[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Proposed Rules]
[Pages 66492-66496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32113]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 63, No. 231 / Wednesday, December 2, 1998 / 
Proposed Rules  

[[Page 66492]]


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NUCLEAR REGULATORY COMMISSION

10 CFR Part 31

RIN 3150--AG06


Requirements for Those Who Possess Certain Industrial Devices 
Containing Byproduct Material To Provide Requested Information

AGENCY: Nuclear Regulatory Commission.

ACTION: Proposed rule.

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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 concerning 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 February 16, 1999. 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.

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 [email protected].
    Certain documents related to this rulemaking, including comments 
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. Mattsen, Office of 
Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory 
Commission, Washington, DC 20555-0001, telephone (301) 415-6264, or e-
mail at [email protected]; or Jayne McCausland, Office of Nuclear Material 
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, 
DC 20555-0001, telephone (301) 415-6219, or e-mail at JMM[email protected].

SUPPLEMENTARY INFORMATION:

Background

    On February 12, 1959 (24 FR 1089), the Atomic Energy Commission 
(AEC) amended its regulations to provide a general license for the use 
of byproduct material contained in certain measuring, gauging, or 
controlling devices (10 CFR 30.21(c)). Under current regulations (10 
CFR 31.5), certain persons may receive and use a device containing 
byproduct material under this general license if the device has been 
manufactured and distributed according to the specifications contained 
in a specific license issued by the NRC or by an Agreement State. A 
specific license authorizing 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 general licensee 
must comply with requirements for labeling, instructions for use, and 
proper storage or disposition of the device. For some devices, the 
general licensee must also comply with leak testing requirements. The 
general licensee 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.
    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 general license is meant to simplify the licensing process so that 
a case-by-case determination 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 general licensees on a regular basis 
because of the relatively small radiation exposure risk posed by these 
devices and the very large number 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, 
considerable 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 general licensees to assess the effectiveness of 
the general license 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 general 
license 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 general licensees sampled could not 
account for all of their generally

[[Page 66493]]

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 rulemaking concerning the accountability of generally licensed 
devices. The proposed rule contained a number of provisions, including 
a requirement for general licensees 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 will use the criteria developed by 
the working group to determine which devices should be registered.
    This proposed rule presents the proposed addition of an explicit 
requirement to provide 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 general licensees 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.

Discussion

    The Atomic Energy Act of 1954 (AEA), as amended, authorizes the NRC 
to request 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 general 
licensees. 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 rulemaking, the Commission (then AEC) had 
proposed the inclusion of 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.
    This proposed rule would add an explicit requirement to 10 CFR 31.5 
that would require general licensees 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 general licensees 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 general license. 
The NRC believes that if general licensees 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 general licensees covered by the registration program would be 
asked to account for the devices in their possession and to verify, as 
well as certify, information concerning:
    1. The identification of devices, such as the manufacturer, model 
and serial numbers;
    2. The persons responsible for compliance with the regulations;
    3. The disposition of the devices; and
    4. The location of the devices.
    While the proposed rule would apply to all 10 CFR 31.5 general 
licensees (about 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 
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 thickness, 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 licensees 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 general licensees as required by 10 CFR

[[Page 66494]]

31.5(c)(8) or (9). If a general licensee 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.
    In addition to the 6000 general licensees identified for 
registration, the NRC may occasionally request information from other 
general licensees on a case-by-case basis as 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 cost expended by general licensees 
to verify the information requested by the NRC regarding licensed 
devices. The NRC believes that the proposed rule's intended effect of 
increased compliance by general licensees 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 
compatibility of 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.

Public Comments on the Original Proposed Rule

    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 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 general licensees 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 categorizing devices that are more likely to present a 
significant risk by exposure of the public 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 most part, general licensees 
using devices meeting these criteria have a limited number of devices 
that would require registration. The NRC is exploring approaches to 
minimize the administrative effort for both general licensees and the 
NRC in implementing this requirement.
    This proposal includes a provision to request an extension to the 
time interval to provide 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 December 27, 1991, proposed rule. Although this difficulty is much 
less likely to arise within the limited population of general licensees 
covered by the current proposal, the Commission 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 of 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 identify deficiencies that might be caused by a concern over 
potential enforcement action. This action would encourage general 
licensees 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 
general licensee'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 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

[[Page 66495]]

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 compatibility. This will be considered in a subsequent 
rulemaking to add more explicit requirements for the registration 
program and additional provisions concerning accountability of 
generally licensed devices.

Environmental Impact: Categorical Exclusion

    The NRC has determined that this proposed rule is the type of 
action described in the categorical exclusion 10 CFR 51.22(c)(3)(iii). 
Therefore, neither an environmental impact 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 the 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:
    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?
    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 [email protected]; 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.

Regulatory Analysis

    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 the NRC Public Document Room, 2120 L Street 
NW. (Lower Level), Washington, 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 
JMM[email protected].

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 would require general licensees 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 general 
licensees 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 general 
licensee would be a negligible increase in administrative burden. The 
proposed rule is intended to ensure that general 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, does 
not apply to this 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 recordkeeping 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. 553, the NRC is proposing to 
adopt the following amendments to 10 CFR Part 31.

PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL

    1. The authority citation for Part 31 continues to read as follows:

    Authority: Secs. 81, 161, 183, 68 Stat. 935, 948, 954, as 
amended (42 U.S.C. 2111, 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:

[[Page 66496]]

10 CFR 31.5  Certain measuring, gauging, or controlling 
devices.2
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    \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.
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* * * * *
    (c) * * *
    (11) Shall respond to written requests from the Nuclear Regulatory 
Commission to provide information relating to the general license 
within 30 calendar days of the date of the request, or other time 
specified in the request. If the general licensee 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 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 19th day of November, 1998.

    For the Nuclear Regulatory Commission.
Malcolm R. Knapp,
Acting Executive Director for Operations.
[FR Doc. 98-32113 Filed 12-1-98; 8:45 am]
BILLING CODE 7590-01-P