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42 CFR Part 84 Respiratory Protective Devices Final Rule [Federal Register: June 8, 1995 (Volume 60, Number 110)] [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.

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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.
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Total................................... ........... ........... .................... 130,805 hr.
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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 cha