[Federal Register Volume 59, Number 70 (Tuesday, April 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8697]


[[Page Unknown]]

[Federal Register: April 12, 1994]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 32

[Docket No. PRM-32-3]

 

Advanced Medical Systems, Inc; Denial of Petition for Rulemaking

AGENCY: Nuclear Regulatory Commission.

ACTION: Denial of petition for rulemaking.

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SUMMARY: The Nuclear Regulatory Commission (NRC) is denying a petition 
for rulemaking (PRM-32-3) from Advanced Medical Systems, Inc. The 
petitioner requested that the NRC amend its regulations because it 
believed that the requirements of part 32, which are applicable to 
original manufacturers and suppliers, were not equally applicable to 
manufacturers and suppliers of replacement parts. The petition is being 
denied because current regulations apply equally to manufacturers and 
suppliers of both original and replacement parts, ensuring the 
integrity of these parts; therefore, no additional requirements 
addressing the regulation of manufacturers and suppliers of replacement 
parts are necessary. Further, current regulations address service and 
maintenance of sources and devices possessed and used under an NRC 
license, including replacement parts, whether manufactured or supplied 
by the original manufacturer or supplier or some other manufacturer or 
supplier. Therefore the amendments suggested by the petitioner are not 
necessary.

ADDRESSES: Copies of the petition for rulemaking, the public comments 
received, and the NRC's letter to the petitioner are available for 
public inspection or copying in the NRC Public Document Room, 2120 L 
Street NW., (Lower Level), Washington, DC.

FOR FURTHER INFORMATION CONTACT:
Naiem S. Tanious, Office of Nuclear Regulatory Research, U.S. Nuclear 
Regulatory Commission, Washington, DC 20555, telephone (301) 492-3878.

SUPPLEMENTARY INFORMATION:

The Petition

    In a letter dated June 28, 1991, Advanced Medical Systems, Inc. 
(AMS) filed a petition for rulemaking with the NRC. The petition was 
docketed by the Commission on July 19, 1991, and was assigned Docket 
No. PRM-32-3. The petitioner requested that the NRC amend its 
regulations because it believed that the requirements of part 32, which 
are applicable to original manufacturers and suppliers, were not 
equally applicable to manufacturers and suppliers of replacement parts. 
The petitioner has suggested two alternatives for accomplishing this 
objective. The first alternative is to insert the necessary language 
regarding manufacturers and suppliers of replacement parts into each 
appropriate section of part 32. The second alternative would revise the 
purpose and scope provisions of Sec. 32.1 to include manufacturers and 
suppliers of replacement parts.

Basis for Petitioner's Request

    The petitioner identified itself as an original teletherapy 
equipment manufacturer. As such, it has a definite and direct interest 
in the health and safety of the public who may use or be treated by 
equipment it manufactures.
    According to the petitioner, it appears that the requirements of 
part 32 are being interpreted as applying only to manufacturers and 
suppliers of original equipment and not to manufacturers and suppliers 
of replacement parts, devices, products, or sources designated for 
units originally manufactured or transferred by others. In the 
petitioner's view, lack of specific requirements applicable to 
manufacturers and suppliers of replacement parts, devices, products, or 
sources, can lead to use of inferior quality replacement parts which in 
turn can cause malfunction or failure of devices, in particular 
teletherapy equipment, and thereby risk of overexposure. Advanced 
Medical Systems cited two incidents as examples of this problem: Access 
No. M49250, Anderson Memorial Hospital, Anderson, South Carolina; and 
Access No. M49324, St. Mary's Medical Center, Saginaw, Michigan.

Public Comments on the Petition

    A notice of receipt of the petition for rulemaking was published in 
the Federal Register on October 10, 1991 (56 FR 51182). Interested 
persons were invited to submit written comments concerning the 
petition. The comment period closed December 9, 1991. The NRC received 
comments from the State of Illinois, Department of Nuclear Safety, and 
the Department of the Air Force, Headquarters Air Force Office of 
Medical Support.
    The State of Illinois, Department of Nuclear Safety, stated that 
the Department fully supports development of the rule proposed in the 
petition. The Department further stated that the integrity of NRC 
evaluated devices (NRC or an Agreement State evaluate for safety any 
devices containing radioactive materials) may be compromised 
significantly if nonstandard replacement parts are used during the life 
of the device. While the Department agreed that the issue of 
replacement components needs to be addressed, it was concerned with the 
use of the term ``replacement sources and devices'' in the wording of 
Secs. 32.74, 32.110 and 32.210 as suggested by the petitioner. The 
Department believed that all sources and devices must be evaluated by 
the NRC or an Agreement State, whether or not they are considered 
``original'' or ``replacement'' equipment. Therefore, the Department 
did not believe it is necessary to distinguish between original or 
replacement sources or devices. The Department was in favor of the 
petitioner's suggested alternative to modify Sec. 32.1, Purpose and 
Scope.
    The Headquarters Air Force Office of Medical Support, Department of 
the Air Force, opposed the rule language proposed by the petitioner, as 
written, although it agreed with the petitioner's intent to ensure that 
the safety and effectiveness of devices not be compromised because 
original parts are replaced by inferior ones. They did not agree that 
all replacement parts should be subject to the requirements of 10 CFR 
part 32. They stated that NRC review and approval should apply to 
replacements of parts or components that are essential to the proper 
and safe operations of a device. The Air Force gave examples of parts 
(such as panel screws and covers) that conform to industry standards. 
These, the Air Force stated, should not be subject to the proposed 
requirements. The Air Force voiced concern that the petition, as 
written, may serve to restrict competition and would lead to greater 
expense which would have to be recouped through higher medical costs 
from patients, or, in the case of the Air Force, from taxpayers.

NRC Action on the Petition

    The NRC reviewed the petition, the public comments, and the two 
cases (incidents) cited by the petitioner as supporting evidence for 
filing this petition. The NRC also reviewed its regulations pertinent 
to the petition.
    Shortly after the NRC received correspondence\1\ from AMS about the 
two cases, the NRC advised\2\ AMS of its intention to investigate these 
incidents, especially with regard to the quality of service and 
replacement parts used in servicing the teletherapy units. From October 
to December 1989, the NRC conducted a thorough investigation which 
included three onsite inspections: Atom Mechanical Company, Cleveland, 
Ohio (The servicing company that conducted the maintenance and 
replacement of parts in the two cases), St. Mary's Medical Center, 
Saginaw, Michigan, and Picker International, Highland Heights, Ohio 
(The company that manufactured the teletherapy units at Anderson 
Memorial Hospital and at St. Mary's Medical Center). The NRC also 
referred the case of Anderson Memorial to the State of Maryland, 
because the company that serviced the teletherapy unit there, Atom 
Mechanical Company, is an authorized user on the Neutron Products, Inc. 
license, and Neutron Products is located in the State of Maryland, an 
Agreement State.
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    \1\Three letters dated June 20, August 8, and August 25, 1989, 
to Hugh L. Thompson, Jr., Deputy Executive for Nuclear Materials 
Safety and Safeguards & Operations Support, NRC, from Sherry Stein, 
Director, Regulatory Affairs, Advanced Medical Systems, Inc.
    \2\By a letter dated September 15, 1989 from Robert M. Bernero, 
Director, Office of Nuclear Material Safety and Safeguards, NRC, to 
Sherry Stein, Director, Regulatory Affairs, Advanced Medical 
Systems, Inc.
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    The incident at Anderson Memorial Hospital was caused by a broken 
spring in a teletherapy unit which failed to retract the source into 
the OFF position following a cobalt-60 cancer treatment. The hospital 
technologist promptly retracted the source manually. According to the 
hospital report, the technologist received very little additional 
exposure over expected monthly exposure, as evidenced by the 
individual's radiation film badge reading. Moreover, according to the 
same report the delivered daily dose to the patient was less than the 
prescribed daily dose, i.e., no patient overexposure for that 
treatment, because the technologist acted promptly. In its 
communication with NRC (prior to filing the petition), AMS stated that 
it was concerned about the quality of the replacement springs used in 
the teletherapy machine.
    The incident at St. Mary's Medical Center was caused by the failure 
of a microswitch. The failure of the switch prevented a timing device 
from operating properly, to automatically terminate the treatment. No 
misadministration occurred because the subsequent treatment times were 
adjusted and the total delivered dose did not differ from the total 
prescribed dose. Neutron Products, Inc. was called to repair the 
machine.
    The NRC investigation and subsequent inspections revealed several 
violations. Enforcement action was taken by the NRC against Atom 
Mechanical for violation of part 21 requirements, and against St. 
Mary's Hospital and Picker International for violations of part 35 and 
part 30 requirements, respectively.3 Moreover, the State of 
Maryland determined from its own investigation that the incident at 
Anderson Memorial Hospital resulted from a failure of the part, i.e., 
breakage of the return spring. No enforcement action was taken by the 
State of Maryland.
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    \3\Specifically, Atom Mechanical Company was found to be in 
violation of 10 CFR 21.21 (October 16, 1989), St. Mary Medical 
Center was found to be in violation of 10 CFR 35.59(g), 10 CFR 
35.605, 10 CFR 35.630(a), 10 CFR 35.615(d)(4), 10 CFR 35.632(a), and 
10 CFR 35.634(a) (October 17 and 26, 1989), and Picker 
International, Inc. was found to be in violation of 10 CFR 30.3 
(subsequent to inspections that occurred on October 26 and November 
9, 1989). Inspection reports are available for review in the NRC 
Public document room.
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    Under current NRC regulations, persons authorized under a specific 
license to use devices containing byproduct material (e.g., use of 
teletherapy equipment under a part 35 specific license) ultimately are 
responsible for the safe use of these devices, and for assuring that 
such devices are properly maintained. Suppliers of sources or devices 
containing byproduct material, whether they are an original 
manufacturer or a manufacturer of replacement sources or devices, must 
be licensed under parts 30 or 32 or an appropriate Agreement State 
license, and also have responsibility for the safety of the sources or 
devices that they supply or replace. Service or repair, which would 
include the replacement of parts or components of medical or industrial 
sources or devices that present a risk of radiation exposure from the 
failure of certain parts, such as the teletherapy devices discussed as 
examples in this petition, may be performed only by qualified persons 
authorized under an NRC or Agreement State license (cf. Secs. 35.605, 
and 39.43(e)). Some generally licensed devices may be serviced by 
general licensees who are authorized to perform limited service work if 
sufficient information about the service work (e.g., procedures, 
training, expected dose, etc.) is submitted by manufacturer or initial 
distributor and accepted by the NRC. However, these devices typically 
are not mechanically complex and do not present the same risk of 
significant radiation exposure. Moreover, the NRC has no record of 
failure of these devices leading to a radiation exposure attributable 
to defective replacement parts or improper servicing. Finally, under 
the provisions of part 21, the supplier of any basic component,4 
whether or not a licensee of NRC or an Agreement State, is also 
responsible for the quality of the component, whether it is original or 
replacement.
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    \4\A ``basic component'' is defined in part 21 as one, ``* * * 
in which a defect could create a substantial safety hazard.''
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Reasons for Denial

    The NRC has examined the petition (1) in light of its regulations 
and policies for both general and specific licensees, and (2) in view 
of the cases cited by the petitioner in support of the petition. The 
NRC is denying the petition because current regulations apply equally 
to manufacturers and suppliers of both original and replacement parts, 
ensuring the integrity of these parts; therefore, no additional 
requirements addressing the regulation of manufacturers and suppliers 
of replacement parts are necessary. Further, current regulations 
address service and maintenance of sources and devices possessed and 
used under an NRC license, including replacement parts, whether 
manufactured or supplied by the original manufacturer or supplier or 
some other manufacturer or supplier.
    Accordingly, the petition for rulemaking is denied.

    Dated at Rockville, Maryland this 28th day of March, 1994.

    For the Nuclear Regulatory Commission.
James M. Taylor,
Executive Director for Operations.
[FR Doc. 94-8697 Filed 4-11-94; 8:45 am]
BILLING CODE 7590-01-P