[ Next ]
The Patient Release Rule, 10 CFR 35.75, "Release of Individuals Containing Radiopharmaceuticals or Permanent Implants," in 10 CFR Part 35, "Medical Use of Byproduct Material," permits licensees to ". . .authorize the release from its control of any individual who has been administered radiopharmaceuticals or permanent implants containing radioactive material if the total effective dose equivalent to any other individual from exposure to the released individual is not likely to exceed 5 millisieverts (0.5 rem)." This rule became effective on May 29, 1997. The final rule was announced in the Federal Register on January 29, 1997 (62 FR 4120). Guidance on the rule can be found in Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials." Regulatory Guide 8.39 was published in April 1997 and is available through the Office of Administration by fax at (301) 415-2260.
Subsections of 10 CFR 35.75(b), (c), and (d) contain additional requirements. Section 35.75(b) requires that the licensee
. . .provide the released individual with instructions, including written instructions, on actions recommended to maintain doses to other individuals as low as is reasonably achievable if the total effective dose equivalent to any other individual is likely to exceed 1 millisievert (0.1 rem). If the dose to a breast-feeding infant or child could exceed 1 millisievert (0.1 rem) assuming there were no interruption of breast-feeding, the instructions shall also include (1) guidance on the interruption or discontinuation of breast-feeding and (2) information on the consequences of failure to follow the guidance.
Section 35.75(c) requires that the licensee ". . .maintain a record of the basis for authorizing the release of an individual, for 3 years after the date of release, if the total effective dose equivalent is calculated (1) using the retained activity rather than the activity administered, (2) using an occupancy factor less than 0.25 at 1 meter, (3) using the biological or effective half-life, or (4) considering the shielding by tissue."
In 10 CFR 35.75(d), the licensee is required to ". . .maintain a record, for 3 years after the date of release, that instructions were provided to a breast-feeding woman if the radiation dose to the infant or child from continued breast- feeding could result in a total effective dose equivalent exceeding 5 millisieverts (0.5 rem)."
Regulatory Guide 8.39 provides guidance to the licensee on determining: (1) when the licensee may authorize the release of a patient; (2) when instructions to the patient are required by 10 CFR 35.75(b); and (3) when records are required, by 10 CFR 35.75(c) and (d), to be generated and maintained. The guide lists activities for commonly used radionuclides and their corresponding dose rates with which a patient may be released in compliance with the dose limits in 10 CFR 35.75.
(Contact: William B. McCarthy, NMSS, 301-415-7894, e-mail: email@example.com.)
[ Prev | Next ]
In a letter dated June 25, 1997, the U.S. Food and Drug Administration (FDA) reminded medical device manufacturers that some computer systems and software applications currently used in medical devices, including embedded microprocessors, may be affected by the Year 2000 problem. In addition, the letter mentioned that computer-controlled design, production, or quality control processes could be adversely affected. To ensure the continued safety and effectiveness of medical devices, the FDA recommended that manufacturers take the following actions: 1) assure that medical devices submitted for premarket approval can perform date recording and computations that will not be affected by the Year 2000 problem; 2) conduct hazard and safety analyses on currently manufactured devices to determine whether device performance could be affected by the Year 2000 problem, and if so, take appropriate steps to correct production and to assist customers who have purchased such devices; and 3) check design, production, and quality control processes to ensure year 2000 compliance. This letter also applies to those manufacturers that use radioactive material in their medical devices.
The FDA requires the manufacturers it regulates to investigate and correct problems with medical devices that present a significant risk to public health. In addition, users or purchasers of such devices, which include some Nuclear Regulatory Commission licensees, are required to be notified when a device presents an unreasonable risk of substantial harm to public health. NRC Information Notice 96-70, "Year 2000 Effect on Computer System Software," issued on December 24, 1996, addressed the Year 2000 problem and its applicability to NRC licensed programs.
To obtain a copy of the FDA letter or if there are any questions related to medical device manufacturers' responsibility regarding the Year 2000 problem, contact the FDA's Center for Devices and Radiological Health, Division of Small Manufacturers Assistance, by phone, at 1-800-638-2041, or by fax at 301-443-8818. Also, a copy of the letter is available on the FDA's World Wide Web home page at http://www.fda.gov/cdrh.
(Contact: Mark A. Sitek, NMSS, 301-415-6155 or e-mail: firstname.lastname@example.org.)
[ Prev | Next ]
Agreement State licensees seeking to conduct activities under reciprocity in "Non-Agreement States," areas of exclusive Federal jurisdiction, or in offshore waters, must file Nuclear Regulatory Commission Form 241, for reciprocity with NRC, at least 3 days before the licensee engages in activities permitted under the general license established by 10 CFR 150.20. This general license, recently revised and published in the Federal Register (62 FR 1662, January 13, 1997), authorizes any person who holds a specific license from an Agreement State to conduct reciprocity activities based on its Agreement State specific license, provided the specific license does not limit the authorized activity to specified locations or installations. The filing of NRC Form 241 informs NRC of the locations and dates of work being performed by Agreement State licensees in NRC jurisdiction and allows NRC to perform safety inspections to ensure that the work is being performed in accordance with NRC requirements.
To perform licensed activities on Federal property within an Agreement State, it must be determined whether the area where the work is to be performed is an area of exclusive Federal jurisdiction. An area of exclusive Federal jurisdiction is an area over which the Federal Government exercises legal control without interference from the jurisdiction and administration of State law. If Agreement State licensees are unsure of the jurisdictional status of a job site on Federal land, they should contact the Federal agency that controls the facility where the work is to be performed. If it is determined to be an area of exclusive Federal jurisdiction, the Agreement State licensee should file NRC Form 241, with NRC, for reciprocity.
Recently, NRC identified cases where Agreement State licensees failed to file for reciprocity with NRC or apply for a specific NRC license regarding the conduct of licensed activities in areas of exclusive Federal jurisdiction on Federal land within an Agreement State. The Agreement State licensees assumed that the Agreement State license allowed the conduct of licensed activities anywhere in the State and were not aware that filing with NRC for reciprocity is required before conducting activities in areas of exclusive Federal jurisdiction. As a result of not filing, NRC was denied the opportunity to inspect and ensure that the public health and safety were protected.
Similarly, NRC licensees authorized to conduct activities at temporary job sites should be aware that most Agreement States require any out-of-state licensee to file for reciprocity when using radioactive material in areas under Agreement State jurisdiction. Therefore, when an NRC licensee is conducting activities in an Agreement State, except in areas of exclusive Federal jurisdiction, it is the responsibility of the NRC licensee to file appropriate documents and fees associated with the reciprocity requirements in that State.
(Contacts: Wade T. Loo, RII, 404-562-4727, e-mail: email@example.com; Susan L. Greene, NMSS, 301-415-7843, e-mail: firstname.lastname@example.org.)
[ Prev | Next ]
The final rule on the revision of 10 CFR Part 34 was published in the Federal Register on May 28, 1997 (62 FR 28948). The new requirements become effective June 27, 1997 (30 days after publication) although particular requirements have different implementation dates as discussed below. (Please note that the notice published on May 28, 1997, listed incorrect compliance dates for the new provisions. A correction will be published in the Federal Register. The correct dates are specified below.)
Principal changes are:
The final rule may be accessed via the internet from the Government Printing Office site at http://www.access.gpo.gov/su_docs/aces/aces14 0.html.
(Contact: Donald O. Nellis, RES, 301-415-6257, e-mail:email@example.com.)
[ Prev | Next ]
As the result of inadvertent meltings of cesium-137 (Cs-137) sources, several steel producers possess approximately 9000 metric tons (10,000 tons) of emission control dust, most of which contains Cs-137 concentrations of less than 3.7 becquerels per gram (Bq/g) or 100 picocuries per gram (pCi/g). This material is typically being stored onsite because of the lack of disposal options that are considered cost-effective by the steel companies. The Nuclear Regulatory Commission has developed a technical position that may be used to evaluate case-by-case requests to dispose of treated emission control dust contaminated with Cs-137 at hazardous waste disposal facilities.
The Cs-137 contamination of this hazardous waste results from a series of three principal events: (1) the loss of control of a radioactive source by an NRC or Agreement State licensee; (2) the inclusion of the source within the scrap metal supply used by the steel producers; and (3) the inability to screen out the radioactive source as it progresses along the typical scrap collection-to-melt pathway. Most, but not all, of this material would be classified as mixed waste because it contains lead, cadmium, and chromium. Thus, it is subject to joint regulation as K061 mixed waste under the Resource Conservation and Recovery Act (RCRA) and the Atomic Energy Act of 1954, as amended, or the equivalent laws of Authorized States and Agreement States.
Two disposal options are available for the material, depending on Cs-137 levels and whether the material is in a packaged or unpackaged form. For packaged waste, the pretreatment average concentration of Cs-137 may not exceed 4.8 Bq/g (130 pCi/g) of material, and for unpackaged waste, the pretreatment average concentration of Cs-137 may not exceed 3.7 Bq/g (100 pCi/g) of material.
Provisions in the technical position that pertain to all forms of the material are that:
In addition, for packaged waste, the dose rate at 1 meter (40 inches) from the surface of any package containing stabilized waste may not exceed 0.20 microsievert per hour (20 microrem per hour) above background and the stabilized material must be packaged for transportation and disposal in non-bulk steel packagings as defined in U.S. Department of Transportation regulations in 49 CFR 173.213.
The position, which was coordinated with EPA, was published in the Federal Register on March 19, 1997 (62 FR 13176).
(Contact: Nick Orlando, NMSS, 301-415-6749, e-mail: firstname.lastname@example.org.)
[ Prev | Next ]
Since mid-1995, representatives of national governments have been meeting periodically at the International Atomic Energy Agency (IAEA) in Vienna, Austria, to prepare an international Convention on the Safety of Radioactive Waste Management. When completed the Convention will contain obligations for the "contracting parties" (i.e., countries ratifying, accepting, or approving the convention) to establish and maintain a legislative and regulatory framework to govern the safe management of radioactive waste, implement measures concerning general safety considerations in waste management activities, and establish safety in the siting, design, construction, operation, and closure of waste 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 conflict, will have to be brought into conformance. Throughout the drafting process, a goal of the Nuclear Regulatory Commission has been to avoid conflicts with the regulations of NRC or its Agreement States, and to avoid placing new requirements on licensees. NRC is seeking licensees' views on this issue.
At a March 1997 meeting, tentative agreement was reached on the draft text. Some of the issues addressed by the Convention that would be of interest to licensees are described below:
At the meetings of national representatives, particular attention was paid to the obligation to provide in this report an "inventory" of the spent fuel and radioactive wastes that are held in storage or have been disposed of, as well as wastes that result from past practices. The final text requires a list of spent fuel and radioactive waste management facilities (i.e., facilities whose "primary purpose" is the management of radioactive waste), together with their location, main purpose, and essential features. An inventory of the spent fuel and radioactive waste would be required, which would include a description of the material and other appropriate information on mass or volume, activity, and specific radionuclides, if available. A similar inventory would also be required with respect to wastes resulting from past practices. For facilities being decommissioned, the report would include a listing of the facilities and the status of decommissioning activities.
Future Activities. From the beginning, the goal has been to produce a completed convention text that would be open for signature at the IAEA General Conference in September 1997. Adherence to this schedule will require convening a Diplomatic Conference before the September IAEA General Conference and reaching agreement on any outstanding issues during the Diplomatic Conference.
Because the discussions that take place in the meetings to draft the text of the Waste Convention are considered negotiating the text of a international treaty, the meetings are not open to the public, and the papers prepared for discussion are not public documents. To facilitate staff's discussions with the Agreement States and interested parties, we have placed staff trip reports of the meetings in our Public Document Room, and included draft Convention texts as attachments. These are now available to any interested parties. The views of Agreement States, State Compact organizations, and industry groups were solicited before the meetings, so that they could be brought to the table in the negotiations by the staff. A paper on the status of the development of the Convention was presented at Waste Management '97 in Tucson, and staff plans to continue to provide visibility of the Convention to, and to seek input from, an even broader segment of the nuclear community. Again, our goal would be to agree to a Waste Convention that would promote a high level of safety worldwide in managing radioactive wastes, but that would not impose burdensome new requirements on NRC, Agreement States, or our licensees. We would be looking for you to point out impacts we might have overlooked, so that before the United States signed the Convention we would have greater confidence there would be no unintended burdensome impacts.
(Contact: Michael J. Bell, NMSS, 301-415-7286, e-mail: email@example.com.)
[ Prev | Next ]
The Nuclear Regulatory Commission is withdrawing a proposed rule regarding the intentional unauthorized use of licensed radioactive material by individuals. The proposed rule was published for comment on January 31, 1996 (61 FR 3334). Of the 86 letters received on this rule, only four commenters were in favor of the rule as proposed. After reviewing these comments the Commission reconsidered the need for this rule, and concluded that the costs of implementing the proposed rule would outweigh the benefits.
(Contact: Mary L. Thomas, RES, 301-415-6230, e-mail: firstname.lastname@example.org.)
[ Prev | Next ]
Note: Contacts may be reached by mail at the U.S. Nuclear Regulatory Commission, Washington, D.C. 20555.
10 CFR Parts 25, 50, 54, and 95, "Access to and Protection of Classified Information," 62 FR 17683, April 11, 1997.
(Contact: Duane G. Kidd, ADM, 301-415-7403, e-mail: email@example.com.)
10 CFR Parts 1, 20, 30, 40, 70, and 73, "NRC Region II Telephone Number and Address Change," 62 FR 22879, April 28, 1997.
(Contact: Jeffrey Lankford, RII, 404-562-4849, e-mail: firstname.lastname@example.org.)
10 CFR Part 2, "Informal Small Entity Guidance," 62 FR 26219, May 13, 1997.
(Contacts: David L. Meyer, ADM, 301-415-7162, e-mail: email@example.com; Michael T. Lesar, ADM, 301-415-7163, e-mail: firstname.lastname@example.org.)
10 CFR Part 51, "Environmental Report--Material Licensees," 62 FR 26729, May 14, 1997. This is a Direct Final Rule.
(Contact: Joseph J. Mate, RES, 301-415-6202, e-mail: email@example.com.)
10 CFR Parts 2 and 110, "Facsimile Telephone Number and Address Change for the NRC's Office of the Secretary," 62 FR 27494, May 20, 1997.
(Contact: Emile L. Julian, SECY, 301-415-1966, e-mail: firstname.lastname@example.org.)
10 CFR Parts 30, 34, 71, and 150, "Licenses for Industrial Radiography and Radiation Safety Requirements for Industrial Radiographic Operations," 62 FR 28947, May 28, 1997.
(Contacts: Donald O. Nellis, RES, 301-415-6257, e-mail: email@example.com.; Mary L. Thomas, RES, 301-415-6230, e-mail: firstname.lastname@example.org.)
10 CFR Parts 170 and 171, "Revision of Fee Schedules; 100% Fee Recovery, FY 1997," 62 FR 29193, May 29, 1997.
(Contact: C. James Holloway, CFO, 301- 415-6213, e-mail: email@example.com.)
10 CFR Parts 170 and 171, "Revision of Fee Schedules; 100% Fee Recovery, FY 1997-- Correction," 62 FR 10626, March 7, 1997.
10 CFR Parts 30, 40, 50, 70, and 72, "Self- Guarantee of Decommissioning Funding by Non-Profit and Non-Bond Issuing Licensees," 62 FR 23394, April 30, 1997.
(Contact: Clark Prichard, RES, 301-415-6203, e-mail: firstname.lastname@example.org.)
10 CFR Part 51, "Environmental Report--Material Licensees," 62 FR 26733, May 14, 1997. This was published concurrently with Direct Final Rule listed above.
(Contact: Joseph J. Mate, RES, 301-415-6202, e-mail: email@example.com.)
Revision 1 of Regulatory Guide 5.15, "Tamper-Indicating Seals for the Protection and Control of Special Nuclear Material," 62 FR 16204, April 4, 1997.
Regulatory Guide 8.39, "Release of Patients Administered Radioactive Materials," 62 FR 19635, April 22, 1997.
Draft Guide DG-0006, "Guide for the Preparation of Applications for Commercial Nuclear Pharmacy Licenses," and Draft Guide DG-0007, "Guide for the Preparation of Applications for Licenses to Authorize Distribution of Various Items to Commercial Nuclear Pharmacies and Medical Use Licensees," and Draft Guide DG-0009, proposed supplement to Revision 2 to Regulatory Guide 10.8, "Guide for the Preparation of Applications for Medical Use Programs," 62 FR 13727, March 21, 1997.
Draft Guide DG-3011, "Use of Fixed Neutron Absorbers at Fuels and Materials Facilities," 62 FR 16629, April 7, 1997.
"Notice of Availability of Memorandum of Understanding between the Nuclear Regulatory Commission and the Department of Energy Concerning Agency Cooperation on Projects and Activities," 62 FR 11936, March 13, 1997.
"Notice of Transition of Regulatory Authority Over the U.S. Enrichment Corporation Gaseous Diffusion Plants," 62 FR 11938, March 13, 1997.
"Notice of Availability of Memorandum of Understanding between the Nuclear Regulatory Commission and the Department of Energy Concerning the Cooperation and Support for Demonstration Phase (Phase I) of DOE Hanford Tank Waste Remediation System Privatization Activities," 62 FR 12861, March 18, 1997.
"Policy and Procedure for Enforcement Actions," request for comments on policy statement amendment regarding predecisional enforcement conferences that are based on findings of discrimination, 62 FR 13906, March 24, 1997.
"Memorandum of Understanding between the U.S. Nuclear Regulatory Commission and the U.S. Department of Health and Human Services, Food and Drug Administration," notice of renewal, 62 FR 15740, April 2, 1997.
"Commonwealth of Massachusetts: Discontinuance of Certain Commission regulatory Authority within the Commonwealth," notice of agreement, 62 FR 16628, April 7, 1997.
"Standard Review Plan for Applications for Licenses to Distribute Byproduct Material to Persons Exempt from the Requirements for an NRC License," notice of availability of NUREG-1562, 62 FR 16630, April 7, 1997.
(Contact: Susan L. Greene, NMSS, 301-415-7843, e-mail: firstname.lastname@example.org.)
"Abnormal Occurrence Reports: Implementation of Section 208 of the Energy reorganization Act of 1974; Revision to Policy Statement," 62 FR 18820, April 17, 1997.
"Revision of the NRC Enforcement Policy," addition of examples for categorizing violations of Part 34, 62 FR 28974, May 28, 1997.
(General Contact: Kevin M. Ramsey, NMSS, 301-415-7842, e-mail: email@example.com.)
[ Prev | Next ]
Note that these are only summaries of U.S. Nuclear Regulatory Commission generic communications. If one of these documents appears relevant to your needs and you have not received it, please call one of the technical contacts listed below.
BL 97-01, "Potential for Erroneous Calibration, Dose Rate, or Radiation Exposure Measurements with Certain Victoreen Model 530 and 530si Electrometer/Dosemeters," was issued on April 30, 1997, to all medical institution licensees, irradiator licensees, manufacturing and distribution licensees, and calibration service licensees. This bulletin alerts them to a defective resistor network identified by Victoreen in certain electrometer/dosemeters and requires licensees possessing one of the affected models to respond to the bulletin.
(Contacts: Robert L. Ayres, NMSS, 301- 415-5746, e-mail: firstname.lastname@example.org. Kevin M. Ramsey, NMSS, 301-415-7887, e-mail: email@example.com.)
IN 97-03, "Defacing of Labels to Comply with 10 CFR 20.1904(b)," was issued on February 20, 1997, to all material licensees involved with disposal of medical waste. The notice alerts them that the requirement to deface radioactive material labels applies to visible labels only and when compliance is not feasible, other methods are acceptable. Licensees should avoid opening waste barrels or other actions that would expose employees to needles and potentially infectious materials.
(Contact: Sally L. Merchant, NMSS, 301-415-7874, e-mail: firstname.lastname@example.org.)
IN 97-04, "Implementation of a New Constraint Rule on Radioactive Air Effluents," was issued on February 24, 1997, to all material, fuel cycle, and non-power reactor licensees. This notice alerts them to a recent change in the regulations in 10 CFR Part 20 for air emissions.
(Contacts: Cynthia Jones, NMSS, 301-415-7853, e-mail: email@example.com.
John Kinneman, RI, 610-337-5252, e-mail: firstname.lastname@example.org.
John Potter, RII, 404-562-4731, e-mail: email@example.com.
Brenda Holt, RIII, 630-829-9836, e-mail: firstname.lastname@example.org.
Linda Howell, RIV, 817-860-8213, e-mail: email@example.com.)
IN 97-20, "Identification of Certain Uranium Hexafluoride Cylinders That Do Not Comply with ANSI N14.1 Fabrication Standards," was issued on April 17, 1997, to all registered users of transportation packages for uranium hexafluoride. This notice informs them that certain Model 30B cylinders do not meet the fabrication standards and are not authorized for transport.
(Contacts: Richard Boyle, DOT, 202- 366-4545, e-mail: rick.boyle@rspa. dot.gov.
Nancy L. Osgood, NMSS, 301-415-8513, e-mail: firstname.lastname@example.org.
William M. Troskowski, NMSS, 301- 415-8076, e-mail: email@example.com.
(General Contact: Kevin Ramsey, NMSS, 301-415-7887, e-mail: firstname.lastname@example.org.)
[ Prev | Next ]
Detailed information regarding these enforcement actions can be accessed via the Nuclear Regulatory Commission homepage [http://www.nrc.gov/OE/rpr/oehome4.htm]. Cases are listed alphabetically. For details, click on the highlighted text following each case.
Grandin Testing Lab., Inc., Los Lunas, New Mexico, EA 96-382. A $2500 civil penalty was assessed for a willful violation involving use of gauges in areas of exclusive Federal jurisdiction without proper authorization from NRC.
Nelson Excavating, Inc., Thomas, West Virginia, EA 96-308. A $5000 civil penalty was assessed for deliberate use of a moisture density gauge in violation of an NRC Order and deliberate failure to provide accurate information to NRC.
Testing Laboratories, Inc., Alamogordo, New Mexico, EA 96-447. A $2500 civil penalty was assessed for a willful violation involving use of gauges in areas of exclusive Federal jurisdiction without proper authorization from NRC.
St. Joseph's Hospital and Medical Center, Paterson, New Jersey, EA 97-066. A $2750 civil penalty was assessed for six violations collectively representing a breakdown in control of the licensed program.
Temple University, Philadelphia, Pennsylvania, EA 96-455. Civil penalties totaling $10,000 were assessed for failure to secure licensed material and willful failure to perform monthly spot checks on high-dose-rate brachytherapy equipment.
Other Materials Licensees
B&W Fuel Company, Lynchburg, Virginia, EA 96-538. A $12,500 civil penalty was assessed for five violations based on an event in which a low-enriched, unirradiated fuel assembly was inadvertently returned in its original shipping container to its point of origin in Germany.
Koppel Steel Corporation, Beaver Falls, Pennsylvania, EA 96-498. An $8000 civil penalty was assessed for discrimination against an employee who engaged in protected activity by providing information to an NRC inspector.
3M Center, St. Paul, Minnesota, EA 96-403. An $8000 civil penalty was assessed for failure to have an irradiator operator present during certain periods when the irradiator was operated.
Robco Production Logging, Inc., Snyder, Texas, EA 96-378. A $1100 civil penalty was assessed for use of licensed material in an NRC State without filing NRC Form-241.
United Nuclear Corporation, Gallup, New Mexico, EA 93-170. A $99,000 civil penalty was assessed for failure to comply with an NRC order to set aside decommissioning funds and for providing incomplete and inaccurate information to NRC regarding those funds.
Connell Limited Partnership, Tulsa, Oklahoma, EA 96-536. An $8800 civil penalty was assessed for three violations of radiography safety requirements involving a personnel overexposure.
(Contact: Joseph DelMedico, OE, 301-415- 2739, e-mail: email@example.com.)
Comments, and suggestions you may have for information that is not currently being included, that might be helpful to licensees, should be sent to:
NMSS Licensee Newsletter Editor
Office of Nuclear Material Safety
Two White Flint North, Mail Stop 8-A-23
U.S. Nuclear Regulatory Commission
Washington, D.C. 20555-0001