[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