Information Notice No. 83-67: Emergency-use Respirator Material Defect Causes Production of Noxious Gases

                                                            SSINS No.: 6835 
                                                            IN 83-67       

                                UNITED STATES
                           WASHINGTON, D.C. 20555
                              October 11, 1983

                                   CAUSES PRODUCTION OF NOXIOUS GASES 


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. 


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 


                                                           IN 83-67        
                                                           October 11, 1983 
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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. 


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 
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If you need additional information about these matters, please contact the 
Regional Administrator of the appropriate NRC Regional Office, or this 

                                   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

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