[Federal Register: June 8, 1995 (Volume 60, Number 110)] [Rules and Regulations] [Page 30335-30398] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [[Page 30335]] _______________________________________________________________________ Part II Department of Health and Human Services Public Health Service 42 CFR Part 84 Department of Labor Mine Safety and Health Administration 30 CFR Parts 11, 49, 56, 57, 58, 70, 72, and 75 Department of Labor Mine Safety and Health Administration Department of Health and Human Services Centers for Disease Control and Prevention _______________________________________________________________________ Respiratory Protective Devices; Final Rules and Notice DEPARTMENT OF HEALTH AND HUMAN SERVICES Public Health Service 42 CFR Part 84 RIN 0905-AB58 Respiratory Protective Devices AGENCY: National Institute for Occupational Safety and Health (NIOSH), Centers for Disease Control and Prevention, Public Health Service, HHS. ACTION: Final rule. ----------------------------------------------------------------------- SUMMARY: This final rule addresses NIOSH and the Department of Labor/ Mine Safety and Health Administration (MSHA) certification requirements for respiratory protective devices. Specifically, the rule replaces MSHA regulations with new public health regulations, while also upgrading testing requirements for particulate filters. This action is the first of a series of modules that will incrementally upgrade current respirator approval requirements. This modular approach will allow improvements to be implemented on a safety and health priority basis as well as facilitate adaptation to new requirements by the manufacturers and users of respirators. It will also expedite the incorporation of technological advancements and will allow for the expeditious response to emerging hazards. Except for the particulate-filter requirements, most requirements of the existing regulations are incorporated into the new regulations without change. The revised testing requirements for particulate filters significantly improve the effectiveness of evaluating air- purifying filters to remove toxic particulates from the ambient air. These requirements are consistent with two decades of advances in respiratory protection technology. The certification of air-purifying respirators under the final rule will also enable respirator users to select from a broader range of certified respirators that meet the performance criteria recommended by CDC for respiratory devices used in health-care settings for protection against Mycobacterium tuberculosis (Mtb), the infectious agent that causes tuberculosis (TB). Elsewhere in this separate part of the Federal Register, MSHA is publishing a final rule to remove existing regulations which are made obsolete by this final rule. EFFECTIVE DATES: This final rule is effective on July 10, 1995. The incorporation by reference of certain publications used in the regulations is approved by the Director of the Federal Register as of July 10, 1995. FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, NIOSH, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888. The telephone number is (304) 285-5907. SUPPLEMENTARY INFORMATION: I. Availability of Copies and Access to Final Rule Additional copies of this final rule can be obtained by calling the NIOSH toll-free information number (1-800-35-NIOSH, option 5, 9:00 AM- 4:00 PM ET). Arrangements have also been made for this final 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. This final rule may also be obtained from the NIOSH Home Page on the World-Wide Web. The location for the NIOSH Home Page is http://www.cdc.gov/niosh/homepage.html. II. Paperwork Reduction Act This final rule contains information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1980 and assigned control Number 0920-0109. The title, description, and respondent description of the information collection are shown below with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. Title: Respiratory Protective Devices. Description: This rule prescribes requirements and procedures which must be met in filing applications for approval by NIOSH of respirators and modifications of respirators. Description of Respondents: Businesses and other for-profits. Estimated Annual Reporting and Recordkeeping Burden: ---------------------------------------------------------------------------------------------------------------- Annual Section number of Annual Average burden per Annual burden respondents frequency response hours ---------------------------------------------------------------------------------------------------------------- 84.35......................................... 56 10.5 79.45 hr............ 46,716 hr. 84.41......................................... 56 10.5 22.70 hr............ 13,347 hr. 84.43......................................... 56 10.5 56.75 hr............ 33,369 hr. ----------------------------------------------------------------- Total................................... ........... ........... .................... 130,805 hr. ---------------------------------------------------------------------------------------------------------------- The above citations are currently cleared under 30 CFR Part 11 as OMB control Number 0920-0109. A Paperwork Reduction package is being submitted to OMB, requesting approval of the requirement for labeling to be effected by Sec. 84.33. A document will be published in the Federal Register when such approval has been obtained. III. Background NIOSH published a proposed rule (59 FR 26850) to establish a new 42 CFR part 84, on May 24, 1994. On May 26, 1994, NIOSH published a notice in the Federal Register (59 FR 27257) for an extension of the public comment period and a rescheduling of a public meeting. A public meeting was held to obtain comments on the proposal in Washington, D.C. on June 23-24, 1994. The proposal and public meeting received response from the full complement of affected parties in the public. Commenters included safety professionals, respirator manufacturers, representatives of industrial and health-care facilities, and workers' associations. Three hundred and three commenters responded to the proposed rule. One hundred twenty six commenters represented health-care workers. Ninety six commenters represented health-care facilities. Fifteen commenters represented associations of health-care professionals. Fifteen commenters represented associations of health-care facilities. Seventeen commenters represented respirator manufacturers. Eight commenters represented trade or manufacturers' associations. Eight individuals commented as private citizens. Six commenters represented regulatory agencies (federal, state, [[Page 30337]] county). Five commenters represented respiratory protection experts. Three commenters represented workers' organizations. Two commenters represented test instrument manufacturers. One commenter represented industrial hygiene professionals. One commenter represented a Federal Advisory Committee. These figures include the 18 presenters at the Public Meeting held in Washington, D.C. on June 23 and 24, 1994. IV. Summary of Major Changes in Response to Comments The requirements of the final rule differ from those proposed (59 FR 26850) in 8 major areas. These changes, discussed in sections V. Administrative and Procedural Matters of Final Rule and VI. Discussion of Final Rule, are summarized as follows: 1. Three categories (series) of particulate filters (N-, R-, and P- series) are included rather than two (solid and liquid and solid); 2. Maximum allowable inhalation and exhalation airflow resistance values have been slightly increased and labelling changes are included to identify the certified efficiency level to users; 3. The new certification categories apply only to non-powered air- purifying respirators. Powered air-purifying particulate respirators (PAPRs) will be approved only with filters meeting the requirements for 30 CFR part 11 high-efficiency filters; 4. A new subpart KK has been added for the issuance of extensions of existing 30 CFR part 11 approvals to address respirator non- conformances when there is a demonstrated safety or health need during the transition period and for the approval of PAPRs; 5. Fit testing during the certification process is not included for particulate respirators; 6. The number of tested units has been reduced and the test data will no longer be treated statistically; 7. The period for sale and shipment of 30 CFR part 11 certified particulate respirators has been increased. The period for processing part 11 applications has been eliminated, except for demonstrated need; and 8. Testing parameters are stated more explicitly. A summary listing of the section-by-section changes from the proposal to this final rule is provided in Appendix A--Comparison of Technical Requirements Final Rule to Proposed Rule. Each of these changes is discussed in detail in the following preamble. V. Administrative and Procedural Matters of Final Rule A. Modular Approach The proposed rule explained the intent to promulgate modifications to the requirements of 30 CFR part 11 in a series of modules. There are numerous benefits to utilizing a modular approach to promulgate 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; 3. Public participation in the rulemaking process will be facilitated by proposing important regulatory changes in individual segments of separate rulemaking; and 4. Improvements made to limited segments of the rule can be implemented in a much shorter time period than comprehensive revisions to the entire rule. Therefore implementation of technological advancements and response to emerging hazards will be expedited. Comments overwhelmingly endorsed the concept of the modular approach with only two comments specifically opposed to this approach. More than 250 comments supported the proposal's approach and approximately 40 specifically endorsed and offered recommendations for changes in the modular scheduling. Some commenters expressed concerns about this new rulemaking procedure. These predominantly questioned the interaction of modules and implementation schedules. Module interaction concerns included added costs, confusion, transition periods (grandfathering) of interrelated modules, and redesign of respirators due to effects of multiple modules. Concerns of scheduling included the priority of modules, additional module topics, transition periods for products to meet prior requirements, timetable for completion of revisions, and availability of NIOSH resources to support work on multiple modules simultaneously. The modular approach represents a continuous improvement strategy for rulemaking. With this process, NIOSH expects regulations and products to be incrementally improved and updated to address worker health concerns and prevent any disruption in the supply of respirators. Each module will constitute a separate rulemaking activity. The modular approach undertaken by NIOSH provides clear advantages over the comprehensive approach to rulemaking. No specific time period has been identified in which all certification standards will be revised. The Institute recognizes that a predetermined revision cycle could ensure the periodic re-examination of standards. However, a requirement of this type would also diminish the capability of the Institute, with its limited resources, to address priority respiratory protection needs. The Institute has determined that a flexible approach is required that will permit expeditious responses to emerging respiratory protection priorities. These can change rapidly as technological advancements, international harmonization, changed working conditions, or the emergence of new hazards make current standards obsolete. As discussed below the Institute will balance industry's need for planning and adjustment time associated with future modules by having ample public involvement in setting the priorities for module selection and with judicious selection of transition periods. NIOSH is aware of the needs of the respirator community to be able to plan future production and purchasing needs. This is true for consumers as well as manufacturers of respirators. NIOSH announced at the informal public meeting its intention to hold ample public meetings in advance of any proposed future modules so that these concerns could be addressed. The concerns expressed in the comments can be addressed in these informal public meetings and with the use of appropriate transition periods. NIOSH intends to establish transition periods for implementing the requirements of each module. These transition periods will be determined by an assessment of the industry's ability to adopt the new requirements, ongoing transition periods from prior modules, and the public health implications of the changes. Anticipated subjects and sequence of the NIOSH rulemaking were outlined in the proposed rule. Numerous comments were received providing suggestions for additional module subjects and their priority. Suggested additional subjects included powered air-purifying respirators, smoke masks, fit testing, supplied air respirators, gas masks, and combination respirators. Suggestions on scheduling priorities indicated a diversity in perceived needs. Based on the public interest in the future module [[Page 30338]] subject areas and timetable, NIOSH will conduct a public meeting to further develop the schedule with input from all interested parties. The location and date for this meeting will be announced in the Federal Register, Morbidity and Mortality Weekly Report (MMWR), and other media. The Institute coordinated the development and implementation of the modular approach with OSHA and MSHA. The specific requirements of this first module were reviewed and accepted by both agencies to ensure that 42 CFR part 84 properly links with OSHA and MSHA respirator use regulations. Both agencies will participate in the development by NIOSH of appropriate user guidelines. NIOSH and MSHA developed a Memorandum of Understanding to delineate roles for the continuing joint approval under 42 CFR part 84 of respirators used for mine emergencies and mine rescue. The Institute will continue to collobrate with MSHA and OSHA as future modules are developed. B. User's Guide The proposal stated the intent to develop a user's notice or guide to explain the use of respirators certified for protection against particulate exposures under the new 42 CFR part 84 that would replace the existing filter respirators certified under 30 CFR part 11 subparts K and M. Commenters indicated that this user's guide should be developed in a public forum with public involvement. One commenter stated that the user's guide should be issued prior to the finalization of part 84. Another believed that its availability should coincide with the publication of the final rule. Constraints on releasing specific information as to the contents of the final rule prior to its publication limits the availability of information needed for development of a user's guide, thus making its development with public input prior to or concurrent with this rule impossible. NIOSH agrees with the commenters that public input into the user's guide will result in a better product. An informational respirator user's guide for part 84 respirators will be developed with public involvement. The user's guide will address both the use of part 11 and part 84 respirators during the transition period. Assigned Protection Factor (APF) values are used in the respirator selection process to indicate the expected protection level for the respirator wearer. NIOSH recommends APFs for respirators certified under 30 CFR part 11 in its Guide to Industrial Respiratory Protection and in the Respirator Decision Logic. The future user's guide will recommend APFs appropriate for use with the part 84 particulate respirators until APFs can be addressed through future rulemaking. It will also provide information and recommendations on a variety of other respirator use issues associated with this current rulemaking. During review of this rule, both OSHA and MSHA expressed strong interest in the APF values for the new part 84 particulate filter classifications. Both agencies agreed with NIOSH that APFs could not be addressed properly in this first module. They therefore urged NIOSH to develop a subsequent module defining APFs for all respirators. In the interim, OSHA regulations under Title 29 and the MSHA regulations under Title 30 will allow the use of the new part 84 particulate classifications with the APFs to be established by NIOSH in the users' guide. OSHA is in the process of updating its respirator use regulations, and the current proposal specifies acceptance of APFs developed and promulgated under part 84. C. Use of Particulate Respirators for Protection Against TB While the requirements in this final rule were not developed specifically to certify respirators against biological agents, this rule will address the important public health need to control the transmission of Mycobacterium tuberculosis, the causative agent of TB, in health-care and other facilities through the use of respiratory protective devices. 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 published ``Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health-Care Facilities, 1994'', in the Federal Register (59 FR 54242) and MMWR (Volume 43, No. RR-13) on October 28, 1994. These guidelines enumerate 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 Guidelines is a respirator with a high efficiency (HEPA) filter. Many comments were received from the health-care community supporting the positive impact of the proposed rule on compliance with the CDC Guidelines. All nine classes of air-purifying, particulate respirators to be certified under the provisions of the new particulate filter tests (filter efficiency) in part 84 meet or exceed the performance recommendations contained in the CDC Guidelines. Several of these new classes of air-purifying, particulate respirators are expected to be less expensive than respirators with HEPA filters. Consequently, 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. D. Conversion From 30 CFR Part 11 to 42 CFR Part 84 Since 1974, the Mine Enforcement and Safety Administration (MESA), MSHA, and the Occupational Safety and Health Administration (OSHA) have regulated the selection, use, and maintenance of respirators in the workplace under their respective enforcement authorities. NIOSH is not including the requirements of Secs. 11.2 and 11.2-1 with this redesignation to 42 CFR part 84. Sections 11.2(a) and 11.2-1 refer to respirator use and selection criteria that since have been superseded by OSHA and MSHA respirator regulations. Section 11.2(b) allows for the continued manufacture and sale of gas masks approved under the former U.S. Bureau of Mines (BOM) Schedule 14F (dated April 23, 1955). This Schedule was replaced by the requirements in Subpart I of 30 CFR part 11 in 1972. Gas masks approved under Subpart I of 30 CFR part 11 (14G canisters) are widely available and only a limited number of types of 14F canisters are marketed. MSHA experience indicates that few of the 14F respirators are currently sold or used. MSHA also indicated that removal of the provisions in Sec. 11.2(b) would remove the authority to market these respirators as approved devices. NIOSH is not transferring the requirements of Sec. 11.2(b) to 42 CFR Part 84 since NIOSH does not have the capability to process applications for these respirators. The approval records on these BOM- approved respirators no longer exist and therefore NIOSH has no way of monitoring the production of these respirators to assure that they continue to meet the approved design. Thus, NIOSH will not authorize the sale and shipment of the Schedule 14F respirators under this part 84. In addition, the codification of the redesignated sections into a non-hyphenated numbering system results in several general heading sections that contained no substantive requirements [[Page 30339]] not being included in this redesignation. These include Secs. 11.85, 11.102, 11.124, 11.140, and 11.162. NIOSH is making a limited revision to the existing requirements of 30 CFR part 11 in this first module, requiring updated particulate filter tests. This revision eliminates the need for unique tests for particulate respirators used for different types of aerosols, such as dust/mist, dust/fume/mist, paint spray, and pesticides. The new certification tests use the most penetrating aerosol size, 0.3m, and either a non-degrading particulate, sodium chloride, or a highly degrading oil, dioctylphthalate. Consequently, particulate filters certified under these new procedures can be used without regard to aerosol size, taking into consideration only the degrading or nondegrading nature of particulates and the APF required by exposure concentrations. To revise respirator nomenclature to be consistent with this fundamental change in certification philosophy, the words dust, fume and mist are replaced with particulate in the final rule. Existing subpart M of part 11 (Secs. 11.170 through 11.183-7) addresses the requirements for pesticide respirators. The requirements of subpart M are not included in this redesignation to 42 CFR part 84. This rule eliminates this category and the tests specific to it, leaving subpart M reserved. All references to subpart M and pesticides as a classification for approval are eliminated. NIOSH will discontinue issuance of certifications that classify these respirators as suitable for use against a specific particulate. The existing test requirements in Secs. 11.124-21 through 11.124-24 specify that a test subject wearing the respirator be exposed to an abrasive blasting environment in which the blasting agent is composed of 99+ percent free silica (SiO2). This requirement is not included in this redesignation to 42 CFR part 84. The purpose of this requirement was to determine the adequacy of protection provided in such environments. NIOSH administratively suspended such tests over 20 years ago because they placed test subjects at risk of exposure to fractured crystalline silica. These tests are not included in this final rule. Requirements for abrasive blasting and other atmosphere supplying respirators as well as fit testing for all respirator types will be addressed in a future module. In the interim, NIOSH will continue the administrative policy of the past two decades of conducting quantitative fit testing in lieu of the tests stipulated in Secs. 11.124-21 through 11.124-24. Two comments recommended the inclusion of administrative policies to the rule. One commenter suggested that Secs. 11.124-21 through 11.124-24 (referring to air-line respirators) be restored or replaced with the current administrative policy of quantitative fit testing. Another commenter was concerned that the NIOSH policy of allowing a mixed-gas Self Contained Breathing Apparatus for fire fighting was not included in the proposed rule. NIOSH agrees with these commenters that administrative policies related to specific changes in a module should be incorporated. However, the topics of concern to these commenters addressed administrative policies in subject areas that were not proposed to be changed in this module, therefore, they have not been incorporated. NIOSH has not included the test procedures of Secs. 11.124-21 through 11.124-24 due to NIOSH's concern of health risks to test subjects during pre-submission testing performed by a manufacturer seeking approval of a respirator intended for use in an abrasive blasting environment. Although no Type AE or BE respirators have ever been certified, Type AE, BE, and CE respirators may be certified for use in an abrasive blasting environment. These respirators will be tested using Air-supplied Respirator Section Test Procedure Number 23 Abrasive-Blast, Type CE. Copies of this procedure are available from the Certification and Quality Assurance Branch, 1095 Willowdale Road, Morgantown, West Virginia, 26505-2888. E. MSHA's Regulatory Role The final 42 CFR part 84 regulation is consistent with the current MSHA and NIOSH respirator approval program, placing responsibility for certifying most respirators with NIOSH. MSHA and NIOSH will continue to jointly review and approve respirators used for mine emergencies, mine rescue, and the associated service-life plans, user's manuals, and other documentation. Among the types of devices for which this role is particularly important are self-contained self-rescue devices. The final rule preserves MSHA's current role in the certification of such respirators whose unique use in mining is an important part of safeguarding the health and safety of miners. In addition, MSHA will continue to test electrical and electronic components of respirators for use in potentially explosive atmospheres in gassy underground mines and issue a separate MSHA approval under 30 CFR part 18 for the electrical components of such respirators. In implementing the final regulation, NIOSH and MSHA have developed a new Memorandum of Understanding (MOU) that reflects administrative matters related to respirator approval, including immediate notification to MSHA of field complaints and identified deficiencies concerning approved respirators. Three commenters recommended that the public be allowed to review and comment on the MSHA/NIOSH Memorandum of Understanding. It was indicated by an agency representative that such comments on the contents of the MOU would be welcomed. Two of these commenters were concerned that the responsibilities and accountability, specifically MSHA's involvement in the certification of mining-specific respiratory protective devices, be maintained in the Memorandum of Understanding. The third commenter was unsure if the Memorandum of Understanding would have an effect on the notice of public rulemaking. Comments submitted subsequent to the public meeting reiterated the concerns stated at the meeting. These comments were considered in the MOU's development and have subsequently been addressed. Copies of the MOU will be available from NIOSH and MSHA. The new Memorandum of Understanding between MSHA and NIOSH delineates the interaction between the agencies in carrying out the responsibilities and authorities provided for in the Mine Safety and Health Act of 1977 (30 USC Sec. 801 et seq) and this final rule. It defines the method of implementation of the regulation and has no effect on its content. The agency has determined that this MOU is most appropriately developed between the two agencies and thus, commenters did not directly participate in the development of the MOU. As indicated above, public comments on the MOU are welcome. F. Transition Period The proposal included provisions for phasing out part 11 particulate respirators. Specifically, no applications were to be accepted after the effective date of part 84, with a maximum of 6 months for processing in-house applications. Sale and shipment (distribution) of part 11 particulate respirators would have been allowed for only 2 years from the effective date of part 84. Several commenters indicated that these transition periods were much shorter than the 5-year phase-out period proposed by NIOSH in 1987. Some comments on the proposed schedule stated that there must be an appropriate [[Page 30340]] time to develop new products, receive certification, and initiate production of the new respirators. Commenters were also concerned the use of the term distribution implied manufacturer control of the distributer system and the resale market. Several commenters recommended 4 years for NIOSH-processing of part 11 applications, and for sale and shipment of part 11 respirators. NIOSH is expanding the phase-out period from two to three years to address these concerns. With the effective date of part 84, MSHA and NIOSH will no longer accept 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. Valid part 11 applications that were received prior to the effective data of part 84 will be processed for approval under part 11 provisions. A subpart KK containing the part 11 requirements for particulate respirators has been added to the final rule to provide continued authority for NIOSH to issue extensions of approvals needed to address respirator recall and retrofit matters that are associated with health and safety issues for workers. Respirators listed as certified under the provisions of 30 CFR part 11, subparts K or M, may not be sold or shipped by the approval holder as NIOSH/MSHA certified respirators effective July 10, 1998. Continued use of distributed particulate respirators is under the jurisdiction of OSHA and MSHA and therefore is not affected by this rule. Because certifications will not be revoked for part 11 devices sold and shipped by the approval holder prior July 10, 1998, NIOSH anticipates that OSHA and MSHA would permit continued use of those part 11 respirators. This 3 year period was selected to ensure the timely replacement of the part 11 respirators that exhibit low initial efficiency levels while allowing an ample supply of respirators to remain available for use. This timeframe will provide sufficient time for manufacturers to have respirators approved and manufactured in quantities to meet demand. Manufacturers' comments to the proposed rule support this timeframe, as some manufacturers appear ready to provide part 84 respirators immediately. At least one commenter stated, without reservation, preparedness to submit applications to meet the new requirements. Several commenters requested that NIOSH accept applications for part 84 respirators upon publication, rather than the effective date of part 84. One manufacturer commented that NIOSH should anticipate at least 10 applications from each manufacturer upon part 84 becoming effective. NIOSH also expects a significant number of presently certified particulate respirators, in addition to new designs, to meet the requirements of this rule. Therefore, a high initial application rate for approval of part 84 particulate respirators is expected. Some commenters expressed concern that NIOSH would not be able to expeditiously process the part 84 applications, thereby delaying introduction of the new respirators to the marketplace. Delays in processing the part 84 applications would prolong the time needed for transition to these new respirators. Division of the NIOSH staff and resources between processing part 84 applications and pending part 11 applications, along with routine extensions of existing part 11 particulate respirator certifications, may initially slow the certification and availability of part 84 respirators. However, the Institute has determined that it cannot reject without action part 11 applications that were validly prepared and submitted while the provisions of part 11 remain in effect. NIOSH therefore will process all valid part 11 applications that were received by NIOSH before the effective date of part 84. The authority for the approval holder to sell and ship particulate respirators under any part 11 certification issued under these conditions will expire along with the other part 11 certifications on July 10, 1998. The new technical requirements of part 84 only address air- purifying respirators. Other classes of respirators, such as self- contained breathing apparatus, gas masks, etc., are not affected by the new filter penetration test requirements. Therefore, NIOSH 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 standards that are transferred to part 84. NIOSH further intends to issue public notices of the new approval designations to be used for products demonstrating performance to the improved standards. VI. Discussion of Final Rule A. Certification Fit Testing The proposal contained two sections (Secs. 84.181 and 84.182) that would have retained the existing Part 11 particulate respirator fit test protocols using isoamyl acetate. These tests were proposed to redesignate the existing Secs. 11.140-1 and 11.140-2 with the tests unchanged to minimize the scope of the changes proposed in the first module. The currently required particulate respirator facepiece fit tests of part 11 use isoamyl acetate, an organic vapor, as the test agent. Under existing part 11, such tests are required for high efficiency (HEPA) and dust, fume, and mist (DFM) respirators, but not dust/mist (DM) respirators. Since particulate filters are not intended to filter organic vapors, the tested respirators must often be modified by the addition of an activated charcoal layer. This added charcoal layer prevents penetration of the isoamyl acetate through the filter so that the respirator-to-face fit can be evaluated. As a result, the certification program tests surrogate respirators that may have fitting characteristics that differ from the marketed (certified) respirators. Numerous and varied comments were provided on these sections. A number of commenters suggested that NIOSH eliminate fit testing as a condition of certification. Two commenters recommended that the rule should require manufacturers to submit test data showing good fit characteristics in lieu of NIOSH conducting fit testing. Other commenters requested that NIOSH test the respirator-to-face fit, or otherwise assure that proper fitting characteristics were provided by every certified respirator. Several other commenters requested that fit testing be made a meaningful test. Several others suggested that a quantitative protocol rather than a qualitative fit protocol should be used. Two commenters stated support for the fit tests as proposed. Several of the reasons given for eliminating fit testing were that fitting respirators to individuals in the certification program does not predict the fit of an individual wearer; fit testing of individual workers at the worksite is required by OSHA and that is the appropriate setting for fit testing; the isoamyl acetate test has not been validated; and, the isoamyl acetate test [[Page 30341]] has to be performed on modified respirators. The comments requesting that fit testing be made a meaningful test were based on reasoning similar to those suggesting elimination of the test. In lieu of elimination, they suggested that some inadequacies could be resolved with modification of the test protocol to use a particulate aerosol, such as Bitrex, as the test agent. Changing the test protocol to test with a particulate would at least permit the tested respirator filters to be as certified, thereby eliminating specially-made surrogates. Commenters endorsing NIOSH continuation of fit testing believed that the present certification process provides an assurance that the respirator will properly fit a given worker when use of the respirator is needed in the workplace. The problems associated with testing the facepiece-fit in a certification program have been recognized for years. Efforts have been made to seek more meaningful test results; nevertheless, the validity of the test results remain questionable. Successful fit testing in the certification process provides no assurance that the respirator will properly fit a given worker when used in the workplace. The only means presently available to assess the fit achieved on the worker is a respirator-to-face fit test conducted on that individual with the chosen respirator. Even this test procedure, conducted on the individual, cannot assure that the respirator will maintain a proper fit when use of the respirator is needed in the workplace. This concern is compounded when the fit is determined with a surrogate respirator. During review of this rule, both OSHA and MSHA favored inclusion of respirator fit testing and fit checking procedures as part of NIOSH respirator certifications under the new part 84 particulate filter classifications. Both agencies accepted the determination by NIOSH that these issues cannot be properly addressed in this first module. Both agencies therefore urged NIOSH to develop a face fit module to include respirator fit testing and fit checking procedures for all respirators. The purpose of face fit testing in the certification program has been to assure that respirators have generally good face fitting characteristics. However, at this time NIOSH does not have studies that define the effectiveness of either the isoamyl acetate or American National Standards Institute (ANSI)/OSHA accepted fit tests in predicting actual workplace protection provided to workers. NIOSH is presently conducting research for this purpose. In the interim, lacking validation and correlation of testing protocols, workers' health concerns are best served through the application of fit-testing and fit-checking procedures on individual workers in a quality respirator program. Therefore, the isoamyl acetate fit tests proposed in Secs. 84.181 and 84.182 are not included in this final rule. NIOSH will address issues associated with face-fit efficacy in a separate module upon completion of the necessary research. B. Powered Air-purifying Particulate Respirators The proposed regulation included filter efficiency requirements for powered air-purifying respirators (PAPRs). The solid and liquid and solid categories were to be tested with sodium chloride (NaCl) and dioctyl phthalate (DOP), respectively. The classes to be certified were the 99.97 and 99% efficiency levels. The remaining design and test parameters for PAPRs were retained from part 11 without change. Commenters questioned why the efficiency levels proposed for PAPRs were not the same as non-powered respirators. The proposal specified three efficiency levels for non-powered (95, 99, 99.97) and only two levels for PAPRs (99 and 99.97). Commenters indicated many present filter cartridges are interchangeable between the non-powered and PAPR units, recommending corresponding filter efficiencies between the non- powered and PAPR units to retain this broader market for a filter design. Numerous commenters stated a concern that the proposed requirements of subpart K did not adequately address PAPRs. These commenters indicated that the respiratory protection provided by PAPRs is dependent on the respirator components working together as a system. The proposed rule, focusing on filter efficiency, did not address the system requirements for these respirators. These commenters reasoned that the performance of these complicated respirator systems deserves special consideration because of unique problems addressing airflow, filter efficiency, and fit. These commenters suggested that the requirements for powered units be removed from subpart K, to be addressed in a separate module. Other commenters addressing PAPR requirements stated concerns over sodium chloride (NaCl) filter test instrumentation capabilities. With the present state-of-the-art capabilities, the proposed PAPR loading requirements are difficult to achieve. This leads to a number of testing difficulties including instrumentation availability, time consuming tests, reproducibility of results, and system costs. NIOSH agrees with these concerns and will address them in the forthcoming module. Commenters to the proposal also acknowledged that the resultant part 84 filters would be a significant improvement over those currently certified and marketed under part 11. Two commenters recognized the concern over the performance of part 11 powered dust, fume, mist respirators. They indicated that this concern could be addressed by incorporating only part 11 high-efficiency filter requirements for PAPRs approved under part 84. NIOSH agrees and has revised the rule to permit the continued use of part 11 high efficiency filters for PAPRs approved under part 84. NIOSH also agrees with commenters that the proposed filter efficiency requirements alone do not adequately address the operational parameters of PAPRs that should be revised. The sections of subpart K have therefore been modified to be applicable only to non-powered air- purifying particulate respirators. The requirements for the powered units will be addressed in a forthcoming module. In the interim, powered air-purifying particulate respirators equipped with HEPA filters will be approved under the provisions of subpart KK. C. Filter Classification The proposal provided for six classes of filters in a filter classification system with three filter efficiency levels and two categories of filter degradation resistance. The three efficiency levels (99.97, 99, and 95%) were determined by testing with the most penetrating aerosol size until a maximum loading of 200 mg was reached. The two degradation resistance categories were established by the choice of either NaCl or DOP as the test challenge aerosol. Sodium Chloride is only mildly degrading to filter media while DOP is a liquid oil that is highly degrading. Accordingly, filters tested with the NaCl aerosol were recognized as not highly resistant to degradation and only appropriate for use with solid aerosols in the workplace. Filters tested with the liquid DOP oil were recognized as highly resistant to degradation and considered appropriate for both liquid and solid workplace aerosols. The categories and classes of filters that would have been certified under the proposal are summarized below: ------------------------------------------------------------------------ Test Category Class Efficiency agent ------------------------------------------------------------------------ Solid and liquid.......................... A 99.97 DOP [[Page 30342]] Solid..................................... A 99.97 NaCl Solid and liquid.......................... B 99 DOP Solid..................................... B 99 NaCl Solid and liquid.......................... C 95 DOP Solid..................................... C 95 NaCl ------------------------------------------------------------------------ The behavior of filters to challenge by each of the two test aerosols depends on the filter type. Mechanical filters and electrostatic filters are the two fundamental types of particulate filters on the market. Mechanical filters' efficiencies are determined by mechanical features such as the diameter, orientation, and arrangement of the fibers that comprise the filter. Electrostatic filters have a static electric charge on the filter fibers to enhance the attraction and retention of the aerosolized particles. The enhanced efficiency due to the electrical charge means that an electrostatic filter generally offers lower breathing resistance than a mechanical filter with the same initial efficiency. This occurs because fewer fibers are needed in the electrostatic filter to achieve the same level of efficiency as a mechanical filter. However, the efficiency of electrostatic filters can be significantly reduced by exposure to certain aerosols while mechanical filters are generally more resistant to degradation. Comments concerning resistance of filters to degradation were generally of two conflicting schools of thought. One school favored replacing the two proposed tests with a single, more severe test. The other favored retaining the two proposed tests at the same or reduced level of severity. Commenters opposing the proposed classification system stated it was not a severe enough test of resistance to filter degradation because it did not represent a worst-case test. They recommended testing all filters with a DOP aerosol with the test continued until there was no further decrease in filter efficiency. Those supporting this position argued that the proposed filter classification system could result in overexposure of workers as workplace aerosols degrade some filters to a level below the certified efficiency level. It was indicated that various workplace contaminants can cause the beneficial filtering effects of the charge on electrostatic filters to become partially or totally ineffective without indication to the wearer. As the electrostatic charge on the filter fibers is masked by the deposition of aerosol, the efficiency of the filter can be reduced to below the anticipated level of protection, based on the certified efficiency level. Further, these contaminants have been identified as solids as well as liquids. With no warning to alert the wearer of a decrease in the performance level of the filter, these commenters believed that the proposed tests to determine filter efficiency should be modified to assure that the filters are tested until the minimum level of efficiency is achieved. The stated advantage of such an approach is that filters could be used with any aerosol for indefinite time periods without concern of filter degradation. The other school argued that the two proposed categories were either appropriate or too severe. They suggested continuing with the two categories either as proposed or with a reduction in the amount of filter loading (to reduce the severity of the test). They argued that the two proposed filter tests, being a combination of worst-case and severe test parameters, would assure adequate filter performance in the workplace. Several commenters stated that the great majority of respirator applications are in worksites with aerosols that do not significantly diminish the efficiency level of the electrostatic filters. Workplace studies were submitted to support the conclusion that, because of the highly degrading nature of DOP and the proposed high loading level, the proposed test were many times more severe than conditions realistically encountered by workers. These commenters recommended, not only the certification of two categories as proposed, but that the proposed test loading levels for both the NaCl and DOP aerosols be reduced to more closely simulate workplace exposures. The advantage of the proposed tests was the benefit of potentially lower breathing resistance, with the resulting increased comfort, of electrostatic filters for the great majority of respirator wearers who are not exposed to highly degrading workplace aerosols. Further, the electrostatic filter types were reported by commenters to have a potentially lower cost than their mechanical filter counterparts. This final rule provides for the needs of both the majority workers with no need for filters highly resistant to degradation and workers needing filters most resistant to degradation. To that end, this rule provides for a third category of filters added to the two categories provided for in the proposal. The new filter category is tested with the highly degrading DOP until no further decrease in filter efficiency is observed. As discussed under VI. Discussion of Final Rule, D. Section-by- Section Discussion, Sec. 84.170, NIOSH is introducing a new terminology for the three filter categories. The solid only filters in the proposal are labeled N-series filters in this final rule. The proposal's solid or liquid filters are now labeled R-series filters. Filters of the new, third category are labeled P-series filters. The three categories, therefore, provide filters for a complete range of applications. Further, to address concerns about the use of A, B, and C in the proposal to indicate the efficiency level, the final rule uses numerical notations of 100, 99, or 95 to indicate filter efficiency. The rationale for retaining the proposed efficiency levels of 99.97, 99, and 95% is discussed in VI. Discussion of Final Rule, D. Section- by-Section Discussion, Sec. 84.170(c)(3). The terminology of this final rule is related to that of the proposal as follows: ------------------------------------------------------------------------ Final Proposal ------------------------------------------------------------------------ N100.......................... Solid only/type A. N99........................... Solid only/type B. N95........................... Solid only/type C. R100.......................... Solid & Liquid/type A. R99........................... Solid & Liquid/type B. R95........................... Solid & Liquid/type C. P100.......................... (Not included in proposal). P99........................... (Not included in proposal). P95........................... (Not included in proposal). ------------------------------------------------------------------------ As stated in the proposal, NIOSH selected the test criteria to be a combination of worst-case and very severe test conditions. The N- and R-series filters will be tested to a specified maximum loading level as in the proposal. Performance of these two filter classes at loadings beyond that maximum will not be evaluated. Furthermore, NIOSH is aware that few data are available to assess the performance of these respirators in workplace settings over an extended period of time. Therefore, the N- and R-series filters will be certified with the recognition that in some settings time-use limitations should be applied. A single shift limitation, for example, may be appropriate to guard against possible degradation of performance below the efficiency certified by NIOSH. In addition to possible time-use restrictions, the N-series filters should be restricted to use in those workplaces free of oil aerosols because the N-series certification tests will involve challenge with non-degrading sodium chloride aerosols. The R-series filters should require no such aerosol-use restrictions because R- series certification tests will involve challenge with highly degrading dioctylphthalate aerosols. Because the P-series certification tests will involve challenge with this highly degrading [[Page 30343]] aerosol that will continue until the filter efficiency declines to its lowest level, the P-series may require neither aerosol- use nor time-use limitations. As for any filter, service time will be limited by considerations of hygiene and increased breathing resistance due to filter loading. Guidelines for the use and selection of part 84 particulate respirators, as described in V. Administrative and Procedural Matters of Final Rule, B. User's Guide, are to be developed with public input. The user's guide will include detailed guidance concerning use limitations for these three filter series. D. Section-by-Section Discussion. All sections redesignated to 42 CFR part 84 without modification from 30 CFR part 11 are excluded in this discussion of the final 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, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888, (3) remove references to subpart M, pesticide respirators, and tests for protection during abrasive blasting, (4) correct nonsubstantive typographical errors and reference the new part 84 section designations, and (5) update references to incorporation-by-reference documents. The sections redesignated without modification are as follows: 84.1, 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, 84.182, 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. 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 is redesignated and revised from Sec. 11.3. This section is unmodified from the proposal. The existing definitions for air contamination level, Bureau, concentration limits for radionuclides, DOP, MESA, pesticide, radionuclides, and smoke are deleted. These terms are used in provisions that are modified or deleted as a result of the filter penetration test changes included in this final rule. These definitions have, therefore, become unnecessary. The existing definition for Testing and Certification Laboratory is modified to reflect the present name of the organization as the Certification and Quality Assurance Branch. One commenter suggested the definition of respirator be modified to require a respirator to have one-way airflow with inspiratory and expiratory valves, able to be properly positive and negative fit-checked under usual working conditions. Additionally, this commenter recommended adding a definition for mask as any device that protects the wearer against inhalation of a hazardous atmosphere. The primary purpose of a respirator is to provide respiratory protection for the wearer. Neither requiring inhalation and exhalation valves nor reclassifying respirators as masks would enhance worker protection. Thus NIOSH retained the current definition. Section 84.3 Respirators For Mine Rescue or Other Emergency Use In Mines This section is new and maintains MSHA's role in the approval of respirators designed for mine rescue or other mine emergency use. This section is unmodified from the proposal. Under this provision, MSHA and NIOSH will 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 replaces MSHA's existing role as a joint approver of all respirators. Several commenters, while endorsing the transfer of the authority for the regulation, recognized MSHA's unique expertise relating to mine- specific respiratory protective devices. These commenters strongly supported MSHA's continued close involvement in this equipment including, but is not limited to, filter self-rescuers, self-contained self-rescuers, and emergency rescue equipment. Paragraph (a) specifies that NIOSH and MSHA will jointly certify any respirator designed for mine emergencies, mine rescue or other emergency use in mines. This joint review and certification includes 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 will jointly address recall and retrofit matters arising from field complaints or identified deficiencies concerning any respirators used in the mining environment. A new Memorandum of Understanding is to 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 is redesignated from existing Sec. 11.10 with only paragraph (e) modified. This section is unmodified from the proposal. Paragraph (e) retains 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 will 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 remains unchanged from the existing policies and practices. Subpart C--Fees Section 84.20 Examination, Inspection, and Testing of Complete Respirator Assemblies; Fees This section is redesignated from existing Sec. 11.20, and modified only to reflect the new particulate filter classification scheme. This section is unmodified from the proposal. [[Page 30344]] Subpart D--Approval and Disapproval Section 84.33 Approval Labels and Markings; Approval of Contents; Use This section is redesignated from existing Sec. 11.33. This section is unmodified from the proposal. Paragraph (b) specifies the use of the NIOSH emblem on the approval label, replacing the MSHA emblem. Paragraph (e) of this section is modified to identify the existing dust, fume, and mist class of respirator as a particulate respirator. The new designation is consistent with the testing criteria under which these respirators are certified. The table in paragraph (e) identifying the approval label requirements is modified by the removal of references specific to paint spray and pesticide respirators, also consistent with the changes associated with the non-powered air- purifying particulate filter efficiency level determination test. Subpart F--Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time Section 84.52 Respiratory Hazards; Classification This section is redesignated from existing Sec. 11.52. This section is unmodified from the proposal. It is modified only to delete paragraph (d). Reference to the pesticide classification is no longer appropriate with the introduction of the particulates classification. Subpart G--General Construction and Performance Requirements Section 84.61 General Construction Requirements This section is redesignated from Sec. 11.61. This section is unmodified from the proposal. The provision for respirator components to meet the permissibility requirements of 30 CFR part 18 [paragraph (e)] has been deleted because MSHA's workplace regulations separately and independently establish this requirement for certain mining applications. This change is 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 is 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. Except for reference to the redesignated section numbers of subpart K, this section is unmodified from the proposal. With the exception of the airflow resistance test of Sec. 84.181, these respirators are required to meet the requirements specified in Secs. 84.170 through 84.183. Subpart K--Non-Powered Air-Purifying Particulate Respirators Section 84.170 Non-Powered Air-Purifying Particulate Respirators; Description This section, derived from Sec. 11.130, is revised to define non- powered air-purifying particulate respirators in a more concise way than previously provided for respirators designed for protection against dusts, fumes, mists, paint sprays, and pesticides. An essential benefit to filter-mask purchasers of new certifications under this part is that they will no longer have to be knowledgeable about the contaminant particle sizes. Under the provisions of this part, NIOSH will certify filter performance with a test aerosol size chosen so that filter performance for essentially all other aerosol sizes will be higher than that certified by NIOSH. Paragraph (a) describes non-powered air-purifying particulate respirators as those with air drawn through the air purifying filter as a result of the negative pressure generated with the inhalation of the wearer. Non-powered respirators 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. These respirators are designed with filters to provide respiratory protection against atmospheres that contain adequate oxygen to support life and are contaminated with particulates not immediately dangerous to life or health. Particulates for which these respirators provide protection include contaminants such as dusts, fumes, mists and smoke. Paragraph (b) establishes three series of non-powered air-purifying particulate respirators designated as N-series, R-series, and P-series. The N-series respirators are intended for use in those workplaces free of oil aerosols. The R-series and P-series respirators are intended for removal of any particulate that includes oil-based liquid particulates. Paragraph (c) establishes the classification of non-powered air- purifying particulate respirators according to the efficiency level of the filter(s) when tested to the requirements of part 84. Paragraph (c)(1) requires N100, R100, and P100 filters to demonstrate a minimum efficiency level of 99.97 percent. Paragraph (c)(2) requires N99, R99, and P99 filters to demonstrate a minimum efficiency level of 99 percent. Paragraph (c)(3) requires N95, R95, and P95 filters to demonstrate a minimum efficiency level of 95 percent. As discussed previously, some commenters supported the two- classification system that was proposed while others stated only one class was needed. NIOSH agrees with commenters that a class of respirators should be available for use in environments where the filter efficiency level is not diminished by the worksite aerosol (N- series). Insufficient studies have been conducted to definitively characterize workplace aerosols and their effect upon filter efficiencies. Therefore, NIOSH will certify the new filter categories recognizing potential aerosol-use and time-use limitations as discussed above and in VI. Discussion of Final Rule, C. Filter Classification. Many commenters expressed concerns of confusion in the selection of the proposed new particulate respirators. Various commenters pointed to the proposed multiple (two) classes, class nomenclatures (Solid Only and Liquid and Solid), type nomenclature (A, B, and C), and filter color requirements as sources for this confusion. Several commenters recommended that the designations (A, B, and C) for the types be changed to eliminate confusion of the particulate respirator classes with other approved respirator types. Some of these commenters suggested nomenclatures similar to P3, P2, and P1 used for particulate filters in the European community. Another of these commenters recommended a further delineation of the alphabetic notation with each type and class designated by a unique letter (A, B, C, D, E, and F) for clarification. Still another commenter suggested that the nomenclatures be changed but made no specific suggestion. To address concerns about confusion in the selection of respirators under part 84, NIOSH has developed new category classifications and will develop a user's guide, as discussed in V. Administrative and Procedural Matters of Final Rule, B. User's Guide. Numerous comments were also received regarding the proposed efficiency levels. Many commenters [[Page 30345]] supported the three efficiency levels as proposed, while others suggested levels different than proposed. A 90% filter efficiency level was the most frequently recommended alternative, sometimes suggested as a fourth class. NIOSH recognizes that the efficiency requirements contained in the proposed rule are to some extent technology-forcing. However, HEPA- level respirators that perform at an efficiency level proposed under part 84 have been available for years. One commenter (a manufacturer) stated that the technology for producing 95% (Class C) efficiency level respirator is practical, reasonable, and available. This commenter further stated that a Class C respirator could be marketed at a price not exceeding the price of a 30 CFR part 11 disposable DFM respirator. The principal advantage of a 90% efficiency class would be to permit a larger percentage of filters certified under part 11 to be certified without modification under the new part 84 tests. The best performing of the current DM and DFM respirators are expected to meet the requirements of a 95% class, but a significant number of DM respirators would not be expected to meet the requirements even of a 90% class. Limiting the minimum filter efficiency to 95% will minimize worker exposure to airborne contaminants from filter penetration. This is important because it is the most controllable element of protection afforded by respiratory protection programs. The human variables in these programs are more difficult to guarantee: that workers are provided the appropriate class of respirator; that the workers are effectively fit tested; that they achieve and maintain an effective face seal each time they wear a respirator; and that they replace disposable respirators and filters before their effectiveness is diminished. Some commenters urged, for these reasons, that all filters should have greater than 99% efficiency. Such high filter efficiency poses technologic challenges, increases costs to manufacturers and users, and increases breathing difficulty for respirator wearers. NIOSH believes that a 95% minimum efficiency best balances the public health concern and these competing considerations. Although a number of manufacturers have indicated they are prepared now to submit filters for certification under these new test procedures, there may be some who are not. These manufacturers will have three years to develop this capacity while they continue to market their existing products. Section 84.171 Non-powered Air-purifying Particulate Respirators; Required Components This section is redesignated from existing Sec. 11.131, modified only to incorporate the new terminology of particulates to describe dusts, fumes and mists. This section is unmodified from the proposal, except for the title change. Section 84.177 Inhalation and Exhalation Valves; Minimum Requirements This section is redesignated from existing Sec. 11.137, modified only to delete reference to the silica dust tests for single-use respirators of Sec. 11.140-5. This section is unmodified from the proposal. The respirator performance requirements of these tests are replaced by the non-powered air-purifying particulate filter efficiency level determination test contained in this rule. Section 84.179 Non-powered Air-purifying Particulate Respirators; Filter Identification This section requires the identification of non-powered air- purifying particulate respirators by labeling with a new classification system for the series and efficiency of the filters. The new terminology of non-powered air-purifying particulate respirator replaces the existing dust, fume, and mist respirator, as discussed previously. The requirement for the manufacturer to specify the filter-series and efficiency level classification in the certification application is contained in paragraph (a). This classification would include the series of the filter and the expected efficiency of the filter based on the test requirements specified in Sec. 84.182. The information to be included on the label of a filter for a certified non-powered air-purifying particulate respirator is specified in paragraphs (b)(1) through (b)(9). This labeling defines the efficiency level achieved in the performance testing (i.e., 99.97%, 99%, or 95%) and the series of the filter (i.e., N, R, or P). This information is necessary to allow the user to make an informed decision on selecting the appropriate respiratory protection. To facilitate this selection process, the P100 filters are color coded magenta to allow them to be easily distinguished from the other filter types. The filters other than the P100 can be of any color except magenta. This color coding is consistent with the present universally accepted color code convention which identifies the best performing filters (HEPAs) by their magenta color. NIOSH has modified these labeling requirements from the proposal in agreement with the commenters who stated that the labelling should clearly state the certified efficiency rating numerically and include the series on the filter, filter package, or respirator box. One commenter suggested that all classes of certified respirators should be color coded for user identification; another stated that the high efficiency filters of each series should be magenta. It was also requested that color coding as well as letter designation be specified for all respirators. A more complex color-coding system may add confusion to the respirator selection process. With the more descriptive classification identifying labels required by this final rule, the potential for confusion in selection of the appropriate respirator has been reduced. Therefore, NIOSH has not adopted these suggestions. Section 84.180 Airflow Resistance Tests Section 84.180 is derived from Sec. 11.140-9. It is modified to delete the final inhalation resistance requirements. The non-powered air-purifying particulate filter efficiency level determination tests are not designed to simulate loading of the filter at the worksite. Therefore, these requirements are not appropriate with the introduction of these new tests. Paragraph (a) provides for determining the inhalation-resistance of the complete non-powered air-purifying particulate respirator. This value corresponds to the pressure drop across the complete respirator mounted on a test fixture with air drawn inward through it at a continuous rate of 852 liters per minute. Tolerance limits have been added to the test flow rates as suggested by commenters. The final rule does not include final breathing resistance limits as requested in some comments. The final breathing resistances previously included in the 30 CFR part 11 requirements were based on filters loading and clogging with a silica dust. The loading experienced at actual worksites is not represented by such a test. The inclusion of final breathing resistances as part of a certification would primarily address two concerns. The first is that the breathing resistance does not exceed physiological limits or pose undue discomfort on the wearer. Wearers will replace filters before breathing resistances reach such levels. The second concern is that the filter efficiency is still at an acceptable level at the certification final resistance value. The filter efficiency level determination [[Page 30346]] and respirator classifications provided for in this rule are sufficiently severe to alleviate this concern. One commenter questioned NIOSH's intent for restricting final inhalation resistance for particulate filters used in conjunction with chemical cartridges. This commenter pointed to Sec. 84.203 requirements which specify maximum allowable final inhalation resistances for these combinations. The final inhalation value is to be measured at the end of the service life tests for the chemical cartridge portion of the combination. NIOSH will continue to measure the initial and final inhalation and exhalation resistances of the combination in conjunction with the service life test of the chemical cartridge. The inhalation and exhalation resistances need not be measured for these combinations in conjunction with the particulate efficiency level determination tests. Paragraph (b) states the inhalation resistance of the complete respirator is not to exceed 35 millimeters of water-column height. The exhalation resistance of the complete respirator is not to exceed 25 millimeters of water-column height. The proposed rule would have limited the inhalation and exhalation resistances to 30 and 20 millimeters of water-column height, respectively. Several commenters requested that the values be increased. Increased breathing resistance values will permit the effective use of presently available filter material in respirators re- designed to meet the efficiency level determination tests at a reasonable cost. Others expressed a concern that respirators with higher breathing resistances are less likely to be fitted properly, often intentionally due to the discomfort. Commenters expressed that this may be true in the health-care profession where the use of certified respirators is new. The final rule has increased the maximum acceptable breathing resistance values slightly from the proposed levels to those suggested by commenters. The proposed resistance levels of 30 and 20 millimeters of water-column height corresponded to the maximum allowable resistance values in part 11 for any particulate respirator. The new resistance levels remain below the acceptable limits for some non-particulate respirator classes under the existing part 11 provision. For example, chemical cartridge respirators, which have use patterns similar to particulate filter respirators, have a maximum initial inhalation resistance of 40 millimeters water-column height. This increase in acceptable breathing resistance for particulate respirators will enable manufacturers to produce respirators meeting the new requirements more expeditiously and at lower cost than the proposal would have allowed. This small increase in maximum allowable breathing resistance for particulate respirators does not add substantially to physiologic burden for respirator users, and will be compensated by increased worker protection provided by the new filter efficiency tests and classification system. The acceptable breathing resistance levels for the non-particulate respirator classes are not affected. Section 84.181 Non-powered Air-Purifying Particulate Filter Efficiency Level Determination This section is new and specifies the test criteria and acceptable performance criteria for the new non-powered air-purifying particulate filter efficiency level determination. This section has been retitled from particulate instantaneous-penetration-filter test in response to a comment. The new title more appropriately represents the intent of the tests in this section to determine the efficiency level of the filters. Paragraph (a) requires the filter efficiency testing of 20 filters of each non-powered air-purifying particulate respirator model. Testing is conducted using a solid sodium chloride or equivalent particulate aerosol for N-series certification or a dioctyl phthalate or equivalent liquid particulate aerosol for R-series and P-series certification. Paragraph (b) requires the filters, including holders and gaskets; when separable, to be tested mounted on a test fixture in the manner as used on the respirator. This provides for testing of the assembly in a configuration as it will be actually used. Paragraph (c) describes preconditioning requirements for the 20 N- series filters to be tested. After removal from their packaging, the 20 filters are placed in an environment of 855 percent relative humidity at 382.5 deg.C for 251 hours. The filters shall be stored in a gas-tight container until tested. Testing for the filter efficiencies must be performed within 10 hours following preconditioning. These preconditioning requirements apply only to N-series filters differing from the proposal which would have had filters of each series subjected to preconditioning. Paragraph (d) provides for blocking the exhalation valves to ensure that any valve leakage is not included in the filter efficiency level evaluation. This only applies when the filters do not have separable holders and gaskets. Paragraph (e) specifies the continuous test aerosol flow rates for the filter efficiency testing. Single filters are tested at a rate of 854 liters per minute; filters used in pairs are tested at a rate of 42.5 2 liters per minute through each filter. Paragraph (f) describes the penetration test aerosols and the test criteria to be used. A sodium chloride or equivalent solid aerosol is used when testing for filter efficiency for N-series filters. A neutralized-dioctyl phthalate (DOP), or equivalent oil, liquid aerosol is specified as the testing agent when testing for filter efficiency of R- and P-series filters. For P-series filters, the filter efficiency test will be continued until minimum efficiency is obtained. However, for N- and R-series respirators it will be terminated when an aerosol mass of 2005 mg has contacted the filter unit, if minimum efficiency has not been obtained. Paragraph (f)(1) identifies the test conditions for the sodium chloride or equivalent solid aerosol to be at 255 deg.C and relative humidity of 3010 percent. The aerosol specified to be used in these tests will be neutralized to the Boltzmann equilibrium state, and the maximum concentration will not exceed 200 mg/m\3\. The relative humidity of the sodium chloride aerosol has been changed from the proposal in response to a comment. This change, a small increase in the relative humidity of the aerosol, allows testing at the values normally encountered with the test instruments commonly used. Paragraph (f)(2) specifies the DOP or equivalent oil liquid particulate aerosol. The test conditions for the liquid aerosol are specified to be at 255 deg.C. The aerosol specified to be used in these tests will be neutralized to the Boltzmann equilibrium state, and the maximum concentration will not exceed 200 mg/m\3\. Paragraph (g) specifies the particle size limitations at the test conditions for the filter efficiency test aerosols. The sodium chloride aerosol will have a particle size distribution with count median diameter between 0.0750.020 micrometer and a standard geometric deviation not exceeding 1.86. The liquid particulate aerosol has a particle size distribution with count median diameter between 0.1850.020 micrometer and a standard geometric deviation not exceeding 1.60. NIOSH will make these particle size distribution determinations at the specified test conditions with a scanning mobility particle sizer (SMPS) or equivalent. The specification of a scanning mobility particle sizer represents newer technology than the [[Page 30347]] differential mobility particle sizer that was specified in the proposal. This reference to the newer technology was added in response to comments from the public. NIOSH will accept manufacturer's size verification data determined by SPMS or an equivalent particle sizing instrument that provides particle sizing information consistent with an SPMS. Paragraph (h) requires the efficiency 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 (i) requires the minimum filter efficiency for each of the 20 filters to be determined and recorded. The minimum efficiency of each tested filter is to be greater than or equal to 99.97% for P100, R100 and N100 filters; 99% for P99, R99 and N99 filters; and 95% for P95, R95 and N95 filters. Many comments were received on all aspects of the testing requirements. Comments were received regarding the proposed loading levels, test agents, preconditioning requirements, number of filters to be tested, and test equipment specifications. The proposal included a statistical treatment of the filter efficiency test results (U statistic). Thirty filter samples were to be tested for each certification application. The number of samples tested and the test statistic used in the treatment of the data was intended to provide a 95% confidence interval of 95% conformance (95% tolerance interval) of manufacturers' product to the certification criterion. These methods rely on the applicability of the ``normal'' or Gaussian distribution for test data. A similar statistical treatment of the test data was included in the 1987 NIOSH proposal. A number of commenters expressed concern with the use of a NIOSH proposed U statistic (based on a 95% tolerance interval for the 95th percentile) to determine if the performance of filters submitted by manufacturers meet the requirements for requested classification (type). Comments concerned the use of the constant 2.22 for the calculation of the U statistic, suggesting that this is too strict a criterion for manufacturers to meet and implying that 95% tolerance intervals based on some lower percentile (e.g., 90th) would be more appropriate. Other comments concerned the distribution assumptions inherent in the calculation of the U statistic. Commenters expressed concern that the assumption that test data represent a sample from a Gaussian distribution is incorrect and that the application of tolerance interval methods for this data is inappropriate. Other commenters questioned NIOSH's justification to ``knowingly'' allow the certification of respirators that do not meet the performance requirements. They interpreted the statistical criterion as NIOSH accepting up to 5% of the distributed respirators to be less than the stated class minimum. This analysis of the data would imply that some of the distributed certified respirators perform below the inferred minimum performance level of its class. The commenters expressed concern that this would cause an unacceptably large number of workers to have inadequate respirator protection. One commenter pointed out that the use of the U statistic was an attempt to predict future production variability. This commenter further asserted that respirators submitted for certification testing do not constitute a random sample of a manufacturer's product. Production variability, this commenter continued, is to be controlled by the separate quality control program. NIOSH concurs with the commenter that the proposed statistical approach addressing pre-market production samples is inconsistent with determining product quality in a controlled process. NIOSH further agrees that the samples submitted for certification testing are not random samples. Therefore, the final rule does not include an acceptance criterion based upon the statistical treatment of test data. A significant portion of the cost attributed to the proposed regulations (25 to 30% of the cost, by one estimate) resulted from the statistical treatment of data. Manufacturers stated that this cost impact would be reduced if a 95% tolerance interval based on a 90 percentile (i.e., 95% confidence of 90% conformance) were used. Manufacturers and others suggested that a pass/fail criterion should be offered. Several commenters suggested reducing the number of test samples and using a pass/fail criterion. A pass/fail criterion is consistent with the current respirator acceptance criterion, and is generally accepted as appropriate for a certification program with testing of pre-production units. The pass/ fail criterion presents another advantage in that it establishes the minimum acceptable performance level consistent with the class definition. A member of a 95% class will not be in compliance with the certification if it has an efficiency below that level when tested. The statistical test criterion could allow some individual units to have performance test measurements below 95% but still meet certification requirements. Based on these comments, NIOSH has reconsidered the use of the tolerance interval approach for the analysis of respirator performance data. NIOSH agrees that the application of the tolerance interval approach is inconsistent with type approval and recognizes that respirators submitted for certification do not constitute a random sample of a manufacturer's product. Consequently, the final rule has been modified to test 20 respirators for laboratory performance, with certification if all 20 units meet the specifications. The proposal specified both sodium chloride (NaCl) as the solid test aerosol and dioctyl phthalate (DOP) as the liquid test aerosol. Although DOP is a suspected carcinogen, the set up of the test instruments precludes laboratory personnel exposure to the aerosol. Sodium chloride does not pose a suspected health hazard. Dioctyl phthalate is the most severe liquid, or degrading test aerosol known. It has been used for decades as the test aerosol for certification of the best (HEPA) part 11 filters. Sodium chloride is a solid test aerosol that provides some degrading characteristics. Sodium chloride has also been used for years as the solid test agent in the European (CEN) certification standards. No comments were received against the use of NaCl as the solid test aerosol for non-powered respirators. One commenter, a former employee of the Department of Defense, questioned its use because the military does not use it in their mask testing. Another commenter, accepting the use of NaCl, stated that part 84 should allow equivalent test aerosols as well. The only negative comments received to the NaCl test aerosol were due to the difficulties associated with the testing of powered air-purifying respirators (PAPRs). The requirements for PAPRs was discussed previously in V. Discussion of Final Rule, B. Powered Air- Purifying Particulate Respirators. Commenters interested in the use of certified respirators for protection against TB suggested the use of biological agents (bioaerosols) for the certification testing. It is not necessary to subject filter respirators to a bioaerosol as a condition of certification. By using test aerosols of the most penetrating size range, the efficiency-level determination of the certification testing will be the lowest obtainable for any size aerosol. Therefore, the efficiency level against [[Page 30348]] any bioaerosol for any certified respirator will meet or exceed the certified efficiency level. Comments concerning the choice of liquid test aerosols were varied. Several different test agents were suggested including paraffin oil, Emery 3004, and hydrofluoric acid. Paraffin oil was suggested because it is consistent with the European (CEN) standards. The U.S. military has adopted Emery 3004 as a DOP replacement in instantaneous testing of filter efficiency. A commenter suggested that because hydrofluoric acid aerosol is common in many industries, it would be a more realistic test agent. Each of the suggested alternative liquid aerosols would provide essentially the same initial or lightly loaded filter efficiency levels. The initial efficiency level of a filter is defined primarily by the particle size of the aerosol, not its degrading ability. The CEN standards use paraffin oil as the liquid test aerosol, but the filters are not loaded to a significant level. Emery 3004 has been adopted as a replacement for DOP by the military in initial efficiency testing as performed for the part 11 HEPA filters. Unlike DOP, none of the recommended alternative test aerosols provide severe degrading effects of the filters. This severity is an integral part of the part 84 testing, and addressing the uncertainties of the effects of actual workplace aerosols. In considering these options, NIOSH is aware that no single test agent is used by every prominent standard-setting agency or organization. The CEN standard uses NaCl as a solid test aerosol. The current draft for revising the ANSI Z88.8 standard proposes NaCl and DOP as the test aerosols. No choice of test aerosol would provide consistency with all other standards, as sought by commenters. A fundamental purpose of the new testing standards is to assure that at least one class of filters is highly resistant to degradation by workplace aerosols. The DOP aerosol was selected for this purpose specifically because of its severe effect on filter efficiency level. The proposed alternatives demonstrate less severe effects on the filter media; therefore, they have been considered inappropriate for the evaluation intended by NIOSH. The generation method of dioctyl phthalate aerosol was a concern to many commenters. Commenters questioned the particle size distribution for this test aerosol specified in the proposal being greater than that specified in the existing part 11 requirements. Commenters also questioned differences in test results based on the use of thermally generated (hot) or cold-nebulized DOP aerosol. Although the proposal did not specify any aerosol generation technique to be used for DOP testing, much of NIOSH's research used as a basis for the proposal was performed with cold-nebulized DOP and NIOSH testing has demonstrated that correlation in results obtained between the two aerosol generation techniques is possible. Some commenters believed that the DOP aerosol generation method must be specified to ensure reproducible test results. These commenters used data from Industrial Safety Equipment Association-sponsored ``round robin'' testing of mechanical and electrostatic filter material. Complete data and specifics of the round robin testing were not provided to NIOSH. These tests were conducted among the majority of the air-purifying respirator manufacturers that are ISEA members. The test results indicated excellent correlation between the two aerosol generation methods for efficiency of standardized mechanical filter media. For standardized electrostatic media, a divergence in efficiency with increased filter loading was reported between the two aerosol generation methods. These commenters also reported that both the initial and stabilized efficiencies of the electrostatic media correlated well between the two aerosol generation methods. The divergence reported appears to be a different degradation rate between the two aerosols. Moreover, several of the participants provided some additional insights into the circumstances of the testing. A significant portion of the manufacturers had recently acquired the cold-nebulized test instruments. The reproducibility problems reported, they admitted, could have resulted from operator inexperience. One of the participants with extensive experience with both aerosol generation methods related some of the experience gained by that manufacturer. Excellent correlation is maintained between this commenter's numerous cold- nebulized DOP instruments in use world-wide. Also, the commenter reported having encountered no reproducibility problems between thermally-generated and cold-nebulized instruments in testing electrostatic media when new DOP is used. In NIOSH testing, some tests have provided good correlation of results between the two aerosol generation methods, while others have not. DOP changes chemically as it ages, becoming less pure. The thermal-generation method induces a similar chemical change, simulating accelerated aging of the DOP. Recent NIOSH testing indicates that the chemically-changed DOP may cause the test instruments to fluctuate from the stated testing parameters. If monitored closely, and kept within the specified parameters, equivalent results are obtained with either aerosol generation method. Therefore, to accommodate these concerns, the final rule specifies a test using a neat cold-nebulized DOP test, or equivalent test. Allowing equivalent test methods permits the use of tests that respirator manufacturers may have already developed. As part of the established certification process, NIOSH evaluates the test results submitted by the applicant by comparing them to the results of NIOSH testing. Any test method yielding results equivalent to the NIOSH testing will be acceptable. To further address the testing reproducibility concerns expressed by commenters, NIOSH is initiating a program whereby a standard mechanical and electrostatic filter media sample will be made available upon request for applicant correlation testing. NIOSH will run characterization tests on these standardized media and send a data sheet showing the test results with the samples. NIOSH has traditionally conducted correlation testing for applicants requesting such testing to document the agreement of their test instruments and procedures and those of NIOSH. This new procedure will continue the service provided to the applicants of assuring that the results they obtain on their instruments and with their procedures provide results comparable with NIOSH's certification tests. This new process will reduce the NIOSH resource requirements for corroborating the test results of the large number of applicants that NIOSH anticipates will be requesting this service and expedite the correlation process. Several comments were received on the humidity preconditioning requirement for filters. One commenter stated that the proposed preconditioning time (24 hours) was inadequate to have much of an effect on the performance of electrostatic filter media. The commenter suggested a thirty-day preconditioning period. Information provided regarding the ISEA round-robin testing stated that the effects of the preconditioning were insignificant when testing with the DOP aerosol. This assessment agrees with NIOSH testing experience. The other commenters had concerns that the proposal did not provide: detail regarding uniform preconditioning, the size of the container, the allowable time after conditioning at which filter media must be placed within the container and [[Page 30349]] the allowable time for the filter to remain within the container until tested. The final rule has been modified to require only N-series filters be taken out of their packaging and humidity preconditioned prior to filter efficiency level testing at 855 percent relative humidity at 382.5 deg.C for 251 hours. The final rule states that following the preconditioning, the filters shall be sealed in a gas-tight container and tested within 10 hours. R- and P-series filters do not have to be preconditioned because they are tested against DOP which is much more severe than humidity in regard to reducing filter efficiency. The preconditioning requirement is retained for the N-series filters to address the effect of humidity on the filter's efficiency because the sodium chloride aerosol is less severe than DOP in reducing filter efficiency. The 10-hour limitation on storage of the filters before efficiency testing will eliminate the variability concerns. The final rule has been modified to specify a scanning mobility particle sizer (SMPS) or equivalent, as recommended by commenters, to be consistent with the latest technology. One commenter suggested a flame photometer be allowed for measurement of sodium chloride. The same commenter also stated that other sizing devices such as the Tyndall Owl have been used for years and should be an acceptable measuring instrument. NIOSH is aware that other instrumentation can provide sizing information that can equate to the values specified in the rule. In specifying the particle size, it is important to identify the technology used in its determination. The differential mobility particle sizer (DMPS) was specified in the proposed rule because this is the technology traditionally used by NIOSH to determine the particle sizes of this test. The use of these other instruments is acceptable and all other such equipment does not have to be specified in the final rule. To make size verification measurements manufacturers may use any particle sizing instrument that provides particle sizing information consistent with an SPMS. Subpart L--Chemical Cartridge Respirators Section 84.203 Breathing Resistance Tests; Minimum Requirements This section is redesignated from existing Sec. 11.162-1. This section is unmodified from the proposal. It is modified only to delete reference to various classifications, such as paints and pneumoconiosis and fibrous producing dusts, that are no longer 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 is redesignated from existing Sec. 11.162-7. This section is unmodified from the proposal. It is modified only to delete reference to various classifications, such as paints and pneumoconiosis and fibrous producing dusts, that are no longer appropriate with the introduction of the particulates classification with the new instantaneous-penetration test. Subpart KK--Dust, Fume, and Mist; Pesticide; Paint Spray Respirators and Combination Gas Masks This subpart has been added to continue the part 11 requirements for the existing dust, fume, and mist; pesticide; paint spray respirators and combination gas masks during the transition period to part 84. These sections are derived from existing 30 CFR part 11, subpart K. They are modified to update them to part 84 section numbers. This subpart also included the upgraded requirements for PAPRs to include only high efficiency filters (HEPA). Derivation Table The following derivation table lists (1) each section number of the final 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 ------------------------------------------------------------------------ 42 CFR 30 CFR 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 [[Page 30350]] 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........................... New. 84.180........................... 11.140-9 84.181........................... New. 84.182........................... 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 84.1100.......................... New. 84.1101.......................... 11.3 84.1102.......................... 11.20 84.1103.......................... 11.33 84.1130.......................... 11.102-4, 11.130, 11.170 84.1131.......................... 11.91, 11.131, 11.171 84.1132.......................... 11.95, 11.132, 11.175 84.1133.......................... 11.96, 11.133, 11.176 84.1134.......................... 11.97, 11.134, 11.177 84.1135.......................... 11.98, 11.135, 11.178 84.1136.......................... 11.99, 11.136, 11.179 84.1137.......................... 11.100, 11.137, 11.180 84.1138.......................... 11.101, 11.138, 11.181 84.1139.......................... 11.139, 11.182 84.1140.......................... 11.140 84.1141.......................... 11.140-1 84.1142.......................... 11.140-2 84.1143.......................... 11.140-3 84.1144.......................... 11.140-4 84.1145.......................... 11.140-5 84.1146.......................... 11.140-6 84.1147.......................... 11.140-7 84.1148.......................... 11.140-8 84.1149.......................... 11.140-9 84.1150.......................... 11.140-10 84.1151.......................... 11.140-11 84.1152.......................... 11.140-12 84.1153.......................... 11.102-4 84.1154.......................... 11.172, 11.173 84.1155.......................... 11.174 84.1156.......................... 11.183, 11.183-1, 11.183-3, 11.183-4, 11.183-5, 11.183-6, 11.183-7 84.1157.......................... 11.162, 11.162-1, 11.162-4, 11.162-5, 11.162-6, 11.162-8 84.1158.......................... 11.162-7 ------------------------------------------------------------------------ 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 final rule (New Section). Distribution Table ------------------------------------------------------------------------ Old section New section ------------------------------------------------------------------------ 30 CFR 42 CFR 11.1............................. 84.1 11.2............................. Removed. 11.2-1........................... Removed. 11.3............................. 84.2, 84.1101 11.4............................. 84.3 11.10............................ 84.10 11.11............................ 84.11 11.12............................ 84.12 11.20............................ 84.20, 84.1102 11.21............................ 84.21 11.22............................ 84.22 11.30............................ 84.30 11.31............................ 84.31 11.32............................ 84.32 11.33............................ 84.33, 84.1103 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, 84.1131 11.92............................ 84.112 11.93............................ 84.113 11.94............................ 84.114 11.95............................ 84.115, 84.1132 11.96............................ 84.116, 84.1133 11.97............................ 84.117, 84.1134 11.98............................ 84.118, 84.1135 11.99............................ 84.119, 84.1136 11.100........................... 84.120, 84.1137 11.101........................... 84.121, 84.1138 11.102........................... Removed. 11.102-1......................... 84.122 11.102-2......................... 84.123 11.102-3......................... 84.124 11.102-4......................... 84.125, 84.1130, 84.1153 11.102-5......................... 84.126 [[Page 30351]] 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, 84.1130 11.131........................... 84.171, 84.1131 11.132........................... 84.172, 84.1132 11.133........................... 84.173, 84.1133 11.134........................... 84.174, 84.1134 11.135........................... 84.175, 84.1135 11.136........................... 84.176, 84.1136 11.137........................... 84.177, 84.1137 11.138........................... 84.178, 84.1138 11.139........................... 84.1139 11.140........................... 84.1140 11.140-1......................... 84.1141 11.140-2......................... 84.1142 11.140-3......................... 84.1143