U.S. Nuclear Regulatory Commission
Respirator User's Notice - Use of Unapproved Subassemblies
HPPOS-147 PDR-9111220069
Title: Respirator User's Notice - Use of Unapproved
Subassemblies
See the above entitled notice issued by J. B. Moran on
November 6, 1984. This notice states that NIOSH / MSHA
approves only complete respirator assemblies and not
subassemblies such as cylinders or air supply hoses. Users
of approved respirators must not interchange subassemblies
or make unapproved modifications to respiratory protection
devices.
The National Institute for Occupational Safety and Health
(NIOSH) had received many questions and complaints in
regard to the interchangeability of respirator
subassemblies and unapproved modifications to NIOSH / MSHA
certified respirators. Further, some problems reported to
NIOSH had, upon investigation, been found to have been
caused by user's modifying certified respirators that
resulted in the modified respirator failing to perform as
anticipated, thus jeopardizing the respirator user.
NIOSH / MSHA respirator certification regulations, Title 30
Code of Federal Regulations Part 11 (30 CFR 11), state that
approved respirators "are maintained in an approved
condition and are the same in all respects as those
respirators for which a certificate has been issued." [30
CFR 11, 11.2 (b)] In addition, the regulations permit
NIOSH / MSHA to approve only complete respirator assemblies
and prohibit the approval of respirator subassemblies such
as cylinders or air supply hoses. These requirements are
intended to ensure that one manufacturer has overall
control and responsibility for the integrity of the
approved respirator.
In some cases even minor modifications to respirators may
make significant changes in the performance of the
respirator. Manufacturers who modify certified respirators
must test the modification to determine if the respirator
continues to meet the minimum requirements of 30 CFR 11,
and must submit the modifications to NIOSH. A user who
modifies a certified respirator may not be able to
determine whether a change will decrease respiratory
protection. Several cases have been reported to NIOSH
where unapproved modifications or use of an unapproved
subassembly have resulted in respirator failures.
Therefore, users of NIOSH / MSHA approved respirators are
cautioned against interchanging subassemblies or making
unapproved modifications to their respiratory protective
devices.
Regulatory references: 10 CFR 20.103, 10 CFR 20.1703
Subject codes: 8.10
Applicability: All