[Federal Register Volume 64, Number 142 (Monday, July 26, 1999)]
[Proposed Rules]
[Pages 40295-40310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-18981]
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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. 64, No. 142 / Monday, July 26, 1999 /
Proposed Rules
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NUCLEAR REGULATORY COMMISSION
10 CFR Parts 30, 31, 32, 170, and 171
RIN 3150-AG03
Requirements for Certain Generally Licensed Industrial Devices
Containing Byproduct Material
AGENCY: Nuclear Regulatory Commission.
ACTION: Proposed rule.
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SUMMARY: The Nuclear Regulatory Commission (NRC) is proposing to amend
its regulations governing the use of byproduct material in certain
measuring, gauging, or controlling devices. The proposed amendments
would include adding explicit requirements for a registration process
that the NRC plans to initiate through a related rulemaking, would add
a registration fee, and would clarify which provisions of the
regulations apply to all general licenses for byproduct material. The
proposed rule would also modify the reporting, recordkeeping, and
labeling requirements for specific licensees who distribute these
generally licensed devices. The proposed rule is intended to allow the
NRC to better track certain general licensees and the devices they
possess and to further ensure that general licensees are aware of and
understand the requirements for the possession of devices containing
byproduct material.
DATES: Submit comments by October 12, 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
web site 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].
SUPPLEMENTARY INFORMATION:
Background
On February 12, 1959 (24 FR 1089), the Atomic Energy Commission
(AEC) amended its regulations to provide a general license (10 CFR
30.21(c)) for the use of byproduct material contained in certain
measuring, gauging, or controlling devices. Under current regulations
in 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 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 its safe operation are adequate and meet regulatory
requirements.
The person or firm who receives such a device is a general
licensee. These general licensees are subject to requirements for
maintaining labels, following instructions for safe use, storing or
disposing of the device properly, and reporting transfers and failure
of or damage to the device. For some devices, the general licensee must
also comply with testing requirements for leakage and for proper
operation of on-off mechanisms. General licensees are also subject to
the terms and conditions in Sec. 31.2 concerning general license
requirements, transfer of byproduct material, reporting and
recordkeeping, and inspection. General licensees 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 except as indicated on the label.
A generally licensed device usually consists of radioactive
material, contained in a sealed source, within a shielded housing. The
device is designed with inherent radiation safety features so that it
can be used by persons with no radiation training or experience. The
general license simplifies 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 authorized by Sec. 31.5 to
possess about 600,000 devices that contain byproduct material. The NRC
has not contacted or inspected these general licensees on a regular
basis because of the relatively small radiation risk posed by these
devices.
Individuals who possess devices under this general license are not
always aware of applicable requirements and thus are not necessarily
complying with all of these requirements. The NRC is most concerned
about occurrences where generally licensed devices have not been
handled or disposed of properly. In some cases, this has resulted in
radiation exposure to the public and contamination of property. Some
generally licensed devices have been accidentally melted in steel mills
causing considerable contamination of the mill, the steel product, and
the wastes from the process, the slag and the baghouse dust. Although
known exposures have generally not exceeded the public dose limits,
there is a potential for significant exposures.
The NRC conducted a 3-year sampling (1984 through 1986) of general
licensees to assess the effectiveness of the general license program.
The sampling revealed several areas of concern regarding the
[[Page 40296]]
use of generally licensed devices. In particular, the NRC concluded
that--
(1) Many general licensees are unaware of the regulations that
apply to the possession of a generally licensed device; and
(2) Many general licensees are unable to account for their devices.
Approximately 15 percent of the general licensees sampled could not
account for all of their generally licensed devices. The NRC concluded
that these problems could be resolved by more frequent and timely
contact between general licensees 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 under Sec. 31.5 for general licensees to provide
information to the NRC upon request, through which a device registry
could be developed. The proposed rule also included requirements in
Secs. 32.51a and 32.52 for 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 fully implement the rule
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,
devices. 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 regulatory
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 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 the recommendations of this working group, the NRC
decided, among other things, to again initiate rulemaking to establish
an annual registration of devices generally licensed under Sec. 31.5.
This registration program would be similar to the program originally
proposed in the 1991 proposed rule. However, it would apply only to
those devices considered to present a higher risk of potential exposure
of the public or property loss in the case of loss of control (compared
to other generally licensed devices). Initially, the NRC has been using
the criteria developed by the working group for determining which
sources should be subject to the registration program. Using these
criteria, it is now estimated that the registration requirement would
apply to about 5100 general licensees possessing about 20,000 devices.
These criteria were based on considerations of relative risk and are
limited to radionuclides currently in use in these types of devices. If
quantities of other radionuclides that would present a similar risk are
used in these devices in the future, the criteria may be revised to
include additional radionuclides. The Commission may also consider
revising the criteria to include a larger number of devices in the
registration requirement for other reasons in future rulemaking.
The Atomic Energy Act of 1954 (AEA), as amended, provides the NRC
with the authority to request information from its licensees concerning
licensed activities. However, the Commission had not included an
explicit provision in its regulations that would require Sec. 31.5
general licensees to provide information on request. On December 2,
1998 (63 FR 66492), the Commission published a proposed rule that would
explicitly require general licensees who possess certain measuring,
gauging, or controlling devices to provide the NRC with information
about the devices. Assuming it becomes a final rule, the NRC intends to
use that provision primarily to institute a registration and accounting
system for the devices containing certain quantities of specific
radionuclides that present a higher risk of exposure to the public or
property damage if a device were lost. That rulemaking was not proposed
as a matter of compatibility for Agreement States. That proposed rule
presented an estimate of 6000 general licensees, based on the estimates
made in the working group report. However, this had not accounted for
the fact that, in the interim, Massachusetts had become an Agreement
State. Using the same criteria, and removing the previously NRC general
licensees in Massachusetts, results in an estimate of 5100 NRC general
licensees that would be subject to the registration requirement.
This proposed rule would add specific requirements concerning the
registration of devices and additional provisions of an enhanced
regulatory oversight program for all general licensees to be
registered. The proposed rule would also establish levels of
compatibility for Agreement State regulations so that an increased
level of oversight for general licensees in Agreement States would also
be required. Some States have already instituted some form of enhanced
oversight for these general licensees. In a few cases, States have
instituted a registration program. A few States have a higher level of
control on these devices through requiring specific licenses. Under the
proposed level of compatibility for Sec. 31.5, the essential objectives
of the regulation should be adopted by the State to avoid conflicts,
duplications, or gaps. However, the manner in which the essential
objectives of the regulation are addressed need not be the same as NRC.
Strict compatibility would only be required for revisions to the
requirements applicable to distributors because of interjurisdictional
distribution.
Discussion
The December 2, 1998, proposed rule would provide one of the key
elements in improving the accountability and control over devices of
particular concern through the institution of a registration process.
However, current regulatory provisions are inadequate to allow for the
NRC to track general licensees and the specific devices they possess.
The NRC needs to track these general licensees in order that they can
be contacted or inspected when appropriate. The NRC also needs to track
individual generally licensed devices, so that the responsible party
can be identified when a device is found in an inappropriate situation.
Tracking devices would also allow the NRC to contact the
appropriate general licensees if a generic defect in a group of devices
is identified. As noted, that proposed rule would not require Agreement
State regulations to be compatible.
There are other means for reducing the likelihood of incidents of
lost sources. The Commission has reconsidered the provisions in its
1991 proposed rule, evaluated the recommendations of the NRC-Agreement
State Working Group, and identified additional issues concerning these
devices in developing this proposed rule.
Summary and Discussion of Proposed Requirements
Revisions to the Requirements for General Licensees Under Sec. 31.5
Registration
This proposed rule would add explicit provisions delineating an
annual registration requirement, as well as a registration fee. The
registration process would be initiated under Sec. 31.5(c)(11),
proposed on December 2,
[[Page 40297]]
1998, if that requirement is adopted in a final rule. Proposed
Sec. 31.5(c)(11) would require licensees to respond to requests for
information from NRC within 30 days or as otherwise specified. The
provisions proposed in this document (new Sec. 31.5(c)(13)) are
essentially consistent with the Commission's plans for the registration
process discussed in the December 2, 1998, proposed rule. This proposed
rule would specifically require that the information about devices be
verified by the licensee through a physical inventory and by checking
label information. The advantage of including more explicit
requirements in the regulation is that information about the
registration process will be more clearly defined and more available.
When the distributor of a device supplies copies of Sec. 31.5 to its
customers (under Sec. 32.51a(a)), the potential general licensees would
be made aware of the registration requirement, the devices to which it
applies, the nature of the registration information, and the
registration fee.
An organization which uses generally licensed devices at numerous
locations is considered a separate general licensee at each location.
Different facilities at the same complex or campus are not, however,
considered separate locations. In the case of portable devices that are
routinely used at multiple field sites, there is one general licensee
for each primary place of storage, not for each place of use. Thus, an
organization would be required to complete more than one registration,
if it possess devices subject to registration at multiple distinct
locations.
The proposed rule would add a fee to Sec. 170.31 to be assessed in
conjunction with the annual registration process. This registration fee
would be for each general licensee filing a registration under
Sec. 31.5(c)(13) regardless of the number of devices. As noted above,
an organization is considered to be a separate general licensee at each
separate address at which devices are used, and would be assessed a
registration fee for each location of use.
The NRC is required by the Omnibus Budget Reconciliation Act of
1990, as amended (OBRA-90), to recover approximately 100 percent of its
budget through fees. Since OBRA-90 was enacted, all costs of the
general license program have been recovered through annual fees paid by
specific licensees. The proposed registration fees would recover the
cost of the general license program associated with this group of
general licensees in an equitable way, as required by law. Those who
are allowed to use devices under the general license would now bear the
operational cost of the program instead of those who hold specific
licenses. However, it should be noted that the initial program startup
costs would be recovered from the annual fee paid by current holders of
specific licenses.
The costs to be recovered through the registration fee include the
costs for obtaining and maintaining information associated with the
devices subject to the registration requirement, the costs of
processing and reviewing the registrations, and the costs for
inspections and follow-up efforts expected to be made as a result of
the registration process identifying noncompliance with existing
regulations. The fee would be based on the average cost of the program
for each of the licensees registering devices. Some of the general
licensees, such as non-profit educational institutions, will be exempt
from the fee under Sec. 170.11. Costs not recovered from this small
segment of the general licensees registering devices would continue to
be recovered from annual fees paid by current holders of specific
licenses.
It is expected that the overall cost will decline after the initial
years of implementation of the registration process, due to increased
compliance leading to reduced inspection and follow-up. However, the
number of generally licensed devices in NRC jurisdiction is reduced
when a State becomes an Agreement State and takes over responsibility
for the general licensees in that State. Although a large part of the
cost of the program is proportional to the number of general licensees,
a portion of the cost is fixed. Thus, the cost per general licensee
could increase if the number of general licensees subject to
registration decreases. The proposed registration fee is $420 based on
the current estimated cost of the program and the current number of
general licensees with devices that would be subject to registration.
If additional States become Agreement States before this rule is made
final, the fee could be somewhat higher in the final rule.
The Commission considered other approaches to the proposed fee
structure, such as a fee per device or a sliding scale, i. e., fees set
for a few ranges of numbers of devices. However, basing fees on the
number of devices or a sliding scale would not necessarily meet the
intent of the Independent Offices Appropriation Act of 1952 (IOAA),
which is the authority under which 10 CFR part 170 fees are
established. The IOAA provides that fees recover the agency's cost in
providing the service. The agency's costs to register generally
licensed devices at each location is projected to be nearly the same
regardless of the number of sources/devices possessed by the licensee.
Costs of follow-up and inspection do not go up substantially with
increased numbers of devices. In addition, these alternative methods
would complicate the determination of the proper fee and the fee
recovery process, not only for NRC but for the registrants as well.
With the uncertainty of the licensees' status from one year to the
next, the additional administrative effort related to the
reconciliation of the fee based on the number of devices possessed from
year to year, would not be cost effective, considering the total amount
projected to be recovered for the registration program. Additionally,
under these alternative methods a large diversified firm that owns one
device would pay a reduced fee, while a small entity whose business may
depend solely on the use of the devices might pay a disproportionate
fee because it has more than one device. The NRC believes that basing
the fee on a per device basis or a sliding scale would not result in a
fair and equitable allocation of its regulatory costs, and would not
achieve the goal of the Regulatory Flexibility Act to reduce the impact
of fees on small entities. The NRC believes that the proposed approach
of assessing a fee for each licensee subject to registration--
(1) Better reflects the costs to administer the program,
(2) Is most consistent with existing NRC fee assessment practices,
(3) Would simplify fee collection,
(4) Would be fair and equitable, and
(5) Would minimize impacts to small entities.
The planned registration process will be somewhat different from
that used in the Commission's other registration programs, in which
blank forms are filled out by registrants. Instead, it is planned to
send a registration request containing the information recorded in the
Commission's database, which would ask the general licensee to verify,
correct, and/or add to the information provided. This would be similar
to the approach typically used by States for the renewal of automobile
registrations. This is intended to be more efficient for the general
licensees and the Commission.
The first registration that would be carried out under
Sec. 31.5(c)(11) would depend on the NRC's ability to contact general
licensees because the NRC must request the information. This proposed
rule also specifies that the general licensee would complete
registration by verifying, correcting, and/or adding to the information
in a request for
[[Page 40298]]
registration received from the Commission. It is silent on when or how
general licensees should register if the Commission fails to contact
the general licensee. Thus, it might be interpreted that, if the
Commission fails to contact a general licensee, the registration
requirement would not apply. The Commission seeks comment on whether
the registration requirement should include a provision that would
require the general licensee to complete registration by a certain
time, such as 15 months after--
(1) The date of the previous registration certificate;
(2) The receipt of a device subject to registration; or
(3) The effective date of this rule for an unregistered device
possessed at the time of the effective date of a final rule enacted in
response to this proposed rule.
This would put the burden of registering on general licensees who
have not been notified by the NRC of the requirement. The intent would
be for general licensees who find out about the new requirements, for
example, from a distributor, to contact the NRC to begin the
registration process. If this approach were taken, the Commission would
likely exercise enforcement discretion in cases where the Commission
locates a general licensee who has not previously registered devices,
if the general licensee was unaware of the requirement. It is
recognized that some general licensees who have received devices in the
past may never be located.
The time of year for registration would vary for licensees.
However, requests for renewal of registration would be made
approximately 1 year after the previous registration request for that
licensee. Although registration would not be required before the
receipt of a device, the Commission plans to send requests for
registration to new general licensees subject to registration that are
identified in distributors' quarterly transfer reports submitted under
Sec. 32.52 shortly after this information is received and recorded. If
a general licensee has previously registered devices and receives
additional devices requiring registration, the new devices would be
registered when the annual reregistration is carried out. The
Commission requests comment on whether the NRC should have earlier
contact with previous registrants who receive additional devices,
either by an acknowledgment by NRC to the user or by a required
response from the general licensee that accounts for the additional
device(s). The effective date of the registration fee will be set to
apply after the initial registration requests have been sent for
response under Sec. 31.5(c)(11) so that the first round of annual
registration will be complete prior to this effective date and the fee
will be imposed with the first reregistration for all devices currently
in use.
Other Revisions for Sec. 31.5 General Licensees.
The proposed rule would establish additional requirements for all
general licensees under Sec. 31.5. These proposed requirements
include--
(1) An explicit requirement for the general licensee to appoint an
individual assigned responsibility for knowing what regulatory
requirements are applicable and having authority to take required
actions to comply with the applicable regulations and through whom the
general licensee carries out its responsibilities to comply with the
applicable regulations (new Sec. 31.5(c)(12));
(2) A provision that limits the amount of time a general licensee
can keep an unused device in storage and allows the deferment of
testing during the period of storage (new Sec. 31.5(c)(15));
(3) A provision to allow transfers to specific licensees authorized
under part 30, or equivalent Agreement State regulations, as waste
collectors, in addition to currently allowed transfers to part 32 (and
Agreement State) licensees; to allow transfers to other specific
licensees but only with prior written NRC approval; and to add the
recipient's license number, the serial number of the device, and the
date of transfer to the information required to be provided to NRC upon
transfer of a device (revision of Sec. 31.5(c)(8));
(4) A provision to notify NRC of address changes, including name
changes (new Sec. 31.5(c)(14));
(5) For device damage or failures that are likely to or are known
to have resulted in contamination, the addition of a plan for ensuring
that premises and environs are suitable for unrestricted access, to the
information that must be sent to NRC in the case of a failure; a change
to the addressee for reporting information concerning a failure; and a
note that the criteria in Sec. 20.1402, ``Radiological criteria for
unrestricted use,'' may be applied by the Commission in the case of
contamination in spite of the exemption in Sec. 31.5(c)(10) (revision
to Sec. 31.5(c)(5)); and
(6) A revision of the reporting requirement, in the case of a
transfer to a general licensee taking over possession of a device at
the same location, to provide the serial number of the device and the
name and phone number for the person designated as the responsible
individual, rather than simply a contact name (revision to
Sec. 31.5(c)(9)(i)).
The rationale for each of these proposed amendments is:
(1) New Sec. 31.5(c)(12)--Responsible person. The ``person'' who
holds a general license is usually a corporation, or public or private
institution, rather than an individual. In practice, in order for the
general licensee to comply with existing regulations, an individual in
the corporation or institution must be aware of the requirements and be
authorized to take the required actions. Appointing a specific
individual to be responsible for knowing about and taking actions to
comply with regulations is an appropriate operational practice, which,
unfortunately, is not always followed. If a device is not subject to
testing under Sec. 31.5(c)(2), there are no routine actions required to
be taken, because the requirements are generally restrictions on
actions, such as not abandoning the device, or actions to be taken only
in the case of particular, non-routine events, such as notification of
NRC of the transfer or failure of the device. It is this type of
situation, where knowledge of the nature of the device, the general
license, and the associated regulations is unlikely to be maintained
and passed on to individuals using the device. Requiring the assignment
of the responsibility for knowing and having authority to take required
actions for complying with regulations to a specific individual would
improve the probability that the general licensees will do what they
are already required to do. The impact of this should be minimal,
somewhat limiting operational flexibility with regard to the assignment
of duties. This individual does not have to work on site at the place
of use of the device and does not have to conduct all required actions,
but would be responsible to ensure that the general licensee is aware
of required actions to be taken. This assignment does not relieve the
general licensee of responsibility.
The NRC/Agreement State Working Group recommended that general
licensees assign a backup responsible individual (BRI) as well. The
proposed rule does not include this requirement, but the Commission
solicits comment on this issue and will consider adding it to the final
rule. A BRI would add some assurance that there is a continuation of
knowledge of the requirements in the event of the person assigned to be
the responsible individual leaves his assigned duties.
[[Page 40299]]
However, even without a BRI, the general licensee would have the
responsibility under the proposed rule to replace the responsible
individual to maintain compliance with proposed Sec. 31.5(c)(12).
(2) New Sec. 31.5(c)(15)--Timeliness of disposition and deferral of
testing while in storage. When a device is not in use for a prolonged
time, it is particularly susceptible to being forgotten and ultimately
disposed of or transferred inappropriately. General licensees are
unlikely to keep a device unused for more than 2 years and subsequently
use it. If a device is being held in storage indefinitely, it is likely
that it is being stored to avoid the costs of proper disposal. If a
general licensee intends to use a device after a period of more than 2
years of nonuse, the device could be sent back to the supplier to be
held under the distributor's specific license until later use, or the
general licensee could request an exemption from Sec. 31.5(c)(15)
indicating the reason(s) why the licensee intends to use the device
after 2 years and prefers to keep it on site in the interim.
If a period of storage exceeds the normal interval for testing,
testing would not need to be done until the device is to be put back
into use again. This would relieve the burden of unnecessary testing
during the period of storage as well as eliminate any unnecessary
exposure that could occur during testing for that period.
(3) Revision to Sec. 31.5(c)(8)--Provisions for transfers to
specific licensees. This proposed revision would provide some
flexibility to the general licensee in transferring a device while
ensuring that it is transferred appropriately. It would allow a general
licensee to transfer a device directly to a waste collector for
disposal, rather than going through a distributor. It would also allow
the transfer of a device to other specific licensees, but would require
NRC approval in these cases so that NRC can ensure that the recipient
is authorized to receive the device.
The inclusion of a recipient's license number in the report of
transfer would better ensure that the general licensee has verified
that the recipient is a part 32 licensee, a part 30 waste collection
licensee, or a specific licensee under equivalent Agreement State
regulations authorized to receive it. It would also supply an
additional means for NRC to identify the recipient, because company
names and addresses sometimes change. The addition of the date of
transfer will make the transfer easier to track and help to ensure that
the general licensee makes the report in a timely manner (required
within 30 days of transfer).
(4) New Sec. 31.5(c)(14)--Change of address notification (including
change in name of general licensee). The quarterly reports required of
distributors under Sec. 32.52(a) and (b) are intended to provide NRC
and the Agreement State regulatory agencies with the identity of
general licensees in their jurisdictions and addresses at which these
general licensees can be contacted (proposed to now be specifically the
mailing address for the location of use of the generally licensed
device). These general licensees can then be contacted or inspected. If
general licensees move their operations without notifying the NRC, or
appropriate Agreement State agency, they may be difficult to locate.
Even a change of name can cause mail to be returned. This proposed
requirement to report address changes would only apply to previously
supplied mailing addresses and, for portable devices, the mailing
address for the primary place of storage, although the devices may be
used at multiple field sites. For those registering devices, other
changes in addresses, if different from the mailing address for the
location of use, will be provided at the time of the next registration.
Note: Changes to the general licensee, other than a simple name
change, such as in the case of a sale of a company, require
reporting of additional information under Sec. 31.5(c)(9)(i).
This simple change of address notification is intended to track
moves into and within NRC jurisdiction and to maintain current mailing
address information. The general license in Sec. 31.5 only applies to
persons within NRC jurisdiction. If a general licensee intends to move
from one jurisdiction to another, it should contact the applicable
regulatory authority, NRC or the particular Agreement State, before
doing so to determine the applicable, current regulations in that
jurisdiction. All jurisdictions do not have a comparable general
license and specific provisions of the general license may vary among
jurisdictions. If a general licensee has obtained a portable device in
an Agreement State and wishes to use the device within NRC
jurisdiction, it must do so under Sec. 31.5, because there is no
reciprocity provision applicable to general licenses. In this case,
they would be subject to the provisions of Sec. 31.5.
(5) Revision to Sec. 31.5(c)(5)--Reports of device failures.
General licensees are not subject to decommissioning requirements. A
general license is granted by regulation and, under normal
circumstances, does not involve any termination of license process. If
a generally licensed device fails or is seriously damaged so as to
cause significant contamination of the premises or environs, the NRC
may need to respond to the notification of an incident made under
Sec. 31.5(c)(5) to ensure that a facility is properly decontaminated.
Following such an incident, the NRC would determine what actions are
necessary on a case-by-case basis and, if necessary, would apply the
criteria set out in Sec. 20.1402, ``Radiological criteria for
unrestricted use.'' The general licensee is exempt from this section of
part 20 when in possession of an intact generally licensed device.
However, when a device has been damaged, the material in the device may
no longer be fully contained within the device, i.e., it may also be
unsealed radioactive material. Action can be taken by the NRC under
Sec. 30.61, ``Modification and revocation of licenses,'' which is
applicable to general licensees. The provision proposed in this action
would require that the general licensee propose to the Commission how
it will be shown that the premises are or will be adequately cleaned
up. Depending on the nature of the event, the remedial action taken
(and reported under existing requirements) along with any confirmatory
surveys may be sufficient to complete action on the event.
The addressee for submitting information under Sec. 31.5(c)(5)
would be changed from Regional Administrator to Director of Nuclear
Material Safety and Safeguards so that all NRC addressees specified in
Sec. 31.5 for reports by these licensees are the same and to eliminate
the need for the general licensee to refer to part 20 to determine the
appropriate addressee. The addressee and address for registration will
be specified in the registration request. Adding a note concerning the
possible applicability of Sec. 20.1402 is a clarification.
(6) Revision to Sec. 31.5(c)(9)(i)--Reporting new general
licensee's responsible individual. Consistent with the provision for
appointing an individual through whom the general licensee will ensure
compliance with the applicable regulations and requirements, and other
reporting requirements being proposed, it is more effective for the
general licensee to provide the name of the new responsible individual
when another general licensee takes over the facility and
responsibility for the device.
An additional proposed amendment to Sec. 31.5 would clarify the
status of a person who receives a device through an unauthorized
transfer and would remove a restriction on devices. Paragraph (b) would
be revised to (1)
[[Page 40300]]
limit the applicability of the general license to those who receive a
device through an authorized transfer and (2) expand the applicability
of the general license to devices authorized for distribution by an
Agreement State that has no general license covering the use of such
devices within that State.
Concerning the first of these issues, the NRC has generally,
although not consistently, interpreted the general license to apply to
any recipient within the group identified in Sec. 31.5(a), i.e., ``* *
* commercial and industrial firms and research, educational and medical
institutions, individuals in the conduct of their business, and
Federal, State or local government agencies * * *'', even if the device
is received through an unauthorized transfer. The proposed language
would clearly provide that the general license does not apply if the
device is obtained through an unauthorized transfer. In the case of an
unauthorized transfer, the recipient would possess the device without a
license.
Section 31.5(b) currently restricts applicability of the general
license in the case of devices from distributors in Agreement States,
to those devices from Agreement States that authorize the devices to be
used under a general license within their respective States. However,
the NRC practice is to allow a device to be used under the general
license in Sec. 31.5, that is distributed in accordance with a license
issued under equivalent regulations to Sec. 32.51 by an Agreement State
that does not authorize devices to be used under a general license
within their State. This approach reserved for NRC the right to require
distributors in this situation to obtain an NRC distribution license in
order to transfer devices into NRC jurisdiction, but did not require
them to do so as long as the State issued acceptably equivalent
licenses. Through NRC's oversight of Agreement State programs, NRC
ensures the safety of these devices. Given this fact and the experience
to date with these few States, the Commission believes that this
restriction is no longer necessary.
In addition to the proposed changes to Sec. 31.5, other amendments
are proposed that would clarify which sections of the regulations in
part 30 apply to all of the general licensees under part 31. Section
31.1, ``Purpose and scope,'' would be amended to clarify that only
those paragraphs in part 30 specified in Sec. 31.2 or the particular
general license apply to part 31 general licensees. Section 31.2,
``Terms and conditions,'' would be amended to reference the sections of
part 30 that are applicable to all of the part 31 general licensees,
including Sec. 30.7, ``Employee protection,'' Sec. 30.9, ``Completeness
and accuracy of information,'' and Sec. 30.10, ``Deliberate
misconduct.'' The proposed clarification would make it easier for
general licensees to be aware of applicable regulations. In addition,
future amendments to part 30 that would apply to part 31 general
licensees would include a conforming amendment to part 31. Note,
however, that while Sec. 31.2 would specify sections of part 30
generally applicable to general licenses, it would not eliminate the
applicability of other parts of the Commission's regulations that may
apply.
The applicability of Sec. 30.34(h) on bankruptcy notification to
general licensees also needs to be clarified. Under the existing
regulations, this requirement appears to apply to all licensees.
However, its application to general licensees is not clear because it
is not referenced in Sec. 31.2 or Sec. 31.5. This proposed rule would
make the bankruptcy notification requirement applicable only to those
general licensees subject to the registration requirement. These
licensees possess devices for which the Commission believes a higher
level of oversight is appropriate. Thus, notification that such a
general licensee is filing for bankruptcy may be important to allow the
Commission to intervene to ensure that the financial status of the
licensee does not lead to the improper disposal or abandonment of a
device.
Requirements for Manufacturers and Initial Distributors of Devices
The proposed rule would modify the quarterly transfer reporting,
recordkeeping, and labeling requirements for specific licensees who
distribute these generally licensed devices, and the requirement for
providing information to users. The existing requirements in these
areas are a matter of strict compatibility of Agreement State
regulation, that is, the State regulations are essentially identical.
The proposed amendments would also be a matter of strict compatibility
so that revisions to Agreement State regulations would be necessary and
distributors in Agreement States would be affected. The basis of this
compatibility requirement is significant direct transboundary
implications. This results from the fact that devices are distributed
under various Agreement State and NRC authorities into other
jurisdictions where different regulatory agencies regulate the
possession and use of the devices. Currently, there are 28 NRC licensed
distributors and approximately 61 licensed distributors in Agreement
States.
Reporting
The following information would be added to the existing quarterly
transfer reporting requirement: The serial number and model number of
the device; the date of transfer; indication if the device is a
replacement, and if so, the type, model number, and serial number of
the one returned; name and license number of reporting company; and the
specific reporting period. The model number of the device is already
required in reports to Agreement States. The general licensee address
would be specified as the mailing address for the location of use of
the generally licensed device.
The name and phone number of the person identified by the general
licensee as having knowledge of and authority to take required actions
to ensure compliance with the appropriate regulations and requirements
would replace the name and/or position of a simple contact between the
Commission and the general licensee.
A form will be provided for use in making these reports. However,
the use of the form would not be required as long as the report is
clear and legible and includes all of the required information.
Proposed amendments would be made to Sec. 32.52(a) and (b).
The existing reporting requirement is intended to provide NRC and
the Agreement State regulatory agencies with the identity of general
licensees in their jurisdictions, addresses at which the general
licensees can be contacted (which are usually the location of use of
the devices), the particulars of the type of device possessed, and the
name (or position) of an individual who constitutes a point of contact
between the NRC or the Agreement State and the general licensee. These
general licensees can then be contacted or inspected. Including the
serial number would allow the NRC and Agreement States to track
individual devices. The existing reporting requirement in
Sec. 31.5(c)(8) does not require the general licensee to report a
transfer if it is for the purpose of obtaining a replacement. This is
consistent with the original intent of this regulation in that the
status of the general licensee is unchanged, only the specific device
is changed. In order for individual devices to be tracked, the NRC or
Agreement State needs to be informed of such a transfer. The proposed
rule would require that the distributor provide this information either
to NRC or the appropriate Agreement State. Under existing requirements,
quarterly reports are
[[Page 40301]]
required to include specifics on any new device transferred but not on
the devices returned. The NRC believes that the distributor could
include this additional information in the quarterly reports without a
significant burden and that the distributor is likely to be more
reliable than the general licensee in providing this information. The
name and license number of the reporting company and the specific
reporting period are typically included in the reports in order to show
compliance with the reporting requirement. However, this information is
not always readily identifiable.
The individual who acts as contact with the NRC or the Agreement
State concerning the general license should have knowledge of the
device, the general license, and the regulations pertaining to the
general license, or at least know who in the organization does. This is
the intent of the existing requirement. However, in practice, the name
given to the distributor and reported to the NRC (or the Agreement
State) frequently is not an individual with this type of knowledge. The
proposed rule would specify that the contact designated be the person
(1) assigned responsibility for ensuring that the general licensee is
aware of its regulatory responsibilities and (2) who has authority to
take required actions for complying with the applicable regulations.
Recordkeeping
The proposed rule would add to the recordkeeping requirements
information on final disposition of devices. The recordkeeping
requirements concerning transfers would have the period of retention
extended from 5 years from the date of the recorded event, to 3 years
after the expected useful life of the device or the final disposition,
if known. Proposed amendments would be made to Sec. 32.52(c).
It is important that information about the general licensees and
the specific devices in their possession be available until the device
is disposed of permanently. Requiring the distributor to keep these
records for an extended time provides a backup to the recordkeeping of
NRC and State regulatory agencies. The records include information on
final disposition that may not have been included in reports to NRC and
the Agreement States. It is NRC's understanding that these distributors
generally keep these records indefinitely. Thus, this regulatory
requirement should have little, if any, impact.
In addition, distributors would be required to make available
records of final disposition of devices to the various regulatory
agencies in the case of bankruptcy or termination of license (new
Sec. 32.51a(d)). When a distributor goes out of business and terminates
its license, the distributor can no longer be required to retain these
records. This requirement would give NRC, as well as State regulatory
agencies, the opportunity to obtain and retain records of this type
previously kept by the distributor. These records could be helpful in
verifying information used to keep track of devices relative to the
final disposition of devices. This provision would not require
distributors to automatically provide these records unless the NRC or
the Agreement State in which the device was distributed makes a request
for these records. In the case of bankruptcy, NRC or the Agreement
State may want to secure these records early in the process, in case
financial difficulties interfere with the licensee fulfilling its
responsibilities.
Labeling
The proposed rule would amend the existing labeling requirements to
require an additional label on any separable source housing and a
permanent label on devices meeting the criteria for registration (new
Sec. 32.51(a)(4) and (5) and Sec. 32.51a(c)). The NRC would consider a
label ``permanent,'' if, for example, it were embossed, etched,
stamped, or engraved in metal. Under these requirements, new
distributors would have labels approved as part of obtaining a license;
distributors, including existing licensees, would have the new labeling
requirements as conditions of license in Sec. 32.51(a)(4) and (5).
Approval of the new labels by NRC for existing distributors would not
be required. However, distributors may voluntarily submit information
for NRC review on how they plan to comply with the new labeling
requirements. In any case, labeling is subject to inspection. To the
extent necessary, the new labeling requirements would supercede
anything contradictory in individual license conditions. The individual
license conditions would be updated to include specifics related to the
new requirements during the first license renewal or amendment
following the effective date of those paragraphs of the rule.
The first change simply carries out the initial intent of the
existing requirement for devices where the source may be separable in a
housing that does not include the label. It is important that this
housing, if separated from the remainder of the device, can also be
identified. The impact of this requirement should be minimal. The
permanent label for devices requiring registration would provide better
assurance that even when a device has been exposed to other than normal
use conditions, for example, when a building has been refurbished or
demolished with the device in place, the label will be intact and the
device may be identified and proper actions can be taken. This may
result in a more significant change to the production of devices.
Distributors would have 1 year after the effective date of the rule to
implement these changes to minimize any impact to the manufacturing and
distributing process.
Information To Be Provided to General Licensees
The proposed rule would amend the requirements pertaining to the
information distributors must provide to the general licensee
(Sec. 32.51a(a) and (b)). Distributors are now required to provide
general licensees with a copy of Sec. 31.5 when the device is
transferred. The proposed rule would require that a copy of Sec. 31.5
be provided before transfer. The distributor would also be required to
provide copies of additional applicable sections of the regulations, a
listing of the services that can only be performed by a specific
licensee, and information regarding disposal options for the devices
being transferred. The disposal options would include the estimated
cost for disposal of the device at the end of its useful life to the
extent that the cost information is available to the distributor at the
time of the sale of the device. For transfers to general licensees in
Agreement States, the distributor may furnish either the applicable NRC
regulations or the comparable ones of the Agreement State. In addition,
the distributor would furnish the name, address, and phone number of
the contact at the Agreement State regulatory agency from which
additional information may be obtained.
The general licensee should be aware of the specific requirements
before purchasing a generally licensed device, rather than afterward.
While the Commission does not want to get involved with details of
licensees' business practices, it is the Commission's intent that
``prior to transfer'' would be before a final decision to purchase so
that the information can be considered in making that decision. The
Commission seeks comment on how best to achieve and enforce this
intent. For example: What are the advantages/disadvantages of using the
words, ``prior to purchase'' in the regulatory text?
[[Page 40302]]
While Sec. 31.5 contains the primary requirements related to the
general license, it does not reference the applicable sections of part
30. The general licensee should have copies of at least those
regulations that may require an action on his part. The sections of the
regulation that would be included in this requirement are believed to
be the most important for the general licensee to be aware of. The
inclusion of a listing of services that can only be performed by a
specific licensee would clarify the services that can and cannot be
performed by the general licensee. These services vary depending on the
nature and design of the particular device and so are not specified in
the regulations. Information on the estimated cost for disposal of the
device at the end of its useful life may be a significant factor in a
decision to purchase a device because of the high costs of disposing of
radioactive materials. In some cases, the cost of disposal could exceed
the purchase price of the device.
Additional clarifying amendments would be made in Secs. 30.31,
30.34(h), and 31.5(c)(9)(ii). The wording of Sec. 30.31 would provide a
similar clarification as that in the Suggested State Regulations with
respect to general licenses. The amendment to Sec. 30.34(h) would be
consistent with the previously discussed change concerning reporting
bankruptcy.
The revision of Sec. 31.5(c)(9)(ii) to include the term,
``intermediate person,'' is intended to provide clarification about
intermediate persons holding devices. Specifically, intermediate
persons holding devices in their original shipping containers at their
intended location of use are general licensees. Distributors licensed
under Sec. 32.51, or equivalent Agreement State regulations, must
provide information about both intermediate persons and intended users
in their quarterly reports submitted under Sec. 32.52(a). Transfers
from intermediate persons to intended users under Sec. 31.5(c)(9)(ii)
do not need to be reported to NRC because information about the
intended user must be reported by the distributor under Sec. 32.52(a).
Minor conforming amendments would also be made to Secs. 170.2,
170.3, 171.5, and 171.16.
Public Comments on the Original Proposed Rule
The NRC reviewed the comments received on the December 27, 1991,
proposed rule in developing both the proposed rule published on
December 2, 1998 (63 FR 66492), and this 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 each rule. A detailed analysis
of the comments received on the December 27, 1991, proposed rule, which
was withdrawn by the notice of proposed rulemaking on December 2, 1998,
is not presented in either of the subsequent proposed rules because
many of the specific comments pertain to specific provisions that have
been withdrawn, a great deal of time has passed since these comments
were made, and additional opportunity for comment is being provided.
Early State and Public Input
These proposed amendments were provided to the Agreement States
twice during its development via the use of the NRC Technical
Conference Website and notification to the States of its availability.
Input was received following the first posting through discussions at
an All Agreement State meeting in October of 1998. The second posting
was also available to the public. A notice of availability was
published December 31, 1998 (63 FR 72216). The States and the
distributors were notified of its availability directly, as well. Two
comments were received. One from a State and one from industry. They
were generally supportive and indicated points needing clarification.
Summary of Proposed Provisions by Paragraph
Section 30.31--Revision would reconcile the apparent conflict
between the description of a general license and a registration
requirement.
Section 30.34, paragraph (h)(1)--Revision would make the bankruptcy
notification requirement applicable only to those general licensees
subject to the registration requirement.
Section 31.1--Revision would clarify that only those paragraphs in
part 30 specified in Sec. 31.2 or the particular general license apply
to part 31 general licensees.
Section 31.2--Revision would clarify references to the sections of
part 30 that are applicable to all of the part 31 general licensees.
Section 31.5, paragraph (b)--Revision would clarify the status of a
person who receives a device through an unauthorized transfer by
limiting the applicability of the general license to those who receive
a device through an authorized transfer; and would remove the
restriction on devices distributed by Agreement State licensees in
Agreement States without a general license.
Section 31.5, paragraph (c)(5)--Revision would add a plan for
ensuring that premises and environs are suitable for unrestricted
access, to the information that must be sent to NRC in the case of a
failure, when device damage or failure is likely to or known to have
resulted in contamination; would change the addressee for reporting
information concerning a failure; and would clarify that the criteria
in Sec. 20.1402 may be applied in spite of the exemption in
Sec. 31.5(c)(10).
Section 31.5, paragraph (c)(8)--Revision would allow transfers to
specific licensees authorized under part 30, or equivalent Agreement
State regulations, as waste collectors, in addition to currently
allowed transfers to part 32 (and Agreement State) licensees; would
allow transfers to other specific licensees but only with prior written
NRC approval; and would add the recipient's license number, the serial
number of the device, and the date of transfer to the information
required to be provided to NRC upon transfer of a device.
Section 31.5, paragraph (c)(9)(i)--Revision would add to the
reporting requirement, in the case of a transfer to a general licensee
taking over possession of a device at the same location, to provide the
serial number of the device and the name and phone number of the person
identified as having knowledge of and authority to take required
actions to ensure compliance with the appropriate regulations and
requirements, rather than simply a contact name.
Section 31.5, paragraph (c)(9)(ii)--Revision would add the term,
``intermediate person,'' to clarify that a report of transfer is not
required only when the information on both an intermediate person and
an intended user was provided through the distributor in a quarterly
material transfer report.
Section 31.5, paragraph (c)(12)--Would add an explicit requirement
for the general licensee to appoint an individual assigned
responsibility for knowing what regulatory requirements are applicable
to the general licensee and having authority to take required actions
to comply with the applicable regulations.
Section 31.5, paragraph (c)(13)--Would add an explicit requirement
for the general licensee to register devices meeting certain criteria,
which specifies the information to be provided and references the fee
requirement in Sec. 170.31.
[[Page 40303]]
Section 31.5, paragraph (c)(14)--Would add requirement for general
licensees to notify NRC of address changes.
Section 31.5, paragraph (c)(15)--Would limit to 2 years the amount
of time a general licensee can keep an unused device in storage and
allow the deferment of testing during the period of storage.
Section 32.51, paragraphs (a)(4) and (5)--Would add requirement for
an additional label on any separable source housing and a permanent
label on devices meeting the criteria for registration.
Section 32.51a, paragraphs (a) and (b)--Revision would amend the
requirements pertaining to the information distributors must provide to
the general licensee. Distributors are now required to provide general
licensees with a copy of Sec. 31.5 when the device is transferred. The
proposed rule would require that Sec. 31.5 be provided before transfer.
The distributor would also be required to provide copies of additional
applicable sections of the regulations, a listing of the services that
can only be performed by a specific licensee, and information regarding
disposal options for the devices being transferred, including estimated
costs of disposal. For transfers to general licensees in Agreement
States, the distributor may furnish either the applicable NRC
regulations or the comparable ones of the Agreement State. In addition,
the distributor would furnish the name, address, and phone number of
the contact at the Agreement State regulatory agency from which
additional information may be obtained.
Section 32.51a, paragraph (c)--Would make labeling requirements a
condition of license 1 year after effective date of rule.
Section 32.51a, paragraph (d)--Would add requirement for
distributors to make available records of final disposition of devices
to the various regulatory agencies in the case of bankruptcy or
termination of the distributor's license.
Section 32.52, paragraphs (a) and (b)--Revision would add the
following information to the existing quarterly transfer reporting
requirement: the serial number and model number of the device; the date
of transfer; indication if device is a replacement, and if so, the
type, model number, and serial number of the one returned; name and
license number of reporting company; and the specific reporting period.
Also, the general licensee address would be specified as the mailing
address for the location of use of the generally licensed device.
The name and phone number of the person identified by the general
licensee as having knowledge of and authority to take required actions
to ensure compliance with the appropriate regulations and requirements
would replace the name and/or position of a simple contact between the
Commission and the general licensee. Also, a form will be provided for
use in making these reports. However, the use of the form would not be
required as long as the report is clear and legible and includes all of
the required information.
Section 32.52, paragraph (c)--Revision would add to the
recordkeeping requirements information on final disposition of devices.
The recordkeeping requirements concerning transfers would have the
period of retention extended from 5 years from the date of the recorded
event to 3 years after the expected useful life of the device or the
final disposition, if known.
Section 170.2--Would conform the scope of part 170 to include a
general licensee registrant.
Section 170.3--Would revise definition of ``Materials License'' to
include part 31 and the words, ``or granted'' as general licenses are
granted by regulation rather than individually issued to licensees.
Section 170.31--Revision would add $420 registration fee for
general licensees subject to Sec. 31.5(c)(13).
Section 171.5--Would revise definition of ``Materials License'' to
include part 31 and the words, ``or granted'' as general licenses are
granted by regulation rather than individually issued to licensees.
Section 171.16--Would add category for part 31 general license
registration for consistency with the Table in Sec. 170.31.
National Database
The Commission is in the process of developing a new computer
database to handle information about general licensees and generally
licensed devices. Among other improvements from the currently used
system, it will be designed to handle the registration process
efficiently with automated features. In doing so, the Commission has
given some consideration to whether a national database should be
established in which information on the identity of general licensees
and device information for all jurisdictions would be maintained,
making this information accessible to all Agreement States and the NRC.
There are variations on the exact approach that might be taken
particularly with respect to access and update authority. At this time,
the Commission has not yet found it practical to resolve all the issues
related to having broad access to the database.
The Commission would like to give further consideration to
establishing such a database. It would not require rulemaking. However,
if it were to be established, one option would be to change the
material transfer reporting requirements so that distributors would
report all transfers to the NRC rather than reporting to all
jurisdictions into which transfers of devices are made.
A primary advantage of a national database would be the ease of
tracing a ``found'' device back to the general licensee owner
responsible for the device. A ``found'' generally licensed device would
be considered an orphan source until such time as the responsible
general licensee is identified and it is returned to the licensee. The
Commission is in the process of modifying the Nuclear Materials Events
Database (NMED) to accept and track information on orphan sources
nationally (i.e. all States). Access to the NMED will be available to
the NRC and all the States. The Commission will encourage the States to
use NMED for this purpose so that this category of information will be
shared nationally. However, NMED would rely on reporting of events for
its data. In order for a device to be traced back to the responsible
general licensee, each jurisdiction would need to search its own files.
In addition, information in a national general license database would
be immediately available, and would contain the most complete
information about general licensees and generally licensed devices.
The primary disadvantage to a national database would be the
difficulty of maintaining the security of the data, which is primarily
made up of proprietary information. A national database would also
present more risk to the integrity of the data, because there would be
a higher potential for illicit corruption of data.
In considering whether or not to implement a national database and,
if so, what the particular approach would be used, there are a number
of aspects to be considered including--
(1) Who will maintain the database (the NRC, an independent third
party, or each agency maintaining its own data)?
(2) How access to the data would be controlled.
(3) Potential changes to the reporting requirements for transfers.
(4) The ability for the NRC and the Agreement States to protect
information of other agencies.
[[Page 40304]]
(5) Costs to implement and maintain the system or systems
(including training).
The Commission seeks comment on the advantages and disadvantages of
implementing a national database and on these related issues.
Specific Questions for Public Comment
The Commission welcomes comments on all aspects of this proposed
rule, and is especially interested in receiving comments on the
specific questions summarized here:
1. The Commission seeks comment on whether the registration
requirement should include a provision that would require the general
licensee to complete registration by a certain time, whether or not the
NRC requests registration.
2. The Commission requests comment on whether it is appropriate for
new devices obtained by registrants to be registered when the annual
reregistration is carried out without the NRC having earlier contact
after additional devices are received. Earlier contact could be made
either by an acknowledgment by NRC to the user or by a required
response from the general licensee to account for the additional
device(s).
3. The Commission solicits comment on whether general licensees
should be required to assign a backup responsible individual (BRI).
4. The Commission seeks comment on how best to achieve and enforce
the intent that full disclosure of information required to be provided
to general licensee customers by distributors be made early enough to
be considered in a decision to purchase. For example: Would it be
better to use the words, ``prior to purchase'' in the regulatory text?
5. The Commission seeks comment on the advantages and disadvantages
of implementing a national database of general licensees and their
devices.
Enforcement
On March 9, 1999 (64 FR 11508), the Commission established an
interim enforcement policy for violations of Sec. 31.5 that licensees
discover and report during the initial cycle of the registration
program. This policy supplements the normal NRC Enforcement Policy in
NUREG-1600, Rev. 1. It will remain in effect through one complete cycle
of the registration program.
Under this interim enforcement policy, enforcement action normally
will not be taken for violations of Sec. 31.5 that are identified by
the general licensee, and reported to the NRC if reporting is required,
provided that the general licensee takes appropriate corrective action
to address the specific violations and prevent recurrence of similar
problems and otherwise has undertaken good faith efforts to respond to
NRC notices and provide requested information. This change from the
Commission's normal enforcement policy is to remove the potential for
the threat of enforcement action to be a disincentive for the licensee
to identify deficiencies. This approach is warranted given the limited
NRC inspections of general licensees. This approach is intended to
encourage general licensees to determine if applicable requirements
have been met, to search their facilities to ensure sources are
located, and to develop appropriate corrective action when deficiencies
are found. Under the interim enforcement policy, enforcement action,
including issuance of civil penalties and Orders, may be taken where
there is--
(a) Failure to take appropriate corrective action to prevent
recurrence of similar violations;
(b) Failure to respond and provide the information required by
regulation;
(c) Willful failure to provide complete and accurate information to
the NRC; or
(d) Other willful violations, such as willfully disposing of
generally licensed material in an unauthorized manner.
As noted in the December 2, 1998, proposed rule, the Commission
also plans to increase the civil penalty amounts specified in its
Enforcement Policy in NUREG-1600, Rev. 1, for violations involving lost
or improperly disposed sources or devices. This increase will better
relate the civil penalty amount to the costs avoided by the failure to
properly dispose of the source or device. Due to the diversity of the
types of sources and devices, the Commission is considering the
establishment of three levels of base civil penalty for loss or
improper disposal. The three levels of base civil penalty would be
$5500, $15,000, and $45,000. The higher tiers would be for sources that
are relatively costly to dispose of and would be based on approximately
three times the average cost of proper transfer or disposal of the
source or device.
Agreement State Compatibility
Under the ``Policy Statement on Adequacy and Compatibility of
Agreement State Programs'' published on September 3, 1997 (62 FR
46517), the proposed rule would be a matter of compatibility between
the NRC and the Agreement States, thereby providing consistency among
Agreement State and NRC requirements. The revisions to part 32 would be
classified as Category B and the revisions to Sec. 31.5 would be
classified as Category C. Through this action, existing provisions of
Sec. 31.5 would also be reclassified from Category D to Category C.
Although changes are being made to Secs. 30.31, 30.34(h)(1), 31.1, and
31.2, and parts 170 and 171 as part of this rulemaking, the existing
compatibility designations for these regulations will not be affected.
Category B means the provisions affect a program element with
significant direct transboundary implications. The State program
element should be essentially identical to that of NRC. Category C
means the provisions affect a program element, the essential objectives
of which should be adopted by the State to avoid conflicts,
duplications, or gaps in the national program. The manner in which the
essential objectives are addressed need not be the same as NRC provided
the essential objectives are met.
Specific information about the compatibility or health and safety
components assigned to this rule may be found at Office of State
Programs website, http://www.hsrd.ornl.gov/nrc/home.html.
As discussed above, revised Sec. 32.52(a) and (b) would add the
following information to the existing distributors' quarterly transfer
reporting requirements: the serial number and model number of the
device, the date of transfer, indication if the device is a replacement
(and if so, the type, model number, and serial number of the device
returned), the name and license number of the reporting company, and
the specific reporting period. The proposed revisions would also
require the name and phone number of a general licensee's ``responsible
individual'' rather than simply a contact and would specify that the
address of the general licensee be the mailing address for the location
of use. According to NRC Management Directive (MD) 5.9, ``Adequacy and
Compatibility of Agreement State Programs,'' NRC regulations that
should be adopted by an Agreement State for purposes of compatibility
should be adopted in a time frame such that the effective date of the
State requirement is no later than 3 years after the effective date of
NRC's final rule. MD 5.9 also provides that some circumstances may
warrant that the States adopt certain regulations in less than the
recommended 3-year time frame or that the effective dates for both NRC
licensees and Agreement State licensees be the same. The Commission
believes it is important to the implementation of this program, and to
Agreement State programs, to begin receiving the additional information
in
[[Page 40305]]
the distributors' quarterly transfer reports as soon as possible. The
Commission requests comments on whether NRC and the Agreement States
should establish a single implementation date for this provision which
would be earlier than is usually allowed for revision of Agreement
State rules for compatibility. One approach would be to request
Agreement States to require distributors to provide all the information
consistent with this rule (proposed Sec. 32.52(a) and (b)) either
coincident with the effective date of the Commission's final action on
this rulemaking or within 1 year of that effective date. Agreement
States would have the flexibility to adopt this provision through
rulemaking, license conditions, or other legally binding requirements.
Plain Language
The Presidential Memorandum dated June 1, 1998, entitled, ``Plain
Language in Government Writing,'' directed that the government's
writing be in plain language. This memorandum was published June 10,
1998 (63 FR 31883). In complying with this directive, editorial changes
have been made in the proposed revisions to improve the organization
and readability of the existing language of paragraphs being revised.
These types of changes are not discussed further in this notice. The
NRC requests comments on this proposed rule specifically with respect
to the clarity and effectiveness of the language used. Comments should
be sent to the address listed under the heading: ADDRESSES above.
Environmental Impact: Categorical Exclusion
The NRC has determined that the revisions proposed in this rule are
the types of actions described in the categorical exclusions in
Sec. 51.22(c)(1) through (3). 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 2 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 time involved is small because most of the
proposals are minor revisions to existing information collection
requirements. 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-6F33), 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 August 25, 1999. 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 a means used to impose 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 draft
regulatory analysis associated with the proposed rule of December 27,
1991, have been considered to the extent that they apply to this
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 Catherine R.
Mattsen, U.S. Nuclear Regulatory Commission, Office of Nuclear Material
Safety and Safeguards, Washington, DC 20555-0001; telephone (301) 415-
6264; or e-mail at [email protected].
Regulatory Flexibility Certification
As required by the Regulatory Flexibility Act (5 U.S.C. 605(b)),
the Commission has evaluated the impact of this rule on small entities.
The NRC has established standards for determining which NRC licensees
qualify as small entities (10 CFR 2.810). The Commission certifies that
this proposed rule, if adopted, would not have a significant economic
impact on a substantial number of small entities. The most significant
cost of this proposed rule would be the proposed $420 fee to be
assessed for each registration. Portions of the proposed rule would
apply to the approximately 45,000 persons possessing products under an
NRC general license, many of whom may be classified as small entities.
However, the annual registration requirement and associated fee would
apply to about 5100 of these general licensees. Based on input received
previously from small entities who hold specific materials licenses,
the NRC believes that the proposed $420 part 170 registration fee would
not have a significant economic impact on a substantial number of small
entities. The NRC believes that the economic impact of the other
proposed requirements on any general licensee would be a negligible
increase in administrative burden. The NRC is soliciting comment from
the general licensees who meet the NRC's small entity size standards
and would be required to register their devices pursuant to part 31 on
whether the proposed part 170 fee for their annual registration would
have a significant economic impact on their business.
The proposed rule would also revise requirements for specifically
licensed distributors of certain generally licensed devices. Currently,
there are 28 NRC licensed distributors and approximately 61 Agreement
State licensed distributors. Many of these licensees are not small
entities and the impact to any of these distributors is not expected to
be significant in any case. Distributors who are small entities are
also invited to comment on whether they believe the economic impact
would be significant.
Those small entities that offer comments on the potential impact on
small entities and how that might be minimized should specifically
include information on the type and size of their business and how the
proposed
[[Page 40306]]
regulations would result in a significant economic impact on them as
compared to larger organizations in the same business community. To the
extent possible, the commenter should provide relevant economic data,
such as the licensee's gross annual receipts, as well as number of
employees.
Backfit Analysis
The NRC has determined that the backfit rule, Sec. 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 Sec. 50.109(a)(1).
List of Subjects
10 CFR Part 30
Byproduct material, Criminal penalties, Government contracts,
Intergovernmental relations, Isotopes, Nuclear materials, Radiation
protection, Reporting and recordkeeping requirements.
10 CFR Part 31
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Packaging and containers, Radiation protection, Reporting
and recordkeeping requirements, Scientific equipment.
10 CFR Part 32
Byproduct material, Criminal penalties, Labeling, Nuclear
materials, Radiation protection, Reporting and recordkeeping
requirements.
10 CFR Part 170
Byproduct material, Import and export licenses, Intergovernmental
relations, Non-payment penalties, Nuclear materials, Nuclear power
plants and reactors, Source material, Special nuclear material.
10 CFR Part 171
Annual charges, Byproduct material, Holders of certificates,
registrations, approvals, Intergovernmental relations, Non-payment
penalties, Nuclear materials, Nuclear power plants and reactors, Source
material, Special nuclear material.
For the reasons set out above 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 parts 30, 31, 32, 170, and 171.
PART 30--RULES OF GENERAL APPLICABILITY TO DOMESTIC LICENSING OF
BYPRODUCT MATERIAL
1. The authority citation for part 30 continues to read as follows:
Authority: Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948,
953, 954, 955, as amended, sec. 234, 83, Stat. 444, as amended, (42
U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201 as
amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C.
5841, 5842, 5846).
Sec. 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat.
2951 as amended by Pub. L. 102-486; sec. 2902, 106 Stat. 3123, (42
U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat.
954, as amended (42 U.S.C. 2234). Section 30.61 also issued under
sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
2. Section 30.31 is revised to read as follows:
Sec. 30.31 Types of licenses.
Licenses for byproduct material are of two types: General and
specific.
(a) The Commission issues a specific license to a named person who
has filed an application for the license under the provisions of this
part and parts 32-36, and 39 of this chapter.
(b) A general license is provided by regulation, grants authority
to a person for certain activities involving byproduct material, and is
effective without the filing of an application with the Commission or
the issuance of a licensing document to a particular person. However,
registration with the Commission may be required by the particular
general license.
3. In Sec. 30.34, paragraph (h)(1) is revised to read as follows:
Sec. 30.34 Terms and conditions of licenses.
* * * * *
(h)(1) Each general licensee that is required to register by
Sec. 31.5(c)(13) of this chapter and each specific licensee shall
notify the appropriate NRC Regional Administrator, in writing,
immediately following the filing of a voluntary or involuntary petition
for bankruptcy under any chapter of title 11 (Bankruptcy) of the United
States Code by or against:
(i) The licensee;
(ii) An entity (as that term is defined in 11 U.S.C. 101(14))
controlling the licensee or listing the license or licensee as property
of the estate; or
(iii) An affiliate (as that term is defined in 11 U.S.C. 101(2)) of
the licensee.
* * * * *
PART 31--GENERAL DOMESTIC LICENSES FOR BYPRODUCT MATERIAL
4. 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).
5. Section 31.1 is revised to read as follows:
Sec. 31.1 Purpose and scope.
This part establishes general licenses for the possession and use
of byproduct material and a general license for ownership of byproduct
material. Specific provisions of 10 CFR part 30 are applicable to
general licenses established by this part. These provisions are
specified in Sec. 31.2 or in the particular general license.
6. Section 31.2 is revised to read as follows:
Sec. 31.2 Terms and conditions.
The general licenses provided in this part are subject to the
general provisions of Part 30 of this chapter (Secs. 30.1 through
30.10), the provisions of Secs. 30.14(d), 30.34(a) to (e), 30.41, 30.50
to 30.53, 30.61 to 30.63, and parts 19, 20, and 21, of this chapter
1 unless indicated otherwise in the specific provision of
the general license.
---------------------------------------------------------------------------
\1\ Attention is directed particularly to the provisions of part
20 of this chapter concerning labeling of containers.
---------------------------------------------------------------------------
7. In Sec. 31.5, paragraphs (b), (c)(5), (c)(8), and (c)(9) are
revised and paragraphs (c)(12), (13), (14), and (15) are added to read
as follows:
Sec. 31.5 Certain measuring, gauging, or controlling
devices.2
---------------------------------------------------------------------------
\2\ Persons possessing byproduct material in devices under a
general license in Sec. 31.5 before January 15, 1975, may continue
to possess, use, or transfer that material in accordance with the
labeling requirements of Sec. 31.5 in effect on January 14, 1975.
---------------------------------------------------------------------------
* * * * *
(b)(1) The general license in paragraph (a) of this section applies
only to byproduct material contained in devices which have been
manufactured or initially transferred and labeled in accordance with
the specifications contained in--
(i) A specific license issued under Sec. 32.51 of this chapter; or
(ii) An equivalent specific license issued by an Agreement State.
(2) The devices must have been received from one of the specific
licensees described in paragraph (b)(1)
[[Page 40307]]
of this section or through a transfer made under paragraph (c)(9) of
this section.
(c) * * *
* * * * *
(5) Shall immediately suspend operation of the device if there is a
failure of, or damage to, or any indication of a possible failure of or
damage to, the shielding of the radioactive material or the on-off
mechanism or indicator, or upon the detection of 0.005 microcurie or
more removable radioactive material. The device may not be operated
until it has been repaired by the manufacturer or other person holding
a specific license to repair such devices that was issued under parts
30 and 32 of this chapter or by an Agreement State. The device may be
disposed of by transfer to a person authorized by a specific license to
receive the byproduct material contained in the device. A report
containing a brief description of the event and the remedial action
taken; and, in the case of detection of 0.005 microcurie or more
removable radioactive material or failure of or damage to a source
likely to result in contamination of the premises or the environs, a
plan for ensuring that the premises and environs are acceptable for
unrestricted use, must be furnished to the Director of Nuclear Material
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001 within 30 days. Under these circumstances, the criteria
set out in Sec. 20.1402, ``Radiological criteria for unrestricted
use.'' may be applicable, as determined by the Commission on a case-by-
case basis;
* * * * *
(8)(i) Shall transfer or dispose of the device containing byproduct
material only by transfer to another general licensee as authorized in
paragraph (c)(9) of this section or to a person authorized to receive
the device by a specific license issued under parts 30 and 32 of this
chapter, part 30 of this chapter that authorizes waste collection, or
equivalent regulations of an Agreement State, or as approved under
paragraph (c)(8)(iii) of this section.
(ii) Shall furnish a report to the Director of Nuclear Material
Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington,
DC 20555-0001 within 30 days after the transfer of a device to a
specific licensee. A report is not required if the device is
transferred to the specific licensee in order to obtain a replacement
device from the same specific licensee. The report must contain--
(A) The identification of the device by manufacturer's name, model
number, and serial number;
(B) The name, address, and license number of the person receiving
the device; and
(C) The date of the transfer.
(iii) Shall obtain written NRC approval before transferring the
device to any other specific licensee.
(9) Shall transfer the device to another general licensee only if--
(i) The device remains in use at a particular location. In this
case, the transferor shall give the transferee a copy of this section
and any safety documents identified in the label of the device. Within
30 days of the transfer, the transferor shall report the manufacturer's
name and the model number and the serial number of the device
transferred, the name and address of the transferee, and the name and
phone number of the responsible individual identified by the transferee
in accordance with paragraph (c)(12) of this section to have knowledge
of and authority to take actions to ensure compliance with the
appropriate regulations and requirements to the Director of Nuclear
Material Safety and Safeguards, U.S. Nuclear Regulatory Commission,
Washington, DC 20555-0001; or
(ii) The device is held in storage by an intermediate person in the
original shipping container at its intended location of use prior to
initial use by a general licensee.
* * * * *
(12) Shall appoint an individual responsible for having knowledge
of the appropriate regulations and requirements and the authority for
taking required actions to comply with appropriate regulations and
requirements. The general licensee, through this individual, shall
ensure the day-to-day compliance with appropriate regulations and
requirements. This appointment does not relieve the general licensee of
responsibility in this regard.
(13)(i) Shall register, in accordance with paragraphs (c)(13)(ii)
and (iii) of this section, 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 americium-241 or any other transuranic,
i.e., element with atomic number greater than uranium (92), based on
the activity indicated on the label.
(ii) If in possession of a device meeting the criteria of paragraph
(c)(13)(i) of this section, shall register these devices annually with
the Commission and shall pay the fee required by Sec. 170.31 of this
chapter. Registration must be done by verifying, correcting, and/or
adding to the information provided in a request for registration
received from the Commission. The registration information must be
submitted to the NRC within 30 days of the date of the request for
registration or as otherwise indicated in the request. In addition, a
general licensee holding devices meeting the criteria of paragraph
(c)(13)(i) of this section is subject to the bankruptcy notification
requirement in Sec. 30.34(h) of this chapter.
(iii) In registering devices, the general licensee shall furnish
the following information and any other information specifically
requested by the Commission--
(A) Name and mailing address of the general licensee.
(B) Information about each device: The manufacturer, model number,
serial number, the radioisotope and activity (as indicated on the
label).
(C) Name and telephone number of the responsible person designated
as a representative of the general licensee under paragraph (c)(12) of
this section.
(D) Address at which the device(s) are used and/or stored. For
portable devices, the address of the primary place of storage.
(E) Certification by the responsible representative of the general
licensee that the information concerning the device(s) has been
verified through a physical inventory and checking of label
information.
(F) Certification by the responsible representative of the general
licensee that they are aware of the requirements of the general
license.
(14) Shall report changes of address (including change in name of
general licensee) to the Director of Nuclear Material Safety and
Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001 within 30 days of the effective date of the change. If it is a
portable device, a report of address change is only required for a
change in the device's primary place of storage.
(15) May not hold devices that are not in use for longer than 2
years. If devices with shutters are not being used, the shutter must be
locked in the closed position. The testing required by paragraph (c)(2)
of this section need not be performed during the period of storage
only. However, when devices are put back into service or transferred to
another person, and have not been tested within the required test
interval, they must be tested for leakage before
[[Page 40308]]
use or transfer and the shutter tested before use.
* * * * *
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER
CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
8. The authority citation for part 32 continues to read as follows:
Authority: Secs. 81, 161, 182, 183, 68 Stat. 935, 948, 953, 954,
as amended (42 U.S.C. 2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841).
9. In Sec. 32.51, paragraphs (a)(4) and (5) are added to read as
follows:
Sec. 32.51 Byproduct material contained in devices for use under
Sec. 31.5; requirements for license to manufacture, or initially
transfer.
(a) * * *
(4) Each device having a separable source housing that provides the
primary shielding for the source also bears, on the source housing, a
durable label containing the device model number and serial number, the
isotope and quantity, the words, ``Caution--Radioactive Material,'' the
radiation symbol described in Sec. 20.1901 of this chapter, and the
name of the manufacturer or initial distributor.
(5) Each device meeting the criteria of Sec. 31.5(c)(13)(i) of this
chapter, bears a permanent (e.g., embossed, etched, stamped, or
engraved) label affixed to the source housing if separable, or the
device if the source housing is not separable, that includes the words,
``Caution--Radioactive Material,'' and, if practicable, the radiation
symbol described in Sec. 20.1901 of this chapter.
* * * * *
10. Section 32.51a is revised to read as follows:
Sec. 32.51a Same: Conditions of licenses.
(a) If a device containing byproduct material is to be transferred
for use under the general license contained in Sec. 31.5 of this
chapter, each person that is licensed under Sec. 32.51 shall provide
the information specified in this paragraph to each person to whom a
device is to be transferred. This information must be provided before
the device may be transferred. In the case of a transfer through an
intermediate person, the information must also be provided to the
intended user prior to initial transfer to the intermediate person. The
required information includes--
(1) A copy of the general license contained in Sec. 31.5 of this
chapter;
(2) A copy of Secs. 31.2, 30.51, 20.2201, and 20.2202 of this
chapter;
(3) A list of the services that can only be performed by a specific
licensee; and (4) Information on acceptable disposal options including
estimated costs of disposal.
(b) If byproduct material is to be transferred in a device for use
under an equivalent general license of an Agreement State, each person
that is licensed under Sec. 32.51 shall provide the information
specified in this paragraph to each person to whom a device is to be
transferred. This information must be provided before the device may be
transferred. In the case of a transfer through an intermediate person,
the information must also be provided to the intended user prior to
initial transfer to the intermediate person. The required information
includes --
(1) A copy of the Agreement State's regulations equivalent to
Secs. 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter or a copy
of Secs. 31.5, 31.2, 30.51, 20.2201, and 20.2202 of this chapter. If a
copy of the NRC regulations is provided to a prospective general
licensee, it shall be accompanied by a note explaining that use of the
device is regulated by the Agreement State;
(2) A list of the services that can only be performed by a specific
licensee;
(3) Information on acceptable disposal options including estimated
costs of disposal; and (4) The name, address, and phone number of the
contact at the Agreement State regulatory agency from which additional
information may be obtained.
(c) Each device that is transferred after (insert date 1 year after
the effective date of this rule) must meet the labeling requirements in
Sec. 32.51(a)(3) through (5).
(d) If a notification of bankruptcy has been made under
Sec. 30.34(h) or the license is to be terminated, each person licensed
under Sec. 32.51 shall provide, upon request, to the NRC and to any
appropriate Agreement State, records of final disposition required
under Sec. 32.52(c).
11. Section 32.52 is revised to read as follows:
Sec. 32.52 Same: Material transfer reports and records.
Each person licensed under Sec. 32.51 to initially transfer devices
to generally licensed persons shall comply with the requirements of
this section.
(a) The person shall report all transfers of devices to persons for
use under the general license in Sec. 31.5 of this chapter to the
Director of the Office of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Commission, Washington, DC 20555-0001. The report
must be submitted on a quarterly basis on Form 653--``Transfers of
Industrial Devices Report'' or in a clear and legible report containing
all of the data required by the form.
(1) The required information includes--
(i) The identity of each general licensee by name and mailing
address for the location of use;
(ii) The name and phone number of the person identified by the
general licensee as having knowledge of and authority to take required
actions to ensure compliance with the appropriate regulations and
requirements;
(iii) The date of transfer;
(iv) The type, model number, and serial number of the device
transferred; and
(v) The quantity and type of byproduct material contained in the
device.
(2) If one or more intermediate persons will temporarily possess
the device at the intended place of use before its possession by the
user, the report must include the same information for both the
intended user and each intermediate person, and clearly designate the
intermediate person(s).
(3) If a device transferred replaced another returned by the
general licensee, the report must also include the type, model number,
and serial number of the one returned.
(4) The report must cover each calendar quarter, must be filed
within 30 days of the end of the calendar quarter, and must clearly
indicate the period covered by the report.
(5) The report must clearly identify the specific licensee
submitting the report and include the license number of the specific
licensee.
(6) If no transfers have been made to persons generally licensed
under Sec. 31.5 of this chapter during the reporting period, the report
must so indicate.
(b) The person shall report all transfers of devices to persons for
use under a general license in an Agreement State's regulations that
are equivalent to Sec. 31.5 of this chapter to the responsible
Agreement State agency. The report must be submitted on Form 653--
``Transfers of Industrial Devices Report'' or in a clear and legible
report containing all of the data required by the form.
(1) The required information includes--
(i) The identity of each general licensee by name and mailing
address for the location of use;
(ii) The name and phone number of the person identified by the
general licensee as having knowledge of and
[[Page 40309]]
authority to take required actions to ensure compliance with the
appropriate regulations and requirements;
(iii) The date of transfer;
(iv) The type, model number, and serial number of the device
transferred; and
(v) The quantity and type of byproduct material contained in the
device.
(2) If one or more intermediate persons will temporarily possess
the device at the intended place of use before its possession by the
user, the report must include the same information for both the
intended user and each intermediate person, and clearly designate the
intermediate person(s).
(3) If a device transferred replaced another returned by the
general licensee, the report must also include the type, model number,
and serial number of the one returned.
(4) The report must be submitted within 30 days after the end of
each calendar quarter in which such a device is transferred to the
generally licensed person and clearly indicate the period covered by
the report.
(5) The report must clearly identify the specific licensee
submitting the report and must include the license number of the
specific licensee.
(6) If no transfers have been made to a particular Agreement State
during the reporting period, this information shall be reported to the
responsible Agreement State agency upon request of the agency.
(c) The person shall keep records of all transfers of devices for
each general licensee including all the information in the reports
required by this section and records of final disposition. Records
required by this paragraph must be maintained for a period of 3 years
following the estimated useful life of the device or the date of final
disposition, if known.
PART 170--FEES FOR FACILITIES, MATERIALS, IMPORT AND EXPORT
LICENSES, AND OTHER REGULATORY SERVICES UNDER THE ATOMIC ENERGY ACT
OF 1954, AS AMENDED
12. The authority citation for part 170 continues to read as
follows:
Authority: 31 U.S.C. 9701; sec. 301, Pub. L. 92--314, 86 Stat.
222 (42 U.S.C. 2201w); sec. 201, 88 Stat. 1242, as amended (42
U.S.C. 5841); sec. 205, Pub. L. 101-576, 104 Stat. 2842, (31 U.S.C.
9012).
13. Section 170.2 is amended by adding a paragraph (r) to read as
follows:
Sec. 170.2 Scope.
* * * * *
(r) A holder of a general license granted by 10 CFR part 31 who is
required to register a device(s).
14. In Sec. 170.3, the definition of Materials License is revised
to read as follows:
Sec. 170.3 Definitions.
* * * * *
Materials License means a license, certificate, approval,
registration, or other form of permission issued or granted by the NRC
pursuant to the regulations in 10 CFR parts 30, 31 through 36, 39, 40,
61, 70, 71 and 72.
* * * * *
15. Section 170.31 is amended by adding a fee category, 3. Q. to
the schedule of materials fees and amending footnote 1 to add a
paragraph (f).
Sec. 170.31 Schedule of fees for materials licenses and other
regulatory services, including inspections, and import and export
licenses.
* * * * *
Schedule of Materials Fees
[See footnotes at end of table]
------------------------------------------------------------------------
Category of materials licenses and type of fees
\1\ Fee 2,3
------------------------------------------------------------------------
* * * *
*
3. * * *
Q. Registration of a device(s) generally $420
licensed pursuant to Part 31.
* * * *
*
------------------------------------------------------------------------
\1\ Types of fees.
* * *
(f) Generally licensed device registrations under 10 CFR 31.5.
Submittals of registration information must be accompanied by the
prescribed fee.
* * * * *
PART 171--ANNUAL FEES FOR REACTOR OPERATING LICENSES, AND FUEL
CYCLE LICENSES AND MATERIALS LICENSES, INCLUDING HOLDERS OF
CERTIFICATES OF COMPLIANCE, REGISTRATIONS, AND QUALITY ASSURANCE
PROGRAM APPROVALS AND GOVERNMENT AGENCIES LICENSED BY THE NRC
16. The authority citation for part 171 continues to read as
follows:
Authority: Sec. 7601, Pub. L. 99-272, 100 Stat. 146, as amended
by sec. 5601, Pub. L. 100-203, 101 Stat. 1330, as amended by sec.
3201, Pub. L. 101-239, 103 Stat. 2106 as amended by sec. 6101, Pub.
L. 101-508, 104 Stat. 1388 (42 U.S.C. 2213); sec. 301, Pub. L. 92-
314, 86 Stat. 222 (42 U.S.C. 2201(w)); sec. 201, 88 Stat. 1242 as
amended (42 U.S.C. 5841; sec. 2903, Pub. L. 102-486, 106 Stat. 3125
(42 U.S.C. 2214 note).
17. In Sec. 171.5, the definition of Materials License is revised
to read as follows:
Sec. 171.5 Definitions.
* * * * *
Materials License means a license, certificate, approval,
registration, or other form of permission issued or granted by the NRC
pursuant to the regulations in 10 CFR parts 30, 31 through 36, 39, 40,
61, 70, 71, and 72.
* * * * *
18. In Sec. 171.16, paragraph (d) is amended by adding a fee
category, 3. Q. to the schedule of annual fees.
Sec. 171.16 Annual fees: Material Licensees, Holders of Certificates
of Compliance, Holders of Sealed Source and Device Registrations,
Holders of Quality Assurance Program Approvals and Government Agencies
Licensed by the NRC.
* * * * *
(d) * * *
[[Page 40310]]
Schedule of Materials Annual Fees and Fees for Government Agencies
Licensed by NRC
[See footnotes at end of table]
------------------------------------------------------------------------
Category of materials license Annual fees 1,2,3
------------------------------------------------------------------------
* * * *
*
3. * * *
Q. Registration of devices generally licensed \11\N/A
pursuant to part 31.
* * * *
*
------------------------------------------------------------------------
\11\ No annual fee is charged for this category since the cost of the
general license registration program will be recovered through 10 CFR
part 170 fees.
Dated at Rockville, MD., this 19th day of July, 1999.
For the Nuclear Regulatory Commission.
J. Samuel Walker,
Acting Secretary of the Commission.
[FR Doc. 99-18981 Filed 7-23-99; 8:45 am]
BILLING CODE 7590-01-P