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[Federal Register Volume 60, Number 110 (Thursday, June 8, 1995)]
[Notices]
[Pages 30403-30404]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13288]

Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / 
Notices
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[[Page 30403]] 

DEPARTMENT OF LABOR

Mine Safety and Health Administration

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Memorandum of Understanding Between the Mine Safety and Health 
Administration and the National Institute for Occupational Safety and 
Health Regarding the Respirator Approval Program

AGENCY: Mine Safety and Health Administration, Labor and National 
Institute for Occupational Safety and Health, CDC, HHS.

ACTION: Notice.

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SUMMARY: This notice is to advise the public of the issuance of a 
memorandum of understanding (MOU) between the Mine Safety and Health 
Administration (MSHA), U.S. Department of Labor, and the National 
Institute for Occupational Safety and Health (NIOSH), Centers for 
Disease Control, U.S. Department of Health and Human Services. This MOU 
delineates the roles of both agencies in a new respirator approval 
program under the provisions of 42 CFR part 84. Concurrently, MSHA is 
removing 30 CFR part 11 which contained the provisions of the existing 
respirator approval program. Both the MSHA and NIOSH final rules are 
published elsewhere in this separate part of the Federal Register.

DATES: This MOU will become operative on July 10, 1995.

FOR FURTHER INFORMATION CONTACT:
Peter M. Turcic, Chief, MSHA Approval and Certification Center, 304-
547-2029, or Richard W. Metzler, Chief, Certification and Quality 
Assurance Branch, NIOSH Division of Safety Research, 304-285-5907.

SUPPLEMENTARY INFORMATION: On December 10, 1984, MSHA and NIOSH entered 
into an agreement for consultation, coordination, and cooperation in 
effectively and efficiently carrying out their respective safety and 
health functions under the Federal Mine Safety and Health Act of 1977. 
This MOU supplements the 1984 agreement and, to the extent inconsistent 
with that agreement, supersedes it. This MOU is being published 
concurrently with the MSHA and NIOSH final rules addressing the 
approval of respirators to aid in understanding these rulemakings.

    Dated: May 24, 1995.
J. Davitt McAteer,
Assistant Secretary for Mine Safety and Health, U.S. Department of 
Labor.

    Dated: May 24, 1995.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention, U.S. Department of Health 
and Human Services.

Memorandum of Understanding Between the Mine Safety and Health 
Administration and the National Institute for Occupational Safety and 
Health

I. Introduction

A. Background

    The Federal Mine Safety and Health Act of 1977 (Mine Act) 
provides for the protection of the health and safety of our Nation's 
miners. In furtherance of the goals of the Mine Act, the Secretaries 
of Health and Human Services (HHS) and Labor coordinate their 
expertise and activities in the field of mine health and safety. 
This Memorandum of Understanding (MOU) sets out the procedures to be 
followed by the Secretaries in coordinating their responsibilities 
with respect to the joint approval of respirators.
    On May 4, 1978, the National Institute for Occupational Safety 
and Health (NIOSH) of the Department of Health, Education and 
Welfare, predecessor to HHS, entered into an Agreement with the Mine 
Safety and Health Administration (MSHA), Department of Labor, to 
ensure full and effective use of the capabilities and resources of 
NIOSH and MSHA to assist in planning research and to provide the 
maximum utilization of technological developments resulting from 
mine health and safety research. That Agreement was revised on 
December 10, 1984. This Memorandum of Understanding (MOU) 
supplements the above mentioned Agreements and, to the extent 
inconsistent with those Agreements, supersedes them.

B. Purpose

    The purpose of this MOU is to establish procedures to be 
followed by MSHA and NIOSH in exercising their respective 
responsibilities for joint approval of certain respirators under the 
provisions of 42 CFR Part 84. It also establishes guidelines for 
interaction between MSHA and NIOSH with respect to issues dealing 
with respirator certification and related matters. These issues 
include but are not limited to: certification, quality assurance, 
and field complaints.

C. Authority

    This MOU is consistent with, and is entered into under the 
authority of, the Mine Act.

II. Joint Approval of Respirators Used for Mine Rescue and Other Mine 
Emergencies

A. Respirators Subject to Joint Approval

    1. NIOSH will conduct the examinations, inspections and tests of 
respirators submitted for certification pursuant to the requirements 
of 42 CFR Part 84.
    2. Except for those respirators used for mine rescue and other 
mine emergencies, NIOSH is solely responsible to evaluate and 
certify respirators under the provisions of 42 CFR part 84.
    3. MSHA and NIOSH will jointly evaluate respirators used for 
mine rescue and other mine emergencies and subsequently issue a 
joint certification of approval for such respirators.
    4. Respirators used for mine rescue and other mine emergencies 
include filter self-rescuers (FSRS), self-contained self-rescuers 
(SCSR), mine rescue apparatus (long duration, closed and open 
circuit devices), and other self-contained breathing apparatus 
(SCBA). In the event a new class of respirator is submitted for 
certification, NIOSH will consult with MSHA concerning the potential 
for mine use and the need for joint approval.
    5. In the event of disagreement as to whether a particular class 
of respirator is used for mine rescue and other mine emergencies, 
MSHA will make a final determination.

B. Preapproval Procedures

    Prior to MSHA/NIOSH joint approval of respirators used for mine 
rescue and other mine emergencies, the following procedures will be 
followed to assist in the determination of whether a candidate 
respirator has fulfilled the applicable requirements of 42 CFR part 
84:
    1. MSHA and NIOSH will provide such consultation and assistance 
to each other as necessary to assure the proper joint approval of 
respirators and fulfill the intent of 42 CFR Part 84.
    2. MSHA will, by mutual agreement with NIOSH, provide subjects 
for NIOSH testing of jointly approved respirators in accordance with 
the pertinent requirements of 45 CFR Part 46 and the Human Subject 
Review Board.
    3. As coequals in the joint approval of respirators used for 
mine rescue and other mine emergencies, MSHA and NIOSH will share 
access to all examinations, inspections, tests, evaluations and 
other pertinent information leading to the certification of such 
respirators.
    4. MSHA and NIOSH will jointly evaluate the respirator service 
life plans and user's manuals for jointly approved respirators.
    5. MSHA and NIOSH will jointly establish any limitations to be 
required for jointly approved respirators.

C. Joint Approval

    1. NIOSH will conduct all examinations, inspections and tests of 
respirators pursuant to the requirements of 42 CFR Part 84.
    2. NIOSH and MSHA will jointly determine whether a candidate 
respirator intended for mine rescue and other mine emergencies has 
fulfilled the requirements of 42 CFR Part 84. Upon such 
determination, NIOSH and MSHA will issue a joint respirator 
approval, which shall include appropriate use limitations.
    3. NIOSH and MSHA shall sign the approval certificate and each 
Agency shall maintain timely processing procedures.
III. Quality Assurance
    1. NIOSH and MSHA will notify each other in advance of the 
intent to conduct audits of respirators and/or manufacturing sites 
for [[Page 30404]] jointly approved respirators and will invite 
joint participation in such activities. Care will be taken to 
prevent duplication or repetition of audit activities.
    2. The results of NIOSH or MSHA audits of jointly approved 
respirators will be shared immediately with the other Agency through 
established procedures.
    3. Discrepancies or nonconformances identified in audits of 
jointly approved respirators and/or manufacturing sites for jointly 
approved respirators will be resolved jointly by MSHA and NIOSH.
    4. NIOSH will notify MSHA of all respirator discrepancies and 
nonconformances identified with any respirator bearing the NIOSH 
certification. If MSHA determines that the respirator in question 
has significant mine use, MSHA will consult with NIOSH and jointly 
participate in resolution of mine use problems.

IV. Post-Approval Complaints

    1. Reports of discrepancies or nonconformances involving jointly 
approved respirators will be shared immediately between the two 
agencies and investigations of such discrepancies and 
nonconformances will be jointly conducted by NIOSH and MSHA.
    2. MSHA and NIOSH will jointly participate in the planning and 
resolution of complaints involving MSHA/NIOSH approved respirators. 
Such joint participation will include all activities related to 
product retrofit, recalls, stop sale notices, user notices, and 
revocation of prior certifications.
    3. MSHA and NIOSH will promptly notify each other of respirator 
field complaints received by either Agency. MSHA will participate 
with NIOSH in resolution of such complaints only if MSHA determines 
that the cause of the complaint or its resolution has an impact on 
the mining industry.

V. Respirators With Electrical Components

    1. Respirators having electrical components and intended for use 
in mines where methane may be present must be permissible and are 
subject to the requirements of 30 CFR Part 18. These respirators 
will be approved for permissibility solely by MSHA. MSHA will 
independently conduct the examinations, inspections and tests of 
respirators submitted for certification pursuant to the requirements 
of 30 CFR Part 18. NIOSH will provide consultation as requested by 
MSHA.
    2. MSHA will independently conduct audits, nonconformance 
investigations, and resolve nonconformances associated with the 
electrical components of respirators approved in accordance with 30 
CFR Part 18 requirements. A report of all such audit results will be 
promptly provided to NIOSH by MSHA.
    3. MSHA will notify NIOSH in advance of the intent to audit Part 
18 respirators. Care will be taken to coordinate audit activities 
and prevent duplication or unnecessary repetition of audit efforts.

VI. Administration

    This MOU will be administered on behalf of MSHA by the Chief, 
Approval and Certification Center or by such other representative as 
the Assistant Secretary for Mine Safety and Health designates in 
writing to NIOSH.
    This MOU will be administered on behalf of NIOSH by the Chief, 
Certification and Quality Assurance Branch or by such other 
representative as the Director of NIOSH designates in writing to 
MSHA.

VII. Effective Date, Amendment and Termination

    This MOU will become operative on the effective date of 42 CFR 
part 84 and upon execution of this MOU by both parties. It may be 
modified or terminated only upon written agreement executed by both 
parties.

    Dated: May 4, 1995.
J. Davitt McAteer,
Assistant Secretary for Mine Safety and Health, U.S. Department of 
Labor.

    Dated: May 4, 1995.
Linda Rosenstock,
Director, National Institute for Occupational Safety and Health, U.S. 
Department of Health and Human Services.
[FR Doc. 95-13288 Filed 6-2-95; 12:10 pm]
BILLING CODE 4510-43-M
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