[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
________________________________________________________________________
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
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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 JMM2@nrc.gov.
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
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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
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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
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 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
