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SUMMARY: This final rule was made available to the public at the Government Printing Office in Washington, DC, on June 2, 1995. It is scheduled for publication in the Federal Register on June 8, 1995, in Part II of that issue. This 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 at 30 CFR part 11 with new public health regulations at 42 CFR part 84, while also upgrading testing requirements for particulate filters. Concurrently with publication by NIOSH of this new rule, MSHA published a final rule to remove existing regulations at 30 CFR part 11, which are made obsolete by this final rule. NIOSH will now have exclusive authority for testing and certification of respirators with the exception of certain mine emergency devices, which will continue to be jointly certified by NIOSH and MSHA.
The certification of air-purifying respirators under the final rule will enable respirator users to select from a broader range of certified respirators. All of these new respirators will 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). The 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. All nine classes of air-purifying, particulate respirators to be certified under the provisions of the new particulate filter tests 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.
This action is the first of a series of modules that will incrementally upgrade current respirator approval standards. 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 expeditious response to emerging hazards.
Except for the particulate-filter standards, most of the existing regulations are incorporated into the new 42 CFR part 84 without change. The revised testing standards for particulate filters will significantly improve the effectiveness of air-purifying filters in removing toxic particulates from the ambient air. These changes are consistent with two decades of advances in respiratory protection technology.
Under the new particulate filter tests, NIOSH will certify three classes of filters, N-, R-, and P-series, with three levels of filter efficiency, 95%, 99%, and 99.97%, in each class. All filter tests will employ the most penetrating aerosol size, 0.3 µm aerodynamic mass median diameter. The N-series will be tested against a mildly degrading aerosol of sodium chloride (NaCl). The R- and P-series filters will be tested against a highly degrading aerosol of dioctylphthalate (DOP):
Filter Minimum Test Maximum Test Designation Efficiency Agent Challenge Loading
N100 99.97% NaCl 200 mg filter loading N99 99% NaCl 200 mg filter loading N95 95% NaCl 200 mg filter loading R100 99.97% DOP 200 mg filter loading R99 99% DOP 200 mg filter loading R95 95% DOP 200 mg filter loading P100 99.97% DOP Maximum filter degradation P99 99% DOP Maximum filter degradation P95 95% DOP Maximum filter degradation
Tested to a specified maximum loading level (200 mg), the N- and R-series will be certified with the recognition that in some settings time-use limitations will apply. A single shift time limitation, for example, may be appropriate. In addition to possible time-use restrictions, the N-series filters should be restricted to use in those workplaces free of oil or other severely degrading aerosols. The R-series filters would not have similar aerosol-use restrictions. The P-series filters will be tested with DOP until no further decrease in filter efficiency is observed. The P-series filters have 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.
The final rule differs from the proposal (59 FR 26850) in eight ways. These changes are summarized as follows:
PROPOSAL FINAL RULE
2 categories of particulate filters (Solid; 3 categories of particulate filters Solid and Liquid) (N-, R-, and P-series)
Filter efficiency tests applied to all Filter efficiency tests apply only
air-purifying particulate filters. to air-purifying particulate filters
for non-powered respirators. Filters
for powered air-purifying respirators
will be addressed in another module.
Inhalation resistance maximum at 30 mm; Inhalation resistance maximum at 35 mm; exhalation resistance maximum at 20 mm. exhalation resistance maximum at 25 mm.
Isoamyl acetate tightness test for Isoamyl acetate tightness test was
particulate respirators was included. eliminated from the certification
procedures.
Certification of filters was based on Pass/Fail test based on results from 20 statistical evaluation of results from 30 filters tested. All must pass. filters tested.
Pending Part 11 applications would be All pending Part 11 applications will be
processed for six months, and no new processed. All new applications received
Part 11 applications accepted after the after the effective date of Part 84 will
effective date of Part 84. be considered applications for approval
under Part 84.
Approval holders allowed to Approval holders allowed to manufacture manufacture and sell Part 11 filters as and sell Part 11 filters as approved approved devices for 2 years from the devices for 3 years from the effective effective date of Part 84. date of Part 84.
No provisions were included for the A new subpart KK has been added for the
continued issuance of extensions of issuance of extensions of existing 30
existing 30 CFR Part 11 approvals. CFR Part 11 approvals to address
respirator non-conformances when there
is a demonstrated safety or health need
during the 3-year transition period and
for the approval of PAPRs until
addressed in a later module.
EFFECTIVE DATE: This final rule is effective on July 10, 1995
FOR FURTHER INFORMATION CONTACT: Richard W. Metzler, Chief, Certification and Quality Assurance Branch, Division of Safety Research, NIOSH, 1095 Willowdale Road, Morgantown, West Virginia 26505-2888. The telephone number is (304) 285-5907. Copies of this final rule can be downloaded from the NIOSH World Wide Web page (http://www.cdc.gov/niosh/homepage.html) or may 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.
The HHS Press Release announcing the publication of the final rule is also available.
The HHS Press Release announcing NIOSH certified respirators is also available.
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