[Federal Register Volume 62, Number 119 (Friday, June 20, 1997)]
[Notices]
[Pages 33682-33687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-16174]


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NUCLEAR REGULATORY COMMISSION

[Docket No. 30-016055]


Advanced Medical Systems, Inc., Issuance of Director's Decision 
under 10 CFR Sec. 2.206

    Notice is hereby given that the Director, Office of Nuclear 
Material Safety and Safeguards, U. S. Nuclear Regulatory Commission, 
has acted on a Petition for action under 10 CFR 2.206 dated March 3, 
1993, filed by William B. Schatz, Esq., on behalf of the Northeast Ohio 
Regional Sewer District (Petitioner), as supplemented by letters dated 
September 13, 1994, October 13, 1994 and April 29, 1996, with regards 
to NRC Licensee, Advanced Medical Systems, Inc. (AMS)
    The Petitioner requested, pursuant to 10 CFR 2.206, that the 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

[[Page 33683]]

Petitioner's Southerly Wastewater Treatment Center; and (2) order AMS 
to decontaminate the sewer connecting its London Road facility with the 
public sewer at London Road, and continue down stream with such 
decontamination to the extent that sampling indicates is necessary.
    By letters dated September 13, 1994, October 13, 1994, and April 
29, 1996, the Petitioner filed supplements to the Petition. The 
September 1994 supplement requested that NRC commence enforcement 
actions against AMS for violations of 10 CFR 20.401(c)(3) and 10 CFR 
20.303(a), based on assertions that the disposal records maintained by 
AMS are grossly inaccurate, in violation of 10 CFR 20.401(c)(3), and 
that AMS discharged material to the sewer that was not readily soluble 
or dispersible in water, in violation of 10 CFR 20.303(a). In addition, 
the September 1994 supplement requested that the March 3, 1993, 
Petition be granted immediately insofar as it requested that AMS be 
held responsible for all costs arising from contamination of the 
Petitioner's treatment plant and that AMS be required to decontaminate 
the sewer downstream from the London Road facility. In its October 1994 
supplement, the Petitioner requested that the NRC commence an 
enforcement action against AMS for violation of 10 CFR 20.2003, based 
on the assertion that AMS had recently discharged cobalt-60 to the 
sewer that was not soluble or readily dispersible biological material, 
in violation of that provision. In its April 1996, supplement, the 
Petitioner requested NRC action on a license requiring AMS to safely 
and reasonably decontaminate the London Road interceptor (the sewer), 
or, if the NRC's position is that such action has already been ordered, 
NRC action requiring AMS to actually complete the decontamination.
    For the reasons stated in the ``Director's Decision Under 10 CFR 
2.206'' (DD-97-13), the Director of the Office of Nuclear Material 
Safety and Safeguards has denied the first request, that NRC require 
AMS to assume all costs resulting from the offsite contamination from 
released licensed material within NRC limits. With regard to the 
request to order AMS to decontaminate the sewer line, as set forth in 
DD-97-13), NRC has already partially granted the Petition, insofar as 
NRC has taken action by amending AMS'' License to require remediation 
of the sewer line connecting the London Road Facility with the public 
sewer at London Road. For the reasons stated in DD-97-13, the Director 
has denied the remaining requests in the Petition and its supplements. 
The complete text of DD-97-13 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, 
Ohio 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 13th day of June, 1997.

    For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director Office of Nuclear Material Safety and Safeguards.

Director's Decision under 10 CFR Sec. 2.206

I. Introduction

    By letter dated March 3, 1993, addressed to Mr. James 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 NRC take action 
with respect to Advanced Medical Systems, Inc. (AMS), of Cleveland, 
Ohio, an NRC licensee. The District requested, pursuant to 10 CFR 
Sec. 2.206, 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 District's Southerly 
Wastewater Treatment Center (SWTC); and (2) order AMS to decontaminate 
the sewer connecting its London Road facility with the public sewer at 
London Road, and continue downstream with such decontamination to the 
extent that sampling indicates is necessary.
    The District alleges the following bases for its request: (1) 
Cobalt-60 has been discovered in the ash piles resulting from the 
incineration of sewage sludge at the District's SWTC; (2) AMS is the 
only licensee in the District's service area authorized to process 
cobalt-60 in a loose metallic form consistent with the form present in 
the ash; (3) AMS is the only entity (except for the former owner of the 
London Road facility) that has reported discharging cobalt-60 to the 
sanitary sewer system leading to the SWTC; (4) NRC documents present 
ample evidence of cobalt-60 contamination at the London Road facility, 
including numerous drains inside the building; (5) there are excessive 
exposure rates in the sewer connecting the building to the public sewer 
system; (6) this sewer line has been classified as a restricted area, 
which effectively denies the District access to the manhole for 
sampling industrial discharges; and (7) the AMS London Road facility is 
the source of the cobalt-60 at the SWTC.
    By letter dated April 2, 1993, the Director, Office of Nuclear 
Material Safety and Safeguards, NRC, formally acknowledged receipt of 
the Petition and informed the District that its request was being 
treated pursuant to 10 CFR Sec. 2.206 of the Commission's regulations. 
A notice of the receipt of the Petition was published in the Federal 
Register on Tuesday, April 13, 1993 (58 FR 19282). Staff sent a copy of 
the letter dated April 2, 1993, with a copy of the Petition, to AMS.
    By letters dated September 13, 1994, October 13, 1994, and April 
29, 1996, the District filed supplements to its March 3, 1993, 
Petition. The District's September 1994 supplement requested that NRC 
commence enforcement actions against AMS for violations of 10 CFR 
Sec. 20.401(c)(3) and 10 CFR Sec. 20.303(a), based on assertions that 
the disposal records maintained by AMS are grossly inaccurate, in 
violation of 10 CFR Sec. 20.401(c)(3), and that AMS discharged material 
to the sewer that was not readily soluble in or dispersible in water, 
in violation of 10 CFR Sec. 20.303(a). In addition, the September 1994 
supplement requested that the March 3, 1993, petition be granted 
immediately insofar as it requested that AMS be held responsible for 
all costs arising from contamination of the District's treatment plant 
and that AMS be required to decontaminate the sewer downstream from the 
London Road facility. In its October 1994 supplement, the District 
requested that NRC commence an enforcement action against AMS for 
violation of 10 CFR Sec. 20.2003, based on the assertion that AMS had 
recently discharged cobalt-60 to the sewer that was not soluble or 
readily dispersible biological material, in violation of that 
provision. In its April 1996 supplement, the District requested NRC 
action on a license requiring AMS to safely and reasonably 
decontaminate the London Road interceptor (the sewer), or, if NRC's 
position is that such action has already been ordered, NRC action 
requiring AMS to actually complete the decontamination.

[[Page 33684]]

    Since receipt of the March 3, 1993, Petition, NRC has amended AMS' 
license such that one of the District's requests has already been 
partially granted, as set forth below. I have completed my evaluation 
of the remaining matters raised by the District and have determined 
that, for the reasons stated below, the other requests in the Petition 
and its supplements should be denied.

II. Background

    NRC issued License No. 34-19089-01 to AMS on November 2, 1979. 
Picker Corporation had previously owned and operated the licensed 
operation, facilities, and equipment since 1959. From 1979 to mid-1991, 
the AMS license authorized the possession of 150,000 curies (5550 
terabecquerels) of cobalt-60 in solid form for the purpose of 
manufacturing sealed sources for distribution to authorized recipients 
for use in teletherapy units (used at medical facilities for treatment 
of medical conditions). The AMS license currently limits possession to 
150,000 curies (5550 terabecquerels) as solid metal and 135,000 curies 
(4995 terabecquerels) in sealed sources, for use in installing and 
servicing teletherapy units, and training; the current license does not 
authorize manufacture of sealed sources for distribution. The license 
also authorizes possession of 40,000 curies (1480 terabecquerels) of 
cesium-137 in sealed sources, and 4040 kilograms of plated depleted 
uranium shielding, incident to teletherapy and industrial radiography 
installation, maintenance, and service. The facility that houses the 
licensed material is located on London Road in Cleveland, Ohio.
    The District is responsible for operating three wastewater 
treatment facilities in and around the Cleveland, Ohio, metropolitan 
area. The District's SWTC has been operating since 1927 to remove grit 
and debris from wastewater that the District services. This process 
involves incineration of sludge, transport of the residual ash in a 
slurry to settlement and evaporation ponds, and eventual transfer of 
the dried ash to landfills. The SWTC also incinerates sludge generated 
at other facilities, including the District's Easterly Plant, which 
services the area where AMS is located.
    In April 1991, NRC identified cobalt-60 at the SWTC in ash piles 
coincidental to an aerial radiation survey of an unrelated site. In 
September 1991 and March 1992, at the request of NRC, Oak Ridge 
Institute for Science and Education (ORISE) performed surveys at the 
SWTC to determine the extent of the cobalt-60 contamination at the 
facility. The results of the ORISE surveys are reported in Radiological 
Characterization Survey for Selected Outdoor Areas, Northeast Ohio 
Regional Sewer District, Southerly Wastewater Plant, Cleveland, Ohio, 
Final Report, August 1992 (hereafter referred to as ``ORISE report''). 
The ORISE report indicated that there were elevated direct radiation 
readings that were caused by cobalt-60 contamination, with elevated 
concentrations in soil and sediment samples. Based on this ORISE report 
and information collected and examined by NRC staff, NRC estimated that 
a total activity of 414 millicuries (15.3 gigabecquerels) of cobalt-60 
existed at the SWTC in 1992.
    Since the District needs to transfer the dried ash from the 
evaporation ponds to continue operations, NRC approved the site 
remediation strategy for ash removal, and had ORISE perform an 
independent survey to evaluate the radiological status of the 
remediated area. The District performed a radiological characterization 
of the facility to better determine the amount of cobalt-60 that is 
actually present on the SWTC site; the District's consultant estimated 
the quantity of cobalt-60 in the North Fill Area, as of 1993, to be 
about 443 millicuries (16.4 gigabecquerels).
    As discussed below, NRC has evaluated the District's concerns and 
bases for its requests for NRC action. Although NRC has amended AMS' 
license to require remediation of the interceptor sewer line operated 
by the District in the vicinity of the connecting line from the AMS 
facility, which partially grants one of the District's requests, the 
District's remaining requests are denied for the reasons discussed 
below.

III. Discussion

A. Timing and Source of Contamination Identified at the SWTC
    In 1991, cobalt-60 was discovered in the North Fill 
Area.1 The staff's review of the history of the SWTC 
revealed that, after renovation of the incinerators between 1975 and 
1978, the incinerators came back on line in November 1978, and the 
current ponds were put into use for the first time. The ponds were then 
cleaned for the first time from December 1982 to March 1983. The 
District removed the ash from the evaporation ponds and placed it in 
the North Fill Area, which was then landscaped. This was the only time 
the North Fill Area was used for ash disposal. Accordingly, the cobalt-
60 entered the District's system and was deposited at SWTC between late 
1978 (when the ponds were first used) and December 1982 (when the ponds 
were first cleaned and the ash placed in the North Fill Area). See 
Memorandum for Carl J. Paperiello, former Deputy Regional 
Administrator, NRC Region III, from Loren J. Hueter, Radiation 
Specialist, Division of Nuclear Material Safety, NRC Region III, on the 
subject of ``Report on Trip to General Chemical Corporation (Non-
licensee), 5000 Warner Road, Cleveland, Ohio, and to Northeast Ohio 
Regional Sewer District, 6000 Canal Road, Cleveland, Ohio,'' (Docket 
No. 030-18276; License No. 34-17726-02) dated June 13, 1991. The 
staff's conclusion as to when cobalt-60 contamination entered the 
sanitary sewer system is supported by the District's letter, dated 
September 13, 1994, which stated that the earliest possible date that 
the cobalt-60 could have been discharged into the sanitary sewer was 
not more than a week or two before the opening of lagoons in October 
1978.
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    \1\ Significant levels of cobalt-60 requiring remediation were 
discovered in the North Fill Area, in the existing In-Place Ash 
section of the South Fill Area, and in the northern section of the 
South Fill Area. Only the North Fill Area contamination can be dated 
with any degree of certainty, although AMS records indicate that 
1989 was the last year AMS discharged cobalt-60 directly into the 
sanitary sewer system.
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    In an attempt to determine all possible contributors of cobalt-60 
contamination to the SWTC, NRC conducted a file review of all licenses 
issued since 1975, active and terminated, for activities at facilities 
in the zip code areas serviced by the District. NRC contacted existing 
and previous licensees for additional information. The U.S. Department 
of Energy was also contacted to determine if any of its operations in 
the Cleveland metropolitan area could have contributed to the cobalt-60 
contamination at the SWTC. Although other cobalt-60 users were found in 
the NRC's file search, it was concluded that no facility, other than 
AMS' facility at 1020 London Road, Cleveland, Ohio, was authorized to 
possess the quantities of unsealed cobalt-60 that could have 
contributed to the levels of cobalt-60 contamination found at the SWTC. 
Memorandum from Roy Caniano, Chief, Materials Inspection Branch, 
Division of Radiological Safety & Safeguards (DRSS), Region III, to 
William L. Axelson, Director, DRSS, dated November 7, 1994 (hereafter 
``Caniano memo'').
    Given the information as to the timing of the disposals into the 
sewer system that caused the cobalt-60 contamination at the SWTC, the 
staff included Picker, which previously used the facility

[[Page 33685]]

under NRC license, in its review and inspection, although the District 
did not seek action against Picker. Current and former Picker 
employees, as noted in Inspection Report No. 030-16055/93003 (Section 
3.C), issued November 7, 1994, stated that liquid radioactive waste was 
routinely discharged from the London Road facility. They stated, 
however, that the 1 curie (37 gigabecquerels) per year annual gross 
quantity disposal limit (10 CFR Sec. 20.303) was never exceeded during 
their respective tenures. Based on the information gathered during the 
inspection, it is highly likely that Picker Corporation discharged 
cobalt-60 into the sanitary sewerage system every year that it operated 
the London road facility, including the 1978 and 1979 time period of 
interest. As for AMS, its records indicate that a total of 209 
millicuries (7.73 gigabecquerels) of unsealed cobalt-60 was disposed of 
into the sanitary sewerage system during the period 1980 to 1989. 
Caniano memo at 3. AMS records indicate that 1989 was the last year 
that cobalt-60 was discharged directly into the sanitary sewerage 
system. NRC Inspection Report No. 030-16055/93003(DRSS) at 7, issued 
November 7, 1994. AMS records also specifically list releases during 
the 1980-82 time frame. Inspection Report No. 030-16055/93002 at 17, 
issued August 2, 1993. The information gathered by the staff indicates, 
therefore, that cobalt-60 was likely released from the London Road 
facility during the 1979-82 period of interest by both Picker and AMS.
    AMS has recorded discharging cobalt-60 to the sanitary sewer system 
that eventually leads to SWTC, as described above. AMS records 
indicate, however, that it had been discharging cobalt-60 in accordance 
with the quantities and concentrations authorized by the then-
applicable regulations and license. NRC's inspection and review of 
records have not revealed any documentation at AMS or other evidence 
that would indicate discharges in excess of authorized limits.
B. Request for NRC Action To Require AMS To Assume the Cost Resulting 
From Offsite Release of Cobalt-60
    The staff has carefully considered the action the District has 
requested and the bases stated by the District for its request. In 
addition, the staff has evaluated the results of its inspections and 
all available information related to the District's requests. None of 
the available information, individually or taken together, demonstrates 
that AMS violated NRC regulatory limits or other requirements related 
to the discharge of cobalt-60 into the sanitary sewer system.
    In a proceeding involving the decommissioning of the Yankee Nuclear 
Power Station near Rowe, Massachusetts, the Commission stated that it 
had no authority to grant an intervenor's request for compensation 
similar to the District's. Yankee Atomic Electric Co. (Yankee Nuclear 
Power Station), CLI-96-7, 43 NRC 235 (1996). In the Yankee Atomic 
proceeding, the licensee had initiated substantial decommissioning of 
its facility through a ``Component Removal Project'' (CRP) under a new 
Commission policy interpreting the decommissioning rule (10 CFR 
Sec. 50.82) and had removed and disposed of many radioactive components 
through the CRP. The intervenors succeeded in challenging the 
Commission policy, which had allowed the licensee to initiate the CRP 
without an opportunity for a hearing. CAN v. NRC, 59 F.3d 294 (1st Cir. 
1995). As relief for the failure to offer an opportunity for a hearing, 
and based on their assertion that the CRP had caused workers and the 
public to receive doses far above those as low as reasonably 
achievable, the intervenors requested the Commission to require the 
licensee to establish a fund for the treatment of cancers caused by the 
doses resulting from the CRP. Yankee Atomic, CLI 96-7 at 268. In 
rejecting the intervenors' arguments, the Commission held that ``no 
statute or regulation grants the Commission authority to require the 
Licensee to pay (in effect) compensatory damages to private 
individuals.'' Id. at 269.
    The District's request for compensation from AMS for costs 
resulting from offsite releases of cobalt-60 from the London Road 
facility is not materially different from the Yankee Atomic 
intervenors' request for compensation. No statute authorizes the NRC to 
require any licensee to pay such compensatory damages, especially in a 
case in which the releases that resulted in the third party's damages 
were within applicable NRC limits.
    The District, in addition to filing its Petition with NRC, 
instituted a court action against AMS and other defendants for tort 
remedies, including property damage and remediation costs, resulting 
from the discharge of cobalt-60 into the District's system. The action, 
which was pending before the United States District Court for the 
Northern District of Ohio, Eastern Division (Case No. 1:94 CV 2555), 
has been settled. Letter dated January 2, 1997, from L. K. English, 
Esq., Northeast Ohio Regional Sewer District, to J. Madera, Division of 
Nuclear Material Safeguards, NRC. A court of competent jurisdiction, 
and not NRC, is the proper forum for the District to seek compensatory 
damages from AMS. Accordingly, the District's request for NRC action to 
require AMS to assume the costs resulting from the release of cobalt-60 
is denied.
C. Request To Require AMS to Decontaminate the Sewer Connecting Its 
London Road Facility With the Public Sewer at London Road and Continue 
Downstream to the Extent AMS/NRC Sampling Indicates Is Necessary
    By letter dated April 29, 1996, the District supplemented its 
original Petition with a request that AMS be required to ``safely and 
reasonably'' decontaminate the London Road interceptor. In addition, 
the District requested that NRC take action to have AMS complete the 
decontamination of the interceptor if NRC believed that it had already 
ordered AMS to take action to decontaminate the interceptor. The 
indicated sewer connection that was identified as having excessive 
exposure rates is on AMS property. NRC did issue a Notice of Violation 
(NOV) for AMS' violation of 10 CFR Sec. 20.105, in that the exposure 
rates in the accessible sewer line on the AMS facility were excessive 
for an unrestricted area. NOV issued to AMS, License No. 34-19089-01, 
dated May 5, 1988, resulting from a special safety inspection conducted 
on April 13, 1988 (NRC Inspection Report No. 16055/88001 (DRSS)). 
However, the manhole controlling access to the sewer connection was 
designated a restricted area; the sewer cover on the AMS property was 
secured with a lock and bar; and the sewer connection area was 
partially decontaminated, reducing the contamination and exposure rate 
levels. Letter from T. J. Hebert, Chairman, Radioisotope Committee, 
AMS, to R. E. Burgin, Senior Radiation Specialist, NRC Region III, 
dated May 23, 1988. These facts were confirmed by Oak Ridge Associated 
Universities, contracted by NRC to perform a radiological survey to 
determine the then current conditions at the AMS facility. See Oak 
Ridge Associated Universities Report Radiation Survey of the Advanced 
Medical Systems, Inc., London Road Facility, Cleveland, Ohio, Final 
Report at 20 (April 1989). The exposure rates are no longer considered 
excessive as a result of the decontamination performed by AMS and the 
designation of the manhole as a restricted area. Moreover, in 1995, AMS 
permanently sealed the lateral from the old manhole to the sewer line. 
AMS also removed most of the original foundation underdrain system and 
replaced it with a new, clean system. AMS is currently required to test 
the groundwater pumped from the new

[[Page 33686]]

foundation underdrain system, to ensure compliance with 10 CFR 
Sec. 20.2003.
    The NRC has taken action by issuing Amendment No. 32 to AMS' 
license, dated March 17, 1995, in which the NRC, through Condition 
19.F., required AMS to remediate the London Road interceptor in the 
vicinity of the abandoned lateral, as described in an AMS letter 
proposing action to remediate contaminated piping. See ``Action Plan 
for the London Road Facility,'' at 2 (Jan. 27, 1996). License Condition 
19 required that remediation of the interceptor be completed within 90 
days (i.e., by June 15, 1995). In Amendment No. 35 to AMS' license, 
dated June 16, 1995, NRC required AMS to initiate remediation 
activities no later than July 8, 1995, and to notify NRC no later than 
July 14, 1995, to confirm initiation of the remediation of the 
interceptor. Amendment No. 35, however, deleted the June 15, 1995, date 
for completion of remediation of the interceptor imposed by Amendment 
No. 32.
    By a letter dated July 12, 1995, AMS informed NRC that it would not 
start the remediation of the interceptor until July 29, 1995, and did 
not provide an estimated completion date for the remediation, as AMS 
further informed NRC that it needed the District's approval to access 
the interceptor. Letter from R. Meschter, Radiation Safety Officer 
(RSO), AMS, to J. Caldwell, NRC, dated July 12, 1995. By a letter dated 
July 19, 1995, AMS informed NRC that, for the same reasons given in the 
July 12, 1995, letter, it would not initiate remediation until August 
11, 1995. Letter from R. Meschter, RSO, AMS, to J. Caldwell, NRC, dated 
July 19, 1995. At that time, AMS and the District still had not agreed 
on arrangements for entry and evaluation of the interceptor.
    In a letter dated January 2, 1997, from L. K. English, Esq., 
Northeast Ohio Regional Sewer District, to J. Madera, NRC, the District 
forwarded a copy of a settlement agreement between the District and AMS 
regarding their court litigation. The settlement indicates that AMS 
agreed, inter alia, to pay the District a fixed sum, and the District 
agreed to allow re-connection of the AMS facility to the London Road 
interceptor after AMS' taking certain actions pertaining to conditions 
of the facility, and to design and construction of the connection. The 
part of the agreement concerning re-connection provides an alternative 
to use the present manhole located in London Road, provided that the 
plans include decontamination of the interceptor, at AMS' cost, before 
such use. The agreement specifies conditions and procedures under which 
AMS may plan to use the present manhole in the interceptor. In a 
meeting with NRC and AMS on February 10, 1997, AMS indicated that it 
was its intention to reconnect. Official Transcript of Proceedings: 
``Public Meeting with Advanced Medical Systems, Inc.,'' pp. 50-51 (Feb. 
10, 1997). AMS stated it will probably take from nine months to a year 
and a half for re-connection to actually happen. Id. at 51. In summary, 
insofar as Amendments No. 32 and 35 require AMS to remediate the sewer 
connecting its London Road facility with the public sewer, this request 
of the District has been partially granted. Although access to the 
interceptor is now controlled, License Condition 19.F. requires AMS to 
remediate the interceptor. The staff intends to pursue this matter in 
the near future. It is the staff's intent that the access concerns be 
resolved promptly, so that remediation may begin and be completed as 
soon as practical.
D. Other Issues Raised in Supplements to Petition
    By letters dated September 13, 1994, and October 13, 1994, the 
District supplemented its original Petition with a request that NRC 
commence an appropriate enforcement action against AMS for the 
maintenance of grossly inaccurate records of disposal of radioactive 
material from 1978 to 1993, in violation of 10 CFR Sec. 20.401(b)(3) 
(in effect through December 31, 1993). The District also asserted that 
AMS had disposed of cobalt-60 that was not ``readily soluble or 
dispersible in water,'' in violation of 10 CFR Sec. 20.303 (in effect 
through December 31, 1993), and had more recently discharged cobalt-60 
which was not ``readily soluble or dispersible biological material,'' 
in violation of 10 CFR Sec. 20.2003 (in effect on January 1, 1994, and 
thereafter).
    The staff has conducted numerous recent inspections at the London 
Road facility to address the District's concerns over cobalt-60 
discharges into the sanitary sewerage system. On March 15, 1995, NRC 
issued a Notice of Violation to AMS for failures to: (1) Evaluate the 
quantity of cobalt-60 released to the sewer system resulting from 
facility floods and certain decontamination activities; and (2) remove 
non-suspendible solids by the use of a cloth filter, as required by 
AMS' license conditions. The background relating to unmonitored 
releases resulting from facility floods and certain decontamination 
activities is set forth below.
    The information as to when the unmonitored releases occurred came 
from current and former Picker and AMS employees and identified several 
occasions in the late 1960s and the mid-to late-1980s when the basement 
was flooded, resulting in backflow into the sewer system. The available 
information indicated that not all these occurrences were evaluated to 
identify the amount of radioactivity that may have been released. 
Inspection Report No. 030-16055/93003, at 16-19. Based on the extensive 
information provided by the interviewees, the staff concluded that it 
was unlikely that the cumulative total quantity of cobalt-60 released 
during these unmonitored releases exceeded a few hundred millicuries. 
Id.
    As to the filtering of the waste water pumped from holding tanks in 
the Waste Hold-Up Tank room, the information gathered from the 
interviewees strongly indicated that the filter was not always in place 
from the mid-1970s through the mid-1980s, thus raising the potential 
for cobalt-60 pellets to have been discharged through this route into 
the sewer system. Id. at 14.
    The NRC has already taken enforcement action for the failures to: 
(1) Evaluate and report certain releases into the sewer system as a 
result of facility floods or decontamination activities that likely 
included cobalt-60; and (2) ensure that waste water in the hold-up 
tanks was passed through filters that should have captured any cobalt-
60 pellets before the release of the water to the sewer system. The 
staff does not believe that further enforcement action for the matters 
identified in the September 1994 supplement is warranted.
    Regarding the October 1994 supplement's request for enforcement 
action for violation of 10 CFR Sec. 20.2003, the staff has not found 
evidence, based on NRC interviews and review of records, that AMS 
intentionally disposed of cobalt-60 into the facility's drains leading 
to the District's sanitary sewerage system since May 1989. The AMS 
records contain no discharge log entries after this date. Furthermore, 
AMS has not generated liquid radioactive waste from manufacturing 
operations in several years, and has no plans to do so in the future, 
because of termination of source manufacturing operations. See 
Inspection Report No. 030-16055/93002. However, both the District and 
the staff performed sampling (post January 1, 1994, the effective date 
of revision of 10 CFR Part 20) that identified cobalt-60 at the point 
of discharge of the sanitary sewerage piping from the London Road 
facility into the District's sewer line. See the

[[Page 33687]]

District's supplement to its Petition, dated October 13, 1994, and 
Inspection Report
    No. 030-16055/94003, issued on December 6, 1994. The presence of 
the cobalt-60 appears to be a result of plate-out of cobalt-60 onto the 
walls of the piping leading from the London Road facility. The staff 
had characterized the results of its sampling as indicating an apparent 
violation of 10 CFR Sec. 20.2003. Id.
    The sampling performed by the District and subsequent sampling 
performed by the staff in early 1995 indicated that some or all the 
cobalt-60 detected might be ``soluble,'' as that term is defined in NRC 
Information Notice No. 94-07, dated January 28, 1994. The uncertainty 
as to the solubility of the cobalt-60 prompted the staff to begin 
preparations for a solubility analysis of the sample taken on August 
17, 1994. In accordance with Region III policy, those samples had been 
transferred back to the District, on whose property the samples had 
been taken. Because of further analyses the District had performed on 
the samples, the samples no longer existed in their original form; 
therefore further solubility analyses could not be performed. Further 
representative samples of the water at this point in the waste stream 
could not be taken because of the District's plugging of the pipe. In 
view of the inability of the staff to determine that the cobalt-60 in 
the sampled water was, in fact, insoluble, there was an insufficient 
basis to cite AMS for a violation of 10 CFR Sec. 20.2003. Furthermore, 
there is not now a significant potential for discharge of cobalt-60 
from the London Road facility to the District's system because: (1) old 
piping connecting the facility to the District's lines has been 
plugged; (2) the District has not permitted AMS to connect new clean 
piping installed by AMS to the District's lines; and (3) AMS collects 
and treats all water used on the site and holds it in tanks before it 
is determined not to contain insoluble cobalt-60.
    The staff believes that the vast majority of cobalt-60 inventory 
and activity discharged into the District's sanitary sewerage system 
was dispersible. It can be expected that a small amount of readily 
dispersible material would plate-out onto the sewer system pipes over 
the long history of cobalt-60 discharges by Picker and AMS. Staff 
concludes that the fact that a small amount of cobalt-60 built up over 
time in sewer pipes leading from the AMS facility, by itself, does not 
support the District's assertion that a discharge in violation of 10 
CFR Sec. 20.303 or 10 CFR Sec. 20.2003 occurred.

IV. Conclusion

    For the reasons discussed above, no basis exists for taking any 
action, in addition to the action described above, in response to the 
requests in the Petition and its supplements. Accordingly, no further 
action pursuant to 10 CFR Sec. 2.206 is being taken in this matter.
    As provided by 10 CFR Sec. 2.206(c), a copy of this Decision will 
be filed with the Secretary of the Commission for the Commission's 
review. The Decision will become the final action of the Commission 
twenty-five (25) days after issuance unless the Commission on its own 
motion institutes review of the Decision within that time.

    Dated at Rockville, Maryland, this 13th day of June, 1997.

    For the Nuclear Regulatory Commission.
Carl J. Paperiello,
Director Office of Nuclear Material Safety and Safeguards
[FR Doc. 97-16174 Filed 6-19-97; 8:45 am]
BILLING CODE 7590-01-P