Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
SSINS No.: 6835
IN 83-67
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF INSPECTION AND ENFORCEMENT
WASHINGTON, D.C. 20555
October 11, 1983
Information Notice No. 83-67: EMERGENCY-USE RESPIRATOR MATERIAL DEFECT
CAUSES PRODUCTION OF NOXIOUS GASES
Addressees:
All nuclear power reactor facilities holding an operating license (OL) or
construction permit (CP), research and test reactor licensees, fuel cycle
licensees, and Priority I material licensees.
Purpose:
This information notice is provided to inform licensees of a potentially
serious problem with the Bio-Pak 60-P respirator manufactured by Rexnord
Company (NIOSH/MSHA approval number TC 13F-85). This respirator is approved
for emergency use by the National Institute for Occupational Safety and
Health (NIOSH) and is a closed-circuit, positive-pressure self-contained
breathing apparatus (SCBA). The oxygen supply valve seat of the high
pressure oxygen bottle (manufactured prior to 1981) tends to shear during
valve operation, creating Kel-FTM fibers. During startup for operation,
these fibers ignited in the pure oxygen supply stream, releasing combustion
products including C02, Co, CF4 and HF. It is expected that licensees will
review the information for applicability to their facilities. Further NRC
action may result from feedback from the ongoing NIOSH review effort. No
written response to this notice is required.
Description of Circumstances:
During a July 1983 training session conducted at Southern California Edison
Company's San Onofre Nuclear Generating Station (SONGS), hot gases and
noxious odors filled the facepiece of a Bio-Pak 60-P respirator being used
as a training aid. SONGS contacted the manufacturer and learned that Rexnord
had become aware of the problem sometime during 1981 and had subsequently
directed the oxygen-bottle vendor to replace the Kel-F valve seat with
another material, Vespel TM. In discussions with the licensee, Rexnord
stated that their previous findings were that the combustion products
liberated by the burning Kel-F were in concentrations less than their
respective threshold limiting values (TLVs). The previously produced units
with the defective Kel-F materials were not recalled, and customer/users and
NIOSH were not notified of the problem or the unauthorized change to the
respirator.
8308300759
.
IN 83-67
October 11, 1983
Page 2 of 3
Following the discussion with the manufacturer, the licensee then notified
the NRC Region V Office, and asked NIOSH about the approval status of the
"modified" Bio-Pak 60-Ps. NIOSH had not approved this modification, thus
voiding the respirator's certification. As a consequence of this
information, the licensee then petitioned NIOSH to extend the approval of
the respirator for 10 days to allow time to take compensatory measures to
comply with site emergency planning (EP) and fire protection requirements.
On September 19, 1983, NIOSH honored this request for extension; in the
interim, SONGS determined that their facility had enough pressure demand
SCBA respirators to meet the EP and fire protection requirements.
Although the manufacturer had not specifically requested a NIOSH review and
approval for the change, the valve seat material change had been tested when
the device was submitted for other unrelated respirator modifications that
were implemented after 1981. However, NIOSH has requested that the
manufacturer submit documentation of the valve seat change and obtain a
written certification from the oxygen-bottle vendor that they will not
modify the bottle's form, materials, and function without specific
authorization/ notification by the Rexnord Company.
Discussion:
Use of defective equipment produced prior to and during 1981 could pose
danger to the user from the toxic materials liberated from ignited fibers of
Kel-F. Although the manufacturer claims the concentrations of the combustion
products may not exceed the TLVs in most cases, inhalation of the toxic
substances may incapacitate the wearer or force the wearer to remove the
respirator in otherwise hazardous or life-threatening situations.
Additionally, the degradation of the valve seats can make valve operation
physically difficult, and can cause leakage of oxygen from the supply
bottle. This unaccountable loss of oxygen may also jeopardize the wearer's
safety. Although the device happened to have been retested subsequent to
replacement of the valve seat with Vespel, the manufacturer had not obtained
the oxygen-bottle vendor's written commitment, documenting the change in the
bottle materials and specifications. NIOSH considers such an omission and
unapproved change to an apparatus to void the equipment's approval. NRC
regulations prohibit the use of emergency respiratory equipment unless
specifically certified by NIOSH.
The manufacturer of the Bio-Pak 60-P respirator, (Biomarine Corp. which was
later purchased by Rexnord Co.), has made two other material changes to this
SCBA without making the required notification to NIOSH. Without formal
manufacturer submittals of all changes to equipment, NIOSH is unable to
perform its design reviews to ensure that user safety has not been adversely
affected (see NIOSH's Stop-Sales and Recall Letter dated April 11, 1980 and
Information Notice No. 83-21: Defective Emergency-Use Respirator, dated April
15, 1983).
.
IN 83-67
October 11, 1983
Page 3 of 3
If you need additional information about these matters, please contact the
Regional Administrator of the appropriate NRC Regional Office, or this
office.
Edward L. Jordan Director
Division of Emergency Preparedness
and Engineering Response
Office of Inspection and Enforcement
Technical Contacts: J. E. Wigginton, IE
(301) 492-4967
L. Hendricks, RES
(301) 442-7970
Attachment:
List of Recently Issued IE Information Notices
.
