ML20138H665

NMSS Licensee Newsletter.Number 96-3

ML20138H665
Person / Time
Issue date:	09/30/1996
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N96-3, NUREG-BR-117, NUREG-BR-117-N96-3, NUDOCS 9701060164
Download: ML20138H665 (11)

Text

NMSS Licensee Newsletter Y 's U.S. Nuclear Office of Nuclear NUREGlBR-0117

{% ,,,,,5I Regulatory Commission Material Safety No. 96-3 and Safeguards Sept.-Oct.1996 i

a WHAT'S NEW IN HPR? to take advantage of the information features / content.

INTERNET WEll SITE NEW DRAFT GUIDANCE: PORTAllLE GAUGE The Ilusiness Process Redesign (llPR) team has ,

created an internal developmental Internet Web Volume 1 of draft NUREG-1556, " Consolidated site, for testing purposes, reachable at the Guidance about Materials Licenses:

following URL: http://nmss26. As written Program-Specific Guidance about Portable Gauge products are developed, they are made available Licenses," is the first program-specific guidance for external access through links from the U.S.

developed for the new materials licensing process Nuclear Regulatory Commission homepage. . and may seiTe as a template for subsequent Members of the public can access this mformation program-specific guidance. It is intended for use directly through the following URL: by applicants, licensees, and staff. It combines the h t t p://www.n rc. gov /N M SS/IIPR/index.h t ml-guidance now found in Draft Regulatory Guide I)G- 0008," Applications for the Use of Sealed These Web sites contain documents ofinterest (e.g., allinformation notices sent to Nuclear Sources in Portable Gauging Devices," dated May 1995, and the guidance for licensing staff now Material Safety and Safeguards licensees and found in Policy and Guidance Directive PG 24)7, applicants since 1979, draft and final NUREGs,

" Standard Review Plan for Applications for the etc.) to materials licensees and applicants, . Use of Scaled Sources in Portable Gauging Agreement States, staff, and the pubhc. The site Devices," dated September 1994. Comments also functions as a central point for the posting of received on DG-0008 were considered in the guidance documents currently out for pubh,c preparation of this report.

cornment. For example, NUREG-1539

(" Methodology and Findings of the NRC's This document is strictly for public comment and Materials Licensing Process and Redesign") and NOT for use in preparation or review of draft NUREG-1541(" Process and Design for applications for portable gauge licenses until the Consolidating and Updating Materials Licensing document is published in final form.

Guidance"), which were published in final and .

draft form, respectively, are available in their NRC is requesting comments, on this draft entirety. The team's latest document, draft NUREG, such as whether a risk-mformed, NUREG-1556, Vol.1, is discussed in more detail performance-based approach to licensing is valM, below and should also be available by the time you as well as comments on the mformation re:;aested read this. in supp rt f a license application. 'n addition, to support NRC's efforts to streamlir.e the materials This segment of the IlPR project is subject to licensing process, NRC is soliciting comments and fairly rapid changes that parallel the changes in suggestions about the document's content, format, Internet technology. Making regular visits to the usefulness, etc., to make the document more Web site should provide you with the opportunity " user-friendly."

p GJ 9701060164 960930 PDR NUREC BR-0117 R PDR

NMSS Licensee Newsletter September-October 1996 NRC sent copies of draft NUREG-1556, Vol.1, to Page each ofits portable gauge licensees. Other ways of obtaining the document are as follows. For a

1. What's New in BPR? (Contact: Pat Rathbun, free single copy of draft NUREG-1556, Volume 1, 301-415-7177) ...... . ......I write to the U.S. Nuclear Regulatory Commission, ATTN: BPR Team, Mail Stop TWFN 8F5,

2. Directions to NRC Offices (Contacts: Washington, DC 20555-0001. For an electronic Brian Brownell,301-415-7152; Bryan version, see the previous discussion of the Internet Champion,301-415-7356) ... . .. . 3 Web site. ]

3. Notifying NRC of Bankruptcy (Contact: Please submit comments by Januaq 15,1997.

Monte Phillips, 630-829-9806). . .3 Comments received after that time will be considered if practicable. Address written

4. Mo-99/Tc-99m Generator Transportation comments on draft NUREG-1556, Volume 1, to Problems (Contact: Robert L. Ayres, the Chief, Rules Review and Directives Branch, 301-415-5746) . . .. . ... ... .3 U. S. Nuclear Regulatory Commission,

5. Annual Reports of Dose to Workers; Washington, DC 20555-0001. Comments may be submitted through the Internet by addressing 10 CFR 19.13(b) (Contact: Mark Sitek,

.4 electronic mail to INTERNET:MTL4 NRC. GOV.

301-415-6155) .... .. ...

6. Major Revision of Part 34 Involving C mments, and suggestions you may have for Industrial Radiography Licensing, inf rmation that is not currently bemg Safety, and Operations (Contact: included, that might be helpful to licensees, Don Nellis, 301-415-6257). .... . . 4 should be sent to:

E. Kraus

7. Iluman Error during Brachytherapy NMSS Licensee Newsletter Editor (Contacts: John Jones, Rill, 630 - 829- 9832; Office of Nuclear Material Safety Dennis Serig. NMSS,301-415-7901) .. 5 and Safeguards Two White Flint North, Mail Stop 8-A-23

8. Strontium-90 Eye Applicators (Contact: U.S. Nuclear Regulatory Commission Donna-Beth flowe, 301-415-7848) .. .5 Washington, D.C. 20555-0001

9. NUREG/CR-6345, " Radiation Dose Estimates for Radiopharmaceuticals" (Contact: Donna-Beth llowe, BPR Pilot Test 301-415-7848) .. . . ... . 6 To validate that the new licensing process and

10. Specific Domestic License of Broad associated automated systems perform Scope for Byproduct Material-Advance adequately, the BPR team has scheduled a Notice of Proposed Rulemaking (Contact: small-scale pilot test to take place at NRC Patricia K. IIolahan,301-415-8125) .. .6 IIeadquarters November 12 through 22,1996. It is anticipated that issues and problems will be

11. Transportation Requirements for surfaced, during the pilot test, that will be Broad-Scope Licensees (Contacts: addressed after each pilot is completed. The staff Ronald Burrows, 630-829-9838; B. J. is planning to invite Agreement States and f lolt, 630-829-9836) . . .. .. .6 volunteer licensees to participate in the pilot tests.

The number of participants must be kept under

12. Generic Communications Issued (May 1, nine licensees or organizations. pending receipt of 1996-August 1,1996)(General

Contact:

Office of Management and Budget clearance Kevin Ramsey, 301-415-7887). .. . .7 (under the Paperwork Reductiori Act) allowing

13. Selected Communications Issued (June 1,

"" *#"' "## """"" "*##8 '

1996-August 31,1996)(General

Contact:

Paul #E*" ## "'

Goldberg. 301-415-7842), .. .. 8 This pilot test will be restricted to portable gauge

14. Significant Enforcement Actions (Contact: applications (using the current guidance in draft Joseph DelMedico, 301-415-2739) .. 9 Regulatory Guide DG-008," Applications for the Use of Sealed Sources in Portable Gauging Devices") and will involve knowledgeable regional 2

l technical and administrative staff, with contractor and to ensure that radioactive material will not be and licadquarters participation as well. abandoned.

Regional pilot tests are planned for February and Specifically, any licensee who is involved in a March 1997, and will involve processing portable bankrupey proceeding, either voluntarily or gauge applications under both the existing and involuntarily, under any chapter of the bankrupey new systems: (a) to ensure technical accuracy law (i.e., chapters 7,11, or 13 of Title 11 of the both of the review (e.g., were the same United States Code) must notify the appropriate deficiencies found?); and of the resulting license NRC Regional Administrator in writing documents (e.g., does license contain same immediately after the filing. The regulations conditions?); (b) to test metrics associated with further define what is meant by being involved in a the new process; and (c) to determine what bankrupey proceeding, namely, if the filing for additional training, management systems, bankrupey is by or against the licensee itself, an Information Technology systems, etc., need to be entity controlling the licensee, an entity listing the implemented to make the new process successful, licensee as property of the estate, or an affiliate of the licensee. For example, take the case where For more information on participating in the pilot Company A owns Company B, and Company B is test, contact: John Pelchat, Ril (404) 331-5083 an NRClicensee. Company A files to reorganize (e-mail JMP2); Jack Whitten, RIV (817) under Chapter 11 of the bankruptcy law.

860-8197 (e-mail JEW 1). Company D must notify NRC immediately after such a filing.

(Contact: Pat Rathbun,301-415-7178 or e-mail .

PAR @ nrc. gov) The regulation further specifies what information must be provided to NRC at the time of DIRECTIONS TO NRC OFFICES n tification. Specifically, the 1icensee must identify the bankruptcy court m which the petition The Office of Information Resources was filed, and the date of the filing of the petition.

Management has developed a new application on In summary, if a licensee or company that owns a the U.S. Nuclear Regulatory Commission Voice licensed company files for bankruptcy, the Mail System. This application provides callers appropriate NRC Regional Administrator must be with directions to Nuclear Regulatory Commission immediately notified of the filing date and of the lleadquarters, any of the regional offices, the bankruptcy court where the filing occurred. NRC rechmcal Trammg Center, or the Walnut Creek will then monitor the licensee's activities to ensure Field Office. By dialing 1-888-415-A MAP from that either the facility is cleaned up and material a touch-tone telephone, one can request faxes of is properly disposed of, or the company is able to maps, written directions, and lists of nearby exit bankruptcy and operate normally, hotels.

(Contacts: Brian Brownell (BDB@ NRC. GOV) on 301-415-7152 or Bryan Champion MO-99frC-99M GENERATOR (BLC@ NRC. GOV) on 301-415-7356) TRANSPORTATION PROBLEMS NOTilTING NRC OF HANKRUPTCY In the last 10 years, the U.S. Nuclear Regulatory ,

Commission has received nine reports of excessive  !

Recently, there have been several cases in which radiation exposure rates related to the '

licensees filed, either voluntarily or involuntarily, transportation of Mo-99/rc-99m generators.

for bankruptcy, and notification to the U.S. Eight of these incidents occurred within the last 3 Nuclear Regulatory Commission was either late or years. Of the nine reported incidents, two not made. The NRC requirements for licensees involved damage to the package / generator during that file for bankruptcy can be found in 10 shipping, two had external contamination on CFR(U.S. Code of Federal Regulations)30.34(h), receipt, and two had radiation levels in excess of 40.41(f),61.24(k),70.32(a)(9), and 72.44(b)(6). those allowed by the stated Transportation These regulations apply to licenses associated with Indexes (tis) on receipt from the vendor. The byproduct material, source material, low-level remaining three reported incidents involved the ,

waste burial sites, special nuclear material, or shipment of defective generators from the '

independent storage of spent nuclear fuel. NRC customer back to the vendor, which resulted in the has promulgated these regulations to o sure the packages producing radiation le.vels in excess of adequate protection of public health . d safety, the allowed tis.

3

I l

These latter incidents are of particular concern to licensees did not advise each worker annually of f NRC, since once a generator has been determined the worker's dose as required by 10 CFR 19.13(b), i to be defective by the customer, it no longer which went into effect January 1,1994.

qalifies as a component of a U.S. Department of Trarmortation (DOT) Type 7A package. This Licensees are encouraged to review their  ;

fJow s logically if one considers that an reporting procedures to ensure that the program  !

i .verable, or improperly functioning, generator includes advising each worker annually of the l has some internal fault and no longer mwts the worker's dose as shown in records maintained by r configuration used to test the DOT Type 7A the licensee pursuant to the provisions of 10 CFR f packaging, of which it is a component. Thus, any 20.2106. This includes internal and external doses  !

attempt to return such a defective package to the from routine operations, and doses received vendor would violate NRC and DOT regulations, during planned special exposures, accidents, and emergencies. In addition, if a worker was If a licensee encounters a defective generator it monitored pursuant to 10 CFR 20.1502, then a  !

can either: (1) decay it in storage for a minimum report must be submitted to the worker regardless ,

of 10 Mo-99 half-lives, before shipping it back to of the dose received by the worker. The report to .

the vendor; or (2) request the vendor supply it the individual must be in writing and must contain j with a salvage container. designed and tested as a all of the information required in 10 CFR  !

DOT Type 7A containen f"the shipment of a 19.13(a). i severely damaged generators, ad use this ,

container to return the generator to the original (Contact: Mark Sitek,301-415-6155) vendor. The licensee may wish to consider the latter option if it cannot conveniently and safely MAJOR REVISION OF PART 34 INVOLVING i store the defective gecerator. INDUSTRIAL RADIOGRAPIIY LICENSING,  !

SAFETY, AND OPERATIONS l One additional item of concern is that several of i the generator vendors believe that some licensees tamper with the generators in an attempt to The U.S. Nuchar Regulatory Commission has correct any problems that may be encountered in revised 10 CFR Part 34 to make it more ,

their operation. These devices are not intended to understandable to licensees and has made a be worked on/ opened by users. Any user who number of changes designed to improve safety in (

either partially or fully disassembles a generator all aspects ofindustrial radiography. Many of the j willinvalidate the criteria under which the changes stemmed from Agreement State i generator was certified as a DOT Type 7A radiographic equipment manufacturer, md NRC  !

package. Should problems be encountered during and Agreement State licensee active participation }

the subsequent shipment of such a generator, the with NRC regarding improving safety in industrial j shipper could be in violation of both NRC and radiography. The regulations underwent several  !

DOT regulations. major changes that are expected to improve both the quality and safety ofindustrial radiography.

(Contact: Robert L Ayres, 301--415-5746) Some of the changes are the requirement to use ,

two persons at all non-permanent radiography  ;

ANNUAL REPORTS OF DOSE TO WORKERS; sites and the requirement for all radiographers to i

10 CFR 19.13(b) have a minimum of 2 months of on-the-job l training and to be certified by an approved  :

On January 1,1994, significant revisions were certifying entity. In the case of the two-person  !

made ta Title 10, U.S. Code of Federal Regulations provision, one person must be a certified 1 (10 CFR) Part 20. As a result of the changes to radiographer and the other must, as a minimum, ,

Part 20, other Parts of 10 CFR were modified, in be a qualified radiographer's assistant. In particular 10 CFR 19.13(b). The provisions of this addition, the qualified radiographer's assistant paragraph state that each licensee shall advise position has been upgraded to require additional  ;

each worker annually of the worker's dose as training, successful completion of a written test on  !

shown in records maintained by the licensee the subject materials covered in the training, and a )

pursuant to the provisions of 10 CFR 20.2106. demonstration of competence in the use of  !

Under the former 10 CFR 19.13 (b), licensees radiography equipment by successful completion were only required to advise workers of their of a practical examination in the use of such f

doses on specific requests from the workers. equipment. j Several recent inspections at licensee facilities Another major change involves the definition of i have found violations of 10 CFR 19.13(b). These the position of Radiation Safety Officer (RSO), f I  ?

l b l 4 ,

i

coupled with the specification of the positions and times and occasional lapses in qualifications, training, experience, duties, and attention to other parameters.

responsibilities of the RSO, including the oversight and control of operations and the ability Although human errors were at the root of the to stop operations whenever necessary. '

misadministration, the licensee's Quality Management Program (OMP) failed to prevent or Other changes include a requirement for daily detect those errors because its procedures for tests (on days of use) of the audible and visual ensuring that the final plans of treatment and warning signals at permanent radiographic related calculations were m accordance with the installations, instead of the current requirement written directive were inadequate. Treatmer t for testing every 3 months. Also the entrance planning involved completion of two separate controls,if used at these installations, must be w rksheets that were used to implement the tested monthly. required procedures. One worksheet contained all the data to be +.ntered at the control console Crushing and kinking tests for guide tubes have except step size. Step size, along with other inf rmation, was on the other.

been modified to require the use of forces that closely approximate the conditions likely to be Division of the data to be entered at the control encountered during use, in addition, devices that console across two worksheets produced a use depleted uranium (DU) shielding must be situation in which individuals entering those data tested for DU contamination at intervals not to might tend to rely more on memory than on the exceed 12 months, except when in storage or not second worksheet for entry of step size. That m use, division also resulted in a situation in which individuals checking for correct entry of data (Contact: Don Nellis, RES,301-415-6257 or might fail to check step size. Inclusion of step size e-mail DON (a NRC. GOV) on the work sheet that would have contained all the other data entered at the control console llUMAN ERROR DURING IHtACIIYTIIERAPY would have reduced the likelihood that anyone would have entered step size incorrectly and A misadministration occurred when a licensee increased the likelihood that entry of an incorrect performed an endometrial treatment using a step size would be detected.

high-dose-rate (IIDR) remote afterloading brachytherapy device. The treatment plan Other licensees have experienced specified a step size of 2.5 millimeters (mm) misadministrations caused by incorrect entry of between source dwell positions, but an incorrect step size and failure to detect that error. There step size of 5 mm was entered into the device's have been similar errors in entry and checking of control console. That resulted in delivery of other parameters (e.g., treatment length).

radiation to an area outside the intended Licensees should review their procedures for treatment site and constituted a misadministration meeting the objectives of the OMP and ensure as defined in 10 CFR 35.2(5)(i) Two human that those procedures reduce the likelihood of errors were at the root of the misadministration. errors in data entry and increase the likelihood The first was entry of the wrong step size into the that data entry errors that do occur are detected device's control console. The second was failure and corrected before treatment. Both the content to identify the first error, before treatment. and layout of worksheets that govern the entry of Neither error, by itself, would have been sufficient data into an IIDR device's control console and to result in the misadministration. Factors checking of those data should be included in the contributing to the first error included: (a) the fact review, that,in prior years, the licensee used a 5-mm step (Contacts: John Jones, Rill, 630-829-9832; size for endometrial treatments; (b) the extensive experience of the individual making the error with Dennis Serig, NMSS, 301--415-7901) the 5-mm step size; and (c) that individual's STRONTIUM-90 EYE APPLICATORS limited experience with the 2.5 mm step size.

Successful entry of step size for an endometrial Licensees with Strontium-90 (Sr-90) eye treatment by that individual demanded special applicators are reminded that these brachytherapy attention to one element of a task that was sources are subject to all of the requirements of otherwise routine. A factor contributing to the Title 10, U.S. Code of Federal Regulations (10 second error was the attention demanded by CFR) 35.59," Requirements for possession of checks of dwell position and time entries. Those sealed sources and brachytherapy sources."

demands may have led to a sharp focus c n dwell Licensees must possess and follow the radiation 5

safety and handling instructions supplied by the responsibilities of management, the Radiation l manufacturer, satisfy the leak test requirements, Safety Officer (RSO), or the Radiation Safety I

conduct quarterly inventories, measure ambient Committee (RSC). In addition to various ongoing dose rates quarterly in areas where the sources staff efforts regarding the possible need for are stored, and retain required leak test and clarification of requirements for broad-scope  !

survey records. llistorically, Sr-90 eye applicator licensees, consideration of changes to Part 33 was i licensees were required to confirm they had a also a recommendation of the Incident  !

properly calibrated Geiger- Mueller type survey Investigation Team reviewing a recent incident i meter on hand to use when receiving the eye involving ingestion of phosphorus-32 at ., broad-  !

l applicator and make arrangements to assure scope facility. NRC is evaluating existing  ?

! continued access to a properly calibrated survey regulations and, for possible codificanon in Part i meter for other occasions (e.g., suspected leakage, 33, appropriate requirements derived from prior '

detachment of the source from its holder, guidance and license standard review plans with contamination problems, and quarterly surveys). reference tc management oversight of This guidance is still appropriate. Licensees broad-scope licensed programs; the role of the r possess: , Sr-90 eye applicators should review RSO; the responsibilities of the RSC; supervision; their procedures to ensure they are in compliance the qualifications of the authorized user; the use with all the requirements in 10 CFR 35.59. of audits and inventory requirements; and security ,

and control oflicensed material. The key ANPR t (Contact: Donna Beth Howe,301 J15-7848) includes issues, questions, and discussion as well as draft rule language that was developed in NUREG/CR-6345 "'MDIATION DOSE partnership with the State ofIllinois. The purpose  !

ESTIMATES FOR of describing the preliminary issues and posing RADIOPilARMACEUTICALS." certaia questions is to illustrate aspects of NRC's evaluuion of Part 33 to date, and to request public ,

This NUREG was published in April 1996 and comment on the completeness of the evaluation t distributed to U.S. Nuclear Regulatory an i whether the proposed changes pose any Commission medical use and comniercial nuclear serious implementation problems. NRCis pharmacy licensees. It consists of 80 tables. Each soliciting comments on the draft text, including l table provides effective dose equivalent and organ the extent to which the text addresses the issues F radiation dose estimates for 70 described and any suggestions of alternative text.

radiopharmaceuticals commonly used in nuclear medicine. (Estimates are provided for multiple (Contact: Patricia K. Holahan, 301-415-8125) routes of administration or procedures for several radiopharmaceuticals.) The tables were TRANSPORTATION REQUIREMENTS FOR developed by the Radiation Internal Dose BROAD-SCOPE I.ICENSEES -

Information Center at Oak Ridge Institute of i Science and Education. These tables as well as in 1996, U.S. Nuclear Regulatory Commission specific package insert data can be used to inspectors identified several examples of estimate radiation doses for patients. university broad scope licensees failing to comply l with U.S. Department of Transportation (DOT)

(Contact: Donna-Beth flowe,301-415-7848) regulations as required by 10 CFR 71.5(a). }

Section 71.5(a) requires that each licensee who j SPECIFIC DOMESTIC LICENSE OF BROAD transports licensed material outside the site of t SCOPE FOR BYPRODUCT MATERIAL- usage, as specified in the NRC license, or where ,

ADVANCE NOTICE OF PRC POSED transport is on public highways, or who delivers  ;

RULEMAKING licensed material to a carrier for transport, shall  !

comply with the applicable requirements of the I The U.S. Nuclear Regulatory Commission will be DOT regulations in 49 CFR Parts 170 through 189 i publishing an Advance Notice of Proposed appropriate to the mode of transport. In all cases, Rulemaking (AUR) in the Federal Registcr. NRC the violations occurred while transporting t is considering amending its regulations governing NRC-licensed material on public roadways,  !

specific licenses of broad scope for byproduct usually from one university building to another, material to clarify the regulatory and health and j

safety bases of current licensing practices and to Although the specific transportation violations  :

provide licensees with the flexibility to make varied, similar underlying causes were identified. t certain types of changes to their radiation safety Typically, licensees were unaware of the programs. Currently,10 CFR Part 33 does not regulation or their radiation safety program contain a clear description of the duties and lacked audit mechanisms to ensure that the  :

t 6 l t

i

university policies were being followed and met GENERIC COMMUNICATIONS ISSUED regulatory requirements. May 1,1996 - August 1,1996 For example, a university Radiation Safety Officer Note that these are only summaries of U.S.

(RSO) had not observed the performance of the Nuclear Regulatory Commission generic shipping and receiving personnel until he communications. If one of these documents accompanied the NRC inspector during a routine appears relevant to your needs and you have not inspection of the university's radiation safety received it, please call one of the technical program. During that accompaniment, the RSO contacts listed below.

realized that packages containing radioactive materials were bemg transported on public roads Administrative Letters (ALs) to users located on the main university campus AL 94-13, Revision 2, " Access to Nuclear and on remote campuses without proper shipping Regulatory Commission Bulletin Board Systems,"

papers. Ilad a means ofinternally auditing the was issued May 3,1996. This revision serves to transportation program been implemented, the provide licensees updated information about the transportation violations could have been avoided. availability of the NRC bulletin board system and list server systems. (Contacts: James W. Shapaker, The following DOT requirements are highlighted NR R, 301-415-1151, Internet:jws@ nre. gov; Tom here as they are often cited m transportation Dunning, NRR, 301-415-1189, violations: 49 CFR 172.200(a) requires, in part, Internet:tgd@ nrc. gov; Kevin Ramsey, NMSS, that each person who offers a hazardous material 301-415-7887, Internet:kmr(E nrc. gov) for transportation describe the hazardous material on the shipping paper in the manner required by llulletins (BLs)

Subpart C of 49 CFR Part 172. Pursuant to 49 CFR 172.101, radioactive material is classified as BL 96-04," Chemical, Galvam.e, or Other hazardous material. Subpart C of 49 CFR Part Reactions in Spent Fuel Storage and 172 requires, in part, that the entries on the Transportation Casks," was issued on July 5,1996.

shipping papers include the following: (1) a This bulletm is addressed to all parties involved description of the hazardous materials w th the use, construction, or sale of spent fuel

[171200(a)]; (2) an emergency response storage and/or transportation casks. The potential telephone number [172.201(d)]; (3) a proper f r certain reactions is outlined along with a shipping name for the hazardous materials description of an actual meident. Actions and

[172.202(a)(1)]; (4) the hazard class of the wntten responses to these actions are required hazardous materials (172.202(a)(2)]; (5) the by the action addressees of the bulletm.

identification number of the hazardous materials (C ntacts: Marissa Bailey, NMSS, 301-415-8531,

[172.202(a)(3)]; and (6) additional descriptions Internet:mgb@ nrc. gov; Wilham Reckley, NRR,

[172.203(d)]. 301-415-1314, Internet:wdr(R nrc. gov)

I" '"'"I " ##"

Section 177.842(d) requires that packages of Class 7 (radioactive) material on vehicles must be so IN 96-33," Erroneous Data from Defective blocked and braced that they cannot change Thermocouple Results in a Fire," was issued on position during conditions normally incident to May 24,1996. This notice serves to alert all transportation. Nuclear Material Safety and Safeguards licensees to an incident where a defective thermocouple When implemented properly, DOT regulations caused an evaporator to run at an excessively high help ensure that safety of NRC-licensed material temperature, resulting in a fire. (Contact: Kevin is maintained during transportation. Licensees Ramsey, NMSS, 301-415-7887 must understand and adhere to the requirements Internet:kmr@ nrc. gov) of 49 CFR Parts 170 through 189 when NRC-licensed material is transported. In IN 96-34,"liydrogen Gas Ignition during Closure addition, internal audits of the transportation Welding of a VSC-24 Multi-Assembly Scaled program should be conducted on a frequent basis Basket," was issued May 31,1996. This notice to ensure that all personnel involved with the alerts independent spent fuel storage installation transportation of NRC-licensed material are designers and fabricators to a hydrogen gas adequately trained and implement the necessary ignition event that occurred during the welding requirements, of the shield lid on a spent fuel storage cask at the Point Beach Nuclear Plant. (Contact: A.

(Contacts: Ronald Burrows, RIII, 630-829-9838; llansen, NRR, 301-415-1390, B. J. Ilolt, RIII, 630.829-9836) Internet:agh@ nrc. gov) 7

5 IN 96-35," Failure of Safety Systems on REGULATORY GUIDES  !'

Self-Sbielded Irradiators Because ofInadequate Mainknance and Training," was issued on June Draft Guide  !

11,1996. This notice alerts irradiator licensees and vendors to two incidents where safety " Preparation of Petitions for Rulemaking under interlocks on self-shielded irradiators (Category 10 CFR 2.802 and Preparation and Submission of  :

I) failed to prevent inadvertant exposure. Proposals for Regulatoiy Guidance Documents," l 1 (Contacts: Douglas Broaddus, NMSS, 61 FR 42448, August 15,1996.

Contact:

T. Y.  !

l 201-415-5847, Internet: dab @ nrc. gov; Anthony Chang, 301-415-6450 or e-mail  !

Kirkwood, NMSS,301-415-6140, TYC@ NRC. GOV. j In ternet:ask@ nrc. gov)

PROPOSED RULES lt l (Genera:

Contact:

Kevin Ramsey, NMSS, " Recognition of Agreement State Licenses in f 301-415-B7, Internet:kmr@ nrc. gov) Areas under Excisive Federal Jurisdiction within an Agreement State," 61 FR 30839, June 18,1996.

SELECTED COMMUNICATIONS ISSUED

Contact:

llampton Newsome, OGC, 301-415-1623, e-mail IHIN@ NRC. GOV or Mark  ;

June 1,1996- August 31,1996 Haisfield, RES, 301-415-6196, e-mail  !

MFliRNRC. GOV. '

NOTE: Contacts may be reached by mail at the I

U.S. Nuclear Regulatory Commission, " Access to and Protection of Classified Washington, D.C. 20555. Information," 61 FR 40555, August 5,1996.

Contact:

Duane Kidd, ADM,301-415-7403, or PETITIONS FOR RULEMAKING e-mail DGK@ NRC. GOV.

FINAL RULES i Amersham Corporation, PRM-34-5, Petition to i remove " associated equipment" from radiography Correcting Amendment to 10 CFR Part 71, equipment regulations, 61 FR 30837, June 18, " Compatibility with International Atomic Energy 1996.

Contact:

Donald Nellis, 301-415-6257 or Agency," 61 FR 28723, June 6,1996. Contact Michael Lesar, 301-415-7163 or toll-free John R. Cook, NMSS, 301-415-8521. i 800-368-5642, or e-mail MTL@ NRC. GOV.

" Export of Nuclear Equipment and Materials" f University of Cincinnati, PRM-20-24, Request for (update),61 FR 35600, July 8,1996. Contact ,

amendment to regulations to allow specified Elaine Hemby, 301-415-2341, e-mail visitors to radiation patients, as members of the EOlI@ NRC. GOV.

public, to receive up to 500 mrem per year,61 FR i 31874, June 21,1996.

Contact:

Michael Lesar, Removal of 10 CFR Part 53," Criteria and i 301-415-7163 or toll-free 800-368-5642,or Procedures e Determining the Adequacy of e-mail MTL@ NRC. GOV. Available Sper t Nuclear Fuel Storage Capacity," l 61 FR 35935, July 9,1996.

Contact:

Gordon  ;

Isostent, Inc., PRM-35-14, Petition for Gundersen, 301-415-6195.

amendment to regulations to address intaluminal stents, includm, g phosphorus-32 and strontium-89 OTIIER NOTICES ,

radioisotope stents, permanently implanted in

, Policy Statement," Conversion to the Metric  !

patients' blood vessels, and related physician System," 61 FR 31169, June 19,1996.

Contact:

I training and expen,ence requirements,61 FR Dr Frank Costanzi, 301-415-6250 or e-mail 33388, June 27,1996.

Contact:

Michael Lesar, f 301-415-7163 or toll-free 800-368-5642,or FAC@ NRC. GOV. l e-mail MTL@ NRC. GOV. Notice," Governors' Designees Receiving )

Advance Notification of Transportation of Nuclear Nuclear Energy Institute, Petition to allow nuclear Waste (update)," 61 FR 33592, July 1,1996.

materials licensees to monitor and maintain parts

Contact:

Spiros Droggitis, OSP,301-415-2367, I of their facilities beyond a 24-month period rather e-mail SCD@ NRC. GOV.

than beginning to decommission them,61 FR i 43193, August 21,1996.

Contact:

Michael Lesar, " Memorandum of Understanding between ,

301-415-7163 or toll-free 800-368-5642,or Department of Labor-Nuclear Regulatory  !

e-mail MTL@ NRC. GOV. Commission with Respect to Gaseous Diffusion  !

i 8 l

Plants,61 FR 40249, August 1,1996.

Contact:

Diamond 11 Testing Company, Chubbuck, Idaho John Ilickey, 301-415-7192. Supplement VI, EA 95-148 (General

Contact:

Paul Goldberg, 301-415-7842, An $8000 Civil Penalty was issued October 25, e-mail PFG(& NRC. GOV) 1995, to emphasize the licensee's recponsibility to ensure that radiographers SIGNIFICANT ENFORCEMENT ACTIONS comply with NRC regulations and the h,censee,s operating procedures so as to ensure not only their safety but that of the public.

These selected enforcement actions (Eas) can be The action was based on a problem involving:

accessed via the U.S. Nuclear Regulatory (1) an apparent willful failure to lock the Commission homepage by clicking on " Nuclear sealed source in the shielded position Materials," then clicking on " Enforcement following a radiographic exposure; (2) a Program," and then finally clicking on " Escalated failure to conduct an adequate survey of the Enforcement Actions issued Smce March 1996."

The Eas are listed alphabetically. The details source guide tube after a nadiographic exposure; and (3) a failure to wear an alarm regarding these may be obtained by clicking on the ratemeter.

highlighted text following each case.

Oncology Services Corporation, liarrisburg, Medical Pennsylvania Supplements IV, V, and VI, EA 94-006 Ashford Presbyterian Community Ifospital, San Juan, Puerto Rico Supplement VI, EA 96-053 A Notice of Violation and Proposed Imposition of Civil Penalties in the amount A $2500 Civil Penalty was issued March 19, f $280,000 was issued May 31,1994, to 1996, to emphasize the importance of full emphasize to the hcensee, m particular, and implementation of the Quality Management the mdustry in general, the importance of Program (OMP) with respect to the meticulous management oversight of the administration of radiopharmaceuticals and radiation safety program, so as to ensure that the need for prompt identification of licensed activities are conducted safely and m violations. The action was based on a problem acc rdance with requirements. The action was involving the licensee's failure to fully based on a November 1992 event in which a implement its OMP as required by 10 CFR 4.2-Curie iridium-192 source was left mside a Part 35. The licensee failed on at least 10 patient who was undergoing a brachytherapy occasions during 1994 and 1995 to properly treatment using a high-dose-rate afterloader use written directives for certain diagnostic umt. The patient received a very high administrations of sodium iodide 1-131 or to r diation exposure and subsequently died.

check the patient's treatment charts for Am ng the violations that contributed to the errors in dosage. The licensee also failed to event were the failure to perform a survey, adequately instruct its nuclear medicine failure to follow procedures regardm, g the technologists on the requirements of the OMP. wall-m unted radiation monitor and entry into the treatment room, and failure to train personnel pursuant to 10 CFR 19.12. The Department of the Army, Madigan Army Medical licensee responded on August 31,1994 and Center, 'lacoma, Washmgton Supplement VI, EA October 4,1994. After consideration of the 96-004 licensee's responses, an Order imposing Civil Penalties in the amount of $280,000 was issued An $8000 Civil Penalty was issued February April 24,1995. The licensee requested a 22,1996, to emphasize the licensee's hearing on May 18,1995, and a settlement was responsibility to NRC to provide adequate approved by the Commission on May 16,1996.

training and to ensure that licensed requirements are being followed/ The action was based on the failures to: (1) provide Washington County Memorial IIospital, Salem, adequate OMP training to employees involved Indiana Supplement VI, EA 96-071 in the brachytherapy program, and (2) maintain and implement the OMP in a A Notice of Violation was issued May 2,1996, manner that ensured that patients implanted based on violations involving the use of with brachytherapy sources received the doses iodine-131. The licensee informed NRC that intended by the prescribing physicians. at the time of an administration of sodium 9

r iodine-131, the licensee did not have a 1995, all without obtaining an NRC license or physician designated as an authorized user filing NRC Form 241.  ;

for therapeutic dosages. A civil penalty was 1 not proposed because the licensee had not A. E. Staley Manufacturing Company, Lafayette, l l been subject to escalated enforcement action Indiana Supplements IV and VI, EA 96-042  !

in the past 2 years or two inspections and the licensee took prompt and comprehensive A Notice of Violation was issued April 4,1996, ,

corrective action that included admonishing based on a violation involving the unauthorized the individuals involved for their failure to removal of an Ohmart level gauge containing adhere to NRC requirements, and amending NRC-licensed material (20 millicuries of the NRC license to withdraw the authority to cesium-137 in a sealed source). The device was [

use unsealed byproduct materials for removed from service in January 1996 by therapeutic administrations. individuals not authorized to remove the device from service. The device was found in a dumpster Academic 1 day later. A civil penalty was not proposed because the beensee had not been the subject of Harvard University, Cambridge, Massachusetts an escalated enforcement action within the last 2  :

Supplement IV, EA 96-068 years or two inspections and the licensee took pr mpt and comprehensive corrective actions.

A Notice of Violation was issued April 18 -

1996, based on violations involving the failure Shif ts, Graves & Associates, Inc., South Bend, to secure from unauthorized removal, or limit access to, licensed material in several Indiana Supplement IV, EA 96-043 laboratories at the licensee's facility and the .

failure of the licensee's staff to maintain A Notice of Violation was issued April 8, control or surveillance of the licensed 1996, based on a violation mvolvm, g damage to material. A civil penalty was not proposed a moisture / density gauge in November 1995.

because the licensee had not been subject to After concluding a measurement, the  ;

escalated enforcement action in the past 2 techm,cians walked 15 feet away from the years or two inspections. gauge and the gauge was struck by a backhoe ,

breaking the carrying handle. The technicians /

Measuring Gauges immediately implemented the emergency procedures and the incident did not cause any Bemis Construction, Inc., Great Bend, Kansas contamination nor personnel exposures. A Supplement VI, EA 95-276 civil penalty was not proposed because the licensee had not been the subject of an A $2500 Civil Penalty was issued March 19, escalated enforcernent action within the last 2 1996, to emphasize the importance of years or two inspections and the licensee complying with NRC requirements. The took prompt and comprehensive corrective action was based on a violatio.: for using a actions that included reviewing operating moisture density gauge in Oklaloma, a procedures with each technic ' and auC%g i non-Agreement State, betwee.i March 1991 employees on the use of their itssigned gauges.  !

and August 1992 and storing the gauge in Oklahoma between March 1991 and July (Contact: Joseph DelMedico,301-415-2730)  ;

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