NUREG-1537, Part 2 - NRC

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Medical therapy at non-power reactors comprises two regulatory components.
The first component involves the medical use licensee, who is responsible for the
patient, preparation of a treatment plan and written directive (as"defined in 10 CFR
Part 35), administration of the boron pharmaceuticals and the neutron beam to the
patient, supervision of the setup and irradiation of the patient; and control of the
byproduct material formed in the patient's body as a result of the treatment. The
regulatory requirements for the' medical use licensee are not discussed in this
chapter other than, to state that the license must list the non-power reactor medical
therapy treatment facility as an additional place of use. 'For firther details on this
aspect of BNCT, contact'the Medical, Academic,'and Commercial Use Safety
Branch of the Division of Industrial and Medical Nuclear Safety in the Office of
Nuclear Material Safety and Safeguards at NRC.
The second regulatory component involves the n6n-power reactor, which provides
the treatment (neutrons) under the 10 CFR Part 50 reactor license. The nonpower
reactor component comprises the'medical therapy treatment facility,
production of the neutron beam, physical characterization of the beam at its
interface with the patient, all health physics considerations associated with the
beam, radioactive contamination and activation of the medical therapy treatment
room and its contents, and adherence to a quality management program for the
conduct of human therapy. The regulatory approach for the non-power reactor is
modeled after the approach found in 10 CFR Part 35, Subpart I, concerning
tdeleheapy. .~
licensees may also have to meet Food and Drug Administration (FDA)
requirements and receive approval from FDA to conduct medical therapy. These
requirements are beyond the scope of this document.
licensees who want to irradiate patients shall hold a Class 104a license from NRC.
The determination if a construction permit (CP) is needed for an existing ficility to
receive a Class 104a license depends on the'amount of modification and
construction required at the facility to initiate BNCT. In general if major
modifications do not need to be made to the reactor core or structure, a CP is not
required. However, the applicant should recognize that failure to address safety
issues at the start of a modification could result in delays or additional
modifications at a later point. Medical therapy treatment facilities can be installed,
filters can be' added to existing beam tubes, and in most cases, additional beam
tubes can be installed in the reactor without a CP.
Areas of review should include the following:
administrative requirements associated with patient irradiations, including
quality assurance
NURBG-1537,PART2 16-4 REv. 0,2/96
NUREG-1537,PART2 16-4 REV. 0, 2/96