Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Notices 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.

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 selfrescuers (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
30404 Federal Register / Vol. 60, No. 110 / Thursday, June 8, 1995 / Notices

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]

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