ML20217N111
| ML20217N111 | |
| Person / Time | |
|---|---|
| Issue date: | 12/02/1998 |
| From: | Rathbun D NRC OFFICE OF CONGRESSIONAL AFFAIRS (OCA) |
| To: | Inhofe J, Schaefer D HOUSE OF REP., SENATE |
| Shared Package | |
| ML20217M898 | List: |
| References | |
| FRN-63FR66492, RULE-PR-31 AG06-1-023, NUDOCS 9910280118 | |
| Download: ML20217N111 (8) | |
Text
D$
[$. -
Dscember 2, 1998 gg d b -/
The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Genate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed -
Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Part 31 to explicitly require that certain general licensees who poFSess devices containing byproduct material respond to NRC requests for information concernir:g devices that they have received for use under a general license.
This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devicer oave not been properly handled or disposed of. This amendment would allow NRC to account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
- Sirniety, i
Original signed by Dennis K. Rathbun Dennis K. Rathbun, Director Office of Congressional Affairs 1
Enclosure:
Identicalletter sent to: The Honorable Dan Schaeffer Federal Register Notice Chairman, Subcommittee on Energy and Power cc: Senator Bob Graham DisTRIDuTION: NMss 199800539/EDO 199800070 EDo r/f JPiccone Mbridgers PHolahan CPoland CRMattsen NMss Dir. Off. r/t JMcCaueland %
)
DACool
%f # #
'(
[O:\\MATTsEN\\GL
- see previous concurrence.
v.
1P\\ PROP _31. con],,,.-e..or..im.o.
ev.
..e....
.n
.3..j
.u OFFICE
- RGBVMNS l RGBUMNS l D:IMNs l
TECHED l,D NMss [ [ oCM//(
l NAME
- CMatteen
'JPiccone
- DCool EKraus Waperiel$
DK#athbun~
DATE 11/04198 11/05198 11/09/98 08/05/96 h /1D 198'
/// L /98 OFFICIAL RECORD COPY j
)
1 l
9910290118 991022 PDR PR l
31 63FR66492 PDR
- 7sev//o 3a 6
%p\\
g g
UNITED STATEE, p
]
NUCLEAR REGULATORY COMMISSION WASHINGTON, D.C. 30086 0001 December 2, 1998 The Honorable Dan Schaefer, Chairman Subcommittee on Energy and Power Committee on Commerce United States House of Representatives
' Washington, DC 20515
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Register soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to a..:end 10 CFR Part 31 to explicitly require that certain general licensees who possess devices containing byproduct material respond to NRC requests for information conceming devices that they have received for use under a general license.
This provision would be used primarily to institute a registration system for devices using certain l
quantities of specific radionuclides that are primarily used in commercial and industrial I
applications.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to account for devices that have been distributed for use under the general license and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, h[ \\
Dennis K. Rathbun, Director i
Office of Congressional Affairs
Enclosure:
Federal Register Notice ec: Representative Ralph Hall i
I
. t.
I
G J
g
\\
UNITED STATES y
j NUCLEAR REGULATORY COMMIS510N 2
WASHINGTON. D.c. 20006 eo01 4
December 2, 1998 The Honorable James M. Inhofe, Chairman Subcommittee on Clean Air, Wetlands, Private Property and Nuclear Safety Committee on Environment and Public Works United States Senate Washington, DC 20510
Dear Mr. Chairman:
Enclosed for the information of the Subcommittee is a copy of a Notice of Proposed Rulemaking to be published in the Federal Reaister soon. The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend 10 CFR Part 31 to explicitly require that certain general licensees who possess devices containing byproduct material respond to NRC requests for information conceming devices that iney have received for use under a general license.
This provision would be used primarily to institute a registration system for devices using certain quantities of specific radionuclides that are primarily used in commercial and industrial applications.
NRC has observed a number of instances in the past where generally licensed devices have not been properly handled or disposed of. This amendment would allow NRC to account for devices that have been distributed for use under the generallicense and thereby reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property. This change will have no adverse impact on the health and safety of workers or the public and is not expected to impose a significant burden on licensees.
Sincerely, My 8
A Dennis K. Rathbun, Director Office of Congressional Affairs
Enclosure:
Federal Register Notice cc: Senator Bob Graham i
. 5..
l
.o l
[7590-01-P]
NUCLEAR REGULATORY COMMISSION i
10 CFR Part 31 RIN 3150 - AG06 Requirements for Thone Who Pus:.ess Certain Industrial Devices Containing Byproduct Material to Provide Requested information AGENCY: Nuclear Regulator / Commission.
i ACTION: Proposed rule.
SUMMARY
- The Nuclear Regulatory Commission (NRC) proposes amending its regulations to add an explicit requirement that general licensees who possess certain measuring, gauging, or controlling devices that contain byproduct material provide the NRC with information conceming these devices. The NRC intends to use this provision to request information concerning devices that present a comparatively higher risk of exposure to the public or property damage.
The proposed rule is intended to help ensure that devices containing byproduct material are maintained and transferred properly and are not inadvertently discarded.
DATES: Submit comments by (Insert date 75 days after publication date). Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received on or before this date.
439M@
/000
,~
ADDRESSES: Send comments by mail to the Secretary, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001. Attention: Rulemakings and Adjudications Staff.
Hand deliver comments to: 11555 Rockville Pike, Rockville, Maryland, between 7:30 am and 4:15 pm on Federal workdays.
You may also provide comments via the NRC's interactive rulemaking website through the NRC home page (http://www.nrc. gov). This site provides the availability to upload comments as files (any format), if your web browser supports that function. For information about the interactive rulemaking site, contact Ms. Carol Gallagher (301) 415-5905; e-mail CAG@nrc. gov.
Certain documents related to this rulemaking, including commenis received and the regulatory analysis, may be examined at the NRC Public Document Room,2120 L Street NW.
(Lower Level), Washington, DC. These same documents also may be viewed and downloaded electronically via the interactive rulemaking website established by NRC for this rulemaking.
FOR FURTHER INFORMATION CONTACT: Catherine R. Ma'.sen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-mail at CRM@nrc. gov; or Jayr.e McCausland, Office of Nuclear Materict Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone (301) 415-6219, or e-mail at JMM2@nre. gov.
2
p L
SUPPLEMENTARY INFORMATION:
l l
Background
1 On February 12,1959 (24 FR 1089), the Atomic Energy Commission (AEC) amended its regulations to provide a generallicense for the use of byproduct material contained in certain measuring, gauging, or controlling devices (10 CFR 30.21(c)). Under current regulations l
(10 CFR 31.5), certain persons may receive and use a device containing 4/ product material under this generallicense if the device has been manufactured and distributed according to the j
specifications contained in a specific license issued by the NRC or by an Agreement State. A specific license authonzing distribution of generally licensed devices is issued if a regulatory authority determines that the safety features of the device and the instructions for safe operation of that device are adequate and meet regulatory requirements. The generallicensee must comply with requirements for labeling, instructions for use, and proper storage or j
disposition of the device. For some devices, the generallicensee must also comply with leak testing requirements. The general licensae is also subject to the terms and conditions in 10 CFR 31.2 concerning general license requirements, transfer of byproduct material, reporting and recordkeeping, and inspection. The general licensee must comply with the safety instructions contained in or referenced on the label of the device and must have the testing or servicing of the device performed by an individual who is authorized to manufacture, install, or service these devices.
1 A generally licensed device usually consists of radioactive material, contained in a sealed source, within a shielded device. The device is designed with inherent radiation safety features so that it can be used by persons with no radiation training or experience. Thus, the
.Ne
i 1
general license is meant to simplify the licensing process so that a case-by-case determination j
of the adequacy of the radiation training or experience of each user is not necessary.
There are about 45,000 general licensees under 10 CFR 31.5 who possess about 600,000 devices that contain byproduct material. In the past, the NRC has not contacted generallicensees on a regular basis because of the relatively small radiation exposure risk posed by these devices and the very large c9mber of general licensees.
However, there have been a number of occurrences where generally licensed devices containing radioactive material have not been properly handled or properly disposed of. In some cases, this has resulted in radiation exposure to the public and contamination of property.
For example, when a source is accidentally melted in a steel mill, cunsiderable contamination of the mill, the steel product, and the wastes from the process, the slag and the baghouse dust, can result.
Because of these incidents, the NRC conducted a 3-year sampling (1984 through 1986) of generallicensees to assess the effectiveness of the generallicense program and to determine whether there was an accounting problem with generally licensed device users and, if so, what action could be taken. The sampling revealed several areas of concern regarding the use of radioactive material under the generallicense provisions of 10 CFR 31.5. The NRC concluded that -- (1) Many general licensees are not aware of the appropriate regulations, and (2) Generally licensed devices are inadequately handled and accounted for.
Approximately 15 percent of all generallicensees sampled could not account for all of their generally licensed devices. The NRC concluded that these problems could be remedied by more frequent and timely contact between the general licensee and the NRC.
' On December 27,1991 (56 FR 67011), the NRC published a notice of proposed ru'emaking concerning the accountability of generally licensed devices. The proposed rule t.
4
0-contained a number of provisions, including a requirement for generallicensees under 10 CFR 31.5 to provide information to the NRC upon request, through which a device registry could be developed. The proposed rule also included requirements in 10 CFR 32.51a and 32.52 for the specific licensees who manufacture or initially transfer generally licensed devices.
Although the public comments received were reviewed and a final rule developed, a final rule was not issued because the resources to implement the proposed rule properly were not available.
The NRC has continued to consider the issues related to the loss of control of generally licensed, as well as specifically licensed, sources of radioactivity. In July 1995, the NRC, with assistance from the Organization of Agreement States, formed a working group to evaluate these issues. The working group consisted of both NRC and Agreement State personnel and encouraged the involvement of all persons having a stake in the process and its final recommendations. All working group meetings were open to the public. A final report was completed in July 1996 and published in October 1996 as NUREG-1551, " Final Report of the NRC-Agreement State Working Group to Evaluate Control and Accountability of Licensed Devices."
In considering these recommendations, the NRC has decided, among other things, to initiate an annual registration program of devices generally licensed under 10 CFR 31.5 that would be similar to the program originally proposed in the December 27,1991, proposed rule.
However, the NRC has decided to do so only for those devices that present a higher risk (compared to other generally licensed devices) of potential exposure to the public and property loss if control of the device is lost. Initially, the NRC w ll use the criteria developed by the working group to determine which devices should be registered.
5
This proposed rule presents the proposed addition of an explicit requirement to provide j
information in response to requests made by the NRC for a second round of comment. While the proposed rule would apply to all 10 CFR 31.5 general licensees, the NRC plans to contact only those generallicensees identified by the working group for the purpose of the registration program.
The NRC is withdrawing the December 27,1991, proposed rule. The NRC plans to review the other provisions contained in the December 27,1991, proposed rule and the recommendations of the working group and develop additional requirements in a separate rulemaking.
i Discussion The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC to request
)
4 appropriate information from its licensees concerning licensed activities. However, the Commission has not included such an explicit provision in the regulations governing 10 CFR 31.5 generallicensees. Although 10 CFR 2.204,30.34(e), and 30.61(a) require information from licensees by order or demand, these provisions are not considered appropriate for the initiation of a routine registration program. In a previous rulernaking, the Commission (then AEC) had proposed the inclusion ci a registration requirement for generally licensed devices before receipt of devices (February 5,1974; 39 FR 4583), in response to comment on that proposal, the Commission decided not to institute a registration requirement as part of the final rulemaking on that action (December 16,1974; 39 FR 43531). Given this history, establishing a device registration program without a rulemaking process is also considered inappropriate.
6 l
This proposed rule would add an explicit requirement to 10 CFR 3':.5 that would require generallicensees to respond to written requests from the NRC for information concerning _
products that they have received for use under a general license in a timely way.
The proposed rule would require a response to requests within 30 days or such other time as specified in the request. For routine requests for information,30 days should be adequate in most instances, and an extension can be obtained for good cause. If more complicated requests are made or circumstances recognized that may require a longer time,
'the Commission may provide a longer response time. In the unusual circumstance of a significant safety concern, the Commission could demand information in a shorter time. The NRC is specifically soliciting comments on this time period. Also, a phone number will be provided in the request for information in case additional guidance is necessary.
The NRC intends to use this provision primarily to institute an annual registration program for devices using certain quantities of specific radionuclides. The registration program is primarily intended to ensure that generallicensees are aware of and understand the requirements for the possession of devices containing byproduct material. The registration process would allow NRC to account for devices that have been distributed for use under the generallicense. The NRC believes that if generallicensees are aware of their responsibilities they would comply with the requirements for proper handling and disposal of generally licensed devices This would help reduce the potential for incidents that could result in unnecessary radiation exposure to the public as well as contamination of property.
The generallicensees covered by the registration program would be asked to account l
for the devices in their possession and to verify, as well as certify, information concerning:
J l
1.
The identification of devices, such as the manufacturer, model and serial numbers,
{
l 2.
The persons responsible for compliance with the regulations; l
l 1
7 j
4 r
l
- l. _
I 3.
The disposition of the devices; and j
4.
The location of the devices.
While the proposed rule would apply to all 10 CFR 31.5 ger oral licensees (about i
45,000), the NRC would only contact, for purposes of registration, approximately 6000 general licensees, possessing about 24,000 devices. This estimate is based on the criteria recommended by the working group for determining which sources should have increased 1
oversight. Requests for information would be sent to general licensees who are expected, based on current NRC records, to possess devices containing at least 370 MBq (10 mci) of cesium-137,3.7 MBq (0.1 mci) of strontium-90,37 MBq (1 mci) of cobalt-60, or 37 MBq (1 mci) of any transuranic (at this time, the only generally licensed devices meeting this criterion contain americium-241). The majority of the devices meeting these criteria are used in commercial and industrial applications measuring thit.kness, density, or chemical composition in petrochemical and steel manufacturing industries. The requests will include the information contained in NRC records concerning the possession of these devices. The licensee.g will be asked to verify, correct, and add to that information. The NRC records are based on information provided to NRC by distributors under 10 CFR 32.52(a) and from generallicensees as required by 10 CFR 31.5(c)(8) or (9), if a general ticensee no longer possesses devices meeting the criteria, it would be expected to provide information about the disposition of the devices previously possessed. Errors in current NRC records concerning these general licensees could be the result of: (1) errors made in the quarterly reports of manufacturers or initial distributors, (2) general licensees not reporting transfers, or (3) errors made by NRC or its contractors in recording transfer information.
l l
In addition to the 6000 general licensees identified for registration, the NRC may i
occasionally request information from other general licensees on a case-by-case basis as j
J 8
i
l necessary or appropriate. For example, this might involve investigating the extent that other users have experienced a problem that has been identified with the design of a particular device model. However, significant modifications to the registration program to include a larger class of licensees would be done through rulemaking.
Although the proposed amendment would impose some additional costs on licensees, the NRC has estimated these costs to be minimal. This cost is the estimated administrative 1
~'
cost expended by general licensees to verify the ink.rrr.ation requested by the NRC regarding licensed devices. The NRC believes that the proposed rule's intended effect of increased compliance by generallicensees with regulatory requirements and resulting NRC and public confidence in the general license program potentially afforded by these new requirements outweigh this nominal administrative cost.
The NRC is currently considering additional rulemaking concerning the control and accountability of devices generally licensed under 10 CFR 31.5. The recommendations made
)
in NUREG-1551 will be considered at that time. That anticipated rule would address fees for registration, additional labeling requirements for 10 CFR 32.51 licensees, and compatibi!ity of i
Agreement State regulations in this area. Public comments on this current proposed rule should only address the requirements proposed in this action. Comments concerning possible future rulemaking and the possible imposition of fees will not be addressed in any rule resulting from this proposed action.
Fublic Comments on the Original Proposed Rule i
The NRC reviewed the comments received on the December 27,1991, proposed rule.
There were 26 comment letters received from a variety of sources including private and publicly 9
held corporations, private citizens, citizens groups, the Armed Forces, and State governments.
These comments have been considered to the extent applicable to this more limited proposed rule and will be considered in the development of a subsequent rulemaking concerning the accountability of devices generally licensed under 10 CFR 31.5. A detailed analysis of the comments received on the December 27,1991, proposed rule will not be presented in either action as many of the specific comments pertain to specific provisions that have been withdrawn, much time has passed since these comments were made, and additional opportunity for comment is being provided.
- Comments received on the December 27,1991, proposed rule demonstrated that there was considerable opposition to the rule as proposed, some of it specifically concerning a registration requirement. Most of this opposition was related to the breadth of the proposal which would have made the registration program applicable to all of the 10 CFR 31.5 general licensees, accounting for as many as 600,000 devices. Some respondents questioned whether this was justified or cost effective. Some thought the impacts were underestimated, particularly for generailicensees possessing many devices, and that the provision would have serious impacts on certain industries. Registration was specifically opposed for devices used by the airline industry, self-luminous signs, static eliminators, and some other devices which present
. relatively low risks.
The NRC found the working group process valuable in identifying criteria for j
I categorizing devices that are more likely to present a significant risk by exposure of the public l
or through contamination of property. Therefore, the registration of devices under this proposed rulemaking would be limited to those devices meeting the criteria recommended by the working group. For the mest part, general licensees using devices meeting these criteria have a limited number of devices that would require registration. The NRC is exploring 10
)
i
)
i approaches to minimize the administrative effort for both general licensees and the NRC in implementing this requirement.
This proposalincludes a provision to request an extension to the time interval to provide l
a complete response to requests for information, if the general licensee is having difficulty in meeting the time limit. This provision was included in response to comments on the i
December 27,1991, proposed rule. Although this difficulty is much less likely to arise within the limited population of generallicensees covered by the current proposal, the Commission i
believes that the additional flexibility is desirable.
Interim Enforcement Policy As had been planned at the time of the 1991 proposed rule, the Commission intends to establish an interim enforcement policy for violations r>f 10 CFR 31.5 that licensees discover and report during the initial cycle of the registration program. This policy will supplement the normal NRC Enforcement Policy in NUREG-1600, Rev.1. It will be issued in the near future and will remain in effect through one complete cycle of the registration program.
Under the current NRC Enforcement Policy, significant violations, such as those involving lost sources, may result in escalated enforcement action including civil penalties. The interim policy would provide that enforcement action normally would not be taken for violations identified by a licensee and reported to the NRC if appropriate corrective action is taken. For the period that the interim policy is in effect, it would also apply to general licensees not subject to the registration requirement if they identify and report violations and take appropriate corrective action. This change from the current NRC Enforcement Policy is intended to remove any disincentive to ide.ntify deficiencies that might be caused by a concern over potential 11 I
L
enforcement action. This action would encourage generallicensees to search their facilities to ensure sources are located, to determine if applicable requirements have been met, and to develop appropriate corrective action when deficiencies are found. A Notice of Violation (NOV) without a civil penalty still may be issued if the NRC staff believes that taking this action is justified by the safety significance of the violation or the need to record and document the generallicensee's corrective action in the formal manner required in a response to an NOV.
In addition, escalated enforcement action still will be considered for violations involving failure to provide the information requested, failure to take appropriate corrective action, or for i
willful violations including the submittal of false information. Sanctions in those situations may include significant civil penalties as well as orders to limit or revoke the authority to possess radioactive sources under a general license.
The Commission also intends to increase the civil penalty amounts specified in its current Enforcement Policy in NUREG-1600, Rev.1, for violations involving lost or improperly disposed sources or devices. This is to ensure that such civil penalties are significantly higher than the costs avoided by the failure to properly dispose of the source or device.
Agreement State Compatibility Under the " Policy Statement on Adequacy and Compatibility of Agreement State Programs" approved by the Commission on June 30,1997 (62 FR 46517), this proposed rule is classified as Compatibility Category D. Category D means the provisions are not required for purposes of compatibility; however, if adopted by the State, the provisions should not create any conflicts, duplications, or gaps in the regulation of AEA material. Ultimately an enhanced oversight program is expected to include provisions that will require a higher degree of 12
- 1, i,.
i
- compatibility. This will be considered in a subsequent rulemaking to add more explicit Y
requirements for the registration program and additional provisions concerning accountability of generally licensed devices.
Environmental Impact: Categorical Exclusion
' The NRC has determined that this propose i ruie is the type of action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii). Therefore, neither an environmentalimpact statement nor an environmental assessment has been prepared for this regulation.
Paperwork Reduction Act Statement This proposed rule amends information collection requirements that are subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq). This rule has been submitted to th Office of Management and Budget for review and approval of the information collection requirements.
. The public reporting burden for this information collection is estimated to average 20 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the
-information collection. The U.S. Nuclear Regulatory Commission is seeking public comment on
' the potential impact of the information collections contained in the proposed rule and on the following issues:
13
1.
Is the proposed information collection necessary for the proper performance of the functions of the NRC, including whether the information will have practical utility?
2.
Is the estimate of burden accurate?
3.
'Is there a way to enhance the quality, utility, and clarity of the information to be collected?
4.
How can the burden of the information collection be minimized, including the use of automated collection techniques?
l Send comments on any aspect of this proposed information collection, including suggestions for reducing the burden, to the Records Management Branch (T-6 F33), U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001, or by Internet electronic mail at BJS1@NRC. GOV; and to the Desk Officer, Office of information and Regulatory Affairs, NEOB-10202 (3150-0016), Office of Management and Budget, Washington, DC 20503.
Comments to OMB on the information collections or on the above issues should be submitted by (insert date 30 days after publication in the Federal Register). Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date.
Public Protection Notification if an information collection does not display a currently valid OMB control number, the NRC may not conduct or sponsor, and a person is not required to respond to, the information collection.
I I.
14 i
l
\\
Regulatory Analysis l
The NRC has prepared a draft regulatory analysis for this proposed regulation. The analysis examines the cost and benefits of the alternatives considered by the NRC. The comments received on the earlier draft regulatory analysis have been considered to the extent that they apply to this more limited action. The regulatory analysis is available for inspection in i
the NRC Public Document Room,2120 L Street NW. (Lower Level), Washingtpn, DC. Single copies of the analysis may be obtained by calling Jayne McCausland, U.S. Nuclear Regulatory Commission, Office of Nuclear Material Safety and Safeguards, Washington, DC,20555-0001; telephone (301) 415-6219; or e-mail at JMM2@nrc. gov.
Regulatory Flexibility Certification As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)), the Commission certifies that this proposed rule, if adopted, would not have a significant economic impact on a substantial number of small entities. This proposed rule woulo require generallicensees who have received specific devices to respond to requests for information from NRC. The proposed rule would apply to the approximately 45,000 persons using products under an NRC general license, many of whom may be classified as small entities. However, the NRC intends to request registration information from only approximately 6000 of these generallicensees about the identification of the devices, accountability for the devices, the persons responsible for compliance with the regulations, and the disposition of the devices. The NRC believes that the economic impact of the proposed requirements on any generallicensee would be a negligible increase in administrative burden. The proposed rule is intended to ensure that general 15
l.
licensees understand and comply with regulatory responsibilities regarding the generally licensed radioactive devices in their possession.
Backfit Analysis The NRC has determined that the backfit rule,10 CFR 50.109. efoes not apply t' 'his proposed rule and, therefore, a backfit analysis is not required because these amendments would not involve any provisions that would impose backfits as defined in 10 CFR 50.109(a)(1).
List of Subjects in 10 CFR Part 31 Byproduct material, Criminal penalties, Labeling, Nuclear materials, Packaging and containers, Radiation protection Reporting and recordkeepin0 requirements, Scientific equipment.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974, as amended, and 5 U.S.C.
j i
553, the NRC is proposing to adopt the following amendments to 10 CFR Part 31.
j l
l l
3 I
E 16 I
I J
l N
l PART 31 - GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL i
l
- 1. The authority citation for Part 31 continues to read as follows:
AUTHORITY: Secs. 81,161,183, S8 Stat. 935, 948, 954, as amended (42 U.S.C.
211: 2201,2233); secs. 201, as amended,202,88 Stat.1242, as amended, 1244 (42 U.S.C.
5841,5842).
Section 31.6 also issued under sec. 274,73 Stat. 688 (42 U.S.C. 2021).
- 2. Section 31.5 is amended by adding paragraph (c)(11) to read as follows:
10 CFR 31.5 Certain measuring, gauging, or controlling devices.2 (c)
(11) Shall respond to written requests from the Nuclear Regulatory Commission to provide information relating to the generallicense within 30 calendar days of the date of the request, or other time specified in the request. If the generallicensee cannot provide the requested information within the allotted time, it shall, within that same time period, request a longer period to supply the information by submitting a letter to the Director, Office of Nuclear 2 Persons possessing byproduct material in devices under a general license in 10 CFR 31.5 before January 15,1975, may continue to possess, use, or transfer that material in accordance with the labeling requirements of 10 CFR 31.5 in effect on January 14,1975.
17
p- ;
l:...
. Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001 and provide written justification as to why it cannot comply.
Dated at Rockville, Maryland, this / f ay of O#tN/N S &
1998.
I I-For the Nuclear. Regulatory Commission.
k.
w Malcolm R. Knapp
[
Acting Executive Director for Operations.
-)
)
I 4
i s
18
l e
.s
- i w
TDC-66492
$ $- /
Proposed Rules redwa+w Vol. 63. No. 231 Wednesday December 2,1998 This section of the FEDERAL REGISTER supports that function. For infonnation must comply with the safety contains notees to the pubhc of the proposed about the interactive rulemaking site, instructions contained in or referenced issuance of rules and regulations The contact Ms. Carol Gallagher (301) 415-on the label of the device and must have purpose of these notices is to give interested 5905; e-mail CAG@nrc gov.
the testing or servicing of the device persons an opportunity to partcipate in the Certain documents related to this performed by an individual who is ru rnaking pnor to the adoption of the final rulemaking, including comments authorized to manufacture, install, or received and the regulatory analysis, service these devices.
may be examined at the NRC Public A generally licensed device usually NUCLEAR REGULATORY Document Room,2120 L Street NW.
consists of radioactive material.
COMMISSION (Lower Level), Washington DC. These contained in a sealed source, within a same documents also may 1: viewed shielded device. The device is designed 10 CFR Part 31 and downloaded electronically via the with inherent radiation safety features RIN 3150--AG06 interactive rulemaking website so that it can be used by persons with established by NRC for this rulemaking. no radiation training or experience.
Requirements for Those Who Possess FOR FURTIfiR INFORMATION CONTACT:
Thus, the general license is meant to Certain Industrial Devices Containing Catherine R. Mattsen, Office of Nuclear simplify the licensing process so that a Byproduct Material To Provide Material Safety and Safeguards, U.S.
case-by-case determination of the R N'::M Information Nuclear Regulatory Commission, adequacy of the radiation training or Washington, DC 20555-0001, telephone experience of each user is not necessary.
AGENCY: Nuclear Regulatory (301) 415-6264, or e-mail at There are about 45,000 general Commission.
CRM@mt. gov: or Jayne McCausland, licensees ur. der to CFR 31.5 who ACTION: Proposed rule.
Office of Nuclear Material Safety and possess about 600,000 devices that Safeguards, U.S. Nuclear Regulatory contain byproduct material. In the past,
SUMMARY
- The Nuclear Regulatory Commission, Washmgton, DC 20555-the NRC has not contacted general Commission (NRC) proposes amending 0001, telephone (301) 415-6219, or e-licensees on a regular basis because of its regulations to add an explicit mail at [MM2@nrc. gov, the relatively small radiation exposure mquirement that general licensees wh SUPPLEMENTARY INFORMATION:
risk posed by these devices and the very possess certain measuring, gauging, or large number of generallicensees.
controlling devices that contain -
Background
flowever, there have been a number of byproduct material provide the NRC On February 12.1959 (24 FR 1089),
occurrences where generally licensed with information concerning these the Atomic Energy Commission (AEC) devices containing radioactive material devices. The NRC intends to use this amended its regulations to provide a have not been properly handled or provision to request information general license for the use of byproduct properly disposed of. In some cases, this concerning devices that present a material contained in certain measuring, has resulted in radiation exposure to the comparatively higher risk of exposure to gauging, or controlling devices (10 CFR public and contamination of property, the public or property damage. The 30.21(c)). Under current regulations (10 For example, when a source is proposed rule is intended to help ensure CFR 31.5), certain persons may receive accidentally melted in a steel mill, that devices containing byproduct and use a device containing byproduct considerable contamination of the mill, material are maintained and transferred materia; under this general license if the the steel product, and the wastes from properly and are not inadvertently device has been manufactured and the process, the slag and the baghouse discarded.
distributed according to the dust, can result.
DATES: Submit comments by February specifications contained in a specific Because of these incidents, the NRC 16,1999. ConuLents received after this license issued by the NRC or by an conducted a 3. year sampling (1984 date will be considered if it is practical Agreement State. A specific license through 1986) of general licensees to to do so, but the Commission is able to authorizing distribution of generally assess the effectiveness of the general ensure consideration only for comments licensed devices is issued if a regulatory license program and to determine I
received on or before this date.
authority determines that the safety whether there was an accounting ADDRESSES: Send comments by mail to features of the device and the problem with generally licensed device the Secretary, U.S. Nuclear Regulatory instructions for safe operation of that users and, if so, what action could be Commission, Washington, DC 20555-device are adequate and meet regulatory taken. The sampling revealed several 0001. Attention: Rulemakings and requirements. The general licensee must areas of concern regarding the use of Adjudications Staff.
comply with requt ments for labeling, radioactive material under the general j
lland deliver comments to:11555 instructions for use, and pmper storage license provisions of 10 CFR 31.5. The Rockville Pike, Rockville, Maryland, or disposition of the device. For some NRC concluded that-(1) Many general between 7:30 am and 4:15 pm on devices, the general licensee must also licensees are not aware of the i
Federal workdays.
comply with leak testing requirements.
appropriate regulations, and (2)
You may also provide comments via The general licensee is also subject to Generally licensed devices are the NRC's interactive rulemaking the tenns and conditions in 10 CFR 31.2 inadequately handled and accounted website through the NRC home page concerning generallicense for.
(http://www.nrc. gov). This site provides requirements, transfer of byproduct Approximately 15 percent of all the availability to upload comments as material, reporting and recordkeeping, generallicensees sampled could not files (any format),if your web browser and inspection. The general licensee account for all of their generally j
3 Fedarel Regitt:r/Vol 63, No. 231/ Wednesday, December 2,1998/ Proposed Rules 66493 l
licensed devices. The NRC concluded plans to contact only those general The NRC intends to use this provision
}
that these problems could be remedied licensees identified by the working primarily to institute an annual by more frequent and timely contact group for the purpose of the registration registration program for devices using between the generallicensee and the program.
certain quantities of specific NRC.
The NRC is withdrawing the radionuclides. The registration program On December 27,1991,(56 FR 67011), December 27,1991, propesed rule. The is primarily intended to ensure that the NRC published a notice of proposed NRC plans to review the other general licensees are aware of and rulemaking concerning the provisions contained in the December understand the requirements for the accountability of generally licensed 27,1991, proposed rule and the ossession of devices containing devices. The proposed rule contained a number of provisions,includmg a recommendations of the working group YProduct material. The registration requirement for general licensees under and develop additional requirements in process would allow NRC to account for 10 CFR 31.5 to provide information to a separate rulernaking.
devices that have been distributed for use under the general license. The NRC the NRC upon request, through which a Discussion believes that if general licensees are device registry could be developed. The The Atomic Energy Act of1954 aware of their responsibilities they proposed rule also m, eluded (AEA), as amended, authorizes the NRC would comply with the requirements for requirements in 10 CFR 32.51a and 32.52 for the specific licensees wh to request appropriate information from proper handling and disposal of manufacture or initially transfer its licensees concerni ig licensed Benerally licensed devices. This would activities. However, th e Commission has help reduce the potential for incidents generally licensed devices. Although the i
pubhc comments rrceived were not included such an explicit provision that could result in unnecessary reviewed and a final rule developed, a in the regulations governing 10 CFR radiation exposure to the public as well final rule was not issued because the 31.5 general licenssas. Although 10 CFR as contamination of property.
resources to implement the proposed 2.204,30.34(e), and 30.61(a) require The general licensees covered by the ru pr e I were not available.
information from licensees by order or registration program would be asked to as continued to consider demand, these provisions are not account for the devices in their the issues related to the loss of control considered appropriate for the initiation p ssession and to verify, as well as of generally licensed, as well as of a routine registration program. In a certify, information concerning:
specifically licensed, sources of prulous rulemaking, the Ccmmission
- 1. The identification of devices, such (then AEC) had toPosed the inclusion as the manufacturer, model and serial radioactivity. In July 1995, the NRC,,
P numbers; with assistance from the Organization of f a registration requirement for Agreement States, formed a working generally bcensed devices before receipt
- 2. The persons responsible for liance with the regulations; comhhe disposition of the devices; and group to evaluate these issues. The f devices (February 5,1974; 39 FR 3.
working group consisted of both NRC 4583). In response to comment on that
- 4. The location of the devices.
l and Agreement State personnel and Proposal, the Commission decided not While the proposed rule would apply l
encouraged the involvement of all t nstitute a registration requirement as to all 10 CFR 31.5 general licensees persons having a stake in the process Part of the final rulemaking on that (about 45,000), the NRC would only and its final recommendations. All action (December 16,1974; 39 FR contact, for purposes of registration, working group meetings were open to 43531L Given this history, establishing approximately 6000 general licensees, the public. A final re ort was completed a device registration program without a possessing about 24,000 devices. This in July 1996 and pub ished in October lemaking process is also considered estimate is based on the criteria 1996 as NUREG-1551, " Final Report of inappropn, ate.
recommended by the working group for the NRC-Agreement State Working This proposed rule would add an determining which sources should have Group to Evaluate Control and explicit requirement to 10 CFR 31.5 that increased oversight. Requests for Accountability of Licensed Devices. -
would require general licensees to information would be sent to general In considenng these respond to written requests from the licensees who are expected, based on recommendations, the NRC has decided, NRC for information concerning current NRC records, to possess devices among other things, to initiate an annual Products that they have received for use containing at least 370 MBq (10 MCI) of registration program of devices under a general license in a timely way.
cesium-137,3.7 MBq (0.1 mCl) of generally licensed under 10 CFR 31.5 The proposed rule would require a strontium-90,37 MBq (1 mci) of cobalt-that would be similar to the program response to requests within 30 days or 60, or 37 MBq (1 mCl) of any originally proposed in the December 27, such other time as specified in the transuranic (at this time, the only 1991, proposed rule. However, the NRC request. For routine requests for generally licensed devices meeting this has decided to do so only for those information,30 days should be adequate criterion contain americium-241). The devices that present a higher risk in most instances, and an extension can majority of the devices meeting these (compared to other generally licensed be obtained for good cause. If more criteria are used in coinmercial and devices) of potential exposure to the complicated requests are made or industrial applications measuring public and property loss if control of the circumstances recognized that may thickness, density, or chemical device is lost. Initially, the NRC will use require a longer time, the Commission composition in petrochemical snd strel the criteria developed by the working may provide a longer response time. In manufacturing industries. The requests group to determine which devices the unusual circumstance of a will include the information contained should be registered.
significant safety concern, the in NRC records concerning the This proposed rule presents the Commission could demand information possession of these devices. The proposed addition of an explicit in a shorter time. The NRC is licensees will be asked to verify, correct, requirement to provide information in specifically soliciting comments on this and add to that information.The NRC response to requests made by the NRC time period. Also, a phone number will records are based on information for a second round of comment. While be provided in the request for provided to NRC by distributors under the proposed rule would apply to all 10 information in case additional guidance 10 CFR 32.52(a) and from general CFR 31.5 general licensees, the NRC is necessary, licensees as required by to CFR
I
- h, G6494 Fed:r:1 Regist r/Vol. 63, No. 231/ Wednesday, December 2,1998/ Proposed Rules t
31.5(c)(8) or (9). If a general licer.4ee no corporations, priv, a citizens, citizens population of general licensees covered longer possesses devices meeting the groups, the Armed Forces, and State by the current proposal, the
.:riteria,it would be expected to provide governments. These comments have Commission believes that the additional i
i information about the disposition of the been considered to the extent applicable flexibility is desirable.
devices previously possessed. Errors in to this more limited proposed rule and l
current NRC records concerning these will be cosidered in the development Interim Enforcement Poh.ey
. generallicensees could be the result of:
of a subsequent rulemaking concerning As had been planned at the time of (1) errors made in the quarterly reports the accountability of devices generally the 1991 proposed rule, the Commission of manufacturers or initial distributors, licensed under to CFR 31.5. A detailed intends to establish an interim (2) generallicensees not reporting analysis of the comments received on enforcement policy for violations of to transfers, or (3) errors made by NRC or the December 27,1991, proposed rule CFR 31.5 that licensees discover and its contractors in recording transfer will not be presented in either action as report during the initial cycle of the information.
many of the specific comments pertain registration program. This policy will in addition to the 6000 general to specific provisions that have been supplement the normal NRC licensees identified for registration, the withcown, much time has passed since Enforcement Policy in NUREG-1600, NRC may occasionally request these comments were made, and Rev.1. It will be issued in the near information from other general licensees additional opportunity for comnent is future and will remain in effect through on a case-by-case basis as necessary or being provided.
one complete cycle of the registration appropriate. For example, this might Comments received on the December program.
involve investigating the extent that 27,1991, proposed rule demonstrated Under the current NRC Enforcement other users have experienced a problem that there was considerable opposition Policy, significant violations, such as that has been identified with the design to the rule as proposed, some ofit those involving lost sources, may result of a particular device model. However, significant modifications to the specifically concerning a registration in escalated enforcement action requirement. Most of this opposition including civil penalties. The intenm registration program to include a larger was rela'ed to the breadth of the Policy would provide that enforcement class oflicensees would be done proposal which would have made the action normally would not be taken for through rulemaking.
registration program applicabb to M1 of violations identified by a licensee and Although the proposed amendment the 10 CFR 31.5 general licensees, reported to the NRC If appropriate would impose some additional costs on accounting for as many as 600,000 corrective action is taken. For the period licensees, the NRC has estimated these devices. Some respondents questioned that the interim policy is in effect. it costs to be minimal.This cost is the whether this was justified or cost would also apply to general licensees estimated administrative cost expended effective. Some thought the impacts not subject to the registration by generallicensees to verify the were underestimated, particularly for requirement if they identify and report information requested by the NRC general licensees possessing many violations and take appropriate regarding licensed devices.The NRC devices, and that the provision would corrective action. This change from the believes that the proposed rule's have serious impacts on certain current NRC Enforcement Policy is intended effect ofincreased compliance industries. Registration was specifically intended to remove any disincentive to 1
by general licensees with regulatory opposed for devices used by the airline identify deficiencies that might be I
requirements and resulting NRC and industry, self-luminous signs, static caused by a concern over potential i
public confidence in the general license eliminators, and some other devices enforcement action. This action would program potentially afforded by these which present relatively low risks.
encourage general licensees to search new requirements outweigh this The NRC found the working group the;r facilities to ensure sources are nominal administrative cost.
process valuable in identifying criteria located, to determine if applicable The NRC is currently considering for categorizing devices that are more rcquirements have been met, and to additional rulemaking concernin8 the likely to present a significant risk by develop appropriate corrective action control and accountability of devices exposure of the public or through when deficiencies are found. A Notice gInerally licensed under 10 CFR 31.5.
contamination of property. Therefore, of Violation (NOV) without a civil The recommendations made in NUREG-the registration of devices under this penalty still may be issued if the NRC 1551 will be considered at that time.
proposed rulemaking would be limited staff believes that taking this action is That anticipated rule would address to those devices meeting the criteria justified by the safety significance of the fees for registration, additional labeling recommended by the working group.
viohtion or the need to record and j
requirements for to CFR 32.51 For the most part, generallicensees document the general licensee's licensees, and compatibility of using devices meeting these crt aria corrective action in the formal manner j
Agreement State regulations in this area. have a limited number of devices that required in a response to an NOV.
l Public comments on this current would require registration. The NRC is In addition, escalated enforcement I
proposed rule should only address the exploring approaches to minimize the rrtion still will be considered for requirements proposed in this action, administrative effort for both general violations involving failure to provide Comments concerning possible future licensees and the NRC in implementing the information requested, failure to rulemaking and the possible imposition this requirement.
take appropriate corrective action, or for
. of fees will not be addressed in any rule This proposal includes a provision to willful violations including the resulting from this proposed action, request an extension to the time interval submittal of false information. Sanctions I
Public Comments on the Original to provide a completa response to in those situations may include
' Proposed Rule requests for information, if the 3eneral significant civil penalties as well as licensee is having difficulty in meeting orders to limit or revoke the authority to The NRC reviewed the comments the time limit.This provision was possess radioactive sources under a received on the December 27,1991.
Included in response to comments on general license, proposed rule.There were 26 comment the December 27.199% proposed rule.
The Commh.sion also intends to htters received from a variety of sources Although this difficulty is much less increase the civil penalty amounts including private and publicly held likely to arise within the limited specified in its current Enforcement
)
i i
i
[
e Fedtral Regist:r/Vol. 63, No. 231/ Wednesday, December 2,1998/ Proposed Rules 66495 Policy in NUREG-1600, Rev.1, for NRC, including whether the information gene.at licensees who have received violations involving lost or improperly will have practical utility?
specific devices to respond to requests disposed sources or devices. This is to
- 2. Is the estimate of burden occurate?
for information from NRC. The ensure that such civil penalties are
- 3. Is there a way to enhance the proposed rule would apply to the significantly higher than the costs quality, utility, and clarity of the approximately 45,000 persons using avoided by the failure to properly information to be collected?
products und'er an NRC general license,
- 4. How can the burden of the
. dispose of the source or device.
many of whom may be classified as inf rmation collection be mmimized, small entities. However, the NRC A',reement State Compatibility including the use of automated Under the " Policy Statement on collection techniques?
intends to request registration Adequacy and Compatibility of Send comments on any aspect of thig Information from only aPProximately Agreement State Programs" approved by PmPosed information collection, 6000 of these general licensees about the the Commission on June 30,1997 (62 FR including suggestions for reducing the identification of the devices.
46517), this proposed rule is classified burden, to the Records Management accountability for the devices, the i
as Compatibility Category D. Category D Branch (T-6 F33), U.S. Nuclear Peisons responsible for compliance with means the provisions are not required Regulatory Commission, Washington, the regulations, and the disposition of for purposes of compatibility; however, DC 20555-0001, or by Internet the devices. The NRC beh, eves that the if adopted by the State, the provisions electronic mail at BJMGNRC. GOV; and economic impact of the proposed should not create any conflicts, to the Desk Officer. Office of requirements on any general licensee duplications, or gaps in the regulation of Information and Regulatory Affairs, would be a negligible increase in AEA material. Ultimately an enhanced NEOB-10202 (3150-0016) Office of administrative burden. The proposed oversight program is expected to Management and Budget Washington, ruia is intended to ensure that general include provisions that will require a DC 20503.
licensees understand and comply with higher degree of compatibility. This will Comments to OMB on the information regulatory responsibilities regarding the be considered in a subsequent collections or on the above issues generally licensed radioactive devices in rulemaking to add more explicit should be submitted by (insert date 30 their possession, istration days after publication in the Federal requirements for the ref provisions Backfit Anal 8i5 Y
program and additiona Register). Comments received after this concerning accountability of generally date will be considered if it is practical The NRC has determined ti at the licensed devices.
to do so, but assurance of consideration backfit rule,10 CFR 50.109, r ces not cannot be given to comments received appIy to this proposed ruIe ind.
EnvironmentalImpact: Categorical after this date.
Exclusion therefore, a backfit analysv is not Public Pmtection Notification required because these cmendments l
The NRC has determined that this If an information collection does not would not involve any provisions that proposed rule is the type of action described in the categoncal exclusion display a currently valid OMB control would impose backfits as defined in 10 10 CFR 51.22(c)(3)(iii). Therefore, number, the NRC may not conduc.t or CFR 50.109(a)(1).
neither an environmentalimpact Sponsor and a person is,not r utred to List of Subjects in 10 CFR Part 31 statement nor an environmental re8 Pond to, the information col ection.
B uct assessment has been prepared for this Regulatory Analysis I
b li n
regu ation.
The NRC has prepared a draft Packaging and containers, Radiation Paperwork Reduction Act Statement regulatory analysis for this proposed protection Reporting and recordkeeping i
regulation. The analysis examines the requirements, Scientific equipment.
This PmPosed rule amends cost and benefits of the alternatives information collection requirements that considered by the NRC. The comments F r the reasons set out in the are subject to the Paperwork Reduction received on the earlier draft regulatory Preamble and under the authority of the Act of 1995 (44 U.S.C. 3501 et seq). This analysis have been considered to the Atomic Energy Act of 1954, as amended, rule has been submitted to the Office of extent that they apply to this more the Energy Reorganization Act of 1974, Management and Budget for review and limited action. The regulatory analysis as amended, and 5 U.S.C. 553, the NRC l
approval of the information collection is ava table for inspection in the NRC 18 PmPosing to adopt the following i
requirements.
Public Document Room,2120 L Street amendments to 10 CFR Part 31.
i The public reporting burden for this NW. (Lower Level), Washington, DC.
information collection is estimated to Single co les of the analysis may be PART 31-GENERAL DOMESTIC LICENSES FOR BYPRODUCT average 20 minutes per response, obtained y calling Jayne McCausland, including the time for reviewing U.S. Nuclear Regulatory Commission, MATERIAL instn.ctions, searching existing data Office of Nuclear Material Safety and sources, gathering and maintaining the Safeguards, Washington, DC,20555-
- 1. The authority citation for Part 31 data needed, and completing and 0001: telephone (301) 415-6219: or e-continues to read as follows:
reviewing the information collection.
mail at JMM2@nrc. gov.
Authority: Secs. 8t.161.183,68 Stat. 935.
The U.S Nuclear Regulatory 948,954, as amended (42 U.S.C. 2111,2201.
Commission is seeking public comment Regulatory Flexibility Certification 2233h secs. 201, as amended. 202,88 Stat.
on the pctentialimpact of the As required by the Regulatory 1242, as amended.1244 (42 U.S.C 5841, information collections contained in the Flexibility Act 85 U.S.C. 605(b)), the 5842).
proposed rule and on the following Commission certifies that this proposed section 31.s also issued under sec. 274,73 issues:
rule, if adopted, would not have a stat. 688 (42 U.s.c 2021).
j 1, is the proposed information significant economic impact on a collection necessary for the proper substantial number of small entities.
- 2. Section 31.5 is amended by adding performance of the functions of the This proposed rule would require paragraph (c)(11) to read as follows:
l t
f 7
?
66496 Fed:rd Regist:r/Vol. 63, No. 231/ Wednesday, December 2. W98/ Proposed Rules v
4 10 CFR 31.5 Certain measuring, gauging, ADDRESSES:The Commission paper. the or not the regulation on the quality or contmHing Mces) staff requirement memoranda (SRM),
management program should be revised and associated documents are available to become more risk-informed and (c) * *
- for public inspection, and copying for a performance-based. For this reason, the (11) Shall respond to written requests fee, at the NRC Public Document Room Commission is withdrawing the from the Nuclear Regulatory located at 2120 L Street NW. (Lower ANPRM.
Commission to provide information Level), Washington, DC 20012-7082, Dated at Rockville, Maryland. this 24th day relating to the general license within 30 telephone: (202) 512-2249.
of November,1998.
calendar days of the date of the request, FOR FURTHER INFORMATION CONTACT:
For the Nuclear Rigulatory Commission.
or other time specified in the request. If Jayne M. McCausland, Office of Nuclear lohn C. Itoyle, the general licensee cannot provide the Material Safety and Safeguards, U.S.
Secretaryof the commission.
requested information within the Nuclear Regulatory Commission,
{FR Doc. 98--32108 Filed 12-1-98; 8:45 aml allotted time,it shall, witlua that same Washington, DC 20555, telephone (301) time period, request a longer period to 415-6219, e-mail imm2@nrc. gov, an.uwo coos neo-ow supply the information by submitting a SUPPLEMENTARY INFORMATION:
letter to the Director, Office of Nuclear On October 2,1987, the Commission NUCLEAR REGULATORY Material Safety and Safeguards, U.S.
published two notices in the Federal COMMISSION Nuclear Regulatory Commission, Washington, DC 20555-0001 and Register regarding medic al use of byprodact material. The first nutice was 10 CFR Part 50 provide wntten justification as to why the proposed rulemaking entitled Basic it cannot comply.
Quality Assurance in Radiation RIN 3150-AF04 Therapy(52 FR 36942), that proposed Steam Generator Tube Integrity for Ditted at Rockville, Maryland, this 19th day a requirement for medical use licensees Operating Nuclear Power Plants of November,1998.
to implement some specific basic For the Nuclear Regulatory Commission.
quality assurance practices to reduce the AGENCY: Nuclear Reguh Malcolm R. Knapp, number of therapy misadministrations Commission.
Acting Executive Duectorfor Opemtions.
involving byproduct material. The ACTION: Proposed rule: Withdrawal.
[FR Doc. 98-32113 Filed 12-1-98; 8:45 am) second notice was an ANPRM entitled
SUMMARY
- The Nuclear Regulatory
, Comprehensive Quality Assurance Medical Use and a Standard of Care,in Commission (NRC)is withdrs, wing an artu m cops neo. w,
(52 FR 36949), that requested pubhc advance notice of pro osed rulemaking NUCLEAR REGULATORY comments on the extent to which a (ANPRM) that was pu lished to request COMMISSION comprehensive quality assurance public comment on the Commission's program requirement was needed. The regulations pertaining to steam 10 FR Part 3.,
NRC believed that this ovo. pronged generator (SG) tube integrity. The RtN 3150-AC42 approach to the misadministrations proposed rule would have implemented problem would provide the best balance a more flexible regulatory framework for Comprehensive Quality Assurance in between assurmg public health and steam generator surveillance and Medical Use and a Standard of Care safety and avoiding madvertent maintenance activities that would interference in the delivery of quality maintain adequate assurance of tube AGENCY: Nuclear Regulatory medical care.
integrity while allowing a degradation-Commission.
On July 25,1991 (56 FR 34104), the specific management a[that theproach. Becau ACTION
- Advance notice of proposed NRC ublishea a final rule entitled the NRC has conclude rulemek 'g: Withdraral.
"Qua ity Management Program and regulatory objectives set forth for this Misadministrations (the QM Rule) effort can be achieved by equally
SUMMARY
- The Nuclear Regulatory which was based on the above-effective regu1atory a1ternatives, the Commission (NRC)is withdrawing an mentioned 1987 proposed rule. During ANPR is bemg withdrawn, advance notice of proposed rulemaking the implementation of the final rule, the ADDRESSES: The Commission paper, the (ANPRM) that requested public NRC decided to assess the effectiveness staff requirement memoranda (SRM).
comments on questions related to of the rule and, based on the results of and associated docu nents are available comprehensive quality assurance and a the assessment, to determine the need f r Public inspection, and copying for a standard of care in medical uses of for a rulemaking on comprehensive fee, at the NRC Public Document Room byproduct material. Tha Commission quality management.
I cated at 2120 L Street NW. (Lower has decided to withdraw this ANPRM Subsequently, a Commission SRM on Level), Washington, DC 20012-7082, because of the effectiveimplementation SECY-97-115 dated June 30,1997, telephone: (202) 512-2249.
of the " Quality Management Program approved subsuming several Part 35 FOR FURTHER INFORMATION CONTACT: Tim
. and Misadministrations" rule and the rulemakings into one major revision to Reed, Office of Nuclear Reactor NRC's current efforts in revising the 10 CFR Part 35 rulemaking activity. The Regulation, U.S. Nuclear Regulatory I
existing regulation for medical uses of proposed rulemaking entitled " Medical Commission, Washington, DC 20555-byproduct materialinto a more risk-Use of Byproduct Material," was 0001, telephone (301) 415-1462, e-mail informed and performance-based published in the Federal Register (RIN tar @nrc. gov.
regulation.
3150-AF74 ) (August 13,1998; ti3 FR SUPPLEMENTARY INFORMATION:
43516).The NRC is in the process of On September 19,1994 (59 FR 47817),
8 Persons possessing byproduct material in developing the final rule governing the Commission published an ANPRM devices under a general heense in 10 CFR 31.s medical use of byproduct material into that requested comments, advice, and uYo*r IrEnsie# bt n aie"ia[in acS"r"dancCh ihe a more risk-informed and performance-YeCommendations from interested I
ri labelins requirements of 30 crR 31.s in effect on based regulation. This overall revision parties on the proposed steam generator January 14,197s.
Includes a Consideration as to whether rule. In response to the ANPRM, two
(.
-