ML20141H992

NMSS Licensee Newsletter.Number 97-2

ML20141H992
Person / Time
Issue date:	07/31/1997
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N97-2, NUREG-BR-117, NUREG-BR-117-N97-2, NUDOCS 9708040206
Download: ML20141H992 (12)

Text

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("" s U.S. Nuclear Office of Nuclear NUREGlBR-0117 I I Regulatory Material Safety No. 97-2 n,,,

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PATIENT RELEASE RULE AND include (1) guidance on the interruption or GUIDANCE discontinuation of breast-feeding and (2)information on the consequences of The Patient Release Rule,10 CFR 35.75, failure to follow the guidance.

" Release ofIndividuals Containing Radiopharmaceuticals or Permanent Section 35.75(c) requires that the licensee Implants," in 10 CFR Part 35," Medical Use of " maintain a record of the basis for Byproduct Material," permits licensees to authorizing the release of an individual, for 3

" authorize the release from its control of

... years after the date of release,if the total any individual who has been administered effective dose equivalent is calculated radiopharmaceuticals or permanent implants (1) using the retained activity rather than the containing radioactive materialif the total activity administered, (2) using an occupancy effective dose equivalent to any other factor less than 0.25 at 1 meter, (3) using the individual from exposure to the released biological or effective half-life, or individual is not likely to exceed 5 millisieverts (4) considering the shielding by tissue."

(0.5 rem)." This rule became effective on May 29,1997. The final rule was announced in In 10 CFR 35.75(d), the licensee is required to the Federal Register on January 29,1997 (62 " ...

maintain a record, for 3 years after the date FR 4120). Guidance on the rule can be found of release, that instructions were provided to a in Regulatory Guide 8.39," Release of Patients breast-feeding woman if the radiation dose to Administered Radioactive Materials." the infant or child from continued breast- i Regulatory Guide 8.39 was published in April feeding could result in a total effective dose 1997 and is available through the Office of equivalent exceeding 5 millisieverts (0.5 Administration by fax at (301) 415-2260. rem)."

Subsections of 10 CFR 35.75(b), (c), and (d) Regulatory Guide 8.39 provides guidance to contain additional requirements. Section the licensee on determining: (1) when the 35.75(b) requires that the licensee licensee may authorize the release of a patient; (2) when instructions to the patient

.. provide the released individual with are required by 10 CFR 35.75(b); and .

instructions, including written instructions, (3) when records are required, by 10 CFR on actions recommended to maintain doses 35.75(c) and (d), to be generated and to other individuals as low as is reasonably maintained. The guide lists activities for

! achievable if the total effective dose commonly used radionuclides and their equivalent to any other individual is likely corresponding dose rat::s with which a patient to exceed 1 millisievert (0.1 rem). If the may be released in compliance with the dose hy dose to a breast-feeding infant or child limits in 10 CFR 35.75. J could exceed 1 millisievert (0.1 rem) l Pr" ming there were no interruption of (Contact: William B. McCarthy, NMSS, a/;

bicast-feeding, iM instructions shall also 301 -415-7894, e-mail: wbm@nrc. gov.) D'/I 9708040206 s/0731 BR-0117 R PDR ,

i, i, ,.

NMSS LICENSEE NEWSLETTER 7. Withdrawal of Unauthorized Use JUNE-JULY 1997 Rule (Contact: Mary L Thomas, RES, 301-415-6230, e-mail:

Page mit1 @nrc. gov.) . . . . . . . . . . . . . . . . . . . . . 7

8. Selected FedemiRegister Notices

1. Patient Release Rule and Guidance (March 1,1997-May 31,1997)

(Contact: William B. McCarthy, (General

Contact:

Kevin M. Ramsey, NMSS, 301-415-7894, e-mail: NMSS, 301-415-7842, e-mail:

wbm@nrc. gov.) . . . . . . . . . . . . . . . . . . . . 1 kmr@nrc. gov.) . . . . . . . . . . . . . . . . . . . . . 7

2. Food and Drug Administration 9. Generic Communications Issued Letter to Medical De+e Manufac- (February 1,1997-May 1,1997) turers on the Year 2000 Problem (General

Contact:

Kevm Ramsey, (Contact: Mark A. Sitek, NMSS, NMSS,301-415-7887, e-mail:

301-415-6155 or e-mail: kmr@nrc. gov.) . . . . . . . . . . . . . . . . . . . . . 8 mas @nrc. gov.) . . . . . . . . . . . . . . . . . . . . . 2 10.Significant Enforcement Actions (Contact: Joseph DelMedico, OE,

3. Reciprocity Requirements for Tempo- 301-415-2739, e-mail: rjd@nrc. gov.) . 9 rary Job Sites (Contacts: Wade T. Loo, RII,404-562-4727; Susan L Greene, NMSS, 301-415-7843, e-mail:

sig@nrc. gov.) . . . . . . . . . . . . . . . . . . . . . . 3 FOOD AND DRUG ADMINISTRATION LETTER TO MEDICAL DEVICE

4. Publication of Revised 10 CFR Part 34 MANUFACTURERS ON TIIE YEAR 2000 (Contact: Donald O. Nellis, RES, PROBLEM 301-415-6257, e-mail: don @

n rc. gov.) . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 In a letter dated June 25,1997, the U.S. Food and Drug Administration (FDA) reminded medical device manufacturers that some

5. NRC's Technical Position on the Disposition of Cesium-137- computer systems and software applications currently used in medical devices, including Contaminated Emission Control Dust embedded microprocessors, may be affected and Other Incident-Related Material by the Year 2000 problem. In addition, the (Contact: Nick Orlando, NMSS,301-letter mentioned that computer-controlled 415-6749, e-mail: dao@nre. gov.) . . . . . 4 design, production, or quality control processes could he adversely affected. To

6. Status of the International Convention ensure the continued safety and effectiveness on the Safety of Radioactive Waste of medical devices, the FDA recommended Management (Contact: Michael J. Bell, that manufacturers take the following actions:

NMSS, 301-415-7286, e-mail:

1) assure that medical devices submitted for mjb2@nrc. gov.) . . . . . . . . . . . . . . . . . . . . 5 premarket approval can perform date recording and computations that will not be affected by the Year 2000 problem; 2) conduct Comments, and suggestions you may have hazard and safety analyses on currently for information that is not currently bein8 included, that might be helpful to licensees, manufactured devices to determine whether should be sent to: device performance could be affected by the Year 2000 problem, and if so, take appropriate MSILicensee Newsletter Editor steps to correct production and to assist Office of Nuclear Material Safety customers who have purchased such devices; and Safeguards and 3) check design, production, and quality Two White Flint North, Mail Stop 8-A-23 control processes to ensure year 2000 U.S. Nuclear Regulatory Commission compliance. This letter also applies to those Washington, D.C. 20555-0001 manufacturers that use radioactive material in their medical devices.

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The FDA requires the manufacturers it that the work is being performed in regulates to investigate and correct problems accordance with NRC requirements.

with medical devices that present a significant risk to public health. In addition, users or To perform licensed activities on Federal purchasers of such devices, which include property within an Agreement State, it must some Nuclear Regulatory Commission be determined whether the area where the licensees, are required to be notified when a work is to be performed is an area of exclusive device presents an unreasonable risk of Federal jurisdiction. An area of exclusiv'.:

substantial harm to public health. NRC Federal jurisdiction is an area over which the Information Notice 96-70," Year 2000 Effect Federal Government exercises legal control on Computer System Software," issued on without interference from the jurisdiction and December 24,1996, addressed the Year 2000 administration of State law. If Agreement problem and its applicability to'NRC licensed State licensees are unsure of the jurisdictional programs. status of a job site on Federal land, they should contact the Federal agency that To obtain a copy of the FDA letter or if there controls the facility where the work is to be are any questions related to medical device Performed. Ifit is determined to be an area of manufacturers' responsibility regarding the exclusive Federal jurisdiction, the Agreement Year 2000 problem, contact the FDA's Center State licensee should file NRC Form 241, with for Devices and Radiological Health, Division NRC, for reciprocity.

of Small Manufacturers Assistance, by phone, at 1-800-638-2041, or by fax at 301-443- Recently, NRC identified cases where 8818. Also, a copy of the letter is available on Agreement State licensees failed to file for the FDA's World Wide Web home page at reciprocity with NRC or apply for a specific http://www.fda. gov /cdrh. NRC license regarding the conduct of licensed activities in areas of exclusive Federal (Contact: Mark A. Sitek, NMSS,301- jurisdiction on Federal land within an 415-6155 or e-mail: mas 6@nrc. gov.) Agreement State. The Agreement State bcensees assumed that the Agreement State license allowed the conduct oflicensed RECIPROCa fY REQUIREMENTS FOR activities anywhere in the State and were not TEMPORARY JOB SITES aware that filing with NRC for reciprocity is required before conducting activities in areas Agreement State licensees seeking to conduct of exchuive Federal jurisdiction. As a result of activities under reciprocity in "Non. not filing, NRC was denied the opportunity to Agreement States," areas of exclusive Federal inspect and ensure that the public health and jurisdiction, or in offshore waters, must file safety were protected.

Nuclear Regulatory Commission Form 241, for reciprocity with NRC, at least 3 days before Similarly, NRC licensees authorized to the licensee engages in activities permitted conduct activities at temporary job sites should under the general license established by 10 be aware that most Agreement States require CFR 150.20. This general license, recently any out-of-state licensee to file for reciprocity revised and published in the FedemlRegister when using radioactive material in areas under (62 FR 1662, January 13,1997), authorizes any Agreement State jurisdiction. Therefore, when person who holds a specific license from an an NRC licensee is conducting activities in an Agreement State to conduct reciprocity Agreement State, except in areas of exclusive activities based on its Agreement State specific Federal jurisdiction, it is the responsibility of f license, provided the specific license does not the NRC licensee to file appropriate limit the authorized activity to specified documents and fees associated with the locations or installations. The filing of NRC reciprocity requirements in that State.

Form 241 informs NRC of the locations and dates of work being performed by Agreement (Contacts: Wade T. Loo, RII,404-562-4727, State licensees in NRC jurisdiction and allows e-mail: wtl@nrc. gov; Susan L Greene, NMSS, NRC to perform safety inspections to ensure 301-415-7843, e-mail: sig@nrc. gov.)

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PUBLICATION OF REVISED 10 CFR NRC'S TECIINICAL POSITION ON TIIE PART 34 DISPOSITION OF CESIUM-137-CONTAMINATED EMISSION CONTROL The final rule on the revision of 10 CFR DUST AND OTIIER INCIDENT-RELATED Part 34 was published in the Federal Register on MATERIAL May 28,1997 (62 FR 28948). The new requirements become effective June 27,1997 As the result ofinadvertent meltings of cesium-137 (Cs-137) sources, several steel (30 days after publication) although particular producers possess approximately 9000 metric lequirements have different implementation tons (10,000 tons) of emission control dust, dates as discussed below. (Please note that the most of which contains Cs-137 concentrations notice published on May 28,1997, listed of less than 3.7 becquerels per gram (Bq/g) or mcorrect comphancqdates for the new . 100 picoeuries per gram (pCi/g). This material provisions. A correction will be published in is typically being stored onsite because of the the Federal Register. The correct dates are lack of disposal options that are considered specified below.)

cost-effective by the steel companies. The Nuclear Regulatory Commission has Principal changes are: developed a technical position that may be used to evaluate case-by-case requests to Section 34.41(a) requires two individuals at dispose of treated emission control dust contamm, ated with Ls-137 at hazardous waste locations other than permanent radio-graphic installations. Licensees will have disposal facilities.

until June 27,1998 (1 year from the .

The Cs-137 contamination of this hazardous effective date of the rule) to hire and train waste results from a series of three principal mdividuals to rmet this requirement.

events: (1) the loss of control of a radioactive source by an NRC or Agreement State Radiation safety officers will have until licensee; (2) the inclusion of the source within June 27,1999 (2 years from the effective the scrap metal supply used by the steel date of the rule) to comply with the producers; and 1) the inability to screen out additional training requirements specified the radioactive wurce as it progresses along in 10 CFR 34.42(a) and the mandatory the typical scrap collection-to-melt pathway.

certification requirement of Section Most, but not all, of this material would be 34.43(a)(2). classified as mixed waste because it contains lead, cadmium, and chromium. Thus it is Licensees will have until June 27,1998 (1 subject to joint regulation as K061 mtxed year from the effective date of the rule) to waste under the Resource Conservation and comply with the additional training Recovery Act (RCRA) and the Atomic Energy requirements for radiographers specified in Act of 1954, as amended, or the equivalent I ws of Authorized States and Agreement Sections 34.43(a) and 34.43(b). States.

Licensees will have until June 27,1999 (2 Two disposal options are available for the years from the effective date of the rule) to material, depending on Cs-137 levels and comply with the certification requirements whether the material is in a packaged or of Section 34.43(a)(1). unpackaged form. For packaged waste, the pretreatment average concentration of The final rule may be accessed via the internet Cs-137 may not exceed 4.8 Bq/g (130 pCi/g) from the Government Printing Office site at f material, and for unpackaged waste, the http://www. access.gpo. gov /su docs / aces /acesl4 Pretreatment average concentration of 0.html. Cs-137 may not exceed 3.7 Bq/g (100 pCi/g) of material.

(Contact: Donald O. Nellis, RES, Provisions in the technical position that 301-415-6257, e-mail: don @nrc. gov.) pertain to all forms of the material are that:

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1. The emission control dust and other The position, which was coordinated with incident-related materials are the result of EPA, was published in the Federal Register on an inadvertent melting of a sealed source March 19,1997 (62 FR 13176).

or device;

, (Contact: Nick Orlando, NMSS,

2. The incident-related materials must be 301-415-6749, e-mail: dao@nrc. gov.)

treated to comply with all Environmental Protection Agency and/or State waste STATUS OF THE INTERNATIONAL treatment requirements; CONVENTION ON THE SAFETY OF RADIOACTIVE WASTE MANAGEMENT

3. Treatment operations must be performed Since mid-1995, representatives of national under an NRC or Agreement State license governments have been meeting periodically (by the owner or a service contractor, at the International Atomic Energy Agency either on, or off site); (IAEA)in Vienna, Austria, to prepare an international Convention on the Safety of

4. The materials have been stored and Radioactive Waste Management. When transferred in compliance with a radiation completed the Convention will contain protection program, as specified at 10 CFR obligations for the " contracting parties",(i.e.,

20.1101; countries ratifym, g, acceptmg, or approving the convention) to establish and maintain a

5. The transfer has been specifically approved legislative and regulatory framework to govern by NRC or the appropriate Agreement the safe management of radioactive waste, State (s) via a license amendment; mpigment measures concerning general safety considerations in waste management activities,

6. The total Cs-137 activity does not exceed and establish safety in the siting, design, the total activity associated with the construction, operation, and closure of waste inadvertent melting mcident; management facilities. If ratified by the U.S.

Senate, it will have the legal authority of a treaty and U.S. laws and regulations, if in

7. The total activity of the Cs-137 in any conflict, will have to be brought into RCRA Subtitle C facility does not exceed conformance. Throughout the drafting 37 gigabecquerels (1 curie); process, a goal of the Nuclear Regulatory Commission has been to avoid conflicts with

8. The Subtitle C facility operator has been the regulations of NRC or its Agreement notified, in writing, and has agreed, in States, and to avoid placing new requirements writing, to receive and dispose of the on licensees. NRC is seeking licensees' views packaged materials; and on this issue.

9. The licensee notifies the Commission or At a March 1997 meeting, tentative agreement Agreement State (s) in which the transferor was reached on the draft text. Some of the and transferee are located, of the issues addressed by the Convention that would impending transfer, at least 30 days before be of interest to licensees are described below:

the transfer.

• An article is included in the Convention to ensure that disused sealed sources, In addition, for packaged waste, the dose rate including radium sources, that had been at 1 meter (40 inches) from the surface of any exported from the United States, be package containing stabilized waste may not allowed to be returned to a manufacturer exceed 0.20 microsievert per hcer (20 qualified to receive and possess them.

, microrem per hour) above backgreand and the stabilized material must be packaged for

• Articles of the Convention apply to the transportation and disposal in non-bulk steel decommissioning of all nuclear facilities, packagings as defined in U.S. Department of requiring that adequate resources for Transportation regulations in 49 CFR 173.213. decommissioning are provided, that 5

k radiation protection measures are facilities whose " primary purpose" is the implemented to protect both workers and management of radioactive waste), together the public, and that relevant records are with their location, main purpose, and maintained. essential features. An inventory.of the spent fuel and radioactive waste would be required,

. Deciding on provisions for radiation which would include a description of the protection of individuals beyond national material and other appropriate information on borders was a very sensitive issue. A few mass or volume, activity, and specific participants wanted international standards radionuclides, if available. A similar inventory and criteria to be applied in such instances. would also be required with respect to wastes The majority view, reflected in the final resulting from past practices. For facilities text, was that the criteria established by the being decommissioned, the report would national regulatory body should take include a listing of the facilities and the status internationally endorsed standards and of decommissioning activities.

criteria into account, but that national standards would be applied. A related Future Activities. From the beginning, the goal matter involved adding a provision that, in has been to produce a completed convention siting a waste management facility, a text that would be open for signature at the Contracting Party would consult with IAEA General Conference m September neighboring countries likely to be affected 1997. Adherence to this schedule will require by the proposed facility. Thus, if a waste convening a Diplomatic Conference before management facility were being sited near the September IAEA General Conference and the Mexican or Canadian border, re chmg agreement on any outstandmg issues consultations would be required between during the Diplomatic Conference.

the United States and the neighboring Because the discussions that take place in the country, meetings to draft the text of the Waste Convention are considered negotiating the text The article of the Convention dealing with of a international treaty, the meetings are not reporting was a subject of ongoing open to the public, and the papers prepared discussion, since it has the pott.ntial to for discussion are not public documents. To place new obligations on both regulatory facilitate staff's discussions with the agencies and licensees, if the Convention Agreement States and interested parties, we were to require information on waste have placed staff trip reports of the meetings management practices to be reported that in our Public Document Room, and included is not currently available. To implement draft Convention texts as attachments. These the Convention, Contracting Parties will are now available to any interested parties.

periodically meet after the Convention The views of Agreement States, State enters into force, to review their progress Compact organizations, and industry groups in achieving its obligations. To effect this were solicited before the meetings, so that approach, the Convention requires that they could be brought to the table in the each contracting party submit a national negotiations by the staff. A paper on the status report before the meeting of the parties, of the developme.. of the Convention was providing information on its national presented at Waste Management '97 in program and measures taken to implement Tucson, and staff plans to continue to provide the convention. visibility of the Convention to, and to seek input from, an even broader segment of the At the meetings of national representatives, nuclear community. Again, our goal would be particular attention was paid to the obligation to agree to a Waste Convention that would to provide in this report an " inventory" of the promote a high level of safety worldwide in spent fuel and radioactive wastes that are held managing radioactive wastes, but that would in storage or have been disposed of, as well as not impose burdensome new requirements on wastes that result from past practices. The NRC, Agreement States, or our licensees. We final text requires a list of spent fuel and would be looking for you to point out impacts radioactive waste management facilities (i.e., we might have overlooked, so that before the 0

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United States signed the Convention we would NRC Small Business Hotline: '

have greater confidence there would be no 800 - 368 - 5642 unintended burdensome impacts.

10 CFR Part 51," Environmental Report--

~ (Contact: Michael J. Bell, NMSS, Material Licensees," 62 FR 26729, May 14, 301-415-7286, e-mail: mjb2@nrc. gov.) 1997. This is a Direct Final Rule.

(Contact: Joseph J. Mate, RES,301-415-WITHDRAWAL OF UNAUTHORIZED USE 6202, e-mail: jjm@nrc. gov.)

RULE 10 CFR Parts 2 and 110," Facsimile Telephone Number and Address Change for the NRC's The Nuclear Regulatory Commission is Office of the Secretary," 62 FR 27494, May 20, withdrawing a proposed rule regarding the 1997, intentional unauthorized use of licensed (Contact: Emile L Julian, SECY, radioactive material by individuals. The 301-415-1966, e-mail: elj@nrc. gov.)

proposed rule was published for comment on January 31,1996 (61 FR 3334). Of the 86 10 CFR Parts 30,34,71, and 150," Licenses letters received on this rule, only four for Industrial Radiography and Radiation commenters were in favor of the rule as Safety Requirements for Industrial proposed. After reviewing these comments the Radiographic Operations," 62 FR 28947, Commission reconsidered the need for this May 28,1997.

rule, and concluded that the costs of (Contacts: Donald O. Nellis, RES, implementing the proposed rule wc'ild 301 -415-6257, e-mail: don @nrc. gov.;

outweigh the benefits. Mary L Thomas, RES,301-415-6230, e-mail: mit1@nrc. gov.)

( (Contact: Mary L Thomas, RES, ..

301-415-6230, e-mail: mit1@nrc. gov.) 10 CFR Pans 170 and 171," Revision of Fee Schedules; 100% Fee Recovely, FY 1997," 62 SELECTED FEDER4L REGISTER NOTICES FR 29193, May 29,1997.

(MARCH 1,1997 - MAY 31,1997) (Contact: C. James Helloway, CFO, 301-415-6213, e-mail: cjh2@nrc. gov.)

Note: Contacts may be reached by mail at the PROPOSED RULES U.S. Nuclear Regulatory Commission, Washington, D.C. 20555. 10 CFR Parts 170 and 171," Revision of Fee Schedules; 100% Fee Recovery, FY 1997--

FINAL RULES Correction," 62 FR 10626, March 7,1997.

10 CFR Parts 25,50,54, and 95," Access to 10 CFR Parts 30,40,50,70, and 72,"Self-and Protection of Classified Information," Guarantee of Decommissioning Funding by 62 FR 17683, April 11,1997. Non-Profit and Non-Bond Issuing Licensees,"

(Contact: Duane G. Kidd, ADM, 62 FR 23394, April 30,1997.

301-415-7403, e-mail: dgk@nrc. gov.) (Contact: Clark Prichard, RES,301-415-

, -mail: cwp@nrc. gov.)

10 CFR Parts 1, 20,30,40, 70, and 73, "NRC

. Region II Telephone Number and Address 10 CFR Part 51," Environmental Report--

Change," 62 FR 22879, April 28,1997. Material Licensees," 62 FR 26733, May 14, (Contact: Jeffrey Lankford, RII, 1997. This was published concurrently with 404-562-4849, e-mail: jbl@nrc. gov.) Direct Final Rule listed above.

10 CFR Part 2," Informal Small Entity (Contact: Joseph J. Mate, RES, Guidance," 62 FR 26219, May 13,1997. 301-415-6202, e-mail: jjm@nrc. gov.)

(Contacts: David L Meyer, ADM, FINAL REGULATORY GUIDES 301-415-7162, e-mail: dim 1@nrc. gov; Michael T. Lesar, ADM,301-415-7163, Revision 1 of Regulatory Guide 5.15, e-mail: mtl@nrc. gov.) " Tamper-Indicating Seals for the Protection 7

1 and Control of Special Nuclear Material," 62 " Memorandum of Understanding between the FR 16204, April 4,1997. U.S. Nuclear Regulatory Commission and the U.S. Department of Health and Human Regulatory Guide 8.39," Release of Patients Services, Food and Drug Administration,"

Administered Radioactive Materials," 62 FR notice of renewal,62 FR 15740, April 2,1997.

19635, April 22,1997.

" Commonwealth of Massachusetts: Discon-DRAFT REGULATORY GUIDES tinuance of Certain Commission regulatory Authority within the Commonwealth," notice Draft Guide DG-0006," Guide for the of agreement,62 FR 16628, April 7,1997.

Preparation of Applications for Commercial Nuclear Pharmacy Licenses," and Draft Guide " Standard Review Plan for Applications for DG-0007," Guide for the Preparation of Licenses to Distribute Byproduct Material to Applications for Licenses to Authorize Persons Exempt from the Requirements for an Distribution of Various Items to Commercial NRC License," notice of availability of Nuclear Pharmacies and Medical Use NUREG-1562,62 FR 16630, April 7,1997.

Licensees," and Draft Guide DG-0009, proposed supplement to Revision 2 to (Contact: Susan L. Greene, NMSS,301-415-Regulatory Guide 10.8," Guide for the 7843, e-mail: sig@nrc. gov.)

Preparation of Applications for Medical Use Programs," 62 FR 13727, March 21,1997. .' Abnormal Occurrence Reports: Imple-mentation of Section 208 of the Energy Draft Guide DG-3011,"Use of Fixed reorganization Act of 1974; Revision to Policy Neutron Absorbers at Fuels and Materials Statement," 62 FR 18820, April 17,1997.

Facilities," 62 FR 16629, April 7,1997.

" Revision of the NRC Enforcement Policy,"

OTIIER NOTICES addition of examples for categorizing violations of Part 34,62 FR 28974, May 28,

! " Notice of Availability of Memorandum of 1997.

I Understanding between the Nuclear (General

Contact:

Kevin M. Ramsey, NMSS, Regulatory Commission and the Department of Energy Concerning Agency Cooperation on 301-415-7842, e-mail: kmr@nrc. gov.)

Projects and Activities," 62 FR 11936, GENERIC COMMUNICATIONS ISSUED March 13,1997. (FEBRUARY 1,1997-MAY 1,1997)

" Notice of Transiti m of Regulatory Authority Note that these are only cummaries of U.S.

Over the U.S. Enrichment Corporation Nuclear Regulatory Commission generic Gaseous Diffusion Plants," 62 FR 11938, communications. If one of these documents March 13,1997. appears relevant to your needs and you have not received it, please call one of the technical

" Notice of Availability of Memorandum of contacts listed below.

Understanding between the Nuclear Regulatory Commission and the Department Bulletins (BLs) of Energy Concerning the Cooperation and Support for Demonstration Phase (Phase I) of BL 97-01," Potential for Erroneous Calibra-DOE Hanford Tank Waste Remediation tion, Dose Rate, or Ran:ation Exposure System Privatization Activities," 62 FR 12861, Measurements with Certain Victorcen Model March 18,1997. 530 and 530si Electrometer/Dosemeters," was issued on April 30,1997, to all medical

" Policy and Procedure for Enforcement institution licensees, irradiator licensees, Actions," request for comments on policy manufacturing and distribution licensees, and statement amendment regarding predecisional calibration service licensees. This bulletin enforcement conferences that are based on alerts them to a defective resistor network findings of discrimination, 62 FR 13906, identified by Victoreen in certain March 24,1997. electrometer/dosemeters and requires 8

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licensees possessing one of the ~affected (Contacts: Richard Boyle, DOT,202-models to respond to the bulletin. 366-4545, e-mail: rick.boyle@rspa, dot. gov.

(Contacts: Robert L Ayres, NMSS,301- Nancy L. Osgood, NMSS,301-415-8513, 415-5746, e-niail: rxal@nrc. gov. e-mail: nlo@nrc. gov. _

Kevin M. Ramsey, NMSS,301-415-7887, William M. Troskowski, NMSS,301-e-mail: kmr@nrc. gov.) 415-8076, e-mail: wmt@nrc. gov.

Information Notices (ins) (General

Contact:

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

IN 97-03, " Defacing of Labels to Comply with SIGNIFICANT ENFORCEMENT ACTIONS 10 CFR 20.1904(b)," was issued on February 20,1997, to all material licensees Detailed information regarding thesc

. involved with disposal of medical waste. The enforcement actions can be accessed via the notice alerts them that the requirement to Nuclear Regulatory Commission homepage deface radioactive material labels applies to 'http://www.ntc. gov /]. Click on " Nuclear visible labels only and when compliance is not Materials," then " Enforcement Program," and feasible, other methods are acceptable, finally " Enforcement Actions Issued." Cases Licensees should avoid opening waste barrels are listed alphabetically. For details, click on or other actions that would expose employees the highlighted text following each case.

to needles and potentially infectious materials.

Measuring Gauges (Contact: Sally L Merchant, NMSS, 301-415-7874, e-mail: slm2@nrc. gov.) Grandin Testing Lab., Inc., Los Lunas, New Mexico, EA 96-382. A $2500 civil penalty was IN 97-04," Implementation of a New Con, assessed for a willful violation involving use of straint Rule on Radioactive Air Effluents," gauges in areas of exclusive Federal jurisdic-was issued on February 24,1997, to all tion without proper authorization from NRC.

material, fuel cycle, and non-power reactor licensees. This notice alerts them to a recent Nelson Excavating, Inc., Thomas, West change in the regulations in 10 CFR Part 20 Virginia, EA 96-308. A $5000 civil penalty for air emissions. was assessed for deliberate use of a moisture density gauge in violation of an NRC Order (Contacts: Cynthia Jones, NMSS nd deliberate failure to provide accurate 301-415-7853, e-mail: cgj@nrc.'gov. inf rmation to NRC.

John Kinneman, RI,610-337-5252, e-mail:

Testing Laboratories, Inc., Alamogordo, New Joh Potfer RII,404-562-4731, e-mail- c, A .A jpp@nrc. gov.

assessed for a willful vio@lation mvolvmg use of0 Brenda Holt, RIII,630-829-9836, e-mail: gauges in areas of exclusive Federal jurisdic-bjh@nrc. gov. tion without proper authorization from NRC.

Linda Howell, RIV,817-860-8213, e-mail: Medical lih@nre. gov.)

St. Joseph's Hospital and Medical Center, IN 97-20," Identification of Certain Uranium Paterson, New Jersey, EA 97-066. A $2750 Hexafluoride Cylinders That Do Not Comply civil penalty was assessed for six violations with ANSI N14.1 Fabrication Standards," was collectively representing a breakdown in issued on April 17,1997, to all registered users control of the licensed program.

of transportation packages for uranium hexafluoride. This notice informs them that Temple University, Philadelphia, Pennsylvania, certain Model 30B cylinders do not meet the EA 96-455. Civil penalties totaling $10,000 fabrication standards aad are not authorized were assessed for failure to secure licensed for transport. material and willful failure to perform monthly 9

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b spot checks on high-dose-rate brachytherapy R:bco Production Logging, Inc., Snyder, equipment. Texas, EA 96-378. A $1100 civil penalty was assessed for use oflicensed material in an Other Materials Licensees NRC State without filing NRC Form-241. )

B&W Fuel Company, Lynchburg, Virginia, EA United Nuclear Corporation, Gallup, New 96-538. A $12,500 civil penalty was assessed Mexico, EA 93-170. A $99,000 civil penalty for five violations based on an event in which a was assessed for failure to comply with an low-enn,ched, umtradiated fuel assembly was NRC order to set aside decommissioning funds inadvertently returned in its onginal shipping and for providing incomplete and inaccurate containet to its pomt of ongin in Germany. information to NRC regarding those funds. i Koppel Steel Corporation, B; aver Falls, Pennsylvania, EA 96-498. An $8000 civil Radiography penalty was assessed for discrimination against an employee who engaged in protected activity Connell Limited Partnership, Tbisa, by providing information to an NRC inspector. Oklahoma, EA 96-536. An $8800 civil penalty was assessed for three violations of 3M Center, St. Paul, Minnesota, EA 96-403. radiography safety requirements involving a An $8000 civil penalty was assessed for failure personnel overexposure.

to have an irradiator operator present during certain periods when the irradiator was (Contact: Joseph DelMedico, OE,301-415-operated. 2739, e-mail: rjd@nrc. gov.)

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