ML20148C539

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Rulemaking Plan, Financial Assurance for Teletherapy & Krypton-85 Licensee, Amends to 10CFR30 & 35
ML20148C539
Person / Time
Issue date: 04/22/1997
From: Morrison D
NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES)
To:
Shared Package
ML20147J307 List:
References
REF-WM-3 PROC-970422, NUDOCS 9705220457
Download: ML20148C539 (6)


Text

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. i RULEMAKING PLAN FINANCIAL ASSURANCE FOR TELETHERAPY AND KRYPTON-85 LICENSEES ,

AMENDMENTS TO 10 CFR PARTS 30 AND 35  :

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- Lead Office: Office of Nuclear Regulatory Research Staff

Contact:

Clark Prichard, RDB/DRA/RES l

Concurrences: /eu A $w D,Mate '77 D. Morrison, RES  ;

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e C. Paperiello, N'iSS Date i

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! l R. L. Bangart, OSP Date j

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i J. Lieberman, OE Date I

B. J. Shelton, IRM Date t

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J.Funches,CFG Date 3

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4 A. J. Galante, CIO Date

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W. J. Olmstead, OGC Date i

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Approval: ,

L. Joseph Callan, EDO Date i N O'

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. s, Rulemaking Plan Response to NMSS Request for Rulemaking 10 CFR Parts 30 and 35 Financial Assurance--Teletherapy and Kr-85 i

Regulatory issue The NRC has developed regulations to assure that licensees provide adequate funding for decommissioning activities. The financial assurance requirements were not intended to be applied to relatively minor situations, and the NRC staff has granted a number of exemptions to licensees who might otherwise be in non-compliance with the decommissioning r J!e, which requires the backup of a surety mechanism. Two categories of these exemptions are teletherapy source exchange and Kr-85 decommissioning.

l Periodically, teletherapy licensees replace decayed sources with new ones. During the exchange process, which lasts up to 30 days, some licensees exceed the possession threshold in 10 CFR 30.35 requiring financial assurance. Because the exchange process is temporary, NRC has issued exemptions from 10 CFR 30.35. A rulemaking allowing i temporary exceptions to the thresholds would eliminate the need for NRC to grant case by-case exemptions.

Decommissioning of Krypton 85 facilities is typically done by release of the gas to the atmosphere or transfer to another licensee. The cost of these methods is minimal, and there is no need for financial assurance, Krypton 85 has been the subject of several exemptions from financial assurance requirements. A rulemaking eliminating Kr-85 from the list of nuclides requiring financial assurance will relieve licensees from a burden and save NRC the expense of processing exemptions.

l Existing Regulatory Framework l

! Subpart I of 10 CFR Part 35 covers requirements for teletherapy licensees. Part 30.35  !

covers threshold amounts of materials requiring an applicant or licensee to provide financial assurance, II How tne Regulatory Problem Will be Addressed By Rulemaking i

Subpart I of Part 35 will be amended to allow for temporary exchanges of sources for teletherapy licensees without triggering financial assurance requirements. A new section will be added to provide for a specified period (30 days) during which possession limits

! might be exceeded for source exchange without financial assurance requirements being

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l Part 30.35 will be amended to ehminate Kr-85 as a nuchde requinng an apphcant or hcensee to provide financial assurance. Section 30.35 (a) will be amended to state that no financial assurance is required for possession of Kr 85. i Rulemaking Options (1) No action: Continue to use the exemption process to deal with these problems.

(2) Proceed with usual notice and comment rulemaking: Issue a proposed rule for public comment, evaluate and resolve public comments, and issue a final rule.

(3) Use direct final rulemaking; issue a notice of a direct final rule.

impacts on Licersees BACKGROUND Teletheraov Licensees There are approximately 80 NRC teletherapy licensees. Ten of these licensees require financial assurance on a permanent basis. For many of the other teletherapy licensees, changing teletherapy sources creates a temporary situation where financial assurance I thresholds are exceeded. This results in licensees not needing financial assurance for normal operations having to request exemptions from NRC. These exemptions have created a significant resource burden on NRC in the past. Of exemptions granted from financial assurance requirements for materials licensees, teletherapy source exchanges accounted for the vast majority (see SECY 94-232 cod SECY 93-288 which are attached).

Most teletherapy licensees that require financial assurance use the $75,000 certification amount. The cost of financial assurance for these licensees is approximately 1.5 % of the assurance amount on an annual basis, The number of exemptions granted teletherapy licensees for source exchanges has averaged about 10 per year in recent years and seems to have been declining over this period.

The exemptions . anted thus save licensees approximately 11K per year. The costs of granting the e..emptions are licensee time to prepare the exemption request and NRC time to review the requests. Assuming 1 hour1.157407e-5 days <br />2.777778e-4 hours <br />1.653439e-6 weeks <br />3.805e-7 months <br /> of NRC staff time to process an exemption and 10 exemptions per year, this would be 0.25 weeks of staff time per year. NRC's annual labor costs are approximately $125K per year, so this translates into an annual estirnated cost of approximately $1K.

. Krypton-85 Licensees Licensees using Kr-85 and requiring financial assurance are primarily manufacturers of electronics components and firms doing leak testing of electronic components.

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a t Upon decommissioning, these licensees d:spose of Kr 85 oy enting to tnr. atmosphere or by transfer to another licensee, processes whiCb generally Costs less than $1K.

Kr-85 financial assurance exemption requests totaled 6 for tr'e years 1992.1993,and 1994. An estimate of the NRC staff time to process a Kr-85 financial assurance exemption is 8 staf f hours. At NRC hourly labor rates this would be a total cost of $3K for this 3 year period or an average of $1K per year.

Benefits (1) The benefit of the no action alternative is that no NRC resources would be expended to complete a rulemaking.

(2) The benefits of regular notice and comment rulemaking are the elimination of the need to process exemptions. The exemption process unnecessarily consumes a modest amount of NRC staff ime, and requires resource experditure by licensees to prepare requests.

(3) The benefits of direct final rulemaking are that it produces the same effect as (2)--

eliminating the need to process exemptions--t"Jt potentially does so at a lower cost to NRC in staff time if no significant adverse comments are received.

Costs (1) The costs of the no action option are the costs to licensees of preparing the exemption request and the cost to NRC of reviewing the requests. Costs to licensees are probably moderate; for the purpose of this analysis it is assumed that licensee costs per exemption request are $1K per request. The cost to licensees of exemption requests would thus total

$12K for 12 requests per year. For NRC review costs, no database exists on costs of processing exemption requests. However as a rough estimate, assuming 1 staff hour for teletherapy exemption review and 8 staff hours for Kr-85 exemption review at normal NRC hourly labor costs, processing 12 exemptions per year would be approximately $2K in annual costs. Total costs for this option would be $14K per year.

(2) The costs of regular notice and comment rulemaking would be the staff time for developing the rulemaking. Assuming a 0.7 FTE allotment for completing the rulemaking, at present hourly NRC labor rates this would be $87.5K.

(3) The costs of a direct final rulemaking would also be the NRC labor costs, which could  !

I be significantly less than (2) because of the shorter time frame and reduced number of steps involved in a direct final rule vs. regular rulemaking. This rulemaking plan estimates O.4 FTE's for direct final rulemaking, which translates to approximately $50K in NRC labor costs.

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. I Preferred Option The preferrea cption is option 3. The benefits of this rulemaking are sufficiently obvious and noncontroversial that proceeding with a direct final rule is justified. No additional l

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fisks, either health and safety or financial assurance, will be imposed. The action will save -

I licensees the cost of preparing requests for exemption and NRC the costs of processing i- these requests.

i 1 A one-time cost of $50K to conduct the rulemaking will save an estimated $14K annual cost to licensees and NRC.

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Office of General Counsel Legal Analysis i

to be added by OGC 1

Backfit Analysis f

The backfit rule,10 CFR 50.109 does not apply to this rulemaking. A backfit analysis is

! not required because 10.CFR 50.109 addresses only the process for controlling backfits of l nuclear power reactors, and this rulemaking does not affect the Commission's I decommissioring financial assurance requirements regarding nuclear power reactors.

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l Agreement State implementation issues i

i Financial assurance is a Division 2 compatibility item; Agreement States must maintain l similar or more stringent regulations. States would therefore have the option of either j taking no action or promulgating rules similar to this rulemaking, which lessens the .

requirements for financial assurance. i Major Rule This is not a major rule; it makes minor adjustments to financial assurance regulations for some categories of materials licensees.

Supportirig Documents Needed i

Regulatory impact Analysis. Environmental assessment. j Issuance by Executive Director for Operations or Commission As this rulemaking does not involve significant policy issues, it is recommended that the EDO issue this rule.

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Resources Needed to Complete Rulemaking 0.4 FTEs total 0.3 RES, 0.05 NMSS, 0.05 OGC i

l Staff Level Working Group Concurring Official Clark Prichard, RES (415-6203) Joseph Murphy

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Louis Bykoski, NMSS Donald A. Cool Stephen Lewis, OGC William Olmstead Dennis Sollenberger, OSP Richard Bangart l

Management Steering Group Not needed for this rulemaking.

Public Participation No special public participation will be sought, Agreement States will have the opportunity to review the rulemaking plan and offer comments.

Schedule Direct final rule schedule based on issuance by EDO.

Direct final rule to the EDO, 3 months from approvai of the rulemaking plan.

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POLICY ISSUE S EG- N- 2 3 2 September 8, 1994 (lg{grgggjgg) l il fDE: The Comissioners  !

fEDd: James M. Taylor j Executive Director for Operations

SUBJECT:

ANNUAL REPORT ON ROUTINE EXEMPTIONS ORANTED TO THE )

FINANCIAL ASSURANCE REQUIREMENTS, FOR THE PERIOD l AUGUST 1, 1993, TO AUGUST 1, 1994 PURPOSE:

To keep the Comission informed about routine exemptions granted from the financial assurance requirements of the Decomissioning Rule for material l licensees. ]

BACKGROUND:

In the Staff Requirements Memorandum dated September 20, 1991, the Chairman requested that the Nuclear Material Sfsty and Safeguards (NMSS) staff keep the Comission informed about all routine exemptions granted to the financial  ;

assurance requirements, by providing a semiannual sumary report. The first of these semiannual reports was provided to the Comission on March 26, 1992 (SECY-92-109), for the period from the effective date of the Decomissioning i Rule, to March 1, 1992. The second semiannual report was provided to the l Comission on September 18, 1992 (SECY-92-321), for the period March 1, 1992, j to August 1, 1992. On October 7,1992, the Comission changed the frequency i for these sumary reports from semiannual to annual. The first annual report I was provided to the Comission on October 18, 1993 (SECY-93-288).

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Contact:

Louis M. Bykoski, NMSS NOTE: TO BE MADE PUBLICLY AVAILABLE 415-6754 in lo wongrug onys paos 7ag j DATE OF THIS PAPER j l

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. ,,t The Commissioners Exemptions to the decomissioning financial assurance requirements are considered on a case-by-case basis. In general, however, exemptions to the financial assurance requirements are granted only if there is reasonable assurance that funding will be available for decomissioning.

Because the financial assurance requirements were not intended to be applied to relatively minor situations, routine exemptions are granted to licensees to allow them to remain in compliance with the decomissioning rule without the need of the backup of a surety mechanism. Such situations include teletherapy unit source exchanges because the licensee possession of material exceeding the threshold is limited in time to less than 30 days. Other situations include exemptions based on an estimated decomissioning cost that is small enough to enable the licensee to fund the decomissioning without the need of a financial surety. Such cases include facilities that have Kr-85, which involves either transfer to another licensee or release of the gas to the atmosphere, in accordance with effluent release requirements.

QJjlCUSSION:

The number of routine exemptions granted totaled six for the period August 1, 1993, to August 1, 1994. Teletherapy unit source exchanges accounted for all six exemptions.

An enclosure has been prepared that presents a listing of the exemptions by name of licensee, the license number, and reasons for the exemption.

Because of the routine nature of the exemptions granted from financial assurance requirements and their steadily declining numbers, the staff considers the annual report on routine exemptions to be of limited utility.

Consequently, the staff intends to eliminate this annual report to the Comission, unless the Comission continues to desire the report and so advises. The Staff continues to monitor tha number and types of exemptions to the financial assurance requirements and will inform the Comission of any significant developments in the future.

COORDINATION:

The Office of the General Counsel has reviewed the paper and has no legal objections.

G es .T or ecutive irector for Operations

Enclosure:

DISTRIBUTION:

Exemptions Granted t commissioners the Financial Assurance OGC Requirements oCAA OIG OPA OCA EDO SECY

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. , , t EXEMPTIONS GRANTED TO THE FINANCIAL ASSURANCE REQUIREMENTS BY LICENSEE, I LICENSE NUMBER, AND EXEMPTION / REASON, FOR PERIOD AUGUST 1, 1993, TO AUGUST 1, 1994 LICENSEE LICENSE NUMBER EXEMPTION / REASON

1. Bothwell Regional 24-16275-02 Teletherapy Source Exchange i Health Center

, 2. Licking Memorial 34-17013-02 Teletherapy Source Exchange (

Hospital l

3. Lutheran Medical 34-01869-02 Teletherapy Source Exchange Center
4. Medical Center 34-11852-02 Teletherapy Source Exchange Hospital 1
5. St. Joseph Hospital 34-04472-02 Teletherapy Source Exchange

,' Health Center j 6. I. Gonzalez Martinez 52-13471-02 Teletherapy Source Exchange i Onocologic Hospital l

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' Enclosure

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October 18, 1993 SECY-93-288 1 ,

fQR: The Comissioners l

FROM: James M. Taylor Executive Director for Operations

SUBJECT:

ANNUAL REPORT ON ROUTINE E"EMPTIONS GRANTED TO THE FINANCIAL ASSURANCE REQUIREMENTS, FOR THE PERIOD AUGUST 1, 1992, TO AUGUST 1, 1993 PURPOSE:

To keep the Comission informed about routine exemptions granted to the financial assurance requirements of the Decomissioning Rule for material licensees.

BACKGROUND:

In the Staff Requirements Memorandum (SRM) dated September 20, 1991, the Chairman requested that the Nuclear Material Safety and Safeguards (NMSS) staff keep the Comission informed about all routine exemptions granted to the financial assurance requirements, by providing a semi-annual summary report.

The first of these' semi-annual reports was provided to the Commission on March 26, 1992 (SECY-92-109), for the period from the effective date of the Decomissioning Rule, to March 1,1992. The second semi-annual report was 18, 1992 (SECY-92-321), for the period provided to the Comission March 1, 1992 to August 1, 1992. on SeptemberOn October 7,1992, the Comission changed the frequency for these sumary reports from semi-annual to annual.

Exemptions to the decomissioning financial assurance requirements are considered on a case-by-case basis. In general, however, exemptions to the

Contact:

Louis M. Bykoski, NMSS NOTE: TO BE ' MADE PUBLICLY AVAILABLE 504-2572 IN 10 WORKING DAYS FROM THE DATE OF THIS PAPER l

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I The Commissioners l financial assurance requirements are granted only if there is reasonable assurance that funding will be nailable for decommissioning. Teletherapy source change exemptions are granted routinely, because the licensee possession of material exceeding the threshold is limited in time to less than 30 days. Other exemptions include facilities having Kr-85, which involves ,

either transfer to another licensee or release of the gas to the atmosphere, ]

in accordance with 10 CFR Part 20 effluent release requirements. l QLSLUSSION:

The number of routine exemptions granted totaled 16 for the August 1,1992, to August 1, 1993, period. In addition, the regions indicated that 18 additional routine exemptions were inadvertently omitted from the previous reports.

Teletherapy unit . source exchanges accounted for 29 exemptions, and 2 exemptions are for decommissioning costs less than 41000. Three exemptions were for short-tenn extensions, to submit decommissioning funding plans.

The magnitude of the problem as a result of the abcve situations continues to l decline since 1) many exemptions have already been approved and are listed in  !

a license condition on the licensee's license, and 2) there appears to be a decline in the sale of teletherapy machines.

As mentioned in previous reports, rulemaking was planned that would eliminate financial assurance requirements for individual teletherapy source changes  ;

i taking 30 days or less and that would eliminate Kr-85 as a nuclide that would be considered in determining financial assurance requirements. This rule change has been deferred at this time in light of the relatively low priority that could presently be given to this administrative rule change due to low health and safety concern and the potentially shrinking magnitude of the problem. Nevertheless, since Agreement States are currently considering new rulemaking, OSP has been requested to contact those Agreement States that do not have this rule in place-and to have them consider the above exemption situations when developing their rule. This effort is intended to eliminate the need to get exemptions for similar Agreement State licensees.

An enclosure has been prepared that presents a listing of the exemptions by name of licensee, the license number, and reason for the exemption.

COORDINATION:

The Office of the General Counsel has reviewed the paper and has no legal objections.

y 3 lor ecutive trector for Operations DISTRIBUTION:

Enclosure:

Commissioners Exemptions Granted to OGC the Financial Assurance OCAA Requirements OIG OPA OCA OPP EDO

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EXEMPTIONS GRANTED TO THE FINANCIAL ASSURANCE REQUIREMENTS Bt LICENSEE, LICENSE NUMBER, AND EXEMPTION / REASON, FOR PERIOD j

AUGUST 1, 1992. THROUGH AUGUST 1. 1993 i

4' LICENSEE- LICENSE NUMBER EXEMPTION / REASON

1. University of Virginia 45-M034-09 Teletherapy Source Exchange l Teletherapy Source Exchange
2. Danville Medical Center 45-15154-02
3. The McGuire Clinic 45-16751-02 Teletherapy Source Exchange
4. University of Puerto Rico 52-01946-09 Teletherapy Source Exchange

.5. Hospital Ramon E. Betances 52-13598-01 Teletherapy Source Exchange

6. DePaul Medical Center 45-00986-02 Teletherapy Source ~xchange
7. Virginia Baptist Hospital 45-10542-02 Teletherapy Source Exchange
8. United Hospital Center 47-01458-02 Teletherapy Source Exchange
9. Charleston Rad Theraphy Consult. 47-15717-01 Teletherapy Source Exchange Hospital Oncologico 52-11832-01 Teletherapy Source Exchange
10. Teletherapy Source Exchange
11. Akron City Hospital 34-01932-01 Doctor's Hospital 34-05458-02 Teletherapy Source Exchange

. 12. Teletherapy Source Schange i 13. Lucy Lee Ho:,pital 24-15652-02*

Teietherapy Source Exchange

14. Mansfield General Hospital 34-02007-02*
15. Miller-Devan Medical Center 22-16390-02* Teletheracy Source Exchanga j 15. Radiarium Corporation 24-19486-0l* Teletherapy Source Exchanc
17. Southwestern Indiana Radiation 13-25945-0l* Teletherapy Jource Excnang:
13. St. Francis Hospital 13-02128-02* Teletherapy Source Exchange l

X-Ray Treatment Center, P.C. 21-19572-0l* Teletherapy Source Exchange 4

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- 20. Good Samaritan Hospital 13-01787-04* Teletherapy Source Exchange Heartland Hospital West 24-13246-02* Teletherapy Source Exchange

21. Teletherapy Source Exchange
22. Hennepin County Medical Center 22-13859-02*

Kraus, Lubert & Associates, Inc. 34-19119-0l* Teletherapy Source Exchange 23.

24-01239-02* Teletherapy Source Exchange

. 24 Menorah Medical Center Teletherapy Source Exchange

. 25. Metrohealth Medical Center 34-03749-07*

St. Elizabeth Hosp Medical Center 13-08615-05* Teletherapy Source Exchange 26.

13-17793-02* - Teletherapy Source Exchange

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27. St. John's Medical Center Teletherapy Source Exchange
23. Terre Haute Regional Hospital 13-09649-0l*

University Heights Cancer Center 13-02486-0l* Teletherapy Source Exchange 29.

30, Ohio State University 34-00293-02* DFP** Submission Date Extension 4

(Medical Institution Broad) SNM-362 DFP Submission Date Extension j 31. U.S. Department of Commerce i (NIST, Broad scope license)

Combustion Engineering, Inc. SNM-33 DFP Submission Date Extension' i 32.

(Hematite - UF6) Decommissioning Costs of less

,' 33. . Solid State Testing 20-18101-01 than $1000 (Kr-85) 37-19629-04 Decommissioning Costs of less

34. Displays, Inc.

than $1000 (Kr-85)

  • These exemptions were inadvertently omitted from previous reports.
** DFP Stands for Decommissioning Funding Plans.

' The licensee, due to the complexity of their program, has requested and was grant a ar l

extension for submission of their DFP.

I Enclosure 1

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