[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
