[Federal Register Volume 63, Number 218 (Thursday, November 12, 1998)]
[Notices]
[Pages 63339-63342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30252]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 030-16055]
Advanced Medical Systems, Inc.; Issuance of Director's Decision
Under 10 CFR 2.206
Notice is hereby given that the Director, Office of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission
(NRC), has acted on a Petition for action under 10 CFR 2.206, dated
August 19, 1994, filed by William B. Schatz, Esq., on behalf of the
Northeast Ohio Regional Sewer District (District), with respect to an
NRC Licensee, Advanced Medical Systems, Inc. (AMS).
The District requested, pursuant to 10 CFR 2.206, that NRC amend
AMS' License No. 34-19089-01 to require AMS to install, maintain, and
operate a radiation alarm system on all drains at 1020 London Road,
Cleveland, OH (AMS Facility) that lead to either sanitary or storm
sewers.
The Petitioner's request to require a radiation alarm system on all
drains at the AMS Facility was based on the risk posed by the
contaminated AMS Facility, and on the basis that the original license
for the site, issued to Picker X-Ray Corporation (Picker) in 1959,
contained a requirement for an alarm system to detect unmonitored
discharges.
For the reasons stated in the ``Director's Decision Under 10 CFR
2.206'' (DD-98-11), the Director of the Office of Nuclear Material
Safety and Safeguards has denied the request. The complete text of DD-
98-11 follows this notice and is available for public inspection at the
Commission's Public Document Room, the Gelman Building, 2120 L Street,
NW., Washington, DC 20555, and at the Local Public Document Room, Perry
Public Library, 3735 Main Street, Perry, OH 44081.
A copy of this Decision will be filed with the Secretary of the
Commission for the Commission's review in accordance with 10 CFR
2.206(c) of the Commission's regulations. As provided by this
regulation, this Decision will constitute the final action of the
Commission 25 days after the date of issuance unless the Commission, on
its own motion, institutes review of the decision within that time.
Dated at Rockville, Maryland, this 4th day of November, 1998.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director, Office of Nuclear Material Safety and Safeguards.
I. Introduction
By letter dated August 19, 1994, addressed to Mr. James M. Taylor,
former Executive Director for Operations, U.S. Nuclear Regulatory
Commission (NRC), William B. Schatz, Esq., on behalf of the Northeast
Ohio Regional Sewer District (District), requested that the NRC take
action with respect to Advanced Medical Systems, Inc. (AMS), of
Cleveland, OH, an NRC licensee.1 The District requested,
pursuant to 10 CFR 2.206, that the NRC amend License No. 34-19089-01,
to require AMS to install, maintain, and operate a radiation alarm
system on all drains at 1020 London Road, Cleveland, OH (AMS Facility),
that lead to either sanitary or storm sewers.
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\1\ Northeast Ohio Regional Sewer District submitted two
previous Petitions for action against AMS under 10 CFR 2.206. In a
Petition dated March 3, 1993, and supplemented by letters dated
September 13, 1994, October 13, 1994, and April 29, 1996, the
Petitioner requested that NRC: (1) modify AMS' License No. 34-19089-
01 to require that AMS assume all costs resulting from the off-site
release of cobalt-60 that has been deposited at the Petitioner's
Southerly Wastewater Treatment Center; (2) order AMS to
decontaminate the sewer connecting its facility with the public
sewer at London Road, and continue down stream with such
decontamination to the extent that sampling indicates is necessary;
(3) commence enforcement action against AMS for violation of 10 CFR
303(a), 401(c)(3) and 20.2003; and (4) take action on the AMS
license to safely, immediately, and reasonably decontaminate the
London Road interceptor (the sewer). The second request had been
partially granted when the NRC amended the AMS license to require
remediation of the sewer line connecting AMS Facility with the
public sewer, and the Petition was denied in all other respects.
Advanced Medical Systems, Inc. (DD-97-13), 45 NRC 460 (1997). In a
second Petition dated August 3, 1993, the Petitioner requested that
the NRC take action to require AMS to provide adequate financial
assurance to cover public liability pursuant to section 170 of the
Atomic Energy Act of 1954, as amended. The second petition was
denied. Advanced Medical Systems, Inc. (DD-94-6), 39 NRC 373 (1994).
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The District asserts two major reasons as the bases for the
request. First, it views the quantity of cobalt-60 waste in the AMS
Facility's basement as a major threat based on the following: (a) The
NRC has admitted that the existing contamination at the AMS Facility
continues to pose a risk; (b) the contamination that exists at the AMS
Facility is estimated to include 393 curies, as of 1988, of loose,
``talcum-like'' cobalt-60 scattered on the floor of the basement waste
hold-up room; (c) cobalt-60 contamination was found in the sewer line
connecting the AMS Facility to the public sewer, and was found directly
under the AMS discharge; (d) the District has already incurred costs of
nearly $2 million to address loose cobalt-60 contamination at the
Easterly and Southerly Wastewater Treatment Plants; (e) the NRC has
been unable or unwilling to explain the source of the cobalt-60 on the
District's property, and unable to identify any likely sources for the
cobalt-60 other than the AMS Facility; and (f) the quantity of cobalt-
60 at the Southerly Plant exceeds that which the AMS records show was
released by AMS into the sewer system. Secondly, the original license
for this site, issued to Picker in 1959, contained a requirement for an
alarm system to detect unmonitored discharges. The District states that
such an alarm system was not a condition of the subsequent AMS license,
despite a recommendation from Oak Ridge Associated Universities that
such an alarm system be installed, along with control valves, to shut
off flow to the sewer if the alarm sounds.
By letter dated September 7, 1994, the NRC formally acknowledged
receipt of the District's letter, and informed the District that its
request was being treated pursuant to 10 CFR 2.206 of the Commission's
regulations. A notice of the receipt of the Petition was published in
the Federal Register on September 19, 1994 (59 FR 47959). The NRC Staff
sent a copy of its acknowledgment letter, with a copy of the Petition,
to AMS. By letter dated November 9, 1995, the NRC informed the District
that further action on its request was being deferred until completion
of an ongoing proceeding on AMS' November 29, 1994, application to
renew its license. While that proceeding has not been terminated, the
NRC staff has decided to deny the renewal application. See letter
[[Page 63340]]
from C. Paperiello, NRC to S. Stein, AMS, dated September 28, 1998.
Accordingly, it is now appropriate for the staff to consider the action
requested by the District.
I have completed my evaluation of the matter raised by the District
and have determined that, for the reasons stated below, the Petition
should be denied.
II. Background
In 1959, the Atomic Energy Commission (AEC) (predecessor to the
NRC) issued License No. 34-07225-09 to Picker X-Ray Corporation
(Picker), for operation of a sealed-source manufacturing facility
located at 1020 London Road. The license authorized Picker to receive,
store, and encapsulate cobalt-60 for the purpose of installing these
encapsulated sources in approved devices and distributing the sources
to customers having valid licenses. The facility at 1020 London Road
had been built specifically for the intended purpose of handling and
encapsulating large quantities of cobalt-60 (in the kilocurie range);
the building included a hot cell for encapsulating the cobalt-60, and
various support areas, including a heavily shielded room that contained
two stainless steel tanks to collect liquid radioactive waste [waste
hold-up tanks (WHUT)]. During the manufacturing of encapsulated
sources, it was not uncommon that the hot cell would become
contaminated with oxidized cobalt-60. To maintain control of
contamination and radiation levels, the cell would be cleaned
periodically, with the liquid waste generated by the cleanup diverted
to the WHUT room, which had a combined holding capacity of 600 gallons.
The stored liquid radioactive waste was then discharged to the sanitary
sewer at irregular intervals, depending on the volume of liquid waste
generated during normal operations. In a manual entitled ``Radiation
Safety Procedures for the Picker X-Ray Corporation, Waite Manufacturing
Division, Inc.,'' dated December 1959, a procedure outlined the
equipment and steps followed to discharge the liquid waste to the
sewer. The liquid radioactive waste was pumped directly from the WHUT
into the sanitary sewer system through a drain in the basement floor.
The hose from the WHUT to the sewer drain was continuously monitored
during discharge, with the liquid passing through a solenoid valve, an
in-line monitor consisting of a G-M tube with a rate meter and a strip
chart recorder, and a water meter. The solenoid valve opened only
during intentional discharge from the WHUT, and only when the
monitoring system detected count rates below a preset level, ensuring
that only authorized concentration levels were being discharged. A
record of the total discharge would be indicated by the total volume of
liquid discharged and the count rate information from the monitor,
calculating the average concentration and the total activity. The
description of the monitoring process did not have the detection system
operating continuously, but only while discharging from the hold-up
tanks to the sanitary sewer drain.
In a letter submitted to the AEC dated January 25, 1974, Picker
submitted a manual entitled ``Radiation Safety Procedures for the
Picker Corporation, Isotope Operations,'' requesting it supersede the
then effective manual, ``Radiation Safety Procedures for the Picker X-
Ray Corporation, Waite Manufacturing Division, Inc.,'' mentioned above.
This new manual modified the facility's liquid waste disposal method
and system, and was later revised in September 1976. See Inspection
Report No. 030-16055/93003(DRSS) at 13. The AEC, and later the NRC, did
not incorporate the January 1974 letter, the manual, and the subsequent
September 1976 revision, into Picker's license. In February 1974 (OR
Inspection Report No. 74-01 for License No. 34-07225-09 at 6), Picker
modified its liquid radioactive waste discharge procedure from the in-
line continuous monitor, to a batch disposal method. This batch
disposal system consisted of a 55-gallon drum located outside the room
housing the WHUT, atop a stand pipe connected to a floor drain leading
to the sanitary sewer line. Waste water was pumped from the WHUT to the
55-gallon drum, the drum liquid was then agitated by an electrically
driven trolling motor, and, after agitation, the liquid was sampled to
determine its radioactive concentration. After determining
radioactivity concentration and the volume in the 55-gallon drum, for
recording concentration and total quantity of radioactive material, the
plug at the bottom of the drum was removed to discharge the contents to
the sanitary sewer. This batch method of disposal was continued until
Picker terminated this license in November 1979.
In 1979, Picker sold the facility and operation at 1020 London Road
to AMS. The provisions of the AMS license application were similar to
the previous Picker license, with many of the procedures carried
forward to the AMS license, including the batch method for liquid
radioactive waste release described above. AMS used the same batch
method for disposal of liquid radioactive waste as Picker, from the
time that AMS' initial license (License No. 34-19089-01) was issued on
November 2, 1979, until April 1986. In 1986, AMS installed a 200-gallon
plastic tank to collect waste from the drain leading from
decontamination showers, the laundry, and sinks, and discontinued use
of the 55-gallon drum for discharge. One of the two tanks in the WHUT
room, a 500-gallon tank, was no longer receiving liquid waste when the
200-gallon tank was installed in 1986, and the use of the other tank in
the WHUT room (100-gallon capacity) was discontinued in 1988, when the
WHUT room was isolated. The batch method of determining concentration
and total volume of the liquid discharge from the 200-gallon tank, to
show compliance, continued until May 1989, when discharge to the
sanitary sewer (via floor drains) was discontinued completely.
III. Discussion
The District's petition requests the NRC to require AMS to install,
maintain, and operate a radiation alarm system on all drains at the AMS
Facility that lead to either sanitary or storm sewers. The request to
modify the license by having alarms installed appears to be an effort
to put in place a mechanism that would indicate when cobalt-60 is
entering the District's sanitary sewer system, and, in turn, to stop
the entry of the cobalt-60 into the sanitary sewer system on positive
indication of material.
Most of the bases for the Petition are restatements of facts, or
existing information in previously published documents, that are
associated with the facility at 1020 London Road. Since 1989, when AMS
changed its decontamination process to a dry method, AMS' records
indicate that AMS has not disposed of any radioactive waste into the
sanitary sewer drain.
The District has incurred costs of nearly $2 million addressing the
cobalt-60 contamination at its Easterly and Southerly wastewater
treatment plants. The District's apparent concern in this Petition is
the threat that the London Road facility poses to the District's
treatment facilities, primarily pertaining to the imposition of
additional costs through release of cobalt-60 from the AMS facility
into the District's system. As described below, however, neither the
nature or activity of the contamination in the WHUT room, in light of
the condition of the WHUT room, nor the requirements formally
applicable to Picker, establish any basis
[[Page 63341]]
to take the requested action. This cobalt-60 contamination is in a dry
state, and the WHUT room is completely isolated from the sewer system
and from accidental access. There are no floor drains in the WHUT room,
and there is no water supply into or out of the room. Accordingly, the
existence of contamination of 393 curies (14.5 terabecquerels) of
loose, ``talcum-like'' cobalt-60 in the WHUT room in the basement does
not warrant granting of the District's request.
The District indicated there had been an alarm and control system
that had once been in place when Picker operated the facility, up to
November of 1979. In connection with this type of system, the District
states that the system had not been a required condition of the license
after Picker terminated work at the facility, and operations continued
under the AMS license. In its original license application to show
compliance with the regulations at that time, Picker included
conditions requiring a water-monitoring system that detected
concentration levels in a drainpipe. The system that Picker described
in the Informational Memorandum No. 6, ``Calibration and Evaluation of
Water Monitor System,'' submitted by Picker to the NRC on December 2,
1959, was used as both a control system, to prevent discharge above a
preset limiting concentration, and as a method of showing compliance
with then-applicable regulations. However, this documentation does not
indicate that there had been any alarm as part of the system--nor is it
documented, from that time, why the in-line system was discontinued,
and a batch method used in its stead, in 1974. See OR Inspection Report
74-01, License No. 34-07225-09, transmittal dated May 3, 1974. Two
interviewees questioned during a 1993 inspection indicated that the in-
line system was discontinued because the in-line G-M detector needed to
be replaced, but was no longer manufactured or available. See Report
No. 030-16055/93003 (DRSS) at 11. Both procedures, the in-line
monitoring method and the batch method, at the time they were being
used, satisfied the requirement to show compliance independently, and,
therefore, either procedure was considered acceptable at the time of
the request.
The Oak Ridge Associated Universities report that recommended
monitoring the discharge to the sanitary sewer and placing a servo-
valve mechanism on the drains was part of a larger report. See
``Evaluation of the Operational Radiation Safety and Fire Protection
Programs of the Advanced Medical Systems, Inc., London Road Facility,
Cleveland, Ohio,'' December 1985. This method was given as an
alternative for developing a contingency plan for controlling release
to the sanitary sewer system in case of a major spill into the
basement. The other alternative offered in this report was to seal the
drains in the basement floor, so that any release could be monitored
before releasing to the sewer system. AMS chose this latter alternative
as a means of preventing an unmonitored release. The method of sealing
the drains was determined to be appropriate to ensure compliance with
10 CFR 20.303 (1985). A continuous monitor could be used for the
purpose of detecting a major unintended release, but might be
relatively insensitive for normal operations.
In October 1994, the District issued an Executive Director's Order
to AMS terminating all sewer service effective October 24, 1994. In
November 1994, the District placed a compression plug in the AMS
lateral sewer line that connects the AMS Facility to the District's
sewer system under London Road. Thus, in effect, the District isolated
the AMS Facility's sanitary and storm drain lines from the sanitary
sewerage treatment system. In mid-1995, AMS grouted shut the entire
lateral line, to immobilize any residual cobalt-60 that remained in the
lateral. AMS' grouting of the lateral line blocked release, through the
lateral, from the AMS Facility to the District's sewer system. At some
point following the grouting operation, the District removed the
compression plug on AMS' lateral sewer line. Currently, there are
drains at the AMS Facility that lead from the rooftop (for rainwater)
to the main sewer system in London Road, but there are no other drains
from the facility that are connected to the sewer system. The lateral
connector, which connects all drains originating from within the AMS
Facility to the District's sewer line, remains grouted. Also, in a
settlement agreement between the District and AMS, executed on December
20, 1996, the District indicated that it would allow re-connection of
the AMS Facility to its London Road Interceptor pursuant to procedures
set forth in the agreement, provided that several conditions were first
satisfied. As of the date of this Director's Decision, AMS has not
executed all the conditions in the agreement. The December 1996
settlement agreement states that re-connection shall be in full
accordance with several criteria and requirements, with one of the
requirements being that AMS must agree not to discharge any cobalt-60
into the sanitary sewer system, directly or indirectly. See Settlement
Agreement dated December 20, 1996, at 10, forwarded by a letter from
Dwight Miller, Stavole & Miller, Attorneys and Counsellors at Law, to
John Madera, Chief, Materials Inspection Branch 1, Region III, dated
January 6, 1997. With this agreement for re-connection in place, and
with the only connection between the interior of the AMS Facility and
the District's sewer system grouted, until AMS satisfies the condition
of the settlement agreement, the requested requirement for an alarm
system is not necessary at this time.
The existence of unsealed cobalt-60 at the AMS Facility does
represent a potential risk. As the NRC staff has previously stated, the
possibility remains that the contamination existing on site might be
spread to areas offsite or that future operations could result in
offsite contamination. Such offsite contamination would not necessarily
spread to the District's system, however. In addition, the likelihood
of accidental release of cobalt-60 from the licensee's facility has
diminished and continues to do so. Advanced Medical Systems (DD-94-6)
39 NRC 373, 379 (1994). Since 1994, the amount of cobalt-60 that could
be released in an accident at the licensee's facility has been greatly
diminished because of disposals to a licensed disposal site. See NRC
Inspection Report No. 030-16055/97001(DNMS) (March 7, 1997). Moreover,
NRC inspection and review of records have not revealed any
documentation at AMS or other evidence that would indicate discharges
into the sanitary sewer system have been in excess of authorized
limits. Advanced Medical Systems, Inc. (DD-97-13) 45 NRC 460, 465
(1997). As the situation exists today, the NRC staff concludes that
neither the contamination at the facility nor the licensee's drainage
system present an immediate health and safety hazard to the public, and
that the requested action is not warranted.
IV. Conclusion
The staff has carefully considered the request of the Petitioner.
In addition, the staff has evaluated the bases for the Petitioner's
request. For the reasons discussed above, the District's request for
action pursuant to section 2.206 is denied, and no action pursuant to
section 2.206 is being taken in this matter.
As provided by 10 CFR 2.206, a copy of this Decision will be filed
with the Secretary of the Commission for the Commission's review. The
Decision will
[[Page 63342]]
become the final action of the Commission 25 days after issuance,
unless the Commission, on its own motion, institutes review of the
Decision within that time.
Dated at Rockville, Maryland, November 4, 1998.
For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director, Office of Nuclear Material Safety and Safeguards.
[FR Doc. 98-30252 Filed 11-10-98; 8:45 am]
BILLING CODE 7590-01-P
