[Federal Register Volume 61, Number 183 (Thursday, September 19, 1996)]
[Notices]
[Pages 49357-49360]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24017]


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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-32908; License No. 29-28784-01; EA 96-152]


Shashi K. Agarwal, M.D., Orange, New Jersey; Order Suspending 
License (Effective Immediately) and Demand for Information

I

    Shashi K. Agarwal, M.D., (Licensee) is the holder of Byproduct 
Nuclear Material License No. 29-28784-01 issued by the Nuclear 
Regulatory Commission (NRC or Commission) pursuant to 10 CFR Part 30. 
License No. 29-28784-01 authorizes possession and use of any byproduct 
material identified in 10 CFR 35.200 for any imaging and localization 
procedure approved in 10 CFR 35.200. The license was issued on November 
27, 1992 and is due to expire on December 31, 1997.

II

    On April 18, and April 30, 1996, the NRC conducted an inspection at 
the Licensee's facility in Orange, New Jersey. During the inspection, 
numerous apparent violations of NRC requirements were identified. One 
of the violations involved the continued use of radioactive material by 
a contractor of Dr. Agarwal despite the fact that the only authorized 
user listed on the license (who was also the Radiation Safety Officer 
(RSO)) had left the employ of the company on April 3, 1996, and has not 
been replaced. Specifically, in a letter dated April 3, 1996, to Dr. 
Agarwal, the only authorized user/RSO listed on the license resigned 
and informed Dr. Agarwal that if Dr. Agarwal wished to remain active 
with the license, he would have to replace the RSO. The authorized 
user/RSO was not replaced. This violation of the license was willful in 
that, at a minimum, it demonstrated careless disregard for NRC 
requirements.
    Furthermore, the authorized user/RSO listed on Dr. Agarwal's 
license made an inaccurate statement to NRC during a telephone inquiry 
conducted on May 20, 1993, when he stated that the licensee had not 
acquired any licensed material. This statement was inaccurate in that 
the inspector later determined that the licensee received 33 doses of 
technetium-99m labeled radiopharmaceuticals in April 1993. This 
inaccurate statement was material in that this information was relied 
on by the NRC in reaching its decision to postpone its initial on-site 
inspection of Dr. Agarwal's facility until October 1993. In a letter to 
Dr. Agarwal dated June 22, 1993, the NRC reported the results of the 
May 20, 1993 telephone inquiry. The letter states that the inspector 
contacted the authorized user/RSO on May 20, 1993, and the letter 
further states: ``From this discussion, we understand that you have 
never possessed material authorized by this license, but you plan to 
acquire such material in the near future.'' The letter also states: 
``If our understanding is incorrect, please inform us in writing.'' 
There is no record of the licensee correcting this inaccuracy.
    In addition, the inspection revealed numerous violations of NRC 
requirements, several of which were repetitive of violations identified 
during the previous NRC inspection conducted at the facility in October 
1993, for which a Notice of Violation was issued to the licensee on 
November 17, 1993 (Inspection Report No. 030-32908/93-002). The 
repetitive violations included: the RSO's failure to review and sign 
records of dose calibrator linearity and accuracy tests; sealed source 
leak tests of dose calibrator sources were not performed every six 
months; dose calibrator linearity test was not performed quarterly; and 
survey meter calibrations were performed without dedicated check source 
measurements. These violations are listed in the Appendix to this 
Order.
    Furthermore, on numerous occasions, Dr. Agarwal resisted attempts 
by inspectors and NRC management to advise him of the findings of the 
inspection, as described below:
     On April 19, 1996, and at least daily during the week 
beginning April 22, 1996, the NRC inspector and his supervisor 
attempted to contact Dr. Agarwal, and were told by Dr. Agarwal's staff 
that Dr. Agarwal was unavailable at that time but would return the 
telephone call as soon as he was available. Dr. Agarwal did not return 
the telephone calls from the NRC officials.
     On April 30, 1996, the NRC inspector spoke briefly with 
Dr. Agarwal at the licensee's facility and informed Dr. Agarwal that 
he, the inspector, was onsite to complete the inspection begun on April 
18, 1996. Dr. Agarwal immediately left the facility without affording 
the inspector any opportunity

[[Page 49358]]

to conduct needed discussions with Dr. Agarwal, or to brief him on the 
preliminary findings of the inspection. Dr. Agarwal provided a member 
of his staff to assist with the inspection. The inspector inquired as 
to what time the office closed at the end of the day. The staff member 
commented that the office would close at 5:00 p.m. The inspector 
informed Dr. Agarwal's assistant that he would complete his inspection 
by 4:30 p.m. and that it would be necessary to exit with Dr. Agarwal in 
order to debrief him on the results of the inspection. The inspector 
was left alone in the nuclear medicine area. When the inspector 
attempted to exit with Dr. Agarwal at 4:30 p.m., he discovered that Dr. 
Agarwal and his office staff had closed and left the facility. The 
inspector located one individual, a physical therapist, who was not 
aware that an inspection was being conducted. The inspector left a 
business card with this individual with instructions that it was very 
important that Dr. Agarwal call the inspector the next day so that the 
results of the inspection could be discussed. Dr. Agarwal did not 
contact the inspector.
     On May 1, 2, and 3, 1996, the NRC inspector and the 
inspector's supervisor attempted to contact Dr. Agarwal by telephone, 
but again were told that Dr. Agarwal was not available to speak at that 
time but that he would return the telephone calls as soon as possible. 
Dr. Agarwal did not return these telephone calls.
     The NRC was able to make contact with Dr. Agarwal by 
telephone on June 13, 1996, at which time the NRC findings were 
presented. During a subsequent telephone conversation on July 12, 1996 
with Dr. Agarwal, a transcribed predecisional enforcement conference 
was scheduled for August 8, 1996. Dr. Agarwal failed to appear for the 
predecisional enforcement conference. On August 8, 1996, the NRC 
contacted Dr. Agarwal's office to inquire as to his whereabouts and was 
told that they didn't know where he was. On September 4, 1996, the NRC 
was able to make contact with Dr. Agarwal by telephone, at which time 
the NRC inquired why Dr. Agarwal failed to appear for the August 8, 
1996, predecisional enforcement conference and why Dr. Agarwal did not 
contact the NRC when he returned to his office. The response given by 
Dr. Agarwal was that personal problems precluded him from attending the 
predecisional enforcement conference. Dr. Agarwal did not provide an 
explanation as to why he did not contact the NRC regarding his 
inability to attend the conference.

III

    The NRC must be able to rely on the Licensee and its employees to 
comply with NRC requirements. It is important that licensed material be 
used by, or under the supervision of, an authorized user. It is also 
essential that all communications between the Licensee and the NRC are 
complete and accurate in all material respects and that licensees are 
forthright with the NRC. It appears that the Licensee has provided 
inaccurate information to the NRC, has failed to comply with numerous 
additional Commission requirements described above, and has 
demonstrated an unwillingness to cooperate with the NRC, as indicated 
herein. These actions by the Licensee have raised serious doubt as to 
whether the Licensee can be relied upon in the future to comply with 
NRC requirements and to provide complete and accurate information to 
the NRC.
    Consequently, I lack the requisite reasonable assurance that the 
Licensee's current operations can be conducted under License No. 29-
28784-01 in compliance with the Commission's requirements, and that the 
health and safety of the public, including the Licensee's employees, 
will be protected, given these findings, as well as the fact that the 
Licensee currently does not have an authorized user or RSO. Therefore, 
the public, health, safety and interest require that License No. 29-
28784-01 be suspended. Furthermore, pursuant to 10 CFR 2.202, I find 
that, given the willfulness of the Licensee's conduct, as described 
above, as well as the safety significance of conducting licensed 
activities without an authorized user, the public health, safety, and 
interest require that this Order be immediately effective.

IV

    Accordingly, pursuant to sections 81, 161b, 161i, 161o, 182 and 186 
of the Atomic Energy Act of 1954, as amended, and the Commission's 
regulations in 10 CFR 2.202 and 10 CFR Part 30, it is hereby ordered, 
effective immediately, that license no. 29-28784-01 is suspended as 
follows, pending further Order.
    A. All NRC-licensed material in the Licensee's possession shall be 
placed in secured storage.
    B. All activities under License No. 29-28784-01 to use licensed 
material shall be suspended. All other requirements of the license 
remain in effect.
    C. No material authorized by the license shall be ordered, 
purchased, received, or transferred by the Licensee while this Order is 
in effect.
    D. All records related to licensed activities shall be maintained 
in their original form and must not be removed or altered in any way.
    The Regional Administrator, Region I, may, in writing, relax or 
rescind this order upon demonstration by the Licensee of good cause.

V

    In accordance with 10 CFR 2.202, the Licensee must, and any other 
person adversely affected by this Order may, submit an answer to this 
Order, and may request a hearing on this Order, within 20 days of the 
date of this Order. Where good cause is shown, consideration will be 
given to extending the time to request a hearing. A request for an 
extension of time must be made in writing to the Director, Office of 
Enforcement, U.S. Nuclear Regulatory Commission, Washington, D.C., 
20555, and include a statement of good cause for the extension. The 
answer may consent to this Order. Unless the answer consents to this 
Order, the answer shall, in writing and under oath or affirmation, 
specifically admit or deny each allegation or charge made in this order 
and set forth the matters of fact and law on which the Licensee or 
other person adversely affected relies and the reasons as to why the 
Order should not have been issued. Any answer or request for a hearing 
shall be submitted to the Secretary, U.S. Nuclear Regulatory 
Commission, ATTN: Chief, Docketing and Services Section, Washington, 
D.C. 20555. Copies of the hearing request also should be sent to the 
Director, Office of Enforcement, U.S. Nuclear Regulatory Commission, 
Washington, D.C. 20555, to the Assistant General Counsel for Hearings 
and Enforcement at the same address, to the Regional Administrator, NRC 
Region I, 475 Allendale Road, King of Prussia, Pennsylvania, 19406, and 
to the Licensee if the hearing request is by a person other than the 
Licensee. If a person other than the Licensee requests a hearing, that 
person shall set forth with particularity the manner in which the 
individual's 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 the Licensee or 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 Order 
should be sustained.
    Pursuant to 10 CFR 2.202(c)(2)(i), the Licensee, or any other 
person adversely affected by this Order, may, in addition to demanding 
a hearing, at the time the

[[Page 49359]]

answer is filed or sooner, move the presiding officer to set aside the 
immediate effectiveness of the Order on the ground that the Order, 
including the need for immediate effectiveness, is not based on 
adequate evidence but on mere suspicion, unfounded allegations, or 
error.
    In the absence of any request for hearing, or a written approval of 
an extension of time in which to request a hearing, the provisions 
specified in Section IV above shall be final 20 days from the date of 
this Order without further order or proceedings. If an extension of 
time for requesting a hearing has been approved, the provisions 
specified in Section IV shall be final when the extension expires if a 
hearing request has not been received.

AN ANSWER OR A REQUEST FOR HEARING SHALL NOT STAY THE IMMEDIATE 
EFFECTIVENESS OF THIS ORDER.

VI

    In addition to issuance of this Order suspending License No. 29-
28784-01, the Commission requires further information from the Licensee 
in order to determine whether the Commission can have reasonable 
assurance that in the future the Licensee will conduct its activities 
in accordance with the Commission's requirements.
    Accordingly, pursuant to sections 161c, 161o, 182 and 186 of the 
Atomic Energy Act of 1954, as amended, and the Commission's 
requirements in 10 CFR 2.204 and 10 CFR 30.32(b), in order for the 
Commission to determine whether your license should be further 
modified, suspended or revoked, or other enforcement action taken to 
ensure compliance with NRC regulatory requirements, the Licensee is 
required to submit to the Director, Office of Enforcement, U.S. Nuclear 
Regulatory Commission, Washington, D.C. 20555, within 20 days of the 
date of this Order and Demand for Information, a response in writing 
and under oath or affirmation, describing why its License should not be 
revoked in light of the NRC findings described herein.
    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, 
Pennsylvania 19406.
    After reviewing your response, the NRC will determine whether 
further action is necessary to ensure compliance with regulatory 
requirements.

    Dated at Rockville, Maryland this 12th day of September 1996.

    For the Nuclear Regulatory Commission.
Hugh L. Thompson, Jr.,
Deputy Executive Director for Nuclear Materials Safety, Safeguards, and 
Operations Support.

Appendix--List of Violations

[Docket No. 030-32908; License No. 29-28784-01 EA 96-152]

Shashi K. Agarwal, M.D., Orange, New Jersey

    During an NRC inspection conducted on April 18 and 30, 1996, the 
following violations of NRC requirements were identified.

I. Violation Involving the Submittal of Inaccurate Information

    10 CFR 30.9(a) requires, in part, that information provided to 
the Commission by a licensee be complete and accurate in all 
material respects.
    Contrary to the above, the licensee did not provide to the 
Commission information that was complete and accurate in all 
material respects. Specifically, on May 20, 1993, the licensee's 
authorized user/Radiation Safety Officer (RSO) stated that the 
licensee had not yet acquired any licensed material. This was an 
inaccurate statement, because the licensee had received 33 doses of 
technetium-99m labelled radiopharmaceuticals in April 1993. This 
information was material because it resulted in a decision by the 
NRC to postpone its initial inspection of the licensee's program 
until the fourth quarter of 1993.

II. Additional Violations of NRC Requirements

    A. 10 CFR 35.25(a)(3) requires, in part, that a licensee that 
permits the receipt, possession, use, or transfer of byproduct 
material by an individual under the supervision of an authorized 
user, periodically review the supervised individual's use of 
byproduct material and the records kept to reflect this use.
    Contrary to the above, from April 25, 1993 until April 3, 1996, 
the licensee permitted the receipt, possession, use, and transfer of 
byproduct material by an individual under the supervision of an 
authorized user, and the licensee failed to periodically review the 
supervised individual's use of byproduct material and the records 
kept to reflect this use.
    B. Condition 12 of License No. 29-28784-01 names a specific 
individual as authorized to use material under the license.
    Contrary to the above:
    1. on April 4 and 16, 1996, an individual not named as 
authorized to use material under the license performed cardiac 
studies using unit dose Tc-99m material; and
    2. on April 9, 1996, an individual not named as authorized to 
use material under the license performed cardiac studies using unit 
dose Tc-99m material.
    C. 10 CFR 35.21(a) requires, in part, that the licensee, through 
the Radiation Safety Officer, ensure that radiation safety 
activities are being performed in accordance with approved 
procedures and regulatory requirements.
    License Condition 14 of Amendment No. 0-1 of License 29-28784-01 
provides in part that the licensee shall conduct its program in 
accordance with procedures contained in its application dated August 
19, 1992.
    1. The application dated August 19, 1992, states in Item No. 9.3 
that, for dose calibrator calibration, the licensee will establish 
and implement the model procedure published in Appendix C to 
Regulatory Guide 10.8, Revision 2.
    Appendix C of Regulatory Guide 10.8, Revision 2 requires, in 
part, that the Radiation Safety Officer review and sign records of 
accuracy and linearity tests.
    Contrary to the above, as of April 30, 1996, the Radiation 
Safety Officer failed to review and sign records of accuracy tests 
performed on May 5, 1994, and December 5, 1995; and failed to sign 
records of linearity tests performed in March, July, and October 
1994, January and November 1995, and February 1996.
    This is a repeat violation.
    2. The application dated August 19, 1992 states in Item No. 9.4 
that, for personnel monitoring, the licensee will establish and 
implement the model procedure published in Appendix D to Regulatory 
Guide 10.8, Revision 2.
    Appendix D of Regulatory Guide 10.8, Revision 2 requires, in 
part, that all individuals who are occupationally exposed to 
ionizing photon radiation on a regular basis be issued a film or 
thermoluminescent (TLD) whole body monitor that will be processed on 
a monthly basis and that all individuals who, on a regular basis, 
handle radioactive material that emits ionizing photons be issued a 
film or TLD finger monitor that will be processed on a monthly 
basis.
    Contrary to the above, (1) between October 27, 1995 and April 
16, 1996, the licensee did not issue whole body monitors to 
individuals (the mobile service staff) who were occupationally 
exposed to ionizing photon radiation on a regular basis or issue 
finger monitors to these same individuals who, on a regular basis, 
handled radioactive material that emitted ionizing photons; and (2) 
between April 1993 and April 1996 the licensee issued TLD whole body 
monitors and TLD finger monitors to its staff which were processed 
quarterly rather than monthly.
    3. The application dated August 19, 1992, states, in Item No. 
10.2, that the licensee will establish and implement the model ALARA 
program published in Appendix G of Regulatory Guide 10.8, Revision 
2.
    Appendix G of Regulatory Guide 10.8, Revision 2 requires, in 
part, that the Radiation Safety Officer will review at least 
quarterly the external radiation doses of authorized users and 
workers to determine that their doses are ALARA.
    Contrary to the above, as of April 30, 1996, the licensee's 
Radiation Safety Officer had not performed a quarterly review of 
external radiation doses of authorized users and workers to 
determine that their doses were ALARA.
    D. 10 CFR 20.2103(b)(1) requires, in part, that each licensee 
maintain certain records, including the record of the results of 
surveys to determine the dose from external sources in the 
assessment of individual dose

[[Page 49360]]

equivalents, until the Commission terminates each pertinent license 
requiring the record.
    Contrary to the above, as of April 30, 1996, the licensee had 
not maintained records of the results of surveys to determine the 
dose from external sources performed during three-month periods 
beginning: April 15, 1993; July 15, 1993; April 15, 1994; July 15, 
1994; October 15, 1995; and January 15, 1996.
    E. 10 CFR 35.50(b)(3) requires, in part, that a licensee test 
each dose calibrator for linearity at least quarterly.
    Contrary to the above, the licensee did not test its dose 
calibrator for linearity at least quarterly. Specifically, the 
licensee utilized the dose calibrator for patient studies from 
January 1 through June 21, 1995, and from October 27 through the end 
of 1995, but performed dose calibrator linearity tests only in 
January and November, 1995.
    This is a repeat violation.
    F. 10 CFR 35.59(b)(2) requires, in part, that a licensee in 
possession of a sealed source test the source for leakage at 
intervals not to exceed six months or at other intervals approved by 
the Commission or an Agreement State.
    Contrary to the above, the licensee did not test a sealed source 
containing 200 microcuries of cesium-137 for leakage between January 
13, 1995, and December 5, 1995, an interval in excess of six months, 
and no other interval was approved by the Commission or an Agreement 
State.
    This is a repeat violation.
    G. 10 CFR 35.59(d) requires in part, that a licensee retain 
records of leakage test results for five years; and that the records 
contain the signature of the Radiation Safety Officer.
    Contrary to the above, as of April 30, 1996, the licensee's 
records of leakage test results did not contain the signature of the 
Radiation Safety Officer.
    H. 10 CFR 35.59(g) requires, in part, that a licensee in 
possession of a sealed source or brachytherapy source conduct a 
quarterly physical inventory of all such sources in its possession.
    Contrary to the above, the licensee did not conduct a physical 
inventory of its sealed sources during the fourth quarter of 1994 
(in that an inventory was not done between July 7, 1994 and January 
13, 1995), and during the second quarter of 1995 (an inventory was 
not done between January 13, 1995 and November 28, 1995).
    I. 10 CFR 35.59(g) requires, in part, that a licensee retain for 
five years records of quarterly physical inventories of sealed 
sources and brachytherapy sources in its possession, and that the 
records contain the signature of the Radiation Safety Officer.
    Contrary to the above, as of April 30, 1996, the licensee's 
records of physical inventories of its sealed sources did not 
contain the signature of the Radiation Safety Officer.
    J. 10 CFR 35.51(a)(3) requires that a licensee conspicuously 
note the apparent exposure rate from a dedicated check source, as 
determined at the time of calibration, and the date of calibration 
on any survey instrument used to show compliance with 10 CFR Part 
35.
    Contrary to the above, as of April 30, 1996, the licensee did 
not conspicuously note the apparent exposure rate from a dedicated 
check source as determined at the time of calibration noted on its 
Ludlum Model 14C survey instrument, and the licensee was using this 
survey instrument to show compliance with 10 CFR Part 35. 
Specifically, the apparent exposure rate from a dedicated check 
source noted on the licensee's survey meter was not determined on 
December 15, 1995, when the survey meter was calibrated, but was 
determined on January 29, 1996, after it was returned to the 
licensee's facility.
    This is a repeat violation.

[FR Doc. 96-24017 Filed 9-18-96; 8:45 am]
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