a Tyvek shroud. The WPFs, along with an overall fifth cassettes containing an unspecified investigators assisted the participants percentile WPF. The authors stated that membrane filter and a porous plastic were assisted with donning the some employees participated more than back-up pad. A nylon Liu probe was sampling equipment; however, they did once during the study. They did not used, and the samplers were positioned not mention training the employees. mention adjusting inside-the-facepiece directly across from the midline They observed the employees during values for particle retention in the between the employee’s nose and sampling, and used field blanks to respiratory tract. The authors found no mouth. Outside-the-facepiece samples determine the effects of handling on significant relationship between B(a)P used 25 mm three-piece cassettes sample contamination. They did not concentrations inside and outside of the containing an unspecified membrane mention determining the particle size of facepiece, but they did find a correlation filter, backed with a cellulose pad. the contaminant. Inside-the-facepiece samples were between WPF and outside B(a)P Outside samples were positioned close collected through a Liu probe inserted concentrations. The authors stated that, to the employee’s breathing zone (the into the faceshield (they did not provide while the data were limited, they investigators provided no further the probe’s specific location). A 25 mm recommended testing PAPRs at details). All samples were collected at 2 cassette containing a 0.8 micron pore relatively high concentrations to obtain Lpm for approximately one and one-half size polycarbonate filter was used, and an accurate measure of their hours (range: 67–156 minutes). Inside-the-facepiece samples and sampling airflow rate was 1.5 Lpm. performance. The inside B(a)P blanks were analyzed by flame atomic Outside-the-facepiece samples were concentration ranged from 0.006 to µ 3 µ 3 absorption spectroscopy and heated gathered as both total and respirable 0.072 g/m , with a GM of 0.012 g/m . graphite furnace atomizer (AAS–HGA). dust. Respirable dust samples were The outside B(a)P concentration ranged Analysis of outside-the-facepiece collected at 1.8 Lpm using a 37 mm 0.8 µ 3 from 246 to 111.48 g/m with a GM of samples was by AAS. The analytical micron pore size polycarbonate filter µ 3 16.73 g/m . WPFs ranged from 371 to methodology used OSHA’s method for placed in a cyclone that attached to the 8658, with a GM of 1,414. The two- Cd in workplace atmospheres (OSHA employee’s lapel. Total dust samples sided 95% confidence interval limits ID–189). The authors provided the mean also used a 37 mm 0.8 micron pore size around the overall GM WPF were 918 mass for inside and outside blanks, but polycarbonate filter. Sampling airflow and 2,173; the fifth percentile was 275. made no mention of data adjustments rate was 2 Lpm, with the sampling The authors cautioned that these results for blanks or pulmonary retention. They cassette attached to the employee’s WPFs achieved under conditions of also reported minimum and maximum lapel. The investigators calibrated the good worker compliance and tight concentrations of inside- and outside- sampling pumps each day, and checked administrative control; however, the-facepiece samples for each proper airflow rate three times without these conditions, WPFs may be employee. Supplemental data contained throughout the day. They collected less because: close surveillance of 41 individual measurements of inside samples over a four-day period, with workers is not usually performed; and outside concentrations, tabulated by sampling times ranging from 30 minutes cleaning during rest periods is not done employee, job area, sample period and to 1 hour. At the beginning and end of prior to returning to the workplace; set, sample time, pump flow rate, and each sample, the authors confirmed that visor locking clips are not routinely sampled air volume. each PAPR’s airflow rate was in excess used; and no respirator is used 100% of WPFs were calculated for 33 of the of 6 cfm. the time while in the workplace. sample sets (8 of the 41 inside-the- The authors used proton induced x- Study 26. At the 2001 AIHCE, D.V. facepiece samples had no detectable ray emission (PIXE) to analyze the Collia, et al. presented a study on the Cd). The calculated GM WPFs ranged samples. They adjusted the inside- and workplace performance of a PAPR from 1,460 to 9,440. The fifth percentile outside-the-facepiece concentrations by against exposure to cadmium (Cd) for WPF was calculated in three different subtracting the mean blank value, but seven workers, over three days, in a ways: the traditional approach yielded a did not mention adjustments for nickel-cadmium battery manufacturing fifth percentile WPF of 315; an analysis pulmonary retention of particles. They facility (Ex. 3–5). The respirator studied of variance (ANOVA) model, yielded a also did not provide individual inside-

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and outside-the-facepiece airflow rate into the helmet. Pumps underestimated respirator performance; concentrations and WPFs. They were stopped before the helmet was higher outside sample loadings presented results in two tables showing disconnected from the air supply and appeared to be less influenced by non- respirable dust samples with values 25 removed. The authors maintained respirator variables. The investigators times the mean blank level, and total continuous one-on-one observation of judged WPF estimates derived from data dust samples with values 100 times the the employees during sampling, and subsets with higher outside filter mean blank level. The investigators used several field blanks during each loadings as providing a better indication provided tables reporting sample size day of sampling. of respirator performance capability. and overall GM, GSD, and fifth The authors collected inside-the The authors also discussed an apparent percentile WPF by type of filter (i.e., facepiece samples on 25 mm cassettes correlation between WPFs and outside dust/mist, HEPA) and the presence or containing 0.8 micron pore size filter loadings (i.e., a higher loading absence of a shroud (i.e., dust/mist with polycarbonate membrane filters. They equaled higher a WPF until reaching a shroud, dust/mist without shroud). attached the cassettes directly to a Liu plateau about 600 times the mean blank Using the respirable dust samples that probe inserted through the center of the value); however, the correlation were 25 times the mean blank value, the faceshield, about midway between the between WPFs and outside authors combined the sampling results nose and mouth; the probe extended concentrations was not statistically of the PAPR with dust/mist filters (i.e., about 3 mm into the helmet. The significant. In addition, the effect of with and without a shroud) and found flowrate for the inside samples was higher versus lower helmet airflow rate an overall GM WPF of 2,480 and a fifth approximately 2 Lpm. The authors on sample results and WPFs was not percentile of 95. The combined collected outside-the-facepiece samples significant. They also discussed the respirable dust results of the HEPA- as both total and respirable dust, using daily and overall WPFs achieved when filtered PAPR gave an overall GM WPF a 37 mm cassette with a 0.8 micron pore using time-weighted-averages for the of 5,730 and a fifth percentile of 762. size polycarbonate membrane filter. calculations. They concluded that their They used a Bendix or SKC cyclone, data supported the ANSI Z88.2 Atmosphere-Supplying (Supplied-Air) operating at 1.7 Lpm airflow rate, to proposed APF of 1,000 for loose-fitting Respirators gather the respirable dust samples and SARs with hoods or helmets. Atmosphere-supplying respirators, obtained total dust samples at flow rates Study 20. At the 1989 AIHCE, A.R. also referred to as supplied-air ranging between 0.5 and 2 Lpm. Both Johnston, C.E. Colton, D.W. Stokes, H.E. respirators (SARs) or airline respirators, outside-the-facepiece sample cassettes Mullins, and C.R. Rhoe presented a operate in one of three modes: Demand, were located on the employee’s lapel. WPF study on a 3M W–8000 Whitecap continuous flow, and pressure demand. The investigators calibrated the II SAR with a helmet, and equipped Demand and pressure demand sampling pumps at least three times a with a breathing tube (W–5114), a respirators can be equipped with half or day, and sampling periods ranged from compressed air hose (W–9435), and full facepieces. Continuous flow 10 to 60 minutes to prevent filter either a vortex cooling assembly (W– respirators can also be equipped with a overloading. 2862) or air regulating valve (W–2907) helmet, hood, or loose-fitting facepiece. The authors analyzed all samples (Ex. 1–64–37). They evaluated exposure using PIXE. They found Si on all 18 7. WPF Studies—Loose-Fitting to iron (Fe) dust and silicon (Si) dust for blanks. Of 68 initial sample sets, they Atmosphere-Supplying Respirators six workers involved in grinding iron discarded 16 (11 due to test With Hood or Helmet parts at a foundry. Air supply pressure malfunctions and 5 due to outside was 60 psi with the vortex cooler or 25 Study 28. A.R. Johnston, et al. in 1987 loadings less than 10 times the mean psi with the regulating valve, thereby conducted a WPF study evaluating blank level and inside loadings at or maintaining a helmet airflow rate of 6.7 exposure to silica (Si) among four below the blank level). They corrected cfm throughout the test. They did not shipyard workers who wore a 3M the remaining 52 sample sets for blank mention employee selection procedures, Whitecap II loose-fitting, continuous value, and then tabulated by inside and previous use of respiratory protection, flow SAR with hood/helmet while outside filter weights, inside and provision of training, or respirator sandblasting paint from the flat top of a outside sample volume, and associated donning and doffing procedures. They barge (Ex. 1–64–36). The respirator was WPFs. Since nearly all of the dust was verified air supply pressure; valve comprised of a W–8100 abrasive of respirable size, the authors did not settings; and integrity of the respirator, blasting helmet, a W–5114 breathing report results for the total dust samples. connections, and sampling train before tube, a W–2862 air / temperature control Comparing the sampling results with starting the sampling pumps. They valve, 50 feet of W–9435 air hose, and the mean blank levels, the investigators stopped the samplers before a W–8054 extended length shroud. To stated that the analytical confidence disconnecting the respirator from the air permit evaluation of the respirator at its limits of the data were poor, with only supply; they then took the participants low and high range of airflow rates, air 11 samples being better than plus or to a clean area to remove the sampling pressure was maintained at 60 or 80 psi, minus 25%. The authors considered cassette. The investigators observed the resulting in an in-helmet airflow rate of samples with inside concentrations employees on a one-on-one basis during either 6.4 or 14.4 cfm. The investigators greater than 1,000 times the mean field sampling, and used field blanks to informed the employees of the purpose blank to be an accurate indicator of the evaluate possible contamination due to and protocols of the study, and respirator’s performance capability; sample handling. instructed them in the proper donning seventeen sample sets met this criteria, The inside-the-facepiece sampling and use of the respirator. They also but they removed two samples WPF train consisted of a 25 mm cassette directed the employees not to adjust or calculation database as outliers. For the containing a 0.8 micron pore size remove the respirator after sampling remaining 15 samples, the GM WPF was polycarbonate filter. The authors began. Sampling trains were connected 4,076, the GSD was 2.3, and the fifth attached the cassette to a Liu probe and disconnected in a clean area when percentile WPF was 1,038. installed into the faceshield possible. Sampling pumps were started The authors concluded that WPFs approximately midway between the after confirming proper operation and generated from sample sets with light nose and mouth; it extended a few donning of the respirator, as well as outside dust loadings significantly millimeters into the helmet. They

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collected inside-the-facepiece samples analytical detection limit. If we do not, the the elasticized inner shroud and out to at an airflow rate of 2 Lpm. The outside- data we get is likely to reflect limitations of the sampling pump; the inside sampling the-facepiece sampling train also used our sampling and analysis procedures, rather flow rate was 2 Lpm. Outside-the- 25 mm cassettes containing 0.8 micron than the respirators we are testing. facepiece samples were collected as pore size polycarbonate filters. The Study 19. At the 1993 AIHCE, C.E. respirable dust through use of a 10 mm investigators collected outside samples Colton, H.E. Mullins, and J.O. Bidwell nylon cyclone; the outside sampling as respirable dust using a MSA or of 3M presented a WPF study on the 3M flow rate was 1.7 Lpm. The authors do Bendix cyclone operating at an airflow Snapcap W–3256 airline respirator (TC not mention the location of the outside rate of 1.7 Lpm; however, they did not 19C–70) with a loose-fitting hood, fitted sampling cassettes, or what method they mention the location of the outside with a W–3258 hard hat, W–5114 used to conduct particle size sampling. sample cassette. They collected area breathing tube, W–2862 vortex tube air The investigators used PIXE to samples for particle size analysis using regulating valve, and 50–100 feet of W– analyze collected samples for Si; cellulose acetate filters and a personal 9435 compressed-air hose (Ex. 1–64– however, overloading of many of the sampling pump operating at 2 Lpm. 17). They measured exposure to silica outside-the-facepiece samples prevented They calibrated the sampling pumps at (Si) for four workers involved in furnace PIXE analysis, requiring analysis of least three times a day, but did not teardown at a foundry. The respirators these samples by Inductively Coupled mention specific calibration times. were operated at an air pressure of 75 Plasma (ICP) spectroscopy. The authors The authors analyzed the samples for psi, with the participants were made no field blank adjustments to the Fe and Si using proton induced x-ray permitted to regulate the airflow rate to measured sample weights (i.e., Si was emission (PIXE) analysis. Having a comfortable level. The authors later not detected on the field blanks). The detected Fe and Si on the field blanks, determined that this level was 8–9 cfm. investigators intended to invalidate they used the mean blank value to The job task consisted of using sample pairs with an outside filter correct inside- and outside-the-facepiece pneumatic chippers to remove the weight less than 1,001 times the field sample weights. They used optical furnace wall and bottom. Pieces of wall blank value, or limit of detection if the microscopy to determine mean particle and bottom either fell into or were field blank value was zero; all outside size range from 6 area samples. The shoveled into a barrel for removal. The sample weights were more that 10,000 investigators presented no data for employees then vacuumed of the times the detection limit. In addition, individual inside- and outside-the- furnace bottom. The job consumed most they rejected sample pairs with inside facepiece concentrations, and associated of the eight-hour shift. Since the furnace sample weights that were less than the WPFs; however, they did provide the was warm and the work was physical, mean blank value. They did not range of outside sampling the employees worked in pairs for about mention correcting inside-the-facepiece measurements, and the overall average one hour before switching with other values for pulmonary retention of outside concentration, for both analytes. employees; therefore, sampling times particles, or how they managed sample While they presented the range of varied over the two separate days of the results that were below the analytical inside-the-facepiece concentrations, study. Participants normally wore air- detection limit. Particle size analysis they did not report the average inside line respirators. The investigators showed the contaminant to be ‘‘a dust informed them of the study’s purpose, concentrations. Outside samples with over 50 percent of the mass greater procedures, and their role, and provided µ averaged 1,500 µg/m3 for iron dust, and than 10 m.’’ The authors established a them with instruction on the proper correlation between the PIXE and ICP ranged from less than 100 to 2,800 µg/ donning, fitting, and operation of the analytical methods by analyzing 37 m3. Outside samples for silicon respirator; however, the authors did not samples using both methods. They averaged about 1,000 µg/m3, with a mention fit testing the participants. The developed a linear regression equation range from less than 100 to 1,500 µg/m3. investigators observed the employees on that permitted PIXE equivalents to be Inside concentrations were at or near a one-on-one basis during sampling. The predicted from the ICP results. They the detection limits for both elements. employees donned and doffed the reviewed the WPF results using: The For the 39 samples with values greater respirators and sampling trains in a ICP results for the outside than 25 times the field blank, the clean area, and the investigators concentrations, and PIXE results for the authors reported a GM WPF of 273, a checked the integrity of the respirator inside concentrations; and the GSD of 5.7, and a fifth percentile of 39. and sampling train before the respirator regression to predict PIXE equivalents For samples with outside filter weights was connected to the air supply. The for the outside concentrations, and PIXE greater than 750 times the field blank, authors started the sampling pump after results for the inside concentrations. they reported a GM WPF of 1,012, a connecting the respirator to the air line, The authors calculated WPFs and GSD of 2.6, and a fifth percentile of 199. and stopped the pump before checked the resulting values for outliers The investigators found a significant disconnecting the respirator from the air at the 99% confidence level. They did correlation between mean filter weights supply. They used field blanks to not provide individual inside- and and WPFs; this correlation did not evaluate the possibility of outside-the-facepiece concentrations, plateau at higher filter loadings. The contamination from handling the but instead reported an overall range of authors stated that their measurements samples. inside and outside concentrations, along never reached a level at which the Inside- and outside-the-facepiece with the ranges’ associated GM and protection factors were independent of samples were collected in 25 mm three- GSD. In addition, the authors did not the outside filter weight. They piece cassettes containing 0.8 micron provide individual WPF values, but concluded that the relatively low pore size polycarbonate filters and presented calculated WPFs as an overall sample loadings resulted in WPFs that porous plastic back-up pads. Inside-the- fifth percentile WPF, GM, and GSD for significantly underestimated the facepiece cassettes were attached to the each of the 2 days, based on both respirator’s performance. They stated inside of the hood, directly across from methods discussed above (i.e., ICP and that, in the case of SARs, the the employee’s mouth, with the cassette PIXE equivalent). They found that the researchers: pointed toward the employee. A nylon two methods gave similar results. Using * * * should attempt to target outside Liu probe was attached to the inside the equivalent PIXE values (i.e., loadings of at least 1000 times the anticipated cassette, and a sample line ran through calculated from ICP values), and the

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PIXE in-facepiece values, the GM WPF in-line calibration. They collected respirators. The concern was that the was 10,344, the GSD was 2.5, and the samples at an airflow rate of 2 Lpm, for interim final lead rule, as issued, went fifth percentile WPF was 2290. The a period consisting of 2 hours for far beyond the HUD guidelines by authors stated that the loose-fitting hood sanding and 90 minutes for painting. At assigning a different and lower performed differently than a loose- the end of sampling period, they in-line protection factor to Type CE respirators fitting PAPR, and this difference should calibrated the pumps, stopped the than the HUD guidelines, which be reflected in the APF assigned. In pumps, capped and removed the incorporated the general industry addition, they briefly discussed a cassettes, and the employees standard at 29 CFR § 1910.1025. Bullard comparison of the study results with the disconnected and doffed the hood. They maintained that its Model 77 and 88 results of several other PAPR and air- collected the system blank by mounting respirators provide much greater line respirator studies. a cassette in an operating hood that was protection, and sought to have the APF Study 25. In 2001, T.J. Nelson, T.H. located away from the work area, and for these models elevated to 1,000 in the Wheeler, and T.S. Mustard published a sampled air from inside the hood at 2 Lead in Construction Standard. OSHA WPF study of a supplied-air hood (Ex. Lpm for 2 hours The authors did not agreed to provide Bullard with the relief 3–6). They measured exposure to mention making a particle size sought only if it contracted with an strontium (Sr) for 19 painters and determination. acceptable third party to design, helpers involved in sanding and The investigators analyzed the monitor, and interpret the results of a painting operations on several types of outside-the-facepiece samples and one simulated workplace study of these aircraft. They judged the work rate to be of the manufacturer’s blanks using models under an appropriate and light to moderate. Prior to sampling, NIOSH Method 7300. They used PIXE acceptable test protocol. As a condition they informed the employees about the analysis for the inside-the-facepiece for granting that relief, the study had to study, and instructed them to remain samples, field blanks, system blank, and demonstrate that the abrasive blasting connected to the air supply during the other manufacturer’s blank. They respirators achieved, at a minimum, a calibration and sampling. The tabulated the sampling results by date, protection factor rating of at least 20,000 participants used a 3M H–422 series activity, employee, sample time, inside and maintained positive pressure supplied-air hood, equipped with an and outside sampled volumes, inside throughout the testing. outer bib with an inner shroud and hard and outside concentrations, and WPF. Bullard contracted with Lawrence hat, H–420 hood, W–3258 hard hat, W– The authors reported thirty-one Livermore National Laboratory (LLNL) 2878 suspension, 50 feet of W–9435 individual inside- and outside-the- which designed, conducted, and hose, and either the W–2862 vortex facepiece concentrations. However, the interpreted the results of the SWPF cooling assembly or the W–2863 vortex results of the outside samples obtained study, based on a protocol that was heating assembly. The investigators during sanding operations were only 30 acceptable to OSHA. The LLNL informal regulated the supply air pressure to times greater than the inside sample report resulting from the testing between 60 and 80 psi. Employees values. Therefore, the authors did not indicated (based on computerized data donned the hoods in the work area, but consider the data from the sanding backed up by strip chart recordings) that investigators did not attach the operations to be a very useful indicator the two Bullard abrasive blast sampling cassettes until after the of respirator performance, and they did respirators achieved a minimum employees connected the hood to the air not calculate WPFs for the initial 19 protection factor of 40,000 and supply and airflow began. They used sanding samples. Of the remaining 18 maintained positive pressure field blanks to identify possible painting samples, they calculated WPFs throughout the testing. contamination due to handling, storage for only 15 samples, after discarding 3 Therefore, the SWPF study conducted or shipment. In addition, they used samples due to sampling errors. The Sr by LLNL demonstrated that, if used manufacturer’s blanks to detect levels measured outside of the respirator properly, the Bullard respirators were contamination from manufacture of the ranged from 340 to 24,529 µg/m3, but acceptable for lead exposures that are filter, and a system blank to determine the investigators found no detectable less than or equal to 1,000 times the PEL if contamination was present in the air amounts of Sr on any inside-the- (50,000 µg/m3). In an August 30, 1995 supply. facepiece sample. Therefore, the authors memo to its Regional Administrators, The investigators collected inside- could not directly determine WPFs for OSHA recognized that the SWPF study and outside-the-facepiece samples using the respirator. However, they estimated results indicated that an APF greater 37 mm or 25 mm three-piece cassettes WPFs by substituting the limit of than 25 was appropriate for the Bullard containing mixed cellulose ester filters. detection for the inside concentration Model 77 and Model 88 respirators, and The first 19 samples (i.e., collected values. This procedure resulted in the Agency granted these models an during sanding) utilized 37 mm estimated WPFs that ranged from more interim APF of 1,000 when used for lead cassettes/filters, but half of the outside than 920 to 52,000. The authors in construction (Ex. 3–8–4; memo to samples had no detectable Sr. To concluded that their study was ‘‘*** RAs dated 8/30/95). However, the memo increase analytical sensitivity, they consistent with other simulated and also noted that the Agency was aware of collected the remaining 18 samples with WPF studies in that the ANSI Z88.2 other data and at least one field study 25 mm cassettes and filters. Once the WPF of 1000 is supported.’’ showing that in the workplace these employee was connected to the air respirators may provide considerably supply, they attached a sampling 8. SWPF Studies—Type CE Abrasive less protection when used in ways that cassette inside the hood at a point Blasting Respirators do not conform to the manufacturer’s midway between the nose and mouth, Bullard: 1995 LLNL Evaluation. specifications (e.g., the air supply hose and to the side of the face. They then During the development of the Interim is too long; the hose diameter is uncapped the cassette and connected a Final Standard for Lead (Pb) in incorrect; the manufacturer’s specified Liu probe to the cassette inlet. The Construction (1926.25; 1996) and the air pressure is not maintained) or that authors placed the outside cassette in Final Respiratory Protection Standard do not comply with the requirements of the lapel area and pointed it forward (63 FR 1152; 1998), the E.D. Bullard paragraphs (b), (d), (e) and (f) of and down. They started the sampling Company (Bullard) expressed concern 1910.134 (e.g., the respirator is not pumps simultaneously, and performed about the APF of 25 for Type CE inspected frequently enough for

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possible deterioration). The memo 97) and 3M (Ex. 3–9–3; memo to LLNL Study of Four N95 Filtering further stated that respirators will Regional Administrators dated 12/08/ Facepiece Respirators. At OSHA’s provide less protection than they are 98). Again, the interim APF was request, researchers at LLNL conducted capable of, when used improperly (e.g., contingent on the final APF for these chamber testing on four of the same donning and doffing the respirators respirators being determined through commercial N95 filtering facepiece half- while still in containment; this rulemaking. mask respirators used in the NIOSH disconnecting the air hose prior to study (Ex. 4–14). The four N95 filtering leaving the exposure area). In addition, 9. SWPF Studies—N95 Air-Purifying Respirators facepieces selected by OSHA for study these respirators are used in extreme were: 3M Model 8210, 3M Model 8511, conditions during construction NIOSH N95 Chamber Studies. In Wilson Model 9501, and MSA Affinity activities (e.g., substantial and, 1999, NIOSH conducted a chamber Ultra (formerly Uvex/Pro Tech Model sometimes rapid, deterioration caused study of N95 respirators and statistically 4010). Six subjects (three male, three by high-speed ‘‘bounceback’’ of the analyzed the respirators’ performance female) with six different face abrasive blasting material; very high (Ex. 4–14). The study involved twenty- dimensions (according to lip length) levels of exposure). The impact of five subjects meeting the criteria of the used each filtering facepiece. These ‘‘bounceback’’ on the integrity of the LANL respirator panel. Twenty-one subjects represented six different boxes respirator was not evaluated in the respirators were tested and included on the Los Alamos National Laboratory LLNL SWPF study since the study twenty filtering-facepiece and one half-mask test panel (Boxes 4, 5, 7, 8, 9, challenge agent was a liquid, not a elastomeric half-mask. Each test and 10). Subjects used the particulate (which is typically the type involved a sequence of six sedentary- manufacturer’s instructions prior to of contaminant found in workplaces). type exercises: Normal breathing, deep Also, because these respirators may, at donning the respirator. Each subject breathing, moving the head side to side, tested each respirator 4 times, for a total times, be used near the limits of their moving the head up and down, reading protective capability, workers wearing of 16 tests per subject and 96 tests the rainbow passage out loud, and overall. The investigators probed the these respirators in abrasive blasting normal breathing. Each exercise took operations could receive acute respirators in the area of the nose, using about 80 seconds. For all tests, the the TSI fit-test probe kit, and measured exposures if the respirators do not subjects donned the respirator and perform properly. Therefore, penetration values with a TSI conducted a user seal check in PortaCount Model 8020. They used performance consonant with the accordance with the manufacturer’s ambient room aerosol as the challenge elevated APF can only be assured when instructions. After each test, the test atmosphere and monitored it the respirators are properly used. operator returned the respirator to its continuously during testing with a As a result of the above, OSHA original pre-test configuration (e.g., second PortaCount. They used room adopted a modified enforcement policy strap was loosened). The investigators aerosol at concentrations greater that for these two respirators. This policy used a PortaCount Plus, a condensation was limited to the Lead in Construction 2,000 particles/cc. Subjects removed the nucleus type of particle detector, to Standard (29 CFR 1926.62) and applied filtering facepiece at the conclusion of determine the protection factor by only to the Bullard Models 77 and 88. each test and, after approximately 2 measuring both the challenge aerosol Also, the interim APF of 1,000 was minutes, redonned the same unit. The (i.e., ambient aerosol) and the aerosol pending until a final APF for this class test operator restored the respirator to penetrating the respirator. of respirators could be determined pre-test configuration (e.g., straps were through this rulemaking. Since OSHA The total penetration of an aerosol loosened) after each donning. Each test believes that proper use of these into a respirator includes the consisted of nine exercises: normal respirators is imperative, the policy penetration through the filter media in breathing, deep breathing, side-to-side made it clear that the Agency would be addition to that resulting from face seal head movement, up and down head leakage. To determine face seal leakage, very strict in assuring that these movement, reading the rainbow passage, the study authors subtracted estimated respirators are used in accordance with normal breathing, scooping rocks filter media penetration from the total the manufacturer’s specifications and between buckets, stacking 30-pound observed penetration. Filter media the requirements of 1926.62. concrete blocks and normal breathing. penetration was ascertained by separate Clemco Apollo Models 20 and 60 and Subjects performed each exercise for 80 testing performed on the filter media 3M Whitecap II. With the assistance of seconds, with a 20-second instrument after human subject testing. Testing was the Industrial Safety Equipment purge cycle and 60 seconds of data conducted at an airflow rate of 31.4 Association (ISEA), other respirator collection per exercise. manufacturers of Type-CE, continuous- Lpm, as determined from a volume- flow, abrasive blasting respirators weighted average cycle having a peak For each model of respirator, the covered by the Lead in Construction flow rate of 40 Lpm. The same investigators used the size that showed Standard were contacted. By penetration for a given media was the least penetration when the subject participating in a similar study, these subtracted from the total penetration for performed a 60-second reading of the manufacturers were provided with an all subjects using a respirator with that rainbow passage. This was a change equal opportunity to obtain the same media. Calculating face seal leakage in from using the penetration measured relief afforded to Bullard. The Clemco this manner assumes all subjects have during normal breathing (as done in the Apollo Models 20 and 60 and the 3M the same constant, volumetric flow rate original NIOSH tests), and was chosen Whitecap II were tested under through the respirator. The authors also because reading is frequently found to conditions similar to the Bullard Model summarized total penetration and face be an exercise that permits high 77and 88 study. Based on the results of seal leakage penetrations. The 95th penetration. A 60-second normal the studies, OSHA granted the percentiles presented by NIOSH were breathing fit test was performed in respirators the interim APF of 1,000, based on a formula using the geometric addition to the reading fit test. Multiple and developed the same enforcement mean and geometric standard deviation, fit tests (both reading and normal policy for Clemco (Ex. 3–7–4; memo to and assumes the distribution to be log breathing) were performed, if necessary, Regional Administrators dated 03/31/ normal. to select a model size. Once fitted, each

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subject completed four full nine- respirators significantly affects results. pebbles, normal breathing, building a exercise tests. For example, a subject was started in the concrete block wall, and normal The NIOSH penetration results LLNL/OSHA test but was not tested breathing. Two exercises, hand scooping without fit-testing were compared to the because the investigators were unable to of pebbles and building a concrete block LLNL test results. In general, the maintain a proper fit on the individual wall, were included to simulate tasks in investigators found good agreement when using Model A (i.e., it fell the pharmaceutical industry. Seventeen between the two studies, with the range completely off the nose of the subject subjects participated in the evaluation of penetrations being similar in both upon donning). If tested, this subject or of five powered air-purifying respirators studies. However, two differences were another less obvious subject who (PAPRs) and six supplied-air respirators noted. For one model, (referred to by the experienced poor fit, could have skewed (SARs). Twelve tests were conducted for researchers as Model D), the OSHA/ the results of the LLNL/OSHA N95 each respirator, with the study being LLNL study result indicated slightly evaluation significantly. The LLNL performed in the LLNL respirator test more penetration than was observed in researchers believed that this latter facility. the NIOSH study. While the minimum analysis illustrates the potential Input from OSHA resulted in two penetration for Model D was 2 in both influence of a single outlier on the modifications to the protocol. It was studies, the maximum penetration was overall results of a study. The decided that at least one of the three 460 in the OSHA/LLNL study compared advantages of controlled SWPF testing units for each respirator model tested to 370 in the NIOSH study. However, are apparent in this example. would be purchased from the open both studies showed this respirator to be market with the others being supplied in the low performance range of 10. SWPF Studies—PAPRs and SARs directly from the manufacturer. A penetrations. The researchers believed ORC Study on Respirators Used in the second change resulted from the that this could be attributed to a poor- Pharmaceutical Industry. Before the Agency’s interest in evaluating intra- fitting individual that participated in publication of the final respiratory personal variability in the performance the larger NIOSH study, but whose fit protection standard, Organization of respirators. This was accomplished factor attributes were not represented by Resources Counselors, Inc. (ORC) raised by testing one PAPR model and one any participants in the smaller OSHA/ an issue that had been the subject of SAR model during six wearings by a LLNL study. They also noted that the discussions between ORC and OSHA for single individual. No significant design features of Model D, such as its several years. In 1997, ORC and a group difference in respirator performance was folded shape and the plastic nose clip, of its member companies sponsored a noted as a result of these modifications, may explain this respirator’s poor study of certain models of powered air- and the overall results are presented performance. Furthermore, while this purifying and supplied-air respirators to below. respirator was available in three sizes, it evaluate the ability of these respirators was very difficult to determine which to protect workers from exposures in the The results of the ORC study size provided the best fit for several of pharmaceutical industries. The study, indicated that although simulated the subjects. ‘‘Simulated Workplace Protection Factor workplace protection factors (SWPFs) The LLNL penetration result for Study of Powered Air Purifying and greater than one million were recorded another respirator, referred to by the Supplied Air Respirators,’’ (Ex. 3–4–1) during some of these tests, a reporting researchers as Model A, was slightly was completed in 1998, and the initial limit of 250,000 was established as the better than the NIOSH result for the results, along with detailed highest value in which reliable same respirator. The LLNL researchers experimental data, were presented to facepiece leakage could be detected believed that the lower penetration they OSHA. (limit of quantification). The median measured for Model A was possibly due The experimental protocol used in the SWPFs for all respirators, except one to the difference in model size/fit study was developed by the SAR, were at or above the reporting selection criteria between the NIOSH Organization Resources Counselors’ limit of 250,000. Lower fifth percentiles tests and the LLNL tests (discussed respirator task force, LLNL investigators, were above 100,000, with the exception above). Again, they felt that another participating respirator manufacturers, of the one SAR. APFs were established possible reason could have been a poor- and representatives from NIOSH and for each of the 11 respirators by dividing fitting individual in the larger NIOSH OSHA. The study included a simulated the lower 5th percentile by a safety study that was not represented by the workplace exercise protocol consisting factor of 25. APFs ranged from 6,000– smaller OSHA/LLNL study. of 12 exercises: normal breathing, 10,000 for PAPRs (including one loose- The LLNL researchers further twisting the head from side-to-side, fitting PAPR), and 3,000–10,000 for investigated the apparent difference moving the head up and down, touching SARs, with the exception of one device. between the LLNL and NIOSH results toes, raising arms above the head, This SAR had lower 5th percentile of for Model A. They found that twisting at the waist, running in place, less than 20 and an APF of 1. Results eliminating subjects with poorly-fitting normal breathing, hand scooping of are presented in the table below.

TABLE 4.—SUMMARY OF SIMULATED WORKPLACE PROTECTION FACTOR RESULTS

Device Range of SWPFs Median SWPF 5th percentile SWPF

PAPR 1 ...... 140,000–>250,000 >250,000 >250,000 PAPR 2 ...... 11,000–>250,000 >250,000 170,000–210,000 PAPR 3 ...... 11,000–>250,000 >250,000 >250,000 PAPR 4 ...... 94,000–>250,000 >250,000 246,000–>250,000 PAPR 5 ...... 240–>250,000 >250,000 150,000–230,000 SAR 1 ...... 68,000–>250,000 >250,000 >250,000 SAR 2 ...... 13,000–>250,000 >250,000 170,000–220,000 SAR 3 ...... 9,700–>250,000 >250,000 86,000–114,000 SAR 4 ...... 5,500–>250,000 >250,000 150,000–240,000 SAR 5 ...... 5–>250,000 GM=1217 13–18

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TABLE 4.—SUMMARY OF SIMULATED WORKPLACE PROTECTION FACTOR RESULTS—Continued

Device Range of SWPFs Median SWPF 5th percentile SWPF

SAR 6 ...... 160,000–>250,000 >250,000 >250,000

List of Respirators The study report was finalized in against airborne particulates, and asked Powered Air-Purifying Respirators With 1999, and ORC requested that OSHA OSHA to issue a directive or similar Hoods/Helmets consider assigning an interim final APF document assigning an interim APF of of 1,000 to the study’s high-performing 1,000 for the SARs and PAPRs that (PAPR1) 3M Whitecap helmet with respirator models, with provisions for tested successfully in the study. ORC chinstrap with GVP blower (hard an APF as high as 5,000 based on believed that SWPF testing of PAPRs plastic helmet with bib). programmatic and environmental and SARs was beneficial, and strongly (PAPR 2) 3M Snapcap hood with factors (Ex. 3–4–3, 1999 communication supported use of a collaborative chinstrap with GVP–100 blower with OSHA). ORC also recommended approach as was pursued in developing (Tyvek hood with bib). that, because the current NIOSH the study. (PAPR 3) Racal BE–5 (clear PVC hood respirator certification procedures are OSHA permitted use of an interim with bib). not capable of distinguishing between APF of 1,000 for 9 of the 11 respirators (PAPR 4) Racal BE–10 (Polycoated high-performing PAPRs and SARs (and tested and developed an enforcement Tyvek hood with bib and head that some respirators may not provide policy similar to that followed for the suspension). adequate protection), the study Bullard, Clemco, and 3M respirators Loose-Fitting Powered Air-Purifying methodology should be the basis for (Ex. 3–4–4; 2002 memo to RAs). Again, Respirator determining APFs for all respiratory the interim APFs are subject to a final protective equipment regulated by APF determination resulting from this (PAPR 5) Racal BE–12 (Polycoated OSHA. Tyvek loose-fitting facepiece). rulemaking. OSHA requests comments In 2000, ORC renewed its requests. on all aspects of this study. Supplied-Air Respirators They pointed out that the study demonstrated that the PAPRs tested, LLNL/OSHA PAPR Study. OSHA (SAR 1) 3M Whitecap helmet with including the loose-fitting facepiece requested that LLNL conduct two chinstrap (hard plastic helmet with PAPRs, were capable of achieving additional PAPR studies using the bib). protection factors of 6,000 to 10,000 protocol of the 1995–96 ORC study. The (SAR 2) 3M Snapcap hood with (rather than the APF of 25 assigned by raw data from the two evaluations were chinstrap (Tyvek hood with bib). NIOSH and adopted by OSHA), and that then compared with the ORC SWPF (SAR 3) MSA VERSA-Hood with #5– the tested SARs achieved protection study data. 613–1 direct hose connection for factors of 3,000 to 10,000. However, one A modified SWPF protocol was used 3/8’’ hose system (Tyvek hood). tested SAR model did not provide a to test two additional PAPRs, an MSA (SAR 4) North Model 85302 TB (Tyvek protection factor of 25, demonstrating to OptimAir and a Neoterik, selected by hood with ratchet head suspension the Agency the importance of testing OSHA. The testing employed the same and bib). specific equipment being considered for exercise protocol as the ORC study; (SAR 5) North Model 85302 T (Tyvek an increased APF to assure the expected however, only three test subjects hood with ratchet head protection. participated in the evaluation. The three suspension). ORC asserted that new APFs for the test subjects each performed four (SAR 6) Bullard CC2OTIC with 2ORT models tested in the study were separate donnings of each respirator suspension and 2ONC chinstrap warranted. They believed that the study model. The 50th and 95th percentiles of (Tyvek hood with bib). results justified a re-evaluation of the the penetration and protection factors Note: All PAPRs tested with high- methods for assessing the ability of for the two respirators are shown in efficiency filters. PAPRs and SARs to provide protection Table 5.

TABLE 5

Penetration Protection factor Respirator model 50th percentile 95th percentile 50th percentile 95th percentile

MSA OptimAir ...... 1.67 × 10¥6(a) ...... 4.08 × 10¥5 ...... 250,000(a) ...... 24,510 Neoterik ...... 2.74 × 10¥5 ...... 1.43 × 10¥3 ...... 36,563 ...... 698

For the Neoterik, SWPFs of 100 and the running in place exercise were ‘‘running-in-place’’ (for both respirators) somewhat less were observed for the observed, while all of the other and ‘‘moving bricks’’ (for the Neoterik running in place and the moving bricks exercises resulted in SWPFs of 10,000 or PAPR). (building a concrete block wall) greater. Penetration levels by type of V. Health Effects exercises. The Neoterik demonstrated exercise were compared between the SWPFs near 1,000 and somewhat less OSHA PAPR analyses and the ORC In a number of previous rulemakings, for the twisting head side to side, results. In general, the comparison OSHA discussed the serious health moving the head up and down, and indicated that the same exercises effects caused by exposure to airborne touching toes exercises. For the MSA triggered increased penetration values. chemical hazards (see, e.g., Appendix A OptimAir, SWPFs approaching 100 for That is, sources of penetration were of the Hazard Communication Standard

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at 29 CFR 1910.1200, and the preambles The risk that an employee will employees with at least the minimum to any of the Agency’s substance- experience an adverse health outcome level of exposure protection listed in the specific standards codified at 29 CFR while exposed to a hazardous airborne proposed APF table, employers must 1910.1001 to 1910.1052). When OSHA substance is a function of the toxicity or comply with the other respiratory promulgates a new or revised PEL for a hazardous characteristics of the protection requirements specified under chemical air contaminant, (e.g., Arsenic, substance, the concentrations of the OSHA’s Respiratory Protection Standard 29 CFR 1910.1018; Asbestos, 29 CFR substance in the air, the duration of at 29 CFR 1910.134. 1910.1001; Benzene, 29 CFR 1910.1028; exposure, the physiology of the In this rulemaking, OSHA also is Lead, 29 CFR 1910.1025; Ethylene employee, and workplace conditions. proposing to supersede the existing APF Oxide, 29 CFR 1910.1047), it determines These factors combined assist in requirements in its substance-specific at what level of exposure to the determination of the type of respirator standards. By superceding these contaminant employees develop serious selected to reduce an employee’s requirements, the Agency expects that health effects (e.g., exposure to the exposure below the PEL for the the benefits estimated for the proposed contaminant is life-threatening, causes hazardous substance. Under many APFs under the Respiratory Protection permanent damage, or significantly workplace-exposure conditions, Standard would be available to impairs employees’ ability to perform prevention of serious health effects employers who must select respirators their jobs safely). depends substantially on the protection for employee use under the substance- As discussed in Section VI, afforded to employees by a respirator. specific standards. In addition, OSHA ‘‘Summary of the Final Economic Employers need the APFs provided in would be harmonizing the APF Analysis,’’ of the final Respiratory this proposal to select appropriate requirements in the substance-specific Protection Standard (63 FR 1171), respirators for employee use when standards with the APF requirements OSHA estimated that improvements and engineering and work-practice controls proposed for its Respiratory Protection clarifications made to the previous are insufficient to maintain hazardous Standard. The Agency believes that Respiratory Protection Standard would substances at safe levels in the harmonization would reduce confusion prevent, each year, between 843 and workplace. In this regard, the proposed among the regulated community and aid 9,282 (best estimate, 4,046) work-related APFs will permit employers to select in uniform application of APFs, while injuries and illnesses, and between 351 respirators for employee protection maintaining employee protection at and 1,626 (best estimate, 932) work- based on the type of hazardous levels at least as protective as the related deaths from cancer and chronic substance and the level of employee existing APF requirements. exposure to that substance, among other diseases such as cardiovascular disease. VI. Summary of the Preliminary factors. OSHA strongly believes that To support this estimate, OSHA used its Economic and Regulatory Flexibility proper respirator selection using the Integrated Management Information Screening Analysis System database to identify several proposed APFs will protect employees substances that had a wide range of from overexposure to hazardous A. Introduction adverse effects, as well as documented substances, thus preventing the serious OSHA’s Preliminary Economic and workplace exposures that exceeded the health effects that result from such Regulatory Flexibility Screening PELs for these substances. The health overexposure. Analysis (PERFSA) addresses issues effects associated with exposure to these While APFs are an important factor in related to the costs, benefits, substances include: respirator selection, employers must technological and economic feasibility, • Sudden death or asphyxiation (e.g., consider other factors as well. In this and economic impacts (including small from exposure to carbon monoxide, regard, simply applying an APF to the business impacts) of the Agency’s carbon dioxide); level of an airborne contaminant in a proposed Assigned Protection Factors • Loss of lung function (e.g., from workplace will not ensure that (APF) rule. The Agency preliminarily exposure to wood dust, welding fumes, employees receive adequate protection. determined that this rule is not an manganese fumes, copper fumes, cobalt Throughout the preamble of the final economically significant rule under metal fumes, silica); Respiratory Protection Standard, OSHA • Executive Order 12866. The economic Central nervous system demonstrated that adequate fit testing, analysis meets the requirements of both disturbances (e.g., from exposure to proper respirator use, employee Executive Order 12866 and the carbon monoxide, trichloroethylene); training, and thorough inspection and • Regulatory Flexibility Act (RFA; as Cancer (e.g., from exposure to maintenance of respirators are some of amended in 1996). The PERFSA chromic acid, wood dust, silica); and the other factors essential to an effective presents OSHA’s full economic analysis • Cardiovascular problems (e.g., from respiratory protection program. The and methodology. The Agency entered exposure to carbon monoxide). Agency believes that failure to comply the complete PERFSA into the docket as Furthermore, most of the airborne with any of these program requirements Exhibit 6–1. The remainder of this contaminants measured as part of the substantially increases the chance that section summarizes the results of that workplace protection factor studies the respirator selected by the employer analysis. considered during development of this will not protect employees against The purpose of this PERFSA is to: proposal cause serious health effects. hazardous air contaminants because of • Identify the establishments and For example, acute lung, skin, and eye respirator malfunction, excessive industries potentially affected by the irritation occur as a result of leakage, improper use, or some rule; occupational exposures to styrene, lead, combination of these problems. • Evaluate the costs employers would strontium, benzo(a)pyrene, and silica. Therefore, employers should expect incur to meet the requirements of Longer-term exposures to other respirators to provide effective proposed APF rule; substances sampled in these studies employee protection against the serious • Estimate the benefits of the rule; cause bone and blood effects (lead health effects of hazardous airborne • Assess the economic feasibility of particulates), neurological effects substances only when they use the the rule for affected industries; and (mercury fumes), chronic lung damage respirators in the context of a • Determine the impacts of the rule (cotton dust), and cancer (asbestos fibers comprehensive respiratory protection on small entities and the need for a and chromium particulates). program. If respirators are to provide Regulatory Flexibility Analysis.

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B. The Rule and Affected Respirator corresponding number of respirator- half-mask and full facepiece Users using establishments on the recent nonpowered air-purifying respirators OSHA’s proposed APF rule would NIOSH–BLS survey of respirator use (49.0 and 21.4 percent, respectively). A 1 amend 29 CFR 1910.134(d)(3)(i)(A) of and practices (Ex. 6–3). The NIOSH– smaller number of establishments the Respiratory Protection Standard by BLS survey provides up-to-date use reported use of powered air-purifying specifying a set of APFs for each class estimates by two-digit industry sector respirators (PAPRs) and supplied-air of respirators. These APFs specify the and respirator type for establishments in respirators (SARs). Fifteen percent of highest multiple of a contaminant’s which employees used respirators establishments with respirators (43,154) permissible exposure limit (PEL) at during the previous 12 months.2 As reported using PAPRs and 19 percent which an employee can use a respirator shown in Table VI–1, an estimated (56,022) reported using SARs. Table VI– safely. The proposed APFs would apply 291,085 establishments reported 2 presents estimates of the number of to respirator use for protection against respirator use in industries covered by respirator users by two-digit industry overexposure to any substance regulated OSHA’s proposed regulation. Most of sector. An estimated 2.3 million under 29 CFR 1910.1000. In addition, these establishments (208,528 or 71.6 employees used filtering facepiece OSHA rules for specific substances percent) reported use of filtering respirators in the last 12 months, while under subpart Z (regulated under the facepieces. Substantial percentages of 1.5 million used half masks, and 0.7 authority of section 6(b)(5) of the OSH establishments also reported the use of million used full facepiece nonpowered Act of 1970, 29 U.S.C. 655) specify APFs air-purifying respirators. Fewer for respirators used for protection 1 Preliminary results from the 2001 NIOSH–BLS employees reported using PAPRs (0.3 against these chemicals (hereafter ‘‘Survey of Respirator Use and Practices’’, in press. million) and SARs (0.4 million). The NIOSH commissioned the survey to be conducted industry-specific estimates show referred to as section 6(b)(5) substances). by BLS, who also tabulated the data after The proposed rule would supercede completing the survey. substantial respirator use in several most of these protection factors, and 2 The survey was conducted between August industries, including the construction harmonize APFs for these substances 2001 and January 2002. It asked: ‘‘During the past sector, several manufacturing industries 12 months, how many of your current employees (SICs 28, 33, 34, and 37), and Health with those for general respirator use. used respirators at your establishment?’’ It excluded OSHA based estimates of the number voluntary use of respirators from detailed followup services (SIC 80). of employees using respirators and the respirator use questions (Ex. 6–3). BILLING CODE 4510–26–P

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The proposed standard would have use, by general respirator class, for substances not reported by NIOSH, different impacts on employers using protection against specific substances OSHA used expert judgments of a respirators to comply with OSHA (see Table VI–3). OSHA applied these consultant with experience in the substance-specific standards than for numbers to all respirator users and respirator industry to estimate the employers using respirators for other establishments within the industries percentage of establishments and purposes. Therefore, OSHA used that make up each sector to derive employees that use respirators for findings from the NIOSH–BLS survey of substance-specific estimates of protection against these chemicals (Ex. establishments that reported respirator respirator use. For those section 6(b)(5) 6–2) (see Table VI–3).

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BILLING CODE 4510–26–C two factors: The total number of users equipment and accessory costs, and the C. Compliance Costs of that type, and the percentage of those costs for training and fit testing. OSHA users for whom the ambient exposure then calculated the incremental cost for The proposal does not raise issues of level is greater than the proposed APF. each combination of upgrades from an technological feasibility because it While survey data are available to existing model to a more protective one, requires only that employers use estimate the number of users, virtually taking into account the effect of respirators already on the market. no information is available in the replacement before the end of the However, costs of the proposed APFs literature that provides a basis for respirator’s useful life. These result from requiring some users to estimating the percentage of users annualized costs range from $49.98 (for switch to more protective respirators required to upgrade respirators. The upgrading from a supplied-air, demand than they currently use. When the percentage of workers switching mode, full facepiece respirator to a proposed APF is lower than the baseline respirators would depend on the profile supplied-air, continuous flow, half- (current) APF, respirator users must or frequency distribution of users’ mask respirator) to $963.73 (for upgrade to a more protective model. exposure to contaminants relative to the upgrading from a nonpowered, air- Both the 1992 ANSI Z88.2 Respiratory PEL. For example, the Agency proposed purifying full facepiece respirator to a Protection Standard and the 1987 to lower the APF for full facepiece full facepiece PAPR). NIOSH RDL specify APFs for certain respirators used to protect against cotton In certain instances, workers who use classes of respirators. The Agency dust from 100 to 50; accordingly, when respirators under the substance-specific assumed that employers currently use workers have ambient exposures that standards may have to upgrade to a SAR the ANSI or NIOSH APFs, or the APFs are greater than 50 times the PEL, with an auxiliary escape SCBA. Several in the OSHA substance-specific employers must upgrade the respirator substance-specific standards currently standards, as applicable, to select from a full facepiece negative pressure specify SARs for exposures that exceed respirators. While the Agency currently respirator to a more protective respirator 1,000, times the PEL.3 OSHA believes refers to the NIOSH RDL as its primary (e.g., a PAPR). that workers are unlikely to regularly reference for APFs, in the absence of an Because of the absence of data on this use respirators at such extreme exposure applicable OSHA standard, this analysis issue, OSHA made several assumptions levels, i.e., they are most likely to use assumes that, in most cases, adhering to regarding the requirement to upgrade them only in exceptional, possibly the existing ANSI APFs fulfills respirators. First, OSHA assumed that emergency-related situations. employers’ legal obligation for proper employers use respirators only when Furthermore, exposures at levels more respirator selection under the existing their employees have exposures above than 1,000 times the PEL would Respiratory Protection Standard. the PEL. Second, OSHA assumed generally be at or above levels deemed However, in the case of full facepiece employers use the most inexpensive immediately dangerous to life or health negative pressure respirators, the respirator permitted. These assumptions (IDLH), so employers already are Agency has established that an APF of most likely overestimate the cost of required by the Respiratory Protection 50, as opposed to ANSI’s APF of 100, is compliance because many employers Standard to provide each worker with a currently acceptable. In this regard, all require their employees to use respirator that has SCBA capability. For but one of the substance-specific respirators when OSHA does not require these reasons, this PERFSA estimated standards with APFs for full facepiece such use, or they require respirators no impacts for these situations.4 negative pressure respirators set an APF with higher APFs than OSHA currently of 50. In addition, the existing respirator requires. As a result, this analysis 3. Aggregate Compliance Costs rule and its supporting preamble require assumes shifts in respirators that For each respirator type affected by that quantitative fit testing of full employers may have implemented the proposed regulation, OSHA facepiece negative pressure respirators already. combined the incremental costs of must achieve a fit factor of 500 when The Agency estimated distributions of upgrading to a more protective employees use them in atmospheres in exposures above the PELs based on respirator, the estimated share of users excess of 10 times the PEL; this reports from its Integrated Management forecast to upgrade, and the number of requirement assumes a safety factor of Information System describing users involved to estimate the 10. Therefore, based on a fit factor of workplace monitoring of section 6(b)(5) compliance costs associated with each 500, such respirators would be safe to toxic substances performed during respirator type. Table VI–4 shows wear in atmospheres up to 50 times the OSHA health inspections. Of the 9,095 estimated compliance costs for OSHA’s PEL, consistent with similar samples reported above the PELs, 68.0 proposed APF rule of $4.6 million. The requirements regarding respirator use percent reported exposures between 1 proposed rule would require 1,918 users found in existing standards for section and 5 times the PEL, 13.1 percent found of nonpowered air-purifying respirators 6(b)(5) chemicals. exposures between 5 and 10 times the to upgrade to some respirator more For each respirator type, OSHA PEL, and 9.5 percent documented expensive than they are now using at a compared the proposed and current exposures between 10 and 25 times the cost of $1.8 million. The Agency APF requirements, including existing PEL. Exposures for the remaining 9.4 estimates that 22,848 PAPR users would APFs for section 6(b)(5) substances, and percent of the samples were greater than upgrade their respirators at a cost of identified an incrementally more 25 times the PEL. Based on these data, $2.3 million. A relatively small number protective respirator model. To be OSHA modeled the current exposure of SAR users (5,110) would upgrade to adequate, the more protective respirator distribution for each respirator type. more expensive respirators at a cost of must have a proposed APF greater than 2. Incremental Costs of Upgrading the current APF. 3 Respirator Models These standards regulate cotton dust, coke oven emissions, acrylonitrile, arsenic, DBCP, ethylene 1. Number of Users Required To OSHA also analyzed the costs of oxide, and lead. Upgrade Respirator Models upgrading from the current respirator to 4 Paragraph (d)(2) of the Respiratory Protection Standard requires employers to provide either a For a given respirator type, the a more protective alternative. In doing pressure demand SCBA or a pressure demand SAR number of users required to shift to a so, OSHA estimated the annualized unit with auxiliary SCBA to any employee who works more protective respirator depends on costs for each respirator type, including in IDLH atmospheres.

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$0.4 million. Industry-specific As discussed previously, however, the potential cost savings are not accounted compliance costs vary according to the Agency believes the actual costs of the for in this cost analysis. number of respirator users and the proposal almost certainly are In many cases, however, employers proportion of these users affected by the overestimated. The cost analysis use respirators when respirators are not proposed rule. Industries with relatively assumes all respirator wearers have required by OSHA, or use respirators large compliance costs include SIC 17, levels of exposures that require the more protective than required by OSHA. Special trade contractors ($0.8 million), particular respirator they are using. As a result, OSHA’s cost analysis and SIC 80, Health services ($0.8 Under this assumption, OSHA estimates overestimates the number of employees million). Potentially offsetting these over 15,000 employees would be who are affected by the standard, and costs are a limited number of cases allowed to safely shift to a less therefore overestimates costs associated where employers would be allowed to expensive respirator, which could lead with the standard. shift to a less expensive respirator. to cost savings for the employer. Such BILLING CODE 4510–26–P

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BILLING CODE 4510–26–C estimated 8,384 have exposure to lead, establishment basis. Accordingly, for D. Benefits 7,287 to asbestos, and 3,747 to cotton each affected industry, the Agency dust, all substances with substantial The benefits that would accrue to compared estimates of per- health risks. respirator users and their employers establishment annualized compliance In addition to health benefits, OSHA take several forms. The proposed costs with per-establishment estimates believes other benefits would result standard would benefit workers by of revenues and per-establishment from the harmonization of APF reducing their exposures to respiratory estimates of profits. It used two worst- specifications, thereby making hazards. Improved respirator selection case assumptions regarding the ability compliance with the respirator rule would augment previous improvements of employers to pass the costs of easier for employers. Employers also to the Respiratory Protection Standard, compliance through to their customers: such as better fit-test procedures and would benefit from greater The no-cost-pass-through assumption, improved training, contributing administrative ease in proper respirator and the full-cost-pass-through substantially to greater worker selection. Employers would no longer assumption. Based on the results of protection. Estimates of benefits are have to consult several sources and these comparisons, which define the difficult to calculate because of several OSHA standards to determine universe of potential impacts of the uncertainties regarding the existing state the best choice of respirator, but could proposed APFs, OSHA then assessed of employer respirator-selection make their choices based on a single, the proposal’s economic feasibility for practices and the number of covered easily found regulation. Some all affected establishments, i.e., those work-related illnesses. At the time of the employers who now hire consultants to covered by the proposal. 1998 revisions to the Respiratory aid in choosing the proper respirator should be able to make this choice on The Agency assumed that Protection Standard, the Agency establishments falling within the scope estimated that the standard would avert their own with the aid of the proposed of the proposal would have the same between 843 and 9,282 work-related rule. In addition to having only one set average sales and profits as other injuries and illnesses annually, with a of numbers (i.e., APFs) to assist them establishments in their industries. best estimate (expected value) of 4,046 with respirator selection for nearly all averted illnesses and injuries annually substances, some employers may be able OSHA believes this assumption is (63 FR 1173). In addition, OSHA to streamline their respirator stock by reasonable because no evidence is estimated that the standard would using one respirator class to meet their available showing that the financial prevent between 351 and 1,626 deaths respirator needs instead of several characteristics of those firms with annually from cancer and many other respirator classes. The increased ease of employees who use respirators are chronic diseases, including compliance would also yield additional different from firms that do not use cardiovascular disease, with a best health benefits to employees using respirators. Absent such evidence, estimate (expected value) of 932 averted respirators. OSHA relied on the best available deaths from these causes. The APFs The proposed APFs would clarify financial data (those from the Bureau of proposed in this rulemaking help ensure when employers can safely place the Census (Ex. 6–4) and Robert Morris these benefits are achieved, as well as employees in respirators that impose Associates (Ex. 6–5)), used a commonly provide an additional degree of less stress on the cardiovascular system accepted methodology to calculate protection. The proposed APFs would (e.g., filtering facepiece respirators). industry averages, and based its analysis reduce employee exposures to several Many of these alternative respirators of the significance of the projected section 6(b)(5) chemicals covered by may have the additional benefit of being economic impacts and the feasibility of standards with outdated APF criteria, less expensive to purchase and operate. compliance on these data. As previously discussed, OSHA thereby reducing exposures to The analysis of the potential impacts estimates that over 15,000 employees chemicals such as asbestos, lead, cotton of the proposed APF standard on before- 5 currently use respirators that would fall dust, and arsenic. While the Agency tax profits and sales shown in Table VI– in this group (i.e., shift to a less did not quantify these benefits, it 5 is a ‘‘screening analysis,’’ so called estimates that 29,655 employees would expensive respirator). because it simply measures costs as a have a higher degree of respiratory E. Economic Feasibility percentage of pre-tax profits and sales protection under the proposed APF under the worst-case assumptions standard. Of these employees, an OSHA is required to set standards that are feasible. To demonstrate that a discussed above, but does not predict 5 In the 1998 rulemaking revising the Respiratory standard is feasible, the courts have impacts on these before-tax profits or Protection Standard, the Final Economic Analysis held that OSHA must ‘‘construct a sales. OSHA used the screening analysis noted that the standard would not directly affect the reasonable estimate of compliance costs to determine whether the compliance benefits for the estimated 5% of employees who use respirators under OSHA’s substance-specific health and demonstrate a reasonable likelihood costs potentially associated with the standards (except to the extent that uniformity of that these costs will not threaten the proposed standard could lead to provisions improve compliance). Therefore, the existence or competitive structure of an significant impacts on all affected Agency likely over-estimated the benefits of that establishments. The actual impact of the rulemaking since the standard did not affect industry’’ (United Steelworkers of directly the type of respirator used by those America, AFL–CIO–CLC v. Marshall (the proposal on the profit and sales of employees (63 FR 1173). Conversely, this proposed ‘‘Lead’’ decision), 647 F2d 1189 (DC Cir. establishments in a specific industry rulemaking directly addresses the APF provisions 1980)). would depend on the price elasticity of of the substance-specific standards; therefore, this proposal would affect directly the respirators used OSHA conducted its analysis of demand for the products or services of by employees covered by these standards. economic feasibility on an these establishments.

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Table VI–5 shows the economic transportation), for which OSHA establishments in all industries shown impacts of these costs. For each estimated the costs impacts to be 0.16 in Table VI–5, OSHA concludes that the industry, OSHA constructed the average percent of revenues. When the Agency APF proposal is economically feasible compliance cost per affected compared average compliance costs for the affected establishments. establishment and compared it to with profits, the costs also are small, i.e., BILLING CODE 4510–26–P average revenues and average profits.6 less than 0.17 percent; again, the major These costs are quite small, i.e., less exception was SIC 44, which had an than 0.005 percent of revenues; the one estimated impact of 2.12 percent of purposes of assessing economic feasibility, imputed 7 major exception is SIC 44 (Water profits. Based on the data for broader sector-level data from the survey to form an estimate of respirator use. This procedure may 6 OSHA defines ‘‘affected establishment’’ as any 7 For some industries, such as SIC 44, data from result in overestimating the impact of the proposal facility that uses respirators, as represented in the the NIOSH–BLS survey were suppressed due to low in some industries. See the full PEA (Ex. 6–1) for NIOSH–BLS survey data. response rates. In these cases, the Agency, for the further details.

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F. Economic Impacts to Small Entities and less than 0.19 percent of profits, in OSHA considers the impact on small all industries. Table VI–7 presents the entities significant for the purposes of OSHA also estimated the economic economic impacts for small entities as a complying with the RFA. For all classes impacts of the proposed rule on affected whole, as defined by SBA. For these of affected small entities, the Agency entities with fewer than 20 employees, firms, average compliance costs are less found that the costs were less than one and for affected small entities as defined than 0.005 percent of average revenues percent of revenues and five percent of by the Small Business Administration and less than 0.03 percent of average profits. Therefore, OSHA certifies that (SBA). Table VI–6 shows the estimated profits. Thus, the Agency projects no this proposed regulation would not have economic impacts for small entities significant impacts from the proposed a significant impact on a substantial with fewer than 20 employees: Average rule on small entities. number of small entities. compliance costs by industry are less When costs exceed one percent of than 0.005 percent of average revenues, revenues or five percent of profits,

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BILLING CODE 4510–26–C [(d)(3)(i)(A)] for APF requirements, and vast majority of employees who use VII. Summary and Explanation of the a definition of APF under paragraph (b). respirators in the workplace. Proposed Standard In its 1987 RDL, NIOSH defined APF The Agency’s review of the available as ‘‘[t]he minimum anticipated data on respirator performance, as well This section of the preamble provides protection provided by a properly as findings from the personal protective a summary and explanation of each functioning respirator or class of equipment surveys (Exs. 6–1, 6–2), proposed revision to OSHA’s respirators to a given percentage of indicate that the existing definitions of Respiratory Protection Standard properly fitted and trained users’’ (Ex. APF are confusing to the respirator- involving assigned protection factors. 1–54–437Q). The American National using public. Accordingly, OSHA A. Revisions to the Respiratory Standards Institute (ANSI) developed a believes that the proposed definition would reduce confusion among Protection Standard definition for APF in its Z88.2–1992 Respiratory Protection Standard that employers and employees regarding This section addresses the revisions reads, ‘‘The expected workplace level of APFs, thereby assisting employers in proposed for paragraphs (b), (d)(3)(i)(A), respiratory protection that would be providing their employees with effective (d)(3)(i)(B), and (n) of OSHA’s exiting provided by a properly functioning respirator protection consistent with its Respiratory Protection Standard at 29 respirator or class of respirators to Respiratory Protection Standard. CFR 1910.134). properly fitted and trained users’ (Ex. 1– The Agency revised the terms in the ANSI APF definition to improve clarity. Paragraph (b)—Definitions 50). The ANSI Z88.2 Subcommittee that developed the 1992 standard used the OSHA’s proposed definition for APF Revisions to this paragraph would NIOSH definition of APF as a template reads as follows: add two important definitions’’— for its APF definition; however, the Assigned protection factor (APF) means the assigned protection factor’’ and Z88.2 Subcommittee revised the phrase workplace level of respiratory protection that ‘‘maximum use concentration’’—to ‘‘minimum anticipated protection’’ in a respirator or class of respirators is expected OSHA’s Respiratory Protection to provide to employees when the employer the NIOSH definition to ‘‘expected implements a continuing, effective Standard. The following sections workplace level of respiratory respiratory protection program as specified explain these proposed definitions in protection.’’ It also dropped the NIOSH by 29 CFR 1910.134. detail. phrase ‘‘to a given percentage’’ from its The revisions made to the ANSI APF 1. Assigned Protection Factor definition. definition in developing this proposed The phrase ‘‘a given percentage’’ APF definition include adding the As part of its 1994 proposed implies that some respirator users will phrase ‘‘when the employer implements rulemaking for the Respiratory not achieve the full APF under a continuing, effective respiratory Protection Standard, OSHA proposed a workplace conditions. The ‘‘given protection program as specified by 29 definition for assigned protection factors percentage’’ usually is about five CFR 1910.134.’’ The Agency added this (APFs) that read as follows: ‘‘[T]he percent, which is a percentage derived phrase to emphasize the requirement number assigned by NIOSH [the from statistical analyses of workplace that employers must select a respirator National Institute for Occupational protection factor (WPF) studies. In this in the context of a comprehensive Safety and Health] to indicate the regard, five percent represents the fifth respiratory protection program. capability of a respirator to afford a percentile of the geometric distribution Accordingly, the APFs in Table I of this certain degree of protection in terms of of protection factors for individual proposal do not apply when any of the fit and filter/cartridge penetration’’ (59 participants in a WPF study. Each program elements required by OSHA’s FR 58938). OSHA proposed this participant’s protection factor is the Respiratory Protection Standard are definition on the assumption that concentration of challenge agent outside absent from an employer’s respirator NIOSH would develop APFs for the the respirator (Co) divided by the program, including fit testing, various respirator classes, building on concentration of that agent inside the maintenance, selection, use, training, the APFs in the 1987 NIOSH Respirator participant’s respirator (Ci), or Co/Ci); and other specified elements. This Decision Logic (RDL) (59 FR 58901– therefore, the fifth percentile is the wording is necessary because the level 58903). However, NIOSH subsequently threshold for specifying the APF for the of employee protection afforded by the decided not to publish a list of APFs as respirator tested under those workplace proposed APFs depends on the other part of its 42 CFR part 84 Respirator conditions. Using the fifth percentile elements of a comprehensive respiratory Certification Standards (60 FR 30338), means that about five percent of the protection program being in place and reserved APFs for a future NIOSH employees who use the respirator under continuously, and operating effectively. rulemaking. these workplace conditions may not Employers and employees cannot During his opening statement on June achieve the level of protection assigned expect to achieve an APF reliably unless 15, 1995 at an OSHA-sponsored expert- to the respirator (or class of respirators). employers ensure that their employees panel discussion on APFs, Dr. Adam Most WPF studies adopt the fifth- use respirators in accordance with a Finkel, then Director of the Agency’s percentile threshold as the conventional continuing, effective respiratory Directorate of Health Standards standard, recognizing that about five protection program. Programs, noted that OSHA would percent of respirator users will not The proposed APF definition is an explore developing its own list of APFs attain the APF determined for the important addition to the Respiratory (H–049, Ex. 707–X). The Agency then respirator or class of respirators even Protection Standard because it informs announced in the preamble to the final when they receive proper fit testing and employers how the APF constrains Respiratory Protection Standard (63 FR use the respirator correctly as part of a respirator use. The APF can only be 1182) that it would propose an APF comprehensive respiratory protection achieved by a respirator or class of table ‘‘based on a thorough review and program. However, ANSI dropped the respirators that are functioning properly analysis of all relevant evidence’’ in a phrase ‘‘to a given percentage’’ to reduce in accordance with paragraphs (b) and subsequent rulemaking. In the final confusion (i.e., the phrase did not (j) of the Respiratory Protection Respiratory Protection Standard, OSHA specify a percentage), and to emphasize Standard. This means that the respirator reserved a table for APFs, a paragraph the level of protection needed by the must be capable of performing its

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function of reducing employee Documents, each of which provided proposed rulemaking, OSHA defines exposures to airborne contaminants by technical information and MUC as follows: being in correct working order. recommendations for specific airborne Maximum use concentration (MUC) means Accordingly, employers must maintain contaminants. These documents also the maximum atmospheric concentration of a the respirator properly, with no defects recommended MUCs for different types hazardous substance from which an such as cracked or distorted facepiece of respirators; NIOSH obtained the employee can be expected to be protected seals, missing exhalation valves, broken information for these MUCs from when wearing a respirator, and is determined straps, or any other defect that would various sources, including NIOSH by the assigned protection factor of the cause leakage into the respirator or Current Intelligence Bulletins and respirator or class of respirators and the prevent proper operation. For air- recognized industrial hygiene exposure limit of the hazardous substance. purifying respirators, the filters must be The MUC usually can be determined references. NIOSH later published this mathematically by multiplying the assigned appropriate for the airborne information in its Pocket Guide to protection factor specified for a respirator by contaminant, and provide an adequate Chemical Hazards. Other source the permissible exposure limit, short-term service life. documents for MUC definitions and exposure limit, ceiling limit, peak limit, or Employers must properly fit and train regulations include the 1987 NIOSH any other exposure limit used for the employees for respirator use, which RDL, and the ANSI Z88.2–1980 and hazardous substance. addresses the requirements in ANSI Z88.2–1992 respiratory protection Under this proposed definition, MUC paragraphs (f) and (k) of the Respiratory standards. represents the maximum atmospheric Protection Standard. Therefore, OSHA’s 1994 proposed Respiratory concentration of a hazardous substance employers must fit employees with the Protection Standard contained the against which a specific respirator or size and model of respirator they will be following definition for MUC: class of respirators with a known APF using in the workplace. They must then can protect employees who use these wear that same size and model of Maximum use concentration (MUC) means respirators. Accordingly, MUCs are a respirator in the workplace, and follow the maximum concentration of an air function of the assigned protection the training they receive for performing contaminant in which a particular respirator factor (APF) determined for a respirator respirator seal checks, inspections for can be used, based on the respirator’s assigned protection factor. The MUC cannot (or class of respirators) and the exposure correct respirator operation, and proper exceed the use limitations specified on the limit of the hazardous substance. donning and wearing the respirator. NIOSH approval label for the cartridge, The last sentence in the proposed 2. Maximum Use Concentration canister, or filter. The MUC can be definition describes this function in determined by multiplying the assigned terms of a mathematical calculation, i.e., Employers use MUCs to select protection factor for the respirator by the appropriate respirators, especially for permissible exposure limit for the air that employers can ‘‘usually’’ determine use against organic vapors and gases contaminant for which the respirator will be the MUC by multiplying the APF for the since the MUC specifies the maximum used. respirator by the exposure limit used for atmospheric concentration of a the hazardous substance.8 The term hazardous substance against which a Several commenters to the 1994 ‘‘usually’’ in this sentence is consistent specific respirator or class of respirators proposal recommended alternatives to with paragraph (d)(3)(i)(B)(2), which is with a known APF can protect this definition. Reynolds Metal part of the proposed MUC requirements employees who use these respirators. Company recommended defining MUC (see section below titled ‘‘Regulatory MUCs are a function of the assigned as ‘‘the maximum concentration of an Text for Maximum Use protection factor (APF) determined for a air contaminant in which a particular Concentrations.’’) This proposed respirator (or class of respirators) and respirator can be used, based on the paragraph reads, ‘‘Employers must the exposure limit of the hazardous respirator’s assigned protection factor’’ comply with the respirator substance. (Ex. 1–54–222). The American manufacturer’s MUC for a hazardous Ed Hyatt in the 1976 LASL report on Petroleum Institute (API) noted NIOSH substance when the manufacturer’s Respiratory Protection Factors (Ex. 2) developed the term ‘‘MUC,’’ and that, to MUC is lower than the calculated MUC recounted the early history of maximum avoid confusion, OSHA should not use specified by this standard.’’ Therefore, use concentration (MUC), starting with the term (Ex. 1–54–330). API proposed while employers would use the the MUC recommendations of the joint using the term ‘‘assigned use proposed calculation to determine most American Industrial Hygiene concentration’’ to replace ‘‘MUC’’; API MUCs, they would have to use MUCs Association and American Conference defined ‘‘assigned use concentration’’ as determined by respirator manufacturers of Governmental Industrial Hygienists ‘‘the maximum concentration of an air when these MUCs are lower than the committee in 1961. This committee contaminant in which a particular MUCs determined using the proposed recommended that, for highly toxic respirator can be used, based on the calculation. As noted below in the compounds, full facepiece respirators respirator’s assigned protection factor’’ explanation of proposed paragraph with high-efficiency filters should use a (Ex. 1–54–330). However, when the (d)(3)(i)(B)(2), OSHA believes that this maximum limit of 100 x the threshold Agency published the final Respiratory requirement would provide employees limit value (TLV). In 1961, in the United Protection Standard in 1998, it reserved with a necessary added measure of Kingdom, Hyatt noted that Letts the definition of MUC in paragraph (b) protection from hazardous substances in recommended that half-mask dust and MUC requirements in paragraph the workplace. respirators provided effective protection (d)(3)(i)(B) for future rulemaking. Importantly, the last part of the against airborne contaminants no greater Employers use MUCs to select proposed definition specifies exposure than 10 x the TLV. appropriate respirators, especially for limits as ‘‘permissible exposure limit In 1974, NIOSH and OSHA started the use against organic vapors and gases. In (PEL), short-term exposure limit (STEL), Standards Completion Program to this regard, the MUC specifies the develop standards for substances with maximum concentration of a toxic vapor 8 For example, when the hazardous substance is nitrobenzene (with a PEL of 1 ppm), and the existing permissible exposure limits or gas at which a respirator will provide respirator used by employees has an APF of 10, (PELs). This process resulted in the protection to an employee who uses the then the calculated MUC is 10 ppm (i.e., 1ppm x development of NIOSH Criteria respirator. Accordingly, in this 10).

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ceiling limit (CL), peak limit, or any original data reported in most of the ANSI standard;’’ Ex. 10, Docket H049) other exposure limit used for the WPF studies reported below. Dr. required fit testing to identify grossly hazardous substance.’’ The exposure Brown’s quantitative analyses justify misfitting half-mask respirators. That limits are consistent with the terms used combining data for filtering facepiece standard assigned an APF of 10 to half- in the Z tables in 29 CFR 1910.1000 and and elastomeric half-mask respirators in mask air-purifying respirators when the substance-specific standards in 29 determining an APF for these two employers performed qualitative fit CFR parts 1910, 1915, and 1926. respirator classes, and using a testing, and an APF as high as 100 when The phrase ‘‘any other exposure limit qualitative analysis of the data for they performed quantitative fit testing used for the hazardous substance’’ refers identifying APFs separately for powered (Ex. 10, Table 5, p. 21, Docket H049). to exposure limits other than the air-purifying respirators, supplied-air ANSI based the latter APF on the results exposure limits specified in the OSHA respirators, and self-contained breathing of studies that quantitatively fit tested a Z tables or in its substance-specific apparatuses. (Note that insufficient WPF panel of respirator users, much as Hyatt standards; employers use the other data were available for Brown to include did in 1976 (Ex. 2). exposure limits to provide additional full facepiece air-purifying respirators in NIOSH developed its RDL in 1987 protection to employees or to comply his analyses.) OSHA discusses the (Ex. 1–54–437Q), which assigned an with OSHA’s general-duty clause procedures and results of these APF of 5 to single-use and quarter mask (Section 5(a)(1) of the OSH Act; 29 statistical analyses in section IV of this air-purifying respirators, and an APF of U.S.C. 654 where OSHA has no preamble. The Agency believes that the 10 to half-mask respirators, including standard). Employers may adopt such APFs developed through the procedures disposable half-mask respirators. In exposure limits from existing consensus discussed below are consistent with the developing these APFs, NIOSH used standards (e.g., the ACGIH TLVs), or results of the analyses performed by Dr. results from quantitative fit-test studies develop them specifically for the unique Brown. performed on its own respirator test hazardous substances found in their panel, several LANL quantitative fit-test workplaces. 2. Half-Mask Air-Purifying Respirators studies (including Hyatt’s 1976 study), Paragraph (d)(3)(i)(A)—APF Provisions Historical development of APFs for and several WPF studies that it half-mask air-purifying respirators. In 1. Introduction conducted in the early 1980s (Exs. 1– 1976, Ed Hyatt of LANL tested eight 64–42, 1–64–47). As early as 1976, respirator scientists commercially available Bureau of Mines were classifying respirators into distinct (the Federal agency then designated to The 1992 Z88.2 ANSI Respiratory groups based on the level of protection approve respirators) half-mask Protection Standard (i.e., ‘‘the 1992 they provided. These early respirator respirators (Ex. 2). Based on quantitative ANSI standard’’; Ex. 1–50) retained an classes are similar to the classes now in fit testing results obtained from a APF of 10 for half-mask air-purifying use, as well as the classes developed by respirator test panel,9 Hyatt assigned six respirators, including quarter masks, OSHA for this proposal. In the following of these respirators an APF of 10; the disposable half-masks, and half-masks parts of this section, the Agency remaining two respirators performed with elastomeric facepieces. In describes the historical development of less effectively than the other six, determining these APFs, a committee of APFs for specific classes of respirators, thereby achieving an APF of less than respirator experts convened by ANSI and then explains OSHA’s proposed 10. Hyatt did not use data from the two reviewed and discussed available APF APF for each of these respirator classes. poor performing respirators to set the studies, and then arrived at a final In addition to basing the APFs APF of 10 for the class because, as he decision using a consensus process. proposed in this rulemaking on the stated in his report, ‘‘For practical The following table summarizes the studies and previous APF standards purposes, the remaining two models are previous APFs assigned to half-mask described in this section, the Agency not available.’’ air-purifying respirators, beginning with contracted with Dr. Kenneth Brown to In 1980, the ANSI Z88.2 Respiratory Hyatt’s studies at LLNL in 1976 through conduct statistical analyses of the Protection Standard (i.e., ‘‘the 1980 the 1992 ANSI standard.

APFs Half-mask air-purifying respirators 1992 ANSI LANL (1976) 1980 ANSI standard NIOSH RDL (1987) standard

Single use (no longer available) 1 .. 5 ...... 5 ...... Filtering facepiece ...... 10 (disposable) ...... 10 Half-mask (elastomeric)...... 10 10 (with QLFT) 100 max. (with 10 ...... 10 QNFT). 1 Filtering facepieces replaced single-use respirators.

OSHA’s proposed APFs for half-mask penetration by airborne hazardous respirator for protection, they unfold the air-purifying respirators. Respirator substances. Filtering facepieces also are mask and place the fabric filter over manufacturers construct elastomeric available in a variety of designs and their mouth and nose and then position half-masks using malleable compounds materials that affect their fit to a user’s the attached elastic headbands or straps (e.g., silicon, natural or synthetic face. For example, the design of the around their head. rubber) that readily conform to the ‘‘fold flat’’ filtering facepiece allows Half-mask respirators, including the respirator user’s face, thereby effectively employees to fold them for easy carrying subclasses of elastomeric and filtering sealing the inside of the mask against and storage; when employees need this facepiece respirators, vary widely in

9 face sizes representing about 95% of the U.S. LANL developed a respirator test panel working population (Ex. 7, docket H049). consisting of 25 men and women selected to have

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design and construction; these OSHA reviewed available WPF and (Co) divided by the concentration of that characteristics could result in different SWPF studies that determined APFs for agent inside the respirator (Ci), i.e., Co/ fitting characteristics which, in turn, separate models of half-mask respirators Ci. After collecting these values, a can affect the level of employee based on each respirator’s performance. statistical analysis determines the protection afforded by the respirators. In These studies usually determine a geometric distribution of the values; the this regard, an important question is protection factor for each respirator user overall APF for the respirator is the whether available WPF and SWPF (e.g., an employee in a WPF study, or a estimated value that lies at the fifth studies demonstrate sufficient member of a panel of respirator users in percentile of the geometric distribution. variability in protection between and a SWPF study) who participates in the Listed in the table below are the WPF among filtering facepiece and study, with each of these values studies on filtering facepiece and elastomeric respirators to warrant expressed as the concentration of elastomeric respirators reviewed by the different APF levels. challenge agent outside the respirator Agency.

Geometric WPF studies for filtering facepieces (by name of authors and model of res- Sample size Geometric standard 5th percentile pirator tested) mean deviation WPF

Cohen (Ex. 1–64–11): Prototype Mercury (disposable respirator) ...... 26 28 5 Albrecht et al. (Ex. 1–64–23): 3M 8710 ...... 13 81 1.99 25 3M 9910 ...... 13 107 2.50 20 3M 9920 ...... 10 223 2.38 45 Nelson and Dixon (Ex 1–64–54): 3M 8710 ...... 18 310 5.3 20 3M 9910 ...... 14 580 4.2 55 AO R1050 ...... 7 52 4.2 5 Reed et al. (Ex. 1–64–61): 3M 9910 ...... 19 18 3.1 3 Johnston and Mullins (Ex. 1–64–34): 3M 8715 (with aluminum particulate) ...... 10 145 2.3 32 3M 8715 (with titanium particulate) ...... 14 59 1.7 24 3M 8715 (with silicon particulate) ...... 14 172 3.1 24 Colton et al. (Ex. 1–64–15): 3M 9906 ...... 23 27 1.5 13 Colton et al. (Ex. 1–64–16): 3M 9970 (with lead particulate) ...... 62 415 4.4 36 3M 9970 (with zinc particulate) ...... 62 681 5.6 40 Myers and Zhuang (Ex. 1–64–51) (conducted in a brass foundry): 3M 9920 (with zinc particulate) ...... 20 108 5.2 7 Myers and Zhuang (Ex. 3–14) (conducted in a steel mill): 3M 8710 (with iron particulate) ...... 10 377 3.7 44 Gerson 1710 (with iron particulate) ...... 11 123 2.7 24 Colton and Mullins (Ex. 1–146): 3M 9920 and 3M 9925 ...... 32 147 2.5 33 Wallis et al. (Ex. 1–64–70): 3M 8710 ...... 70 50 3.5 7.5 Lenhart and Decker (Ex. 1–64–56): 3M 9920 ...... 5 12 3M 9970 (two separate studies) ...... 2 86 and 98 Gaboury and Burd (Ex. 1–64–24): AO, Willson, Survivair ...... 18 47 2.5 9 Gavin et al. (Ex. 1–64–22): North 7709 (with OV cartridge) ...... 63 75 3.1 11.7 Weber and Mullins (Ex. 3–15): 3M 5000 (with OV cartridge) ...... 46 39.7 2.14 11 Myers and Zhuang (Ex. 1–64–51) (conducted in a brass foundry): AO 5-Star (with DFM filter) ...... 6 98 5.8 5 MSA Combo II (with DFM filter) ...... 9 163 3.1 26 Scott 65 (with DFM filter) ...... 6 94 4.8 7 Myers and Zhuang (Ex. 3–14) (conducted in a steel mill): AO 5-Star (with DM filter) ...... 11 280 2.7 56 MSA Combo II (with DM filter) ...... 8 427 4.3 39 Scott 65 (with DM filter) ...... 11 252 2.9 45 Myers and Zhuang (Ex. 1–64–52) (conducted in a paint-spraying facility): AO 5-Star (with HEPA or OV filter) ...... 38 2,211 171 MSA Combo II (with HEPA or OV filter) ...... 38 4,580 437 Scott 65 (with HEPA or OV filter) ...... 38 6,630 1,121 Lenhart and Campbell (Ex. 1–64–42): MSA Combo (with HEPA filter) ...... 25 180 4.1 18 Albrecht et al. (Ex. 1–64–23): 3M Easi-Air 7000 (with HEPA filter) ...... 8 56 1.35 31 3M Easi-Air 7000 (with DM filter) ...... 6 68 1.66 28 Dixon and Nelson (Ex. 1–64–54): Survivair 2000 and MSA Combo II (with DFM filter) ...... 17 240 6.3 12

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Geometric WPF studies for filtering facepieces (by name of authors and model of res- Sample size Geometric standard 5th percentile pirator tested) mean deviation WPF

Survivair 2000 and MSA Combo II (with HEPA filter) ...... 14 94 3.0 16 North 7700 (with HEPA filter) ...... 14 250 6.9 11 Dixon and Nelson (Ex. 1–64–19): Survivair 2000 (with HEPA or OV filter) ...... 37 3,400 3.8 390 Colton et al. (Ex. 1–64–13): 3M 6000 (with HEPA filter and cadmium particulate) ...... 25 333 4.18 32 3M 6000 (with HEPA filter and lead fume) ...... 31 129 3.15 19 Colton and Bidwell (Ex. 4–10–4): 3M 7000 (with 7255 HEPA mechanical filter) ...... 21 1,006 4.65 80 3M 7000 (with 2040 HEPA electrostatic filter) ...... 22 562 3.5 71

OSHA found only one SWPF study on corroborate these conclusions. These ANSI standard increased this APF to a half-mask air-purifying respirators. In analyses could not differentiate between maximum of 1,000 when the respirator 1987, Skaggs, Loibl, Carter, and Hyatt filtering facepieces and elastomeric half- used HEPA filters and the respirator (Ex. 1–38–3) of LANL performed a masks, which justifies combining the users received quantitative fit testing. SWPF study that included laboratory study data for these two subclasses into Based on Hyatt’s 1976 data, the 1987 testing of the MSA Comfo II half-mask a single class for a subsequent APF NIOSH RDL recommended that this air-purifying elastomeric respirator. The determination. This determination respirator class receive an APF of 50 geometric mean fit factors they showed that nearly 96% of the WPF when equipped with a HEPA filter, and measured during simulated work data in these combined studies were at an APF of 10 when using DFM filters. exercises ranged from 800 to 5,700 for or above an APF of 10. NIOSH developed the lower APF of 10 this half-mask. These results appear to 3. Full Facepiece Air-Purifying for respirators equipped with DFM complement the WPF results discussed Respirators filters after it tested the efficiency of in the following paragraph. these filters. In the absence of workplace Historical development of APFs for The summary statistics for WPF protection factor studies of full full facepiece air-purifying respirators. studies of filtering facepieces and facepiece respirators, NIOSH based In 1976, Ed Hyatt of LANL developed an elastomeric half-masks presented in the these APFs on results from earlier APF table that included this respirator previous tables show little difference quantitative fit testing performed by class (Ex. 2). In this report, Hyatt used between these two major subclasses of LANL on panels of respirator users. half-mask respirators. Most importantly, the results from quantitative fit testing the estimated protection factors for to assess six models of full facepiece The 1992 ANSI standard retained the these two subclasses evidence negative pressure air-purifying 1980 ANSI standard’s APF of 100 for considerable overlap. In addition, both respirators equipped with HEPA filters. full facepiece air-purifying respirators, tables show that many respirators in Five of these respirators achieved a but required that respirator users each class received estimated protection protection factor of at least 100 for 95% perform fit testing and achieve a factors above 10, while a few respirators of the respirator users; the sixth minimum fit factor of 1,000 prior to performed below that level. respirator attained this level of using the respirators; in this regard, Accordingly, the WPF studies overall protection for 70% of the users. Based quantitative fit testing was necessary support assigning an APF of 10 for this on the results for the sixth respirator, because no qualitative fit test could respirator class (i.e., half-masks), which Hyatt recommended an APF of 50 for achieve a fit factor of 1,000. The ANSI consists of quarter masks, filtering the respirator class as a whole. standard kept this APF because the facepieces, and elastomeric half-mask The 1980 ANSI standard listed an ANSI committee found that no new respirators. OSHA could find no studies APF of 100 for full facepiece air- WPF or SWPF studies had been on the performance of quarter masks, purifying respirators with DFM filters. performed for this respirator class since but just as in the 1992 ANSI standard ANSI increased the APF for this it last issued APFs in 1980. (Ex. 1–50) has included quarter masks respirator class from 50 to 100 because The following table summarizes the with half-masks. the poorly performing respirator in previous APFs assigned to full facepiece The statistical analyses of these Hyatt’s study was no longer in air-purifying respirators, beginning with studies performed by Dr. Kenneth production. Using the 1976 LANL Hyatt’s studies at LLNL in 1976 through Brown (see section IV above) quantitative fit-testing results, the 1980 the 1992 ANSI standard.

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

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

OSHA’s proposed APFs for full that studies completed after 1992 day period by the 3M 7800 full facepiece air-purifying respirators. indicate that an APF of 100 is too high. facepiece air-purifying respirator Although the 1992 ANSI standard Colton, Johnston, Mullins, and Rhoe equipped with a HEPA filter. In this assigned an APF of 100 to full facepiece (Ex. 1–64–14) assessed the protection WPF study, the employees performed air-purifying respirators, OSHA believes afforded to 13 employees over a four their regular tasks in the blast furnace,

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reverberatory furnace, and casting and afford employees an adequate and PAPRs because it assumed, as did Hyatt, warehouse areas of a lead smelter while consistent level of respirator protection that these respirators would maintain the authors sampled lead dust and in the workplace. positive pressure during use. fumes inside and outside the respirator. Importantly, an APF of 50 The 1987 NIOSH RDL assigned an The authors found a fifth percentile corresponds with the APF assigned to APF of 25 to half-mask PAPRs after protection factor of 95 for the combined full facepiece air-purifying respirators NIOSH reviewed the results of two WPF samples, but concluded that the by OSHA in its substance specific studies that it conducted on these respirator provided reliable protection standards, and by NIOSH in its 1987 respirators (Ex. 1–64–42 and 1–64–46). at protection factors in excess of 50. RDL. In determining that an APF of 50 The RDL also gave loose-fitting PAPRs Skaggs, Loibl, Carter, and Hyatt (Ex. was appropriate for protecting with hoods or helmet an APF of 25 1–38–3) completed the only SWPF employees against the contaminants based on data from two studies study on a full facepiece air-purifying identified in its substance specific performed by Myers, Peach, Cutright, respirator at LANL; this study measured standards, the Agency reviewed the and Iskander (Exs. 1–64–47 and 1–64– the protection afforded by the MSA existing scientific and technical 48). However, the RDL recommended an Ultra Twin with a HEPA filter. Ten information, and carefully considered APF of 50 for other PAPRs equipped members of the respirator test panel comments in the records. OSHA with a tight-fitting facepiece or a hood used the respirator under varying believes that the information now or helmet, as well as high efficiency temperature and humidity conditions in available does not justify revising the filters or gas-vapor cartridges used in a test chamber while performing previous APF determined for its combination with high efficiency filters. simulated work tasks. The authors substance specific standards. To ensure The committee developing the 1992 reported fit factors with geometric that the final APF for this class of ANSI standard updated the APFs means ranging from 1,000 to 5,300 for respirators provides employees with specified in the 1980 ANSI standard. this respirator. However, 23 of the 60 appropriate protection, the Agency Accordingly, the committee measurements reported were less than requests that commenters submit to the recommended an APF of 50 for tight- 1,000, 7 were less than 100, and 3 of record any additional WPF and SWPF fitting half-mask PAPRs based on the these measurements were less than 50. studies that may be available on full same WPF studies used by NIOSH in After carefully reviewing these facepiece air-purifying respirators. studies, OSHA is proposing an APF of developing the 1987 RDL. Tight-fitting 50 for full facepiece air-purifying 4. Powered Air-Purifying Respirators full facepiece PAPRs received an APF of respirators. The proposed APF agrees (PAPRs) 100 when equipped with dust filters with the conclusion of Colton, Johnston, Historical development of APFs for (based on performance limitations of the Mullins, and Rhoe (Ex. 1–64–14) that PAPRs. In 1976, Ed Hyatt of LANL gave filters), and an APF of 1,000 when used this class of respirators provides reliable PAPRs equipped with high efficiency with HEPA filters. While the ANSI protection at an APF of 50. filters, regardless of facepiece type, a committee retained an APF of 25 for Additionally, the geometric mean protection factor of 1,000. In doing so, loose-fitting facepiece PAPRs, including simulated work fit factors reported by Hyatt assumed, based on quantitative fit loose-fitting hoods and helmets, it Skaggs, Loibl, Carter, and Hyatt (Ex. 1– tests, that both tight-fitting and loose- treated tight-fitting PAPRs with hoods 38–3) were low for a SWPF study, and fitting facepiece PAPRs would always or helmets much as it did tight-fitting a few of the individual measurements maintain a positive pressure inside the full facepiece PAPRs (i.e., by assigning were below an APF of 50; in the facepiece. them an APF of 100 when used with a workplace, the fifth percentile APF for The committee responsible for dust filter, and an APF of 1,000 when this respirator may fall well below 100. drafting the 1980 ANSI standard equipped with a HEPA filter). Therefore, in view of the paucity of data assigned an APF of 3,000 to PAPRs The following table summarizes the reported for this class of respirators, and equipped with high efficiency filters. previous APFs assigned to PAPRs, the constraints imposed by the available When the respirators used DFM filters, beginning with Hyatt’s studies at LANL studies, the Agency is proposing a they received an APF of 100. The ANSI in 1976 through the 1992 ANSI conservative APF that it believes would committee did not require fit testing for standard.

APFs Powered air-purifying respirators (PAPRs) LANL (1976) 1980 ANSI standard NIOSH RDL (1987) 1992 ANSI standard

Half-mask ...... 1,000 100 (with DFM filter), 3,000 max. (with HEPA 50 (with HEPA filter) .. 50. filters). Full facepiece ...... 1,000 100 (with DFM filter), 3,000 max. (with HEPA 50 (with HEPA filter) .. 100 (with dust filter), 1,000 (with filters). HEPA filter). Hoods or helmets ...... 1,000 100 (with DFM filter), 3,000 max. (with HEPA 50 (with HEPA filter) .. 100 (with dust filter), 1,000 (with filters). HEPA filter). Loose-fitting facepiece 1,000 100 (with DFM filter), 3,000 max. (with HEPA 25 (with any filter) ...... 25. filters).

OSHA’s proposed APFs for half-mask used the half-mask PAPRs ranged from PAPR blower housing, as well as to PAPRs. In 1983, Meyers and Peach 19 to 193, with a geometric mean inadequate facepiece fit. performed a WPF study on tight-fitting protection factor of 54 for the entire Lenhart and Campbell of NIOSH in half-mask and full facepiece PAPRs in a sample. The authors attributed the poor 1984 conducted another WPF study of silica-bagging operation (Ex. 1–64–46). performance of the half-mask PAPRs to tight-fitting half-mask PAPRs used by The geometric mean protection factors leakage around the filter assembly employees in the sinter plant and for each of the seven employees who connection where it attached to the furnace areas of a primary lead smelter

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(Ex. 1–64–42). For the entire sample, the chamber under variable temperature work rates (Ex. 1–64–94). The geometric authors reported a geometric mean and humidity conditions. They found mean protection factor for the entire protection factor of 380 and a fifth- that the geometric mean protection sample (i.e., combining respirator percentile protection factor of 58. factor for the entire sample ranged from performance at all work rates) was Two SWPF studies also evaluated 14,200 to 20,000. In the second SWPF 5,000. tight-fitting half-mask PAPRs. Skaggs, study, da Roza, Cadena-Fix, and Kramer Loibl, Carter, and Hyatt (Ex. 1–38–3) The following table provides a tested a panel of respirator users who summary of the WPF and SWPF studies used fit testing to assess the exercised on a treadmill at different performance of the respirators in a test for tight-fitting half-mask PAPRs.

Geometric WPF studies for half-mask PAPRs (by name of authors and type/model of Sample size Geometric standard 5th percentile respirator tested) mean deviation WPF

Lenhart and Campbell (Ex. 1–64–42), MSA ...... 25 380 2.6 58 Myers and Peach (Ex. 1–64–46), PAPR (manufacturer and model not spec- ified) ...... 10 54 2.44 ......

Geometric SWPF studies for half-mask PAPRs (by name of authors and type/model of Sample size Geometric standard 5th percentile respirator tested) mean deviation SWPF

Skaggs et al. (Ex. 1–38–3), MSA with Comfo II facepiece ...... 60 14,200–20,000 ...... da Roza et al. (Ex. 1–64–94), MSA with Comfo facepiece ...... 1 6 2 5,000 ...... 1 The six respirator users of the test panel exercised on a treadmill. 2 The geometric mean is for all exercise rates combined.

In arriving at a proposed APF of 50 for the APFs assigned to tight-fitting half- including these samples, the geometric tight-fitting half-mask PAPRs, OSHA mask respirators by the 1987 NIOSH mean protection factor increased to relied to a large extent on the WPF RDL and the 1992 ANSI standard, both 8,843, and the fifth percentile protection study conducted by Lenhart and of which based their APF factor rose to 1,335. No SWPF studies Campbell. This study was well determinations on data reported in the on full facepiece PAPRs were available. controlled and collected data under existing scientific literature, as well as One WPF study and one SWPF study actual workplace conditions; these the opinions of well known experts on are available for tight-fitting PAPRs with conditions ensure that the results are respiratory protection. hoods or helmets. In the WPF study, reliable and represent the protection OSHA’s proposed APFs for full Keys, Guy, and Axon, determined the employees likely would receive under facepiece PAPRs and PAPRs with hoods protection afforded to employees in a conditions of normal respirator use. The or helmets. Two WPF studies pharmaceutical manufacturing plant by Agency did not consider the Meyers and determined protection factors for tight- three different respirators in this class Peach WPF study for this purpose fitting full facepiece PAPRs. Myers and because of problems involving filter Peach conducted the first of these (Ex. 1–64–40). The fifth percentile assembly leakage and poor facepiece fit studies in 1983 (Ex. 1–64–46); OSHA protection factors for these respirators reported by the authors; consequently, described this study in its earlier were 997, 1,197, and 1,470. Johnson, the abnormally high levels of silica discussion of tight-fitting half-mask Biermann, and Foote of LLNL and measured inside the mask would most PAPRs. As noted in this discussion, the Cohen, Hecker, and Mattheis of the likely underestimate the true protection Agency did not use the results of this Organization Resources Counselors afforded by the respirator. The two study because of problems involving (ORC) performed the single SWPF study SWPF studies reported much higher filter assembly leakage and poor (referred to here as ‘‘the ORC-LLNL geometric mean protection factors than facepiece fit reported by the authors. SWPF Study’’) in which they collected did the WPF study performed by The second WPF study, by Colton and 576 test samples from four different Lenhart and Campbell. However, OSHA Mullins, reported a geometric mean PAPRs with hoods or helmets, and believes that the higher protection protection factor of 4,226, and a fifth equipped with bibs (Ex. 3–4–2). The factors reported for these SWPF studies percentile protection factor of 728 for lowest protection factor among the 576 are consistent with the proposed APF of employees in a secondary lead smelter test samples was 11,000; overall, the 576 50 based on data obtained for this (Ex. 1–64–12). Thirty-four samples in test samples had a fifth percentile respirator class in the Lenhart and this study had no detectable lead inside protection factor greater than 250,000. Campbell WPF study because SWPF the respirators; therefore, the authors The following tables summarize the studies typically report significantly used the limit of detection for lead as a WPF studies for tight-fitting full higher protection factors than WPF proxy for the concentration of lead facepiece PAPRs, and the WPF and studies of the same respirator. In inside the facepiece. When the authors SWPF studies involving PAPRs with addition, the proposed APF duplicates corrected their data analysis by hoods or helmets.

Geometric WPF studies for full facepiece PAPRs (by name of authors and model of Sample size Geometric standard 5th percentile respirator tested) mean deviation WPF

Colton and Mullins (Ex. 1–64–12) 3M W–3205 Whitecap (with 3M 7800 full facepiece and HEPA filter): Study 11 ...... 20 4,226 2.9 728

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Geometric WPF studies for full facepiece PAPRs (by name of authors and model of Sample size Geometric standard 5th percentile respirator tested) mean deviation WPF

Study 2 ...... 55 8,843 3.2 1,335 Myers and Peach (Ex. 1–64–46) Full facepiece PAPR (manufacturer and model not specified) ...... 10 54 2.44 ......

1 Study 1 consisted of 20 samples with Ci values over the detection limit, while Study 2 consisted of 34 samples that had Ci values below the detection limit; for analytic purposes, the investigators assigned these 34 samples a Ci value equal to the detection limit.

Geometric WPF studies for PAPRs with hoods or helmets (by name of authors and Sample size Geometric standard 5th percentile model of respirator tested) mean deviation WPF

Keys et al. (Ex. 1–64–40): Racal Breathe Easy 10 (hood, double bib, HEPA filter) ...... 29 11,137 3.9 1,197 Bullard Quantum (hood, double bib, HEPA filter) ...... 9 9,574 3.1 1,470 3M Whitecap II (helmet, double bib, HEPA filter) ...... 22 42,260 9.8 997

SWPF studies for PAPRs with hoods or helmets (by name of authors and Geometric median 5th percentile model of respirator tested) Range of SWPFs SWPF SWPF

ORC–LLNL SWPF Study (Ex. 3–4): 3M Whitecap (helmet with bib and HEPA filter) ...... 140,000–>250,000 >250,000 >250,000 3M Snapcap (Tyvek hood with bib and HEPA filter) ...... 11,000–>250,000 >250,000 >170,000–210,000 Racal BE–5 Clear PVC (hood with bib and HEPA filter) ...... 11,000–>250,000 >250,000 >250,000 Racal BE–10 (Tyvek hood with bib and HEPA filter) ...... 94,000–>250,000 >250,000 246,000–>250,000

OSHA is proposing an APF of 1,000 1000 or greater, receive an APF of protection factor of 25 for this respirator for full facepiece PAPRs and PAPRs 1,000.’’ The footnote continues, ‘‘All class. with hoods or helmets. With regard to other helmet/hood respirators are A WPF study conducted later by full facepiece PAPRs, the corrected fifth treated as loose-fitting facepiece Albrecht, Gosselink, Wilmes, and percentile protection factor of 1,335 respirators and receive an APF of 25.’’ Mullins (Ex. 1–64–23) reported a fifth reported by Colton and Mullins in their OSHA is proposing that respirators from percentile protection factor of 42 for the WPF study fully supports the proposed this class be able to demonstrate that 3M Airhat, a loose-fitting facepiece APF. The WPF study of PAPRs with they maintain a positive pressure inside PAPR with a helmet. Stokes, Johnston, hoods or helmets by Keys, Guy, and the facepiece during use and achieve a and Mullins (Ex. 1–64–66) performed a Axon justifies the proposed APF of level of protection of 1000 or greater. WPF study in a roofing granule 1,000 for this respirator class. These Available WPF and SWPF studies have production plant using the 3M Airhat; authors reported that the average fifth found that some of these respirators they found a fifth percentile protection percentile protection factor for the three were shown to only achieve protection factor of 95. However, when employees respirators tested in their study was factors well below 1,000 (Exs. 3–4, 3–5). used the respirator with a Tyvek shroud, well over 1,000. Moreover, the ORC– In all likelihood, the burden of the fifth percentile protection factor LLNL SWPF Study (Ex. 3–4), in which conducting any testing would fall on increased to 1,615. Gaboury and Burd this class of respirators received respirator manufacturers, but the (Ex. 1–64–24) reported a fifth percentile extremely high fifth percentile employer would be responsible for protection factor of 275 in a WPF study protection factors, lends substantial selecting a properly tested respirator, in which employees in an aluminum validation to OSHA’s proposed APF. In thereby assuring employees that they smelter wore a Racal Breathe Easy loose- addition, the proposed APFs for full will receive adequate protection against fitting facepiece PAPR with a helmet. facepiece PAPRs and PAPRs with hoods toxic hazards. Collia, Colton, and Bidwell (Ex. 3–5) or helmets corresponds with the APFs found a fifth percentile protection factor assigned to these respirator classes in OSHA’s proposed APFs for loose- of 315 in a WPF study performed on the the 1992 ANSI standard; ANSI made fitting PAPRs. A number of WPF and 3M Breathe Easy 12 PAPR with a loose- these APF determinations only after a SWPF studies are available for loose- fitting head cover. careful review and discussion of the fitting facepiece PAPRs. An important OSHA evaluated three SWPF studies available research by a panel of purpose of these studies was to addressing the performance of loose- respirator experts. While the proposed determine if APFs differed between fitting facepiece PAPRs with hoods or APF for these respirators is much higher loose-fitting facepiece PAPRs and helmets. Skaggs, Loibl, Carter, and Hyatt than the APF recommended in the 1987 PAPRs with tight-fitting hoods or (Ex. 1–38–3) reported geometric mean NIOSH RDL, the Agency believes that helmets. The NIOSH WPF study by protection factors ranging from 1,900 to the WPF and SWPF studies conducted Myers, Peach, Cutright, and Iskander 5,600 for the 3M Airhat, and from 1,200 on these respirators since publication of (Ex. 1–64–47) was the first to report that to 3,500 for the Racal AH3 PAPR with the RDL justify the proposed increase. loose-fitting facepiece PAPRs did not a loose-fitting helmet. A study by da Footnote 4 of the proposed APF table perform at an APF of 1,000, the value Roza, Cadena-Fix, and Kramer (Ex. 1– states that ‘‘* * * only helmet/hood determined by Ed Hyatt in 1976 after 64–94) found geometric mean protection respirators that ensure the maintenance quantitatively fit testing a panel of factors ranging from 10 to 10,000, and of a positive pressure inside the respirator users. A follow-up study by from 100 to 20,000, for the two loose- facepiece during use, consistent with Myers, Peach, Cutright, and Iskander fitting facepiece PAPRs with helmets performance at a level of protection of (Ex. 1–64–48) reported a fifth percentile they tested.

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Johnson, Biermann, and Foote of cover as part of the ORC–LLNL SWPF respirator ranged from 150,000 to LLNL and Cohen, Hecker, and Mattheis Study; the results of this study reported 230,000. of ORC (Ex. 3–4) assessed the three APFs below 10,000, with the The following tables summarize the performance of one loose-fitting lowest value being 240. The fifth WPF and SWPF studies for loose-fitting facepiece PAPR with a Tyvek head percentile protection factor for this facepiece PAPRs with hoods or helmets.

Geometric WPF studies for loose-fitting facepiece PAPRs with hoods or helmets Sample size Geometric standard 5th percentile (by name of authors and model of respirator tested) mean deviation WPF

Myers et al.(Ex. 1–64–47): 3M W–344 (helmet with HEPA filter) ...... 23 165 3.57 26 Racal AH 3 (helmet with HEPA filter) ...... 23 205 2.83 26 Albrecht et al. (Ex. 1-64–23) 3M Airhat (helmet with HEPA filter) ...... 7 199 2.36 42 Myers et al. (Ex. 1–64-48): 3M W–316 (helmet with DM filter) ...... 22 135 1.89 25 Racal AH 5 (helmet with DM filter) ...... 24 120 2.64 25 Gaboury and Burd (Ex. 1–64–24) Racal Breathe Easy I (helmet with HEPA or OV filter) ...... 20 1,414 2.51 275 Collia et al. (Ex. 3–5) 3M Breathe Easy 12 (Tyvek head cover with HEPA filter) ...... 41 2,523 ...... 315 Stokes et al. (Ex. 1-64–66): 3M Airhat (helmet) with: HEPA filter (total)1 ...... 12 5,370 3.0 762 DM filter (without shroud) ...... 27 877 5.2 53 DM filter (with shroud) ...... 18 11,792 3.1 1,615 DM filter (total) ...... 45 2,480 7.0 95 1 The total consists of the shroud and no-shroud samples combined.

SWPF studies for loose-fitting facepiece PAPRs with hoods or helmets Geometric Geometric 5th percentile (by name of authors and model of respirator tested) Sample size mean median SWPF

Skaggs et al. (Ex. 1–38–3): 3M Airhat W–344 (helmet) ...... 60 1,900–5,600 ...... Racal AH3 Airstream (helmet) ...... 60 1,200–3,500 ...... da Roza et al. (Ex. 1–64–94): 3M Airhat W–344 (helmet) ...... 1 6 10–10,000 ...... Racal Breathe-Easy 1 (helmet) ...... 6 100–20,000 ...... ORC–LLNL SWPF Study (Ex. 3–4): Racal BE–12 (Tyvek head cover) ...... 144 240–250,000 250,000 150,000–230,000 1 Used same panel of six respirator users for both respirators; panel exercised on treadmill at 80% cardiac capacity.

OSHA is proposing an APF of 25 for Kramer (Ex. 1–64–94) in their SWPF while full facepiece SARs received an loose-fitting PAPRs with hoods or assessments. In the workplace, these APF of 50 in the demand mode. These helmets, which is consistent with both low geometric mean SWPFs likely APFs are the same APFs that Hyatt WPF studies conducted by Myers, would translate into fifth percentile assigned to negative pressure half- Peach, Outright, and Iskander (Ex. 1– WPFs of less than 50. Therefore, the masks, and full facepiece, air-purifying 64–47 and 1–64–48), as well as the limited and highly variable data in the respirators. Hyatt based the APF of 10 APFs for this respirator class established SWPF studies support OSHA’s for half-mask SARs operating in the by the 1987 NIOSH RDL and by the conclusion that a conservative APF of demand mode on LANL studies 1992 ANSI standard. The extreme 25 would afford employees an adequate performed in 1971 and 1972 on a variability of the fifth percentile and consistent level of respirator respirator test panel wearing eight half- protection factors in the WPF studies protection in the workplace. mask air-purifying respirators equipped warrants a conservative approach in with HEPA filter. In determining an 5. Supplied-Air Respirators (SARs) proposing an APF for this respirator APF of 50 for full facepieces, Hyatt class. In this regard, seven of the 11 Historical development of APFs for relied on LANL studies in which a WPF studies found fifth percentile SARs. SARs operate in one of three respirator test panel consisting of 31 protection factors of less than 100, and modes—demand, continuous flow, or firemen wore full facepiece SCBAs five of these APFs were below 50. The pressure demand. Demand or pressure operating in the demand mode. Agency believes that a proposed APF of demand respirators have either a tight- Hyatt regarded SARs that operate in a 25 would provide employees who use fitting half-mask or a tight-fitting full positive pressure mode to be more these respirators with an adequate safety facepiece, while continuous flow protective than SARs used in a negative margin in view of the unreliability of respirators have either a tight-fitting, or pressure mode; therefore, he assigned the protection factors found for this a loose-fitting, hood or helmet, or a half-mask and full facepiece SARs that respirator class. tight-fitting half-mask or full facepiece. function in the continuous flow, The geometric means reported by In 1976, Ed Hyatt of LANL published pressure demand, or other positive Skaggs, Loibl, Carter, and Hyatt (Ex. 1– the initial protection factors for SARs pressure modes APFs of 1,000 and 38–3) were low for a SWPF study, as (Ex. 2). In making these determinations, 2,000, respectively; the half-mask were a number of the geometric means Hyatt gave an APF of 10 to half-mask respirators received a lower APF than determined by de Rosa, Cadena-Fix, and SARs operated in the demand mode, the full facepiece respirators because

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Hyatt considered a half-mask to be less escape configuration, these respirators ANSI standard did not support this stable on the face than a full facepiece. had a maximum APF of 10,000. practice. After comparing the SARs with hoods or helmets operated in Continuous flow or pressure demand operational characteristics of half-mask continuous flow mode received an APF SARs with hoods or helmets also and full facepiece SARs to half-mask of 2,000, consistent with the APF Hyatt received a maximum APF of 10,000 and full facepiece air-purifying gave to full facepiece SARs operating in when not used in an escape respirators, the 1992 ANSI standard the continuous flow or pressure demand configuration; however, when operated gave APFs of 10 and 100, respectively, mode. in a escape configuration, the maximum to half-mask and full facepiece SARs The 1980 ANSI standard APF for these respirators was of 10,000+ when operated in the demand mode. differentiated APFs for some SARs (i.e., employees could use them to Pressure demand and continuous flow depending on the type of fit testing escape from IDLH atmospheres). performed. Accordingly, half-mask and The 1987 NIOSH RDL recommended half-mask SARs received an APF of 50, full facepiece SARs used in the demand APFs of 10, 50, and 1,000, respectively, consistent with their operational mode received APFs of 10 and 100, for half-mask SARs when operated in similarities with half-mask PAPRs. Full respectively, when qualitatively fit demand, continuous flow, and positive facepiece continuous flow SARs tested. When tested quantitatively, the pressure (including pressure demand) received an APF of 1,000, determined APFs for these respirators were the modes. All SARs with hoods or helmets from their operational analogy to SARs protection factors achieved during fit received an APF of 25 when used in the having tight-fitting hoods or helmets. testing, with the APF limited to the sub- continuous-flow mode. The RDL Based on their operational similarities IDLH value 10 of the hazardous assigned full facepiece SARs an APF of to loose-fitting continuous flow PAPRs, substance in the workplace. 50 when they functioned in the demand the committee drafting the 1992 ANSI Half-mask or full facepiece SARs that or continuous flow mode, an APF of standard gave loose-fitting facepiece functioned in continuous flow or 2,000 when operated in the pressure SARs operated in the continuous flow pressure demand modes required no fit demand or other positive pressure mode an APF of 25. testing because of their positive pressure mode, and a maximum APF of 10,000 The following table summarizes the operation; consequently, these when used in the pressure demand respirators received an APF limited only mode with an auxiliary SCBA. APFs given to the various classes of to the sub-IDLH value of the hazardous The 1992 ANSI standard did not set SARs (i.e., half-mask, full facepiece, substance in the workplace when used different APFs for the same class of tight-fitting with hoods or helmets, and without an auxiliary air supply or respirator based on the type of fit testing loose-fitting facepiece), beginning with escape bottle (i.e., the ‘‘escape conducted because WPF studies Hyatt’s studies at LLNL in 1976 through configuration’’). When equipped in an performed after publication of the 1980 the 1992 ANSI standard.

APFs SARs LANL (1976) 1980 ANSI standard NIOSH RDL (1987) 1992 ANSI standard

Half-mask ...... 10 (demand) ...... 10 (demand; with 10 (demand) ...... 10 (demand). QLFT). 1,000 (continuous flow) ...... Same as QNFT factor 50 (continuous flow) ...... 50 (continuous flow). (demand; sub-IDLH value max.). 1,000 (pressure demand) ...... Sub-IDLH (continuous 1,000 (pressure demand) ...... 50 (pressure demand). flow or pressure de- mand; no escape configuration). 10,000 max. (with es- cape configuration). Full facepiece ...... 50 (demand) ...... 100 (demand; with 50 (demand) ...... 100 (demand). QLFT). 2,000 (continuous flow) ...... Same as QNFT factor 50 (continuous flow) ...... 1,000 (continuous flow). (demand; sub-IDLH value max.). 2,000 (pressure demand) ...... Sub-IDLH (continuous 2,000 (pressure demand) ...... 1,000 (pressure demand). flow or pressure de- mand; no escape configuration). 10,000 max. (with es- cape configuration). Hood or helmet ...... 2,000 (continuous flow) ...... Sub-IDLH (continuous 25 (continuous flow) ...... 1,000 (continuous flow). flow or pressure de- mand; no escape configuration). 10,000 max. (with es- cape configuration). Loose-fitting facepiece ...... 25 (continuous flow) ...... 25 (continuous flow).

10 The concentration of the hazardous substance just below its IDLH value.

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OSHA’s proposed APFs for half-mask 38–3). The study, performed at LANL, grinding operations in a foundry. The SARs. No WPF studies were available evaluated the respirators under different authors stated that ‘‘because of the for half-mask SARs. Therefore, OSHA is temperature and humidity conditions; relatively low sample loadings, the WPF proposing an APF of 10 for this the results of the study showed that numbers obtained significantly respirator class when used in the these respirators had geometric mean underestimate the performance demand mode based on their analogous protection factors ranging from 8,500 to capability of the respirator.’’ Therefore, operational performance with negative 20,000. Therefore, the Agency is OSHA did not use the WPFs from this pressure half-mask air-purifying proposing an APF of 1,000 for full study in developing the proposed APF respirators tested during WPF and facepiece SARs used in the pressure for this respirator class. SWPF studies. In addition, the Agency demand or other positive pressure Colton, Mullins, and Bidwell (Ex. 1– proposes to give half-mask SARs that modes based on their performance in 64–17) published a WPF study on function in the continuous flow or this study (i.e., that the likelihood is foundry employees who used the 3M pressure demand modes an APF of 50, high that the geometric mean SWPFs Snapcap continuous flow SAR with an consistent with the performance of half- would translate to fifth percentile WPF abrasive blasting hood while exposed to mask PAPRs in WPF and SWPF studies of 1,000. Further justification for the silica during tear-down operations. The (and operated at the same airflow rates). proposed APF comes from the similarity authors reported a fifth percentile Additional support for the proposed in operational characteristics (including protection factor over 1,000, which they APFs comes from the 1992 ANSI the same minimum airflow rates) noted was consistent with the APF of standard, which assigned an APF of 10 between these respirators and tight- 1,000 assigned to these respirators by to half-mask airline SARs operated in fitting full facepiece continuous flow the 1992 ANSI standard. the demand mode, and an APF of 50 PAPRs, which are receiving a proposed In another WPF study, Nelson, when operated in the continuous flow APF of 1,000 in this rulemaking. (See Wheeler, and Mustard (Ex. 3–6) or pressure demand mode. The 1987 the discussion of these PAPRs above). sampled aircraft assembly employees NIOSH RDL also gave half-mask The proposed APF of 1,000 for full involved in sanding and primer demand SARs an APF of 10, but facepiece SARs operated in the pressure spraying operations while using the 3M recommended an APF of 1,000 for these demand or other positive pressure H–422 continuous flow SAR hood with respirators when functioning in the modes also is consistent with the APFs both an outer and inner shroud. The pressure demand or other positive of 1,000 assigned by the 1992 ANSI authors reported that 14 of the 31 pressure modes. standard to these respirators when used samples taken during primer spraying Regarding the recommended APF of in the continuous flow or pressure operations showed measurable 1,000, OSHA preliminarily finds that demand modes, and the APF of 2,000 concentrations of strontium (Sr) outside these respirators warrant the more recommended by the 1987 NIOSH RDL the facepiece (Co), but none of the conservative APF of 50 because of the for pressure demand respirators in this samples showed any measurable possibility that negative pressure could class. Although the RDL gave an APF of concentration of Sr inside the facepiece develop inside the mask during tasks 50 to these respirators in a continuous (Ci). Based on these Co data, and using that stress the facepiece seal; moreover, flow mode, the Agency believes that the the lowest detectable limit for Ci, the in the absence of WPF and SWPF data SWPF study, as well as the WPF studies authors concluded that ‘‘the WPFs were for these respirators, the Agency performed on analogous tight-fitting full greater than 1,200 for all samples with believes that a conservative approach to facepiece continuous flow PAPRs, a mass of Sr on the Co samples 1,000 setting this APF is appropriate. justify the proposed APF. times the detection limit for the Ci OSHA’s proposed APFs for full OSHA’s proposed APF for SARs with samples.’’ They stated further that their facepiece SARs. No WPF or SWPF hoods or helmets. The Agency found a study supports the APF of 1,000 given studies were available involving tight- number of WPF studies on these to these respirators by the 1992 ANSI fitting full facepiece SARs operated in respirators, including one by Johnston, standard. the demand mode. Therefore, in the Stokes, Mullins, and Rhoe (Ex. 1–64– In a WPF study conducted at absence any such data, the Agency is 36). Avondale shipyard, Kiefer, Trout, and assigning this respirator class an APF of These authors performed a WPF study Wallace (Ex. 2–1) sampled the total 50 based on the analogous operational on the 3M Whitecap continuous flow particulate exposures (i.e., small and characteristics between these respirators abrasive blasting helmet (equipped with large particle fractions combined) of and negative pressure air-purifying an extended length shroud) used by four employees involved in abrasive blasting respirators when operated in the shipyard employees while sandblasting operations while using the Bullard Type demand mode under WPF conditions. a barge. After performing several data 88 CE (continuous flow) SAR abrasive The proposed APF is the same as the analyses, the authors concluded that blasting hood. The authors reported APF recommended for this respirator outside-the-respirator samples with WPFs ranging from 2,817 to 10,000. class by the 1987 NIOSH RDL, and filter loadings at least 1,000 times OSHA identified four SWPF studies similar to the APF (i.e., 100) given to greater than the mean blank value were of this respirator class, all performed by these respirators by the 1992 ANSI most representative of the respirator’s LLNL or LANL for manufacturers of standard. In choosing an APF of 50 performance. Therefore, OSHA is using continuous flow SARs with abrasive instead of 100 for this class of only statistics based on these samples blasting hoods or helmets. The respirators, the Agency believes that the for its APF determinations; these geometric mean protection factors found paucity of WPF and SWPF studies statistics indicate that the estimated for these respirators were 40,000 for the warrants taking a conservative approach fifth percentile protection factor is 1,038 Bullard Model 77 and 88 Type CE in this determination. for these samples. (continuous flow) SARs with an While no WPF studies for full Johnston, Stokes, Mullins, and Rhoe abrasive blasting hood (Ex. 1–157), and facepiece SARs operated in the pressure (Ex. 1–64–37) conducted a second WPF 100,000 for the Clemco Apollo 20 and demand or other positive pressure study on the 3M Whitecap II general 60 Type CE (continuous flow) SARs modes were available, there was one purpose SAR with a helmet. In this with an abrasive blasting hood (Ex. 3– SWPF study of this respirator class by study, the authors sampled six 7–3) and the 3M Whitecap Model W– Skaggs, Loibl, Carter, and Hyatt (Ex. 1– employees while they performed 8100 Type CE (continuous flow) SAR

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with abrasive blasting helmet (Ex. 3–9– helmets as part of the ORC–LLNL SWPF bib. When the manufacturer corrected 2). Based on the results of these studies, Study. Five of these respirators had fifth this design problem by adding a tuck-in OSHA granted these respirators an percentile SWPFs ranging from 86,000 bib, the resulting model (designated the interim APF of 1,000 (Exs. 3–7–4, 3–8– to over 250,000. However, the fifth North Model 85302 TB) performed as 4, 3–9–3). percentile SWPFs for the sixth well as most of the other respirators In the latest SWPF study, Johnson, respirator (the North Model 85302 T) tested in the study. Biermann, and Foote of LLNL and ranged from 13 to 18. The authors Cohen, Hecker, and Mattheis of ORC The following tables summarize the attributed the poor performance of this WPF and SWPF studies for tight-fitting (Ex. 3–4) tested six models of respirator to the absence of a ‘‘tuck-in’’ continuous flow SARs with hoods or SARs with hoods or helmets.

Geometric WPF studies for SARS with hoods or helmets (by name of authors and Sample size Geometric standard 5th percentile model of respirator tested) mean deviation WPF

Johnston et al. (Ex. 1–64–36) 3M W–8100 Whitecap II (abrasive blasting helmet with extended-length shroud) ...... 15 4,076 2.3 1,038 Johnston et al. (Ex. 1–64–37): 3M W–8000 Whitecap II (helmet) Study 1 (using >750 x field blank with iron dust samples) ...... 8 1,012 2.6 199 Study 2 (using >30 x field blank with silicon dust samples) ...... 8 1,417 3.0 224 Colton et al. (Ex. 1–64–17), 3M Snapcap W–3256 (abrasive blasting hood) 14 10,344 2.5 2,290 Nelson et al. (Ex. 3–6), 3M H–422 (hood) ...... 31 ...... >1,000 Kiefer et al. (Ex. 2–1), Bullard 88 Type Type CE (abrasive blasting hood) ... 11 ...... >1,000

SWPF studies for SARs with hoods or helmets (by name of authors and Geometric mean/ 5th percentile model of respirator tested) Range of SWPFs median SWPF SWPF

Bullard-LLNL (Ex. 1–157) 1, Bullard 77 and 88 Type CE (abrasive blasting hel- met) ...... >40,000 (mean) ...... Clemco-LANL (Ex. 3–7–3) 2, Apollo 20 and 60 Type CE (abrasive blasting hood) ...... >100,000 (mean) ...... 3M–LANL (Ex. 3–9–2) 3, 3M Whitecap Model W–8100 Type CE (abrasive blasting helmet) ...... >100,000 (mean) ...... ORC–LLNL SWPF Study (Ex. 3–4–2): 3M Whitecap SAR (helmet with bib and chinstrap) ...... 68,000–>250,000 >250,000 (median) >250,000 3M Snapcap (Tyvek hood with bib and chinstrap) ...... 13,000–>250,000 >250,000 (median) 170,000–250,000 MSA Versa-hood (Tyvek hood) ...... 9,700–>250,000 >250,000 (median) 86,000–114,000 North Model 85302 TB (Tyvek hood with bib) ...... 55,000–>250,000 >250,000 (median) 150,000–240,000 North Model 85302 T (Tyvek hood, no bib) ...... 5–>250,000 1,217 (mean) 13–18 Bullard CC20TIC (Tyvek hood and bib and chinstrap) ...... 160,000–>250,000 >250,000 (median) >250,000 1 Collected 288 samples (a panel of 4 respirator users × 12 exercises × 6 helmets). 2 Collected 264 samples (a panel of 4 respirator users × 11 exercises × 6 helmets). 3 Collected 132 samples (a panel of 4 respirator users × 11 exercises × 3 helmets).

The Agency is proposing an APF of Under this proposed requirement, an Accordingly, researchers have 1,000 for continuous flow SARs with employer must select for employee use recommended that such testing be hoods or helmets based on their only continuous flow SARs with hoods performed to ensure that employees use performance in the WPF and SWPF or helmets that attained a protection only respirators from this class that studies. In each of the WPF studies factor of at least 1,000. While better provide them with the specified level of [except the second WPF study by performance has been associated with protection during exposure to hazardous Johnston, Colton, Stokes, Mullins and certain designs (e.g., double bibs, neck substances. In this regard, while the Rhoe (Ex. 1–64–37)], these respirators seals or dams, blouses, higher airflows), respirator manufacturer most likely attained a fifth percentile protection the presence of such design would perform the required testing, it factor over 1,000. In addition, the large considerations are no guarantee of would be incumbent on the employer to geometric mean protection factors found superior performance. In order to ensure that the respirators they selected for these respirators provide substantial receive an APF of 1,000, it is contingent for employee use received this testing. evidence for this proposed APF. upon the respirator manufacturer to be While the 1987 NIOSH RDL The Agency qualified the proposed able to demonstrate that their particular recommended an APF of 25 for APF in footnote 4 of its proposed APF respirator meets the criteria specified in continuous flow SARs with hoods or table. This footnote states that * * * Table I of the proposed standard. This helmets, this recommendation is the only helmet/hood respirators that level of performance can best be result of combining these respirators ensure the maintenance of a positive demonstrated by performing a WPF or into a single class with loose-fitting pressure inside the facepiece during facepiece SARs, and giving the entire SWPF study. OSHA is proposing this use, consistent with performance at a class the low APF (i.e., 25) assigned requirement because previous WPF and level of protection of 1000 or greater, originally to loose-fitting facepiece receive an APF of 1000.’’ and that ‘‘[a]ll SWPF testing conducted on these respirators. However, the 1992 ANSI other helmet/hood respirators are respirators shows that they do not standard established a separate class for treated as loose-fitting facepiece always result in the requisite protection continuous flow SARs with hoods or respirators and receive an APF of 25.’’ factor (Exs. 3–4, 3–5). helmets based on analogous operating

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characteristics between these respirators tested; when quantitatively fit tested, 2001 letter to OSHA’s Directorate of and airline respirators at the same flow the APFs for half-mask or full facepiece Compliance Programs (Ex. 7–1), Mr. rates, with the new class having an APF SCBAs functioning in the demand mode Richard Metzler of NIOSH justified the of 1,000 (loose-fitting facepiece SARs were the protection factors obtained classification of the Draeger respirator as continued to receive an APF of 25). during fit testing, with this APF limited an SCBA on the basis that the neck seal, Accordingly, OSHA is proposing in this to the sub-IDLH value. Full facepiece which is integral to the facepiece, forms rulemaking to follow the procedure SCBAs used in the pressure demand a gas-tight or dust-tight fit with the face, adopted by the 1992 ANSI standard and mode received an APF of 10,000+. The consistent with the definition of a tight- divide the two respirator types into 1987 NIOSH RDL recommended that fitting facepiece specified by 42 CFR separate classes, based principally on half-mask and full facepiece SCBAs 84.2(k). This letter also noted that the fit the WPF and SWPF performance of the operated in the demand mode receive testing procedures used for full continuous flow SARs with hoods or APFs of 10 and 50, respectively, and facepiece demand SCBAs apply to the helmets. that the APF for full facepiece SCBAs Draeger SCBA, and that, as a full OSHA’s proposed APF for loose- operated in the pressure demand or facepiece demand SCBA, NIOSH fitting facepiece SARs. No WPF or other positive pressure mode be 10,000. recommended that the respirator receive SWPF studies involving this respirator The committee responsible for the an APF of 50 in accordance with its class were available. Therefore, using 1992 ANSI standard could not reach a 1987 RDL. analogous operational characteristics consensus on an APF for full facepiece NIOSH subsequently reviewed the between these respirators and loose- pressure demand SCBAs. As noted in Survivair Puma respirator, which has a fitting facepiece PAPRs, OSHA is footnote 4 of the APF table in this ANSI tight-fitting hood supplied by an air proposing to assign loose-fitting standard, available WPF and SWPF cylinder; and certified the respirator as facepiece SARs an APF of 25. In this studies reported that, in some a pressure demand SCBA with a tight- regard, loose-fitting facepiece SARs, individual cases, the respirators did not fitting facepiece. As part of the when evaluated under the NIOSH achieve an APF of 10,000 (Ex. 1–50). certification process, NIOSH specified respirator-certification standards (42 Nevertheless, the committee found that that fit testing required of SCBAs would CFR part 84), had the same minimum a maximum APF of 10,000 was apply to this respirator. However, Steve airflow rates found for loose-fitting appropriate when employers used the Weinstein of Survivair (Ex. 7–2) stated facepiece PAPRs. Additional support for respirators for emergency planning that the hood totally encapsulates the the proposed APF comes from the 1987 purposes and could estimate levels of respirator user’s hair, making NIOSH RDL and the 1992 ANSI hazardous substances in the workplace. quantitative fit testing (e.g, with a standard, both of which gave this Portacount) impossible; in such cases, respirator class an APF of 25. Two newly developed respirators equipped with hoods, Draeger’s Air the fit testing instrumentation treats 6. Self-Contained Breathing Apparatuses Boss Guardian and Survivair’s Puma, dander and other material shed by the (SCBAs) have operational characteristics similar hair as particulates from outside the Historical development of APFs for to SCBAs. The facepiece of the Draeger respirator, causing the fit factor to be SCBAs. As he did with full facepiece respirator consists of a hood with an artificially low. However, qualitative fit SARs used in the demand mode, Hyatt inner nose cup and a seal at the neck; testing with the hood is possible in 1976 assigned a protection factor of an air cylinder supplies air to the because Survivair provides an adapter 50 to a full facepiece SCBA operated in facepiece. NIOSH reviewed this and P100 filters for this purpose; such this mode. Based on results from a panel respirator in accordance with its fit testing meets the fit-testing of 31 respirator users tested at LANL, he certification requirements specified at requirements for tight-fitting SCBAs gave full facepiece SCBAs used in the 42 CFR part 84, and in January 2001 specified in paragraph (f)(8) of OSHA’s pressure demand mode an APF of certified the respirator as a tight-fitting Respiratory Protection Standard. 10,000+ (Ex. 2). The 1980 ANSI full facepiece demand SCBA, with the The table below provides a summary standard listed half-mask and full cylinder having a 30-minute service life; of APFs given to the half-mask and full facepiece SCBAs operated in the NIOSH also approved the respirator for facepiece SCBAs from Hyatt’s 1976 demand mode as having APFs of 10 and use in entering and escaping from studies at LLNL to the 1992 ANSI 100, respectively, when qualitatively fit hazardous atmospheres. In a May 16, standard.

APFs SCBAs LANL (1976) 1980 ANSI standard NIOSH RDL (1987) 1992 ANSI standard

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

OSHA’s proposed APFs for SCBAs. fitting half-mask SCBAs and tight-fitting demand mode were available. In the No WPF or SWPF studies for tight- full facepiece SCBAs operated in the only WPF study conducted on full

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facepiece positive pressure SCBAs, tasks. After analyzing the data for these tested the Survivair Mark 2 SCBA that Campbell, Noonan, Merinar, and Stobbe firefighters using two different methods, met NFPA 1981 airflow requirements; of NIOSH assessed the performance of the authors estimated that the overall during testing, a panel of 27 respirator two different models of full facepiece protection factor exceeded 10,000. users exercised on a treadmill at 80% of pressure demand SCBAs that met the In the first of two SWPF studies their cardiac reserve capacity. Although NFPA 1981 airflow requirements for performed on full facepiece SCBAs used the authors found negative-pressure respirators used by firefighters (Ex. 1– in the pressure demand mode, McGee incursions inside the facepiece at high 64–7). While the authors could not and Oestenstad (Ex. 1–64–86) work rates, they concluded that the determined the protection afforded to determine WPFs for these respirators respirator ‘‘provided [a minimum] members of a respirator test panel because contaminant levels measured average fit factor of 10,000 [for any consisting of 23 men wearing the single subject], with no single subject inside the facepiece were too low, Biopack 60 closed circuit SCBA (Ex. 1– having a fit factor less than 5,000 at a pressure measurements taken inside the 64–86). Three members of the panel had facepiece proved more useful. These protection factors of 4,889, 7,038, and high work rate.’’ measurements showed that four of the 18,900, with the remaining members The tables below summarize the 57 firefighters experienced one or more having protection factors over 20,000. In results of the WPF and SWPF studies negative-pressure incursions inside the the second study, Johnson, da Roza, and performed on full facepiece pressure facepiece while performing firefighting McCormack of LLNL (Ex. 1–64–98) demand SCBAs.

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

Campbell et al. (Ex. 1–64–7), Unspecified model (with NFPA-compliant air- flow) ...... 57 ...... 10,000 (estimated)

Geometric SWPF studies for tight-fitting full facepiece pressure demand SCBAs Sample size Geometric standard 5th percentile (by name of authors and model of respirator tested) mean deviation 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 air- flow) ...... 27 29,000 1.63 ......

OSHA is proposing APFs of 10 and experienced momentary negative- protection is at or below an APF of 50, respectively, for tight-fitting half- pressure spikes inside the facepiece, 10,000. mask SCBAs and tight-fitting full indicating possible leakage of ambient In proposing to limit use of tight- facepiece SCBAs operated in the contamination into the facepiece, and fitting full facepiece positive pressure demand mode. In the absence of any the breathing zone of the user, under SCBAs to planned emergency WPF and SWPF studies on these some workplace conditions. conditions only, OSHA acknowledges that while these respirators are among respirators, the Agency derived the The two SWPF studies also provide the most protective respirators available, proposed APFs based on analogous support for the proposed APF, although operational characteristics between the existing WPF and SWPF data several individual protection factors fell demonstrate that they do not these respirators and half-mask below 10,000 in the two studies, and the facepiece and full facepiece air- consistently provide employees with a Johnson, da Roza, and McCormack protection level of 10,000 under some purifying respirators for which WPF and study (Ex. 1–64–98) found negative- SWPF studies (described previously) are exposure conditions. Therefore, the pressure incursions inside the facepiece Agency is proposing that employers not available. In addition, the proposed during high exercise rates. Since the APFs are consistent with the APFs use these respirators routinely for WPF and SWPF studies indicate that protecting employees against workplace recommended by the 1987 NIOSH RDL these respirators fail to provide the for these respirators. (Note that the 192 exposures requiring an APF above designated level of protection under 1,000, but instead limit their use to non- ANSI standard did not assign APFs for some conditions, OSHA states in these respirator classes.) routine (i.e., emergency) conditions that footnote 5 of its proposed APF table that require high levels of respirator For tight-fitting full facepiece SCBAs ‘‘[w]hen employers can estimate protection. In this regard, the Agency used in the pressure demand or other hazardous concentrations for emergency believes that few, if any, routine positive pressure modes, OSHA is planning purposes, they must use a exposure conditions in the workplace proposing an APF of 10,000, which is maximum assigned protection factor no require protection above an APF of consistent with the 1987 NIOSH RDL higher than 10,000.’’ Therefore, this 1,000; consequently, the proposed and the 1992 ANSI standard. Empirical proposed provision limits use of tight- restriction would have minimal effect support for the proposed APF comes fitting full facepiece positive pressure on routine respirator use.11 from the WPF study conducted by SCBAs to conditions for which an Campbell, Noonan, Merinar, and Stobbe emergency-response plan exists and the 11 In preparing the risk analysis for the final (Ex. 1–64–7). This study showed that employer can estimate the concentration Respiratory Protection Standard, OSHA reviewed individual protection factors for these of the hazardous substance in those data in its Integrated Management Information System for the years 1992 to 1996 to determine respirators, when operating at NFPA- conditions; in addition, the employer overexposure rates to the hazardous substances compliant airflows, far exceed 10,000; must restrict respirator use to conditions listed in Table Z (‘‘Limits for air contaminants’’) of however, four respirator users in which the required level of employee Continued

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To use full facepiece positive pressure substance must never exceed the lower MUC for their respirators under SCBAs under emergency exposure conditions specified by the MUC, which specific hazardous-substance conditions, the proposal specifies that is the exposure limit specified for the conditions. Respirator manufacturers employers must develop an emergency hazardous substance multiplied by the warrant such deference because they are plan (which several substance specific respirator’s APF. Accordingly, the most familiar with the functional standards already require), and provide proposed requirement ensures that limitations of their respirators when an estimate of the concentration levels employers maintain employees’ direct exposed to airborne concentrations of likely to result under the emergency exposure to hazardous substances (i.e., hazardous substances. Also, conditions. Emergency plans would inside the respirator) within levels manufacturer’s may base their limit employee exposure to the specified by OSHA’s Z tables and recommended MUCs on unpublished hazardous conditions by informing substance-specific standards, and where WPF or SWPF studies; such studies, them in advance of the specific tasks OSHA has no standards, within when conducted properly, would they are to perform, while estimating consensus standards levels. Therefore, increase the validity of their concentration levels of the hazardous this provision would not only provide recommendations. As with a MUC substance would increase the likelihood employee protection consistent with determined using OSHA’s proposed that their exposures to the substance prevailing industrial-hygiene practice, calculation method, the Agency believes will remain within the APF assigned to but with existing regulatory and that the protection afforded to the respirator. In addition, OSHA’s statutory requirements as well. employees by a respirator proposal to limit use of these respirators The single note in the proposed MUC manufacturer’s MUC depends on the to emergency conditions is similar to provisions follows paragraph employer’s full compliance with the the restriction placed on them in (d)(3)(i)(B)(1). This note reads that comprehensive respiratory-protection footnote 4 of the APF table published in ‘‘MUCs are effective only when the program specified by OSHA’s the 1992 ANSI standard; this restriction employer has a continuing, effective Respiratory Protection Standard. reads, in part: respiratory protection program as The Agency would not defer to specified by 29 CFR 1910.134, including respirator manufacturers who [A] definitive assigned protection factor training, fit testing, maintenance and recommend higher MUCs than an could not be listed for positive-pressure SCBAs. For emergency planning purposes use requirements.’’ This provision employer would obtain using the where hazardous concentrations can be implies that MUCs are dependent on the proposed calculation method because estimated, an assigned protection factor of no APFs of the respirators selected by such results would not be consistent higher than 10,000 should be used. (Ex. 1– employers to protect employees against with the maximum ambient level of a 50) airborne contaminants. In this regard, hazardous substance in which For the class of respirators designated as the Agency determined the APF for a employees can use the respirators, i.e., pressure demand SCBAs with tight- respirator or class of respirators based the maximum ambient level of a fitting hoods or helmets, including the on studies that assessed the respirator hazardous substance would exceed the Survivair Puma, OSHA is proposing an under conditions that met or exceeded level determined from the known APF of 10,000 maximum. The basis for the program requirements of its exposure limit for the hazardous this proposed APF are the analogous Respiratory Protection Standard at 29 substance and the protection of the operational characteristics between CFR 1910.134. These studies ensured APFs determined by this proposed these respirators and tight-fitting full that the study participants who used the rulemaking. Under these conditions, the facepiece pressure demand SCBAs. respirators received thorough respirator respirator manufacturer would be basing Accordingly, the Agency proposes to training and fit testing, and used the the recommendation on an invalid limit use of demand SCBAs with tight- respirators correctly; also, employers (or application of the known exposure limit fitting hoods or helmets to emergency research staff in the case of SWPF or the APF (or both); therefore, such an planning purposes, similar to the studies) maintained the respirators in invalid application would cause restriction it is placing on tight-fitting proper operating condition. employers to select respirators that are full facepiece pressure demand SCBAs. Consequently, the APF used in incapable of protecting employees from calculating a MUC is valid for this the ambient level of a hazardous Paragraph (d)(3)(i)(B)—MUC Provisions purpose only if employers implement a substance, resulting in serious health These proposed requirements consist continuing, effective, and impairments to their employees. of four separate paragraphs comprehensive respiratory-protection Paragraph (d)(3)(i)(B)(3) of the [(d)(3)(i)(B)(1) through (d)(3)(i)(B)(4)]. program as required by OSHA’s proposed MUC provisions states, Paragraph (d)(3)(i)(B)(1), which Respiratory Protection Standard. When ‘‘Employers must not apply MUCs to proposes requirements on the use and employers do not meet the conditions conditions that are immediately application of MUCs, reads, ‘‘The specified in this note, they may not use dangerous to life or health (IDLH); employer must select a respirator for the respirator’s APF in determining the instead, they must use respirators listed employee use that maintains the MUC. for IDLH conditions in paragraph (d)(2) employee’s exposure to the hazardous The next MUC provision, proposed of this standard.’’ Accordingly, substance, when measured outside the paragraph (d)(3)(i)(B)(2), states that employers could not use the proposed respirator, at or below the MUC.’’ This ‘‘[e]mployers must comply with the MUC calculation method (or a respirator proposed paragraph requires employers respirator manufacturer’s MUC for a manufacturer’s MUC) to select a to select respirators for employee hazardous substance when the respirator for employees who are protection that are appropriate to the manufacturer’s MUC is lower than the entering an IDLH atmosphere. OSHA ambient levels of the hazardous calculated MUC specified by this found support for these proposed substance found in the workplace, i.e., standard.’’ While OSHA believes that a requirements in comments cited in the that the ambient level of the hazardous MUC calculated according to the preamble to the final Respiratory proposed MUC definition normally Protection Standard. These comments 29 CFR 1910.1000. The Agency found that less than would provide adequate employee noted that employers should not use 0.01% of the exposures to these substances protection, it defers to respirator MUCs to select respirators for exceeded an APF of 1,000. manufacturers when they recommend a employees exposed to IDLH

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atmospheres (Ex. 1–54–381), or stated applicable to this proposed requirement. proposed APFs represent the best data that employees should not use air- In addition, commenters cited in the and analytic techniques available, purifying respirators, including preamble to the final Respiratory thereby lending a high degree of powered air-purifying respirators, while Protection Standard believed that reliability and validity to the results. exposed to IDLH or oxygen-deficient employers should not rely on MUCs Accordingly, the proposed APFs will atmospheres (Ex. 1–54–38); these determined using the proposed provide employers with confidence that commenters believed that the MUCs calculation method to estimate the their employees will receive the level of (and the APFs on which they are based) service life of cartridges and canisters protection from airborne contaminants would not protect employees under (Exs. 1–54–153, 1–54–165A, 1–54–222, signified by these APFs. In addition, these extremely hazardous exposure 1–54–381). applying the proposed APFs to the conditions. B. Superseding the Respirator-Selection substance-specific standards is For employees exposed to IDLH Provisions of Substance-Specific consistent with OSHA’s goal of bringing conditions, employers must select a Standards in Parts 1910, 1915, and 1926 uniformity to its respiratory-protection respirator according to the requirements requirements. Moreover, protection for specified by paragraph (d)(2) of OSHA’s 1. Introduction workers is increased since the proposed Respiratory Protection Standard. The substance-specific standards in Paragraph (d)(2) requires employers to APFs will provide equivalent or 29 CFR parts 1910, 1915, and 1926 increased protection compared to the select a full facepiece, pressure demand specify numerous requirements for SCBA certified by NIOSH to have a ANSI Z88.2–1992 standard, and regulating employee exposure to toxic incorporates the use of APFs into the service life of at least 30 minutes, or a substances, including APFs for employer’s respiratory protection combination full facepiece, pressure respirator selection. Under this program. The Agency believes that demand, supplied-air respirator with an proposed rulemaking, OSHA would auxiliary self-contained air supply, for revise the provisions in its substance- superseding the APF requirements of its IDLH exposures. In the preamble to the specific standards that regulate APFs existing substance-specific standards final Respiratory Protection Standard, (except the APF requirements for the would result in regulatory consistency, the Agency justified selecting these 1,3-Butadiene Standard at 29 CFR which would improve employer respirators as follows: 1910.1051). These proposed revisions compliance with these provisions, In [IDLH] atmospheres there is no tolerance would remove the APF tables from these reduce the compliance burden on the for respirator failure. This record supported standards, as well as any references to regulated community, and, OSHA’s preamble statement that IDLH these tables, and would replace them consequently, further enhance the atmospheres ‘‘require the most protective with a reference to the APF and MUC protection afforded to employees who types of respirators for workers. provisions specified in proposed use respirators. (59 FR 58896.) Commenters and paragraphs (d)(3)(i)(A) and (d)(3)(i)(B) of In the final rulemaking for its respirator authorities, including NIOSH, the Respiratory Protection Standard at Respiratory Protection Standard, OSHA ANSI, and both labor and management, 29 CFR 1910.134. The Agency believes noted that the revised standard was to agree that, for IDLH atmospheres, the that the proposed revisions would ‘‘serve as a ‘building block’ standard most highly protective respirators, with simplify compliance for employers by with respect to future standards that escape capability, should be required removing many inconsistencies in APF may contain respiratory protection (63 FR 1201). requirements across its substance- requirements.’’ (See 63 FR 1265, 1998.) The last proposed MUC provision, specific standards; therefore, the In this regard, the Agency believes that, paragraph (d)(3)(i)(B)(4), requires that proposed revisions would enhance ‘‘[w]hen the calculated MUC exceeds consolidation and uniformity of these to the extent possible, future substance- another limiting factor such as the IDLH requirements. Accordingly, the purpose specific standards should refer to level for a hazardous substance, the of revising the APF provisions of provisions of the final Respiratory lower explosive limit (LEL), or the OSHA’s substance-specific standards is Protection Standard instead of performance limits of the cartridge or to conform these standards, to the extent containing their own respirator canister, then employers must set the possible, to each other and to general requirements, including the generic APF maximum MUC at that lower limit.’’ As APF and MUC requirements specified and MUC provisions specified in this with manufacturers’ MUCs, these by 29 CFR 1910.134. proposed rulemaking. However, on limiting factors would take precedence The proposed revisions would occasion a substance-specific standard over the calculated MUC when they improve the substance-specific may have respirator-selection result in lower employee exposures to standards because the Agency requirements that supplement or the hazardous substances than the developed these proposed APF supplant the generic APF and MUC calculated MUC; consequently, requirements after careful review and provisions (e.g., organic-vapor cartridge employees would receive increased analysis of the available scientific data and canister procedures, prohibiting use protection against these hazardous and the most recent consensus of filtering facepieces or half-mask substances. standards (i.e., the APF provisions in respirators) that are necessary for This proposed paragraph cites several the NIOSH RDL and the ANSI Z88.2– ensuring adequate employee protection performance limits (i.e., the IDLH or 1992 respiratory protection standard). In against the toxic substance regulated by LEL for a hazardous substance, or the this regard, the Agency preliminarily the standard. Accordingly, the Agency service life of a cartridge or canister) as finds that the proposed APFs are a is retaining a number of existing examples of limiting factors. In this significant improvement over the respirator-selection provisions that are regard, OSHA is including these existing NIOSH and ANSI APFs because unique to the substance-specific limiting factors as examples only; other it developed them based on the latest standards; the following paragraphs limiting factors specified in a variety of WPF and SWPF studies, and used OSHA standards, or used by employers advanced statistical methods to identify describe these provisions, and provide to meet their obligation to provide a safe common and unique variance among OSHA’s rationale for retaining them. and healthful workplace, also would be respirator classes. Therefore, the

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2. Retaining the Respirator-Selection for BD concentrations above 50 ppm. • Lines 13–17 13 and 21–21 under Provisions of the 1,3-Butadiene Accordingly, these short breakthrough ‘‘Required apparatus’’ in the Standard times justified limiting to 50 ppm the undesignated table of 29 CFR 1910.1017 As noted earlier in this section, OSHA upper limit at which employees can use (Vinyl Chloride (VC) Standard); and is not proposing to revise the respirator- air-purifying respirators for protection footnote 1 to Table 1 of 29 CFR selection provisions of the 1,3- against BD exposures. From the 1910.1028 (Benzene Standard). These Butadiene Standard (‘‘BD Standard’’). Agency’s analysis of these data, OSHA provisions specify a minimum service Therefore, the APFs located in Table 1 also developed change schedules for life for cartridges and canisters used to (‘‘Minimum Requirements for cartridges and canisters that are unique protect employees during exposure to Respiratory Protection for Airborne for BD exposures (see Table 1 of the BD these substances. In the VC Standard, BD’’) of the BD Standard would remain Standard). Additionally, these employers must provide organic-vapor as currently published in paragraph conclusions still are likely to be valid cartridges or canisters with a service life of at least one hour at VC concentrations (h)(3) (‘‘Respirator selection’’) of 29 CFR because OSHA reviewed the test data up to 10 ppm when using chemical- 1910.1051. only six years ago (i.e., 1996). Therefore, cartridge respirators. These cartridges The BD Standard requires that the Agency is proposing to retain the employers use respirators during work and canisters must have a service life of conservative NIOSH APFs as necessary operations when engineering and work- at least four hours at VC concentrations to protect employees from BD practice controls ‘‘are not yet sufficient up to 25 ppm when using a canister to reduce employee [BD] exposures to or exposures. Nevertheless, OSHA is with a powered air-purifying respirator below the [permissible exposure asking employers and employees who that has a hood, helmet, half-mask, or limits]’’ [see 29 CFR are subject to the provisions of the full facepiece; the four-hour service-life 1910.1051(h)(1)(iii)]. Employers must existing BD Standard to provide requirement also applies when an select these respirators based on the additional information that supports employee uses a gas mask, but in this APFs listed in Table 1 of the BD retaining the existing APFs or adopting case, the employee must use a front-or Standard; in addition, they must equip the generic APFs specified under this back-mounted canister. According to the air-purifying respirators with organic- proposed rulemaking (See Section VII , Benzene Standard, employers must vapor cartridges or canisters. Issues, of this preamble). ensure that canisters used with non- OSHA adopted the APFs in Table 1 powered air-purifying respirators have a 3. Retaining the Respirator-Selection from the Respirator Decision Logic minimum service life of four hours Provisions in Other Substance-Specific developed by the National Institute for when tested at 150 ppm benzene at a Standards Occupational Safety and Health flow rate of 64 liters per minute (Lpm), ° (NIOSH), even though a negotiated While OSHA is proposing to retain a temperature of 25 C, and a relative agreement between manufacturers who the existing BD Standard in its entirety, humidity of 85%; testing for canisters use BD and the unions representing it also is proposing to retain a number used with tight-fitting and loose-fitting their employees recommended the more of respirator-selection provisions in powered air-purifying respirators must permissive ANSI Z88–1992 APFs. other substance-specific standards as be at flow rates of 115 Lpm and 170 In the preamble to the final BD well. The respirator-selection Lpm, respectively. Standard, the Agency noted that its The Agency believes that these requirements proposed for retention ‘‘decision to rely on the more protective minimum service-life specifications often provide protection against a NIOSH APFs is based on evidence ensure that employers use the showing that organic-vapor cartridges hazardous characteristic or condition designated respirators at appropriate and canisters have limited capacity for that is unique to the regulated concentration levels of the regulated adsorbing BD and may have too short a substance. Additionally, OSHA believes substances. Accordingly, OSHA is service life when used in environments that retaining these requirements in proposing to retain these specifications containing greater than 50 ppm BD.’’ their present form (except for plain- to provide employees with a minimum (See 61 FR 56816.) While developing language revisions, as appropriate) level of cartridge and canister the final BD Standard, OSHA reviewed would not increase existing employer endurance when they use the the breakthrough test data that were burden because they already must designated respirators at these available for organic-vapor cartridges comply with these requirements; concentrations. While retaining these and canisters challenged against BD consequently, retaining these provisions specifications may limit employers’ (and summarized in Table X–1 of the will maintain the level of respirator flexibility in adopting change schedules, preamble to the final BD Standard; see protection currently afforded to the Agency considers this limitation 61 FR 56817). Based on this review, the employees. The following sections warranted in view of the properties of Agency concluded: describe the most important provisions the substance that require greater 12 Allowing for a reasonable margin of that the Agency is proposing to retain. protection or a higher level of protection protection, and given that test data were for employees. Moreover, retaining available only for a few makes of cartridges 12 Most of the provisions described in these these specifications adds no regulatory and canisters, OSHA believes that air- sections are in, or are footnotes to, the respirator- burden on employers because they must purifying devices should not be used for selection tables proposed for removal from the use the specifications under the existing protection against BD present in substance-specific standards. These sections also describe several other respirator-selection standards. concentrations greater than 50 ppm, or 50 • Paragraphs (h)(3)(ii), and lines 6, 7, times the 1 ppm PEL. Thus, OSHA finds that provisions that are not part of these tables, but which OSHA is retaining and which may be of the ANSI APFs of 100 for full facepiece, air- 10, and 11 under ‘‘Required respirator’’ interest to the regulated community. If this proposal in Table II of 29 CFR 1910.1018 purifying respirators and 1,000 for PAPRs does not specifically identify or describe a equipped with tight-fitting facepieces are respirator-selection provision for removal or (Inorganic Arsenic Standard); lines 1–4 inappropriate for selecting respirators for BD. revision, then OSHA is retaining that provision in its existing form. The Agency believes that retaining 13 Only lines with written text were counted in In summary, test data cited by the these provisions does not increase the regulatory determining the number of lines; blank lines that Agency in the final BD Standard burden of employers because they must currently occurred before a written line were ignored for demonstrate short breakthrough times comply with them. counting purposes.

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under ‘‘Respirator type’’ in Table 1 of 29 Standard prohibits their use at under ‘‘Respirator type’’ in Table 1 of 29 CFR 1910.1028 (Benzene Standard); line exposures greater than five times the CFR 1910.1050 and 1926.60 1 under ‘‘Minimum required respirator’’ permissible exposure level (PEL). (Methylenedianiline Standard); lines 1, in Table 1 of 29 CFR 1910.1047 However, the Agency does not define 3–4, 7, and 8 under ‘‘Required (Ethylene Oxide Standard); lines 1–4 the terms ‘‘disposable respirator’’ or respirator’’ in Table 1 of 29 CFR 1926.62 under ‘‘Minimum respirator required’’ ‘‘single-use respirator’’ in any of its (Lead Standard); and lines 1, 3, 6, 8, and in Table 1 of 29 CFR 1910.1048 standards, including its Respiratory 11 under ‘‘Required respirator type’’ in (Formaldehyde Standard); and lines 1– Protection Standard at 29 CFR 1910.134; Table 1 of 29 CFR 1926.1127 (Cadmium 3 and 8, and footnote 2, under therefore, to update these requirements, Standard). ‘‘Respirator type’’ in Table 1 of 29 CFR the Agency is proposing to replace these Under these provisions, employers 1910.1050 and 1926.60 terms with ‘‘filtering facepiece,’’ which must equip air-purifying (including (Methylenedianiline (MDA) Standards). it defines in paragraph (b) of 29 CFR powered air-purifying) respirators with These paragraphs identify the types of 1910.134. OSHA believes this revision high-efficiency particulate air (HEPA) cartridges and canisters employers must will not only make these provisions filters, high-efficiency and high- select under specific respirator-use consistent with its new Respiratory efficiency particulate filters (defined as conditions. The Inorganic Arsenic Protection Standard, but will prevent a filter that is at least 99.97% efficient Standard requires employers to provide employers from using respirators not against mono-dispersed particles of 0.3 employees with: Air-purifying designed with the high-efficiency micrometers in diameter or larger), and respirators that have a combination particulate filters necessary to capture particulate filters (for the Cotton Dust high-efficiency particulate air (HEPA) respirable asbestos fibers (see 51 FR Standard only). While OSHA is filter with an appropriate gas-sorbent 22718) and coke oven emissions (see 41 proposing to retain these provisions, it cartridge or canister when their FR 46773–46774), and, in the case of is also proposing to replace the terms exposure exceeds the permissible cotton dust, to provide protection at ‘‘high-efficiency filters’’ and ‘‘high- exposure level for inorganic arsenic, and exposure levels higher than five times efficiency particulate filters’’ with the their exposure also exceeds the relevant the PEL (see 50 FR 51153–51154). term ‘‘HEPA filters.’’ These three terms limit for other gases; front- or back- • Paragraphs (h)(2)(iv) of 29 CFR have the same meaning, so use of the mounted gas masks equipped with 1915.1001 and (h)(3)(iii) of 29 CFR term ‘‘HEPA’’ would impose no HEPA filters and acid-gas canisters or 1926.1101 (Asbestos Standards) also additional burden on employers, nor any full facepiece supplied-air prohibit employers from selecting would it diminish employee protection. respirators when the inorganic arsenic disposable respirators for employees The Agency believes that the usual and concentration is at or below 500 µg/m3; who conduct specific types of Class II customary practice among employers in and half-mask air-purifying respirators and III asbestos work. Consistent with the cotton-dust industry is to use HEPA equipped with HEPA filters and acid- the explanation and rationale provided filters with air-purifying respirators; gas cartridges when the inorganic in the previous section, OSHA is therefore, employers should experience arsenic concentration is at or below 100 proposing to revise the term ‘‘disposable no additional burden, and employee µg/m3. The Benzene Standard specifies respirator’’ to ‘‘filtering facepiece’’ in protection should remain at current that employers must use an organic- these standards. The Agency also is levels, as a result of this revision. In vapor cartridge or canister with air- proposing to revise these paragraphs, as addition, the proposed revision would purifying respirators, and a chin-style well as paragraph (h)(2)(v) of 29 CFR make the filter requirements of the canister with full facepiece gas masks. 1915.1001 and (h)(3)(iv) of 29 CFR Cotton Dust Standard consistent with The Ethylene Oxide Standard states that 1926.1101 (which address respirator other OSHA substance-specific employers are to equip air-purifying, selection for conducting Class I asbestos standards and with its Respiratory full facepiece respirators with front- or work in regulated areas), into plain Protection Standard, thereby reducing back-mounted canisters approved for language to clarify the multifaceted any confusion that may exist among the protection against ethylene oxide, while requirements specified by these regulated community regarding the the same respirators under the paragraphs. By improving employer appropriate filter to use with air- Formaldehyde Standard must use a understanding of the respirator- purifying respirators. cartridge or canister approved for selection requirements, OSHA believes • Footnote 2 to Table II of 29 CFR protection against formaldehyde. The that the revisions proposed for these 1910.1018 (Inorganic Arsenic Standard). MDA Standard requires that employers paragraphs would enhance employee This provision prohibits the use of half- provide air-purifying respirators with a protection without increasing mask respirators for protection against combination HEPA filter and organic- employers’ regulatory burden. arsenic trichloride because it is rapidly vapor cartridge or canister when MDA • Lines 2, 3, and 4 under ‘‘Required absorbed through the skin. OSHA is is in liquid form or is part of a heated respirator’’ in Table 1 of 29 CFR retaining this provision to protect process. 1910.1001, 1915.1001, and employees from the cumulative toxic • Line 1 under ‘‘Required respirator’’ 1926.1101(Asbestos Standards); lines 5– effects that result from skin absorption. in Table 1 of 29 CFR 1910.1001, 6, 8, and 11 under ‘‘Required respirator’’ • Footnote 2 to Table II of 29 CFR 1915.1001, and 1926.1101(Asbestos in Table I , and lines 6 and 10 under 1910.1025, and footnote 2 to Table 1 of Standards); line 6 under ‘‘Required ‘‘Required respirator’’ in Table II, of 29 29 CFR 1926.62 (Lead Standard). These respirator’’ in Table I of 29 CFR CFR 1910.1018 (Inorganic Arsenic footnotes specify that employers must 1910.1029 (Coke Oven Emissions Standard); lines 1, 2, and 3 under provide employees with full facepiece Standard); and line 2 under ‘‘Required ‘‘Required respirator’’ in Table II of 29 respirators when employees experience respirator’’ in Table I of 29 CFR CFR 1910.1025 (Lead Standard); lines 1, eye or skin irritation that results from 1910.1043 (Cotton Dust Standard). 3, 5, 6, and 10 under ‘‘Required exposure to lead aerosols at use These provisions prohibit the use of respirator type’’ in Table 2 of 29 CFR concentrations. These provisions disposable respirators (single-use 1910.1027 (Cadmium Standard); lines 1, prevent serious eye and skin injuries respirators in the Coke Oven Emissions 3, 4, and 5 under ‘‘Required respirator’’ among employees. Standard) to protect employees against in Table I of 29 CFR 1910.1043 (Cotton • Footnote b to Table 2 of 29 CFR these toxic substances; the Cotton Dust Dust Standard); lines 1, 2, 3, and 8 1910.1027 and footnote b to Table 1 of

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29 CFR 1926.1127 (Cadmium Standard). facial skin and eyes are protected during previous rulemakings identified these These provisions require a full facepiece MC exposure. Here the Agency is respirators based on the unique respirator when an employee directly prohibiting the selection of half- characteristics of the regulated experiences eye irritation, thereby masks, and explicitly limiting respirator substances, as well as the conditions reducing the risk of eye injury among selection to respirators (i.e., full under which employees must use employees. facepiece respirators, and respirators escape respirators. • Table 1 of 29 CFR 1910.1047 with hoods or helmets) that would As is required currently, respirators (Ethylene Oxide (EtO) Standard). This provide the appropriate level of covered by these emergency-escape table lists only full facepiece respirators, protection to employees. provisions must meet the requirements or respirators with hoods or helmets, • Lines 10 and 11 under ‘‘Respirator of paragraph (d)(2)(ii) of OSHA’s implying that employers must not select type’’ in Table 1 of 29 CFR 1910.1028 Respiratory Protection Standard, which half-mask respirators for protection (Benzene Standard); lines 6–11 under specifies that these respirators must be against EtO. The preamble to the final ‘‘Respirator type’’ in Table 1 of 29 CFR NIOSH-certified for escape from the EtO Standard states: 1910.1044 (1,2-dibromo-3- atmosphere in which employees will chloropropane Standard); lines 16 and use them. In addition, employees are to The record reflects that high exposures to EtO have been shown to cause eye irritation 17 under ‘‘Respirator type’’ in Table I of use these respirators only for escaping and that such effects may occur at exposures 29 CFR 1910.1045 (Acrylonitrile from, not entering, IDLH atmospheres. that may be reached for short periods. Standard); line12 under ‘‘Minimum For entering such atmospheres, Therefore, OSHA has chosen to retain the required respirator’’ in Table 1 of 29 paragraph (d)(2)(i) of the Respiratory requirement for full-facepiece respirators in CFR 1910.1047 (Ethylene Oxide Protection Standard requires that the final rule. (49 FR 25781) Standard); lines 11–13 under employees use only full facepiece, Accordingly, in this proposal the ‘‘Minimum respirator required’’ in Table pressure demand SCBAs certified by Agency is making explicit the 1 of 29 CFR 1910.1048 (Formaldehyde NIOSH for a minimum service life of 30 prohibition against the use of half-mask Standard); lines 8–10 under ‘‘Respirator minutes, or full facepiece, pressure respirators to ensure that employers type’’ in Table 1 of 29 CFR 1910.1050 demand SARs with an auxiliary self- select only those respirators (i.e., full and 1926.60 (Methylenedianiline contained air supply. • Paragraphs (g)(2)(ii) of 29 CFR facepiece respirators, and respirators Standards); lines 13 and 14 under 1910.1001, (h)(2)(iii)(A) of 29 CFR with hoods or helmets) that OSHA ‘‘Minimum respirator required’’ in Table 1915.1001, and (h)(3)(ii) of 29 CFR found, in the earlier rulemaking, will 2 of 29 CFR 1910.1052 (Methylene 1926.1101 (Asbestos Standards); provide the requisite level of protection Chloride Standard). (f)(3)(ii) of 29 CFR 1910.1025 (Lead to their employees. These provisions specify which Standard); (f)(3)(ii) of 29 CFR 1910.1043 • Footnote 2 to Table 1 of 29 CFR respirators employers are to use under (Cotton Dust Standard); and (g)(3)(iii) of 1910.1048 (Formaldehyde Standard). emergency-escape conditions. With 29 CFR 1910.1048 (Formaldehyde This provision requires that employers regard to respirators used for escape, Standard). who select half-mask respirators instead OSHA adopts the same position it did in the final rulemaking for the These paragraphs require employers of full facepiece respirators for to upgrade a negative pressure formaldehyde exposures up to 7.5 ppm Respiratory Protection Standard. In the final rulemaking for this standard, the respirator, or a non-powered air- provide effective gas-proof goggles for purifying respirator in the case of the employees to use in combination with Agency noted the variety of escape respirators permitted under its Cotton Dust Standard, to a tight-fitting the half-mask respirators. powered air-purifying respirator (PAPR) • Table 2 of 29 CFR 1910.1052 substance-specific standards, and found that these standards addressed hazards when the employee chooses to use a (Methylene Chloride (MC) Standard). tight-fitting PAPR; for the Formaldehyde This table lists only full facepiece associated with many different substances and escape situations. In Standard, this requirement applies respirators, or respirators with hoods or when the employee has difficulty using helmets, thereby indicating that support of this conclusion, the Agency cited the following examples: a negative pressure respirator and the employers are not to select half-mask tight-fitting PAPR provides the respirators for protection against MC. In [U]nder current 29 CFR 1910.1050, the employee with adequate protection standard covering exposure to the preamble to the final MC Standard, against the airborne contaminant. OSHA the Agency states: methylenedianiline (MDA), escape respirators may be any full facepiece air- is proposing to retain these OSHA has determined that this standard is purifying respirator equipped with HEPA requirements because tight-fitting necessary because exposure to MC places cartridges, or any positive pressure or PAPRs increase the protection provided employees at significant risk of developing continuous flow self-contained breathing to employees when the respirator- exposure-related adverse health effects. apparatus with full facepiece or hood; for selection provisions identify a low-end These effects include * * * skin and eye formaldehyde exposure, escape respirators respirator (i.e., a negative pressure irritation. (62 FR 1572) may be a full facepiece with chin style, front, respirator or a non-powered air- or back-mounted industrial canister Later in the preamble, the Agency states purifying respirator) for use. approved against formaldehyde (29 CFR • that ‘‘employers are required to provide 1910.1048). Paragraph (h)(2)(iii)(B) of 29 CFR employees who are at risk of skin and/ 1915.1001 (Asbestos Standard). The or eye contact with MC with appropriate (63 FR 1202.) As noted earlier in this Agency also is proposing to retain this protective clothing and eye protection.’’ section, the adverse physical effects of paragraph in the Asbestos Standard for (See 62 FR 1589.) specific substances (e.g., skin and eye Shipyards, which specifies that The risk of MC-related skin and eye irritation) often limit respirator employers must inform employees that irritation and the need for proper skin selection; these limitations would apply they (the employees) may require and eye protection convinced OSHA to as well to the selection of escape employers to provide them with a tight- limit respirator selection to full respirators. Accordingly, OSHA is fitting PAPR instead of a negative facepiece respirators and respirators retaining the requirements for escape pressure respirator. This requirement with hoods and helmets in the final MC respirators identified in the existing provides an extra margin of protection Standard to ensure that employees’ substance-specific standards because to employees by ensuring that

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employers take positive action to inform (d)(3)(iii)(B)(1) and (B)(2) of the employer compliance with the them of their option to upgrade to a Respiratory Protection Standard to provisions, thereby increasing the level more protective respirator than the one select respirators that protect employees of protection afforded to employees. that they would normally receive for use against the gases and vapors regulated when exposed to asbestos. by these substance-specific standards. In 6. Summary of Superseding Actions • While the paragraphs described in addition, this revision would provide The following table summarizes the previous section require employers employers with increased flexibility in OSHA’s proposed revisions to existing to upgrade employee respirators, every selecting respirators without adding to substance-specific standards. This table substance-specific standard has a their compliance burden (i.e., their lists only those provisions for which the provision, usually as a footnote to its existing respirator-selection procedures Agency is proposing substantive APF table, that gives employers would be acceptable under this revisions (e.g., proposing to replace discretion to select respirators that revision). (Note that the exemption existing requirements with new provide employees with more would still remain for the 1,3-Butadiene requirements); it does not list provisions protection from atmospheric Standard because, as noted above, the that OSHA is proposing to retain in contaminants than the required Agency is retaining the existing their present form (although the Agency respirator. Under this proposal, the respirator-selection provisions of that is rewriting them in plain language). Agency would consolidate this standard.) discretionary alternative into a generic • Paragraph (g)(2)(ii) of 29 CFR provision in proposed paragraph 1910.1048 (Formaldehyde Standard). SUMMARY OF SUPERSEDING ACTIONS (d)(3)(i)(A) of the Respiratory Protection This paragraph specifies a change FOR SPECIFIC STANDARDS Standard (i.e., ‘‘[employees must * * * schedule for chemical cartridges and select a respirator that meets or exceeds canisters used for formaldehyde Existing section Proposed action (29 the required level of employee exposures that do not have an end-of- (29 CFR 1910) CFR 1910) protection’’ [emphasis added]). The service life indicator (ESLI) approved by 1001(g)(2)(ii) ...... Revise. Agency concludes that relocating this NIOSH. OSHA is proposing that 1001(g)(3) ...... Remove Table 1 and provision in proposed paragraph employers select respirators according revise. (d)(3)(i)(A) of the Respiratory Protection to paragraphs (d)(3)(iii)(B)(1) and (B)(2) 1001(l)(3)(ii) ...... Redesignate Table 2 Standard will highlight this alternative of its Respiratory Protection Standard as Table 1. to employers, and will encourage more instead of these requirements. 1017(g)(3)(i) ...... Remove table and re- of them to select more protective The paragraphs proposed for removal vise. respirators for their employees than is require employers who use a change 1017(g)(3)(iii) ...... Remove. now the case. schedule to select a cartridge or canister 1018 Tables I and II .. Remove. that has a NIOSH-approved ESLI, or to 4. Substantive Revisions to the 1018(h)(3)(i) ...... Revise. use a change schedule for which they 1018(h)(3)(ii) ...... Remove. Respirator-Selection Requirements in must provide ‘‘objective information or Substance-Specific Standards 1018(h)(3)(iii) ...... 1018(h)(3)(ii). data that will ensure that canisters and 1025(f)(2)(ii) ...... Remove Table II. OSHA is proposing to revise cartridges are changed before the end of 1025(f)(3)(i) ...... Revise. respirator-selection requirements in their service life’’ (see paragraph (d)(3) 1027(g)(3)(i) ...... Remove Table 2 and several substance-specific standards that of OSHA’s Respiratory Protection revise. regulate employee exposure to organic- Standard). When they choose the latter 1028(g)(3)(ii) ...... Remove Table 1. vapor substances. The following option, this revision would limit the 1028(g)(2)(i) ...... Revise. sections describe these proposed change schedule to one work shift 1028(g)(3)(i) ...... Revise. revisions. because of possible vapor migration in 1029(g)(3) ...... Remove Table I and • Paragraphs (g)(2) of 29 CFR the cartridges and canisters during revise. 1910.1017 (Vinyl Chloride Standard), storage. The Agency believes that this 1043(f)(3)(i) ...... Remove Table I and (g)(2)(i) of 29 CFR 1910.1028 (Benzene revision would: Provide employers with revise. Standard), (h)(2)(i) of 29 CFR 1910.1045 flexibility to use other change schedules 1043(f)(3)(ii) ...... Revise. (Acrylonitrile Standard), and (g)(2)(i) of when a NIOSH-approved ESLI is not 1044(h)(3) ...... Remove Table I and 29 CFR 1910.1048 (Formaldehyde available; not increase the regulatory revise. Standard). These paragraphs exempt burden of employers because the 1045(h)(2)(i) ...... Revise. employers from paragraphs existing change schedule would remain 1045(h)(3) ...... Remove Table I and revise. (d)(3)(iii)(B)(1) and (B)(2) of OSHA’s valid; and ensure that employees 1047(g)(3) ...... Remove Table I and Respiratory Protection Standard; the receive at least the same level of exempted paragraphs consist of revise. protection as they receive with the 1048(g)(2) ...... Revise. respirator-selection provisions that existing change schedule, because protect employees against gases and 1048(g)(3) ...... Remove Table 1 and employers must use a change schedule revise. vapors. Because OSHA would be that they can demonstrate is safe for this 1050(h)(3)(i) ...... Remove Table 1 and removing the existing change schedules purpose. revise. from these substance-specific standards 5. Use of Plain Language for Proposed 1052(g)(3) ...... Remove Table 2 and under this proposed rulemaking, it revise. becomes necessary to identify Revisions requirements that it believes would Whenever possible, OSHA is using provide employees with at least the plain language in revising the regulatory same level of protection as the existing text of the substance-specific standards provisions. These requirements are identified in this proposal. The Agency Existing section Proposed action paragraphs (d)(3)(iii)(B)(1) and (B)(2) of believes that this approach improves the (29 CFR 1915) (29 CFR 1915) its Respiratory Protection Standard; by comprehensibility and uniformity of the 1001(h)(2)(i) through Remove Table 1 and removing the current exemptions, proposed revisions. OSHA believes that (h)(2)(v). revise. employers would apply paragraphs these improvements would enhance

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different APF should be provided for procedures used by respirator these respirator classes? manufacturers to ensure that the Existing section (29 Proposed action (29 5. While there are no WPF or SWPF facepieces they make will fit respirator CFR 1926) CFR 1926) studies for quarter-mask respirators, the users properly. 1976 LANL Respiratory Protection 10. When a limiting factor such as 60(i)(3)(i) ...... Remove Table 1 and Factor by Hyatt found protection factors IDLH, LEL, or the performance limit revise. 62(f)(3)(i) ...... Remove Table 1 and ranging from 5 to 10. Should OSHA specified for a cartridge and canister by revise. continue to include quarter-masks in the the manufacturers are less than the 1101(h)(3)(i) through Remove Table 1 and half-mask class, or separate them into a calculated MUC, proposed paragraph (h)(3)(iv). revise. class of their own with and APF of 5? (d)(3)(i)(B)(4) requires employers to set 1127(g)(3)(i) ...... Remove Table 1 and 6. OSHA is proposing a method by the MUC at the lower limit. revise. which to separate loose-fitting facepiece Accordingly, OSHA is seeking comment supplied-air and PAPR hood/helmet on the following questions: Section XII (‘‘Proposed Amendments respirators from the better-performing a. What other limiting factors should to Standards’’) of this notice provides hood/helmet respirators. Respirator OSHA include as examples in this the full regulatory text of the proposed performance studies have shown that proposed paragraph? revisions to OSHA’s existing substance- some PAPR and continuous-flow b. Should the Agency specify the LEL specific standards dealing with supplied-air respirators provide greater or 10% of the LEL as the limiting factor? respirator selection. This section protection than others of the same class. 11. Some hazardous substances found describes both substantive revisions The 1987 NIOSH Respirator Decision in the workplace do not have an OSHA proposed for the existing respirator- Logic gives an APF of 25 for all of these PEL. However, a number these selection requirements, as well as respirators while ANSI’s 1992 respirator substances may have an exposure limit respirator-selection requirements standard gives an APF of 25 to loose- designated by sources other than OSHA retained in their current form but fitting facepiece models and an APF of (e.g., recommended by the chemical rewritten in plain language. 1000 to hood/helmet models. OSHA is manufacturer, ACGIH, NIOSH, EPA). proposing an APF of 25 except for those Accordingly, the Agency is asking for VIII. Issues models that ensure the maintenance of comment on the following issues OSHA requests the public to comment a positive pressure inside the facepiece involving MUCs: on, and to provide additional during use, consistent with a protection a. Should OSHA expand the information regarding, any of the issues factor of 1000 or greater, in which case definition and application of MUC to listed below. Please provide a detailed those models would receive an APF of hazardous substances that it does not explanation of each response you make. 1000. Is this the appropriate method by regulate? which to distinguish high-performing b. Should the Agency require Developing and Updating APFs hood/helmet respirators from others? employers to determine MUCs for 1. Is the method used by OSHA in 7. The assigned protection factor for a substances that have no OSHA PEL (i.e., developing the proposed APFs full facepiece respirator in Table 1 of the substances not regulated specifically by appropriate? OSHA used a multi-faceted proposed standard does not currently OSHA), and to base respirator selection approach incorporating both analyses of take into account the type of particulate on such a determination? data collected in WPF and SWPF filter that is used. An N95 particulate c. For hazardous substances that studies, as well as OSHA’s review of all filter could potentially, under a worst OSHA does regulate, should it require relevant materials. OSHA requests case scenario, have up to 5% leakage employers to comply with the MUC comment on the usefulness of this through the filter. This would decrease values developed by NIOSH when these approach to data collection. the APF for a full facepiece respirator to values are lower than the calculated 2. Are there any additional studies a maximum of 20 when N95 filters are MUC values (i.e., MUC = APF × PEL)? that may be useful in determining APFs, used. Should OSHA take into account 12. A prevailing view is that exposure that have not already been identified by the limitations of the filter and assign an to multiple contaminants in the OSHA in Section IV of this proposal? APF of 20 for full facepiece respirators workplace affect the performance of Please provide these to the Agency. when N95 filters are used? respirator filters and cartridges 3. Are statistical analyses, treatments, 8. Other Federal Agencies, such as the differently than exposure to single or approaches, other than those Nuclear Regulatory Commission (NRC), contaminants. To assist it in developing described in Section IV of the proposal, have set no APF for filtering facepiece MUCs for single and multiple available for differentiating between or air-purifying respirators (APRs) for use contaminants, OSHA is asking the comparing the highly variable in their particular work environments. public to address the following issues: respirator-performance data? In some cases, such APRs are not a. What information and data are 4. OSHA is aware of discussions allowed to be used at all. In other available that either support or do not within the respirator community settings, e.g., the healthcare industry, support this view? indicating some sentiment for setting some employers rely very heavily upon b. Should MUCs for contaminant APFs for filtering facepiece respirators such APRs to protect their employees mixtures differ from MUCs for single at 5, and for setting an APF of 10 for who work with patients who have mixtures? other half-mask air-purifying infectious airborne illnesses. How 13. Section VII proposes to revise respirators. Based upon OSHA’s should OSHA incorporate such most of the respirator-selection reviews, OSHA cannot differentiate information, if at all, into an APF requirements in OSHA’s substance- between the performance of the two requirement for all industries under specific standards. Accordingly, the types of respirator, and OSHA finds OSHA’s jurisdiction? Agency is asking for comment on the compelling evidence from the large 9. Proper facepiece fit is important in following questions: number of observed data points (N = achieving the proposed APF for tight- a. This proposal excludes the 917 Co/Ci pairs) to support proposing fitting respirators. Accordingly, the respirator-selection provisions of the an APF of 10 for both of these classes Agency would appreciate receiving 1,3-Butadiene Standard from any of respirators. Is there evidence that a information on current testing and revision. Is this exclusion warranted?

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b. Special or unique respirator- the informal public hearing that the issues, the proceeding is informal and selection requirements in the substance- Agency will convene after the comment legislative in purpose. Therefore, the specific standards (e.g., requirements for period ends. In this regard, the Agency hearing provides interested parties with emergency-escape, HEPA filters, invites interested parties having an opportunity to make effective and upgrading respirators at the employee’s knowledge of, or experience with, APFs expeditious oral presentations in the request, eye protection) remain largely and MUCs to participate in this process, absence of procedural restraints or rigid intact. Should the Agency standardize and welcomes any pertinent data and procedures that could impede or these provisions across all of its cost information that will provide it protract the rulemaking process. In substance-specific standards, and, if so, with the best available evidence on addition, the hearing is an informal what requirements should it which to develop the final regulatory administrative proceeding, rather than standardize. requirements. adjudicative one in which the technical 14. The Agency has developed its This section describes the procedures rules of evidence would apply, because Preliminary Economic Analysis (PEA) the public must use to submit their its primary purpose is to gather and based on survey data indicating what comments to the docket in a timely clarify information. The regulations that types of respirators employees are using manner, and to schedule an opportunity govern public hearings, and the pre- currently. The Agency does not, to deliver oral testimony and provide hearing guidelines issued for this however, have data on the exposure documentary evidence at the informal hearing, will ensure participants levels as a multiple of the PEL that public hearings. Comments, notices of fairness and due process, and also will respirator users are currently exposed intention to appear, hearing testimony, facilitate the development of a clear, to. For the purposes of this analysis, the and documentary evidence will be accurate, and complete record. Agency has used its internal Integrated available for inspection and copying at Accordingly, application of these rules Management and Information System the OSHA Docket Office. You also and guidelines will be such that (IMIS) data to estimate the distribution should read the sections above titled questions of relevance, procedure, and of exposures as a multiple of the PEL. DATES and ADDRESSES for additional participation generally will favor The Agency also assumes that information on submitting comments, development of the record. employers are currently using the documents, and requests to the Agency Conduct of the hearing will conform respirator with the lowest possible costs for consideration in this rulemaking. to the provisions of 29 CFR part 1911, that can still satisfy existing guidance Written Comments. OSHA invites ‘‘Rules of Procedure for Promulgating, on APFs, allowing employees to be interested parties to submit written data, Modifying, or Revoking Occupational exposed up to the full limit of a views, and arguments concerning this Safety and Health Standards.’’ The currently assigned APF for that class of proposal. In particular, OSHA would regulation at 29 CFR 1911.4 ‘‘Additional respirator. OSHA seeks comment on encourage interested parties to comment or Alternative Procedural whether other data sources or on the issues raised in section VIII Requirements,’’ specifies that the methodologies for making this (‘‘Issues’’) of the preamble. When Assistant Secretary may, on reasonable projection exist. submitting comments, parties must notice, issue alternative procedures to a. Is it common for employers to put follow the procedures specified above in expedite proceedings or for other good employees in respirators at the highest the sections titled DATES and ADDRESSES. cause. Although the ALJs who preside exposure levels permitted by the APF The comments must clearly identify the over these hearings make no decision or range? provision of the proposal you are recommendation on the merits of b. Are there particular types of addressing, the position taken with OSHA’s proposal, they do have the respirators that frequently do not fit this respect to each issue, and the basis for responsibility and authority to ensure pattern (i.e., are selected for reasons that position. Comments, along with that the hearing progresses at a other than having a high APF or due to supporting data and references, received reasonable pace and in an orderly a medical reason for a particular by the end of the specified comment manner. employee)? period will become part of the To ensure that interested parties c. How do employers approach the proceedings record, and will be receive a full and fair informal hearing issue of uncertainty in possible available for public inspection and as specified by 29 CFR part 1911, the exposure levels when integrating APFs copying at the OSHA Docket Office. ALJ has the authority and power to: into their respirator selection? Informal Public Hearings. Pursuant to Regulate the course of the proceedings; d. To what extent will having a single section 6(b)(3) of the Act, members of dispose of procedural requests, OSHA APF table result in less confusion the public will have an opportunity at objections, and comparable matters; than the existing multiplicity of APF an informal public hearing to provide confine the presentations to matters tables? oral testimony concerning the issues pertinent to the issues raised; use e. Do OSHA’s cost estimates of using raised in this proposal. The hearings appropriate means to regulate the different types of respirators adequately will commence at 9:30 a.m. on the first conduct of the parties who are present represent all of the costs associated with day. At that time, the presiding at the hearing; question witnesses, and each type of respirator use? administrative law judge (ALJ) will permit others to question witnesses; and f. Are their any alternative approaches resolve any procedural matters relating limit the time for such questioning. At consistent with the OSH Act that could to the proceeding. The hearings will the close of the hearing, the ALJ will reduce the burden of this standard on reconvene on subsequent days at 8:30 establish a post-hearing comment period small entities? a.m. for parties who participated in the The legislative history of section 6 of hearing. During the first part of this IX. Public Participation—Comments the OSH Act, as well as OSHA’s period, the participants may submit and Hearings regulation governing public hearings (29 additional data and information to OSHA encourages members of the CFR 1911.15), establish the purpose and OSHA, while during the second part of public to participate in this rulemaking procedures of informal public hearings. this period, they may submit briefs, by submitting comments on the Although the presiding officer of such arguments, and summations. proposal, and by providing oral hearings is an ALJ, and questioning by Notice of Intention To Appear To testimony and documentary evidence at interested parties is allowed on crucial Provide Testimony at the Informal

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Public Hearings. Interested parties who Labor for Occupational Safety and 2. Section 1910.134 is amended as intend to provide oral testimony at the Health; the record will consist of all of follows: informal public hearings must file a the written comments, oral testimony, a. The text of the definitions for notice of intention to appear by using and documentary evidence received ‘‘Assigned protection factor (APF)’’ and the procedures specified above in the during the proceeding. However, the ‘‘Maximum use concentration (MUC)’’ is sections titled DATES and ADDRESSES. ALJ does not make or recommend any added to paragraph (b); This notice must provide the: Name, decisions as to the content of the final b. The text of paragraphs (d)(3)(i)(A) address, and telephone number of each standard. Following certification of the and (d)(3)(i)(B) is added; and individual who will provide testimony, record, OSHA will review the proposed c. Paragraph (n) is revised. and their preferred hearing location; APF provisions in light of all the The added and revised text read as capacity (e.g., name of the evidence received as part of the record, follows: establishment/organization the and then will issue the final APF individual is representing; the provisions based on the entire record. § 1910.134 Respiratory protection. individual’s occupational title and List of Subjects in 29 CFR Parts 1910, * * * * * position) in which each individual will 1915, and 1926 (b) * * * testify; approximate amount of time Assigned protection factor (APF) required for each individual’s Assigned protection factors, Hazardous substances, Health, means the workplace level of respiratory testimony; specific issues each protection that a respirator or class of individual will address, including a Occupational safety and health, Respirators, Respirator selection. respirators is expected to provide to brief statement of the position that the employees when the employer individual will take with respect to each Authority and Signature implements a continuing, effective of these issues; and any documentary John L. Henshaw, Assistant Secretary respiratory protection program as evidence the individual will present, specified by 29 CFR 1910.134. including a brief summary of the of Labor for Occupational Safety and evidence. Health, U.S. Department of Labor, 200 * * * * * OSHA emphasizes that the hearings Constitution Ave., NW., Washington, Maximum use concentration (MUC) are open to the public, and that DC 20210, directed the preparation of means the maximum atmospheric interested parties are welcome to attend. this notice. The Agency issues the concentration of a hazardous substance However, only a party who files a proposed sections under the following from which an employee can be proper notice of intention to appear may authorities: Sections 4, 6(b), 8(c), and expected to be protected when wearing ask questions and participate fully in 8(g) of the Occupational Safety and a respirator, and is determined by the the proceedings. While a party who did Health Act of 1970 (29 U.S.C. 653, 655, assigned protection factor of the not file a notice of intention to appear 657); section 107 of the Contract Work respirator or class of respirators and the may be allowed to testify at the hearing Hours and Safety Standards Act (the exposure limit of the hazardous if time permits, this determination is at Construction Safety Act) (40 U.S.C. substance. The MUC usually can be the discretion of the presiding ALJ. 333); section 41, the Longshore and determined mathematically by Hearing Testimony and Documentary Harbor Worker’s Compensation Act (33 multiplying the assigned protection Evidence. Any party requesting more U.S.C. 941); Secretary of Labor’s Order factor specified for a respirator by the than 10 minutes to testify at the No. 5–2002 (67 FR 65008); and 29 CFR permissible exposure limit, short term informal public hearing, or who intends Part 1911. exposure limit, ceiling limit, peak limit, to submit documentary evidence at the Signed at Washington, DC, on May 28, or any other exposure limit used for the hearing, must provide the complete text 2003. hazardous substance. of the testimony and the documentary John L. Henshaw, * * * * * evidence as specified above in the Assistant Secretary of Labor. (d) * * * sections titled DATES and ADDRESSES. X. Proposed Amendments to Standards (3) * * * The Agency will review each (i) * * * submission and determine if the OSHA proposes to amend 29 CFR parts 1910, 1915, and 1926 as follows: (A) Assigned Protection Factors information it contains warrants the (APFs). Employers must use the amount of time requested. If OSHA PART 1910—[AMENDED] assigned protection factors listed in believes the requested time is excessive, Table I to select a respirator that meets it will allocate an appropriate amount of Subpart I—[Amended] or exceeds the required level of time to the presentation, and will notify employee protection. When using a 1. The authority citation for subpart I the participant of this action, and the combination respirator (e.g., airline of part 1910 is revised to read as reasons for the action, prior to the respirators with an air-purifying filter), follows: hearing. The Agency may limit to 10 employers must ensure that the assigned minutes the presentation of any Authority: Sections 4, 6, and 8 of the protection factor is appropriate to the participant who fails to comply Occupational Safety and Health Act of 1970 mode of operation in which the substantially with these procedural (29 U.S.C. 653, 655, and 657); and Secretary respirator is being used. requirements; in such instances, OSHA of Labor’s Order No. 12–71 (36 FR 8754), 8– may request the participant to return for 76 (41 FR 25059), 9–83 (48 FR 35736), 1–90 Note to paragraph (d)(3)(i)(A): The questioning at a later time. (55 FR 9033), 6–96 (62 FR 111), or 3–2000 assigned protection factors listed in Table I Certification of the Record and Final (62 FR 50017). are effective only when the employer has a continuing, effective respiratory protection Determination After the Informal Public Sections 1910.132, 1910.134, and 1910.138 or 29 CFR also issued under 29 CFR part program as specified by 29 CFR 1910.134, Hearing. Following the close of the 1911. including training, fit testing, maintenance hearing and post-hearing comment Sections 1910.133, 1910.135, and 1910.136 and use requirements. These assigned period, the presiding ALJ will certify the of 29 CFR also issued under 29 CFR part protection factors do not apply to respirators record to the Assistant Secretary of 1911 and 5 U.S.C. 553. used solely for escape.

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TABLE I.—ASSIGNED PROTECTION FACTORS

12 Loose-fitting Type of respirator Half mask Full facepiece Helmet/hood facepiece

1. Air-Purifying Respirator ...... 3 10 50 ...... 2. Powered Air-Purifying Respirator (PAPR) ...... 50 1000 4 1000 25 3. Supplied-Air Respirator (SAR) or Airline Respirator: • Demand mode ...... 10 50 ...... • Continuous-flow mode ...... 50 1,000 4 1,000 25 • Pressure-demand or other positive-pressure mode ...... 50 1,000 ...... 4. Self-Contained Breathing Apparatus (SCBA): • Demand mode ...... 10 50 50 ...... • Pressure-demand or other positive-pressure mode (e.g., open/ closed circuit) ...... 10,000 10,000 ...... 5 (maximum) 5 (maximum) Notes: 1 Employers may select respirators assigned for use in higher workplace concentrations of a hazardous substance for use at lower concentra- tions of that substance or when required respirator use is independent of concentration. 2 The assigned protection factors in Table I only apply when the employer implements a continuing, effective respirator program as specified by OSHA’s Respiratory Protection Standard at 29 CFR 1910.134, including training, fit testing, maintenance and use requirements. 3 This APF category includes quarter masks, filtering facepieces, and half-masks. 4 Previous studies involving Workplace Protection Factor (WPF) and Simulated Workplace Protection Factor (SWPF) testing on helmet/hood respirators show that some of these respirators do not provide a level of protection consistent with an APF of 1000. Therefore, only helmet/hood respirators that ensure the maintenance of a positive pressure inside the facepiece during use, consistent with performance at a level of protec- tion of 1000 or greater, receive an APF of 1000. All other helmet/hood respirators are treated as loose-fitting facepiece respirators and receive an APF of 25. 5 Although positive pressure SCBAs appear to provide the highest level of respiratory protection, a SWPF study of SCBA users concluded that all users may not achieve protection factors of 10,000 at high work rates. When employers can estimate hazardous concentrations for planning purposes, they must use a maximum assigned protection factor no higher than 10,000.

(B) Maximum Use Concentration Subpart Z—[Amended] (i) Select, and provide to employees, (MUC). (1) The employer must select a the appropriate respirators specified in respirator for employee use that 3. The general authority citation for paragraph (d)(3)(i)(A) of 29 CFR maintains the employee’s exposure to subpart Z of part 1910 is revised to read 1910.134; however, employers must not the hazardous substance, when as follows: select or use filtering-facepiece measured outside the respirator, at or Authority: Sections 4, 6, and 8 of the respirators for protection against below the MUC. Occupational Safety and Health Act of 1970 asbestos fibers. (29 U.S.C. 653, 655, and 657); Secretary of Note to paragraph (d)(3)(i)(B)(1): MUCs are (ii) Provide HEPA filters for air- Labor’s Orders 12–71 (36 FR 8754), 8–76 (41 purifying respirators. effective only when the employer has a FR 25059), 9–83 (48 FR 35736), 1–90 (55 FR continuing, effective respiratory protection 9033), 6–96 (62 FR 111), or 3–2000 (62 FR * * * * * program as specified by 29 CFR 1910.134, 50017); and 29 CFR Part 1911. 5. In § 1910.1017, remove the table in including training, fit testing, maintenance paragraph (g)(3)(i), remove paragraph and use requirements. * * * * * 4. Section 1910.1001 is amended by: (g)(3)(iii), and revise paragraph (g)(3)(i) (2) Employers must comply with the a. Removing Table 1 in paragraph to read as follows: respirator manufacturer’s MUC for a (g)(3); § 1910.1017 Vinyl chloride. hazardous substance when the b. Redesignating Table 2 in paragraph * * * * * manufacturer’s MUC is lower than the (l)(3)(ii) as Table 1; (g) * * * calculated MUC specified by this c. Removing the reference to ‘‘Table standard. 2’’ in paragraph (l)(3)(ii) and adding (3) * * * (i) Employers must: (3) Employers must not apply MUCs ‘‘Table 1’’ in its place; and (A) Select, and provide to employees, to conditions that are immediately d. Revising paragraphs (g)(2)(ii) and the appropriate respirators specified in dangerous to life or health (IDLH); (g)(3). paragraph (d)(3)(i)(A) of 29 CFR instead, they must use respirators listed The revisions read as follows: 1910.134. for IDLH conditions in paragraph (d)(2) (B) Provide an organic-vapor cartridge § 1910.1001 Asbestos. of this standard. that has a service life of at least one * * * * * hour when using a chemical-cartridge (4) When the calculated MUC exceeds (g) * * * respirator at vinyl chloride another limiting factor such as the IDLH (2) * * * concentrations up to 10 ppm. level for a hazardous substance, the (ii) Employers must provide an (C) Select a canister that has a service lower explosive limit (LEL), or the employee with tight-fitting, powered life of at least four hours when using a performance limits of the cartridge or air-purifying respirator (PAPR) instead powered air-purifying respirator having canister, then employers must set the of a negative-pressure respirator a hood, helmet, or full or half facepiece, maximum MUC at that lower limit. selected according to paragraph (g)(3) of or a gas mask with a front- or back- * * * * * this standard when the employee mounted canister, at vinyl chloride (n) Effective date. Paragraphs chooses to use a PAPR and it provides concentrations up to 25 ppm. (d)(3)(i)(A) and (d)(3)(i)(B) of this adequate protection to the employee. * * * * * section become effective September 4, * * * * * 6. In § 1910.1018, remove Tables I and 2003. (3) Respirator selection. Employers II and paragraph (h)(3)(ii), redesignate * * * * * must: paragraph (h)(3)(iii) as paragraph

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(h)(3)(ii), and revise paragraph (h)(3)(i) § 1910.1027 Cadmium. select or use filtering facepieces for to read as follows: * * * * * protection against coke oven emissions. § 1910.1018 Inorganic arsenic. (g) * * * * * * * * (3) * * *(i) Employers must: 11. In § 1910.1043, remove Table I in * * * * * (A) Select, and provide to employees, paragraph (f)(3)(i) and revise paragraphs (h) * * * (f)(3)(i) and (f)(3)(ii) to read as follows: (3) * * *(i) Employers must: the appropriate respirators specified in paragraph (d)(3)(i)(A) of 29 CFR (A) Select, and provide to employees, § 1910.1043 Cotton dust. the appropriate respirators specified in 1910.134. (B) Provide employees with full- * * * * * paragraph (d)(3)(i)(A) of 29 CFR (f) * * * 1910.134. facepiece respirators when they experience eye irritation. (3) * * * (B) Ensure that employees do not use (i) Employers must: half-mask respirators for protection (C) Provide HEPA filters for air- purifying respirators. (A) Select, and provide to employees, against arsenic trichloride because it is the appropriate respirators specified in absorbed rapidly through the skin. * * * * * paragraph (d)(3)(i)(A) of 29 CFR (C) Provide HEPA filters for air- 9. In § 1910.1028, remove Table 1 in 1910.134; however, employers must not purifying respirators. paragraph (g)(3)(ii) and revise select or use filtering facepieces for (D) Select for employee use: paragraphs (g)(2)(i) and (g)(3)(i) to read protection against cotton dust (1) Air-purifying respirators that have as follows: concentrations greater than five times (5 a combination HEPA filter with an X) the PEL. appropriate gas-sorbent cartridge or § 1910.1028 Benzene. (B) Provide HEPA filters for air- canister when the employee’s exposure * * * * * purifying respirators used at cotton dust exceeds the permissible exposure level (g) * * * concentrations greater than ten times for inorganic arsenic and the relevant (2) * * * (10 X) the PEL. limit for other gases. (i) Employers must implement a (ii) Employers must provide an (2) Front- or back-mounted gas masks respiratory protection program in equipped with HEPA filters and acid- employee with a powered air-purifying accordance with 29 CFR 1910.134 (b) respirator (PAPR) instead of a gas canisters or any full-facepiece through (d) (except (d)(1)(iii)), and (f) supplied-air respirators when the nonpowered air-purifying respirator through (m). selected according to paragraph (f)(3)(i) inorganic arsenic concentration is at or * * * * * µ 3 of this standard when the employee below 500 g/m ; and half-mask air- (3) * * * purifying respirators equipped with chooses to use a PAPR and it provides (i) Employers must: HEPA filters and acid-gas cartridges adequate protection to the employee as (A) Select, and provide to employees, when the inorganic arsenic specified by paragraph (f)(3)(i) of this the appropriate respirators specified in concentration is at or below 100 µg/m3. standard. paragraph (d)(3)(i)(A) of 29 CFR * * * * * * * * * * 1910.134. 12. In § 1910.1044, remove Table 1 in 7. In § 1910.1025, remove Table II in (B) Provide employees with any paragraph (f)(2)(ii) and revise paragraph (h)(3) and revise paragraph organic-vapor gas mask or any self- (h)(3) to read as follows: paragraphs (f)(3)(i) and (f)(3)(ii) to read contained breathing apparatus with a as follows: full facepiece to use for escape. § 1910.1044 1,2-Dibromo-3-chloropropane. § 1910.1025 Lead. (C) Use an organic-vapor cartridge or * * * * * * * * * * canister air-purifying respirators, and a (h) * * * (f) * * * chin-style canister with full-facepiece (3) Respirator selection. Employers (3) * * *(i) Employers must: gas masks. must: (A) Select, and provide to employees, (D) Ensure that canisters used with (i) Select, and provide to employees, the appropriate respirators specified in nonpowered air-purifying respirators the appropriate atmosphere-supplying paragraph (d)(3)(i)(A) of 29 CFR have a minimum service life of four respirator specified in paragraph 1910.134. hours when tested at 150 ppm benzene (d)(3)(i)(A) of 29 CFR 1910.134. (B) Provide employees with full- at a flow rate of 64 liters per minute (ii) Provide employees with one of the facepiece respirators instead of half- (LPM), a temperature of 25° C, and a following respirator options to use for mask respirators for protection against relative humidity of 85%; for canisters entry into, or escape from, unknown lead aerosols that cause eye or skin used with tight-fitting or loose-fitting, DBCP concentrations: irritation at the use concentrations. powered air-purifying respirators, the (A) A combination respirator that (C) Provide HEPA filters for air- flow rates for testing must be 115 LPM includes a supplied-air respirator with a purifying respirators. and 170 LPM, respectively. full facepiece operated in a pressure- (ii) Employers must provide * * * * * demand or other positive-pressure or employees with a powered air-purifying 10. In § 1910.1029, remove Table I in continuous-flow mode, as well as an respirator (PAPR) instead of a negative- paragraph (g)(3) and revise paragraph auxiliary self-contained breathing pressure respirator selected according to (g)(3) to read as follows: apparatus (SCBA) operated in a paragraph (f)(3)(i) of this standard when pressure-demand or positive-pressure an employee chooses to use a PAPR and § 1910.1029 Coke oven emissions. mode. it provides adequate protection to the * * * * * (B) An SCBA with a full facepiece employee as specified by paragraph (g) * * * operated in a pressure-demand or other (f)(3)(i) of this standard. (3) Respirator selection. Employers positive-pressure mode. * * * * * . must select, and provide to employees, * * * * * 8. In § 1910.1027, remove Table 2 in the appropriate respirators specified in 13. In § 1910.1045, remove Table I in paragraph (g)(3)(i) and revise paragraph paragraph (d)(3)(i)(A) of 29 CFR paragraph (h)(3) and revise paragraphs (g)(3)(i) to read as follows: 1910.134; however, employers must not (h)(2)(i) and (h)(3) to read as follows:

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§ 1910.1045 Acrylonitrile. end of the workshift, whichever § 1910.1052 Methylene chloride. * * * * * condition occurs first. * * * * * (h) * * * (3) Respirator selection. (i) Employers (g) * * * (2) * * * must: (3) Respirator selection. Employers (i) Employers must implement a (A) Select, and provide to employees, must: respiratory protection program in the appropriate respirators specified in (i) Select, and provide to employees, accordance with 29 CFR 1910.134 (b) paragraph (d)(3)(i)(A) of 29 CFR the appropriate atmosphere-supplying through (d) (except (d)(1)(iii)), and (f) 1910.134. respirator specified in paragraph through (m). (B) Equip each air-purifying, full (d)(3)(i)(A) of 29 CFR 1910.134; facepiece respirator with a canister or however, employers must not select or * * * * * cartridge approved for protection use half-masks of any type because MC (3) Respirator selection. Employers against formaldehyde. may cause eye irritation or damage. must: (C) For escape, provide employees (ii) For emergency escape, provide (i) Select, and provide to employees, with one of the following respirator employees with one of the following the appropriate respirators specified in options: A self-contained breathing respirator options: A self-contained paragraph (d)(3)(i)(A) of 29 CFR apparatus operated in the demand or breathing apparatus operated in the 1910.134. pressure-demand mode; or a full continuous-flow or pressure-demand; or (ii) For escape, provide employees facepiece respirator having a chin-style, a gas mask with an organic-vapor with any organic-vapor respirator or any or a front- or back-mounted industrial- canister. self-contained breathing apparatus size, canister or cartridge approved for permitted for use under paragraph * * * * * protection against formaldehyde. (h)(3)(i) of this standard. (ii) Employers may substitute an air- PART 1915—[AMENDED] * * * * * purifying, half-mask respirator for an 18. The authority citation for part 14. In § 1910.1047, remove Table 1 in air-purifying, full facepiece respirator if 1915 is revised to read as follows: paragraph (g)(3) and revise paragraph they equip the half-mask respirator with (g)(3) to read as follows: a cartridge approved for protection Authority: Section 41, Longshore and against formaldehyde and provide the Harbor Workers’ Compensation Act (33 § 1910.1047 Ethylene oxide. U.S.C. 941); Sections 4, 6, and 8 of the affected employee with effective gas- * * * * * Occupational Safety and Health Act of 1970 proof goggles. (20 U.S.C. 653, 655, and 687); and Secretary (g) * * * (iii) Employers must provide (3) Respirator selection. Employers of Labor’s Order No. 12–71 (36 FR 8754), 8– employees who have difficulty using 76 (41 FR 25059), 9–83 (48 FR 35736), 1–90 must: negative-pressure respirators with (55 FR 9033), 6–96 (62 FR 111), or 3–2000 (i) Select, and provide to employees, powered air-purifying respirators (62 FR 50017). the appropriate respirators specified in permitted for use under paragraph Sections 1915.120 and 1915.152 also paragraph (d)(3)(i)(A) of 29 CFR (g)(3)(i)(A) of this standard and that issued under 29 CFR 1911. 1910.134; however, employers must not provide adequate protection against select or use half-masks of any type their formaldehyde exposures. Subpart Z—[Amended] because EtO may cause eye irritation or injury. * * * * * 19. In § 1915.1001, remove Table 1 in 16. In § 1910.1050, remove Table 1 in (ii) Equip each air-purifying, full paragraph (h)(2)(iii) and revise paragraph (h)(3)(i) and revise paragraph facepiece respirator with a front- or paragraph (h)(2) to read as follows: (h)(3)(i) to read as follows: back-mounted canister approved for § 1915.1001 Asbestos. protection against ethylene oxide. § 1910.1050 Methylenedianiline. (iii) For escape, provide employees * * * * * * * * * * (h) * * * with any respirator permitted for use (h) * * * (2) Respirator selection. (i) Employers under paragraph (g)(3)(i) of this (3) * * * must select, and provide to employees standard. (i) Employers must: at no cost, the appropriate respirators * * * * * (A) Select, and provide to employees, specified in paragraph (d)(3)(i)(A) of 29 15. In § 1910.1048, remove Table 1 in the appropriate respirators specified in CFR 1910.134; however, employers paragraph (g)(3)(i) and revise paragraphs paragraph (d)(3)(i)(A) of 29 CFR must not select or use filtering-facepiece (g)(2) and (g)(3) to read as follows: 1910.134. respirators for use against asbestos (B) Provide HEPA filters for air- § 1910.1048 Formaldehyde. fibers. purifying respirators. (ii) Employers are to provide HEPA * * * * * (C) For escape, provide employees filters for air-purifying respirators. (g) * * * with one of the following respirator (iii) Employers must: (2) Respirator programs. (i) Employers options: Any self-contained breathing (A) Inform employees that they may must implement a respiratory protection apparatus with a full facepiece or hood require the employer to provide a tight- program in accordance with 29 CFR operated in the positive-pressure or fitting, powered air-purifying respirator 1910.134 (b) through (d) (except continuous-flow mode; or a full- (PAPR) permitted for use under (d)(1)(iii)), and (f) through (m). facepiece, air-purifying respirator. paragraph (h)(2)(i) of this standard (ii) If employees use air-purifying (D) Provide a combination HEPA filter instead of a negative-pressure respirator. respirators with chemical cartridges or and organic-vapor canister or cartridge (B) Provide employees with a tight- canisters that do not contain end-of- with air-purifying respirators when fitting PAPR instead of a negative- service-life indicators approved by the MDA is in liquid form or part of a pressure respirator when the employees National Institute for Occupational process requiring heat. choose to use a tight-fitting PAPR and Safety and Health, employers must * * * * * it provides them with the required replace these cartridges or canisters as 17. In § 1910.1052, remove Table 2 in protection against asbestos. specified by paragraphs (d)(3)(iii)(B)(1) paragraph (g)(3) and revise paragraph (iv) Employers must provide and (B)(2) of 29 CFR 1910.134, or at the (g)(3) to read as follows: employees with an air-purifying, half-

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mask respirator, other than a filtering- § 1926.60 Methylenedianiline. (A) Select, and provide to employees, facepiece respirator, whenever the * * * * * the appropriate respirators specified in employees perform: (i) * * * paragraph (d)(3)(i)(A) of 29 CFR (A) Class II or Class III asbestos work (3) * * * 1910.134; however, employers must not for which no negative-exposure (i) Employers must: select or use filtering-facepiece assessment is available. (A) Select, and provide to employees, respirators for use against asbestos (B) Class III asbestos work involving the appropriate respirators specified in fibers. disturbance of TSI or surfacing ACM or paragraph (d)(3)(i)(A) of 29 CFR (B) Provide HEPA filters for air- PACM. 1910.134. purifying respirators. (v) Employers must provide (B) Provide HEPA filters for air- (ii) Employers must provide an employees with: purifying respirators. employee with tight-fitting, powered (A) A tight-fitting, powered air- (C) For escape, provide employees air-purifying respirator (PAPR) instead purifying respirator or a full-facepiece, with one of the following respirator of a negative-pressure respirator supplied-air respirator operated in the options: Any self-contained breathing selected according to paragraph pressure-demand mode and equipped apparatus with a full facepiece or hood (h)(3)(i)(A) of this standard when the with either HEPA egress cartridges or an operated in the positive-pressure or employee chooses to use a PAPR and it auxiliary positive-pressure, self- continuous-flow mode; or a full- provides adequate protection to the contained breathing apparatus (SCBA) facepiece, air-purifying respirator. employee. whenever the employees are in a (D) Provide a combination HEPA filter (iii) Employers must provide regulated area performing Class I and organic-vapor canister or cartridge employees with an air-purifying, half- asbestos work for which a negative- with air-purifying respirators when mask respirator, other than a filtering- exposure assessment is not available MDA is in liquid form or part of a facepiece respirator, whenever the and the exposure assessment indicates process requiring heat. employees perform: that the exposure level will be at or * * * * * (A) Class II or Class III asbestos work below 1 f/cc as an 8-hour time-weighted 22. In § 1926.62, remove Table 1 in for which no negative-exposure average (TWA). paragraph (f)(3) and revise paragraph assessment is available. (B) A full-facepiece, supplied-air (f)(3)(i) to read as follows: (B) Class III asbestos work involving respirator operated in the pressure- disturbance of TSI or surfacing ACM or demand mode and equipped with an § 1926.62 Lead. PACM. auxiliary positive-pressure SCBA * * * * * (iv) Employers must provide whenever the employees are in a (f) * * * employees with: regulated area performing Class I (3) * * * (A) A tight-fitting, powered air- asbestos work for which a negative- (i) Employers must: purifying respirator or a full-facepiece, exposure assessment is not available (A) Select, and provide to employees, supplied-air respirator operated in the and the exposure assessment indicates the appropriate respirators specified in pressure-demand mode and equipped that the exposure level will be above 1 paragraph (d)(3)(i)(A) of 29 CFR with either HEPA egress cartridges or an f/cc as an 8-hour TWA. 1910.134. auxiliary positive-pressure, self- (B) Provide employees with a full- * * * * * contained breathing apparatus (SCBA) facepiece respirator instead of a half- whenever the employees are in a PART 1926—[AMENDED] mask respirator for protection against regulated area performing Class I lead aerosols that cause eye or skin asbestos work for which a negative- Subpart D—[Amended] irritation at the use concentrations. exposure assessment is not available (C) Provide HEPA filters for air- and the exposure assessment indicates 20. The authority citation for subpart purifying respirators. that the exposure level will be at or D of part 1926 is revised to read as * * * * * below 1 f/cc as an 8-hour time-weighted follows: average (TWA). Authority: Section 107, Contract Work Subpart Z—[Amended] (B) A full-facepiece, supplied-air Hours and Safety Standards Act respirator operated in the pressure- (Construction Safety Act) (40 U.S.C. 333); 23. The authority citation for subpart Z of part 1926 is revised to read as demand mode and equipped with an sections 4, 6, and 8 of the Occupational auxiliary positive-pressure SCBA Safety and Health Act of 1970 (29 U.S.C. 653, follows: 655, and 657); Secretary of Labor’s Orders whenever the employees are in a Authority: Sections 4, 6, and 8 of the regulated area performing Class I 12–71 (36 FR 8754), 8–76 (41 FR 25059), 9– Occupational Safety and Health Act of 1970 83 (48 FR 35736), 1–90 (55 FR 9033), 6–96 (29 U.S.C. 653, 655, 657); Secretary of Labor’s asbestos work for which a negative- (62 FR 111), or 3–2000 (62 FR 50017); and Orders 12–71 (36 FR 8754), 8–76 (41 FR exposure assessment is not available 29 CFR part 11. 25059), 9–83 (48 FR 35736), 1–90 (55 FR and the exposure assessment indicates Sections 1926.58, 1926.59, 1926.60, and 9033), 6–96 (62 FR 111), or 3–2000 (62 FR that the exposure level will be above 1 1926.65 also issued under 5 U.S.C. 553 and 50017); and 29 CFR part 11. f/cc as an 8-hour TWA. 29 CFR part 1911. Section 1926.1102 not issued under 29 Section 1926.62 also issued under section * * * * * U.S.C. 655 or 29 CFR part 1911; also issued 25. In § 1926.1127, remove Table 1 in 1031 of the Housing and Community under 5 U.S.C. 553. Development Act of 1992 (42 U.S.C. 4853). paragraph (g)(3)(i) and revise paragraph 24. In § 1926.1101, remove Table 1 in (g)(3)(i) to read as follows: Section 1926.65 of 29 CFR also issued paragraph (h)(3)(i) and revise paragraph under section 126 of the Superfund (h)(3) to read as follows: § 1926.1127 Cadmium. Amendments and Reauthorization Act * * * * * of 1986, as amended (29 U.S.C. 655 § 1926.1101 Asbestos. (g) * * * note), and 5 U.S.C. 553. * * * * * (3) * * * 21. In § 1926.60, remove Table 1 and (h) * * * (i) Employers must: revise paragraph (i)(3)(i) to read as (3) Respirator selection. (i) Employers (A) Select, and provide to employees, follows: must: the appropriate respirators specified in

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paragraph (d)(3)(i)(A) of 29 CFR (B) Provide employees with full- (C) Provide HEPA filters for air- 1910.134. facepiece respirators when they purifying respirators. experience eye irritation. * * * * * [FR Doc. 03–13749 Filed 6–5–03; 8:45 am] BILLING CODE 4510–26–P

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