# Respiratory Protective Devices; Proposed Rule DEPARTMENT OF HEALTH AND HUMAN SERVICES > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A94-11879 ## Record - **Collection:** Federal Register - **Document type:** Uncategorized Document - **Published:** May 24, 1994 ## Text SUMMARY: This proposed rule addresses NIOSH's and the Department of Labor/Mine Safety and Health Administration's (MSHA) certification requirements for respiratory protective devices. Specifically, the proposal would replace existing MSHA regulations with new public health regulations, while also upgrading current testing requirements for particulate filters. This action is the first of a series of modules which will, over the next several years, upgrade current respirator requirements. This modular approach will allow improvements to be implemented on a priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. Except for the particulate- filter requirements, most requirements of existing regulations would be incorporated into the new regulations without change. The proposed testing requirements for particulate filters would significantly improve the current approach to evaluating the effectiveness of an air- purifying respirator's filter to remove toxic particulates from the ambient air, updating existing provisions to be consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under these proposed requirements would also enable respirator users to select from a broader range of certified respirators that meet the current performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis, the infectious agent that causes tuberculosis (TB). This Notice also announces an informal public meeting on the proposed rule, as indicated below. Elsewhere in this issue of the Federal Register, MSHA is publishing a proposal to remove existing regulations at 30 CFR part 11, which would be made obsolete by a final rule resulting from this proposed rule. DATES: Written comments must be received at the NIOSH Docket Office before the close of business on July 8, 1994. Interested persons wishing to provide oral comments at an informal public meeting should file a request for appearance with the NIOSH Docket Office no later than the close of business May 31, 1994. The informal public meeting will be held on June 7th and 8th, 1994, beginning both days at 9 a.m. ADDRESSES: Comments on the proposed rule should be mailed in triplicate to the NIOSH Docket Office, Robert A. Taft Laboratories, Mail Stop C34, 4676 Columbia Parkway, Cincinnati, Ohio 45226. Requests to participate in the public meeting should be mailed in duplicate to the NIOSH Docket Officer, at the same address. The informal public meeting will be held at the Holiday Inn/Capitol, 550 C St., SW., Washington, DC. FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, Chief, Certification and Quality Assurance Branch, Division of Safety Research, NIOSH, 944 Chestnut Ridge Road, Morgantown, West Virginia 26505-2888; the telephone number is (304) 284-5713. Additional copies of this proposed rule can be obtained by calling the NIOSH toll-free information number (1-800-35-NIOSH). Arrangements have also been made for this proposed rule to be listed on the electronic bulletin boards of the Government Printing Office and of the Department of Labor; the telephone numbers are (202) 512-1387 and (202) 219-4784, respectively. SUPPLEMENTARY INFORMATION: I. Paperwork Reduction Act Manufacturers seeking approval of respiratory protective devices would continue to be required to submit applications for approval, including related drawings, drawing lists, specifications, and descriptions. The paperwork burden for this application process is identical to that included in existing 30 CFR 11.10, previously approved by the Office of Management and Budget (OMB). However, those sections containing information collections are being submitted to OMB for review under section 3504(h) of the Paperwork Reduction Act of 1980. Other organizations and individuals desiring to submit comments on the information collections should direct them to the NIOSH Docket Office and to the Office of Information and Regulatory Affairs; OMB, New Exectutive Office Building (Room 3208), Washington, DC 20503, ATTN: Desk Officer for HHS/PHS/CDC/NIOSH. II. Background The existing rules and procedures in 30 CFR Part 11 for approval of respiratory-protective devices, or respirators, evolved from rules and procedures developed by the U.S. Department of the Interior, Bureau of Mines (BOM). Until 1972, the BOM was solely responsible for testing and approving respirators. In 1972, Part 11 was published jointly by the BOM and NIOSH. This regulation replaced the BOM's rules and procedures, and delineated the responsibilities of the two agencies. Under this regulation, the BOM evaluated respirator performance, and NIOSH was responsible for administration of the quality control provisions. The BOM also tested the safety of electrical components of respirators for use in potentially explosive atmospheres in underground-gassy mines (intrinsic safety) under the requirements of 30 CFR part 18. A Memorandum of Understanding, dated May 30, 1972, between the two agencies refined their respective roles, and part 11 was amended in 1973. Under this arrangement, NIOSH undertook primary responsibility for performance testing of respirators. Although all approvals continued to be issued jointly, the BOM primarily retained only the responsibility to test for intrinsic safety on the small number of respirators that had electrical components. The Mining Enforcement and Safety Administration, MSHA's predecessor agency, was created in 1974, and the responsibilities of the BOM under part 11 were transferred to that agency. Since MSHA was created in 1978, it has continued to test electrical components of respirators for intrinsic safety. MSHA has issued separate approvals for respirators meeting the requirements of 30 CFR part 18. While MSHA currently reviews applications for respirator certifications and has conducted some product evaluations, laboratory testing, quality assurance, and product audit for certain respirators, the principal testing and approval activities specified by part 11 are primarily conducted by NIOSH. NIOSH is proposing to redesignate the requirements for the certification of respiratory-protective devices of part 11 to part 84 of Title 42 (42 CFR part 84) under this action. Following promulgation of 30 CFR part 11 in 1972, NIOSH began conducting research in several areas of respiratory protection. Concurrently, NIOSH began to receive public input concerning the respirator-certification program. In December 1977, NIOSH conducted a public meeting to obtain comments on changes needed in 30 CFR part 11. In 1979, a group of outside consultants conducted a thorough review of the program. The report received from those consultants was published by NIOSH for further consideration by other interested persons, and a public meeting was held in July 1980 to obtain their comments on the program. In December 1981, the American National Standards Institute Z88 Committee on Respiratory Protection commented on 30 CFR part 11. In January 1982, the Mine Health Research Advisory Committee transmitted its recommendations to NIOSH for further changes to the program. Since 1982, NIOSH has solicited and investigated reports of problems with NIOSH/MSHA-certified respirators with the purpose of obtaining direct public input into the approval program. Investigations, research, comments, and analyses were considered by NIOSH and MSHA in preparation of a proposed comprehensive revision to the approval requirements. These changes to existing requirements and tests were proposed as a new 42 CFR part 84, which was published on August 27, 1987 (52 FR 32402). Two public meetings were held to obtain comments on the proposal (in San Francisco, CA on January 20, 1988, and in Washington, D.C. on January 27-28, 1988). Two extensions of the public comment period were issued (52 FR 37639 and 53 FR 5595), with it ending on March 28, 1988. Concurrent with the publication of the proposed part 84, MSHA published a notice in the Federal Register (52 FR 32313) proposing the withdrawal of 30 CFR part 11 upon final publication of 42 CFR part 84. Under that proposal, MSHA would have retained a consultative role in the approval of respirators used in mining in order to protect the health and safety of miners, particularly concerning mine rescue and mine emergency respirators. During the 7-month comment period following the publication of the proposed part 84, NIOSH received 271 comments on this comprehensive proposal. Since receiving these comments, NIOSH has been conducting investigations and research to consider the technical issues addressed in these comments. Delays have been experienced in finalizing a revised part 84 draft as a result of the number and diversity of the comments received. NIOSH determined that at least four major, and more than one hundred minor technical and administrative changes to the first comprehensive proposal would be required to adequately address all the areas of concern. Consequently, NIOSH has reevaluated its intent to develop and implement a single, comprehensive revision to the existing regulation of part 11. Instead, NIOSH intends to promulgate modifications to the existing requirements of 30 CFR part 11 in a series of modules. There are numerous benefits to utilizing a modular approach to promulgate the anticipated changes to the existing requirements. Among these are the following considerations: 1. Improvements can be implemented on a priority basis, assuring that those expected to contribute most to improving worker protection are implemented first, 2. Incremental promulgation of improvements should facilitate adaptation to new requirements by the respirator manufacturer and user communities, minimizing the potential for any disruption in the supply of certified respirators, and 3. Public participation in the rulemaking process will be facilitated by proposing important regulatory changes in individual segments of separate rulemaking. The anticipated subjects and sequence of the NIOSH rulemaking, according to this modular approach are: ------------------------------------------------------------------------ Anticipated Subject area timetable for proposed rule ------------------------------------------------------------------------ Particulate Filter Tests.............................. May 1994. Assigned Protection Factors........................... Late 1994. Administrative Program (application submittal and Early 1995. processing, fee structure, etc.). Quality Assurance Requirements........................ Early 1995. Gas and Vapor Requirements............................ Mid 1995. Positive Pressure SCBA Requirements................... Early 1996. Simulated Workplace Protection Factor Test............ Early 1997. ------------------------------------------------------------------------ NIOSH is proposing a limited revision to the existing requirements of 30 CFR part 11 in this first ``module'', requiring updated particulate filter tests. These proposed changes would produce significant improvements in the level of protection provided to the wearers of the respiratory protective devices and would enable users to easily discern the level of protection that can be expected when using a particular respirator, with little impact on the certification process. NIOSH estimates that these changes to the particulate filter requirements will affect approximately 80% of all respirators currently marketed. These new filter requirements would update the existing 30 CFR part 11 provisions to provide a particulate efficiency determination and classification system consistent with advances in respiratory protection technology. The tests to determine the respirator filter's particulate efficiency enable classification of the filters on their ability to inhibit the penetration of particulates of the most penetrating size. The effectiveness of a device to remove particulates from the ambient air would be reflected in a three-tiered classification system based on the filter's demonstrated efficiency. Classification of the filters in this manner eliminates the need to test and classify the filter respirator according to composition of contaminant (e.g., ``dust, fume, and mist'', ``asbestos''), since the penetration rate for particulates in the atmosphere, regardless of composition, will not exceed that of the test particulate. To revise respirator nomenclature to be consistent with this fundamental change in certification philosophy, the words ``dust, fume and mist'' have been changed to ``particulate'' in the proposed rule. NIOSH has long been concerned with the health risks to workers due to the inappropriate selection and use of dust/mist and dust/fume/mist respirators. Assigned Protection Factor (APF) values are used in the respirator selection process to indicate the expected protection level. NIOSH has considered the possibility of reducing the Assigned Protection Factor (APF) values given in the NIOSH Guide to Industrial Respiratory Protection and in the Respirator Decision Logic for dust and fume respirators to account for filter penetration that can occur, theoretically, when these respirators are inappropriately used against aerosols less than 2 micrometers in diameter. On September 15, 1992, NIOSH prepared a draft report, ``A Performance Evaluation of DM and DFM Filter Respirators Certified for Protection Against Toxic Dusts, Fumes, and Mist,'' explaining its concerns and suggested course of action. NIOSH solicited an external scientific peer review of this draft report on September 15, 1992. This review did not support an immediate revision of the APF values. The reviewers recommended that NIOSH address the concern about excessive filter penetration by incorporating improved filter-penetration tests into the respirator certification regulation. After careful consideration of this issue, NIOSH agrees with the scientific reviewers that, during the transition period for the implementation of the provisions contained in this rule, an adjustment of APF values is unnecessary and may confuse respirator users. NIOSH will continue to recommend the APF values contained in the NIOSH Guide to Industrial Respiratory Protection (September 1987) and in the Respirator Decision Logic (May 1987) for respirators previously certified under the provisions of 30 CFR part 11. For respirators certified for protection against particulate exposures under the new part 84 which would replace the existing Dust/Mist and Dust/Fume/Mist filter respirators under 30 CFR part 11, NIOSH will be recommending new APF values that account for the new nomenclature and test criteria. These new values, updating the recommendations cited above, will be published in a Respirator User's Notice accompanying publication of this rule as final. It is anticipated that the module on Assigned Protection Factors will be proposed in late 1994, at which time public comment will be solicited. The current regulation in 30 CFR part 11 was developed to certify respirators used in mining and general industry. They do not contain performance requirements for certifying air-purifying respirators against biological agents. Likewise, the modifications to the current requirements in this proposed rule were not developed specifically to certify respirators against biological agents. However, the provisions of this rule will address an important public health need regarding the control of Mycobacterium tuberculosis, the causative agent of TB, transmission in health care and other facilities. In response to the recognized risk of TB transmission in health- care facilities, increases in TB in many areas, and recent outbreaks of multidrug-resistant TB, CDC has published draft recommendations revising existing CDC guidelines for preventing the transmission of tuberculosis in health care facilities, entitled ``Guidelines for Preventing the Transmission of Tuberculosis in Health-Care Facilities, Second Edition'', published in the Federal Register on October 12, 1993 (58 FR 52810). This draft enumerates four performance criteria that CDC has determined are necessary for respiratory protective devices used in health-care settings for protection against TB. The only currently certified air-purifying respirator class that meets all the respiratory protection performance criteria in the CDC draft is a respirator with a high efficiency (HEPA) filter. However, all six classes of air- purifying, particulate respirators to be certified under the provisions of the new particulate filter tests (filter penetration) would meet or exceed the performance recommendations contained in the CDC document. These other classes of air-purifying, particulate respirators are expected to be markedly less expensive than respirators with HEPA filters. Consequently, immediate implementation of the modifications included in this rule should promote a substantial increase in respiratory protection provided to health care and other workers potentially exposed to the M. tuberculosis droplet nuclei in health- care and other occupational settings. For this reason, NIOSH is moving forward with a schedule to publish a final rule pertaining to particulate filters in late-1994. III. Public Meeting The record of the informal public meeting will remain open until July 8, 1994 to allow interested persons to submit written statements or comments regarding oral presentations made at the public meeting. The rule is proposed to be effective as follows: 1. 42 CFR part 84 will be effective 30 days from publication of this rule as final, and; 2. Sale and distribution of respirators listed as certified under the provisions of 30 CFR Part 11, subparts K or M will no longer be authorized effective 2 years from the date of publication of this rule as final. NIOSH is specifying an effective date for implementation for the final rule to allow the introduction of filters demonstrating enhanced performance as soon as possible. The existing 30 CFR part 11 is expected to remain in effect for 6 months after this rule becomes final to provide a transition period for manufacturers to prepare for new 42 CFR part 84 applications. NIOSH believes that this period provides ample transition time for manufacturers to assemble the information necessary for application for certification of particulate respirators under the new part 84. Additionally, 2 years from the date this rule becomes final, respirators can no longer be distributed or sold as NIOSH-approved under part 11, subpart K or M, unless they demonstrate compliance with and are certified under the provisions of the new part 84. This 2-year period was selected to ensure that an ample supply of respirators remain available for use. NIOSH believes that this timeframe will provide ample time for manufacturers to have respirators approved and manufactured in sufficient quantities to meet the demand. NIOSH specifically requests comments on the appropriateness of a 2-year phase-in period, as proposed. The administrative record of this rulemaking will consist of this May 24, 1994 Notice of Proposed Rulemaking; all other relevant Federal Register notices; agency records on this subject; all written submissions made in response to the Notices; and the record of the informal public meeting. The record of the informal public meeting will consist of the meeting schedule, transcripts made by NIOSH of the oral comments at the meeting, any written comments submitted by presenters at the meeting, and statements or comments regarding oral presentations made at the public meeting submitted by interested persons within the allotted comment period. No written submission, or any portion thereof, made in response to this Notice will be received or held in confidence. The administrative record of the rulemaking will be made available for viewing and copying in the NIOSH Docket Office. All requests for any portion of the administrative record must be submitted in writing. All interested persons are encouraged to submit written comments to assure receipt on or before the close of business July 8, 1994, and to advise the NIOSH Docket Office by the necessary date of their intent to participate in the informal public meeting. All requests for appearance at the informal public meeting should contain the name, address, and telephone number, any business affiliation of the person desiring to make a presentation, a brief summary of the presentation, and the approximate time requested for the presentation. NIOSH requests that oral presentations be limited to 10 minutes. Groups having similar interests are requested to combine their comments and present them through a single representative. NIOSH will assign the time available for the meeting among the persons who properly file a request for appearance. After reviewing the submitted summaries and the requests for appearance, NIOSH will schedule each appearance and notify each participant by mail or telephone of the time assigned to the person and the approximate time the person's oral presentation is scheduled to begin. The meeting schedule will be placed on file in the NIOSH Docket Office. The proceedings of the meeting will be transcribed. Any interested person may, consistent with the orderly conduct of the meeting, record or otherwise make a transcript of the meeting. Each participant may present relevant written information, data, or views for inclusion in the record of the meeting. Any person who desires to submit an advance written statement may file three copies with the NIOSH Docket Office. A participant may be accompanied by a reasonable number of additional persons, space permitting. If a participant is not present when his or her presentation is scheduled to begin, the remaining participants will be heard in order. At the conclusion of the meeting, an attempt will be made to hear any scheduled participants who missed his or her assigned time. Interested persons attending the meeting who did not request an opportunity to make an oral presentation may be given an opportunity to do so at the conclusion of the meeting, at the discretion of the presiding officer. IV. Discussion of Proposed Rule--Testing of Particulate Filters The BOM was solely responsible for testing and approving respirators until 1972. In 1972, the existing rules and procedures in 30 CFR part 11 for approval of respiratory protective devices, or respirators, were published jointly by the BOM and NIOSH. Since 1974, the Mining Enforcement and Safety Administration (MSHA's predecessor agency), MSHA, and the Occupational Safety and Health Administration (OSHA) have regulated the selection, use, and maintenance of respirators in the workplace under their enforcement authorities. With this redesignation of the requirements for the certification of respirators, NIOSH is deleting Secs. 11.2 and 11.21 because these sections of part 11 have been superseded by OSHA's and MSHA's respirator workplace regulations. Also, the codification of the redesignated sections into a non-hyphenated numbering system results in the deletion of several ``general heading'' sections that contain no substantive requirements. These include Secs. 11.85, 11.102, 11.124, 11.140, and 11.162. Existing subpart M of part 11 (Secs. 11.170 through 11.183-7) addresses the requirements for pesticide respirators. The proposal eliminates this category and the tests specific to it, leaving subpart M reserved. The proposal also eliminates all references to subpart M and pesticides as a classification for approval. Manufacturers can continue to manufacture and market respirators labelled for use as pesticide respirators, as well as other contaminant classifications, based on the testing performed under the proposed filter penetration test. NIOSH, however, would discontinue issuance of certifications that classify these respirators as suitable for use against a specific particulate. The proposed test would provide a suitable determination as to the effectiveness of the filter element in removing particulates from the ambient air, regardless of the contaminant. The existing test requirements in Secs. 11.124-21 through 11.124-24 specify a person wearing the respirator to be exposed to an abrasive blasting environment in which the blasting agent is composed of 99+ percent free silica (SiO2). The purpose of this requirement was to determine the adequacy of protection provided in such environments. Over the past two decades, NIOSH has not conducted these tests which would pose known or potential health risks of exposure to fractured crystalline silica to prospective test subjects. These tests have been replaced administratively. This policy will remain in effect until these regulatory requirements are addressed in a later module. The proposed 42 CFR part 84 regulation is generally consistent with the current MSHA and NIOSH respirator approval program, placing responsibility for certifying most respirators with NIOSH. MSHA and NIOSH would continue to jointly review and approve respirators used for mine emergencies, mine rescue, and the associated service-life plans, users' manuals, and other documentation. Among the types of devices for which this role is particularly important are self-contained self- rescue devices. This preserves MSHA's current role in the certification of certain respirators whose unique use in mining is an important part of safeguarding the health and safety of miners. In addition, MSHA would continue to test electrical and electronic components of respirators for use in potentially explosive atmospheres in underground gassy mines and issue a separate MSHA approval under 30 CFR part 18 for such respirators. In implementing the proposed regulation, NIOSH and MSHA will develop a new Memorandum of Understanding which will reflect administrative matters related to respirator approval, including immediate notification to MSHA of field complaints and identified deficiencies concerning approved respirators. With the transfer of part 11 from title 30 to part 84 of title 42, MSHA and NIOSH would no longer process applications for new approvals or extensions of approval of respirators under part 11 provisions. All applications received after the effective date of part 84 will be considered as applications for a new or extension of approval under part 84. NIOSH realizes that with this step in the development of part 84, some of the respirators that are currently approved would need to be modified to meet the new requirements, while some would not. Additionally, with each step in the modular rulemaking approach being pursued, an increasing number of respirator designs will be affected by the new regulation. NIOSH realizes that the incremental implementation of improved test and performance requirements could cause some confusion as to which respirators have demonstrated performance to the improved requirements. To address this possibility, the Institute intends to continue issuing new and extension of approval numbers in the same format designation (TC number) as issued under existing part 11 for those respirator types whose technical requirements for approval under part 84 have not been modified from existing part 11. A new approval number series will be initiated for the products whose technical requirements have been upgraded under part 84. By checking the approval number, respirator users will be able to quickly and easily distinguish those products that have demonstrated the improved performance requirements of the new part 84 from those that have demonstrated compliance with only the existing part 11 standard. The Institute further intends to issue public notices of the new approval designations to be used for the products demonstrating improved performance to alert users that such improved standards are available. Section-by-Section Discussion All sections redesignated to 42 CFR part 84 without modification from 30 CFR part 11 are not included in this discussion of the proposed rule. The sections redesignated without modification will be revised, where appropriate, to: (1) remove references to MSHA, except for those related to certain mining applications, (2) update the NIOSH certifying organization to the Certification and Quality Assurance Branch, Division of Safety Research, NIOSH, 944 Chestnut Ridge Road, Morgantown, West Virginia 26505-2888, (3) remove references to subpart M, pesticide respirators, and tests for protection during abrasive blasting, and (4) correct nonsubstantive typographical errors and reference the new part 84 section designations. The sections redesignated without modification are as follows: 84.1, 84.3, 84.11, 84.12, 84.21, 84.22, 84.30, 84.31, 84.32, 84.34, 84.35, 84.36, 84.40, 84.41, 84.42, 84.43, 84.50, 84.51, 84.53, 84.60, 84.62, 84.63, 84.64, 84.65, 84.66, 84.70, 84.71, 84.72, 84.73, 84.74, 84.75, 84.76, 84.77, 84.78, 84.79, 84.80, 84.81, 84.82, 84.83, 84.84, 84.85, 84.86, 84.87, 84.88, 84.89, 84.90, 84.91, 84.92, 84.93, 84.94, 84.95, 84.96, 84.97, 84.98, 84.99, 84.100, 84.101, 84.102, 84.103, 84.104, 84.110, 84.111, 84.112, 84.113, 84.114, 84.115, 84.116, 84.117, 84.118, 84.119, 84.120, 84.121, 84.122, 84.123, 84.124, 84.126, 84.130, 84.131, 84.132, 84.133, 84.134, 84.135, 84.136, 84.137, 84.138, 84.139, 84.140, 84.141, 84.142, 84.143, 84.144, 84.145, 84.146, 84.147, 84.148, 84.149, 84.150, 84.151, 84.152, 84.153, 84.154, 84.155, 84.156, 84.157, 84.158, 84.159, 84.160, 84.161, 84.162, 84.163, 84.172, 84.173, 84.174, 84.175, 84.176, 84.178, 84.179, 84.186, 84.190, 84.191, 84.192, 84.193, 84.194, 84.195, 84.196, 84.197, 84.198, 84.199, 84.200, 84.201, 84.202, 84.204, 84.205, 84.207, 84.250, 84.251, 84.252, 84.253, 84.254, 84.255, 84.256, 84.257, and 84.258. These sections, and revisions of these sections, will be subject to public comment in future rulemaking. The following section-by-section analysis discusses each new or revised section to 42 CFR part 84. All part and section references for part 11 are to Title 30 of the Code of Federal Regulations (30 CFR). All part and section references for part 84 are to Title 42 of the Code of Federal Regulations (42 CFR). Subpart A--General Provisions Section 84.2 Definitions This section would be redesignated and revised from the existing Sec. 11.3. The existing definitions for ``air contamination level'', ``Bureau'', ``concentration limits for radionuclides'', ``DOP'', ``MESA'', ``pesticide'', ``radionuclides'', and ``smoke'' would be deleted. These terms are used in provisions that are modified or deleted as a result of the filter penetration test changes being proposed. These definitions would, therefore, become unnecessary. The existing definition for ``Testing and Certification Laboratory'' would be modified to reflect the present name of the organization as the ``Certification and Quality Assurance Branch.'' Section 84.4 Respirators For Mine Rescue or Other Emergency Use In Mines This section would be new, and would maintain MSHA's role in the approval of respirators designed for mine rescue or other mine emergency use. Under the proposal MSHA and NIOSH would conduct joint review and certification of respirators used for mine emergencies and mine rescue. This provision recognizes MSHA's expertise in identifying the special needs and considerations for respirators used in the mining environment. This role would replace MSHA's existing role as a joint approver of all respirators. Paragraph (a) specifies that NIOSH and MSHA would jointly certify any respirator designed for mine emergencies, mine rescue or other emergency use in mines. This joint review and certification would include any associated service-life plans, user's manuals, and other supporting documentation. This paragraph further specifies that certifications for these respirators include any identified use limitations related to mine safety and health as a condition of certification. Paragraph (b) specifies NIOSH and MSHA would jointly address recall and retrofit matters arising from field complaints or identified deficiencies concerning any respirators used in the mining environment. The new Memorandum of Understanding would further delineate MSHA's role in such matters, including participation in any related field or manufacturing site audits. Subpart B--Application for Approval Section 84.10 Application Procedures This section would be redesignated from existing Sec. 11.10 with only paragraph (e) modified. Paragraph (e) would retain the existing requirement for inspection, examination, and testing by MSHA of electrical and electronic components to be permissible in accordance with 30 CFR part 18 for respirators intended for use in mining environments and having permissible electrical or electronic components. MSHA would continue to conduct this testing and issue a separate MSHA approval number for those respirators found acceptable. The process for conducting the permissibility evaluation of these components and their identification would remain unchanged from the existing policies and practices. Subpart C--Fees Section 84.20 Examination, Inspection, and Testing of Complete Respirator Assemblies; Fees This section would be redesignated from existing Sec. 11.20, and modified only to reflect the new particulate filter classification scheme. Subpart D--Approval and Disapproval Section 84.33 Approval Labels and Markings; Approval of Contents; Use This section would be redesignated from existing Sec. 11.33. Paragraph (b) would specify the use of the NIOSH emblem on the approval label, replacing the MSHA emblem. Paragraph (e) of this section would be modified to identify the existing ``dust, fume, and mist'' class of respirator as a ``particulate'' respirator. The new designation is consistent with the proposed testing criteria under which these respirators are certified. The table in paragraph (e) identifying the approval label requirements would be modified by the removal of references specific to paint spray and pesticide respirators, also consistent with the changes associated with the instantaneous penetration tests. Subpart F--Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time Section 84.52 Respiratory Hazards; Classification This section would be redesignated from existing Sec. 11.52. It would be modified only to delete paragraph (d). Reference to the pesticide ``classification'' would no longer be appropriate with the introduction of the ``particulates'' classification with the new instantaneous-penetration test. Subpart G--General Construction and Performance Requirements Section 84.61 General Construction Requirements This section would be redesignated from existing Sec. 11.61. The provision for respirator components to meet the permissibility requirements of 30 CFR part 18 [paragraph (e)] would be deleted because MSHA's workplace regulations separately and independently establish this requirement for certain mining applications. This change would be consistent with existing practice, whereby, MSHA conducts the evaluation and testing of these components and issues a separate approval to cover this aspect of respirator design. Subpart I--Gas Masks Section 84.125 Particulate Tests; Canisters Containing Particulate Filters; Minimum Requirements This section would be redesignated from existing Sec. 11.102-4, without modification except to specify the new requirements that respirators for protection against particulates (dusts, fumes, mists, and smokes) in combination with gases, vapors, or gases and vapors, must meet. With the exception of the airflow resistance test of Sec. 84.183, these respirators are required to meet the proposed requirements specified in Secs. 84.170 through 84.186. Subpart K--Particulate Respirators Section 84.170 Particulate Respirators; Description This section would be derived from existing Sec. 11.130. It would be revised to define particulate respirators in a more concise way than previously provided for those designed for protection against dusts, fumes, and mists. Paragraph (a) would describe particulate air-purifying respirators as those designed with filters to provide respiratory protection against atmospheres that: (1) Contain adequate oxygen to support life and (2) are contaminated with particulates not immediately dangerous to life or health. The particulates for which protection would be provided include contaminants such as dusts, fumes, mists and smoke. The respirator could be designed to remove contaminants, either solid or both liquid and solid, from the wearer's breathing air. Paragraph (b) would establish the classification of particulate air-purifying respirators as either powered or non-powered. Powered respirators would include those designs where a motor or other device enhances the air flow of inhalation air through the filter to provide breathing air to the wearer. Non-powered respirators would include respirators that depend solely on the inhalation and exhalation of the wearer to provide an adequate supply of purified-breathing air to the wearer. Either class of respirator, powered or non-powered, could be designed and intended for removal of solid particulates only or for both liquid and solid particulates. A ``liquid only'' category is not included because a filter that can effectively remove liquid particulates from the ambient air will also effectively remove solid particulates. Paragraphs (c) and (d) would establish the classification of filter elements used with non-powered and powered air-purifying respirators, respectively. These classifications are based on the filter's efficiency in removing particulates from the ambient air as demonstrated by the test requirements specified in this subpart. Paragraphs (c)(1) and (d)(1), (c)(2) and (d)(2), and (c)(3) would define the efficiency level for particulate removal needed to be achieved in the performance testing for a filter element to be classified as a Type A, B, or C filter, respectively. A Type A filter would be required to perform at a minimum efficiency of 99.97%, a Type B filter at a minimum efficiency of 99%, and a Type C at a minimum efficiency of 95%. Section 84.171 Particulate Respirators; Required Components This section would be redesignated from existing Sec. 11.131, modified only to incorporate the new terminology of ``particulates'' to describe dusts, fumes and mists. Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements This section would be redesignated from existing Sec. 11.137, modified only to delete reference to the existing silica dust tests for single-use respirators of Sec. 11.140-5. The respirator performance requirements of these existing tests are replaced by the particulate instantaneous filter penetration test contained in this proposal. Section 84.180 Particulate Respirators; Filter Type Identification This section proposes a new classification system for identification of the efficiency of the filters for particulate respirators. The new proposed terminology of ``particulate respirator'' would replace the existing ``dust, fume, and mist respirator'', as discussed previously. The requirement for the manufacturer to specify the filter- efficiency/particulate-type classification in the certification application would be contained in paragraph (a). This classification would include the type of particulates that the filter is designed to remove, either solid or both liquid and solid, and the expected efficiency of the filter based on the test requirements specified in Sec. 84.184. The information to be included on the label of a filter for a certified particulate respirator is specified in paragraphs (b)(1) through (b)(6). This labeling would define the efficiency level achieved in the performance testing (i.e., Type A, B, or C filter) and whether the filter would perform properly in the removal of solid only (S) or both liquid and solid (L&S) particulates. This information would be necessary to allow the user to make an informed decision on selecting the appropriate respiratory protection. To facilitate this selection process, the Type A, L&S filters are color coded magenta to allow them to be easily distinguished from the other filter types. The filters other than Type A, L&S could be of any color, except magenta. This color coding would be consistent with the present universally- accepted color-code convention which identifies the best performing filters (HEPA's) by their magenta color. Section 84.181 Isoamyl Acetate Tightness Test; Particulate Respirators With Filters Not Intended To Be Replaced This section would be redesignated from existing Sec. 11.140-1 with the test unchanged. Because the proposal would not classify respirators as designed for protection against fumes from various metals having an air contamination level not less than 0.05 milligram per cubic meter, the test would be redirected to evaluate the performance of particulate respirators with filters not intended to be replaced. Section 84.182 Isoamyl Acetate Tightness Test; Respirators With Replaceable Filters; Minimum Requirements This section would be redesignated from existing Sec. 11.140-2 with the test unchanged. Because the proposal would not classify respirators designed for protection against dusts, fumes and mists having an air contamination level less than 0.05 milligram per cubic meter, or radionuclides, the test would be redirected to evaluate the performance of particulate respirators with replaceable filters. Section 84.183 Airflow-Resistance Tests Section 84.183 would be redesignated from Sec. 11.140-9, modified to delete the final inhalation resistance requirements. The proposed instantaneous-penetration tests are not designed to simulate loading of the filter at the worksite, and represent a significant change in the testing philosophy from the existing requirements. Therefore, these requirements would not be necessary or appropriate with the introduction of these new tests. Section 84.184 Particulate Instantaneous-Penetration-Filter Test This section would be new. Section 84.184 would specify the test criteria and acceptable performance criteria for the new particulate instantaneous-penetration-filter test. Paragraph (a) would require the instantaneous-penetration efficiency testing of 30 filters of each particulate respirator model. Testing would be conducted using a solid particulate aerosol or an oil liquid particulate aerosol for solid particulate certification and both liquid and solid particulate certification, respectively. Paragraph (b) would apply to filters having separable air-purifying elements. All the respirator's air-purifying elements, including the element's holders and gaskets, are specified to be installed on the respirator as used when mounted for testing. Paragraph (c) would require the preconditioning of all air- purifying elements of the respirators prior to testing. The elements, removed from their packaging, are placed in an environment of 855 percent relative humidity at 382.5 degrees celsius (1004.5 degrees fahrenheit) for 251 hours. Following the humidity conditioning, filters are required to be sealed in a gas-tight container until tested. Paragraph (d) would apply to filters having non-separable air- purifying elements. It would require the exhalation valves to be sealed during the testing. Sealing of the valves would ensure that the test results were not affected by any valve leakage, if present. Paragraph (e) would specify the continuous test-aerosol airflow rates to be used in testing single and paired filters. Respirators with a single filter are penetration-tested at a continuous airflow rate of 85 liters (3.0 cubic feet) per minute 5 percent. For pairs, the test-aerosol airflow rate would be 42.5 liters (1.5 cubic feet) per minute 5 percent through each filter. This airflow rate is representative of a high work rate. These test conditions would ensure that a sufficient number of particulates are applied to the filter during the test period to provide an adequate indication of the efficiency of the filters. Paragraph (f) would specify the test criteria for powered air- purifying particulate respirators (PAPRs). The PAPRs are penetration tested while operating in their routine operational mode. This would require fully-charged batteries, if so equipped, or at normal line voltage, if line-powered. PAPRs with loose fitting facepieces are tested in a free-flow mode, while those with tight-fitting facepieces are tested on a headform connected to a breathing machine or equivalent breathing device. The breathing machine would have a workrate cam of 622 kp-m/min. operated at a rate of 24 respirations per minute with a minute volume of 40 liters. Paragraph (g) would describe the penetration test aerosols and the test criteria to be used. A sodium chloride solid aerosol would be used when testing for filter leakage of solid particulate aerosols. A neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol would be specified as the testing agent when testing for filter leakage of liquid particulate aerosols. The penetration test would be continued until maximum penetration is achieved or until an aerosol mass of at least 2005 mg for non-powered respirators, or at least 2,00050 mg for powered air-purifying respirators, has contacted the filter unit. Paragraph (g)(1) would identify the test conditions for the sodium chloride solid aerosol to be at 255 degrees celsius (779 degrees fahrenheit) and relative humidity of less than 30 percent. The aerosol specified to be used in these tests would be neutralized to the Boltzmann equilibrium state, and the maximum concentration would not exceed 200 mg/m\3\. Paragraph (g)(2) would specify the DOP or equivalent oil, liquid particulate aerosol. The test conditions for the liquid aerosol are specified to be at 255 degrees celsius. The aerosol specified to be used in these tests would be neutralized to the Boltzmann equilibrium state, and the maximum concentration would not exceed 200 mg/m\3\. Paragraph (h) would specify the particle size limitations at the test conditions for the filter-penetration-test aerosols. The sodium chloride aerosol would have a particle size distribution with count median diameter between 0.06 and 0.11 micrometer and a standard geometric deviation not exceeding 1.84. The liquid particulate aerosol would have a particle size distribution with count median diameter between 0.17 and 0.22 micrometer and a standard geometric deviation not exceeding 1.60. These particle size distribution values would be determined at the specified test conditions with a differential mobility particle sizer. Paragraph (i) would require the instantaneous penetration of the filter (i.e., the amount of aerosol particles that pass through the filter) to be monitored and recorded throughout the test period by a suitable forward-light-scattering photometer or equivalent instrumentation. Paragraph (j) would require the maximum filter penetration for each of the 30 filters to be determined and recorded. The mean maximum penetration, m, and the standard deviation, s, would be required to be calculated from these data. The test static U for the particulate respirator filter would be calculated as the sum of the mean maximum penetration and 2.22 multiplied by the standard deviation. The test static would be used to determine if the performance of the filter would meet the requirement for the requested classification (type). For a type A filter, the test static would be less than or equal to 0.0003; for a type B, the test static would be less than or equal to 0.01; for a type C, the test static would be less than or equal to 0.05. Section 84.185 Powered, Particulate Respirator Flow Requirements This section would be new. It would specify the minimum requirements and criteria for verification of the airflow rates of powered, particulate respirators. This section would also define the classes as loose-fitting and tight-fitting, depending on their reliance on the tightness of the face seal. The airflow of a powered air-purifying respirator would be measured after each of the penetration tests. The airflow requirements that a powered air-purifying respirator would be required to meet are specified based on its design classification as tight-fitting or loose- fitting. The minimum airflow requirements for each class are specified in paragraphs (a) and (b) of this section. A tight-fitting, powered, air-purifying respirator would be defined as designed to seal to the wearer's face and provide protection as a non-powered respirator in the event of a blower failure. A loose-fitting, powered, air-purifying respirator would be defined as designed to function without reliance on a tight-fitting face seal. Paragraph (a) would require tight-fitting, powered air-purifying respirators to maintain an air-flow rate of at least 115 liters (4.06 cubic feet) per minute for a period of at least 4 hours unless otherwise specified. Paragraph (b) would require loose-fitting, powered air-purifying respirators to maintain an air-flow rate of at least 170 liters (6.0 cubic feet) per minute for a period of at least 4 hours, unless otherwise specified. Paragraph (c) would require powered air-purifying respirators to be provided with an acceptable mechanism and appropriate instructions, whereby, the user can routinely and simply determine that the minimum airflow is maintained. Subpart L--Chemical Cartridge Respirators Section 84.203 Breathing Resistance Tests; Minimum Requirements This section would be redesignated from existing Sec. 11.162-1. It would be modified only to delete reference to various ``classifications'', such as paints and pneumoconiosis and fibrous producing dusts, that would no longer be appropriate with the introduction of the ``particulates'' classification with the new instantaneous-penetration test. Section 84.206 Particulate Tests; Respirators With Filters; Minimum Requirements; General This section would be redesignated from existing Sec. 11.162-7. It would be modified only to delete reference to various ``classifications'', such as paints and pneumoconiosis and fibrous producing dusts, that would no longer be appropriate with the introduction of the ``particulates'' classification with the new instantaneous-penetration test. Derivation Table The following derivation table lists: (1) Each section number of the proposed rule (New Section); and (2) The section number of the existing standard from which the proposed standard is derived (Old Section). Derivation Table ------------------------------------------------------------------------ New section Old section ------------------------------------------------------------------------ 84.1............................... 11.1 84.2............................... 11.3 84.3............................... 11.4 84.4............................... New. 84.10.............................. 11.10 84.11.............................. 11.11 84.12.............................. 11.12 84.20.............................. 11.20 84.21.............................. 11.21 84.22.............................. 11.22 84.30.............................. 11.30 84.31.............................. 11.31 84.32.............................. 11.32 84.33.............................. 11.33 84.34.............................. 11.34 84.35.............................. 11.35 84.36.............................. 11.36 84.40.............................. 11.40 84.41.............................. 11.41 84.42.............................. 11.42 84.43.............................. 11.43 84.50.............................. 11.50 84.51.............................. 11.51 84.52.............................. 11.52 84.53.............................. 11.53 84.60.............................. 11.60 84.61.............................. 11.61 84.62.............................. 11.62 84.63.............................. 11.63 84.64.............................. 11.64 84.65.............................. 11.65 84.66.............................. 11.66 84.70.............................. 11.70 84.71.............................. 11.71 84.72.............................. 11.72 84.73.............................. 11.73 84.74.............................. 11.74 84.75.............................. 11.75 84.76.............................. 11.76 84.77.............................. 11.77 84.78.............................. 11.78 84.79.............................. 11.79 84.80.............................. 11.79-1 84.81.............................. 11.80 84.82.............................. 11.81 84.83.............................. 11.82 84.84.............................. 11.83 84.85.............................. 11.84 84.86.............................. 11.85-1 84.87.............................. 11.85-2 84.88.............................. 11.85-3 84.89.............................. 11.85-4 84.90.............................. 11.85-5 84.91.............................. 11.85-6 84.92.............................. 11.85-7 84.93.............................. 11.85-8 84.94.............................. 11.85-9 84.95.............................. 11.85-10 84.96.............................. 11.85-11 84.97.............................. 11.85-12 84.98.............................. 11.85-13 84.99.............................. 11.85-14 84.100............................. 11.85-15 84.101............................. 11.85-16 84.102............................. 11.85-17 84.103............................. 11.85-18 84.104............................. 11.85-19 84.110............................. 11.90 84.111............................. 11.91 84.112............................. 11.92 84.113............................. 11.93 84.114............................. 11.94 84.115............................. 11.95 84.116............................. 11.96 84.117............................. 11.97 84.118............................. 11.98 84.119............................. 11.99 84.120............................. 11.100 84.121............................. 11.101 84.122............................. 11.102-1 84.123............................. 11.102-2 84.124............................. 11.102-3 84.125............................. 11.102-4 84.126............................. 11.102-5 84.130............................. 11.110 84.131............................. 11.111 84.132............................. 11.112 84.133............................. 11.113 84.134............................. 11.114 84.135............................. 11.115 84.136............................. 11.116 84.137............................. 11.117 84.138............................. 11.118 84.139............................. 11.119 84.140............................. 11.120 84.141............................. 11.121 84.142............................. 11.122 84.143............................. 11.123 84.144............................. 11.124-1 84.145............................. 11.124-2 84.146............................. 11.124-3 84.147............................. 11.124-4 84.148............................. 11.124-5 84.149............................. 11.124-6 84.150............................. 11.124-7 84.151............................. 11.124-8 84.152............................. 11.124-9 84.153............................. 11.124-10 84.154............................. 11.124-11 84.155............................. 11.124-12 84.156............................. 11.124-13 84.157............................. 11.124-14 84.158............................. 11.124-15 84.159............................. 11.124-16 84.160............................. 11.124-17 84.161............................. 11.124-18 84.162............................. 11.124-19 84.163............................. 11.124-20 84.170............................. 11.130 84.171............................. 11.131 84.172............................. 11.132 84.173............................. 11.133 84.174............................. 11.134 84.175............................. 11.135 84.176............................. 11.136 84.177............................. 11.137 84.178............................. 11.138 84.179............................. 11.139 84.180............................. New. 84.181............................. 11.140-1 84.182............................. 11.140-2 84.183............................. 11.140.9 84.184............................. New. 84.185............................. New. 84.186............................. 11.140-10 84.190............................. 11.150 84.191............................. 11.151 84.192............................. 11.152 84.193............................. 11.153 84.194............................. 11.154 84.195............................. 11.155 84.196............................. 11.156 84.197............................. 11.157 84.198............................. 11.158 84.199............................. 11.158-1 84.200............................. 11.159 84.201............................. 11.160 84.202............................. 11.161 84.203............................. 11.162-1 84.204............................. 11.162-2 84.205............................. 11.162-3 84.206............................. 11.162-7 84.207............................. 11.162-8 84.250............................. 11.200 84.251............................. 11.201 84.252............................. 11.202 84.253............................. 11.203 84.254............................. 11.204 84.255............................. 11.205 84.256............................. 11.206 84.257............................. 11.207 84.258............................. 11.208 ------------------------------------------------------------------------ Distribution Table The following distribution table lists: (1) The section number of the existing part 11 standard (Old Section); and (2) each section number of the proposed rule (New Section). Distribution Table ------------------------------------------------------------------------ Old section New section ------------------------------------------------------------------------ 11.1............................... 84.1 11.2............................... Removed. 11.2-1............................. Removed. 11.3............................... 84.2 11.4............................... 84.3 11.10.............................. 84.10 11.11.............................. 84.11 11.12.............................. 84.12 11.20.............................. 84.20 11.21.............................. 84.21 11.22.............................. 84.22 11.30.............................. 84.30 11.31.............................. 84.31 11.32.............................. 84.32 11.33.............................. 84.33 11.34.............................. 84.34 11.35.............................. 84.35 11.36.............................. 84.36 11.40.............................. 84.40 11.41.............................. 84.41 11.42.............................. 84.42 11.43.............................. 84.43 11.50.............................. 84.50 11.51.............................. 84.51 11.52.............................. 84.52 11.53.............................. 84.53 11.60.............................. 84.60 11.61.............................. 84.61 11.62.............................. 84.62 11.63.............................. 84.63 11.64.............................. 84.64 11.65.............................. 84.65 11.66.............................. 84.66 11.70.............................. 84.70 11.71.............................. 84.71 11.72.............................. 84.72 11.73.............................. 84.73 11.74.............................. 84.74 11.75.............................. 84.75 11.76.............................. 84.76 11.77.............................. 84.77 11.78.............................. 84.78 11.79.............................. 84.79 11.79-1............................ 84.80 11.80.............................. 84.81 11.81.............................. 84.82 11.82.............................. 84.83 11.83.............................. 84.84 11.84.............................. 84.85 11.85.............................. Removed. 11.85-1............................ 84.86 11.85-2............................ 84.87 11.85-3............................ 84.88 11.85-4............................ 84.89 11.85-5............................ 84.90 11.85-6............................ 84.91 11.85-7............................ 84.92 11.85-8............................ 84.93 11.85-9............................ 84.94 11.85-10........................... 84.95 11.85-11........................... 84.96 11.85-12........................... 84.97 11.85-13........................... 84.98 11.85-14........................... 84.99 11.85-15........................... 84.100 11.85-16........................... 84.101 11.85-17........................... 84.102 11.85-18........................... 84.103 11.85-19........................... 84.104 11.90.............................. 84.110 11.91.............................. 84.111 11.92.............................. 84.112 11.93.............................. 84.113 11.94.............................. 84.114 11.95.............................. 84.115 11.96.............................. 84.116 11.97.............................. 84.117 11.98.............................. 84.118 11.99.............................. 84.119 11.100............................. 84.120 11.101............................. 84.121 11.102............................. Removed. 11.102-1........................... 84.122 11.102-2........................... 84.123 11.102-3........................... 84.124 11.102-4........................... 84.125 11.102-5........................... 84.126 11.110............................. 84.130 11.111............................. 84.131 11.112............................. 84.132 11.113............................. 84.133 11.114............................. 84.134 11.115............................. 84.135 11.116............................. 84.136 11.117............................. 84.137 11.118............................. 84.138 11.119............................. 84.139 11.120............................. 84.140 11.121............................. 84.141 11.122............................. 84.142 11.123............................. 84.143 11.124............................. Removed. 11.124-1........................... 84.144 11.124-2........................... 84.145 11.124-3........................... 84.146 11.124-4........................... 84.147 11.124-5........................... 84.148 11.124-6........................... 84.149 11.124-7........................... 84.150 11.124-8........................... 84.151 11.124-9........................... 84.152 11.124-10.......................... 84.153 11.124-11.......................... 84.154 11.124-12.......................... 84.155 11.124-13.......................... 84.156 11.124-14.......................... 84.157 11.124-15.......................... 84.158 11.124-16.......................... 84.159 11.124-17.......................... 84.160 11.124-18.......................... 84.161 11.124-19.......................... 84.162 11.124-20.......................... 84.163 11.124-21.......................... Removed. 11.124-22.......................... Removed. 11.124-23.......................... Removed. 11.124-24.......................... Removed. 11.130............................. 84.170 11.131............................. 84.171 11.132............................. 84.172 11.133............................. 84.173 11.134............................. 84.174 11.135............................. 84.175 11.136............................. 84.176 11.137............................. 84.177 11.138............................. 84.178 11.139............................. 84.179 11.140............................. Removed. 11.140-1........................... 84.181 11.140-2........................... 84.182 11.140-3........................... 84.183 11.140-4........................... Removed. 11.140-5........................... Removed. 11.140-6........................... Removed. 11.140-7........................... Removed. 11.140-8........................... Removed. 11.140-9........................... 84.183 11.140-10.......................... 84.146 11.140-11.......................... Removed. 11.140-12.......................... Removed. 11.150............................. 84.190 11.151............................. 84.191 11.152............................. 84.192 11.153............................. 84.193 11.154............................. 84.194 11.155............................. 84.195 11.156............................. 84.196 11.157............................. 84.197 11.158............................. 84.198 11.158-1........................... 84.199 11.159............................. 84.200 11.160............................. 84.201 11.161............................. 84.202 11.162............................. Removed. 11.162-1........................... 84.203 11.162-2........................... 84.204 11.162-3........................... 84.205 11.162-4........................... Removed. 11.162-5........................... Removed. 11.162-6........................... Removed. 11.162-7........................... 84.206 11.162-8........................... 84.207 11.170............................. Removed. 11.171............................. Removed. 11.172............................. Removed. 11.173............................. Removed. 11.174............................. Removed. 11.175............................. Removed. 11.176............................. Removed. 11.177............................. Removed. 11.178............................. Removed. 11.179............................. Removed. 11.180............................. Removed. 11.181............................. Removed. 11.182............................. Removed. 11.183............................. Removed. 11.183-1........................... Removed. 11.183-2........................... Removed. 11.183-3........................... Removed. 11.183-4........................... Removed. 11.183-5........................... Removed. 11.183-6........................... Removed. 11.183-7........................... Removed. 11.200............................. 84.250 11.201............................. 84.251 11.202............................. 84.252 11.203............................. 84.253 11.204............................. 84.254 11.205............................. 84.255 11.206............................. 84.256 11.207............................. 84.257 11.208............................. 84.258 ------------------------------------------------------------------------ V. Executive Order 12866 and Regulatory Flexibility Act Section 1 of Executive Order 12866 requires that before the Department promulgates a new regulation, the need for the regulation must be assessed, alternatives identified and assessed, the regulations designed to achieve their objectives in the most cost-effective manner, and, to the extent feasible, use performance standards. In addition, Section 5 of the Order requires an assessment of the burden imposed by existing regulations, to identify those that have become unjustified or unnecessary as a result of changed circumstances. The Department is proposing these changes in compliance with both sections of the Executive Order. The Department generally prepares a regulatory flexibility analysis, in accordance with the Regulatory Flexibility Act, if the rule is expected to have a significant impact on a substantial number of small entities. That Act also requires that the Department periodically review existing regulations and consider reforming those that burden small entities, taking into account the degree to which technology or other factors have changed in the area affected by the rule. The Department does not believe that this proposal is ``economically significant'' within the definition of E.O. 12866 (e.g., it would not have an effect on the economy of $100 million). Nor does the Department believe that the proposal will have a significant impact on a substantial number of small firms. However, it will create costs for some firms in the respirator industry, and benefits for hospitals and other entities using respirators. The magnitude of these effects is uncertain. Accordingly, the Department has prepared the following voluntary Initial Regulatory Flexibility Analysis. Most employers rely on government standards to determine acceptable levels of respirator performance. It would be inefficient and unreasonably costly for each of millions of occasional purchasers of these inexpensive devices to independently attempt to determine which devices operate effectively to filter out minuscule particles. This proposal will remove a regulatory impediment to the improved design of respirators by substituting a performance standard for an obsolete specifications standard. The practical effect of this will be to enable firms to substitute a more effective and efficient filter material in low-cost Class B and Class C respirators (respirators already using high efficiency filters meeting Class A requirements will not be affected by this proposal). It is our understanding that substituting better filter material will have negligible effects on the costs of filters, over the long run. The material may cost very slightly more, but its cost will remain measured in pennies per filter. NIOSH specifically solicits comments and data for projected estimates of cost for materials and labor for these improved respirators. The demonstrated level of performance for filters will, however, be substantially more effective. Instead of an efficiency rate of 95 percent for removing particles sized at 1 to 2 micrometers in diameter, they will demonstrate the ability to remove particles of less than 1 micrometer in diameter at a typical efficiency rate of 95 to 99.97 percent. The importance of this change will vary considerably from workplace setting to setting. However, in at least some settings the benefits will be considerable. For example, the classes of particulate filter respirators certified under this rule will meet or exceed the CDC recommendations for respiratory protective devices used for M. tuberculosis. Of the currently NIOSH-certified respirators, only high-efficiency particulate air (HEPA) filters meet or exceed these recommendations. The certification to an enhanced performance level will create options for the choice of respirators that adhere to CDC recommendations at reduced expense. A disposable (one-time use) HEPA filter respirator generally sells for around $7 to $10 and replaceable respirators equipped with HEPA filters can cost $20 or more, with replacement filters costing about $5 each. Replacement non-HEPA filters cost about $1 to $2 each. Disposable non-HEPA filters cost about $1 to $8 each when purchased in bulk. The Department would expect similar effects--both improved health and cost avoidance--in many other settings. The Department does not have any basis at this time for quantifying either benefits or costs. The Department does know that as many as seven million workers use respirators at some time each year. NIOSH estimates that employers annually purchase over 110 million disposable respirators. The Department requests comments on potential savings in other settings. There are approximately 35 manufacturers of these devices. NIOSH believes that most of these already possess or have access to test equipment needed to perform the new filter tests the Department proposes to require. As is currently required under 30 CFR part 11, NIOSH would continue to require that applicants conduct or have conducted examinations, inspections, and tests of respirator performance at least equivalent to those set by the respirator certification tests. This is to assure that all necessary research and development is conducted by the applicant prior to submitting an application to the Federal Government for testing of the respirator by NIOSH. For those manufacturers that do not currently possess this capability, NIOSH estimates that the purchase of this equipment represents an investment of approximately $60,000. Amortized over time, this would not represent a significant cost for most manufacturers. Filter materials are currently available that can be substituted into present filter designs with minimal redesign (if any) to meet the performance requirements of the new tests. Some currently NIOSH- certified respirators have, when tested using the new standards, demonstrated acceptable performance. Therefore, little or no cost will be needed to develop suitable filtration materials or redesign existing devices. However, the Department does realize that additional development and redesign costs may be incurred to augment the presently available products. NIOSH specifically requests relevant data and comments on projected costs of redesign of respirators. Notwithstanding these general conclusions, there may be some manufacturers that will find it financially difficult, or a poor investment, to meet the new standards. The Department would expect such problems to result from free market competition rather than the specific standards of these proposed regulations. That is, most knowledgeable employers would purchase more cost-effective respirators voluntarily and force major changes in the market if the present regulatory barriers were removed. Nonetheless, there may be regulatory alternatives that would minimize burdens on the smallest firms and the Department welcomes suggestions for these. List of Subjects in 42 CFR Part 84 Labeling, Mine safety and health, Occupational safety and health, Personal protective equipment, Reporting and recordkeeping requirements, Respirators. Dated: February 14, 1994. Philip R. Lee, Assistant Secretary for Health. Approved: March 8, 1994. Donna E. Shalala, Secretary. For the reasons set out in the preamble, 42 CFR part 84 is proposed to be added to read as follows: PART 84--APPROVAL OF RESPIRATORY PROTECTIVE DEVICES Subpart A--General Provisions Sec. 84.1 Purpose. 84.2 Definitions. 84.3 Incorporation by reference. 84.4 Respirators for mine rescue or other emergency use in mines. Subpart B--Application for Approval 84.10 Application procedures. 84.11 Contents of application. 84.12 Delivery of respirators and components by applicant; requirements. Subpart C--Fees 84.20 Examination, inspection, and testing of complete respirator assemblies; fees. 84.21 Examination, inspection, and testing of respirator components or subassemblies; fees. 84.22 Unlisted fees; additional fees; payment by applicant prior to approval. Subpart D--Approval and Disapproval 84.30 Certificates of approval; scope of approval. 84.31 Certificates of approval; contents. 84.32 Notice of disapproval. 84.33 Approval labels and markings; approval of contents; use. 84.34 Revocation of certificates of approval. 84.35 Changes or modifications of approved respirators; issuance of modification of certificate of approval. 84.36 Delivery of changed or modified approved respirator. Subpart E--Quality Control 84.40 Quality control plans; filing requirements. 84.41 Quality control plans; contents. 84.42 Proposed quality control plans; approval by the Institute. 84.43 Quality control records; review by the Institute; revocation of approval. Subpart F--Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time 84.50 Types of respirators to be approved; scope of approval. 84.51 Entry and escape, or escape only; classification. 84.52 Respiratory hazards; classification. 84.53 Service time; classification. Subpart G--General Construction and Performance Requirements 84.60 Construction and performance requirements; general. 84.61 General construction requirements. 84.62 Component parts; minimum requirements. 84.63 Test requirements; general. 84.64 Pretesting by applicant; approval of test methods. 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; public demonstrations. 84.66 Withdrawal of applications; refund of fees. Subpart H--Self-Contained Breathing Apparatus 84.70 Self-contained breathing apparatus; description. 84.71 Self-contained breathing apparatus; required components. 84.72 Breathing tubes; minimum requirements. 84.73 Harnesses; installation and construction; minimum requirements. 84.74 Apparatus containers; minimum requirements. 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum requirements. 84.76 Facepieces; eyepieces; minimum requirements. 84.77 Inhalation and exhalation valves; minimum requirements. 84.78 Head harnesses; minimum requirements. 84.79 Breathing gas; minimum requirements. 84.80 Interchangeability of oxygen and air prohibited. 84.81 Compressed breathing gas and liquefied breathing gas containers; minimum requirements. 84.82 Gas pressure gages; minimum requirements. 84.83 Timers; elapsed time indicators; remaining service life indicators; minimum requirements. 84.84 Hand-operated valves; minimum requirements. 84.85 Breathing bags; minimum requirements. 84.86 Component parts exposed to oxygen pressures; minimum requirements. 84.87 Compressed gas filters; minimum requirements. 84.88 Breathing-bag test. 84.89 Weight requirement. 84.90 Breathing resistance test; inhalation. 84.91 Breathing resistance test; exhalation. 84.92 Exhalation valve leakage test. 84.93 Gas flow test; open circuit apparatus. 84.94 Gas flow test; closed circuit apparatus. 84.95 Service-time test; open circuit apparatus. 84.96 Service-time test; closed circuit apparatus. 84.97 Test for carbon dioxide in inspired gas; open- and closed- circuit apparatus; maximum allowable limits. 84.98 Tests during low temperature operation. 84.99 Man tests; testing conditions; general requirements. 84.100 Man tests 1, 2, 3, and 4; requirements. 84.101 Man test 5; requirements. 84.102 Man test 6; requirements. 84.103 Man tests; performance requirements. 84.104 Gas tightness test; minimum requirements. Tables to Sub-Part H of Part 84 Subpart I--Gas Masks 84.110 Gas masks; description. 84.111 Gas masks; required components. 84.112 Canisters and cartridges in parallel; resistance requirements. 84.113 Canisters and cartridges; color and markings; requirements. 84.114 Filters used with canisters and cartridges; location; replacement. 84.115 Breathing tubes; minimum requirements. 84.116 Harnesses; installation and construction; minimum requirements. 84.117 Gas mask containers; minimum requirements. 84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit; minimum requirements. 84.119 Facepieces; eyepieces; minimum requirements. 84.120 Inhalation and exhalation valves; minimum requirements. 84.121 Head harnesses; minimum requirements. 84.122 Breathing resistance test; minimum requirements. 84.123 Exhalation valve leakage test. 84.124 Facepiece tests; minimum requirements. 84.125 Particulate tests; canisters containing particulate filters; minimum requirements. 84.126 Canister bench tests; minimum requirements. Tables to Subpart I of Part 84 Subpart J--Supplied-Air Respirators 84.130 Supplied-air respirators; description. 84.131 Supplied-air respirators; required components. 84.132 Breathing tubes; minimum requirements. 84.133 Harnesses; installation and construction; minimum requirements. 84.134 Respirator containers; minimum requirements. 84.135 Half-mask facepieces, full facepieces, hoods, and helmets; fit; minimum requirements. 84.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements. 84.137 Inhalation and exhalation valves; check valves; minimum requirements. 84.138 Head harnesses; minimum requirements. 84.139 Head and neck protection; supplied-air respirators; minimum requirements. 84.140 Air velocity and noise levels; hoods and helmets; minimum requirements. 84.141 Breathing gas; minimum requirements. 84.142 Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators; minimum requirements. 84.143 Terminal fittings or chambers; Type B supplied-air respirators; minimum requirements. 84.144 Hand-operated blower test; minimum requirements. 84.145 Motor-operated blower test; minimum requirements. 84.146 Method of measuring the power and torque required to operate blowers. 84.147 Type B supplied-air respirator; minimum requirements. 84.148 Type C supplied-air respirator, continuous-flow class; minimum requirements. 84.149 Type C supplied-air respirator, demand and pressure demand class; minimum requirements. 84.150 Air-supply line tests; minimum requirements. 84.151 Harness test; minimum requirements. 84.152 Breathing tube test; minimum requirements. 84.153 Airflow resistance test, Type A and Type AE supplied-air respirators; minimum requirements. 84.154 Airflow resistance test; Type B and Type BE supplied-air respirators; minimum requirements. 84.155 Airflow resistance test; Type C supplied-air respirator, continuous flow class and Type CE supplied-air respirator; minimum requirements. 84.156 Airflow resistance test; Type C supplied-air respirator, demand class; minimum requirements. 84.157 Airflow resistance test; Type C supplied-air respirator, pressure-demand class; minimum requirements. 84.158 Exhalation valve leakage test. 84.159 Man tests for gases and vapors; supplied-air respirators; general performance requirements. 84.160 Man tests for gases and vapors; Type A and Type AE respirators; test requirements. 84.161 Man tests for gases and vapors; Type B and Type BE respirators; test requirements. 84.162 Man test for gases and vapors; Type C respirators, continuous-flow class and Type CE supplied-air respirators; test requirements. 84.163 Man test for gases and vapors; Type C supplied-air respirators, demand and pressure-demand classes; test requirements. Tables to Subpart J of Part 84 Subpart K--Particulate Respirators 84.170 Particulate respirators; description. 84.171 Particulate respirators; required components. 84.172 Breathing tubes; minimum requirements. 84.173 Harnesses; installation and construction; minimum requirements. 84.174 Respirator containers; minimum requirements. 84.175 Half-mask facepieces, full facepieces, hoods, helmets, and mouthpieces; fit; minimum requirements. 84.176 Facepieces, hoods, and helmets; eyepieces; minimum requirements. 84.177 Inhalation and exhalation valves; minimum requirements. 84.178 Head harnesses; minimum requirements. 84.179 Air velocity and noise levels; hoods and helmets; minimum requirements. 84.180 Particulate respirators; filter type identification. 84.181 Isoamyl acetate tightness test; particulate respirators with filters not intended to be replaced. 84.182 Isoamyl acetate tightness test; respirators with replaceable filters; minimum requirements. 84.183 Airflow resistance tests. 84.184 Particulate instantaneous-penetration-filter test. 84.185 Powered, particulate respirator flow requirements. 84.186 Exhalation valve leakage test; minimum requirements. Subpart L--Chemical Cartridge Respirators 84.190 Chemical cartridge respirators; description. 84.191 Chemical cartridge respirators; required components. 84.192 Cartridges in parallel; resistance requirements. 84.193 Cartridges; color and markings; requirements. 84.194 Filters used with chemical cartridges; location; replacement. 84.195 Breathing tubes; minimum requirements. 84.196 Harnesses; installation and construction; minimum requirements. 84.197 Respirator containers; minimum requirements. 84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods, and helmets; fit; minimum requirements. 84.199 Facepieces, hoods, and helmets; eyepieces; minimum requirements. 84.200 Inhalation and exhalation valves; minimum requirements. 84.201 Head harnesses; minimum requirements. 84.202 Air velocity and noise levels; hoods and helmets; minimum requirements. 84.203 Breathing resistance test; minimum requirements. 84.204 Exhalation valve leakage test; minimum requirements. 84.205 Facepiece test; minimum requirements. 84.206 Particulate tests; respirators with filters; minimum requirements; general. 84.207 Bench tests; gas and vapor tests; minimum requirements; general. Tables to Subpart L of Part 84 Subpart M--[Reserved] Subpart N--Special Use Respirators 84.250 Vinyl chloride respirators; description. 84.251 Required components. 84.252 Gas masks; requirements and tests. 84.253 Chemical-cartridge respirators; requirements and tests. 84.254 Powered air-purifying respirators; requirements and tests. 84.255 Requirements for end-of-service-life indicator. 84.256 Quality control requirements. 84.257 Labeling requirements. 84.258 Fees. Authority: 29 U.S.C. 577a, 651 et seq., and 657(g); 30 U.S.C. 3, 5, 7, 811, 842(h), 844. Subpart A--General Provisions Sec. 84.1 Purpose. The purpose of the regulations contained in this part 84 is: (a) To establish procedures and prescribe requirements which must be met in filing applications for approval by the National Institute for Occupational Safety and Health of respirators or changes or modifications of approved respirators; (b) To establish a schedule of fees to be charged each applicant for the inspections, examinations, and testing conducted by the Institute under the provisions of this part; (c) To provide for the issuance of certificates of approval or modifications of certificates of approval for respirators which have met the applicable construction, performance, and respiratory protection requirements set forth in this part; and (d) To specify minimum requirements and to prescribe methods to be employed by the Institute and by the applicant in conducting inspections, examinations, and tests to determine the effectiveness of respirators used during entry into or escape from hazardous atmospheres. Sec. 84.2 Definitions. As used in this part-- (a) Applicant means an individual, partnership, company, corporation, association, or other organization that designs, manufactures, assembles, or controls the assembly of a respirator and who seeks to obtain a certificate of approval for such respirator. (b) Approval means a certificate or formal document issued by the Institute stating that an individual respirator or combination of respirators has met the minimum requirements of this part 84, and that the applicant is authorized to use and attach an approval label to any respirator, respirator container, or instruction card for any respirator manufactured or assembled in conformance with the plans and specifications upon which the approval was based, as evidence of such approval. (c) Approved means conforming to the minimum requirements of this part 84. (d) Auxiliary equipment means a self-contained breathing apparatus, the use of which is limited in underground mine rescue and recovery operations to situations where the wearer has ready access to fresh air and at least one crew equipped with approved self-contained breathing apparatus of 2 hours or longer rating, is in reserve at a fresh-air base. (e) Certification and Quality Assurance Branch means the Certification and Quality Assurance Branch, Division of Safety Research, Appalachian Laboratory for Occupational Safety and Health, National Institute for Occupational Safety and Health, 944 Chestnut Ridge Road, Morgantown, West Virginia 26505-2888. (f) Compressed-breathing gas means oxygen or air stored in a compressed state and supplied to the wearer in gaseous form. (g) dBA means sound pressure levels in decibels, as measured with the A-weighted network of a standard sound level meter using slow response. (h) Dust means a solid mechanically produced particle with a size ranging from submicroscopic to macroscopic. (i) Respirators for entry into and escape from means respiratory devices providing protection during entry into and escape from hazardous atmospheres. (j) Respirators for escape only means respiratory devices providing protection only during escape from hazardous atmospheres. (k) A facepiece or mouthpiece is a respirator component designed to provide a gas-tight or dust-tight fit with the face and may include headbands, valves, and connections for canisters, cartridges, filters, or respirable gas source. (l) Final inspection means that activity carried out on a product after all manufacturing and assembly operations are completed to insure completeness and adherence to performance or other specifications, including satisfactory appearance. (m) Fume means a solid condensation particle, generally less than 1 micrometer in diameter. (n) Gas means an aeriform fluid which is in a gaseous state at ordinary temperature and pressure. (o) Hazardous atmosphere means: (1) Any atmosphere containing a toxic or disease producing gas, vapor, dust, fume, mist, or pesticide, either immediately or not immediately dangerous to life or health; or (2) Any oxygen-deficient atmosphere. (p) A hood or helmet is a respirator component which covers the wearer's head and neck, or head, neck, and shoulders, and is supplied with incoming respirable air for the wearer to breathe. It may include a headharness and connection for a breathing tube. (q) Immediately dangerous to life or health means conditions that pose an immediate threat to life or health or conditions that pose an immediate threat of severe exposure to contaminants, such as radioactive materials, which are likely to have adverse cumulative or delayed effects on health. (r) Incoming inspection means the activity of receiving, examining, and accepting only those materials and parts whose quality conforms to specification requirements. (s) In-process inspection means the control of products at the source of production and at each step of the manufacturing process, so that departures from specifications can be corrected before defective components or materials are assembled into the finished product. (t) Institute means the National Institute for Occupational Safety and Health, Department of Health and Human Services. (u) Liquefied-breathing gas means oxygen or air stored in liquid form and supplied to the wearer in a gaseous form. (v) Mist means a liquid condensation particle with a size ranging from submicroscopic to macroscopic. (w) MSHA means the Mine Safety and Health Administration, U.S. Department of Labor. (x) Not immediately dangerous to life or health means any hazardous atmosphere which may produce physical discomfort immediately, chronic poisoning after repeated exposure, or acute adverse physiological symptoms after prolonged exposure. (y) Oxygen-deficient atmosphere means an atmosphere which contains an oxygen partial pressure of less than 148 millimeters of mercury (19.5 percent by volume at sea level). (z) Powered air-purifying respirator means a device equipped with a facepiece, hood, or helmet, breathing tube, canister, cartridge, filter, canister with filter, or cartridge with filter, and a blower. (aa) Respirator means any device designed to provide the wearer with respiratory protection against inhalation of a hazardous atmosphere. (bb) Single-use respirator means a respirator that is entirely discarded after excessive resistance, sorbent exhaustion, or physical damage renders it unsuitable for further use. (cc) Vapor means the gaseous state of a substance that is solid or liquid at ordinary temperature and pressure. Sec. 84.3 Incorporation by reference. Note: The technical publications referenced in this part 84, which have been prepared by organizations other than the Institute, were approved for incorporation by reference in 30 CFR part 11. The Institute will be submitting these publications for approval of the incorporation by reference by the Director of the Office of the Federal Register under this part 84 prior to the publication of a final rule. Sec. 84.4 Respirators for mine rescue or other emergency use in mines. (a) (1) NIOSH and the Mine Safety and Health Administration (MSHA), U.S. Department of Labor, shall jointly review and issue certifications for respirators used for mine emergencies and mine rescue, including any associated service-life plans, users' manuals and other supporting documentation. (2) Each certification for a respirator designed for mine rescue or other emergency use in mines shall include, as a condition of approval, any use limitations related to mine safety and health. (b) NIOSH and MSHA shall jointly determine appropriate recall and retrofit remedies for field complaints or identified deficiencies involving any respirators used in the mining environment. Subpart B--Application for Approval Sec. 84.10 Application procedures. (a) Inspection, examination, and testing leading to the approval of the types of respirators classified in subpart F of this part shall be undertaken by the Institute only pursuant to written applications which meet the minimum requirements set forth in this subpart B. (b) Applications shall be submitted to the Certification and Quality Assurance Branch, and shall be accompanied by a check, bank draft, or money order in the amount specified in subpart C of this part, payable to the order of the National Institute for Occupational Safety and Health. (c) Except as provided in Sec. 84.64, the examination, inspection, and testing of all respirators shall be conducted by the Certification and Quality Assurance Branch. (d) Applicants, manufacturers, or their representatives may visit or communicate with the Certification and Quality Assurance Branch in order to discuss the requirements for approval of any respirator or the proposed designs thereof. No charge shall be made for such consultation and no written report shall be issued to applicants, manufacturers, or their representatives by the Institute as a result of such consultation. (e) Respirators having electrical or electronic components that are required to be permissible under chapter I of title 30 shall be tested in accordance with 30 CFR part 18. Applications for approval of such respirators by MSHA shall be submitted in writing to: MSHA, Approval and Certification Center, Box 251, Industrial Park Road, Triadelphia, West Virginia 26059. Sec. 84.11 Contents of application. (a) Each application for approval shall contain a complete written description of the respirator for which approval is requested together with drawings and specifications (and lists thereof) showing full details of construction of the respirator and of the materials used. (b) Drawings shall be titled, numbered, and dated; any revision dates shall be shown on the drawings, and the purpose of each revision being sought shall be shown on the drawing or described on an attachment to the drawing to which it applies. (c) Each application for approval shall contain a proposed plan for quality control which meets the minimum requirements set forth in subpart E of this part. (d) Each application shall contain a statement that the respirator has been pretested by the applicant as prescribed in Sec. 84.64, and shall include the results of such tests. (e) Each application for approval shall contain a statement that the respirator and component parts submitted for approval are either prototypes, or made on regular production tooling, with no operation included which will not be incorporated in regular production processing. Sec. 84.12 Delivery of respirators and components by applicant; requirements. (a) Each applicant shall, when an application is filed pursuant to Sec. 84.10, be advised by the Institute of the total number of respirators and component parts required for testing. (b) The applicant shall deliver, at his own expense, the number of completely assembled respirators and component parts required for testing, to the Certification and Quality Assurance Branch. (c) Respirators and component parts submitted for approval must be made from materials specified in the application. (d) One completely assembled respirator approved under the provisions of this part may be retained by the Institute as a laboratory exhibit, the remaining respirators may be returned to the applicant at his own expense, upon written request within 30 days after notice of approval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate. (e) Where a respirator fails to meet the requirements for approval set forth in this part, all respirators and components delivered in accordance with this section may be returned to the applicant at his own expense, upon written request within 30 days after notice of disapproval. If no such request is made, the respirators will be disposed of by the Institute in such manner as it deems appropriate. Subpart C--Fees Sec. 84.20 Examination, inspection, and testing of complete respirator assemblies; fees. Except as provided in Sec. 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of complete respirator assemblies: Self-contained breathing apparatus: Entry and escape, 1 hour or more............................ $3,500 Entry and escape, less than 1 hour.......................... 2,750 Escape only................................................. 2,000 Gas masks: Single hazard............................................... 1,100 Type N...................................................... 4,100 Supplied-air respirators...................................... 750 Particulate respirators: All Types................................................... 1,250 Chemical cartridge respirators................................ 1,150 Sec. 84.21 Examination, inspection, and testing of respirator components or subassemblies; fees. Except as provided in Sec. 84.22, the following fees shall be charged by the Institute for the examination, inspection and testing of the individual respirator components or subassemblies: Facepieces...................................................... $450 Canisters....................................................... 900 Cartridges...................................................... 600 Filters......................................................... 650 Hoses........................................................... 250 Blowers......................................................... 250 Harnesses....................................................... 100 Sec. 84.22 Unlisted fees; additional fees; payment by applicant prior to approval. (a) Applications for the examination, inspection and testing of complete respirator assemblies which are not listed in Sec. 84.20, or for the examination, inspection, and testing of respirator components or subassemblies which are not listed in Sec. 84.21, shall be accompanied by the following deposits: Complete respirator assembly.................................. $1,500 Each individual component or subassembly...................... 500 (b) The Institute reserves the right to conduct any examination, inspection, or test it deems necessary to determine the quality and effectiveness of any listed or unlisted respirator assembly or respirator component or subassembly, and to assess the cost of such examinations, inspections, or tests against the applicant prior to the issuance of any approval for such assembly, component, or subassembly. (c) The fees charged for the examination, inspection, and testing of unlisted respirator assemblies, unlisted individual respirator components or subassemblies, and for the additional examination, inspection, and testing of listed respirator assemblies and components or subassemblies shall be at the rate of $100 per day for each man-day required to be expended by the Institute. (d) Upon completion of all examinations, inspections, and tests of unlisted respirator assemblies or components, or following the completion of any additional examination, inspections, or tests of listed assemblies, or components or subassemblies, including retesting subsequent to disapproval, the Institute shall advise the applicant in writing of the total cost assessed and the additional amount, if any, which must be paid to the Institute as a condition of approval. (e) In the event the amount assessed by the Institute for unlisted assemblies, or components or subassemblies is less than the amount of the deposit submitted in accordance with paragraph (a) of this section, the Institute shall refund the overpayment upon the issuance of any approval or notice of disapproval. Subpart D--Approval and Disapproval Sec. 84.30 Certificates of approval; scope of approval. (a) The Institute shall issue certificates of approval pursuant to the provisions of this subpart only for individual, completely assembled respirators which have been examined, inspected, and tested, and which meet the minimum requirements set forth in subparts H through L of this part, as applicable. (b) The Institute will not issue certificates of approval for any respirator component or for any respirator subassembly. (c) The Institute shall not issue an informal notification of approval. However, if the application for approval, submitted in accordance with Sec. 84.11, states that the submitted respirator and component parts are only prototypes, the Institute will examine, inspect, and test such respirator and component parts in accordance with the provisions of this part 84. If, upon completion of such examinations, inspections and tests, it is found that the prototype meets the minimum requirements set forth in this part, the Institute may inform the applicant, in writing, of the results of the examinations, inspections, and tests, and may require him to resubmit respirators and component parts made on regular production tooling, with no operations included which will not be incorporated in regular production processing, for further examination, inspection, and testing, prior to issuance of the certificate of approval. (d) Applicants required to resubmit respirators and component parts made on regular production tooling, with no operation included which will not be incorporated in regular production processing, shall be charged fees in accordance with subpart C of this part. Sec. 84.31 Certificates of approval; contents. (a) The certificate of approval shall contain a classification and a description of the respirator or combination of respirators for which it is issued, as provided in this part. (b) The certificate of approval shall specifically set forth any restrictions or limitations on the respirator's use in hazardous atmospheres. (c) Each certificate of approval shall be accompanied by the drawings and specifications (and lists thereof) submitted by the applicant in accordance with Sec. 84.11. These drawings and specifications shall be referenced in the certificate of approval, and shall be maintained by the applicant. The drawings and specifications listed in each certificate of approval shall set forth in detail the design and construction requirements which shall be met by the applicant during commercial production of the respirator. (d) Each certificate of approval shall be accompanied by a reproduction of the approval label design to be employed by the applicant with each approved respirator, as provided in Sec. 84.33. (e) No test data or specific laboratory findings will accompany any certificate of approval, however, the Institute will release pertinent test data and specific findings upon written request by the applicant, or as required by statute or regulation. (f) Each certificate of approval shall also contain the approved quality control plan as specified in Sec. 84.42. Sec. 84.32 Notice of disapproval. (a) If, upon the completion of the examinations, inspections, and tests required to be conducted in accordance with the provisions of this part, it is found that the respirator does not meet the minimum requirements set forth in this part, the Institute shall issue a written notice of disapproval to the applicant. (b) Each notice of disapproval shall be accompanied by all pertinent data or findings with respect to the defects of the respirator for which approval was sought with a view to the possible correction of any such defects. (c) The Institute shall not disclose, except to the applicant or as required by statute or regulation, any data, findings, or other information with respect to any respirator for which a notice of disapproval is issued. Sec. 84.33 Approval labels and markings; approval of contents; use. (a) Full-scale reproductions of approval labels and markings, and a sketch or description of the method of application and position on the harness, container, canister, cartridge, filter, or other component, together with instructions for the use and maintenance of the respirator shall be submitted to the Institute for approval. (b) Approval labels shall bear the emblem of the National Institute for Occupational Safety and Health and the seal of the Department of Health and Human Services, the applicant's name and address, an approval number assigned by the Institute and, where appropriate, restrictions or limitations placed upon the use of the respirator by the Institute. The approval number assigned by the Institute shall be designated by the prefix TC and a serial number. (c) The Institute shall, where necessary, notify the applicant when additional labels, markings, or instructions will be required. (d) Approval labels and markings shall only be used by the applicant to whom they were issued. (e) Legible reproductions or abbreviated forms of the label approved by the Institute for use on each respirator shall be attached to or printed at the following locations: ------------------------------------------------------------------------ Respirator type Label type Location ------------------------------------------------------------------------ Self-contained Entire.................... Harness assembly and breathing apparatus. canister (where applicable). Gas mask............. Entire.................... Mask container and canister. Supplied air ......do.................. Respirator container respirator. or instruction card. Particulate ......do.................. Respirator container respirator. and filter container. Abbreviated............... Filters. Chemical-cartridge Entire.................... Respirator container, respirator. cartridge container, and filter containers (where applicable). Abbreviated............... Cartridges and filters and filter containers. ------------------------------------------------------------------------ (f) The use of any Institute approval label obligates the applicant to whom it is issued to maintain or cause to be maintained the approved quality control sampling schedule and the acceptable quality level for each characteristic tested, and to assure that it is manufactured according to the drawings and specifications upon which the certificate of approval is based. (g) Each respirator, respirator component, and respirator container shall, as required by the Institute to assure quality control and proper use of the respirator, be labeled distinctly to show the name of the applicant, and the name and letters or numbers by which the respirator or respirator component is designated for trade purposes, and the lot number, serial number, or approximate date of manufacture. Sec. 84.34 Revocation of certificates of approval. The Institute reserves the right to revoke, for cause, any certificate of approval issued pursuant to the provisions of this part. Such causes include, but are not limited to, misuse of approval labels and markings, misleading advertising, and failure to maintain or cause to be maintained the quality control requirements of the certificate of approval. Sec. 84.35 Changes or modification of approved respirators; issuance of modification of certificate of approval. (a) Each applicant may, if he desires to change any feature of an approved respirator, request a modification of the original certificate of approval issued by the Institute for such respirator by filing an application for such modification in accordance with the provisions of this section. (b) Applications shall be submitted as for an original certificate of approval, with a request for a modification of the existing certificate to cover any proposed change. (c) The application shall be accompanied by appropriate drawings and specifications, and by a proposed quality control plan which meets the requirements of subpart E of this part. (d) The application for modification together with the accompanying material, shall be examined by the Institute to determine whether testing will be required. (e) The Institute shall inform the applicant of the fee required for any additional testing and the applicant will be charged for the actual cost of any examination, inspection, or test required, and such fees shall be submitted in accordance with the provisions of subpart C of this part. (f) If the proposed change or modification meets the requirements of this part, a formal certificate of modification will be issued, accompanied, where necessary, by a list of new and revised drawings and specifications covering the change(s) and reproductions of revised approval labels. Sec. 84.36 Delivery of changed or modified approved respirator. An approved respirator for which a formal certificate of modification has been issued shall be delivered, with proper markings and containers, by the applicant to the Certification and Quality Assurance Branch, as soon as it is commercially produced. Subpart E--Quality Control Sec. 84.40 Quality control plans; filing requirements. As a part of each application for approval or modification of approval submitted pursuant to this part, each applicant shall file with the Institute a proposed quality control plan which shall be designed to assure the quality of respiratory protection provided by the respirator for which approval is sought. Sec. 84.41 Quality control plans; contents. (a) Each quality control plan shall contain provisions for the management of quality, including: (1) Requirements for the production of quality data and the use of quality control records; (2) Control of engineering drawings, documentations, and changes; (3) Control and calibration of measuring and test equipment; (4) Control of purchased material to include incoming inspection; (5) Lot identification, control of processes, manufacturing, fabrication, and assembly work conducted in the applicant's plant; (6) Audit of final inspection of the completed product; and, (7) The organizational structure necessary to carry out these provisions. (b) Each provision for incoming and final inspection in the quality control plan shall include a procedure for the selection of a sample of respirators and the components thereof for testing, in accordance with procedures set forth in Military Standard MIL-STD-105D, ``Sampling Procedures and Tables for Inspection by Attributes,'' or Military Standard MIL-STD-414, ``Sampling Procedures and Tables for Inspection by Variables for Percent Defective,'' or an approved equivalent sampling procedure, or an approved combination of sampling procedures. Incoming bulk raw material inspection or verification of specification, and in-process inspection shall be sufficient to ensure control of product quality through the manufacturing cycle. (c) The sampling procedure shall include a list of the characteristics to be tested by the applicant or his agent. (d) The characteristics listed in accordance with paragraph (c) of this section shall be classified according to the potential effect of such defect and grouped into the following classes: (1) Critical. A defect that judgment and experience indicate is likely to result in a condition immediately hazardous to life or health for individuals using or depending upon the respirator; (2) Major A. A defect, other than critical, that is likely to result in failure to the degree that the respirator does not provide any respiratory protection, or a defect that reduces protection and is not detectable by the user; (3) Major B. A defect, other than Major A or critical, that is likely to result in reduced respiratory protection, and is detectable by the user; and (4) Minor. A defect that is not likely to materially reduce the usability of the respirator for its intended purpose, or a defect that is a departure from established standards and has little bearing on the effective use or operation of the respirator. (e) The quality control inspection test method to be used by the applicant or his agent for each characteristic required to be tested shall be described in detail. (f) Each item manufactured shall be 100 percent inspected for defects in all critical characteristics and all defective items shall be rejected. (g) The Acceptable Quality Level (AQL) for each major or minor defect so classified by the applicant shall be: (1) Major A. 1.0 percent; (2) Major B. 2.5 percent; and (3) Minor. 4.0 percent. (h) Except as provided in paragraph (i) of this section, inspection level II as described in MIL-STD-105D, or inspection level IV as described in MIL-STD-414, shall be used for major and minor characteristics and 100 percent inspection for critical characteristics. (i) Subject to the approval of the Institute, where the quality control plan provisions for raw material, processes, manufacturing, and fabrication, inspections are adequate to insure control of finished article quality, destructive testing of finished articles may be conducted at a lower level of inspection than that specified in paragraph (h) of this section. Sec. 84.42 Proposed quality control plans; approval by the Institute. (a) Each proposed quality control plan submitted in accordance with this subpart shall be reviewed by the Institute to determine its effectiveness in insuring the quality of respiratory protection provided by the respirator for which an approval is sought. (b) If the Institute determines that the proposed quality control plan submitted by the applicant will not insure adequate quality control, the Institute shall require the applicant to modify the procedures and testing requirements of the plan prior to approval of the plan and issuance of any certificate of approval. (c) Approved quality control plans shall constitute a part of and be incorporated into any certificate of approval issued by the Institute, and compliance with such plans by the applicant shall be a condition of approval. Sec. 84.43 Quality control records; review by the Institute; revocation of approval. (a) The applicant shall keep quality control inspection records sufficient to carry out the procedures required in MIL-STD-105D or MIL- STD-414, or an approved equivalent sampling procedure. (b) The Institute reserves the right to have its representatives inspect the applicant's quality control test methods, equipment, and records, and to interview any employee or agent of the applicant in regard to quality control test methods, equipment, and records. (c) The Institute reserves the right to revoke, for cause any certificate of approval where it is found that the applicant's quality control test methods, equipment, or records do not insure effective quality control over the respirator for which the approval was issued. Subpart F--Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time Sec. 84.50 Types of respirators to be approved; scope of approval. Approvals shall be issued for the types of respirators which have been classified pursuant to this subpart F, have been inspected, examined and tested by the Institute, in accordance with the provisions of subparts G through L of this part, and have been found to provide respiratory protection for fixed periods of time against the hazards specified in such approval. Sec. 84.51 Entry and escape, or escape only; classification. Respirators described in subparts H through L of this part shall be classified for use as follows: (a) Entry and escape. Respirators designed and approved for use during entry into a hazardous atmosphere, and for escape from a hazardous atmosphere; or (b) Escape only. Respirators designed and approved for use only during escape from a hazardous atmosphere. Sec. 84.52 Respiratory hazards; classification. Respirators described in subparts H through L of this part shall be classified as approved for use against any or all of the following respiratory hazards: (a) Oxygen deficiency; (b) Gases and vapors; and (c) Particles, including dusts, fumes and mists. Sec. 84.53 Service time; classification. (a) Respirators described in subparts H through L of this part shall be classified, where applicable, as approved for use during the following prescribed service times: (1) Four hours; (2) Three hours; (3) Two hours; (4) One hour; (5) Forty-five minutes; (6) Thirty minutes; (7) Fifteen minutes; (8) Ten minutes; (9) Five minutes; or (10) Three minutes. (b) Other service times may be prescribed by the Institute. Subpart G--General Construction and Performance Requirements Sec. 84.60 Construction and performance requirements; general. (a) The Institute shall issue approvals for the types of respirators described in subparts H through L of this part which have met the minimum requirements set forth for such respirators in this part 84. (b) In addition to the types of respirators specified in subparts H through L of this part, the Institute shall issue approvals for other respiratory protective devices not specifically described in this part 84 subject to such additional requirements as may be imposed in accordance with Sec. 84.63(c). Sec. 84.61 General construction requirements. (a) Respirators will not be accepted by the Institute for examination, inspection and testing unless they are designed on sound engineering and scientific principles, constructed of suitable materials and evidence good workmanship. (b) Respirator components which come into contact with the wearer's skin shall be made of nonirritating materials. (c) Components replaced during or after use shall be constructed of materials which will not be damaged by normal handling. (d) Mouthpieces, hoods, helmets, and facepieces, except those employed in single-use respirators, shall be constructed of materials which will withstand repeated disinfection as recommended by the applicant in his instructions for use of the device. Sec. 84.62 Component parts; minimum requirements. (a) The component parts of each respirator shall be: (1) Designed, constructed, and fitted to insure against creation of any hazard to the wearer; (2) Assembled to permit easy access for inspection and repair of functional parts; and (3) Assembled to permit easy access to parts which require periodic cleaning and disinfecting. (b) Replacement parts shall be designed and constructed to permit easy installation and to maintain the effectiveness of the respirator. Sec. 84.63 Test requirements; general. (a) Each respirator and respirator component shall when tested by the applicant and by the Institute, meet the applicable requirements set forth in subparts H through L of this part. (b) Where a combination respirator is assembled from two or more types of respirators, as described in this part, each of the individual respirator types which have been combined shall, as applicable, meet the minimum requirements for [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A94-11879. Public record. Not legal advice.