[Federal Register Volume 59, Number 111 (Friday, June 10, 1994)]
[Unknown Section]
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From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-14208]


[[Page Unknown]]

[Federal Register: June 10, 1994]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 030-19747 License No. 52-21082-01 IA 94-013]

 

In the Matter of Guillermo Velasquez, M.D. San Juan, PR

Confirmatory Order

I
    Guillermo Velasquez, M.D. (Licensee) is the holder of expired 
Byproduct Materials License No. 52-21082-01 (license) issued by the 
Nuclear Regulatory Commission (NRC or Commission) pursuant to 10 CFR 
parts 30 and 35 on September 3, 1982. The license authorized the use of 
strontium-90 for ophthalmic radiotherapy in accordance with the 
conditions specified therein. The license was renewed in its entirety 
on August 21, 1987, and expired on August 31, 1992. The byproduct 
material remained in the possession of the Licensee until it was 
transferred to an authorized recipient on January 7, 1994 pursuant to 
an NRC Order to Transfer Byproduct Material to an Authorized Recipient 
(Effective Immediately) and Demand for Information issued July 21, 
1993.
II
    The Licensee did not submit an application for renewal of the 
license prior to its expiration, as required by 10 CFR 30.37, nor did 
the Licensee notify the Commission in writing, pursuant to 10 CFR 
30.36, of a decision not to renew the license. Therefore, on September 
11, 1992, NRC Region II issued a Notice of Violation (Notice) to the 
Licensee for failure to request renewal prior to expiration of the 
license or to file a notice of non-renewal or transfer of the byproduct 
material. The letter forwarding the Notice directed the Licensee to 
place the strontium-90 in storage and to discontinue use of the 
material until he obtained a new NRC license. In the alternative, the 
Licensee was directed to transfer the material to an authorized 
recipient if adequate storage was not available, or to submit an NRC 
Form 314 to the NRC if the Licensee chose to dispose of the byproduct 
material. During a December 4, 1992 telephone conversation between a 
Region II inspector and the Licensee, the Licensee stated that the 
source was locked in storage and that the Licensee had not used the 
source. The Licensee responded to the Notice on December 4, 1992, by 
requesting renewal of the license. Because the Licensee failed to 
provide the appropriate licensing fee, no action was taken by the NRC 
to renew the license and the Licensee was notified.
    The NRC performed a routine inspection of the Licensee's facility 
in Rio Piedras, Puerto Rico on February 24, 1993. One purpose of this 
inspection was to determine the status of the strontium-90 source. The 
inspection revealed that the Licensee had continued to use the 
material: (1) After expiration of the license; (2) after receipt of the 
NRC letter and Notice dated September 11, 1992, which directed the 
Licensee to place the material in storage and to discontinue use of the 
material until a new license was obtained; and (3) after the December 
4, 1992 telephone conversation with the Region II inspector when the 
inspector explained that the source could not be used and the Licensee 
had stated the source was in locked storage and not being used.
    In April and May 1993, the NRC Office of Investigations conducted 
an investigation of the circumstances surrounding the Licensee's 
apparent use of the source after the license had expired and after 
receiving notification from the NRC to discontinue use of the material 
until a new license was obtained. As a result of this investigation, it 
was determined that on 20 occasions, between October 9, 1992, and 
February 19, 1993, the Licensee, with the full understanding that use 
of the source was prohibited, deliberately used the strontium-90 source 
for patient ophthalmic radiotherapy, in violation of 10 CFR 30.3. In 
addition, the investigation confirmed that the Licensee deliberately 
provided false information to the NRC inspector during the December 4, 
1992 telephone conversation and during the inspection conducted at the 
Licensee's facility on February 24, 1993. Specifically, the Licensee 
told the NRC inspector that the strontium-90 source had not been used 
for ophthalmic radiotherapy since receipt of the Notice which was 
issued on September 11, 1992, when in fact the Licensee had used the 
strontium-90 source at least 20 times between October 9, 1992 and 
February 19, 1993, which was as recently as five days before the 
inspection. This deliberate submission of materially false information 
constitutes violations of 10 CFR 30.9 and 30.10.
III
    Based on the NRC inspection and the subsequent investigation, the 
NRC determined that the Licensee, by continuing to use licensed 
material after being notified of the expiration of the license which 
authorized that use and by deliberately providing false information to 
an NRC inspector, had demonstrated an unwillingness to comply with 
Commission requirements. The Commission must be able to rely on its 
licensees to provide complete and accurate information. Willful 
violations are of particular concern to the Commission because they 
undermine the Commission's reasonable assurance that licensed 
activities are being conducted in accordance with NRC requirements. 
Therefore, on July 21, 1993, the NRC issued an Order to the Licensee 
requiring the transfer of the strontium-90 source to an authorized 
recipient within 45 days of the date of the Order. The NRC also issued 
a Demand for Information with the Order requiring the Licensee to 
submit a written statement, under oath or affirmation, stating why the 
NRC should have confidence that in the future the Licensee would comply 
with NRC requirements or provide complete and accurate information to 
the NRC.
    The Licensee responded to the Order in letters dated September 7 
and 13, 1993, and in telephone conversations with the NRC Region II 
staff on September 10 and 20, 1993. During these communications, the 
Licensee indicated that he was making a good faith effort to transfer 
the byproduct material to an authorized recipient. Based on this good 
faith effort, the NRC by letter dated October 15, 1993, extended the 
strontium-90 transfer date to December 6, 1993. On January 24, 1994, 
the Licensee submitted a completed NRC Form 314 notifying the NRC that 
the strontium-90 source had been transferred to an authorized recipient 
and provided the documentation required by the Order to demonstrate 
that the source was tested for leakage prior to the transfer and that 
the transfer had taken place.
    On September 13, 1993, the Licensee responded to the Demand for 
Information indicating that he did not intend to perform licensed 
activities or to use the strontium-90 source in his possession, or one 
in anyone else's possession. Further, in a telephone conversation on 
June 2, 1994, with Mr. Charles M. Hosey of the NRC Region II office, 
Dr. Velasquez agreed to the provisions and to the issuance of this 
Confirmatory Order. I find that the Licensee's commitments as set forth 
in that conversation are acceptable and necessary and conclude that 
with these commitments the public health and safety are reasonably 
assured. In view of the foregoing, I have determined that the public 
health and safety require that the Licensee's commitments in the 
telephone call of June 2, 1994 be confirmed by this Order.
IV
    Accordingly, pursuant to Sections 81, 161b, 161i, 160o, 182 and 186 
of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations at 10 CFR 2.202 and 10 CFR parts 30 and 35, it is hereby 
ordered that:
    1. For a period of three years from the date of this Confirmatory 
Order, Guillermo Velasquez, M.D., shall not supervise or engage in any 
way in NRC-licensed activities. NRC-licensed activities are those 
activities which are conducted pursuant to a specific or general 
license issued by the NRC, including, but not limited to, those 
activities of Agreement State licensees conducted pursuant to the 
authority granted by 10 CFR 150.20.
    2. For a period of three years from the date of this Order, Dr. 
Velasquez shall provide a copy of this Order to any prospective 
employer who engages in NRC-licensed activities (as defined in 1. 
above) prior to his acceptance of employment with such prospective 
employer. The purpose of this requirement is to ensure that the 
employer is aware of Dr. Velasquez' prohibition from engaging in NRC-
licensed activities.
    3. The first time Guillermo Velasquez, M.D., is employed in NRC 
licensed activities following the three year prohibition, he shall 
notify the Regional Administrator, NRC Region II, 101 Marietta Street, 
NW., suite 2900, Atlanta, Georgia 30323, prior to engaging in NRC 
licensed activities including activities under an Agreement State 
license when activities under that license are conducted in areas of 
NRC jurisdiction pursuant to 10 CFR 150.20. The notice shall include 
the name, address, and telephone number of the NRC or Agreement State 
licensee and the location where licensed activities will be performed.
    The Regional Administrator, NRC Region II, may, in writing, relax 
or rescind any of the above conditions upon a showing by the Licensee 
of good cause.
V
    Any person adversely affected by this Confirmatory Order, other 
than the Licensee, may request a hearing within 20 days of the date of 
its issuance. Any request for a hearing shall be submitted to the 
Secretary, U.S. Nuclear Regulatory Commission, Attn: Chief, Docketing 
and Service Section, Washington, DC 20555. Copies shall be sent to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
Washington, DC 20555, to the Assistant General Counsel for Hearings and 
Enforcement at same address, and to the Regional Administrator, NRC 
Region II, 101 Marietta Street, NW., suite 2900, Atlanta, Georgia 30323 
and to the Licensee. If such a person requests a hearing, that person 
shall set forth with particularity the manner in which his interest is 
adversely affected by this Order and shall address the criteria set 
forth in 10 CFR 2.714(d).
    If a hearing is requested by a person whose interest is adversely 
affected, the Commission will issue an Order designating the time and 
place of any hearing. If a hearing is held, the issue to be considered 
at such hearing shall be whether this Confirmatory Order should be 
sustained.
    In the absence of any request for hearing, the provisions specified 
in section V above shall be final 20 days from the date of this Order 
without further order or proceedings.

    For the Nuclear Regulatory Commission.

    Dated at Rockville, Maryland this 3rd day of June 1994.
James Lieberman,
Director, Office of Enforcement.
[FR Doc. 94-14208 Filed 6-9-94; 8:45 am]
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