[Federal Register Volume 60, Number 121 (Friday, June 23, 1995)]
[Notices]
[Pages 32716-32718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-15402]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-01888 License No. 20-06900-01 EA 95-038]
In the Matter of: Elias Charles Dow, M.D. Boston, Massachusetts;
Order Imposing a Civil Monetary Penalty
I
Elias Charles Dow, M.D. (Licensee) is the holder of Byproduct
Materials License No. 20-06900-01 (License) issued by the Atomic Energy
[[Page 32717]] Commission on November 7, 1960. The License was most
recently renewed by the Nuclear Regulatory Commission (NRC or
Commission) on April 24, 1990, and is currently under timely renewal.
The License authorizes the Licensee to possess and use certain
byproduct materials in accordance with the conditions specified therein
at the Licensee's facility in Brookline, Massachusetts.
II
An inspection of the Licensee's activities was conducted on
February 8, and March 1, 1995, at the Licensee's facility located in
Brookline, Massachusetts. The results of this inspection indicated that
the Licensee had not conducted its activities in full compliance with
NRC requirements. A written Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was served upon the Licensee by letter dated
April 20, 1995. The Notice states the nature of the violations, the
provisions of the NRC's requirements that the Licensee had violated,
and the amount of the civil penalty proposed for one of the violations.
The Licensee responded to the Notice in two letters, both dated
April 28, 1995. In its responses, the Licensee denies the violation
assessed a civil penalty (Violation I), and requests that the penalty
be withdrawn.
III
After consideration of the Licensee's response and the statements
of fact, explanation, and argument contained therein, the NRC staff has
determined, as set forth in the Appendix to this Order, the Violation I
occurred as stated in the Notice. The staff also has determined that an
adequate basis was not provided for mitigation of the penalty and that
a penalty of $750 should be imposed.
IV
In view of the foregoing and pursuant to Section 234 of the Atomic
Energy Act of 1954, as amended (Act), 42 U.S.C. 2282, and 10 CFR 2.205,
It is Hereby Ordered That:
The Licensee pay a civil penalty in the amount of $750 within 30
days of the date of this Order, by check, draft, money order, or
electronic transfer, payable to the Treasurer of the United States and
mailed to James Lieberman, Director, Office of Enforcement, U.S.
Nuclear Regulatory Commission, One White Flint North, 11555 Rockville
Pike, Rockville, Maryland 20852-2738.
The Licensee may request a hearing within 30 days of the date of
this Order. A request for a hearing should be clearly marked as a
``Request for an Enforcement Hearing'' and shall be addressed to the
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission,
Washington, D.C. 20555, with a copy to the Commission's Document
Control Desk, Washington, D.C. 20555. Copies also shall be sent to the
Assistant General Counsel for Hearings and Enforcement at the same
address and to the Regional Administrator, NRC Region I, 475 Allendale
Road, King of Prussia, PA 19406.
If a hearing is requested, the Commission will issue an Order
designating the time and place of the hearing. If the Licensee fails to
request a hearing within 30 days of the date of this Order, the
provisions of this Order shall be effective without further
proceedings. If payment has not been made by that time, the matter may
be referred to the Attorney General for collection.
In the event the Licensee requests a hearing as provided above, the
issues to be considered at such hearing shall be:
(a) Whether the Licensee was in violation of the Commission's
requirements as set forth in Section I of the Notice referenced in
Section II above, and
(b) Whether on the basis of such violation, this Order should be
sustained.
Dated at Rockville, Maryland this 16th day of June 1995.
For the Nuclear Regulatory Commission.
James Lieberman,
Director, Office of Enforcement.
Appendix
Evaluations and Conclusion
On April 20, 1995, a Notice of Violation and Proposed Imposition
of Civil Penalty (Notice) was issued for violations identified
during a NRC inspection conducted at the Licensee's facility located
in Brookline, Massachusetts. The penalty was issued for one
violation. The Licensee responded to the Notice in two letters, both
dated April 28, 1995. In its responses, the Licensee denies the
violation assessed a penalty (Violation I), and requests that the
civil penalty be withdrawn. The NRC's evaluation and conclusion
regarding the Licensee's requests are as follows:
Restatement of Violation I
10 CFR 20.1801 requires that the licensee secure from
unauthorized removal or access licensed materials that are stored in
controlled or unrestricted areas. 10 CFR 20.1802 requires that the
licensee control and maintain constant surveillance of licensed
material that is in a controlled or unrestricted area and that is
not in storage. As defined in 10 CFR 20.1003, unrestricted area
means an area, access to which is neither limited nor controlled by
the licensee.
Contrary to the above, as of February 8, 1995, the licensee did
not secure from unauthorized removal or limit access to licensed
materials stored in an unrestricted area. Specifically, on numerous
occasions, the licensee did not secure diagnostic capsules (each
containing between 14 and 129 microcuries of iodine-131(I-131))
located in patients' homes, an unrestricted area, nor did the
licensee control and maintain constant surveillance of this licensed
material.
Summary of Licensee's Response to Violation I
In its responses, the Licensee denies the violation and requests
that the civil penalty be withdrawn.
The Licensee states that the NMSS Licensee Newsletter 95-1
issued in March/April 1995, and the Federal Register dated January
25, 1995, both state that the medical administration of any
radiation or radioactive material to any individual, including an
individual who is not supposed to receive a medical administration,
is regulated by the Commission's provisions governing the medical
use of byproduct material (10 CFR Part 35) rather than the dose
limits in NRC's regulation concerning standards for protection
against radiation (10 CFR Part 20). The Licensee states that Part 35
takes precedence over Part 20 because the Licensee's use of I-131 in
this instance is a medical use. The Licensee states that the
regulation for unrestricted areas does not apply, and asserts that
this is stated in 10 CFR 20.1002. The Licensee states that it
appears that there should not have been a citation, since the I-131
was used for medical use.
The Licensee also states that the dispensing of I-131 capsules
for diagnostic use has never resulted in any harm, and there is no
way that capsules containing between 14 and 129 microcuries could
have caused unnecessary exposure to members of the public anymore
than if the patient had ingested the same capsule prior to leaving
the premises. The Licensee further states that there have never been
any reports in medical literature of instances of I-131 causing any
harm to anyone at this dosage. The Licensee states that it is purely
speculative and misleading to state that this could cause any
unnecessary exposure to members of the public.
The Licensee further states that a patient who ingests 25
millicuries of I-131 for therapeutic purposes is permitted to go
home, be with family, and mingle with the public without
restriction. In addition, the licensee states that it seems
paradoxical and illogical that the possession of a 100 microcurie
capsule, either in the patient's possession or ingested internally,
would constitute any public health hazard.
NRC Evaluation of Licensee's Response to Violation I
Notwithstanding the Licensee's contention, the NRC maintains
that a violation of 10 CFR Part 20 occurred, and that 10 CFR 20.1801
and 20.1802 required that the I-131 be [[Page 32718]] secured or
controlled until such time as it was administered to a patient. By
giving the I-131 capsules to patients to take to their residence for
self administration at a later time, the Licensee failed to secure
or control the licensed material as required.
With respect to the Licensee's comment regarding the NMSS
Licensee Newsletter 95-1 issued March/April 1995, and the Federal
Register notice on January 25, 1995 (60 FR 4872), these documents
describe a proposed NRC rulemaking concerning errors in
administering radiation or radioactive materials for medical
purposes. That rulemaking, if adopted in final form, would clarify
that the dose limits for individual members of the public in 10 CFR
20.1301 do not apply to the exposure that the individual receives
from such an error.\1\ There is nothing in the proposed rulemaking
that would exempt the medical use of licensed material from 10 CFR
20.1801 and 20.1802, which are the requirements that are cited in
the violation. 10 CFR Part 35 does not take precedence over 10 CFR
Part 20. 10 CFR 20.1002, ``Scope'', specifically states that the
regulations in 10 CFR Part 20 apply to persons licensed pursuant to
10 CFR Parts 30 through 36, which includes 10 CFR Part 35, ``Medical
Use of Byproduct Material.'' Similarly, 10 CFR 35.1, ``Purpose and
scope'', states that the requirements and provisions of 10 CFR Part
20 apply to licensees subject to 10 CFR Part 35, unless specifically
exempted.
\1\ Currently, 10 CFR 20.1002 provides that the limits of that
Part do not apply to doses due to exposure of patients to radiation
for the purpose of medical diagnosis or therapy.
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Therefore, the NRC maintains that the violation occurred as
stated in the Notice.
With respect to the Licensee's statement that dispensing of
capsules containing between 14 and 129 microcuries of I-131 could
not have caused any unnecessary exposure to members of the public
anymore than if the patient had ingested the same capsule prior to
leaving the premises, the NRC disagrees. Because of the Licensee's
lack of security or control over the capsule (i.e., after the
capsule had been given to the patient to take to the patient's
home), the capsule could have been ingested inadvertently by someone
other than the patient. Such an event would result in an unnecessary
radiation exposure to an unintended person far in excess of the
regulatory limits for radiation exposure to members of the public.
Therefore, the violation was properly categorized at Severity Level
III in accordance with the Enforcement Policy because of the
potential safety hazard.
NRC Conclusion
The NRC has concluded that the violation assessed a penalty
occurred as stated in the Notice. In addition, the NRC has concluded
that the Licensee did not provide an adequate basis for withdrawal
of the civil penalty. Accordingly, the proposed civil penalty in the
amount of $750 should be imposed.
[FR Doc. 95-15402 Filed 6-22-95; 8:45 am]
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