ML20216G370

NMSS Licensee Newsletter.Number 97-3.September-October 1997

ML20216G370
Person / Time
Issue date:	10/31/1997
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N97-3, NUREG-BR-117, NUREG-BR-117-N97-3, NUDOCS 9804200285
Download: ML20216G370 (12)

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,,,) Regulatory Comrnission Material Safety and Safeguards No. 97-3 Sept.-Oct.1997 r  :. .

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REVISION TO 10 CFR PART 35 months before the draft proposed rule language and associated draft documents are In a Fedeml Register notice (FRN), dated provided to the Commission for approval.

August 6,1997 (62 FR 42219), the U.S. (Currently the draft proposed rule and l Nuclear Regulatory Commission published a associated draft documents are scheduled to  !

request for public input and a description of be provided to the Commission in Spring the overall program for revising the 1998.) Public input received after the time regulations governing the medical use of indicated will be considered later, as part of byproduct material. Specifically, the FRN the ongoing interaction process and along with (a) describes NRC's rationale and program for the comments received during the formal revising the medical use regulation; public comment period on the proposed rule.  !

(b) identifies plans for review of the 1979 Medical Policy Statement; (c) describes plans for guidance development; (d) notifies the At the proposed final rule stage and on public of the availability of documents Commission approval, the proposed rule and associated with the revision process; and associated draft documents will be published (e) solicits informal pubh,c m, put on in the Fedeml Register for a public comment development of proposed rule language and period of 75 days. These documents will also associated documents. Further, the program be made available at the NRC Technical specifies Commission plans to formally Conference Forum and the NRC Public propose specific nilemakmg text for pubh.c Document Room. Draft documents will comment durmg the summer of 1998, with the continue to be at these locations, but the staff goal of beginning final Commission approval will not be able to consider further public m Sprmg 1999, input on these documents after the time beginning approximately 4 months before the The staff plans to solicit public input on the submission of the draft documents for revision to 10 CFR Part 35, associated Commission approval (currently scheduled for guidance, and the 1979 Medical Policy Spring 1999).

Statement on an informal and formal basis during the rulemaking process. The first Further, the staff plans to interact with version of the draft rule language is expected professional societies on an ongoing basis to to be available for public review at the NRC solicit input. The staff will conduct facilitated Technical Conference Forum (Internet access: public meetings in Philadelphia, PA, from http://techconf.llnl. gov /noframe.html) and October 28-30,1997, and in Chicago, IL, through the NRC Public Document Room,in from November 12-14,1997. These meetings g/

Fall 1997. During the development process, will be used to focus discussion on specific rule ,

the staff will make drafts publicly available, text proposals. Discussions will also be held m y) k but will only be able to ensure consideration of meetings with the Advisory Committee on the .

informal public input that is received before Medical Uses ofIsotopes and the Organization the time beginning approximately 2 to 3 of Agreement States, in the Fall of 1997.

9804200285 971031 PDR NUREG BR-0117 R PDR

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l NMSS LICENSEE NEWSLETTER 8. Year-2000 Effect on Computer SEI"rEMBER-OCTOLER 1997 System Software (Contact: Gaiy Purdy, NMSS, 301 - 415 - 7897, Page e-mail: gwpl @nrc. gov) . . . . . . . . . . . . . . 8 -

9. Selected Federal Register Notices

1. Revision to 10 CFR Part 35 (Con- (June 1,1997- August 31,1997) tact: Susanne Woods, NMSS, (General

Contact:

Kevin Ramsey, 301-415-7267, e-mail: srw@nrc. gov) . 1 NMSS, 301-415-7887, e-mail:

kmr@n rc. gov) . . . . . . . . . . . . . . . . . . . . . . 9

2. Medical Licensee Unauthorized Us

10. Generic Communications Issued of Byproduct Materials (Contact:

(May 1,1997-July 31,1997)

Robert Ayres, NMSS,301-415-5746, (General

Contact:

Kevm Ramsey, e-mail: rxa@nrc. gov) . . . . . . . . . . . . . . . . 2 NMSS, 301 -415-7887, e-mail:

• " 'E '''''''''''''''"""

3. Authorized Activities at Locations Identified on Industrial Radiography 11.Significant Enforcement Actions Licenses (Contact: J. Bruce Carrico, (Contact: Joseph Delmedico, OE, '

NMSS, 301-415-7826, e-mail: 301-415-2739, e-mail: rid @

jbc@nrc. gov) . . . . . . . . . . . . . . . . . . . . . . . 3 nrc. gov) . . . . . . . . . . . . . . . . . . . . . . . . . . 11

4. Consolidating and Updating Materials Licensing Guides (Contact: Sally Merchant, NMSS, 301 - 415 - 7874, e-mail: sim@nrc. gov) . . . . . . . . . . . . . . . . 4 As indicated in the FRN, public input and suggestions may be submitted either 1

5. Publication of Final Guidance on electronically, via Internet, or in writing at the Portable Gauge Licenses (Contact: following addresses:

Patricia Vacca, NMSS,301-415-7908, .

1. Send written input and suggestions to e-mail: pcv@nrc. gov) . . . . . . . . . . . . . . . . 5 ,

Secretary, Nuclear Regulatory Commission, Washington, DC 20555-0001, Attention:

6. New Draft Guidance on Industrial Rulemakings and Adjudication Staff.

Radiography Licenses (Contact: J.

Bruce Carrico, NMSS,301-415-7826, 2. Hand-deliver comments to 11555 Rockville e-mail: jbc@nrc. gov) . . . . . . . . . . . . . . . . 6 Pike, Rockville, MD, between 7:30 a.m.

and 4:15 p.m. on Federal workdays.

7. Nuclear Byproduct Material Risk Review Group (Contact: Dennis I. 3. Public input may also be submitted Scrig, NMSS, 301-415-7901, e-mail: electronically on the Internet via NRC's i

dis @nre. gov) . . . . . . . . . . . . . . . . . . . . . . . 7 Technical Conference Forum c

(http:\\techconf.llnl. gov /noframe.html).

1 (Susanne Woods, NMSS,301-415-7267, Comments, and suggestions you may have ,

email: srw@nrc. gov) for information that is not currently being included, that ght be helpful to licensees, MEDICAL LICENSEE UNAUTHORIZED E. Kraus USE OF BYPRODUCT MATERIALS NMSS Licensee Newsletter Editor .

Office of Nuclear Material Safety Occasionally tile Nuclear Regulatory , ,

Commission discovers a medical licensee using and Safeguards j Two White Flint North, Mail Stop 8-A-23 byproduct material in a manner not authorized U.S. Nuclear Regulatory Commission by its NRC license. This occurs most Washington, D.C. 20555-0001 frequently in the conduct of radiation therapy treatments. One of the most recent examples 2

'f of this type oflicense violation occurred when not require quantities of a given radionuclide an NRC licensee used its high-dose-rate (HDR) in excess of the licensee's possession limits. If remote, afterloading brachytherapy device to the licensee is uncertain whether a new perform surface treatments of superficial skin procedure is permitted by its existing license .

lesions, a use not authorized by its license. The conditions, it should contact its NRC regional typical license condition for HDR devices office for clarification before implementing authorizes uses for " interstitial, intracavitary, any questionable procedures that my be in and intraluminal uses only," and thus excludes violation ofits existing license conditions. If a

other uses such as topical or surface new procedure or therapy is found to be treatments and intravascular treatments unauthorized, then the licensee must request intended to reduce or eliminate restenosis, and receive an appropriate amendment to its existing license before beginning the Often uses not presently authorized by existing procedure. It should be noted that Ocense conditions, such as the previously cited broad-scope licensees are granted much more surface treatments, have been and can be authority to approve the adoption of new authorized by licensee request for a license procedures and research involving the use of

. amendment. Other uses, such as the new byproduct materials _than are licensees of intravascular brachytherapy procedures for the limited specific scope and are less likely to be prevention of restenosis, can also be approved, limited, by license condition (s), from but may require a much more complex license conducting new procedures without prior NRC amendment procedure. The " Draft Guidance approval. However, in some instances even for Intravascular Brachytherapy Investigative broad-scope licensees may find license Device Exemption (IDE) Applications"* amendments are necessary.

issued by the U.S. Food and Drug Adminis-tration (FDA) on May 9,1996, states that the (Contact: Robert L. Ayres, NMSS, FDA considers the use of intravascular 301-415-5746, e-mail: rxal@nre. gov.)

brachytherapy an unproven therapy with the potential for significant risk to patients. As AUTHORIZED ACTIVITIES AT

'such, the FDA continues to require all such LOCATIONS IDENTIFIED ON procedures to be conducted under an FDA. INDUSTRIAL RADIOGRAPHY LICENSES approved IDE. Thus, the NRC approval process requires the submission of proof that As previously reported in this newsletter, the the required IDE has been approved by the final rule on the revision of 10 CFR Part 34 FDA as one component of the NRC approval was published in the Fedemi Register on pr cess. Another consideration that needs t May 28,1997 (62 FR 28948). The revision of be addressed, in some procedures, is whether Part 34 introduc the device and/or source has been evaluated changes, affectm.

ed arad.iography g mdustrial number of regulatory end ap roved for the intended use and is listed Perations, of which licensees need to be for suc use in the NRC " Registry of Sealed aware. NRC has learned that there may be Sources and Devices." s me e afusion regardm, g changes affectmg the activities licensees may conduct, under the Whenever a licensee is considering changing revised regulations, at locations identified on its services to provide a new radiation therapy the license.

service or treatment, or implementing a new or sigmficantly revised diagnostic procedure, it As a result of a contentious enforcement should carefully examme its byproduct action involving a licensee that was conducting matenals license to ensure that the new radiography operations in a shielded cell at its procedures do not require any new place of business, the Commission directed the radionuclides, and that the procedures are staff to revise Part 34 to more clearly define a authonzed on its license. This should als " permanent radiographic installation" and to i melude checkmg that the new procedure (s) d ensure that the Nuclear Regulatory I Commission understands when activities are I conducted in such installations, and the 7.7c'o'* UE.*$". ."iNe'$'.$'%iS*s'y%".l$p*l conditions of use at the installations. In an mA. .ooi-4+a2o .nauerd.or. corn.14. sov attempt to achieve this goal, the staff revised 3

i

the definition for a permanent radiographic are described in 10 CFR 34.33. Section 34.41(a) installation, and added new definitions for requires that there be at least two qualified

" field station" and " temporary job site." The individuals present whenever radiography is permanent radiographic installation definition conducted, except when conducted in a establishes that these installations are not permanent radiographic installation. Section located at temporary job sites. Section 34.13(j) 34.47(a) requires, in part, that alarm requires radiography license applicants to ratemeters must be worn when conducting identify the locations of and describe all field radiography, except at permanent radiographic stations and permanent radiographic installations where other required warning installations. Section 34.41(b) provides that devices are in use. Section 34.51 specifies that radiographic operations conducted at locations continuous direct visual surveillance must be identified on a license must be conducted in a maintained during radiographic operations, permanent radiographic installation unless except at permanent radiographic installations otherwise specifically authorized. where entryways are locked.

As noted previously, NRC believes that Therefore, industrial radiography licensees radiography performed in a permanent (and applicants) should note that they may not radtographic mstallation provides a safer treat a location identified on their license as a ,

environment for workers and the pubh,e; temporary job site for purposes of conducting however, other conditions of use may be radiography, and that radiography at these uthorized. In addition, when conducting l locations may only be performed in a ,

Perations m a permanent radiographic permanent radiographic installati<>n that has , ,

installation, a smgle individual may conduct been described in the license application, the radiography, contmuous surveillance is not unless otherwise specifically authorized. If a required provided the entrance ways are location identified in an existing license was 1 eked, and alarm ratemeters are not required.

described as a storage location, but the

)

licensee also wishes to perform radiography at that location, the licensee must submit a (Contact: J. Bruce Carrico, NMSS, 301-415-7826, e mail: jbc@nrc. gov) license amendment request that describes the I

conditions of use at the location. CONSOLIDATING AND UPDATING MATERIALS LICENSING GUIDES The " Statements of Consideration" (SOC) During a Business Process Re-engineering supportmg the final rule noted that the . effort to evaluate and improve the materials proposed rule specified that all radiographic

, , licensing process, the Nuclear Regulatory operations conducted at locations identified Commission determined that much of the on a heense must be conducted m a existing licensing guidance was very old, and in permanent radiographic mstaliation. The SOC some cases duplicative, or unavailable in a further states, "The NRC has always beheved current or readily accessible electronic format.

that radiography performed m a fixed facility,

, As a result, the Division of Industrial and meeting the requirements of Sec. 34.33, would Medical Nuclear Safety is updating and provide a safer environment for workers and consolidating all existing licensing guidance the public. Iflicensees need to perform

, documents over the next 3 years. Thereafter, radiography at their place of busmess outside guidance documents will be updated on a of a permanent facility due to some unique .

, , 3-year revision cycle. During this initial 3-year circumstances, i.e., item to be radiographed is cycle, all existing documents will be subsumed too large for the facility, Commission into " specific use" documents, and published authonzation would be required. NRC notes as NUREGs. This effort will result in the j that no pubhc comments were received development of approximately 22 NUREGs, concermng the proposed rule language.

each containing applicant information, review instructions, licensing checklists, sample There are several provisions in Part 34 directly

, licenses, and inspection / audit guidelines.

applicable to permanent radiographic installations. The control devices that must be By January 1998, IMNS expects to have used at permanent radiographic installations published NUREGs about portable gauges, 4

1 1

industrial radiography, self-shielded document, in the preparation of the final irradiators, fixed gauges, master material NUREG report.

licenses, and guidance on sealed source and device reviews. The final version of NUREG-1556, Vol.1,is now available for use by applicants, licensees, The NUREGs series is numbered NRC license reviewers, and other NRC staff.

NUREG-1556, and is entitled: " Consolidated It supersedes the guidance for applicants and Guidance about Materials Licenses." Each licensees previously found in Draft Regulatory topic has a different volume number and Guide DG-0008," Applications for the Use of subtitle. For example, NUREG-1556, Sealed Sources in Portable Gauging Devices,"

Volume 1,is entitled: " Consolidated Guidance dated May 1995, and the guidance for about Materials Licenses," and subtitled: licensing staff now found in Policy and

" Program-Specific Guidance about Portable Guidance Directive PG 2-07," Standard Gauge Licenses." Review Plan for Applications for the Use of Sealed Sources in Portable Gauging Devices,"

Each of the NUREGs will be published in dated September 1994.

hard copy, and on NRC's Nuclear Material Safety and Safeguards Internet Homepage. Implementation: The performance-based The address is http://www.ntc. gov /NRC/ approach in NUREG-1556, Vol.1, gives NUREGS/SR1556/V1/Index.html (for portable gauge licensees greater flexibility l portable gauge). To access other guidance than previously permitted under licenses based 1 NUREGs, the "V1" in the address is changed on applications prepared according to l to the appropriate NUREG Volume number DG-0008. This permits licensees to make (2,3,4, etc.). more changes in their radiation safety program I without amending their licenses, thus reducing l Each of the NUREGs will be published first in the regulatory burden on licenses and the staff. I draft, for a 3-month comment period, then in Accordingly, existing portable gauge licensees final. During the comment period, we would have the option of submitting a complete appreciate suggestions that would improve the application, using NUREG-1556, Vol.1, at development of this licensing guidance. the time they file an amendment request.

Portable gauge licensees choosing this option (Contact: Sally Merchant, NMSS, should incorporate the requested change inte  :

301-415-7874, e-mail: slm2@nrc. gov) the complete application, submit it with the appropriate amendment fee, and indicate that PUBLICATION OF FINAL GUIDANCE ON the complete application is an amendment PORTABLE GAUGE LICENSES request to take advantage of the new guidance. When the staff has reviewed the On October 3,1996 (61 FR 51729), the

, request and resolved any outstanding issues,it Nuclear Regulatory Commission announced will amend the license in its entirety without the availability of draft NUREG-1556, Vol.1, changing the expiration date.

" Consolidated Guidance about Materials Licenses," subtitled, " Program-Specific Portable gauge licensees wishing to renew Guidance about Portable Gauge Licenses," their licenses should submit a complete dated September 1996, and requested application according to NUREG-1556, comments on it. This draft NUREG report is Vol.1. The staff's action will be similar to that the first program-specific guidance developed described for amendments, but willinclude an to support an improved materials licensing extension of the license's expiration date. By process. On December 6,1996 (61 FR 64768), following this procedure, the staff expects all NRC requested volunteers to participate in a existing portable gauge licenses to be January 1997 pilot test to evaluate the converted to the more performance-based document's content, format, and usefulness. format within a few years.

Most of the public comments and those of the participants in the pilot test were positive. The Note: NUREG-1556, Vol.1, permits staff considered all the comments, including applicants to make a " generic" request for constructive suggestions to improve the portable gauges (i.e., any source and device 5

combination registered by NRC, according to addition this draft report also contains 10 CFR 32.210, or by an Agreement State). information found in pertinent technical After the publication of NUREG-1556, assistance requests and information notices.

Vol.1, the Office of the General Counsel examined the provisions of 10 CFR The draft NUREG report has been distributed..

30.32(g)(1), determined that " generic" for comment to encourage public participation requests do not meet its requirements, and in .its development. It represents the current advised that applications must contain the position of NRC, which is subject to change manufacturer's name and model number of after the review of public comments.

each requested sealed source and device. Comments received will be considered in Accordingly, applicants will need to provide developing the final NUREG report that the manufacturer's name and model number represents the official staff position. Until the for each requested sealed source and device. final report is published, this draft NUREG report represents the best available guidance, Availability: NUREG-1556, Vol.1, is and may be used when preparing requests for available on the Internet at the following licensing actions. Once the final NUREG address: http://www.nrc. gov /NRC/ report is published, staff will use it in its NUREGS/SR1556/V1/index.html. Copies of review of requests for licensing actions. The NUREG-1556, Vol.1, may also be obtained draft and final NUREG reports may differ. If by writing to the Superintendent of a license were issued or amended based on Documents, U.S. Government Printing Office, recommendations in the draft NUREG report P.O. Box 37082, Washington, DC 20402-9828. and the final guidance is believed to be more Copies are also available from the National advantageous, licensees may choose to request Technical Information Service,5285 Port an amendment.

Royal Road, Springfield, Virginia 22161.

NRC sent copies of draft NUREG-1556, V 1. 2, to each of its radiography licensees.

(Contact: Patricia C. Vacca, NMSS, Other ways of obtammg the document are as 301-415-7908, e-mail: pcv@nrc. gov) follows: For a free smgle copy of draft NUREG-1556, Volume 2, write to the U.S.

NEW DRAFT GUIDANCE ON INDUSTRIAL uclear egu aton Cornnu,ssion, AM L RADIOGRAPHY LICENSES Bruce Carrico, Mail Stop TWFN 8F5, Washington, DC 20555-0001. Alternatively, Draft NUREG-1556, Vol. 2," Consolidated

, submit requests through the Internet by Guidance about Materials Licenses," subtitled,

, addressing electronic mail to "jbc@nrc. gov."

" Program-Specific Guidance about Industrial NUREG-1556, Volume 2, is also available Radiography Licenses," dated August 1997,is electronically by visiting NRC's Home Page the second program-specific guidance (http://www.nrc. gov) and choosing " Nuclear developed as part of this redesigned materials Materials," then " Business Process Redesign heensmg process. This draft NUREG report is project," then "Libraiy," and then " draft mtended for use by appbcants, heensees, and

, NUREG-1556, Volume 2."

staff. The guidance corresponds with the revision to 10 CFR Part 34 published in May Please submit comments by December 31, 1997. It combines and updates the guidance, 1997. Comments received after that time will for applicants and licensees, previously found be considered if practicable. Address written in draft Regulatory Guide FC 401-4," Guide comments to: Chief, Rules and Directives for the Preparation of Applications for the Branch, Division of Administrative Seivices, Use of Scaled Sources and Devices for Office of Administration, U.S. Nuclear Performing Industrial Radiography (dated Regulatory Commission, Washington, DC October 1984), and the guidance for licensing 20555-0001. Comments may also be submitted staff previously found in Policy and Guidance through the Internet by addressing electronic Directive FC 84-15," Standard Review Plan mail to dim 1@nrc. gov.

for' Applications for the Use of Scaled Sources and Devices for Performing Industrial (Contact: J. Bruce Carrico, NMSS, Radiography," dated October 1994. In 301-415-7826 e-mail: jbc@nrc. gov) 6

NUCLEAR BYPRODUCT MATERIAL RISK The review group's activities will address REVIEW GROUP byproduct materials as defined in Section 11.e(1) of the Atomic Energy Act of 1954 and Title 10 of the U.S. Code ofFedemiRegulations, As part of the Nuclear Regulatory Section 30.4. Specific areas to be addressed Commission,s strategic assessment and rebasehm,ng efforts, one of the will include Part 30," Rules of General direction-setting issues (DSIs) considered was Applicability to Domestic Licensing of

" Risk-Informed, Performance-Based Byproduct Material"; Part 31," General Regulation." In a staff requirements Domestic Licenses for Byproduct Material";

Part 32,"Specified Domestic Licenses to memorandum (SRM) dated April 15,1997, Manufacture or Transfer Certain Items the Commission directed the staff,m, part to Containing Byproduct Material"; Part 33, reexamme the applicability of risk-informed, performance-based or risk-informed, " Specific Domestic Licenses of Broad Scope

. for Byproduct Material"; Part 34," Licenses less-prescriptive approaches, to regulation of for Radiography and Radiation Safety nuclear material. Another issue considered was DSI No. 7, which addressed nuclear Requirements for Radiographic Operations";

byproduct materials / medical oversight. The Part 35," Medical use of Byproduct Material";

Commission's March 20,1997, SRM, related Part 36," Licenses and Radiation Safety l

to that issue, mdicated Requirements for Irradiators"; and Part 39, for contmumg the existm, Commission " Licenses and Radiation Safety Requirements support g nuclear byproduct for Well Logging."

materials / medical oversight program-with improvements-and for decreased oversight of The goals of the Nuclear Byproduct Material i low-risk activities, and continued emphasis on Risk Review Group are: 1) to identify and l high-risk activities. document a technical basis for a risk-informed approach to the regulation of nuclear A December 31,1996, SRM, related to a staff byproduct material; and 2) to develop plans proposal for improving NRC's control over, for a graded approach to nuclear byproduct material regula'. ion, based on risk information.

l- and hcensees' accountability for, generally and specifically licensed devices, directed the staff The group's approach will involve systematic l

I to quantify the risks associated with evaluations of " nuclear byproduct material systems." Nuclear byproduct material systems unaccounted-for devices. The Comm. .ission's will be defhied as broadly as is necessary to direction to the staff included establishm, g the identify '.ne real-world risks associated with probabilities associated with devices bemg lost, devices causmg exposures to members of them. A multi-dimensional characterization of risk will be used in evaluating the systems. The the public, devices entermg the metals plans for a graded approach to regulation will manufacturmg stream, devices bemg smelted, be based on results of the systems evaluations and other meidents the staff recommended and, as appropriate, will take into account analyzing. Finally, a March 3,1997, SRM ,

societal and socio-economic factors and addressed a rule-makmg plan for revision of non-radiological risks ascociated with the prototype testmg requirements for hands, dials, and pomters usmg 'Ilritium. The nuclear byproduct material systems.

l Commission directed the staff to make rules The review group met in June, July, August, for manufacture and distribution of generally and September 1997 and is expected to meet licensed and exempt products or materials at approximately monthly intervals through more flexible and user-friendly, while still September 1998. Meetings will be in the maintaining an adequate level of safety. In Washington, DC, area, or at other areas response to these Commission directions, the agreed on by working group members. The Office of Nuclear Material Safety and meetings will be announced in advance Safeguards, in cooperation with the Office of through the NRC Public Meeting Notice State Programs, Organization of Agreement System and, with some exceptions, will be States, and State of Colorado, has formed open for public observation. Persons attending the Nuclear Byproduct Material Risk working group meetings will be welcome to Review Group. provide comments to the working group for its 7

consideration, either in written form or orally, examine their uses of computer systems and at times specified by the working group chair. software well before the turn of the century. In assessing computer software, licensees may ,

want to consider reviewing those programs (Contact: Dennis I. Serig, NMSS, used to meet licensing requirements or those 301-415-7901, e-mail: dis @nrc. gov) that have safety significance.

NRC has established an Internet list server YEAR-2000 EFFECT ON COMPUTER dedicated to the Year-2000 problem. The SYSTEM SOFTWARE purpose of the list server is to facilitate the exchange of information among licensees, Information Notice 96-70," Year 2000 Effect NRC, and the public. Licensees are on Computer System Software," and encouraged to monitor the list server and to Information Notice 97-61,"U.S. Department provide suggestions and solutions to the of Health and Human Services Letter to Year-2000 problem. To subscribe to this list, Medical Device Manufacturers on the Internet e-mail may be sent to listproc@

Year-2000 Problem," notified licensees that nrc. gov with the message: subscribe year-2000 many computer systems will potentially fail to username, where the username is the first and recogmze the change to a new century. These last name of the individual making the request systems will misread "00" or the year 2000, as (e.g., John Doe). Furthermore, Year-2000 1900, and thus may cause the system to fail or information is available on the NRC generate faulty data. The Year-2000 problem homepage (http://www.nrc. gov) under the may affect computer systems, software " News and Information" option.

applications, and embedded microprocessors.

Because dates are involved in many facets of NRC inspectors will review the following computer systems and software, the magnitude points during all routine inspections, to draw of the Year-2000 issue poses problems to all attention to this issue:

those potentially affected.

1. Confirm that the licensee has received This issue may affect Nuclear Regulatory information Notices 96-70 and 97-61.

Commission licensees in many different ways.

For example, computer software used to 2. Confirm that the licensee is aware of the calculate dose or to account for radioactive NRC list server for the Year-2000 problem decay may not recognize the turn of the and encourage its use in sharing any century, which could lead to incorrectly identified problems and solutions.

calculated doses or exposure times for medical treatment planning and other applications. 3. Determine whether the licensee has Other examples of software that may be . identified any potential problems and, if affected include computer-controlled design,

, so, taken corrective actions.

production, quality control processes, security control, radiation monitoring, technical-specification surveillance testing, and NRC intends to review this information ,

accumulated reactor-fuel burn-up programs. Periodically and publish additional information notices and newsletter articles to maintam, Also, equipment that licensees have purchased may contain computer software or embedded awareness in the licensee community of microprocessors susceptible to the Year-2000 Year-2000 issues and corrective actions that problem. The problem could occur not only in have been developed. None of the above items computer software or data acquired from is a specific mspection requirement, and no external sources, but also in programs Specific actions are required to comply with developed by licensees or consultants. For them.

many licensees, this issue may not prove to be a significant health and safety concern. (Gary W. Purdy, NMSS,301-415-7897, However, licensees are encouraged to e-mail: gwpl@nrc. gov) 8

SELECTED FEDERAL REGISTER NOTICES 10 CFR Part 35," Medical Use of Byproduct (June 1,1997 - August 31,1997) Material: Issues and Request for Public input," 62 FR 42219," August 6,1997.

Note: Contacts may be reached by mail at the (Contacts: Catherine Haney, NMSS, U.S. Nuclear Regulatory Commission, 301-415-6825, e-mail: cxh@nrc. gov; Diane Washington, D.C. 20555. Flack, NMSS, 301-415-5681, e-mail:

dsf1@nrc. gov; Susanne Woods, NMSS, FINAL RULES 301-415-7267, e-mail: snv@nrc. gov) 10 CFR Parts 170 and 171," Revision of Fee 10 CFR Part 35," Medical Use of Hyproduct Schedules; 100% Fee Recovery, FY 1997, Material: Workmg Group for Revision, , 62 Correction," 62 FR 32682, June 16,1997. ' '

fConct a rine ar$ey, NMSS,

~

'** " #'E 10 CFR Part 20, et al., " Radiological Criteria '

for License Termination," 62 FR 39057, 10 CFR Part 20,"Recorting Requirements for July 21,1997.

Unauthorized Use of Licensed Radioactive (Contacts: Cheryl A. Trottier, RES. Material: Withdrawal," 62 FR 42948, 301-415-6232, e-mail: catl@nrc. gov; Frank August 11,1997.

Cardile, RES,301-415-6185, e-mail: (Contact: Mary L Thomas, RES, fpc@nrc. gov; Dr. Carl Feldman, RES, 301-415- 6230, e-mail: mit1@nrc. gov) 301-415-6194, e-mail: cxf@nre. gov; Christine M. Daily, RES,301-415-6026, OTHER NOTICES l e-mail: cxd@nre. gov) l

" Multi-Agency Radiation Survey and Site 10 CFR Part 13," Program Fraud Civil Investigation Manual (MARSSIM): Method of Remedies; Technical Amendment," 62 FR Armouncing Working Group Meetings," 62 FR 40427, July 29,1997. 37585, July 14,1997.

(Contact: Susan Fonner, OGC, (Contact: CDR, Colleen Petullo, EPA, 301-415-1634, e-mail: sgf@nrc. gov) 702- 798- 2446) l PROPOSED RULES (General

Contact:

Kevin Ramsey, NMSS, 301-415-7887, e-mail: kml@nrc. gov) 10 CFR Parts 30 and 32," Exempt Distribution of a Radioactive Drug Contammg One GENERIC COMMUNICATIONS ISSUED Microcurie of Carbon-14 Urea," 62 FR 32552, (May 1,1997 - July 31,1997)

June 16,1997.

Note that these are only summaries of U.S.

l (Contact: Dr. Anthony N. Tse, RES, Nuclear Regulatory Commission generic 301-415-6233, e-math ant @nrc. gov) communications. If one of these documents appears relevant to your needs and you have 10 CFR Parts 20 and 40," Radiological not received it, please call one of the technical Criteria for License Termination: Uranium contacts listed below.

Recovery Facilities," 62 FR 39093, July 21, 1997.

' Generic Letters (GLs)

(Contacts: Joseph J. Holonich, NMSS, 301-415-7238, e-mail: jjhl@nrc. gov; Duane GL 97-03," Annual Financial Surety ,

Schmidt, NMSS,301-415-6919, e-mail: Update Requirements for Uranium dws2@nrc. gov; Frank Cardile, RES, Recovery Licensees," was issued on July 9, 301-415-6185, e-mail: fpc@nrc. gov) 1997, to uranium recovery licensees and State officials. The letter documents 10 CFR Part 35," License Term for Medical certain procedural requirements for surety Use Licenses," 62 FR 40975, July 31,1997. submittals.

(Contact: Torre 'Paylor, NMSS, (Contact: Daniel M. Gillen, NMSS,

! 301-415-7900, e-mail: tmt@nrc. gov) 301-415-7295, e-mail: dmg2@)nrc. gov) l 9

I f;rmiti:n N::tices (ins) IN 96-53, Supplement 1," Retrofit to Amersham 660 Posilock Radiography IN 97-23," Evaluation and Reporting of Camera to Correct Inconsistency in l

i Fires and Unplanned Chemical Reaction 10 CFR Part 34 Compatibility," was issued Events at Fuel Cycle Facilities," was issued on June 23,1997, to all industrial on May 7,1997, to all fuel cycle conversion, radiography licensees. The supplement enrichment, and fabrication facilities. The informs them that the retrofit discussed in notice alerts them to requirements for the original notice must be completed notification and/or reporting of fires and before January 1,1998, to maintain Part 34 unplanned chemical reaction events (e.g., compatibility.

l (Contact: Michele Burgess, NMSS, explosions) at their facilities.

(Contact: Garrett Smith, NMSS, 301-415-5868, e-mail: mlb5@nrc. gov) 301-415-8118, e-mail: gas @nrc. gov)

IN 97-36, " Unplanned Intakes by Worker IN 97-24," Failure of Packing Nuts on f Transuranic Airborne Radioactive Materials and External Exposure Due to One-Inch Uranium Hexafluoride Cylinder ,

Valves," was issued on May 8,1997, to all Inadequate Control of Work, was issued on June 20,1997, to fuel cycle and power licensees and certificate holders authorized l to handle uranium hexafluoride in 76-cm yeactor licensees. The notice alerts them to ncidents where m, adequate controls (30-inch) and 122-cm (48-inch) -diameter created a substantial potential for cylinders. This notice alerts them to incidents where valve packing nuts were verexposures and resulted m unplanned intakes of radioactive matenals.

found to be cracked.

(Contacts: Merri Horn, NMSS, (Contacts: Ronald L. Nimitz, RI, 610--337-5267, e-mail: rin@nrc. gov; 301-415-8126, e-mail: mlhl@nrc. gov; Wilham J. Raymond, RI,860-267 ,571, 2 Christopher Tripp, NMSS,301-415-7733, e-mail: est@nrc. gov) e-mail: wjr@nrc. gov; James E. Wiggmton, NRR, 301-415-1059, e-mail:

IN 97-30," Control of Licensed Material ew2@nrc. gov) during Reorganizations, Employee- IN 97-39, " Inadequate 10 CFR 72.48 Management Disagreements and Financial Safety Evaluations of Independent Spent Cnses," was issued on June 3,1997, to all Fuel Storage Installations," was issued on material and fuel cycle licensees. The

, June 26,1997, to allindependent spent notice discusses the potential for the fuel storage licensees and all power reactor security and control of heensed material t

, licensees. The notice alerts them to inade-be compromised dunng penods of quate safety evaluations used to determine orgamzational instability. whether a change, test, or experiment (Contact: Mark A. Sitek,301-415-6155, involved an unreviewed safety question.

e-mail: mas 6@nrc. gov) (Contacts: M. Waters, NMSS, 301-415-3875, e-mail: mdwl@nrc. gov; V.

IN 97-35, " Retrofit to Industrial Nuclear Hodge, NRR,301-415-1861, e-mail:

Company IR100 Radiography Camera to cvh@nrc. gov)

Correct Inconsistency in 10 CFR Part 34 Compatibility," was issued on June 18, IN 97-42," Management Weaknesses 1997, to all industrial radiography Resulting in Failure to Comply with licensees. The notice informs them of a Shipping Requirements for Special scenario where the IR100 camera would Nuclear Material," was issued on June 27, not pass the h'orizontal shock test required 1997, to all fuel cycle conversion, by Part 34 and alerts them to a retrofit to enrichment, and fabrication facilities. The correct the problem. notice alerts them to three recent events (Contacts: David Wesley, CA Dept. of involving the inadvertent shipment of Health Services,916-445-1884; Michele special nuclear material to or from Burgess, NMSS, 301-415-5868, e-mail: NRC-licensed facilities.

mlb5@nrc. gov) (Contacts: Charles A. Hughes, RI, 10

804-847-7343, e-mail: cah2@nrc. gov; consider actions to assure future waste D.L Whaley, NMSS, 301 - 415 - 8108, shipments do not place Envirocare in e-mail; dlwl@nrc. gov) violation of its license, (Contacts: Harry Felsher, NMSS, ,.

IN 97-47," Inadequate Puncture Tests for 301-415-5521, e-mail: hdf@nrc. gov; Tim Type B Packages under 10 CFR 71.73(c) Harris, NMSS, 301-415-6613, e-mail:

(3)," was issued on June 27,1997, to all teh@nrc. gov) users and fabricators of Type B l

transportation packages. The notice alerts IN 97-57," Leak Testing of Packaging them to the recent discovery that tw Used in the Transport of Radioactive fabricators performed puncture tests using Material," was issued on July 30,1997., to a bar that was not mounted as required all suppliers and users required to perform packaging leak tests. The notice informs n ac : vi Tiktinsky, NMSS, them of shortcomings found in the 301-415-5723, e-mail: bws1@nrc. gov; Performance of packag,mg leak tests Ross Chappell, NMSS,301-415-8510, required for certain transportation packages.

e-mail: crcl@nrc. gov) (Contacts: James E. Spets, NMSS, 301-415-8553, e-mail: jes2@nrc. gov);

Nancy L. Osgood, NMSS,301-415-8513, IN 97-51," Problems Experienced with e. mail: nlo@nrc. gov)

Loading and Unloading Spent Nuclear Fuel Transportation Casks," was issued on IN 97-58, " Mechanical Integrity of In-Situ July 11,1997, to independent spent fuel Leach Injection Wells and Piping," was storage licensees, designers, and issued on July 31,1997, to all in situ leach fabricators ofindependent spent fuel facility licensees. The notice alerts them to storage installations, and power reactor leaks related to faulty coupling and licensees. The notice informs them of configuration of piping. (Contact: J. Robert operating experiences and problems Tinsley, NMSS,304-415-6251, e-mail:

encountered with loading and unloading jrt1@nrc. gov) casks for spent nuclear fuel.

(Contacts: William D. Reckley, NRR, (General

Contact:

Kevin Ramsey, NMSS, 301-415-1314, e-mail: wdr@nrc. gov; Eric 301-415-7887, e-mail: kmr@nrc. gov)

J. Benner, NRR,301-415-1171, e-mail:

ejb1@nrc. gov) SIGNIFICANT ENFORCEMENT ACTIONS IN 97-55," Calculation of Surface Activity Detailed information regarding these ,

for Contaminated Equipment and enforcement actions can be accessed via the .

Materials," was issued on July 23,1997, to Nuclear Regulatory Commission homepage all uranium recovery licensees. The notice gov. Click on " Nuclear alerts them to the correct method of Materials," then " Enforcement Program,', and calculating surface activity of contami- finally " Enforcement Actions Issued." Cases nated materials. are listed alphabetically. For details, click on (Contact: Elaine Brummett, NMSS, the highlighted text followmg each case.

301-415-6606, e-mail: esb@nrc. gov)

Academic IN 97-56," Possession Limits for Special National Institutes ofIIealth, Bethesda, l Nuclear Material at the Envirocare of Maryland, EA 96-027. A $2500 civil penalty Utah Low-Level Radioactive Waste was assessed for failure to secure material Disposal Facility," was issued on July 28, from unauthorized removal.

1997, to all licensees authorized to possess special nuclear material. The notice alerts Measuring Gauges them to recent violations of Envirocare's possession limit for special nuclear Indiana Department of Transportation, 1 material and recommends that they Crawfordsville, Indiana, EA 96-248. A $2500 I

j

civil penalty was assessed for two deliberate Lower Bucks H: spit:1, Bristol, Pennsylvania, violations oflicense requirements. EA 97-005. A $2500 civil penalty was assessed for failure to follow procedures for recovering Indianapolis Department of Capital Asset and disposing of a nuclear pacemaker.

Management, Indianapolis, Indiana, EA 97-166. A $2750 civil penalty was assessed for St. Francis Hospital, Escanaba, Michigan, EA a number of violations indicative of a ,96-491. A $2500 civil penalty was assessed for breakdown in control of licensed activities. deliberately preparing inaccurate records.

David E Johns, IA 97-026. An order l Prohibiting Involvement in NRC-Licensed Washington Hospital Center, Washington, Activities was issued because the individual D.C., EA 96-385. A $5000 civil penalty was deliberately violated the conditions of a assessed for failure to perform bioassays and Commission order by continuing to use loss of control of material.

moisture density gauges.

Medical Other Materials Licensees Fairbanks Memorial Hospital, Fairbanks,

, Roy Sadovsky, D.V.M., Floral Park, New York, Alaska, EA 96-505. A $2500 civil penalty was EA 97-150, IA 97-024. An Order Prohibiting assessed for willful failure to obtam, the Involvement in Licensed Activities was issued physician authorized user's signature on a and a $4000 civil penalty was assessed for written directive, which led to a

, deliberate use of licensed material at a location misadmmistration. not authorized on the license and numerous ther violations indicative of a very significant Jose L. Fernandez, M.D., San Juan, Puerto , ,

Rico, EA 97-137. An $8000 civil penalty was breakdown in control of licensed activities.

assessed for numerous violations indicative of a very significant breakdown in control of the (Contact: Joseph DelMedico, OE, licensed program. 301-415-2739, e-mail: rjd@nrc. gov)

UNITED STATES FIRST CLASS MAIL NUCLEAR REGULATORY COMMISSION POSTAGE AND FEES PAID WASHINGTON, DC 20555-0001 U PEN N OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300

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